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Transcript of the Pesticide Program Dialogue Committee Meeting
Hilton Crystal City - Crystal Room 2399
Jefferson Davis Highway Arlington, Virginia
December 4-5, 2001

Marcia Mulkey, Director, Office of Pesticide Programs
Jay Ellenberger, Associate Director, Field & External Affairs Division, OPP
Jeff Kempter, Senior Advisor, Antimicrobial Division, OPP
Michele Wingfield, Chief, Product Science Branch, Antimicrobial Division, OPP
Arnold Layne, OPP Public Health Officer Chief, Insecticide Branch, Registration Division, OPP
Dr. Kathryn Aultman, National Institute of Allergy & Infectious Disease, NIH
Lt. Col. Richard Johnson, Research Liaison Officer, Armed Forces Pest Management Board, DOD
Keith Chanon, OPP
Lois Rossi, Director, Special Review & Reregistration Division
Kerry Leifer, Registration Division, OPP
Kathryn Boyle, Registration Division, OPP
Peter Caulkins, Associate Director, Registration Division, OPP

Dr. Jose Amador, Director, Agricultural Research & Extension Center, Texas A&M University
Dr. Steven S. Balling, Director, Agricultural Services, Del Monte Foods Corporation
Phillip R. Benedict, Director, Plant Industry, Vermont Department of Agriculture, Food & Markets
Dr. Lori A. Berger, Director of Technical Affairs, California Minor Crops Council
Daniel A. Botts, Director, Environmental and Pest Management, Florida Fruit & Vegetable Association
Dr. N. Beth Carroll, Stewardship Manager for Food, Feed & Fiber, Syngenta Crop Protection, Inc.
Larry Elworth, Executive Director, Center for Agricultural Partnerships, Inc.
Adam Goldberg, Policy Analyst for Pesticides Consumers Union
Dr. Michael Surgan, New York Attorney General's Environmental Protection Bureau
Sean Gray, Environmental Working Group
Lori Harder, Yurok Enviro Program Coordinator Yurok Tribe
Winand K. Hock, Ph.D. Professor Emeritus of Plant Pathology, Pesticide Education Program, Pennsylvania State University
Dr. Robert Holm, Executive Director, IR-4 Project, Rutgers University
Allen James, President, Responsible Industry for a Sound Environment
Allen Jennings, Director, Office of Pest Management, U.S. Department of Agriculture
Melody Kawamoto, MD Medical Officer, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention
Stephen Kellner, Senior Vice President and Corporate Secretary, Consumer Specialty Products Association
Dr. Nancy Lewis, Associate Professor, Department of Nutritional Science and Dietetics, University of Nebraska
Gary Libman, Director, Regulatory Affairs & Quality Assurance, Emerald BioAgriculture Corporation
Dr. Alan H. Lockwood, Chair, Environment Committee Physicians for Social Responsibility, Center for Positron Emission Tomography
William McCormick, III, Project Manager, The Clorox Company
Erik Nicholson, Northwest Tree Planters & Farmworkers United (PCUN)
Dr. Jennifer Sass, Natural Resources Defense Council
Patrick H. Quinn, Principal, The Accord Group
Robert Rosenberg, Director of Government Affairs National Pest Management Association, Inc.
Brad Johnson, Product Safety & Regulatory Affairs, The Procter & Gamble Company
Troy Seidle, People for the Ethical Treatment of Animals
Dr. Hasmukh Shah, Manager, Biocides Panel, American Chemistry Council
Julie Spagnoli, Director, Federal Regulatory Affairs, Bayer Corporation, Agriculture Division
John Ward, Waste, Pesticides & Toxics Division, U.S. Environmental Protection Agency
Dr. Warren Stickle, President, Chemical Producers & Distributors Association
Bill Tracy, National Cotton Council of America
Michael Kashtock, Office of Plants, Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
John C. Vickery, John Vickery Consulting
Ray McAllister, American Crop Protection Association
Edward Zuroweste, MD Medical Director, Migrant Clinician Network

Day One

December 4, 2001 PROCEEDINGS

MS. MULKEY: Well, good morning, all.

AUDIENCE: Good morning.

MS. MULKEY: I am really truly excited to have a renewed and revitalized Pesticide Program Dialogue Committee convening today, and we're going to get to know each other quickly from the evidence of closeness. If you can spread yourselves just a little bit if you want to try to ease up a little bit. We'll try to do what we can to make that -- I can tell you're not -- maximally comfortable. But you'll get to know each other better this way, right? This is an exciting new committee that -- and it may not feel that way to those of you who sat on the predecessor PPDC, but it truly is a new committee. It's newly chartered. It has quite a few new members. We have some points of view that have not been directly represented before in our group, and we have the opportunity, I think, to do business in a new and better way. We greatly valued the work of the PPDC over the last several years, and we certainly aren't feeling that we had some kind of problem on our hand that needed fixing. But on the other hand, we are excited about the opportunity to go forward with this committee in a way that is even more productive, finds even more ways to be useful to the agency, to the program, and to the people we serve. So, we look forward with a lot of excitement to this next phase of the PPDC. I know I am eager to have each of you introduce yourselves to us and to each other. But if you will indulge me and let me make just a few opening remarks that's sort of for state setting, and then what I will ask is that as you introduce yourselves, you react a little bit to some of these ideas that I've mentioned or to your -- give us a little flavor of what your perspective is, and we don't have time for everybody to do remarks on that. And, in fact, we have two places in the day -- in the two days, two additional places for us to talk about what kind of topics we're interested in, what kind of format we think works best, what kind of working approach is ideal. So, we don't need that dialogue now. But at least if, as you introduce yourself, you'll choose to give us something that sort of adds a little more than your name and your affiliation to your introduction. It can be about your vision for the committee or perhaps something else. I wanted to mention that Jim Jones, who is Deputy Director of the Pesticide Program, Pesticide for Programs, will be here late today. He would have been here for the entire time and, in fact, helped chair a couple of the topics, but for the fact that we have hearings today on the Hill about the anthrax clean-up and the pesticide program is intimately involved in that because, as you well know, we have a lot of the agency's expertise about the materials that might be used in such a clean-up. So, he will be here later this afternoon. I want to thank our fellow Federal agencies, first and foremost, the U.S. Department of Agriculture, which works with us on all the agriculture-related aspects of our work, which is, of course, a very large portion of our work. We also have FDA here. Can you help me identify all these folks? Michael for Terry Troxell. We have CDC on the phone, I believe.


MS. MULKEY: And Dr. Kawamoto here. We have our Region 5 Office, which is the lead region for pesticides at EPA. Is John at the table? I know the Division Director is in the audience. Bob. He will be here shortly. We have Colonel Johnson -- Lieutenant Colonel Johnson from DOD who's going to help us with a presentation today, and he may not be here yet either because his presentation -- oh, he's over here. Now, have I -- and Dr. Aultman from NIH, who's also going to help with a presentation today. Is that our Federal family? Have I missed anybody? I wanted to start by acknowledging those folks. We do have a few -- only a few of our members who were unable to be here today, Steve Kellner, Carolyn Brickey, Bill McCormick and Dr. Wang (phonetic), some or all of them are on the phone. So, when we do introductions, we'll ask them to mention it. This forum is very, very important to us. It is important in part because each of you represents a specific interest or group of interests which we need to hear from. So, you are all here because of your affiliations and your points of view. But our work is very broad and so is the range of specific interest and points of view represented here. There will be some topics for which each of you really have no special interest that derives from your affiliation or your point of view. There will be some topics relating, for example, to agriculture pesticides where some of you who work in the antimicrobial world will not probably have much stake, and vice versa. And so, we also have the opportunity for some of you to weigh in on topics where you are literally a well-informed citizen on the topic rather than a stakeholder. And we will get a lot of value from that, we believe, as well as from the situation where you have -- and we need to hear from the perspective of the organization or the folks that you're chosen frankly, because you are a representative of. We also will have topics where there will be a group of -- some subgroup of this group that has a special interest, but that your interests are very divergent from each other with regard to that topic. That's also a matter of great value to us, not only because we need balance and a multitude of perspectives, but because you have an opportunity here from each other around those kinds of topics, and understand not only the other voices we are hearing, but another point of view with regard to the matters that you come to the table for. So, we are interested in finding ways to tap into all these variables. We believe we have generally been pretty good at hearing directly from each of you about your point of view on a matter in which you have a stake. We want to get better at engaging your work and your perspective on all issues, including those in which you may not have a stake, and we want to get better at working on these synergies within an issue from multiple points of view and the opportunity for you to affect, inform, perhaps even influence, each other.I need to mention that -- something that most of you know, which is that there is another important advisory committee engaged with the Pesticide Program, the Committee to Advise on Reassessment and Transition, the CARAT Advisory Committee. It is chaired at a very senior level within EPA and USDA. It is a joint committee with USDA, and it is focused primarily on FQPA, tolerance reassessment, the food use pesticides, and even within that, the ones -- both the pesticides and the crops where the FQPA implications are significant. That committee has a lot of work to do. It has done a lot of work with its predecessors. It has active workgroups now and it is planning a full meeting in the winter. I'm still saying the date. I don't know, Al, if you have any feeling that we can say something more specific, but --

MR. JENNINGS: Late February, I think we're hoping for.

MS. MULKEY: Okay. But, in any event, before too much longer, probably before this group is able to meet again, in any event. So, we will, of course, need to have that committee's jurisdiction understood. We will not want to duplicate its work, and we are not designed with the right -- necessarily all the right stakeholders for that set of topics. So, while we won't be so rigid that we cannot discuss something that might also be of interest to them, and, in fact, we have an update on tolerance reassessment on the agenda today so you folks can hear about that from us, we do not anticipate trying to duplicate the subject matter or the jurisdiction, if you will, of that committee. We also are mindful that as interesting as we think we have made today's agenda and tomorrow's, and we hope you go away feeling that it was time well spent, that there are topics that you have identified that are of potentially compelling interest which did not -- were not included in this first agenda. And we have, as I said, two different places later today and also tomorrow, for us to talk together about topics as well as other things having to do with the working of this committee. And we have asked some of you -- we've asked Dan and Larry to talk about worker risk assessment and their vision about how we might engage on that topic through this committee, John Vickery to talk about pesticide management plans, especially the issue of groundwater management at the state level or interacting between state and federal level, as a topic that he had suggested we might want to put some energies into going forward. And Bob Palmer (phonetic) has graciously agreed to help us frame a way of talking about the challenges and issues involved in the use of bio-pesticides in pest control systems. So, those are three topics that we've actually asked some of you to help us focus a little bit on how we might talk about them. But you should all be thinking in terms of those two sessions and issues that you want to have us at least identify for some possibility of talking about. I also wanted to talk a little bit about ways to enhance the operational working of this committee. We have had feedback in the past from a number of you that you would like to see this committee deliver more product, feel more like it has depth and breadth in terms of the tackling of the issues, and that you'd like more sense that your work is really useful to us, and that resonates with us. And we are very open to a range of ideas about format, approach, techniques and so forth. We have made some very modest steps in planning for this meeting to try to enhance its usefulness. One thing is we're going to ask some of our staff to chair some of the sessions, so it's not just me chairing. So, at least a person who is directly involved in the issue is also engaged in some of the chairing. And we would like your thoughts about whether some of you ought to chair any of the sessions or whether there's something involving the chair function that we ought to modify in some way.We are working so that, at least, when we do some of our presentations, we will pose some questions that we ask you to react to as part of the way you react, so that you get some sense of where we would most value input by reference to these questions. And we're working toward whether we can do that ahead of time, whether that would be a useful technique. And we're going to experiment, I think, as soon as this meeting, with having, at least for certain topics, an open invitation for you to supplement your input to us for a period after the meeting closes by e-mail response or something like that so that you're not limited to the window of time that you're able to speak publicly in this meeting, but that you have sort of a structured way around the meeting to give us more input. We are mindful that you're also interested and we're interested in talking about the role of workgroups, subgroups, pre-sort of prep information, either from us or from each other, and a number of other techniques that might make it a more workable and more effective committee. So, we look forward to a dialogue on that. Finally, I want to mention just very briefly some things about the Advisory Committee Act, which is what we convene under. It's been around a while. It's been around about the same time as the environment laws, most of them, 1972. FIFRA, of course, is the great granddaddy of the environmental laws. It's pretty broad. It doesn't have a lot of requirements, but there are some that really matter. All the meetings must be open to the public and everything must be in public, and it needs to be balanced with a diversity of viewpoints, and we certainly think we have that. They have to be chartered, and we have a charter and you got a copy of the charter. Anybody can make statements to the public docket, so it's -- there's no -- every voice can be heard. And we always have public comment, which we limit in terms of time, but not in terms of who, among the public, can be heard. So, I'm really excited. I think we have an opportunity to really work through a good agenda. I want us to stay on time, and so I started by leaving only 10 minutes for the introductions, which won't be enough. Nevertheless, we do want to hear just a little bit from each of you. There will be other opportunities, but give us a flavor of who you are and not just your name and affiliation, a little flavor, we'll start it out, Al.

MR. JENNINGS: Department of Agriculture. I'm Director of the Office of Pest Management Policy. We help EPA. (Laughter).

DR. ZUROWESTE: I'm Ed Zuroweste. I'm a family physician. I'm the Medical Director of the Migrant Clinicians' Network, which is based out of Austin, Texas. We're a grassroots organization of clinicians who take care of migrant seasonal farm workers, who are obviously very interested in pesticides.

MS. MULKEY: Thank you.

MR. SEIDLE: Good morning. I'm Troy Seidle. I'm a Research Associate with People for the Ethical Treatment of Animals. This is my first meeting, and I'm very pleased to be here. Our interest is in dealing with EPA on various issues, particularly animal testing and the reduction of animal testing. And pesticides is, obviously, a priority area for us.


DR. HOCK: I'm Win Hock. I'm Professor Emeritus at Penn State University, Plant Pathology, and I was Director of the Pesticide Education Program for 27 years there. So, I'm interested very much in education, training for all applicators, make them as efficient and responsible as possible. And one area that, unfortunately, tragically, but as a result of 9/11, we're really concerned about bio-security, chemical security of pesticides more so than ever before. So, that's a key topic for the organization I represent, and that's AAPSE, American Association of Pesticide Safety Educators.

MR. ROSENBERG: My name is Bob Rosenberg. I'm the Director of Government Affairs for the National Pest Management Association, which is the national trade association, which represents -- we're proud to say -- 6,000 companies that do what used to be called structural pest control, pest control operators, which we now call pest management professionals, except that the acronym PMP some people read as pimp. (Laughter).

MR. ROSENBERG: So, we're rethinking our decision on that. (Laughter).

MR. KASHTOCK: I'm Mike Kashtock. I'm with the Food and Drug Administration, Center for Food Safety, and I'm representing our Office Director, Terry Troxell, who is not going to be able to be here at this meeting. FDA has a role to play in a lot of the significant pesticide issues, ranging from starlink to tolerance reassessment. So, we look forward to participating and learning a lot while we're here.

DR. KAWAMOTO: I'm Melody Kawamoto. I'm a Medical Officer for CDC, National Institute for Occupational Safety and Health. I've been interested in pesticides since I was quite young because I grew up in an agricultural area. But I found that in occupational health, I've encountered pesticides throughout my career, both in agricultural, ornamental, as well as structural uses, or a lot of times mis-use of pesticides. So, I'm very interested in the -- in how workers get affected by this.

MR. JOHNSON: Good morning. I'm Brad Johnson. I work with Procter & Gamble in Cincinnati, and I'm a Regulatory Affairs Manager dealing mainly with antimicrobial submissions, and we're getting involved in PPDC hoping to bring a toxicology and microbiology perspective to the discussions here at the table. Thank you.

MR. NICHOLSON: Good morning. My name is Erik Nicholson. I'm here representing PCUN, which is the Spanish acronym for Northwest Tree Planters & Farmworkers United. We're Oregon's farmworker and tree planter union. We're the largest Latino organization in the State of Oregon. I've been coordinating the union's pesticide work for my 11 years with the union. We're particularly concerned about, obviously, the impact of pesticides on farmworkers, and most particularly, on farmworker children.

MR. VICKERY: Good morning. My name is John Vickery. I'm just representing myself as an independent consultant, and just one current project is I'm helping to develop a Minnesota Pesticide Resource Center, an information gateway for pesticide and pest management information for the State of Minnesota. But it's not a state entity owned, it's a collaborative effort.

DR. LOCKWOOD: Good morning. I'm Alan Lockwood. I'm a new member of the committee. I'm a Professor of Neurology at the University of Buffalo and I'm currently chair of the Environment and Health Committee for Physicians for Social Responsibility. PSR is interested in the health and environmental effects of pesticide exposure, and I'm hoping that there will be, at least, some opportunity to discuss proposed use of humans as test subjects in pesticide safety testing.

MR. BENEDICT: Good morning. I'm Phil Benedict with the Vermont Department of Agriculture. I think I'm representing State Lead Agency's Pesticide Programs. I guess my interest still, and has been for a long time, is pesticide management. In the States, we try to -- the pesticide programs are pretty much together in one agency. At the Federal level, they seem to be more dispersed, which from a State perspective creates some problems occasionally. I'd like to see more focus on management of the pesticides instead of looking at registration versus enforcement versus groundwater versus on and on and on. Thanks.

MS. HARDER: Good morning. I'm Lori Harder. I work for the Yurok Tribe Environmental Program, and I've been elected here by the Tribal Pesticide Program Council to represent tribal interests.

MR. QUINN: I'm Pat Quinn. I'm with the Accord Group, which is a government relations consulting firm here in town, and we work with a variety of clients on pesticide policy. I'm also an alumnus of both the Department of Agriculture and the Environmental Protection Agency, and a chance to renew acquaintances with people like Dan Botts and Larry, who I knew seems like a lifetime ago in the fresh fruit and vegetable industry, and more recently have focused on antimicrobial policy.

MR. JAMES: Allen James, President of the Responsible Industry for a Sound Environment. We're a trade association that represents the interests of specialty pesticides predominantly used in urban areas.

MR. McALLISTER: I'm Ray McAllister, Vice President for Science and Regulatory Affairs with the American Crop Protection Association. I'm sitting in for Jay Vroom today. By the end of the month, we'll become CropLife America, another name change. We represent the manufacturers and formulators of the agricultural pesticides used to protect crops.

DR. STICKLE: My name is Warren Stickle. I'm President of the Chemical Producers and Distributors Association. We're a group of about 95 companies that manufactures, formulates and distributes largely generic pesticide products, lawn and garden products, copper products, adjuvants, and inerts.

MR. ELLENBERGER: Good morning. I'm Jay Ellenberger with EPA's Office of Pesticide Programs. I'm the Associate Director of the Field and External Affairs Division. Besides responsibilities of helping Ann Lindsay, who many of you know, oversee that Division and its communication regulatory field programs, in the last three months I've been tagged as having some lead responsibility within the program for pesticide security and preparedness issues.

MR. KEANEY: My name is Kevin Keaney. I'm the Branch Chief for Certification and Worker Protection in the Office of Pesticides in the Field and External Affairs Division. We implement the worker protection regulation and the regulation and program for certifying and training pesticide applicators, and we also have an aggressive initiative to raise the awareness in the health care provider networks about the implications of workers working with and around pesticides.

MR. KEMPTER: I'm Jeff Kempter, Antimicrobials Division, Senior Advisor, and I have the luck of working on anthrax issues. (Laughter).

MS. WINGFIELD: Good morning. I'm Michele Wingfield, Chief of the Product Science Branch in the Antimicrobials Division. I've been in the Antimicrobials Group since 1993 where I've watched them evolve from a branch into a division. The Product Science Branch is responsible for reviewing and evaluating the end use product specific data, particularly acute tox, product chemistry and product performance or efficacy.

DR. SURGAN: I'm Michael Surgan from the New York State Attorney General's Office. Our office is involved in a wide variety of law enforcement activities related to pesticides and also initiatives for public education, public outreach, and I'm sitting here today as a representative of Becky Goldberg from Environmental Defense.

MS. SPAGNOLI: My name is Julie Spagnoli with Bayer Corporation. I'm the Director of Federal Regulatory Affairs. I think Bayer Corporation's probably better known right now as the manufacturer of Cipro than we are of our pesticide products. But, obviously, as a health care company, also the manufacturer of Bayer Aspirin, public health and health care are important to our company. We make a wide range of products that are regulated by OPP. Biocides, public health pesticides for mosquito control, animal health products, structural pest control products, as well as our crop protection products. So, a number of the issues that this committee will address will be of importance to my company, and I hope to bring -- what I look for is that we can look for solutions that will work in the best interests of all the stakeholders.

DR. AMADOR: Good morning. My name is Jose Amador. I'm Director of the Texas A&M Research and Extension Center in Weslaco, Texas, the extreme part of Texas right next to the Mexican border. I'm particularly interested in the pesticide legislation and the implementation of pesticide legislation and the impact that it has on producers in that part of the state. We are a diversified agricultural area with field crops and fruit crops, citrus and others, and many vegetables, and I'm particularly interested in the amount of crops and amount of uses. We have a very intense (inaudible) program at our center in which we try to get chemicals to growers that grow things like dills and cilantro and crops that you've probably never heard of, a very small acreage. I'm also particularly interested and have worked with EPA before on the training of farmworkers. We have a large concentration of Spanish-speaking farmworkers in South Texas, and it's always been my interest to get the proper information and the proper training on the use of pesticides, particularly on the relationship between the farmworkers and employers, which are the farmers, which have to work, also.

DR. SASS: Good morning. My name is Jennifer Sass. I'm a Senior Scientist with the Natural Resources Defense Council. I'm new to the NRDC and new to this meeting. This is my first time here. I'm primarily trained as a lab scientist. I'm a molecular biologist, developmental biologist, neurobiologist and toxicologist, and our interest with NRDC is the safe use of pesticides.

MR. LIBMAN: Good morning. My name is Gary Libman. I'm Director of Regulatory and Quality Assurance for Emerald BioAgriculture, and I'm here today representing the BPIA, which is a bio-pesticide industry alliance, a new organization which has just been formed about a year ago, to make people more aware of the bio-pesticides and how important they are and to weed out some of the snake oils from our industry.

MR. TRACY: Good morning. I'm Bill Tracy. I'm a family farmer from California, which I happen -- as you, got up at 4:00 on our biological time to make this meeting. (Laughter).

MR. TRACY: I'm a grower member of the National Cotton Council. My charge for my family ranch is employee safety, injury/illness prevention program, and I look forward to working with you folks, and it's a pleasure to be reappointed to this committee.

MR. GRAY: Good morning. I'm Sean Gray from Environmental Working Group. We're responsible for a series of reports looking at the safety of pesticides with respect to human interaction in various ways, specifically children and pregnant women and (inaudible) committee.

MR. HOLM: Good morning. I'm Bob Holm, the Executive Director of the IR-4 program at Rutgers University, and I'm a new member and pleased to be with this group. We have the charge of providing pest control solutions for minor crop growers in the United States, and basically, as Jose mentioned, that's basically all the fruits and vegetables and other crops that are grown in the United States, about $40 billion worth of produce every year.We're charged with -- and our mission, really the last four or five years, is to develop reduced risk and safer chemistries and we partnered with the EPA in that manner and we think we've made a lot of progress. I'm particularly interested in forwarding and promoting the use of reduced risk chemistries and biologicals, and Marcia and I talked at the recent NAFTA Bio-Pesticide Registration Workshop that we sponsored, and we really think there's some opportunities for expanded use of bio-pesticides in agriculture and are looking at ways that we might promote those uses.

DR. LEWIS: Good morning. I'm Nancy Lewis from the University of Nebraska in the nutrition field, and I'm most interested in bio-technology, especially bio-technology education for nutrition professionals.

MR. GOLDBERG: Good morning. I'm Adam Goldberg with Consumers Union, the non-profit publisher of Consumer Reports Magazine. Our primary interest is FQPA implementation and reducing risk for children.

DR. BERGER: Good morning. My name is Lori Berger and I'm with the California Minor Crops Council. I get asked a lot of times what is a minor crop, and a minor crop basically is a specialty crop. These are all the things that are good to eat; peaches, plums, nectarines, strawberries, et cetera. (Laughter).

DR. BERGER: The Minor Crops Council represents about 17 grower groups in California. We're very interested in integrated pest management and transitioning to reduced risk for the sake of dietary concerns and worker protection, and I'm a first-time PPDC member and very glad to be here.

DR. BALLING: You may regret that. (Laughter).

DR. BALLING: My name is Steve Balling. I'm Director of Agricultural Services for Del Monte Foods. We're the ones that put those minor crops in cans and sell something like eight billion of them a year. I'm also the chair of the National Food Processors Association Crop Protection Committee, and therefore, supposedly am representing all processors. They may not think so, but . . . We -- our goal is certainly to provide the safest possible pest management programs to our growers and to our own folks in the field so that we can produce cans with minimal residues in the safest possible environmental situations.

MR. ELWORTH: I'm Larry Elworth. I'm Executive Director of the Center for Agricultural Partnerships. We're a non-profit organization that is working to create new ways to solve problems in agriculture that -- by helping farmers adopt more profitable and environmentally sound practices. I've been on the committee for a while. I, along with Pat, nail down the political hack wing of the committee -- the former political hack wing of the committee. I'm glad to see a lot of new members. I'm interested to see that we've raised the issue of human testing and of animal testing in the same committee already. It will be an interesting discussion. And, also, just to hint to you new members, from painful personal experience, I would recommend you move the microphone away from you when you're not talking. (Laughter).

MR. BOTTS: Dan Botts. I'm Division Director for the Environmental and Pest Management Division of Florida Fruit and Vegetable Association, which is a voluntary membership organization that represents about 95 percent of the fresh fruit and vegetable production coming out of the State of Florida. In addition to fruits and vegetables, we also represent the tropical fruit industry side production to some degree, and also sugar cane, and anybody who's willing to pay a voluntary commodity assessment to pay for me to spend most of my time being an unpaid consultant to EPA. (Laughter).

MR. BOTTS: I have been on this committee since its inception and the government shut-down, which prevented us from having our first series of meetings in 1995, I think it was, along with, I think, every other advisory committee that EPA has ever constituted. My main job is to be a professional equal opportunity cynic, to keep everybody in this process honest so my growers have tools that will allow them to produce the crops that they grow, that the American public enjoys, through a regulatory program that's based on real issues and risks that need to be identified and dealt with. It's been a long run, and I often question why an aquatic ecologist, vertebrate zoologist ever ended up in the position I'm in. (Laughter).

DR. SHAH: I'm Has Shah. I'm with the American Chemistry Council. I'm the Manager of the Biocides Panel. My interest is antimicrobials use.

MS. MULKEY: And the folks on the phone? And we'll come back to Margie. Folks on the phone.

MR. McCORMICK: I'm Bill McCormick with the Clorox Company. We make both antimicrobial products and insecticide products. I'm a returning member of PPDC and am encouraged by the -- I probably had broad spectrum before. This sends it into a whole new era. And, Marcia, I want to echo your thoughts that I'm really hoping that this round is more indepth of the PPDC members and that we participate in a full manner in assisting EPA in their programs.

MR. KELLNER: I'm Steve Kellner, Senior Vice President of the Chemical Specialty Products Association. We represent the antimicrobial test management products, non-agricultural products, if you will, home and garden products for consumer, industrial and institutional uses. And we, of course, are interested in working with the agency and members of this committee to arrive at mutual solutions to mutual problems. Thank you.

MS. MULKEY: Anybody else on the phone? (No response.)

MS. MULKEY: Did somebody just arrive?

DR. CARROLL: Yes. Beth Carroll with Syngenta.

MS. MULKEY: Thank you. And Margie Fehrenbach is the most important person in the room because she's the one who can shut us down if we misbehave. (Laughter).

MS. MULKEY: She's the designated Federal officer for the Advisory Committee among other vital roles. You want to say a quick hello?

MS. FEHRENBACH: Well, hello, and I am also a Special Assistant to Marcia. But they all know me, electronically and personally. (Laughter).

MS. MULKEY: All right. Well, it is -- I knew some -- you know, I knew the names of all the members and the affiliations, but it really is exciting to hear you go around and you do have a sense of what an incredibly rich textured group we have here. That -- we'll have to work extra hard to be sure that we take advantage of all this high-powered talent. And it's interesting to see how much strong science expertise we also have. This is not a science committee. We won't be posing the kind of questions we pose to our Scientific Advisory Panel, but the committee will undoubtedly benefit from the depth of professional expertise. Some of you didn't mention your professional expertise, but I know that there are others, who didn't mention it, who have advanced degrees in fields directly related to this as well. So, it's an extremely well-educated committee, among other things. So, it's time, I think, to plunge into our agenda, which starts with -- my inability to find it -- some issues that would not have been on this agenda if we were meeting this time last year. They are issues that clearly are defined by the dramatic changes in national life in this country following 9/11. Now, the -- I suppose it's possible that the anthrax problem would have surfaced like the Unabomber did, or something like that, that would have been independent of this really strange new world we're in. But one of the things that's interesting, foot and mouth disease, we avoid it in this country. But if we were in the UK, we would be spending a lot of time here talking about how we responded to that. So, that's when we added that to this mix of things. So, without further -- and now you've had introductions of the key players, so they can plunge right into some information, and then we'll go from there.


MR. ELLENBERGER: -- introduction. I am the Office of Pesticide Programs lead for security and preparedness issues over the last three months, since 9/11. And as you all can imagine or know from listening to the daily press reports throughout the country, there's certainly a new focus within all of government, and including EPA, on preventing any further potential terrorism and also planning for how to react to anything that might happen. We've been looking very broadly within the agency, not only in pesticides and whatever their potential threat might be, but all industrial chemicals, biological terrorism as well as nuclear threats. But it's been -- over the last few months, it's been a very concerted effort, I would say, between -- in both the public and private sectors in response to 9/11. It's certainly unprecedented, as we all know. I've worked my whole career with EPA, and I really see just an astounding amount of fresh, invigorated effort to deal with many of these issues. As you all know, there's a new Homeland Security within the Federal Government. EPA has its own committee at the very senior level, headed by Linda Fisher (phonetic), our Deputy Administrator, and includes representatives from all EPA's program offices as well as their regions. But -- and that was established, I would say, about six weeks ago. But I should say within minutes, literally minutes of the first jet hitting the first tower in Manhattan, EPA started to interact with the key leaders within the agency here at headquarters, and then within the regional offices on the East Coast deciding what kind of action would be necessary in New York City. Then, as the morning unfolded here in Washington at the Pentagon site, as well as the Pennsylvania site. Within hours of the four terrorist attacks, EPA had crews at sites starting to work with other Federal, state and local agencies and other organizations dealing with the horrific situation. Another way that EPA has been very actively involved at these sites is, for example, at the World Trade Center site. EPA worked with government agencies to collect thousands of samples, air samples, water samples, dust samples, so on and so forth, even sediment samples of the Hudson River, to look for what the contamination level might be as a result of the impact and collapse of the towers, looking for heavy metal, dioxins, asbestos, so on and so forth, to determine what sort of risks there might be to the environment and public health off the -- away from the site. But even before 9/11, EPA and other Federal agencies were very much involved in preparing for events such as that, although I think we've all seen you can never really prepare -- totally be prepared for an act of terrorism like we saw in September. But EPA is strongly involved with the National Response Team, which the agency is the lead -- the Coast Guard is the co-lead -- working with 16 other Federal agencies and industry to prepare for chemical -- major chemical spills and other kinds of disasters. EPA has also worked with other Federal agencies, like DOD, CDC and others, on the National Food Safety System, again, sort of thinking ahead and preparing for contamination of our food supply. But what I'd like to spend the next 20 minutes or so discussing with you is five broad areas that the Office of Pesticide Programs has been involved in over the last three months in dealing with this situation, and those are communications, risk identification and assessment, how we've provided technical assistance to other authorities, improving security, and, of course, as you see on your agenda, how we've been dealing with the anthrax situation, which will be described by Jeff Kempter and Michele Wingfield, sitting to my right. I think my personal experience being tagged to lead OPP's effort on security is really being forced to think outside the box. As I said, I've been with the agency for a long time and thinking, sort of, in a very linear kind of direction on many different diverse issues. But this is very twisted around thinking -- trying to think what terrorists might do relative to using pesticides or other chemicals within the United States to cause further terrorism. We needed -- a group of us within the program, including toxicologists, epidemiologists, other technical experts needed to think, how do we communicate, what do we communicate, what shouldn't we communicate, what should we take off our website. And the first few days, I think as we all experienced -- as it was unfolding, it was just a grand uncertainty about what's going to happen, how is this unfolding, how sure can we be, who we talk to and what kind of information do we communicate. Well, one of the first things that OPP did was produce a fact sheet that is in your folder. It's Pesticide Alert, Pesticide Safety and Site Security, which is a summary of an existing, more extensive agency document that was actually produced about a year ago. It deals with industrial chemical site security that was on EPA's -- that is on EPA's website and was also published and sent around to industry and others. So, we boiled that down and really focused on pesticide site security, but also dealing with sort of the cradle to grave, as I would call it, for pesticide manufacturing, transportation, wholesale and retail distribution, storage, whether it's at a farm or other kind of site and disposal, and just some very quick, I think, very good information. We sent that out to about 3,000 organizations and individuals, including all the pesticide registrants, all the organizations, and even the general public who is on our electronic list serve. We also mailed out copies of it. We also put it up on our website. I personally, along with others, met with or talked with all of the major industry associations that we deal with to make sure that they knew what we were doing, and I was pleased -- we were pleased to find out that, no surprise to any of us, that they also were working very fast to put up on their websites and to send out to all their members similar kinds of information about pesticide security. We had a very quick engagement, as I mentioned earlier, with our regional offices, industry, agricultural extension service, many of the state agencies. I know that Governor Whitman called into her office, in later September, heads of all of the major industry associations to find out sort of what they were doing, what their plans were about security and preparedness. And we were pleased to see that, again, many of the websites that trade associations have, they quickly put up information about security, ideas and suggestions that their members take heart very seriously. We also worked with extension service to get them to publish our pesticide alert or anything else that they may have put together. Doing PSAs on radio shows, TV shows, publishing articles in trade journals, so on and so forth. One of the aspects of communications that we had to do was, as I said, sort of flipping around how we think. Instead of thinking, what other information can we put on our website, we had to think, what is on our website and should any of it quickly come off. Was there any information on there that might be of benefit to a potential terrorist getting access to, particularly information that is pretty unique and that they couldn't have ready access from any other source? So, actually the -- not only OPP, but the whole agency looked at all the agencies' websites. There was a committee, which OPP played a role in, that looked and went through everything deciding what should or shouldn't stay or come off. Risk assessment and -- I should say risk identification and assessment, we were very curious, as well as the FBI that we were working with, and some of the other Federal authorities, including CDC. The question arose, well, what about pesticides? What kind of role could they play potentially in another terrorist attack? And we looked at all the pesticides, the conventional chemicals as well as even the biologicals that are registered, which might pose a risk and what kind of risk to human health and the environment? And if they could be a risk, how would they be a risk? What kind of vehicles would terrorists need to employ to make them an effective risk? Considering food safety, water contamination, particularly municipal water supplies, air contamination within large buildings or structures, so on and so forth. So, we really went through quite a task of sort of weeding out and making some decisions, trying to be very realistic about this. When we finished, we worked and communicated with the FBI. They were very interested, particularly who the manufacturers, the registrants were of some of the riskiest chemicals. So, we also communicated with some other authorities who had a key interest in that. Other offices within EPA did the same kind of task, looking at industrial chemicals. Our Water Program, for example, has been working very hard about what's the vulnerability of municipal water supplies, of private water supplies around the country. How could they be attacked and attacked in what fashion? Could they be attacked at the site of -- at sort of the water production site, or what about between there and an outsource or a -- sort of in between the whole water supply system, so on and so forth? So, there's been a lot of thinking about the what-ifs and how it could happen. As I mentioned earlier, EPA provided -- has been providing technical assistance to authorities, FBI, Department of Defense, even the Customs Service. We wanted to know for particular types of pesticides what might be imported, who's doing importing, so on and so forth. There's a lot of sharing of information about all of you who make pesticides, all of the pesticide manufacturers, where they're located, what they produce, who all of the distributors are and their addresses, where we have individual's names, like a plant manager and telephone number. A lot of that information was provided at the request of the FBI. Many of us heard, especially as all this was unfolding over the last couple of months, how crop dusters were a real concern and issue about -- because we knew that terrorists were looking into the possibility of using crop dusters in some fashion. So, having a -- personally have a role in spray drift issues and working with the National Agricultural Aviation Association, that was another aspect that OPP got involved in, working with the FBI, of, you know, what is the potential there of using crop dusters and how would they -- what kind of chemicals would they deliver? How realistic would that be of causing a particular sort of large scale, or even on just a small scale, but a terrorism kind of situation? Another issue dealing with spray drift is we got a call -- I got a call from one of the industry gentlemen that I deal with on spray drift about a model that's been co-produced by EPA and the Spray Drift Task Force registrants, and it had been publicly available on a website, and the Spray Drift Task Force individual who had been monitoring public requests for copies of it, actually got a request from someone who he had never heard of before who wanted to get a copy and asked why -- what were you going to do with it. Well, the story goes that the individual was interested in actually figuring out how much pesticide could be applied and how far it would drift to cause harm to human health. So, that kind of information went immediately to the FBI and you can be assured that the model was not provided to that individual. So, it's been a very interesting time over the last three months dealing with some very specific cases, as well as sort of thinking very broadly about this. Improving security has been, I think, a major role for small companies, medium sized, as well as large companies, as well as the agency. We've been working not only with industry, but also with the extension service and state lead agencies as they've been adding to their training programs for pesticide applicators more and more pesticide security, making them much more responsible partners in storage and disposal of pesticides. We've also, just recently, published -- and this is also in your folder -- the Executive Summary of our Clean Sweeps Report. Again, this is just the Executive Summary. The full report will be available within the next few days. It's being printed as we speak. But I sort of throw this out as -- you know, what does this have to do with security? Well, many of you know, the Clean Sweeps Program, it's a national program. It really occurs in 47 of the 50 states. It's a program to get unwanted and old pesticides out of buildings, farms, even private homes, get them disposed of properly. It's been very successful over the last 20 years. I think states have disposed of something like 23 million pounds of unwanted, old pesticides. And this is a -- I think we can look at this as a way of getting potential unwanted pesticides out of the hands of potential terrorists. So, take a look at that. It's a very interesting Executive Summary. Also, there's a relatively new organization, it's only two years old, called the National Pesticide Stewardship Alliance. I had the privilege and opportunity last week to speak at their second annual meeting in Memphis last week. That organization is made up of anybody and everybody interested in pesticide stewardship, from manufacture, transportation, use and disposal, and there was a very deep interest about security, as you can imagine. I gave a talk there about EPA's efforts. We also heard from a number of industries, large as well as medium sized pesticide companies, what they're doing. And interestingly enough, there are new industry guidance documents that have just come out and that are on the American chemistry website. These are guidance documents about site security as well as transportation security of all chemicals, not just pesticides. They look very promising, very useful, and those of you who are interested, I'd suggest you click up on to AmericanChemistry.com. You'll find those very useful guidance documents there. EPA is partnering with private industry and others to hold a number of conferences around the country on security. For example, this week in Kansas City, there's a week long -- I believe it's a week long conference on all kinds of issues, again, from manufacturing, transportation, selling and use of all kinds of chemicals, training sessions for employees, so on and so forth. That workshop, as I said, is cosponsored by EPA. And our Chemical Emergency Preparedness Prevention Office will be held, again, in Baltimore next week, Los Angeles in January. Information on that very useful conference can be found at www.2001conference.org. So, I suggest those of you who are interested in perhaps looking into that checking that out. One of the last things I would like to mention is President Bush, a few weeks ago, signed a new Executive Order called the Presidential Task Force on Citizen Preparedness in the War on Terrorism, and that established a task force which EPA is a member, obviously. But the mission of this task force is to identify, review and recommend appropriate means for which the American public can prepare for potential consequences and volunteer to assist Federal, state, local, government agencies, to prevent, prepare for and respond to any kind of possible terrorist attacks in the U.S. So, EPA, along with other Federal agencies, is thinking about how can we foster that, how can we help American citizens. What existing programs exist within communities that we could sort of tap into or provide information or assistance, so on and so forth? The last item I would like to mention -- I'm actually going to turn this over to Kevin Keeney, to my immediate right -- is some new initiatives that are being considered in the certification and training of workers and how some of those initiatives can and will increase the security of pesticides in the U.S. Kevin?

MR. KEANEY: Thank you. As much as we would like to think we have a secure chain or a secure train of control in pesticides or chemicals through manufacture or through transportation and storage, the ultimate end point in the chain is the applicator. It's the -- it can be the strongest link in a chain, it can be the first line of risk mitigation, or it can be the weak link. It can be the weak link in trying to control access to potential chemical weapons. For a while now, we, in the agency, have been looking at the regulation controlling the pesticide applicator certification program and the training of applicators. We've been working with the Department of Agriculture, with the state lead pesticide agencies, and with the state extension services to assess the program and to construct a stronger, more consistent Federal guidance package for the programs, reshape the regulation governing the programs and create consistency across the country in the way that the competency of applicators is gauged and the way that they're trained. This has become, I think, much more compelling as a result of the activities in September, and I would propose to you a number of provocative questions and urge you to consider the ultimate end point as chemicals are used. Who do you want to have access to chemicals that can be productively used, competently used, safely used, or can be turned into weapons of terror? The regulation that governs the program is an old regulation. It's not been changed since it's inception in the seventies. In assessing the program nationally and in assessing the regulation, we are of agreement, I think, with a number of the state partners we have and with the extension services about a number of things that need to be done. Unfortunately, FIFRA contains some odd artifacts from the seventies as well. Our enabling statute has some distinctions that are currently outmoded. We, through FIFRA, make distinctions between private applicators and commercial applicators, private applicators being farmers. I would suggest that our concerns should not be distinguished that way. We should have the same concern for competency and safe use of pesticides no matter who is applying the pesticide. As it exists now, there are provisions in FIFRA that specifically prohibit testing for competency of private applicators. That seems a rather bizarre, odd artifact from the early stages of the regulation. That might be some outmoded elements in FIFRA that we could have you consider and work with us on. There are also distinctions in the way that pesticides are classified into general use or restricted use. I would suggest, as well, that a distinction of occupational use and residential use might be a better classification for control, for safety's sake, for environmental safety's sake and for securities sake. There are a number of security elements in training that are appropriate, and we're working with the extension service to include them voluntarily in the training now and eventually, perhaps, through regulation, make them a specific part of the training packages that are given to applicators. Currently, there's no restriction against felons holding tickets to buy restricted use pesticides. That might be of concern. I should think it would be. Currently, there's no national provision for positive identification or photo identification. I have a commercial license in Maryland. As far as I recall, I signed who I was and gave a Social Security number. I don't think I was asked for a photo ID in taking the exam. I certainly don't have a photo ID on the Maryland ticket that I have to purchase fairly toxic substances for use. That might be something that we should consider nationally as a provision. There's very little control over sale by mail or Internet sales. That's a great concern for our enforcement office and us, as well as the states. I would ask that you consider these points, consider the basic questions; who do you want to have access to chemicals, chemicals that are useful tools, but also have the potential to be tools of terror. You can -- we can work together to create a secure system. We can create a safe system, and as I said to begin, we can create a system that is the first line of risk mitigation. We'll be bringing projects to you. We'll be bringing suggestions to you. The networks that we work with, some of you have been working with us on these projects, and when we get fuller blown proposals, we'll bring them before you. But underlying all of your concerns for safety and security should be the awareness that the end point is the applicator. The applicator is, what do you want to make a strong link in your chain of control for safety and security.

MS. MULKEY: Before we go to the anthrax, why don't we take a few minutes for some feedback and we'll keep an eye on the clock, but -- did you have some questions you wanted to pose to people, Jay?

MR. ELLENBERGER: Yeah. I'm interested in hearing from companies or organizations any things that they're doing, you know, in security, any -- for the ramped-up initiatives, and I think everybody would be interested in some of those initiatives. And then likewise, any thoughts that anyone has about other kinds of initiatives, EPA could be or should be doing to strengthen security around pesticides.

MS. MULKEY: Okay. Steve's had his card up a while.

STEVE: Jay, I was curious what you consider to be, when looking at pesticides as a tool of terrorism, the end point? What's the sort of threshold end point that you are looking at in the context of, is this an issue or not?

MR. ELLENBERGER: Well, you know, we looked at it from the standpoint of sort of the acute end point. What kind of pesticides could really cause some significant acute effects, including death, to a large number of people. But on the other hand, we didn't want to totally discount less acutely toxic pesticides, because after all, if terrorists are just looking for terrorizing, you don't need anything that's highly acutely toxic to do that. It's really just contamination, particularly in a water supply. The public mistrust now something that they take for granted is safe. So, we looked at it from all different kinds of aspects, and as I said, even though a particular chemical might pose a significant acute health threat to a large number of people, could it be really effectively delivered in a particular way, and a lot of chemicals can't because of either their physical state or some other aspects of them would sort of -- it just wouldn't work, we wouldn't think. So, we've looked through -- we also considered, sort of historical aspects of various chemicals. What's the track record of suicide attempts, of other terrorist attempts around the world with various chemicals, so on and so forth? Again, what's sort of historically popular, if you will. Taking a look at this.

UNIDENTIFIED MALE: Well, in the food industry, we've given this a lot of thought, as you might imagine, and all you have to do is look back at the cyanide in grapes incident --


UNIDENTIFIED MALE: -- or the aldicarb (phonetic) in watermelons and you begin to understand that it won't take very many of those kinds of incidents to begin to break down the credibility and the safety of the food system.


UNIDENTIFIED MALE: So, looking at very small isolated incidents that are easily recognizable as terrorism are probably the kinds of things that we need to guard against. So, please keep that in mind.

MS. MULKEY: Thank you. Larry?

MR. ELWORTH: Steve mentioned vegetables. As a child, I was concerned about the toxic effect of brussel sprouts. When you talk about what's outmoded with FIFRA, an observation is, it occurs to me that what's outmoded about FIFRA is what's outmoded about many of our attitudes and statutes after September 11th. FIFRA depends on a set of regulations that make sense, that are widely recognized as being safe and effective, and that people's willingness to obey the law is based on both protecting themselves and recognizing that protecting themselves and the people and environment around them makes sense for society as a whole. And so, I would be a little concerned about us looking really quickly at changes to FIFRA that are -- that aren't going to solve the problem for us as a society. I mean, if I were going to go cause some mayhem, I'd go get $1.13 a gallon gas and could probably cause a whole lot more problems with gasoline, Dan and I were talking. But I think it poses a dilemma for a Federal agency. About the worst thing that can happen to you as a Federal agency is for something to go wrong and they'll come up and say, Marcia, why weren't you folks looking at new regulations on pesticides. So, I don't really know how -- I haven't been that close to what people are doing in government. But it seems to me that there has to be some sort of balance between covering every conceivable avenue for mayhem and making sure you're allocating your resources in a way that doesn't skew you constantly on the side of trying to find loopholes in your existing program. So, I think it's a real dilemma and I'm not sure -- I'm not sure what we, as a committee, can offer to you in that, except some sense that one way or another the world has to go on. I mean, we still want you folks to be doing all the other stuff that's important with pesticides.

MS. MULKEY: Well, we don't mean to leave the impression that we diverted large amounts of resources to this effort. In fact, we have not. We have been working at this. But it's been a pretty modest burden, wouldn't you say, Jay?

MR. ELLENBERGER: Absolutely.


BOB: Well, I just wanted to follow on Kevin's comments. You know, I think certification and training is an important homeland security issue, but I think it's also, at least in our judgment, the premier pesticide stewardship issue, and, you know, I guess our thinking is that training is the cornerstone of any programs designed to mitigate risks and improve pesticide safety. And yet, it's been a program that's always been a little bit of a stepchild. You know, we still have a Federal statute that says the only people required to be certified are folks that supervise the application of restricted use pesticides, and even the people who apply the products themselves do not have to be trained or certified. I guess why I say all that is, you know, maybe this is ahead of where we're supposed to be, but I would love to see this committee focus its attention more on that and I just -- you know, I think it would be a worthwhile endeavor.

MS. MULKEY: There seems to be a lot of interest in that I'm picking up. Don't let me over-pick that up if I'm overrating it. Alan, I believe, was next.

DR. LOCKWOOD: Thank you. At Physicians for Social Responsibility, we're wrestling with the issue of how do you protect the environment and health in an age of terrorism. And I'm looking at the quotation by Thomas Jefferson that's on the inside page of this EPA folder here that says, "People are inherently capable of making proper judgments when they are properly informed," and would like to express a concern that we not trample on community-right-to-know principles in an attempt to restrict information that has been heretofore publicly available. I mean, we've heard reference to the methylisocyanate disaster in Bopal by Steve a few moments ago that led to enabling TRI production and the great reductions in the emissions of toxic substances that ensued. And I would express the hope of our organization that community-right-to-know principles don't get trampled in the stampede to secrecy.


BILL: Just a couple of comments. An earlier one that was mentioned was just the pesticide site security, and a question maybe for EPA. In agricultural areas, pesticide theft is a real problem. This was even before 9/11. In my younger years as an aerial applicator, the materials would be delivered the night before and just left out at a vacant airstrip and it was secure. That has progressed now to where people realize this is valuable material and running off with two five-gallon jugs could net you to the cost to the grower anywhere from $200 to $6,000, depending on the material. So, site security has grown from putting fencing -- chain link fencing around. Those folks have learned that you can use wirecutters and cut through the chain link fence, to where the majority of the growers now have sea trains, the sea-going secure vessels that you lock the material in. Thieves found out that you can use bolt cutters to cut the lock. So, growers then are to the point of putting shrouds over the hasps. Now, thieves finally bring acetylene torches out and you can cut the shroud off and get into it, although I have heard some growers are now epoxying shotgun shells inside the shroud -- (Laughter).

BILL: -- to deter the acetylene torch. But that's the problem. That leads up to my question. The few times that the thieves are apprehended, they're usually given very minimal sentences. And the thought came to my mind that maybe they are crossing some Federal laws, also, by -- when they disperse this material without a license. And possibly, we can help our district attorneys by showing them certain Federal laws that these people are opposing.

MS. MULKEY: Who are these thieves and where do they fence this material?

BILL: Well, that's a good question, too, because I think there should be -- there's somebody buying it, who aren't asking questions. In our area, we feel a lot of it's going down across the border. But we also feel that there are some unscrupulous growers who don't ask questions, who are buying materials that are worth up to $600 a gallon for probably $100. Anyway, I have a couple other points. I don't want to --

MS. MULKEY: Sure, go ahead.

BILL: We can talk about this further. I think on the aerial applicators, when they were grounded, if I read the newspaper correctly, the FBI expressed surprise at how tightly regulated the aerial applicators were and how they could be accounted for, and I think that goes back to your office a lot, Marcia, on the accountability of pesticides and being able to find out and point out where they all are located. On the question of the private and commercial applicators, there are many states now that require certification, and I believe it's a Federal law that they all do. I know all of us have to -- an EPA -- I'm carrying my worker verification card as a landowner. I --


BILL: -- because that puts the states who are being diligent at a disadvantage competitively to states who maybe aren't following the rules as closely.

MS. MULKEY: Thank you. Julie?

MS. SPAGNOLI: To answer some of Jay's question about what the chemical industry is doing, I think, of course, everybody's doing what -- kind of the things you think they would do as far as site security, limiting access to sites, inspection of vehicles entering and exiting. In fact, I know we -- at our Kansas City site, the president of the division was denied access to the site because he left his ID at home. So, he actually had to prove who he was before they would allow him access to the site. So, I think those are the things that everyone would expect would be done and I think those are being done. But as, you know, you said what the agency is doing, I think the challenge is to think outside the box and think about what are the things that we wouldn't think of and that could be done, and to that end, you know, I think the industry is working together with like the Ag Retailers Association, with the Aerial Applicators, through ACPA, has formed a task force to try to look at, and, you know, collectively share ideas and share thoughts on what are some of the maybe not so apparent things. I guess the other aspect that I would wonder if the agency is looking at, too, is some of the international aspects. I think this is a global industry. The food industry is, obviously, a global industry, and how, you know, they're working with their counterparts in like Europe and in other countries to say, you know, kind of coordinating some of these efforts as chemicals cross borders and food crosses borders and where are the areas that we might have vulnerabilities there. So, I guess that would be one of the areas I would wonder, you know, what is the agency doing on the international aspects.

MR. ELLENBERGER: Julie, just real quickly, on international, I had mentioned EPA has started working with Customs looking for imports or particular pesticides. We've also started -- I've also started working with our Canadian and Mexican government counterparts. They're obviously very interested in security issues. Same kind of issues that we've been talking about all morning. But at least from a North American perspective in the border situation, we're trying to coordinate and share information on that. So, we are reaching out.


DR. HOCK: Just a few comments about the education and training. I've been in the cooperative extension service for 27 years and am greatly involved in education and training, outreach education, and I might add that in Pennsylvania, we do certify all commercial applicators and, of course, private applicators that use RUPs. But we basically look at all pesticides pretty much the same. What I mean is, we don't necessarily distinguish that readily between RUPs and general use. When we educate our growers, we educate them to use pesticides and we ask them to respect that all pesticides have a potential for some negative impact. And if I could just address -- just make a quick comment, you know, I'm not as actually concerned maybe as some about the acute toxicity of some products. Certainly I'm concerned about it, but, you know, that would cause certainly maybe some death and destruction, which is, you know, beyond comprehension. But I'm also concerned about the environmental terrorism and psychological terrorism. The psychological terrorism, and I think about my own community in Central Pennsylvania, a lot of small water supplies. What if somebody dumped atrazine -- I'm not picking on atrazine just because it's atrazine, I want you to know. (Laughter).

DR. HOCK: I could have picked another brand name. But what happens if somebody did dump atrazine into a small community water supply? Now, that's psychological terrorism. Nobody's going to die from it, but can you imagine what it would do in disrupting the infrastructure of that small community, or for that case, of even a larger community like State College. So, I am greatly concerned about that. You mentioned about industry security, Julie, and, you know, I think that's great. But, you know, each step we take from industry security down to distribution to the dealer, to the warehouse, and finally to the farmer, that level of security goes down. I really feel that way, and seeing what some of the facilities are in my own state. So, each level, it kind of goes down. And when I look at the Chem Sweep Program that Pennsylvania's had for years, you know, they're still picking up DDT. I mean, after 25 years, they're still picking up DDT. They've been warehoused in the farmer's storage facility for that long of a period of time. So, again, I want to go back to the issue of education and training. We need some consistency. We train people, we educate people right now that use RUPs and all commercial applicators, but many states don't. Many states only do RUPs. The farmer doesn't take an exam. There's no evidence of competency. I think we need to upgrade this program to some level of consistency where across the United States we have a higher threshold, if you will. I really feel that's very important. Not to put anybody in jeopardy of their business or anything, but the bottom line is we need to upgrade the level of the competency of these applicators.

MS. MULKEY: Well, I think we have at least one topic on our agenda for further -- we'll hear from Sean and then we'll wrap this one up for now and talk about our agenda. Sean?

MR. GRAY: Yeah. I just wanted to raise a second voice of concern about the availability of public information, and that I can understand removing some information from a website. In fact, I had a recent conversation with the Office of Water on the same issue. But the appropriate information should still be available to parties that are privilege to that information, public interest groups being the first group I can think of.

MS. MULKEY: Okay. Oh, I'm sorry, Ray, I didn't see your --

MR. McALLISTER: What I have to say is quick. ACPA is holding in the next couple of weeks a security conference for our members. It's not open to the public and I think you can understand that. But we would welcome input from the agency and from other interested groups on topics we should be addressing and considering.

MS. MULKEY: Well, that's a welcome invitation, I'm sure, to -- and I'm sure Jay, if he hasn't already been in touch, he will, and maybe some of the folks represented here will take advantage of that opportunity to share their thoughts with the industry. Okay, Phil?

MR. BENEDICT: I've heard a lot about the chemicals, but I haven't heard anybody mention the delivery devices or the application equipment. Is the agency doing anything to get a handle on that? You really don't regulate that very well, in my opinion.


MR. ELLENBERGER: No, we don't regulate that to any extent. But part of our message has been not only site and transportation security, but also security of application equipment. But that's more -- I think as Win was mentioning, the further down you go, you get to the grower level, the applicator level --

MR. BENEDICT: There's a whole different group of manufacturers, though. You're not dealing with traditional chemical manufacturers when you deal with pesticide application equipment. You somehow need to, I think, need to get a handle on that. Because it's going to be the delivery device that's probably the most important factor in the end.

MR. ELLENBERGER: You're right.

MS. MULKEY: There's a whole chain of that. That's a good thought. I thought this feedback was really terrific. It was provocative, and it was not, obviously, a fulsome discussion of this topic. We didn't really allow for that. But it got us started, I think. What I suggest we do is that we use the time until 10:45 to focus on the anthrax. If we didn't take our 15-minute break, that we borrow that 15 minutes from the next topic and hopefully that will get us back. So, can you guys do a brief enough presentation that we have an opportunity for folks to give us feedback?

MR. KEMPTER: Sure. We can talk for 60 seconds or 60 minutes, whichever.

MS. MULKEY: Let's try about four minutes.

MR. KEMPTER: Okay. Well, I'm Jeff Kempter, again, Senior Advisor of the Antimicrobial Division. I'm just going to give you a brief background. I'll talk quickly to try to cram in a bunch of stuff. What started for me as a normal day on Thursday, October 25th, turned out sort of like a detective novel. I'm sitting there and I'm pecking away at my computer and everything's sort of normal, and in bursts Marsha Swindel, one of our product managers, says, hey, I've got these registrants next door and Michele's not here, and they've got this product that they say works on anthrax, and oh, by the way, they have it down on the Hill and they're about to apply and these guys need to go train those people to use it, is it okay to use it? I'm going, holy cow, what have we got here? I mean, this is an unregistered product. You normally have to have a Section 18 in place and that sort of thing. So, about an hour later, I was in Marsha's office with a bunch of people and we talked about it and we sent these folks on their merry way. And ever since then, it's been just mushrooming every day. It's just amazing the amount of time we could spend on this. Our basic role is, of course, to review the safety and efficacy of antimicrobial products or devices. And we've been doing this in two veins. First and foremost is what emergency exemptions we might need to issue, or what products we might need to review on an emergency basis to support what's going on down the Hill or where on-the-scene coordinators are having to choose products and they want our opinion about how well does this work or what -- that sort of thing. So, most of our efforts, to date, have actually been in all that vein of the emergency use, and some of you might have heard that we've issued crisis exemptions from one part of the agency to the other. That's a unique new approach. And -- for chlorine dioxide aqueous, for enviro foam and alpha chlorine dioxide gas for use only in the Hart Building at the moment, but we have others coming along. On the registration side, we have met with a number of companies who've come in with proposals and data and some of them are already registered sterilizers, for example, and they want to know how to get the anthrax claim. And we say, do the AOAC sporicidal test on bacillus anthraces, and they all look at us like, okay, who can do that. We know there's only one lab in the country that can do it, so we say, well, we're working on a surrogate, we still haven't figured that out yet, in place of bacillus anthraces and when we do figure it out, we'll let you know. So, we've got emergency exemptions, we've got registration, then we have -- I alluded to the technical support to other parts of the agency; in particular, the on-scene coordinators in the Office of Solid Waste and Emergency Response. We also have been meeting -- there's a daily meeting that we participate in, the Emergency Operations Center of (inaudible). We also are connected to the Technology Innovations Office, which has set up a vendor hotline for all folks who think they have the greatest thing since sliced bread that will work on anthrax. They call this number, (703)390-0701, and basically they give their name, product, description, da, da, da, da, and if it's anything that sounds like what we regulate, they refer those folks over to me to tell me what they've got and I ask the first question, do you have any sporicidal data, show me the money. Okay? I got to see sporicidal data or I can't talk with you really. If you want to go develop it, if you want to give us a protocol on how to test it, send that in, that's fine. But we only have time to deal with people who have data and good data. We have, at least, two dozen products we're looking at and we -- we're working on them.

MS. MULKEY: Is that two dozen different active ingredients?

MR. KEMPTER: Approximately, yes, um-hum. Or combinations.

MS. MULKEY: Right.

MR. KEMPTER: Some are combinations. And some of these involve devices that involve things that we don't ordinarily look at, ultraviolet light, ultrasound, this sort of thing. Another part of our job is coordinating extensively, not just across EPA, but with other agencies. We work with the Department of Justice on their testing of ethylene oxide to sterilize mail down at Richmond. They got some good results on that. We're working with them on that.They're also going to do some testing at the Landover facility for another product. And in all these cases, we're working with these folks, reviewing their plans, giving them recommendations and so forth. We're also plugged into the White House Office of Science, Technology and Policy, who's trying to coordinate at the mega level, across the agencies and with the U.S. Postal Service. That involves the Chief Science Advisor of each agency. In the case of EPA, that's Peter Jutrow (phonetic) who attends those meetings. So, we have quite a range of things that we're working on. We also have, I think -- I'm going to leave it to Michele to talk about the Beltsville who's doing some testing on products as well. I'll hand it over to Michele.

MS. WINGFIELD: Thank you, Jeff. I'll expand upon the anthrax comments that Jeff made a few minutes ago in just a little bit. I want to first touch upon the Foot and Mouth Disease and the activities that we've been involved with in that area. Starting in late February/early March with the increased outbreak in the U.K. and other countries, we were approached by companies and USDA about products that may be used for preventing, in the event that Foot and Mouth Disease should enter the United States, prevention products for disinfection measures. And at the time, we only had one registered product for this use. To date, we now have two registered products. But working with AFIS (phonetic), working with the Ministry of Agriculture, Fisheries and Farms, which is now DEFRA (phonetic) in the U.K., and other portions of the regulated community will now have an additional product for Foot and Mouth Disease. The difference that the agency has taken in this approach is that historically we've only reviewed efficacy data for products which have claims against pathogens specific to public health uses, human public health uses. And we decided that for Foot and Mouth Disease, that before adding any label claims with that microorganism, we would like to review the data first because of the possible economic impact of having Foot and Mouth Disease in the United States. And so, we've looked at some data and it's not -- it's not the normal testing that we would require. Being a virus, we normally do the carrier-based tests, but this virus is not conducive to being tested in that manner and so, we're looking at suspension tests. That activity somewhat came to a head and arrest by the end of August, and our activities into Foot and Mouth Disease have not increased significantly since then. September 11th came and we had activities mainly focused on the use of disinfectants in refrigerated trucks that may be used as temporary morgues in New York. And so, that was relatively easy to handle until we heard about the first inhalation anthrax case in Florida. And so, when Frank Sanders, the Division Director for Antimicrobials Office called and said, Michele, how many products do we have registered against bacillus anthraces, that was an easy answer? Zero. And to date, we still have zero products specifically registered against anthrax. The reason being, as Jeff mentioned before, that from a registration standpoint, the type of data that we're looking at is the AOAC Sporicidal Test and products simply do not have that testing right now for that label claim. We have taken the approach of looking at some of these new technologies and products for remediation efforts as opposed to registration efforts. In remediation efforts, when you have identified a contaminated site, perhaps conducted some pre-cleaning, treatment of the surface, the contaminated surface with your antimicrobial agent, followed by post-treatment sampling to determine the levels of reduction. And in this case, we're really looking for zero since no one has established a safety number re-entry after anthrax-contaminated surfaces. And so, taking all of those measures into account, you can evaluate products who have some safety and efficacy data on their merit for remediation purposes and separate that from registration purposes, not to say that we're not still considering products for registration. We are. But as Jeff mentioned before, coming up with a suitable surrogate, what's commonly used is a microorganism known as bacillus glabigia (phonetic). The Department of Defense uses this. CDC has some information on it and other units have information on it as well. We're working with these groups to get that data so that we can make a decision on whether this would be the appropriate surrogate for anthrax claims since, as also Jeff mentioned, it's not -- it's going to be very difficult, I should say -- I shouldn't say it's not. It's going to be very difficult to have that kind of testing conducted in the United States. And so, from that standpoint, we're working with groups on appropriate surrogates. We're working with groups on remediation efforts. We're working with industry on amending label claims and getting their products into the hands of remediators. We're weeding out some snake oil vendors, which a lot of have cropped up from home anthrax kits to products that can be used in the home to decontaminate suspected surfaces against anthrax. But that's just a flavor of the activities that we've been involved with thus far.

MS. MULKEY: Okay, we'll take a few minutes on this. Dan?

MR. BOTTS: Just one quick question. Looking at the efficacy testing side of this, I know if it was going to be used against Foot and Mouth, it would probably have to meet the (inaudible) for APHIS for quarantine type treatment, which is much higher than most other efficacy standards that are out there, and zero is hard to obtain in most cases, at least with any kind of scientific reliability that you've actually got zero. So, what are you using as a standard? What do you actually use as your cut-off to say you can make a claim?

MS. WINGFIELD: On the Foot and Mouth Disease, we've been following the three and four log (phonetic) reduction targets that are used by the MAF (phonetic). On the anthrax claims, again, we're not having any specific label claims for anthrax, but we're looking at the reduction numbers, and in many cases, it's about a six log reduction on many of these technologies that have been evaluated. It's not the same standard test that we would require for registration. But, again, in using the product in an overall remediation effort, I think we're comfortable that if you do have post sampling and you get those numbers down to zero, that you have a product that's useful for decontamination purposes. Not that it's a sterilant, but an appropriate decontaminate.

MS. MULKEY: Did that answer your question, Dan?

MR. BOTTS: Up to a point. I'll talk to (inaudible).

MS. MULKEY: Okay. Lori?

MS. HARDER: Tribes, especially Navajo, are really interested in the Foot and Mouth products that are hopefully coming out. Another issue that we've been discussing at the TPPC is the black mold issue and are there any fungicides or any companies that are coming with -- trying to get registration for anything to deal with this?

MS. WINGFIELD: We have had some inquiries on stockibotris (phonetic), but at this time, we don't have any, again, specific registration against the black mold. But we have had inquiries and we are looking into that as well.

MS. MULKEY: Lori, you want to take a minute to tell people why the tribes are interested in the black mold issue?

MS. HARDER: The issue has been cropping up on several tribal territories, and there have been some housing projects that had to be completely dismantled because they've had black mold. And so, it's just something that we're sending to the Tribal Science Council, as well, to deal with the issue.

MS. MULKEY: Thank you. Ray? Oh, Ray's card is left up from last time. Jennifer?

DR. SASS: I'm not sure if this is off topic or not, just a question. But in doing these different kinds of testings, are you also considering the possibility of the BSE or Mad Cow?

MS. WINGFIELD: We've had some discussions, again, on BSE. To my knowledge, there's not a lot of disinfectant-related work ongoing in BSE, simply because they really haven't fully characterized the causative agent. There's suggestions that it's apreon (phonetic), whether that's a protein basis or not, how you can effectively disinfect or sterilize against that. I think that the information is still forthcoming on BSE, but even with that one, there are no registrations specific.

MS. MULKEY: Michele, tell --

MS. WINGFIELD: I'm sorry?

MS. MULKEY: -- all of us what BSE is?

MS. WINGFIELD: Bovine spongiform encephalitis, Mad Cow Disease.

DR. SASS: But I'm wondering if it falls under the EPA to begin a food screening or testing for it since this country doesn't test for it at all, or is --

MS. MULKEY: That would be USDA, wouldn't it?

DR. SASS: I would say prior to September 11th, it was always definitely the USDA that wasn't testing for it. But I'm wondering now that you're tackling these other things, are you considering the potential for doing a screen for that?

MS. MULKEY: I don't think that would fall under our jurisdiction.

UNIDENTIFIED MALE: I'm not sure there is a test for it.

DR. SASS: Well, there is screening. There's definitely screening for it that's not being done here.

UNIDENTIFIED MALE: We've relied on regulations about feed and what can be fed and not fed.

DR. SASS: Right.

UNIDENTIFIED MALE: As a preventative. But as far as I know, there is no efficient and effective monitoring system out there.

MS. MULKEY: Larry?

MR. ELWORTH: I realize there's a hearing going on today to ask all these questions, I'll just ask a couple. What is the statutory mechanism that you're using for the -- I don't even know what the phrase is -- the decontaminants being used in Hart? I mean, do --

MR. KEMPTER: CIRCLA (phonetic).

MR. ELWORTH: Really?

MR. KEMPTER: Yeah. As I understand it, when the EPA goes in and oversees an onsite -- a site clean-up and they have an on-scene coordinator there, that that falls under CIRCLA, a national contingency plan of some sort, and I'm not a lawyer, but my understanding is under that law, those folks acting in the nation's behalf are exempt from all other laws. They do try to comply with the spirit of FIFRA and whatever, obviously, you know, try to make sure that they're using products safely that are effective, that sort of thing. And they did consult with us.

MR. ELWORTH: So, there's no registration status of the materials being used, is that right?

MS. MULKEY: Well, we have issued some Section 18s, and -- but that is to authorize the sale.


MS. MULKEY: It basically provides, if you will, legal authority for the entities that sell the materials to the response personnel rather than the use. But, obviously, they're interested in knowing that what they're dealing with is effective. And so, the same issues that we would probe for a Section 18, the on-scene coordinators need and want to know the answer to. But you asked a specific legal question. That's why you got the answer you did.

MR. ELWORTH: Yeah, no, that's -- and what was the material used in Mr. Daschell's office?

MR. KEMPTER: They have used -- my understanding is they have used both the foam and the liquid chlorine dioxide.


MR. KEMPTER: Now, that's within, as Michele mentioned, within the context of sampling to see how much anthrax is there, hepa vacuuming in grossly contaminated areas first, then use your liquid or foam. Then clean that out. Then swab and see what you've got left.

MR. ELWORTH: Um-hum. Okay, thanks.

MS. MULKEY: Okay. Jose?

MR. McCORMICK: Marcia, this is Bill McCormick. I have a question (inaudible).

MS. MULKEY: Sure, go ahead.

MR. McCORMICK: And this is strictly a program issue about mail. Could you guys address what's happening with EPA mail now? Because I understand it's all being routed through Ohio and decontaminated.

MS. MULKEY: Go ahead, Jeff, do you know?

MR. McCORMICK: Is that true?

MR. KEMPTER: That's my understanding, Bill. Jeff Kempter here.

MR. McCORMICK: (Inaudible).

MS. MULKEY: Our mailroom was --

MR. McCORMICK: We're starting to experience, you know, missing-in-action submissions with the -- people just say, well, it went to Ohio, we haven't seen it and it's taking a month. Do you guys have any idea of how long it's taking to go through that process?


MR. KEMPTER: I don't know how long it's taking right now, Bill. It certainly -- all that mail was held up since October 16th, and then about, I think, 10 days ago, they said they were running it through and then starting to send that mail back to us. So, it's starting to come in. My obvious suggestion is, if it's got stuck somewhere and it didn't get here, you better send it in by courier.

MR. McCORMICK: Yeah, that's what we've started doing.

MS. MULKEY: I don't know whether this is a -- I don't know whether this is an ongoing routing of our mail or whether it was a one-time routing.

MR. KEMPTER: My general understanding is it's a continuing process for all mail that's heading to Brentwood, which would be government kind of mail, is going through the treatment first.


UNIDENTIFIED MALE: Well, what do you mean the treatment?

MR. KEMPTER: The radiation. And then when it comes to us it gets x-rayed to make sure there aren't bomb materials in it.

MS. MULKEY: Right. EPA has long x-rayed its mail inhouse. Jose, I think you were next.

DR. AMADOR: Yeah, Marcia. One issue that came to my mind during the discussion is the issue of mold in houses and buildings, particularly schools and hospitals. This is getting to be quite a heated topic in our part of the country. The insurance companies are making everybody take extra insurance because of this issue. I read in the paper the other day that last year there were only about a couple hundred complaints. Right now, we've got about 8,000 cases that are being brought up for litigations. A lot of the things are getting involved in that, and I wonder what role EPA might play in this. I wish it would know more about what some of the recommended things are being made, you know, for the control of mold. This is getting to be quite an issue for us, and I can think that down the line, EPA will probably might be concerned about the regulation of some of the (inaudible). I think most of the thing right now is penalizing somebody for something they're doing. I don't see a lot of recommendation on how to solve the problem other than some recommendation (inaudible). But I'm pretty sure that chemicals will be recommended sooner or later because some of this mold is the same mold we deal with on plants and crops.

MS. MULKEY: I assume this is the same question that Lori -- the same black mold issue, or is this a different one? Michele, do you want to repeat what you --

DR. AMADOR: It's just a combination of different molds -- aspergiols is one or it could be classified as a black mold. This is getting to be quite a structural problem, you know, in homes, and particularly some of the schools. Some of the school districts have been sued for a tremendous amount of money for providing an environment where the kids are exposed to all different kinds of (inaudible) and things like that. This is going to be quite a problem, I think, in the future.

MS. WINGFIELD: From the standpoint of mold and mildew claims on current antimicrobial labels. It's mainly been reserved for non-public health related mold and mildew that you find in your bathroom on surfaces outside, things -- areas like that, not so much on the toxic mold issue, although as I mentioned before, we are getting additional reports on that. We are gathering additional information on appropriate products that may be used for this type of scenario. Keep in mind that for something like the toxic mold, without having identified the source of the moisture and getting rid of all of that, chemicals aren't going to be your answer in all of these scenarios. In some cases, you may have to resort to breaking down and destruction and things of that nature, that's correct.

MS. MULKEY: Gary, and then we'll -- and Allen, and then we'll try to regroup on our agenda.

MR. LIBMAN: Just a fast question to Michele. I was interested when you said bacillus glabigia, which is actually bacillus sitoes variety niger (phonetic), putting on my microbiology hat and maybe the medical side rather than the ag side, the medical device people and also the parenteral -- small and large volume parenteral manufacturer people for years have been involved with bacillus glabigia and other indicators for more -- for less stable spores, such as bacillus anthraces. Have you been dealing with the FDA at all to find out the history? Because there's a lot of history there on bacillus glabigia.

MS. WINGFIELD: Not specifically that group. Most of our discussions have been with Yusamrid (phonetic) or Dugway (phonetic) out in Utah on their specific use of glabigia and why they chose that as a surrogate in trying to gather information from them. They seem to have the motherload of that kind of information, and so, we've used them as our focal point. But that's certainly a good suggestion to take to look at different agencies. Thank you.

MS. MULKEY: And Allen.

ALLEN: Just a little further note on the mold issue. I participate on a task force that's meeting on Wednesday over at

HUD. Three primary areas have been identified that are troubling for low income and inner city housing around the country, and that is mold, pests and lead paint. So, the issue of mold is being addressed somewhat over at HUD.

MS. MULKEY: Thank you very much. Well, I think one of the things we want to do is when we come back to the next topics is what, out of this group of topics -- and certification and training certainly seems to be one of them -- is there some interest in drilling down more deeply in a more focused way? We will take a break. We will come back at 10 after and not a minute later.

(Whereupon, a brief recess was taken.)

MS. MULKEY: -- accomplish things during breaks and that the communing, if you will, that occurs during breaks is a good thing, and we don't want to discourage that. I think one of the lessons we need to learn is how much can we practically cover in these agendas because there's always time-related tension. So, when we have an opportunity to discuss the way we handle this committee, I think one of the questions in our mind is depth versus breadth in terms of subject matter. Please, if everybody will retake your seats. This next topic I think you'll find very interesting. But for anthrax and 9/11, West Nile Virus would have been a topic of a lot -- getting, I think, even more public attention. We have gone through another season. There have been, again this year, some West Nile Virus related deaths. The virus has spread to parts of the country -- I'm filling time now, you understand, to try to get everybody at the table. The virus has spread to parts of the country, and mosquito borne illnesses, in general, remain an issue of public health significance in the United States. It is an issue of profound public health significance in other parts of the world. So, it should not come as a surprise that the United States Government has been and does pay a lot of attention to this issue, and that international organizations do, as well. But we thought those of you involved in the pesticide industry might be surprised and informed to learn something about the scope of research support and interest for, among other things, chemical mosquito control. So, we put together this little program, and then hope that we'll get some feedback on it. So, Arnold Layne, who is the Office of Pesticide Programs Public Health Official -- FQPA contemplated that we have some leadership and structure around public health pesticide issues, and he's going to chair this segment. Arnold?

MR. LAYNE: Good morning. In addition to being the OPP Public Health Official, I am also Chief of the Registration Division's Insecticide Branch. It gives me great pleasure to introduce this issue and moderate this session on mosquito control research. On July 26th, 2001, OPP held a meeting in Atlanta at the Centers for Disease Control and Prevention to explore opportunities to facilitate and encourage the development of new, safer approaches to vector control and vector management. A number of government agencies participated in that meeting, including CDC, the Department of Defense, the National Institutes of Health and the IR-4 Program. There are not many chemistries available for adult mosquito control. Some of those that are available pose very challenging environmental and public health issues. As you may know, the Food Quality Protection Act provided special provisions for public health pesticides, including coordination with CDC, expedited registration of public health pesticides as defined by the statute and a requirement for CDC to create a data development program analogous to the IR-4 program at USDA, which generates data for minor use crops. Subsequent to the emergence of West Nile Virus, several agencies and states were engaged in combating mosquitos that vectored this deadly virus, and not surprisingly, spending money in the area of research, including applied research for mosquito control. The meeting that we held at CDC focused on three major points; one, being opportunity; two, awareness; and three, coordination. It offered an opportunity for good exchange of information about mosquito control research efforts among government agencies. The meeting allowed for each agency to be aware of each other's efforts, sort of letting the left hand know what the right hand is doing. And lastly, this -- what we call a good government meeting, was designed to enable all agencies involved to be better stewards of the people's money sort of with the sum being greater than the parts. Also, to bring new insecticides to the table, and lastly, to identify specific next steps for moving forward. Several follow-up possibilities were discussed at the meeting, one of which was to share some of the information presented at that meeting with Office of Pesticide Programs stakeholders, such as yourself, in a more public forum. Today, we are sharing information that we learned from the National Institutes of Health and the Department of Defense, along with information about the World Health Organization that was learned by one of our employees while on assignment at World Health Organization. As you listen to the presentations, I offer three questions for you to ponder for discussion following the presentations. The first question is, what do you think EPA's role is in further pursuing new mosquitocide technologies? The second question is, what is the registrant's role? The third question, what role might this advisory committee have in this arena? This morning, we are very pleased to have the following speakers provide a view of the ongoing efforts in their respective agencies. First up is Dr. Katherine Aultman from the National Institute of Health's National Institute of Allergy and Infectious Diseases. After Katherine's short presentation, she will be followed by a second short presentation by Lieutenant Colonel Richard Johnson of the Department of Defense's Armed Forces Pest Management Board. Lieutenant Colonel Johnson is here on behalf of Colonel Strickman (phonetic), the Chair of the Research Committee of the Armed Forces Pest Management Board. Colonel Strickman has been or will shortly be deployed to aid our country and soldiers during our current military effort. And finally, we will end the presentations with Keith Chanon of EPA's Office of Pesticide Programs, Field and External Affairs Division, who spent time working with the World Health Organization. Following Keith's presentation, we will engage in a discussion of this topic. Please hold your questions until after each of the presentations have concluded. With that, I give you Dr. Aultman.

DR. AULTMAN: Thank you very much for inviting me here and for giving me a chance to tell you what we're doing at the NIH. As Arnold said, I'm Kate Aultman from the National Institute of Allergy and Infectious Diseases. The NIH, as a whole, supports research on health and this is a graph to show you sort of in gross outline the kinds of research that we support. We support basic research. The vast majority of the research that we support is what you would call phase one, development, phase one. It's very basic laboratory characterizations of pathogens of human processes, of physiology, of the environment. We go forward from that to try and develop interventions that will improve public health, and we have tried to make sure that we have a certain degree -- these blue bars are the ideal, okay? A certain degree of very specific applied product development type of research projects. In typical clinical research, this involves clinical trials of drugs and vaccines of diagnostic reagents, et cetera. In medical etymology, until recently, we have focused almost entirely on very basic research and did not have an opportunity to pursue the more applied efforts. In response to the Food Quality Protection Act that Arnold Layne described and to other actions in the international arena, there's a Persistent Organic Pollutants Treaty that has been a great issue, and also to an increasing threat of vector borne infectious diseases in the United States, we have been pushing to add applied research in medical etymology. Toward that end, we convened a series of meetings -- actually, this is a summary of a meeting that took place in Atlantic City in connection with the American Mosquito Control Act. To identify priorities and opportunities for research you don't need to really read all of the words on here. The point is to look at the bar across the bottom. We have, in the pale blue, fundamental research. That is our stock and trade and that is what we support in the vast majority. But we also try to identify opportunities for translational research, for limited field studies and eventually for large scale field studies of actual products that will help to control vector borne infectious diseases. We convened a group of experts to advise us on opportunities and priorities, and this is just a sample of them. Across the top, insecticide resistance was a very big item in this group -- identified by this group. Behavioral ecology was identified as an important topic. Identification of new compounds and target agents or target molecules that would interview with vector biology, and also genetic manipulation of vectors. Again, we identified a series of immediate priorities that would be ready to have an impact on public health in the next one to five years. Okay? These are the near term priorities. The primary one was studies of insecticide resistance. You might have -- you might be aware of insecticide resistance that was problematic in -- in Washataw Parish, Louisiana this year, where there was an outbreak of St. Louis encephalitis, because -- putatively because of insecticide resistance, whether the general or particular factor, supposedly because of insecticide resistance, the vector control efforts failed, and there were tens of humans of cases and horse -- equine cases of SLE. No, in fact, there are people who said that it was less a problem or resistance than misapplication of existing pesticides. But this is an example of insecticide resistance being an immediate public health issue. The methods for detection of insecticide resistance are still relatively crude, and the WHO Bioassay is the gold standard. Do they die or do they not die? Insecticide management in public health vector control is a well developed art ad. There's -- there's not a great deal that we can add to it given the sparsity of tools available. But it's something, nevertheless, that we're keeping in mind. Prevention of insecticide resistance and its significance, this is the most important thing. How do we know whether it will have an impact on public health vector control efforts? This is not a given and the data that are coming in are very contradictory. In some cases, the presence of insecticide resistance traits, the ability of insects to survive supposedly lethal doses of insecticides do not impact the incidents of disease in the human population. In other cases, there's a strong and clear correlation. So, we need to really get a grip on all these aspects of resistance and we have been actively soliciting research proposals primarily from academic scientists to address these points.We have specific solicitations in process. The one that is first in the pipeline, should be out literally any day, is for the development of novel vector control tools. And here we mean that we would consider supporting research conducted by industry and academic scientists in partnership to develop and deploy near term, that is to say in the next three to five years, novel vector control approaches. And I'll talk to you more about that in a minute. Beyond that, we need to -- we believe we need to augment the field ecology, particularly of some of the rarer vectors and the less understood vectors that occur overseas. We have -- we're the NIH, you know, we support sequencing of the genomes --


DR. AULTMAN: -- increased by logs. There was a discussion this morning of log decreases. This is log increases in the amount of manipulation that's available for the drosophila (phonetic). We're hoping that we can do the same thing for anopheles gambium (phonetic), for adese egypti (phonetic), for culex pipians (phonetic), these are the major vectors of human disease. For pesticide development, for the purposes of our solicitations, we have divided it into these categories, the fundamental research on vector biology, again, we're doing that and we have -- I guess we spend about $45 million a year in about 120 different grants for people who are studying arthro pod (phonetic) vectors. Beyond that, we tried to encourage them to identify targets for intervention. These might be crucial compounds that would -- or crucial entities in the vector that would be required for that vector's survival, but they might equally be required for the vector to support development of the pathogen. So, we would be interested in studying, for example, the mid-gut receptors for plasmodium attachment and integration into the organism in malaria. Beyond that, identification of chemical entities that can interfere, we have a program of odorant binding proteins and odorant receptor research, and then trying to figure out how to go beyond that to develop attractants that might be useful as vector controlled strategies. We do not yet have, except in one small example, the studies of whole organism efficacy, this is on our view screen. The toxicity in toxicology are really not currently supported or supportable at the NIAID. And this is an issue that we're grappling with in trying to partner with the National Institute of Environmental Health Sciences and in other ways, which I'll come back to. We do have limited field testing of both efficacy and safety aspects of products and we hope, again, soon, to be able to move on to large scale field testing of new products. This is a graph that was provided to me by one of the companies that we interact with. It makes a point, which is more important than the actual numbers. The bars represent cash flow. The red are the investments by a company. The blue are the returns gained by a company. This is a hypothetical cash flow analysis for development of a new insecticide, regardless of its intended use. The line represents cumulative cash flow, and you can see that by the end of six years after a patent is issued, a company will have to have invested $40 million, according to this analysis, in the development of a new pesticide. And as the pesticide -- as the product is launched and returns are gained, then that can be recouped. The problem is that the public health pesticide market is on the same order of magnitude as the cost to develop a single pesticide. The global public health pesticide market is on the same order of magnitude. And here, there are, of course, very careful and thorough analyses of this, but it's going to be very difficult, in the normal course of events, for a company to develop a novel public health vector control strategy or product. In the NIH scheme of things, there's such a thing in the world as an orphan disease and an orphan drug. Okay? And this is both a legal definition as well as a philosophy. When a disease affects a small number of people, such a small number of people that the market is unlikely to support the development of the product, that's called an orphan disease. The product that would be useful against that disease is an orphan product, and we have specific legal permission to extend our support, that is Federal Government support for product development beyond the normal cut-offs. We have made the argument, and I'm grateful to say successfully, to these upper echelons of the NIH that public health pesticides should be considered in the same vein. That because the market is not sufficient to support development of new products, we should be able, as an NIH, to provide support further down the research and development pathway to remove some of the risks that these companies would otherwise have to bear. Typical orphan products are addressed at the NIH in these two different gross methods, by the push mechanisms where we provide public support for early R&D, and that's what I'm talking to you about today. Also, where we can provide -- the Federal Government can provide tax relief for donated licenses. There are examples of this -- you might have heard of the mektazan (phonetic) donation program where a drug is being used to wipe out river blindness, onchocerciasis (phonetic) in Africa. The drug is just donated free. There's also discussion, and here this comes back to Arnold Layne's question to you of easing the regulatory burdens. I'm not sure exactly what that means, but that would be something you all could think through. Pull mechanisms exist. Revolving funds for the purchase of drugs, vaccines, diagnostic reagents. In the case of pesticides, the PAHO, Pan American Health Organization, based here in Washington, has a revolving fund for the purchase of public health pesticides. Extended patent life, tax credits, et cetera. These are different mechanisms that could be used for orphan pesticides. This is coming back now to the specific solicitation that should be out any day. It builds on these principles. It is one specific example of these principles. It's called Partnership for the Development of Novel Vector Control Strategies, and I need to say to you that it was approved for release in August. It would have probably been in the September 11th NIH guide, that has been held back, and they're adding bioterrorism bullets. So, I'm not sure exactly what the title will be. This will be -- this will be included in the title, but there will be some -- and bioterrorism or something. We're not quite sure how we're going to straighten this out. Nevertheless, it's a solicitation that provides up to $6 million for efforts by partnerships, and that is partners of industry, academia and government. Government in the sense that we provide the funds and have an organizing and catalyzing role, but industry and academia to jointly do the work. To develop products that will be available in the short term. To cost share this product development. The first -- in the earliest versions of the solicitation, the first $500,000 would be provided by the NIH, you know, just free and clear, and any dollar beyond that would have to be matched one-to-one by the industrial partner or the academic partner, or some combination. In fact, we ran afoul of legal rules and now we say we're strongly encouraged and it's an evaluation criteria in the degree of cost sharing, but it's not an obligation. We specifically identify adulticides (phonetic), larvacides, synergists, semio-chemicals and other possible products. And because it's meant to be novel vector control, that will improve upon those products, again, that present the several environmental challenges, we wanted investigators to emphasize studies of environmental fate and effects of these compounds and these uses. Again, this should be advertised in the NIH guide for grants and contracts very soon, and we are hoping very much that industrial commercial partners will contact us to learn about how to submit an application. Two last notes. The first is that insecticides -- public health insecticides, obviously, are closely linked with agricultural uses. Because the market is not sufficient to develop public health pesticides in their own right, they're often piggybacked onto agricultural uses. But this has several implications that I just would like to put out for you to think about. The first is that the public health use is often a second use. That means that selective pressure for insecticide resistance has already been applied and the useful life may be shortened. The fact that it's a secondary use means that there are other avenues for human exposure, and so, the human exposure may already be significant in the U.S. and the risk conception of things, you may already have issues to deal with human exposure. And similarly, by definition, if it's a secondary use, there's going to be at least one other species of organism affected. So, non-target species are going to be impacted. One of the issues that we tried to think through in Atlanta was the possibility of having very narrowly specific public health pesticides, pesticides that would be active against the vectors that we care about, but not broadly effective against all arthropods or all dipterins. You know, the jury is out. There are many people who say that's clearly not possible, it's not feasible, it's technologically too difficult. There's another group who say, well, it's much too expensive, to which I say, so show me the bill. I think the value might be enough to make it worth pursuing that question. How narrowly specific can we make a public health pesticide? If not the compound which is toxic, in and of itself, then of an attractant, which will limit the impact of that insecticide or the exposure of that toxic compound to the species that we hear about. Lastly, insecticide resistance, even though public health pesticide insecticide resistant is developed to a fine art in certain specific cases, again, the onchocerciasis control program in West Africa is a shining example of how they've forestalled the impact of resistance on public health measures just for decades. It was a fabulous effort. Nevertheless, there is a great deal more known in an agricultural context than we ever have a chance to make use of. We know a very great deal about the genetic mechanisms, but the epidemiologic significance of the resistance is not well understood. And just to emphasize the importance of this point, the -- I'll give one example. In Western Africa, there's a malarious region of Cote-d'Ivoire where 95 percent of the mosquitos, the adult mosquitos survive typically lethal doses of pyrethrins. Nevertheless, pyrethrin impregnated bed nets reduce the incidence of new cases of childhood malaria by at least 80 percent over the use of bed nets, untreated nets alone. So, it's the chemical itself, not the physical barrier. And the nets alone have an improvement over sleeping without nets. So, we need to understand really what resistance means in public health terms, and we don't have a good grip. We also don't have a monitoring system and we have non-existent mitigation plans in the case of malaria, because, again, there are so few products. We convened a meeting in March of this year in Harare in Zimbabwe in connection with the Multi-Lateral Initiative on malaria, a big research -- an international research consortium. And they gave us a set of recommendations which I just -- I put out here almost as a plea for people outside the public health arena to think about how to help us in this regard. The first thing was to study the impact of resistance on the efficacy of vector control. Secondly, to collect standardized data about the development and distribution of resistance. And specifically to look at the movement of insecticide resistance traced through populations. Vector populations are often fragmented and have mating structures such that the flow of genes is not uniform throughout the population, and we don't have really a very good grip on how that impacts the development of resistance as a public health issue. The impact of agricultural uses via vector migration patterns, et cetera. Alternative vector control tools in the pipeline, I think I will stop with this one. We have large field trials underway of bacillus sphericus or recombinant bacillus sphericus to which has been added bacillus thorengensis toxins. We have limited field trials of a hormone that will affect larval development. We are supporting proof of principle leading to field trials for genetic engineering methods. And I think I will just stop there and take questions or.

LT. COL. JOHNSON: Good morning. I'd like to talk a little bit about the Department of Defense and our interest in (inaudible) control. Just to give you a little bit of background, I'm from an organization known as the Armed Forces Pest Management Board, and we provide oversight to the Department. The Board, in addition to the full-time staffers, includes participation from military and civilian pest management professionals, and we are going to keep that term, from all branches of the service. The Board also includes liaison members from the USDA, Department of Interior, EPA, CDC, other Federal agencies. The Board's mission for the Department of Defense is, as you can see, their policy guidance and information, basically overall to make sure that we try and do things better for being environmentally correct and integrating pest management into our programs. Although we do -- we're focusing on mosquito control for this talk, let me just mention that Department of Defense does own about 25 million acres of land. We've got a couple million people in uniform either full-time or as reservists. We've got hundreds of thousands of civilians that work on our installations. And so, we have a broad interest in pest management.When it comes down to, you know, the real reason for being, we look at disease outbreaks and the importance of disease in military operations, we could extend this to include military operations in Haiti and Somalia and now even Afghanistan, where vector borne diseases are very important. When we try to deal with -- on the medical etymology side of pest management for the Department of Defense, is emphasizing and promoting the personal protection measures against vector borne diseases, primarily repellents. This is, in part, due to the mobility of our operations. We may not be in a fixed facility, and so, we may not have the luxury of being able to do area-wide control. Promoting integrated pest management, when we do our operations, just sometimes it's not possible. Sometimes we need to have the quick fix because of the nature of the problem. But whenever possible, looking at the long-term problem, because a lot of times military operations start out with we're just going to be here a week and we wind up being in Bosnia for years and years and years. But we also try and cooperate with other Federal, state and local private and international agencies to achieve our goals. So, basically, what we're looking at is -- within the research realm is to develop new methods to minimize the threat from vector borne diseases. Of course, malaria is the number one disease that we're interested in, but also some of the arvo (phonetic) viruses are important, not only here in the United States on the East Coast with West Nile, but elsewhere in the world. And we're trying to influence the war fighters in complying with what we call our DOD repellant policy, and that's basically you use repellant on exposed skin, you put repellant on your uniform, you keep your sleeves down, and believe it or not, sometimes soldiers, sailors, airmen, Marines, they don't like to follow our policies. So, we try and get that in at the basic level in training. And probably as the aftermath of the Gulf War, reporting and recording and archiving pesticide use is a priority these days. We've learned a lot of lessons since the Persian Gulf. And part of the problem that we had with that is not necessarily knowing what we use because, although we have certified applicators, there is some general use pesticides available for use. So, we weren't really sure what was used over there. So, we're trying to do military operations better and know what we're using and where we're using it. And on the information side, we're also trying to make sure that we have up-to-date information on what vectors are present in an area. We do this through a regional -- what we call a disease vector ecology profile, and we focus on a region rather than just a single country, because a lot of times military operations go across borders, either intentionally or unintentionally. Military etymology research is covered under the Science and Technology Objective 1-U, as you can see there the title, identification and control of insects. It's an Army and Navy joint program. You may say, well, what about the Air Force, and I just say, well, the Air Force reaps the benefit of the Army and the Navy's work. (Laughter).

LT. COL. JOHNSON: There are basically four Army research laboratories that have medical etymologists on their staff. The major one is the Walter Reed Army Institute of Research now located in Silver Spring, Maryland on the Walter Reed Army Medical Center Annex. Of course, Fort Dietrick has gotten a lot of press these days and USAMRD (phonetic) is located there. They do have (inaudible) network with arvo viruses in particular. The Army Medical Research Unit in Kenya, located in Nairobi on the grounds of the Kenya Medical Research Institute, and lastly, the Armed Forces Research Institute of Medical Sciences, which is actually a Thai organization which has a U.S. Army medical component to it. The research unit in Kenya basically acts -- in addition to the medical etymologists that are stationed there, it also acts as a base of operations for stateside researchers that want to put their stuff to use and see if it really works. Thailand's similar. A little bit larger organization, but again, with field sites spread out in Nepal, Cambodia, throughout Thailand, to work on a variety of the tropical diseases that are present. The Navy has three labs that -- for working. You see that they're all overseas labs. Basically, they rely on USAMRD (phonetic) and RARE (phonetic) for stateside operations for medical etymology research. But they do their own research and then can act as a base of support for field testing. First, we have coordination and collaboration with a variety for sources. Of course, EPA. CHPPM (phonetic) is the Army Center for Health Promotion and Preventive Medicine. The USDA, we've had a long-standing relationship with the USDA starting -- well, not starting, but kicking off during World War II with the development of Deet (phonetic), and that was the origin of my position as research liaison is working with the USDA. The Smithsonian, various universities, we send military officers back to school. We have universities collaborating with our researchers. CDC we work with closely and have increased the collaboration with CDC in the last couple years with West Nile. And of course, we have industrial partners with whom we've formed (inaudible) and the small business initiatives. Basically, our product development folks are at USAMRD and they're also located at Fort Dietrick. One of the products that -- the systems that we've come up with is a series of products, the Dengi (phonetic) Vector Control System. We've been working on this for about five years now. It has an information component, surveillance monitoring, modeling, population and then also a control aspect. Within the military, one of the things we also have to be concerned with is the amount of expertise that we'll be using a particular product or particular information. We may have a PhD trained etymologist onsite, but we also may have just an enlisted soldier who has some preventative medicine training, been trained on application techniques, certified -- DOD certified for application. So, we have kind of a broad range of people that we're maybe dealing with. With the Dengi (phonetic) System, we're working on basically being able to identify any vector anywhere. You know, with the movement of (inaudible) or claratotis mosquitos around the world, we have to be able to know when a particular vector is in a new area. With the USDA lab, we've developed computer modeling for Dengi problems. We're working on surveillance for adults, control for larvae and adults and to include a (inaudible) trap, and integrating personal protective measures into the whole system. Repellents are a big program for research within the DOD. For years, we just used the 76 percent or so technical Deets for repellant. We found that that was a great plasticizer. One of the pluses for that is it made camouflage face paint go on very smoothly. It was almost like painting. When we went with the extended duration Deets, which last longer but is -- has some cosmetic problems. We figured we need to find a way to meet our operation -- military operational needs along with our personal protection measures, and so we have developed a face paint that comes in different colors so they can have the typical soldier-in-the-field with camouflage exposed skin, but it would be protected with Deet. You can see that we're continually looking for new active ingredients, again, with the USDA Lab in Beltsville, chemicals affecting insect behavior, finding new -- trying to find new ingredients, also working with Bayer to find new things, also looking at things that are on the shelf, racemers (phonetic) and others, things we know about, we just may not have pursued, and then also looking for a new clothing repellant from Ethran (phonetic). New insecticides, I keep mentioning that $40 million which is -- if it was a new tank, we'd say, go for it. But when it comes to insecticides -- (Laughter).

LT. COL. JOHNSON: -- DOD is not willing to put in that $40 million. So, we basically rely on industry. So, new insecticides are not a priority within our program. We look for targets of opportunity, though. You know, if somebody's using a new compound or a current compound in new ways, we're willing to, you know, benefit from their use, and also looking at DNA-based insecticides similar to if you know the genome, can you find something that works better? One aspect that we've been fairly successful in the last couple of years is identifying pathogens in the insects, and basically giving you a real-time answer to, do we have to worry about malaria or another disease in the area. It's one thing to have a vector in an area, it's another thing to have to pull out all stops to find out, do we need to protect the service members from the disease that that vector could transmit. With (inaudible) we've developed this vec test which, you know, you can determine if a particular mosquito or a pool of mosquitos is infected with any of the malaria. It comes out with four strips. It depends on, you know, which malaria species will show up where. We have wicking assays for Dengi virus, developed through USAMRD, also tested in Thailand. West Nile Virus was a big push in the last couple months and seems to work out very well and they've worked this out for field testing both with CDC and also the State of New York this last summer. Again, it gives you a real-time answer. You can know in minutes as opposed to sending a pool of mosquitos off somewhere and finding out days later. This can give you an answer in just a few minutes. St. Louis encephalitis is another thing. These are all kind of based on the same principles, so it's been fairly easy to come up -- I shouldn't say fairly easy to come up because nothing's that easy. But they're all based on the same principle, so it's kind of an additive effect for being able to determine other arvo viruses. We also work with systematics and identification. We have a team of taxonists (phonetic) that are located in the Smithsonian Museum Support Center down in Suitland, Maryland that curates the mosquito collection for the National Museum of Natural History. They've been there for years. They work on basic and applied taxonomic and systematic studies. Basically, if a mosquito is sent to the Smithsonian for identification, the Walter Reed Bio Systematic Unit is the one that would actually do the identification. They are working on interactive keys. They have had interactive keys for mosquitos. They are -- they're working on basically having the best library collection of systematic articles, and you can see their website there. It's a very extensive website for accessing journals, such as Mosquito Systematics, which most of us don't really care about, but taxonomists do. And, of course, we are working on other studies, both operationally and what we consider real research, for the most part, doing risk assessment. If we deploy to an area, do we have to worry about malaria all over the area, do we have to worry about malaria in a specific area? What are the key characteristics of where we would have a bivouac area? We do -- without overseas labs, we do just basic disease surveillance, what diseases are common in the area, what are emerging diseases, what diseases seem to be disappearing. Research with associations of vectors and pathogens, you know, what -- are there ways that we can modify the pathogens? And again, we're not doing genetic modification, but we're more interested in finding out -- working with other people that are. And just basically doing basic work on pathogens. All the labels include a lot more than just medical etymologists. In fact, there are very few in the organization such as the RARE. And that concludes my presentation.

MR. CHANON: Good morning, thank you. Last year, I had the fortunate opportunity to work at the World Health Organization in Geneva, specifically to initiate and coordinate their activities for assisting countries and reducing reliance on the use of DDT for malaria control. And while there, I also worked closely with WHO's program, Pesticide Evaluation Scheme Program, which is their program to coordinate the testing and evaluation of new pesticides for public health use. Some people call this WHOPES, others WHOPES. It's been around for 40 odd years, and WHO is very good with the use of acronyms. So, you can use whichever you prefer. What this program does is evaluates specifically the safety, efficacy, cost effectiveness and acceptability of public health pesticides. So, not only does it rely on laboratory studies, but they go out into the field and conduct small, medium and large scale field studies. And that's really the only way to assess whether or not a pesticide is acceptable in a community and can be used in the developing country context. In addition to this review process, WHO establishes international guidelines for the use of pesticides, as well as for the equipment, the applicator spraying equipment and publishes specifications and analytical methods for assuring the quality control of these pesticides. And this slide just gives you an idea of the wide range of collaborators that WHO works with in conducting these tests and evaluation procedures. Just about on every continent, there's a research institute or other organization. And here, just to give you an idea of the types of products that are under review by WHO, and it involves all sorts of pesticides, including larvacides, insect repellents, mosquito net treatments and the application equipment itself. Now, under the umbrella of the WHOPES Program, there's an advisory committee. Again, a mouthful, but it's the Global Collaboration for Development of Pesticides for Public Health, and this group is comprised of industry, government, international organizations, as well as research and research institutions. And they get together to provide recommendations to WHO to coordinate the testing and the development of alternatives and to also make recommendations on the safe use of pesticides. They also contribute to a trust fund that is managed by WHO, which is then used to support the testing activities. And in the course of last year, at the advice of this committee, WHO has met with some of the major pesticide manufacturers in order to assess the new chemistries that are being developed and whether or not they can be applied in the public health setting. So, that should result in an inventory of applicable pesticides. Also, they're soliciting proposals from industry for the development of alternative mosquito sites and are now working very closely with the Gates Malaria Program at the London School of Tropical Medicine and promoting further research and development. Now, aside from these global sort of testing and evaluation procedures, I wanted to just give you a quick overview of a real-life successful case study, and this is looking at Mexico and its use of alternatives that go much beyond the use of chemicals, but also non-chemical alternatives. And resulting from NAFTA and its Environmental Side Agreement, the three countries, Canada, Mexico and the U.S. identified a number of priority pollutants that pose risks, environmental and human health risks to the region. And they agreed to -- they agreed to develop a North American Regional Action Plan to phase out DDT. And at that time, Mexico committed to reducing its reliance on DDT by 80 percent by the year 2002. And this was in 1997 and Mexico was one of the top three producers and users of Mexico -- of DDT worldwide, and at that time was using 430 tons of DDT. Well, not only have they met this target, but they've actually exceeded the goal by completely eliminating the use of DDT last year, and they did that by employing a number of alternatives, such as greatly strengthening their epidemiological and surveillance and treatment programs. They've targeted the use of pyrethroids for indoor residual house spraying, and they've worked closely with communities in actually eliminating breeding sites. So, the community, itself, is cleaning up streams and rivers, taking out the algae, for which the larvae feed on. And, you know, they're using geographic information systems, rapid diagnosis techniques and ultra low volume spraying equipment. So, these are all strategies that were developed in Mexico and which they've been able to successfully employ. So, not only do you have the global research activities, but we see on the regional and national level that a number of activities can be taken, looking at pesticides and non-pesticide alternatives, to effectively control a very important disease. Thank you.

MS. MULKEY: Thank you. Let me do a little bit about the timetable. I know everybody is beginning to think about lunch. Why don't we take about 10 minutes now, and if there's an interest when we come back, can all of you be here after lunch for a little while? If that's a difficultly, we'll still -- we'll get the feedback and feed it to you after lunch as well. Why don't we take about 10 minutes now and then another 15 or so after lunch. Arnold's going to try to --

MR. LAYNE: Moderate this.

MS. MULKEY: -- moderate this.

MR. LAYNE: Angelina, I think you --

ANGELINA: I wanted to make various comments on efforts to identify new chemistries or to use older chemistries, specifically, the timelines that were originally presented by Dr. Aultman. I would consider those, from my experience many years in discovery, as being extremely optimistic. I mean, the patent that would be identified maybe could possibly be a use patent or something of that sort, a new formulation. But actual discovery of new chemistries would add years and millions and millions of dollars on to that estimate, up to even 70, 80 million to do a typical discovery research program.The incentives for that issue, as all of the speakers pointed out, not only do you not want to undertake them yourselves, but there's very little incentives for industry to do such a thing. You know, most of the discovery programs are targeted towards the economically important pests, the major crops, things along those lines, and for dipter (phonetic) only compounds, it's unlikely that they would proceed very far in development. So, in order to, I think, compensate people for the investments they would have to put into identifying a new chemistry, I think you need to think in terms of more liberal use of patents, such as what they've done perhaps in pharmaceutical industry, extending the life of patents to provide greater economic viability for an incentive to make these investments, because you know over time there's the likelihood that you would get them back through an extended life exclusive use of these products. So, I think you should think along those lines of seeking those types of solutions to the problems. Secondly, as far as the screening program, the WHO undertakes, I don't know a lot about it. I know in the past there have been a lot of joint industry government agencies type screening programs towards targeted chemistry. You may be able to solicit the support of private industry to look in their archives to do some type of targeted screening around older chemistries that, perhaps, didn't get very far in development because the economic incentives weren't there, but they may either provide new leads or may even, of themselves, be suitable to take into some type of development. So, those are just comments that I would add to what you said.

MR. LAYNE: Thank you very much. I think, Julie, you were next.

MS. SPAGNOLI: I'll actually ask my second question first because it kind of leads on to what Angelina said. You know, I think the graph that they showed with the corporate cash flow and the development of a new hypothetical -- or hypothetical new insecticide, how it goes down and then it goes up, I think what we're also seeing in the area with products and public health uses is that after a point that line starts going back down again, where there are costs associated with maintaining products, and as uses are lost, that agricultural uses are dropped or other uses are dropped, that it gets harder and harder to support the defense or to maintain a registration of products. So, I think some of these orphan products where perhaps -- and I know in the case of one of our products, the public health use is the only registered use of that product, and the economics make it very difficult to continue to support it in light of new data requirements and on other requirements that are put on that product. So, I think that's just, you know, another consideration that was put in and it was actually put in to FQPA, with consideration for CDC to perhaps support and fund the continued registration of products that do not otherwise -- you know, would not otherwise be economically viable. But I think, to date, no money has actually be appropriated to do so. So, I think that's an area, from CDC's standpoint, where maybe they need to look more closely at it. The second question I have is with regard to the use of -- the bed net use specifically, the use of pyrethroids in bed nets, and I think we do have a product that is used for treatment of bed nets, and I think where the products have shown their effectiveness is actually as a repellant. Even though they may not be lethal to the mosquitos, they do have a repellent effect that has been shown to be very effective. Where, I think, the agency needs to maybe look at some policy with regard to such uses is where there could be funding or support, like through USAID, to help provide these products to people who would not otherwise be able to afford them, and this is particularly in sub-Saharan Africa. But one of the issues that we have confronted was that in order for USAID to provide that funding, they wanted the product to be U.S. registered. Now, to register a product in the U.S. for a use that it would not ever be used in the U.S. kind of poses some problems, because it's -- again, the economics aren't necessarily there to support the registration in the U.S. for something that would never be used in the U.S. But in order to allow that important public health use, you know, to combat, you know, where malaria -- I think there are a million people a year dying of malaria. So, I think if the agency maybe wants to look in the area of could they develop maybe a registration policy for products that are exclusively for public health uses outside the U.S.

MR. LAYNE: Thank you very much, Julie. Dr. Carroll?

DR. CARROLL: I just wanted to echo what Julie and Angelina have said about the costs from the standpoint of development. And I wanted to ask Dr. Aultman if that was a post-FQPA slide or if it was pre, and that may account for some of the differences, even though pre actually probably would have been -- it was '96?

UNIDENTIFIED MALE: No, I'm telling her what --

DR. AULTMAN: He's telling me when the FQPA was --

DR. CARROLL: Oh, sorry.

DR. AULTMAN: That slide was provided to me by a company with which I have signed a confidentiality agreement, but had gotten specific permission to show that slide. And I can't tell you for sure. He just showed me, hypothetically, roughly this is how much it costs. So, I'm sorry I can't tell you.

DR. CARROLL: Can we provide you with some additional information on the costs? (Laughter).




DR. CARROLL: -- the alternative program in Mexico. I guess I'm curious as to what the statistics are or were for Mexico, what -- how many people there get malaria, what percentage of those people die? Have the statistics changed? What I'm leading to is, are you suggesting that this program will -- is adaptable to other areas of the globe? And then the second part to that is, if pyrethroids are the sole thing being used in homes, what sort of resistance management are you looking at?

MR. CHANON: Actually, I do have a couple statistics. I'm looking at in '97, in Mexico, there were 17,000 malaria cases. Now they have -- I think they've only had two deaths in the last decade because of the -- the vector is not -- the main vector is not life threatening in Mexico. And now, in 2001, they've only had 235 cases. But -- and there are so many factors involved in terms of climate, weather, flooding, hurricanes, that that really affects that trend. And in terms of the adaptability of Mexico's program to other regions, I mean, I think it's very important to look at the -- Mexico's program because, whereas maybe some of the specific interventions may not function in other climates or other geographical areas where there are different vectors, but still, the approaches, the risk management approaches, the surveillance approaches that they use and some equipment that's being used can certainly be assessed and possibly adapted in other parts of the world. But you really have to look carefully at the vector dynamics and, you know, a range of just the capacities in other countries. They did switch to primarily delta methrine (phonetic) and they're trying to -- they've targeted their spraying, but in terms of resistance management, I -- my guess is that the pyrethroids are being used in agriculture as well and that, in a few years from now, you may have severe resistance problems. They are -- that's why Mexico really is putting most of its efforts in the health services area to rapidly diagnose and treat the problems and to get to -- and to control the breeding grounds, which they can do in Mexico, which may not be as applicable in some countries in Africa. But, yeah, I think it's a lesson that can be shared with other countries.

MR. LAYNE: Thank you. Gary?

MR. LIBMAN: One of the places where the system actually works, certainly in the United States, but also globally, is on the microbial side. Dr. Anderson's division has helped our situation where we can get something through the system a lot quicker. And you talked about the River of Blindness, the BTI certainly has, you know, really done its job as a biological larvacide for those products. Bacillus sphericus, as well, too. So, those numbers that you showed up there can be reduced if you have a reduced risk type of a pesticide. That does help the situation.

UNIDENTIFIED MALE: The Food Quality Protection Act also provides for expedited review and registration of public health pesticides, and it actually cuts across three of the divisions within the program that have registration responsibilities. The Registration Division is our pesticides and pollution prevention, and Antimicrobials Division.

MR. LAYNE: Dr. Alan Lockwood?

DR. LOCKWOOD: A quick two-part question for Lieutenant Colonel Johnson. I wonder what you can tell us about Department of Defense policies with regard to the use of non-registered pesticides and drugs for purposes that are not FDA-approved by the military. I'm thinking of -- and how has this been affected by the events of 9/11? I'm thinking specifically of the ruckus that was created at the time of the Gulf War by the military policy for using mestinon, which is a drug that we use in neurology for treating myostheniagravis (phonetic) to allegedly confer protection against nerve agents. There were lawsuits and quite a lot of dispute about that.

LT. COL. JOHNSON: I can talk to the issue as far as the pesticide use. It's the DOD's policy that we will only use EPA-registered pesticides. Now, when you deploy to a foreign area and if EPA-registered pesticides are not available, then there is a procedure whereby we can evaluate what is there and what is available for us. As far as the whole PB tabs and that -- that's a medical issue that I can't deal with. You know, that's echelons above reality for me. But for pesticides, we only use DOD -- we only use EPA-registered compounds.

MR. LAYNE: Okay, we've gone about 15 minutes over. I think there are about three more questions.

MS. MULKEY: Why don't we try to take these three.

MR. LAYNE: Okay. Dan, I think you were up next.

MR. BOTTS: You might regret doing that, Arnold, because this is a multi-part question for several different people. (Laughter).

MR. BOTTS: One of the hats I wear is Technical Committee Chairman, Minor Crop Farmer Alliance, which the mosquito control and public health people have been members of since its creation back in 1990, when we first started trying to get FQPA, in different forms, passed as a minor crops title, specifically dealing with minor use pesticides. To make a long story short -- most of these questions are for Kate -- one of the issues within the provisions of the law was building a structure within some entity, whether it was CDC or National Institutes of Health or wherever, we didn't care, to do the type of thing that the presentation that you presented to the agency was designed to do somewhere to what IR-4 does for minor use pesticides. I applaud your efforts. The first question is, how was your presentation received by CDC and National Institutes of Health, and how are they going to move forward with soliciting funding for these programs? It sounds like you've got some fairly significant dollars to start doing some of this type of work. We are extremely concerned, though, if it's all targeted at new products, rather than the expansion of existing products or support for existing labeled products, which is probably more important than going out there trying to find something that's five to seven to ten years down the road in a pipeline, to go to Julie's comment and Angelina's comment on the cost of maintaining registration for products that are already registered. How are you all looking at that process to integrate into your search for new active ingredients? And then I've got a question for you.

DR. AULTMAN: Okay, let's think. We were alerted to the passage of the Food Quality Protection Act when, actually, several groups came to visit us. And at the time, in those discussions, the issue was -- if I can frame it in NIH terms -- to immediately divert resources to support existing compounds, compounds that were registered, which is analogous, in our case, to doing licensed drugs, support for post-licensing data collection on drugs or vaccines. We have both logistics and procedural issues against doing anything on a dime, which we've now broken, much to everyone's amazement, after September 11th, and we also have sort of reserve -- not reservations -- I don't know quite the right word to say -- about continuing the use of existing compounds. We think that that's a regulatory issue that we don't exactly have the background to have a strong opinion about. Nevertheless, from 1998, when I first heard of this until now, we have done what the NIH always does. We have gotten input from experts, as far as we can find them, to identify research priorities, put them in a big pot and stirred them together and gotten another group of experts to start to rank the research opportunities into priorities and public health pesticides have risen to the top -- you know, have risen up to the fundable group, to the top -- enough to be funded. This without earmarks. There's also a budgetary phenomenon that we grappled with in 1998. That -- in many agencies, there are earmarks where the appropriation language comes along and says, you must do this and you must do this and you must do that. We're very fortunate at the NIH in not having many of those. We take absolutely seriously the intent of Congress. We work closely with our appropriations and authorization committees. We have got language in our -- both appropriation and authorization language from 2001 that direct us to pay attention to public health pesticides, which I'm very grateful for. And we are trying to take that seriously. We don't have an earmark. We are never going to go and ask for an earmark. That's just not -- that's just not going to happen. I think it took huge huztpa for me to stand up at the NIH Advisory Council and say, I really want you to put money in chemical pesticides. You know, it's the National Institutes of Health, they kind of rolled their eyes and looked at me. But to ask them to also ask for an earmark for it is just not going to happen. The issue of the best way to spend -- the best way to invest our effort and our energy and our enthusiasm and our dollars in intervening in vector control for public health, I think, is one that's continually revisited and comments are always -- it's always possible to write to me. It's also always possible to comment on some of the documents that are on our website. The report that I -- whose summary table I showed you is on the website. It's also possible to intervene at the Advisory Council level. The vast majority of the research that we support is investigator initiated. That means that a scientist sends an application for support and it goes to a review committee and he has to persuade the reviewers that it's worthwhile doing and possible to do. So, it's both -- there are points of intervention for you at the programmatic level where we describe general areas of interest, public health pesticides, and at the individual project level by submitting an application, and we are now reaching out to companies, in particular, to get them to submit applications. In the partnership's RFA, to have a new use of an existing compound is completely possible and, in fact, encouraged, because this partnership is meant to be effective over the short term. But it would be a new use of an existing compound, maybe something that was useful against boll weevils that could be used against mosquitos. I'm making a trivial example.

MR. LAYNE: Dan, you had one other question for Marcia.

MR. BOTTS: A quick question for Marcia, which actually dovetails on Dr. Aultman's last comment. How is the agency helping to expedite that process? Are you all providing any kind of direct supported guidance other than Arnold being overworked and underpaid to do what he does to screen these applications and push these buttons, and what can be done to overcome a reluctance of a company in having something go out as an adulticide. And I'm primarily focusing on adulticides because of their broad distribution and spectrum, especially use in urban areas and some other things where the collateral damage associated with the use of that product, even though it might be the most efficacious and least risky compound in the world for that use, oftentimes creates other issues around the product's good name or bad name or whatever thing it has.

MS. MULKEY: Well, we have -- I mean, maybe that would be -- if we're going to talk about (inaudible) that would be a good one for that, because I -- and, in fact, I'd like to find some time, if not in this session, to have a good dialogue that includes the companies around that very topic. To date, I would say our primary role has been the bully pulpit role. Every time I meet with these companies they'll tell you I say, well, all right, let's talk about your insecticide technology and what are its prospects for mosquito control. It's been more of that kind of thing than anything systematic. But with that really short answer, now, we are trying to be a good resource to Kate and their organization so that they have the benefit of what we know. But you were asking, what are we doing to encourage companies to enter this market, in effect, I think is essentially the thrust of what you were asking.

MR. BOTTS: Well, I've heard you've got a real good arm twisting mechanism coming out of your office -- (Laughter).

MS. MULKEY: Well, now, if you know about that, maybe you can tell me about this arm twisting mechanism. I haven't discovered it to carry huge amounts of clout. But we have been -- I've personally been using the bully pulpit, as well as others, and we can talk about that a little more. I think that would be a good topic. But I do want to -- we are going to have to -- we have now really transcended our lunch. Larry, can yours wait till after lunch, too?

MR. ELWORTH: Certainly.

MS. MULKEY: All right.

MR. LAYNE: We've got Warren.

MS. MULKEY: Oh, and, Warren, can yours wait till after lunch, too?


MS. MULKEY: All right, very good. Let's do that. Let's reconvene -- we're scheduled to reconvene at 1:15. Let's really aim for that. We can do that, if we eat lunch in this area, and can put us back at least on track with a little bit more time for this topic. (Whereupon, a luncheon recess was taken.)


MS. MULKEY: All right, greetings. We will get started. I want to make a few prepare-you remarks, and hopefully, as your colleagues come in, somebody will tell you a few things. One is that Dr. Aultman and Colonel Johnson both had to leave, as did Arnold. Nevertheless, we will, as I'll keep my promise, to wrap up that topic a little bit further. And to the extent that that topic, like the first one, prompted your sense that there's some subset of it or related topic that you want a more thorough -- that we can revisit that this afternoon in the discussion regarding priority issues. Then we will move to a status report on a number of key developments. I said to somebody over lunch, can you believe that we completed the preliminary cumulative risk assessments for the organophosphates yesterday and we are meeting today and we haven't even talked about it yet.

UNIDENTIFIED MALE: That's just because we're polite.

MS. MULKEY: Believe me, if things had gone a less chaotic path by route -- I mean, a more chaotic path by route to that, we would have talked about little else this morning no matter what the agenda had said. So, I think it really is a good sign that there's a good bit of order in the universe. But we do have an update on that. As I mentioned earlier, this is really not the Advisory Committee focused on that subset of issues, so we didn't plan for a significant discussion of those issues, but we did want to give this committee the benefit of the latest news on tolerance reassessment. We'll do that after we do the finish of this -- of the topic we just concluded. The inerts disclosure topic, although it has two hours is, in fact -- in that is a break, plus it is a topic which will need that or more because you have had a workgroup that has been working that for a very long time. So, that -- there is no slack in the afternoon schedule at all. One of the lessons I've already learned is we're too ambitious about the number of topics that we can cover and have meaningful discussion on. And so, again, when we get to the discussion, I want to learn from you, how do we manage that. I mean, you will undoubtedly have felt there are many topics we didn't get to in this day and a half that you would like us to have, and yet, also be frustrated about the scope of our ability to discuss any of the topics we got to. I am trying to stall a little bit. (Laughter).

MS. MULKEY: But I'm about to stop that and take any further discussion of the topic relating to research efforts and mosquito control. Okay, Dan?

MR. BOTTS: I didn't get to ask my last question.

MS. MULKEY: Okay, fair enough.

MR. BOTTS: Well, actually, the last two questions. One was directed to Kate and that was the bacillus sphericus. That was actually developed by Lee County Mosquito Control. They've been using it since 1976. Why is it still identified as a new product in the pipeline registration, when it's already registered? And on the world (inaudible) you have methoprene and two or three other products that were also listed, but relaying the questions back to the other group. The other question --

MS. MULKEY: Okay. We will relay these questions, absolutely.

MR. BOTTS: The other, not necessarily question, but comment -- and I wish some of the registrant group was here, but it's my understanding in those collaborative efforts in looking at what happened with some of the drug models relative to intellectual property rights and ability to maintain control over products. What happens when they get into some of these international consortiums for developing products, especially if it's a brand new active ingredient, on retaining the ability to control their fate with those products? And I don't -- probably Keith, if he's here, or you could bring that up with Julie.

MS. MULKEY: Well, Julie's here. I don't know if you have any expertise on this subject.

MR. BOTTS: I mean, intellectual property rights is a big issue.

MS. MULKEY: Is Keith still here?


MS. MULKEY: Can you speak to that issue at all?

MR. CHANON: No, not really.

MS. MULKEY: Okay. (Laughter).

MS. SPAGNOLI: Actually, I think a lot of these development efforts tend to be cooperative efforts. So, I think that the company or the manufacturer would probably -- to enter into any kind of cooperative development effort would have to want to do that. You know, I don't know any specific case -- I don't know of any specific case where development went on that the company was not involved with or not in favor of. I'm not -- I don't know of any. Now, there could be. I mean, I'm just not aware of any.

MS. MULKEY: When we got the presentation at CDC, both Kate's presentation and the military presentation involved the development of some or the anticipated development of something that would have value to the corporate participant and they were, in both those instances, able to retain whatever rights they would otherwise have, whether it was patent protection or trademark or anything like that. So, I do know that the fact that it's developed cooperative with government does not necessarily destroy intellectual property. And I know you were asking a more complex question than that, but --

MR. BOTTS: Well, it's my understanding that we have patent law in this country which -- and you have to have -- the patent starts when you go in for the initial request that goes in. But it's my understanding in the international community that once (inaudible) or anything else relative to that use goes in, that's when the clock starts whether you've got an official patent or not, and there's some issues relative to term of patent life and protection for intellectual property in those regards. And I just --

MS. MULKEY: I'm sure you're right, there are some intellectual property issues that are drivers in this. All right, anything else on that topic before we move on? Larry?

MR. ELWORTH: Well, it was -- my initial question was for Kate. I ended up being kind of dissatisfied -- not dissatisfied, but feel like there's still some -- there's something lacking in the response, I think, more from the HHS side than from EPA's side, on implementing the provisions of FQPA on public health pesticides. I mean, I understand they have a research program that they're running through NIH, but I kind of interpret the law as asking HHS to do something rather a bit more extensive. And I know you folks work on registration issues, but I don't see the kind of effort that I remember us envisioning when the language was put together, and maybe it involves somebody in addition to Kate, or maybe we need to kind of -- I'd like to follow up more than we had a chance to do.

MS. MULKEY: Dr. Wang, are you on the phone still? (No response.)

MS. MULKEY: Apparently not. We do have a memorandum of understanding between us and CDC that details all the various ways in which we collaborate. I'd say the other most significant joint activity is the consultation process for each registration, reregistration involves the public health pesticides. And they have been actively involved in that.

MR. ELWORTH: Um-hum, um-hum.

MS. MULKEY: But there are other elements to that, so we could -- Arnold could give you a little more detail about the involvement of CDC.

MR. ELWORTH: Well, if the issue is that HHS really needs to pay some attention to this, then if there's a way to get somebody from HHS to kind of understand, maybe this committee can demonstrate that it's something besides a few folks at EPA who are having kind of like a crabby day or something, that there's actually -- that there are some people who believe that these provisions were intended to accomplish something broader than a research program, just into new uses.

MS. MULKEY: Well, we -- Dr. Wang, who is on Dr. Dick Jackson's staff, is actually actively participating in this committee, and he was on the phone this morning, and apparently, he's not back on right now.

MR. ELWORTH: Can we key this up for some further discussion then?

MS. MULKEY: Sure, sure. Why don't you bring it up for the afternoon topic?

MR. ELWORTH: Well, maybe at a subsequent meeting even.

MS. MULKEY: Well, the afternoon topic is about subsequent meetings. That's what I meant.



BOB: Just one question. I guess the discussion this morning seemed to be principally mosquitos.

MS. MULKEY: Um-hum.

BOB: And I guess the question is, does that reflect a determination that only mosquitos really qualify as public health pesticides?

MS. MULKEY: No, it does not reflect that determination.

BOB: Okay.

MS. MULKEY: And, in fact, when we gathered at CDC, we deliberately titled our discussion as vector control. We did not spend much time on any vectors other than mosquitos, that's true. But there -- it's not anything other than a focus on where most of the interest has been. Okay, very good. All right. Well, Lois Rossi, many of you know from her many public appearances to talk about these topics this afternoon. But like the rest of us, she's not been with this committee for some time because this committee has not been active for some time, and there are a lot of new members. She wasn't here this morning to meet all of you because she was with Steve Johnson, who was doing, I think, a press technical availability briefing relating to the release of the preliminary cumulative risk assessment which occurred -- which briefing occurred at 11:00 this morning. So, Lois can, not only, give us the same kind of information that occurred there and some more, but give us a flavor of what happened there, as well. So, thanks, Lois.

MS. ROSSI: Okay, great. Well, as always, I am very pleased to present the status of the Reregistration Program and the Tolerance Reassessment Program. I mean that sincerely. For those older members of this committee, I know they've heard this many, many, many times. So, I'm going to cover three topics in the time that we have today. I'm going to talk about the reregistration status, the program, our outputs for the fiscal year 2001 and 2002, the status of the Tolerance Reassessment Program and where we are in meeting our goal for the 66 percent for August 3, 2002, and lastly, I'm going to talk about the cumulative risk assessment for the organophosphates that is being sent on to the web as we speak, and will pretty much be giving you many of the same remarks that Steve Johnson did at the press briefing just a couple hours ago. But first of all, with regard to reregistration and our outputs for 2001, as of September 30th, we completed 14 decisions for that fiscal year. We had three REDs on -- three full reregistration eligibility decision documents on benomyl, ethion and propargite. We had some interim reregistration eligibility documents on the organophosphates, acephate, chlorpyrifos, ethoprop, methidathion, pirimiphosmethyl and terbufos. And we had five tolerance reassessment decisions, which we abbreviate -- we call TREDs, which were butylate, chlorpyrifos-methyl, oxadixyl, phosalone and trichlorfon. And these either will be on the web or are on the web already as our 2001 outputs. We have a fact sheet and we've updated the progress that we've made. For this year so far, we have issued an interim reregistration eligibility document on azinphos-methyl and also on phosmet, and I would say within the next week or two, we will be issuing one on naled, three -- again, three organophosphates. With regard to the organophosphates, we have 12 more organophosphate decisions to go. And that is on our web page, a sheet that gives which phases the organophosphates are in, which ones still remain, and there are 12 left to go, including naled. The hand-out that's in front of you does give you our candidates for tolerance reassessment for this year. But before we talk about tolerance reassessment and the counts there and our progress towards the goal, so far with regard to reregistration, we're up to 207 reregistration eligibility decision documents. We have 174 more to go. And one thing that is to be noted is none of the organophosphate decisions are counted yet because they're only interim, awaiting the cumulative tolerance reassessment decision. So, that's where we are with regard to just the reregistration program. With regard to the tolerance reassessment, our goal is 9,721, 9,721 tolerances as of August 3rd, 1996, when FQPA was enacted. That's the number that we have to reassess. Right now, we have reassessed 3,832, and we have to meet our 66 percent goal, again, by August 3rd, of which the organophosphates factor in excess of 1,000 tolerances into that count. But this sheet that you all had coming back from lunch in front of you, with the columns across, basically is the work plan to meeting that goal. There are some listed on here -- for example, I know ones that are going to cause immediate attention and concern is atrazine, and atrazine does not have to be counted towards the goal, but we are actively working on atrazine this year. But the majority of these chemicals need to be -- the tolerances need to be reassessed in order for us to make the 6,416, which is 66 percent of the total. So, those are all the numbers that are involved in our progress towards meeting our mandated goals under FQPA, as well as carrying out the reregistration process under FIFRA. So, that's where we basically are on those two programs. Now, I'd like to talk mostly about the cumulative risk assessment, which is a major milestone for our program today. And with me at the table is Margaret Stasikowski who's the Division Director for the Health Effects Division, who really deserves all of the credit for getting this unbelievable task done today. Margaret and her staff have been working 24/7 for quite a long time now, and it's a remarkable step for our program. It's also a major step towards EPA's ability to evaluate the safety of pesticides. The assessment is one of the most complex and sophisticated risk assessments ever conducted by EPA. It required the development of many ground-breaking scientific techniques and collection of development of extensive actual data on pesticide use and residues. Why did we do this? The background, as far as a little background for those of you on FQPA. FQFQPA required the agency to conduct both an aggregate risk of pesticides, which is exposure from food, water and residential sources, and cumulative risks, which is the exposure to multiple pesticides that are thought to have a common mechanism of toxicity, before determining if you could reassess one of those 9,721 tolerances. The requirement to consider cumulative risks involved first determining which pesticides acted in the same way in the human body and, therefore, should be considered together, and then estimating the likelihood that individuals would actually be concurrently exposed to multiple different chemicals in this group. Two basic things. First, you've got to figure out if there's a common mechanism group and then you got to figure out probabilities of this all happening. And clearly in 1996, we didn't have the tools to do either one of those actually. What was emphasized this morning by Steve Johnson in his press briefing was, while this type of assessment adds to our knowledge about pesticide exposure, he repeated several times during the course of the hour that the United States has the safest, most abundant food supply in the world, and EPA continues to emphasize the importance of eating a varied diet rich in fruits and vegetables. That was throughout his remarks. The methods which were developed to perform the assessment are new, and therefore, we are not ready to draw firm conclusions about the pesticides in this initial evaluation. It is a preliminary evaluation, a preliminary risk assessment. For those of you who are familiar with the process that we've been using throughout the organophosphates' individual reassessment, you know that we begin a public comment period called phase three, and we issue a preliminary risk assessment. While the preliminary risk assessments have gotten more refined as we've gone through the process over the years, we still are calling them preliminary assessments, and this is a preliminary assessment. It begins a comment period which will end on or around March 8th, and during this comment period, we welcome comment on the methodologies, on the like assumptions, on the data used, on the assessment techniques on this. We have already had quite a bit of public participation in this process in that we've been working with a CARAT subgroup, the Committee to Advise on the Reassessment and Transition, which Al Jennings and myself chair. And they have been working on the process of -- the public process related to the whole cumulative risk assessment. In August, we shared -- well, I'll get to that in a minute, the public process. Let me just spend a few seconds or a few minutes on that. This whole assessment that is being released today is a major milestone, not only on the methodology, but in our ability to meet the requirements of FQPA. In my report to you all on the tolerance reassessment progress, we have said all along, as we've been working on reassessing tolerances over the last few years, we've put an extreme amount of resources into reassessing organophosphates, knowing that those tolerances would not be completely able to be called reassessed until cumulative was done. So, having this methodology and having it right now in early December, when our deadline is August 2002, is extremely important in order for us to allow a lot of comment and review, as well as be able to make the decisions to meet that deadline. And this is where our resources have been put in over the last few years, into the organophosphates, and we have always said repeatedly that it's necessary to reassess those 13-odd hundred tolerances to meet that 66 percent goal. The -- this piece of work that's being issued today represents about five years of intensive work. We have, all along, been making individual chemical risk management decisions, which have considered the aggregate risk. We've completed -- as I said, we've completed all but 12 of the organophosphates, and even in those 12, major decisions have already been announced and taken on diazinon and methyl parathion. But we still have to go back and write the reregistration eligibility decision document and look at, obviously, worker risk and eco risk. But we have had significant risk exposure and risk reduction as a result of many of these OP decisions. Our work began in 1996 on this assessment. We used input from many sources, primarily the Science Advisory Panel, the International Life Sciences Institute, our own Office of Research and Development, the consulting firm of Novagen (phonetic), USDA, CDC and many others. We haven't -- we don't have an exact count, but we stopped counting after 30. We've had at least 30 SAP meetings on topics related to this cumulative assessment. We have utilized public comment on nine science policy papers that are related, many of which are related to the cumulative assessment, and we've had four technical briefings on this methodology. We've had three technical briefings. We had one in August on the hazard, where we talked about how we combine the OPs and use relative potency factors. We had one in October, where we talked about the water assessment methodology, and we just had -- it seems like we just had one in November -- on November 15th on the food and the residential methodology. So, together with the CARAT, we decided to reveal the methodologies as they became completed to facilitate the ability of the public and stakeholders to comment on this piece of work which, I must say, is, in total, over 3,000 pages, and we'll explain -- we've done some things to facilitate stakeholder input and getting through this document, but it is an enormous piece of work. The structure of the assessment is basically three major pieces. There's a hazard assessment. There's the food, drinking water and residential exposure assessment, and then there's the risk assessment. And I'll just talk a little bit about how we made this document. There are parts of it that everyone will read, there are parts of it that many will read, there are parts of it that some will read, and there are parts that very few will read. Just as we have done for all our risk assessments, we have put out a summary and an overview, and that's probably something that everyone will read, and we're expecting those -- they're in the docket right now, we're expecting them to be on the web sometime this afternoon. The document itself has a technical executive summary. That's another less than 10 pages, I believe, that many will read. And then the first part of the document, Roman numeral I, talks about the hazard, and there's a very important part of Roman numeral 1, which is called the risk characterization section. So, that's another piece that everyone probably, who has a major stake in this assessment, will read. And then we go through regional assessments that discuss water and the residential by region, and then there's a large number of appendices, references, computer runs, graphs, charts and whatever. So, that's the basic structure of these 3,000. There's, obviously, some summary documents, the overview and summary in plain English; an executive summary to the document; the whole Chapter 1, which, again, there was a risk characterization part of that that I think is very well-written and important to the understanding of this whole piece of work; the regional assessments for water and residential; and then many number of assessments. We will also be providing on CD-ROM -- and I understand that -- I guess the verb is to burn them -- we're burning them as we speak and we may have some supply of them tomorrow morning. But we are providing also all the inputs that if somebody wanted to run this assessment themselves, they could do it with all of the inputs that we're going to provide. Let me just spend a couple of minutes on these different pieces. The hazard assessment examines the common effects shared by all the OPs, the inhibition of cholinesterase activity. It uses sophisticated dose response modeling to compare different pesticides' ability to produce this toxic effect and to determine the dose levels to be used in risk estimation. The analogy -- this was the topic, again, of the August technical briefing. The calculation of relative potency factors. An index chemical was picked. It was methamidophos, picked because of the quality of its database, and all potencies were measured in relation to that one. The analogy that we've used many, many times is the currency of converting many currency to the dollar or the Euro, whatever choice you may prefer. And that's the hazard part, and it explains how those relative potency factors were calculated, it gives the data that they were based on, the graphs, the whole thing. With regard to the exposure methods, I said earlier in my discussion that one of the things you have to do in cumulative assessment, after you identify a common mechanism -- group of chemicals that have a common mechanism, is determine the likelihood, which is probability. So, the assessment is a probabalistic assessment. The whole assessment is a probabalistic assessment. In the individual OP assessments, the food has been probabalistic for a long time. Most people -- most people know that as using the Monte Carlo method. The model was DEEM, D-E-E-M, and I don't know what that acronym means.

MS. MULKEY: Dietary is the first word.

MS. ROSSI: Dietary, right. And M is model.

UNIDENTIFIED MALE: Dietary Exposure Evaluation Model.

MS. ROSSI: Thanks. Okay. And we have been doing probabalistic for a long time. I think the first probabalistic food assessment we ran was for azinphos-methyl back in May of 1999, and we explained that Monte Carlo assessment at that technical briefing that we held in May of 1999 on azinphos. We have not been doing a probabalistic assessment for water and we have not been doing a probabalistic assessment for residential. So, this does a probabalistic assessment to determine the likelihood of getting exposure to these chemicals. The risk assessment also combines the exposures in an overall probabalistic assessment that appropriately attracts demographic characteristics of individuals while incorporating seasonal and regional aspects into the timing of potential exposure; i.e., lawn exposure most likely in the summer months, and what have you. What remains to be done is a lot. This is -- while this is the end of a lot of work, it's the beginning of an enormous amount of work. The cumulative assessment, the completion of a preliminary assessment is completed as of today and we're sharing those results with you. Finishing the processes of or the risk determination and risk management will require extensive additional analyses by the agency, scientific review by the SAP, continued implementation of the public process that has been developed with the CARAT and USDA and other stakeholders, and decisions on several science policy issues related to the cumulative. As I said before and explained that the cumulative assessment and completion of the cumulative assessment is so critical to reassessing and making final determinations on the organophosphate tolerances, which are -- making those decisions are critical towards meeting our goal of August 3rd, 2002. So, despite the necessity that a lot of work remains, the agency is putting out this preliminary assessment today so that the scientific community and stakeholders can have an opportunity to become familiar with these new methods and their application to the OPs in the complete assessment. We anticipate and hope for a very robust comment period and stakeholder input in the coming months.


MS. ROSSI: -- in August. It is too early, and this is emphasized in the document, and it was also emphasized in Steve's remarks this morning, in the process to draw firm conclusions about the pesticides in this initial evaluation. However, it does appear that drinking water is likely not to be a major contributor to the organophosphate cumulative risk. Although most indoor uses of the organophosphates have been phased out or canceled through individual organophosphate decisions, and we -- we had quite an extensive discussion in our briefing on November 15th on the regulatory actions that have been taken on the residential uses and the mitigation measures that have been imposed and whatever, there are some remaining uses that may pose risks of concern, and there are still, again, 12 chemicals, some of which have indoor uses, that are -- we're still doing individual management decisions on. And we have just begun thinking and analyzing the results of the assessment to determine what different foods and commodities may be contributing to any potential risk at the higher percentiles of exposure. That work is just beginning. We've had a couple of conversations already with USDA on looking at that, very parallel to what we do with the individual assessments. After the preliminary is put out, we then begin to look at and analyzing a lot of the results and what they mean. We believe, at this time, again, and Steve emphasized again this morning, that we have confidence in the safety of our food supply. And finally, I think it's important to note that after further analysis and review of the assessment and decisions on the many outstanding science policy issues, if there are risk mitigation actions that are necessary for food, the actions, most likely, would be limited to a fairly number of -- a small number of food commodities. The other part of the Roman numeral I that you might also want to pay attention to, besides the risk characterization, is a title called Future Work, and in that Future Work is listed under each heading, under hazard, under food exposure, under drinking water, under residential, it lists various items that the agency so far has identified as areas that need to be worked on between -- some between now and January, some between now and February, some between now and March and April, and other ones that may have long-term impacts just on the whole methodology and may not directly impact the organophosphates. That's a very important part to look at as you're thinking about the comments and thinking about analyses. For example, in the food exposure one, we've listed seven things that right now we can think of, seven or eight things that right now -- and I'm not going to read all seven or eight things, but they are in there. But I'll give you a flavor of what they are. To conduct a series of sensitivity analysis for input parameters to determine those most likely to impact the outcome of the assessment. That's one sensitivity analysis, one that we've been doing for individual assessments, except it's a little more complicated now that we have many more inputs. Further evaluation of monitoring data to better account for the non-detects; analysis of food exposure to identify major contributors to exposure and identify specific food pesticide combinations; complete the analysis of the organophosphate market basket and its implications on the OP cumulative assessment; look at the -- what we call the tails of the distribution, the 95 and above percentiles; and evaluate the impact of assumptions regarding residue concentrations, and particularly in baby foods. Steve emphasized this morning that in our assessment for children, we are not assuming that they are consuming commercially prepared baby food. We are assuming that they are consuming baby food that basically is, how I like to say, the raw commodity or the agricultural commodity. It's put in a blender and make into something a small child can eat. We know that over the years we've had discussions with various baby food manufacturers, and we know that many of them have adopted policies of no residues on various chemicals, not just the organophosphates, but organophosphates are one, carcinogens are another. So, we know that there are those policies for commercial baby food, and in all likelihood, based on their market sales data, there are a lot of children consuming those commercially for food. So, that's an area that we're going to explore. Looking at the consumption data for records that may be -- although this is a very statistical term, outliers, I'm not using it in a statistical sense. But there could be outliers, there could be a child that -- it could be a recording error or it could be the truth. We don't know. We would look into that if it looks like an individual is eating a large amount of a commodity. And also, we're able to look at whether various residues from a commodity -- from a chemical came from a domestic source or an import source, and I think that's an important thing, also, to remember. So, we'd be able to look at that. We have done none of this yet. And I did end up reading all seven of these. So, that's the kind of thing that we would be going through, and we developed the same type of things for drinking water and for residential, and I really focus your attention on to that future work. Next steps, there will be a technical briefing on this whole assessment, just as we've done many, many, many technical briefings on the individual risk assessments, on January 15th. And that will be followed on the 16th with a workgroup meeting, the CARAT workgroup meeting. Then the next major step is in February. February 5th through the 8th, there will be the Science Advisory Panel meeting on the whole risk assessment. Then the next milestone is that early March date, on or about March 8th, when the comment period would close on the assessment. So, those are the near term steps. We'll be talking to the CARAT on the 16th about the process beyond March 8th, because that is the mission of that group, is to advise the agency on the process for the cumulative risk assessment. In the meantime, we'll be working with USDA. We'll be proceeding with getting a better understanding of some of the things that I've talked about and start looking at the assessment and looking at the various impacts of different parameters and different data and whatever. And that, basically, is the discussion that was had at 11:00 this morning and basically is probably the cumulative risk assessment at a glance.

MS. MULKEY: Thank you, Lois. Do we have some clarifying questions? Steve?

STEVE: I'm probably loud enough without this. Outliers on the food, didn't we already do that when we did individual assessments? Wouldn't we have looked at outliers in the dietary --

MS. ROSSI: High consumption individuals?

STEVE: Yeah, yeah.

MS. ROSSI: We do look at those, but I don't believe we ever removed them from the database.

STEVE: No, you did not.

MS. MULKEY: But this is a new consumption database, too.


STEVE: Oh, it is?

MS. ROSSI: Yes. That's a very good point. It's '94 through '98, and it also is supplemented by the children's. But Al should probably give the details on that.

UNIDENTIFIED MALE: Oh, well, you gave all the details.


UNIDENTIFIED MALE: No. The data were looked at and weighed, but we never formally rejected any specific data points. So, we're looking at that now. We've done some measurements about how many standard deviations some of these consumption points lie outside of some norms. We're starting to.

STEVE: The second questions, in the individual assessments you did 99.9 percent (inaudible), is that the same with the cumulative or --

MS. ROSSI: That decision has not -- we haven't even begun to look at percentiles, and that is one of the things, I think, that we'll be pursuing as far as, you know, what's in the higher percentiles and the sensitivity analysis, and even the whole methodology and the ability to the confidence in the distribution and asking for input on if the methodologies support a percentile, what percentile do they support?

STEVE: Okay, thank you. And you'll do a sensitivity analysis presumably different percentiles --

MS. MULKEY: You can actually --

MS. ROSSI: You can (inaudible).

MS. MULKEY: -- see that in this document.

STEVE: Okay.

MS. MULKEY: Dan? Oh, I'm sorry, I didn't -- we'll take Dan and then we'll come over here.

MR. BOTTS: First of all, I'd just like to say I never thought you'd be able to do this. (Laughter).

MR. BOTTS: Especially not in the time frame that it's come forward, and recognizing that it is a preliminary risk assessment, but having the privilege of participating in a meeting (inaudible) where there was multiple models looked at relative to how to do a cumulative exposure, all of which have been carried forth to the SAP at some level or other. It's my understanding that this cumulative assessment is based on calendex, which is one of those models. And looking at the overall process, has the agency made the final decision that is the model you're going to use or how will those other models be brought in to the process, because of some of the issues that came up in that workshop down there relative to the ability to be able to tease out some of the types of information to lead the risk mitigation efforts at the other end of the process?

MS. ROSSI: You are correct in that this assessment is based on the Calendex model. I think the timing, and I think Margaret can comment on the lifeline, which the agency is involved in, and then the industry sponsored model, I think, is CARES.

MR. BOTTS: CARES. But then there's also the (inaudible) model which ORD presented as well.

UNIDENTIFIED FEMALE: Right. We hope that some of these models will be able to be used before we finalize the next version of the risk assessment, and we think that lifeline probably will be at that point. We don't know -- industry has sponsored the development of CARES and I don't know exactly how far along that is. SHEDS, again, if it will be finalized, we would like to see the results running those models, to be able to compare them to do the sensitivity analysis.

MS. MULKEY: There have been some enhancements to Calendex, I think, since that meeting to improve the ability to (inaudible). Is that (inaudible), Margaret? I dreamed that?

MARGARET: Well, earlier this summer, there were.

MS. MULKEY: There were some -- there have been some enhancements of recent vintage to Calendex with an eye toward that issue.

MR. BOTTS: Well, the thing that came out -- and the reason I brought it up is what came out of that meeting down there, when you looked at each of the models, each one brought different things to the table. The perfect world would have been some combination of all four models that was integrated to get to an end point that brought it forward, and it would be unfortunate to lose some of the refinements and some of the other models if we're tied to something just because it's a matter of convenience of time, having a model to put this forward. I'm assuming that there will be fairly robust comments relative to that issue brought forward probably prior to the SAP meetings in February, looking at some of the other models. I know the time line on the ROD model was sometime about that same time line. It's my understanding that that's what CARES time line was as well, which I don't think we need to be married to this. Again, the cumulative exposure assessment, to get to where you were from the very first ISLE (phonetic) meetings back in January of 19 -- or December of 1996, laying out what they thought was going to be (inaudible), I never figured you would be anywhere near the level of sophistication. And there's been a tremendous amount of work that's gone into this, and we're so far ahead now from where we were to be able to look at some of these things. The agency is to be congratulated on the process and the way they've done that. I just don't think we're at the end point yet of having the absolute decision tool that we need in a cumulative exposure assessment model from what I've seen. Not having seen the cumulative preliminary assessment, which brings me to the next question. The CD-ROM process, is that going to have the total document on it or just the data set that supports the model running, or what's exactly going to be on this CD-ROM that you all are burning and are going to bring to us tomorrow morning?

MARGARET: There are actually two sets of CD-ROMs. The CD-ROM -- there will be a CD-ROM available mid-December that will let you do the analysis if you have a program to run the analysis. By tomorrow morning, we will have all regional assessments. We will have the appendices and we will have the section -- the chapter that Lois described, which has the risk characterization, a description of the methodologies, executive summary. And that, by the way, should be on the web this afternoon.

MS. ROSSI: I did get a note saying everything except the appendices is currently on the web, although no sooner do I usually get that out of my mouth than somebody goes on the web and says it's not there. So -- but I have been told it's been put on the web.

PAT: I actually saw it.

MS. ROSSI: You saw it?

PAT: Yeah.

MS. ROSSI: Yes, Pat. Thank you very much.

MS. MULKEY: Jennifer? Oh, I'm sorry, Win was -- I've got a right eye problem. We'll go here and then we'll go back there.

DR. HOCK: Okay, thank you. Again, congratulations, Lois, on an incredible job.

MS. ROSSI: Margaret and her people.

DR. HOCK: And Margaret, yeah. It's just amazing. Just a quick question, not to muddy the waters, but I'm just curious. How will the carbamate insecticides be integrated into this kind of an assessment, common mode of action, cholinesterase inhibitors and so forth, and yet you have some that are significant products on the market? And I'm just curious, will there be a point where they will be integrated into this risk assessment?

MS. MULKEY: You mean with the organophosphates?

DR. HOCK: Yeah. Because of the common mode of action.

MARGARET: They will not be integrated together with the organophosphates. We will perform a cumulative risk assessment on N-Methyl carbamates by themselves.

DR. HOCK: Thank you.

MS. MULKEY: And that's because each of these were determined to be separate common mechanism groups and not one big common mechanism group, and there was a lot of science on that and science review of that and so forth. So, while it facially may seem to be the same mechanism, in fact, divided into different -- and not all the carbamates were found to belong in a common mechanism group.

DR. HOCK: Right, yes, I agree.

MS. MULKEY: Okay. Now, Jennifer.

DR. SASS: I was just wondering if that document would be available, not just for us to print out on the computer, but it's 3,000 pages. Can we get it double-sided provided to us rather than all printing it out separately.

MS. MULKEY: You mean a paper copy? We have a CD-ROM that you're going to be able to, I don't know whether buy or get, but it would be at nominal cost if you buy it. I think we can give it to most people, unless the run on it gets really hot. That will allow you to print; however, you have the capability of printing from the CD-ROM or to read. The paper copies would have to be obtained from our paper docket. I'm hoping there won't be a lot of demand for that. (Laughter).

MS. MULKEY: But I think we have the capacity to double-sided print it there. I'm pretty sure we do.

MS. ROSSI: I mean, the beauty of the CD-ROM is that you're not going to be probably interested in every single page of this document.

DR. SASS: Right.

MS. ROSSI: And, you know, if you can scan it and then print out the pages you're interested in, that's probably the best way to maneuver your way through it.


DR. SASS: Congratulations on a good job.

MS. ROSSI: Thank you.

MR. QUINN: Margaret, maybe you can talk a little bit. Is this for -- this is for cancer and non-cancer health effects?

MS. ROSSI: This is for cholinesterase inhibition.

MR. QUINN: Okay. Can you -- maybe this is unrelated then, but can you talk a little bit about how HED has looked at what is an acceptable risk range in a Monte Carlo assessment for cancer and non-cancer health effects, whether you've looked at a 95th percentile or you've done something more like what the air program has done?

MS. MULKEY: Well, I'm a little unclear about how best to answer that. We have, for threshold kind of effects for dietary risk assessments, produced a science policy paper in which we say that when the dietary -- or food, when the food risk assessment is done probabilistically, we generally aim at 99.9, but that it's -- you know, it's particularized with a hard look. Now, that's the only policy paper that we've produced that takes the position about what your regulatory cut point ought to be, and that's very specific to a certain database, it's for individual chemicals, and it's for a certain kind of risk. Where cancer is done as a linear or a non-threshold analysis, we have, as you know, the legislative history and other indications are that your sort of starting point is one times ten to the minus six risk. Other than those two, I'm not aware of any definitive statement about what the acceptable risk level is for anything else. Now, with regard to individual chemicals, the MOE question, as you know, it's a matter of how much safety factor you think you should have. And there's -- if it's animal database, ten times ten, and then you can sometimes have the FQPA safety factors. So, there's sort of a 100 MOE or 1,000 MOE. But that's the only other area I know of or can think of where there is an answer to your question.

MR. QUINN: Okay, I appreciate that.


DR. LOCKWOOD: Are you able to say anything about how the agency plans to deal with other non-cancerous related end points? In particular, as a neurologist, I'm interested in links between pesticide exposure and Parkinson's Disease and other neuro-degenerative disorders, where there is now quite a few papers in the peer review literature indicating that the risk for development of Parkinson's Disease is significantly increased by pesticide exposure, including in-home pesticide use.

MS. MULKEY: We pay a lot of attention to the available epidemiological data. But to date, I'm not aware that we've had any epidemiological based data that has allowed us to pick regulatory input. Generally, it informs the choices we make from the more controlled toxicological data. I do know that for the organophosphates and other neurotoxins, where we're looking at a very early -- cholinesterase inhibition, which is very early in the chain of symptoms, we have believed that by focusing on small levels of cholinesterase inhibition, that we are bracketing any clinical signs of any kind of effects that would be more powerful than those.

DR. LOCKWOOD: These might be side effects or factors that emerge decades after exposure, admittedly a difficult problem to deal with, but one that is important.

MS. MULKEY: We are interested in anything epidemiology studies can tell us, and we do try to pay close attention to them. Lori?

LORI: I was curious. What is the status of the OP market basket study? Have you (inaudible)?

MARGARET: We have done some analysis of the market basket study. Randy, can you describe what we have done so far and what we plan to do?

MR. PROFETTI: Randy Profetti, Health Effects Division. What we've done so far is we've analyzed the OP market basket survey which, as you know, was a number of children's foods, fruits and vegetables, and analyzed the single servings for a large number, I think, almost all of the OPs and a lot of their metabolites. We've taken that data and analyzed it. It has not -- we have not done or issued a formal review on it yet. But what we've done is we've taken that data, those crops and those residues, and done a DEEM run on it. We also then took the PDP data for the corresponding crops, because PDP -- the crops in PDP and the crops in the market basket, there are no different ones, no (inaudible). And it turns out that when we do a head-to-head, in other words a DEEM run using PDP data and the subject crops, and a DEEM run using the market basket survey on the subject crops, that the resulting MOEs are essentially the same. If there was a difference, it might be that the market basket shows a little difference in MOEs, but not enough to really be called a true difference, just a slight, you know, few numbers. Does that answer your question?

LORI: Yes, thank you. And will you be doing the same thing for the carbamates?


LORI: Okay. And when will that be initiated or has it already?

MS. ROSSI: The individual carbamates aren't even done yet. I mean, I don't -- so, we're a ways off on that.

LORI: Thank you.


UNIDENTIFIED FEMALE: Two questions. One is in the last few weeks there's been a change in policy so that human studies are now -- that have been submitted are now going to be possibly, maybe considered on their scientific merits, kind of. I think that sums up where the policy is at. This might be an opportunity to try and loop in some of those neurological symptoms that aren't available in the mouse and rat studies, the rat I guess what you've been using, such as malaise, headaches, dizziness, nausea, feelings of nausea, these kinds of things, all of which are reported in the people that have been exposed to these pesticides' oral doses in these studies that have been submitted. Are you going to -- now that you're considering, will you be looping in those kinds of end points as well?

MS. MULKEY: Well, I think that the question of both the science and the ethics of those human studies is a matter still under consideration at the agency, and that there is not, and there has not been, any announcement of a policy approaching either of those two aspects of it. Your question went to the aspect of the science of those studies and what we can learn from it. And I think that issue, along with all the complex of issues around both the science and the ethics are still under internal deliberations about an appropriate approach, both in terms of process and in terms of policy. So, I don't think there is a policy, but that question is certainly one of the science related questions about what the data in those studies do and don't tell you that would be an element of any inquiry.

UNIDENTIFIED FEMALE: My other question is, while this cumulative risk assessment is in progress, the OPs are still being used under Section -- I mean, they're still being used, but there's also Section 18s for emergency responses. Are the OPs being used under those conditions?

MS. MULKEY: With one exception, no.


MS. MULKEY: The one exception is the use of coumaphos in beehives.

UNIDENTIFIED FEMALE: In beehives, okay.

MS. MULKEY: Because of an extremely problematic mite, the veroa mite, and you will -- that is the only -- to my knowledge, the only Section 18 that has been authorized. Because in order to issue a tolerance associated with Section 18, you have to make the FQPA safety finding. In order to make the FQPA safety finding, you have to have completed a cumulative risk assessment, have room in the risk cup and so forth.


MS. MULKEY: So, since FQPA, we have not issued Section 18s for the OPs.

UNIDENTIFIED FEMALE: And my final question is going to be, are you expecting trouble at the SAP regarding the N-Methyl carbamates not being included since they had overly requested them to be included?

MS. MULKEY: To be included with the OPs?

UNIDENTIFIED FEMALE: The N-Methyl carbamates.

MS. MULKEY: The N-Methyl carbamates to be included with the OPs, is that what you understand the SAP recommended?


MARGARET: No, we don't think so.

MS. MULKEY: We don't think they recommended that?


MS. MULKEY: Okay. We have a public comment process, and there's no question that issues like that are welcome in them. All right, any other questions in this section? (No response.)

MS. MULKEY: Well, great, great timing for all concerned. That got us back on track. I cannot resist the opportunity to use this public forum to offer my appreciation to all of the parts of the Office of Pesticide Programs, but especially the Health Effects Division, whose work in this regard not only over the last three months where it has been extremely intense, but over the last five years, has been something to truly be proud of. And I have the great fortune to sit in a chair which allows me to be associated with this extraordinary work. And it is my great pleasure and professional satisfaction to be part of that effect.

MR. SIDWELL: Okay, next up is inert disclosure. I'm Bruce Sidwell. I'm the Chief of the Policy and Regulatory Support Branch of the Field and External Affairs Division. And what I'm going to do for a moment, in order to stage this, I'm going to have to be a stage director. We have about five or six different speakers, and I want to make sure that they're all available for the presentation. So, what's actually going to happen is for about ten minutes, Cameo Smoot, who's a Pesticides employee, will be discussing the background of this issue so, in fact, you understand what it is you're about to hear. And then from there, we have several members of the subgroup that has been working on this issue who are going to be explaining some of the issues that they have been grappling with. After that, since there has not been a consensus on one particular recommendation, we're going to have presentations of actually four different recommendations, three that you might characterize as being basically comprehensive, and then a fourth which is more targeted to a number of narrower kinds of things. So, at this point, I am going to turn the floor over to Cameo Smoot, who's going to go right into the background, so that you can understand what it is that you received in your package. It is a 102-page document, which is nowhere near 3,000 pages, but it seems heavy enough for the work that's gone into it.

MS. SMOOT: Good afternoon. My name is Cameo Smoot. I'm with the Field and External Affairs Division of the Office of Pesticide Programs. The last year and a half, I've been one of the coordinators for the Inert Disclosure Stakeholder Workgroup. Before we get into the presentations, a lot of you have been given -- I know it's hard to see the overheads, but a lot of you have been given a hard copy of the briefing. There are four basic areas I want to cover in this briefing, just to catch you up to speed, for those of you who are new to the PPDC. One of the questions is, what is an inert? Why is confidential business information a concern? Why was the workgroup formed? And what was the mission that EPA asked the workgroup to accept? We'll start with the simple one first. Formulated pesticides contain two types of ingredients generally, the entity that's designed to be active against a target pest and everything else. The everything else, the so-called inert ingredients, are there for lots of reasons. But no claim is made for their pesticidal action. Why is CBI a concern? Section 10 of FIFRA provides for the protection of trade secret information in pesticide products. Why pesticide registrants may disclose all ingredients on the label, registrants frequently claim CBI for inert ingredients. If registrants claim inert ingredients at CBI, the information still must meet the FIFRA test for confidentiality. Even when this test is met, FIFRA allows disclosure under certain circumstances. The current mechanisms for disclosure include voluntary disclosure by registrants, Freedom of Information or FOIA requests for disclosure. In the agency's authority to make case-by-case decisions, that disclosure is required. An example of this is the 1987 listing policy, where the agency has required inerts of toxilogical concern, also know as List 1 inerts, to be listed on the label. This third question is why was this group created? Over the last decade, there's been a rise in public concern for ingredient exposure. For example, in 1994 the Northwest Coalition for Alternatives to Pesticides filed suit against EPA seeking disclosure of inert ingredients and certain pesticide products. By `96, the Court had determined that the identities of most of the inert ingredients, subject to the lawsuit, were not eligible for confidential treatment. In 1998, NCAP and a series of Attorney Generals from nine states and territories filed petitions with the agency seeking changes to EPA labeling regulations to require full disclosure of all ingredients in pesticide products. In response to the rise of public concern and for more information on inert agreements, and to invest a concern raised by the petitions, EPA supported the formation of the Inert Disclosure Stakeholder Workgroup. The workgroup is currently comprised of approximately 20 members drawn from public health, environmental, industry, academia, state government organizations. The first meeting of the workgroup was sponsored in March of 2000. EPA asked the workgroup to accept the following charge. To consider the potential measures to increase the availability of information about inerts to the public. EPA also asked the group to factor into any workgroup recommendations, the informational needs of a variety of stakeholders, current agency processes and policies for disseminating inert ingredient information, and also to consider the protection of confidential business information. As part of the workgroup investigation process, workgroup members in EPA and a number of guest speakers helped answer questions about public availability of inert ingredient information. Topics included asking questions about how is inert information provided to health providers. How does EPA disclose information about inerts? What is the role of patents in protecting industry's proprietary interests? What are the regulatory requirements for ingredient exposure for other products, such as cosmetic, over-the-country drugs and prescription drugs? What barriers or restrictions for sharing inert ingredient information exist between the Federal Government and the States and/or within the States? What are the informational needs of sensitive and vulnerable populations such as persons with multiple chemical sensitivities? To what extent can ingredients in a pesticide product be reverse-engineered. To what extent is there standard nomenclature or common names for inert ingredients? As part of the evaluation process, the workgroup established evaluation criteria. Questions asked were, who are the audiences, what are their informational needs, how can those needs be met, how can commercial interests be protected, and what other regulatory policies and schemes might be relevant? So, here today we're going to have members of the Inert Disclosure Workgroup. We have about six or seven members here today who will discuss their perspectives on the workgroup activities, and also the highlights -- some of their issues on their proposals, and we expect that -- well, this is only an hour and 45 minuter or so. The report is not completed. It is marked interim final draft. But we do expect that the workgroup will complete the report by the end of the first quarter 2002. So, unless there are any questions, I want to turn it over to our first speaker. (No response).

MS. SMOOT: Carolyn Cox, who is going to discuss her proposals and her activities on the workgroup.

MS. COX: My name is Carolyn Cox, and I'm a staff scientist for the Northwest Coalition for Alternatives to Pesticides, and also served as one of the public interest representatives on the IDSW. And my job today, together with Wally, was to try to summarize some of the controversial issues that were discussed by the IDSW. A lot of times, it was quite a controversial group, and so, I'm going to use my share of that time to sort of point out the controversies by talking about why identifying inert ingredients on the table is a good idea, because that's kind of focusing on where there are controversies. So, what I believe is that identifying inert ingredients on pesticide labels is a common sense solution to a variety of problems, and solves these problems for a variety of audience groups that Cameo mentioned in her presentation. I think it's fairly clear that health professionals need information about inert ingredients in order to treat patients who might have been poisoned by pesticides, and in an emergency situation, they need a quick, accurate source of information about the ingredients, and the pesticide label is maybe the easiest way to provide this information. If any of you have kids in school, they've probably come home with the little Mr. Yuck presentation that, I believe, poison control centers do for elementary schools all over the country, and one of the things they teach every kid is that, you know, if you get into something that you shouldn't have gotten into and you got to go to the doctor, you bring that container with you because your doctor needs to read the label. And it's sort of a common sense thing that's been drilled into -- you know, starting with kids on up to adults. Putting this information on the label eliminates some of the confusion that occurs when there are pesticide products with similar names, but different ingredients, and also products who have -- with the same name, but maybe the ingredients have changed over time. But you know that what you have on the label is actually what the patient might have been exposed to. Researchers are another audience group that also need information about pesticide inerts, both when they're doing toxicological studies, and in studies of various kinds of ecological research. Again, the label is a simple straightforward common sense way to get -- to make this information available, and I have some examples of published scientific research in which researchers had to resort to fairly complicated mechanisms of getting that information when they needed it, because it's not on the label right now. People who are occupationally exposed to pesticides also need information about inerts so they can make decisions about protective clothing that are based on their individual sensitivities, allergies and concerns. They also need this information in case of an accidental overexposure so they can provide it to their health care professional. And, again, the label is a simple direct way to make sure they have quick access to this information. Pesticide consumers need information about inerts, and again, putting it on the label gives it to them quickly and accurately, makes it available to them at the time and place where they're making a decision about purchasing. It's true that some inert ingredients have long, complicated chemical names that may be incomprehensible to some consumers, but many consumers, as the Consumer Labeling Initiative pointed out when they did their focus groups, they want the information anyway, even if they don't really know what those names mean, because they want to be able to provide it to their doctor in case it's an emergency. Other people have sensitivities or allergies and they need to prevent exposure to a particular substance, and in that case, many of these people are well aware of the chemical name of the substance or substances that cause them problems. So, they, obviously, would benefit from having this information on the label. Other pesticide consumers are agencies or institutions that have a lot of professional expertise to evaluate unfamiliar chemicals and wouldn't have any trouble with long complicated names. In fact, some of these agencies and institutions are required by law, like the Americans with Disabilities Act or the National Environmental Policy Act, or their own pest management policies require evaluation of either health or environmental hazards of the pesticides that they use, and they can't complete this fully without full ingredient information. And finally, though I know this is probably the most controversial thing that I'll say today, and many on the industry side of the workgroup will say they don't agree, but I definitely believe that identifying inert ingredients on pesticide labels is also good for the pesticide industry. Right to know, in general, is a really extremely popular idea, and it's one that creates good relationships with customers and potential customers. Essentially, it's a clear sign that there's nothing to hide. Concerns about protecting confidential business information need to be considered but, for the most part, the simple identity of inert ingredients doesn't add up to confidential business information. It's not a recipe for producing a pesticide. It doesn't provide information about manufacturing processes and suppliers and all the other things you need to know to make a pesticide. According to information provided by EPA to our workgroup, the identity of most inerts is available through laboratory analysis. Other information is available through the Freedom of Information Act, the material safety data sheets and other sources. So, I think the confidential business information problem is a good deal smaller than it's often portrayed. The pesticide industry, as well as EPA, has a great opportunity here to step forward and make this popular change in pesticide labeling. Thank you.


UNIDENTIFIED MALE: -- all the presentations have been made. Next up is Wally Puckett.

MR. PUCKETT: Thank you very much for your attention this afternoon, and I'm going to try to be brief. I have trouble saying hello in five minutes. It's because of the part of the country I'm from. So, bear with me. I'm representing sort of the industry and trade group side of this issue. And while you may have understood from Carolyn that she thinks we have these huge gaffs and huge differences, in fact, we're really pretty close on most of these issues, and I hope to give you a flavor for that today. Just directly on some of these issues that Carolyn brought up, and I don't need to reiterate them, we feel that health professionals can get information from the manufacturers of pesticides if we could have a more flexible approach to disclosing more information, that is, the use of generic descriptors instead of specific names, that would still allow us to protect confidential business information, but would disclose essentially what health professionals need on the label. And we, on the industrial side, that labels would be the only way we'd disclose information to health professionals. Now, the current status is that we disclose information to health professionals regularly using 800 numbers and websites and third parties. So, we do that right now. So, what could stand to happen is that that whole process could be standardized in cooperation with EPA. Pesticide consumers and the general public, the Consumer Labeling Initiative, which was done by EPA in cooperation with lots of other groups, showed that this audience does not need or want specific chemical or tradenames because they're unfamiliar with those types of terms. In fact, what they want is some description of what's in there that they can understand and utilize and, in fact, what they really want is the hazard involved with using what they're using, and we would support any system that would provide useful and needed information to them. But just as an aside, this is a fairly elite group of people, and it doesn't have to be a long chemical name. If I were to say to you, well, I have L-ascorbic acid in my formulation, many of you would jump pretty quickly at what that is. But if I asked you what the L meant, then if I asked you -- if I said, I have D-ascorbic acid, would that make a difference to you, many of you would start scratching your head. And so, that's why we're saying that we should provide information that's useful to most people, and that's what we'd like to see done. Government agencies, there was a survey done by Brad Mitchell and Eileen Mahoney on our -- those are members of our group who are also from state agencies. They surveyed 12 agencies, got responses -- states. They got responses from eight states, and those people that they surveyed said that in the rare instances that they need more information about the ingredients and pesticide formulations, they were able to get them almost all the time. And so, we think that there may be some problems with instate agencies and governmental communications. But I wouldn't want to see us change laws or do a rule-making because the government needs to learn to communicate better. I think that the government should learn to communicate better, I think, is the bottom line there. Pesticide researchers, those of us who have made pesticides for years have -- can almost universally tell you we respond very favorably to researchers doing all kinds of research. The only thing we typically ask, because we wish to protect the confidential business status of our ingredients, is that they keep our ingredients confidential. That does not preclude them from publishing the work. It's simply that they have to use some generic descriptor to do that and most have no problem doing that. So, as long as they're willing to sign a non-disclosure agreement, pesticide researchers typically have no trouble getting information from the registrants. Now, as to the best method of providing information, there's no doubt that the label is an essential part of communication. The agency wouldn't have spent so much time and registrants wouldn't have spent so much time on the label if it was not. But the label contains a whole variety of information, and these labels tend to be large and crowded and sometimes hard to understand what's on them. We think that the best way to provide information is with the label, but we think that you need to have useful information that the general public can understand and derive meaning from. We also think there are other means of disseminating ingredient information, including the use of back panels, and the agency needs to come to grips with if that's possible for registrants to do. Right now, you can only put ingredient information on the front panel of the label. We also think we should have standardized websites where, in cooperation with the EPA, industry agrees to some standardized ways of putting on a website information that could be useful to the consumers, in general. Now, to reiterate, for confidential business information, Cameo's already done this well, FIFRA Section 10 does provide for the non-disclosure of certain CBI, including specifically identity and percentage quantity of any deliberately added inert ingredient, and that's what we're talking about today. And registrants usually protect the formulation information by not disclosing it. I mean, if it's disclosed, it's no longer confidential. So, in order for it to be confidential, we don't disclose it in general, but we will disclose it when third parties need the information, and we normally do that under a non-disclosure agreement. The confidential business information area is one that's very important to industrial concerns, and I'll tell you why. Let's go to the last point first on this particular slide. Full disclosure would enable competitors under current U.S. EPA policy to sell under what's called a me-too registration. If you disclose the formulation, a competitor, without doing the toxicology and having the long time frame for EPA evaluation, would simply be able to cite the data of the already registered product and say that their product is substantially similar. It would be immediately in the market, and they would not have made any investment whatsoever in the development of that product. And so, unless policy changes, so that that is not an obstacle, this becomes a big marketing -- a marketing obstacle for disclosure. Beyond that, there's a negative effect on U.S. global competitiveness because global competitors watch what's going on everywhere, including patent literature. If you disclose everything, global competitors can use your information to essentially copy your U.S. registered product, sell it in their domains, and many U.S. companies are competing on a global basis. So, there needs to be some protection of a company's investment and innovation if we're to move forward on this issue. Other issues that need to be talked about are the pace in dealing with ingredient issues, and these go both ways. It's both the agency taking longer than maybe some of us would like to deal with issues, and then sometimes the agency dealing with an issue that gives the registrant very little time to complete and comply with what's required. The other issue that needs to be talked about is the implementation of label modifications. Even in the instance that we do generic or functional names of inerts to be listed, it's one thing to say that sounds simple. It's another thing to actually be a registrant and to have to comply with that. And so, these are all issues of concern that have come out in the group. That's my summary. I thank you very much.

UNIDENTIFIED MALE: Thank you, Wally. I think you've heard kind of the flavor of the issues from the presentations by Carolyn and Wally. I think what we want to do now is move on to the proposals that have come out of the workgroup. There is not a single proposal that has a full consensus of the workgroup, and what we have are three different -- three that are fairly comprehensive, I think, in their orientation, and then there's a fourth which is more a fill-in-the-gaps kind of -- it's much more -- it's a collection, I think, of ones that are more narrow. And to start off there, I wonder if Julie would like to go ahead and. . . (Whereupon, there was a brief pause in the proceedings.)

UNIDENTIFIED MALE: Yeah, these presentations of the proposals are going to track with the package that you've been given. Cameo, do you have the page number of Julie's, I guess, and they can be turning to that.

MS. SMOOT: It says May 14th, 2001 on the date of proposal for disclosure, and then I'm also just passing around a copy of the proposal.

UNIDENTIFIED MALE: I think there's a page -- I believe there's a page number for the actual paper.

MS. SMOOT: Oh, is there? Okay, nine.


UNIDENTIFIED MALE: Okay. So, Julie will be speaking from page nine on that particular proposal. (Whereupon, there was a brief pause in the proceedings.)

JULIE: The copy of the proposal is in the packets and I'm not going to go into detail on the proposal itself, as much as kind of give some of the background and the basis for the proposal that I think helps outline why we came up with this proposal. Looking at inerts from the industry's perspectives is that we're either marketing products or services, and I'm looking at services as applicators are often marketing services to the public. And so, what we are looking at is we want to provide information that consumers can use to make informed choices based on their values and needs in product selections and selections of services. And we need to look at providing the type of information that they want and that they can use. And we also -- as I think Wally alluded to, need to protect our business interests, and in particular, confidential business information. One of the areas, and it's already been referred to, that we looked for for some of the information is inputs from the Consumer Label Initiative. This was a comprehensive survey of consumers looking at three categories of products, cleaners, household insecticides and lawn and garden products. And there was surveys of, I think, about 1,500 consumers. So, this was a very comprehensive survey. Some of the information that we got back was to find out what information was of most importance to consumers. This is what -- when they were looking at product labels, what was most important. And so, this gives us an idea of these are -- this is the information the public wants to know with regard to using our products. But also what was important to see was what information was not important to consumers. This is the information they considered least important. And one of those categories of information considered least important to consumers was ingredients. Further, we saw that -- when we looked at the information that consumers said they most often never read, ingredients was one of the top areas of label information that consumers indicated they had never read. And the reasons for not reading ingredient information was primarily that they didn't need to know it, or they didn't understand it, or that they just didn't, and this was not an area that they particularly were focused on. Further investigation into ingredient information, we did some actual probing into -- more into details with ingredient information primarily in some focus groups, and what we found was that -- some of the key findings were that most of the consumers never looked for ingredients information. When they did, it was primarily looking at active ingredients for comparison shopping. They were looking to see what -- you know, which product had more active ingredient or less active ingredient for -- as a comparison. But we also found in looking -- when given choices, that they did prefer to have ingredient information as opposed to not having ingredient information. When provided with the choice of a label with ingredient information or not, they chose to have it. However, I did not -- in any of the focus groups that I heard, I never did hear from any of the consumers that the reason that they liked to have it was so they could provide it to a doctor. It was more in general, just over -- in general, they preferred to have information over not having information. They -- also, though, we did look at the different types of presentations of ingredient information and the preference that we saw was for generic descriptions of ingredient information with a -- even more so if you gave a reason for that ingredient, the purpose of that ingredient. When given the choice for full chemical disclosure where the chemical names were used, along with -- with percentages of those chemical ingredients, that was the least chosen option among consumers, I think primarily because the chemical names, they just generally did not find useful. We saw the same reaction with active ingredients, that they did not find the chemical names of active ingredients useful. They preferred either common or tradenames. To give you just some idea of what we are kind of talking about is an example of, you know, an ingredient statement that would contain a generic description. Some ingredients lend themselves more easily than others to giving a description. Something as like glycerine. You know, if you said, what is it, trihydroxypropanol, that probably wouldn't mean a whole lot. But if you said glycerine, then people know what that is. You know, but that, in general, especially if a lot of these ingredients are in the product at very, very low levels and really aren't of a particular concern. So, this seemed to be the preference that consumers had for having ingredient information made available. A lot of areas, such as surfactants, these are very complicated blends. To try to list out all the different components of a surfactant would be a lot of information that would not be particularly useful, especially given that it's usually in very low concentrations. From the Consumer Labeling Initiative, the recommendations that came from the partners and task force of the CLI, and this was made up of industry, government agencies, and other stakeholder groups was that the -- they recommended that registrants list all other ingredient information on their labels, as long as it was presented in some way, either generic description or functional category, functional category being something like fragrance, hydrocarbon propellant, that it would be a category and not, you know -- or a functional category instead of a generic name. But that, you know, individual percentages generally weren't required. So, in putting together a proposal, the industry issues -- key issues that we saw was that most consumers were not particularly interested in ingredient information and, you know, in particular, I went and looked at our -- we have a line of consumer products, and we have an 800 number for information on our label. Year-to-date, for this year, we've gotten over 14,000 calls on that line, and out of those 14,000 plus calls, we've had six calls asking for inert ingredient information. So, it -- just from a marketer's perspective, this is not one of the hottest issues from a marketing perspective. Probably more important is that, you know, label space is limited, and, you know, I think -- especially from a consumer product perspective, we want to focus on the information that consumers have said is most important to them. When you have a very limited amount of space, you want to focus on what's most important. And I think, you know, as Carolyn stated, too, more detailed information is available from a lot of other sources. Material safety data sheets or other sources make this information available. So, we're kind of reluctant to use up a lot of, as I want to call it, valuable real estate for information that people don't find particularly useful or are not interested in. We want to make -- you know, we're looking more for customer satisfaction. And I think, also, just to further what Wally had said, that, you know, as product development costs escalate and we need to -- we become more protective, I think, of our data -- our proprietary data and the intellectual property concerns. So, our objectives in putting together a proposal was, you know, what type of information is needed and looking at the different groups that might need information, what type of information is most useful to each of these groups, and what are the ways of providing this information, the label being only one of the mechanisms. There are other mechanisms, either 800 numbers, or other mechanisms for health care providers that can make that information available, and then, how can the information be provided in such a way that it can address information needs while still protecting confidential aspects. So, the industry proposal took two approaches, and you'll see this in your -- you know, in the proposal that we have both a labeling aspect and what we want to call a publicly releasable summary of ingredient information. There's a draft form in there that would be our -- kind of our concept of a publicly releasable summary of ingredient information that would be provided to the agency. This information could then be released via a FOIA request. When a FOIA request came in for ingredient information, this could be released immediately. As it is now, if someone from the public puts in a FOIA request for ingredient information, the agency has to go back to the registrant and ask for them to substantiate their claims of confidentiality for every specific ingredient. This would be a way to expedite that process, that the agency could just release this document without having to go back to the -- it's been released already for public consumption, so that they would be able to expedite that process. Another idea, I think, that was referred to is that it also could be made available on a database searchable by registration number or some other mechanism and access that way. With regard to labeling, what we're looking to is a voluntary label disclosure. This would be able to be implemented without any formal rule-making, which would much expedite the process. We would gain a lot of flexibility at this time, especially in the type of nomenclature that would be used, given the fact that we -- right now, one of the shortcomings that we have in this industry is a lack of standardized nomenclature, as opposed to some of the other -- like the cosmetics industry. So, we look at this as a measure that -- of a proposal that can be implemented instead of focusing on what we should do or can't do or this, at least, is what we feel we can do, and, you know, looking at does this address the needs and if further evaluation finds that there's still needs that aren't being addressed, then we would look to try to address that in the future. I guess we'll answer questions at the end of all the proposals.

UNIDENTIFIED MALE: Right. Thank you, Julie. Next we have a presentation by Shelley Davis.

MS. DAVIS: I'm going to speak on behalf of a compromise proposal put forward by about seven members of the committee. Initially, the public interest groups and Attorneys General requested that all ingredient information be provided, and that is still one of the proposals pending. And as you just heard, the industry proposal essentially is they'll disclose what they want voluntarily. And our proposal is really in the middle of those. It would require mandatory disclosure of all inert ingredients except those that were deemed -- that were determined to be confidential business information or trade secrets. So, just to briefly go over -- some of the ground was covered, but just to give a few additional points on it. The first thing is what information is available or ready. And there are a couple of main sources. The EPA requires on the label the List 1 Inerts, which they deem to be of toxicological concern. But that's a relatively small number of ingredients. Some are listed on material safety data sheets. Some information is available to the public through the Freedom of Information Act. But any of you who have tried to actually use that process will know that it takes months, and sometimes years, to get that information. Doctors have access to some information through Poisondex (phonetic), which is a proprietary database that, again, depends on voluntary disclosure. So, who needs this information? And there's been some talk about this, and I think also I need to make a few points on who needs it and why and when they need it. Well, first, obviously, is health professionals. There's no dispute about that. But I think there has been some dispute as to how easily available that information is to health professionals. The members of our group who work in poison control or the EPA hotline have said that they have had difficulty getting information on inert ingredients when they needed it. In my own personal experience, I worked with a doctor who was treating a farmworker for chronic dermatitis, and he initially had tried to get the information on inert ingredients from the companies. There were about 12 products involved. And when he was unsuccessful, we filed a FOIA request. That was in May of 2001, and we are now some seven months later, and of the 12 products we requested, we got information on about two. So, this is -- information is not readily available to doctors. Consumers also need this information, and Julie talked about consumers. But I think that in the numbers that she cited, she overlooked the fact that consumers who have special needs for this information do look for it, do use it and do want it. And that would be especially consumers who have allergies or have children with allergies or chemical sensitivity. And I know that any of you have seen a child allergic to peanut butter or peanuts, has seen how diligently they look at product labels and do want to have that kind of information. Farmworkers need it and others who are exposed to the chemicals so that they know what they are exposed to. So, why do we need a change in policy? Basically it's because there's too little and it comes too late. So, what's our proposed solution? We propose that the EPA follow the model of the Food and Drug Administration in labeling cosmetics and similar to the Occupational Safety and Health Administration with regard to material safety data sheets, and require the disclosure of inert ingredients upfront. If there's a dispute about confidential business information or trade secret status, that that dispute get resolved in the registration process. So, that would -- what our proposal is is that for newly registered products, that as part of registration, the EPA determine any claim of confidential business information or trade secret, and otherwise, all inert ingredients are listed on the label. That for products that are currently registered, that the registrant have three years to either obtain a determination from the agency or a court that they're entitled to withhold the information, or issue modified labels which disclose all inert ingredients. So, what would be the benefit of this approach? Well, the first is that both the FDA and OSHA, who came to our meeting, said that most inert ingredients are disclosed. When you put it to the registrant or the manufacturer, you have to substantiate any claim of confidential business information or trade secret or disclose the vast majority of information that is just disclosed. So, there really becomes very few disputes in this area. The information is also on the label, so it's available to all who need it in the place they expect to find it. People don't expect to find ingredient information on a website, necessarily. They expect it to be on the label. And when they're in the grocery store, in the hardware store purchasing a product, they don't have access to a website. They need the information where it is the most practical to make a determination as to whether it might pose a problem for them as far as allergies or chemical sensitivity; and then, of course, in a case of emergency, they need it to give to their doctor. So, the advantage is that the information would be available in a practical way, in a timely manner. Does the EPA have the authority to do it? Under the EPA's current regulations, the EPA can require disclosure of inert ingredients that may pose a hazard to man or the environment, and the EPA uses that authority in a very limited fashion right now to require disclosure of List 1 Inerts. We think that under that authority they could go much farther because, as I was saying, many pesticides cause either allergic reactions or provoke chemical sensitivity. And those are both significant adverse effects. One classic example of that is that peanut products are on List 4 Inerts, and as is pretty common knowledge, for some people, exposure to peanut products can be fatal. So, they -- so, the EPA could use its existing authority to -- its existing regulatory authority to require this disclosure. Also, the Court in -- I'm not sure if I've got this right -- it's Northwest -- it's either NCAP (phonetic) v. Brown or Brown v. NCAP, I'm not sure. But in this case, the Court ruled that under FIFRA, inert ingredients can be disclosed unless they are entitled to CBI or trade secret status. So, the agency does have the authority to do this. A couple of other things we would like to recommend is that the EPA standardize the nomenclature for inert ingredients and issue them CAS numbers so that they could be easily identified, and that they make these determinations on exemptions quickly. And finally, I guess I would just like to say that our proposal is entirely consistent with protecting CBI and trade secrets. What we're asking is that the identity of the inert ingredients be disclosed and that their cumulative weight be disclosed. There are a lot of ways in which -- there is a lot of information that would not be disclosed in this vein. It doesn't require disclosure of reactants or catalysts or chemical processes. So, there's much that the industry could retain as their competitive advantages and it really allows for the protection of only that which is really entitled to confidential business information or trade secret status while allowing full disclosure of the rest in a way that benefits the public. Thanks.

UNIDENTIFIED MALE: Thank you, Mary -- excuse me, thank you, Shelley. I was just looking at my list here. I think Mary Lamuel (phonetic) now is going to be talking about another proposal.

MS. LAMUEL: I'm Mary Lamuel. I'm Executive Director of the National Center for Environmental Health Strategies. I'm a Public Interest Member of the Inerts Disclosure Stakeholder Workgroup. And I'm going to be looking at a proposal for label disclosure on inert ingredients, which is a June 21st, 2001 proposal that's on page 14 of the -- in terms of the notebook. And I'm going to summarize that and then make some comments with regard to the larger picture here. The actual proposal itself is based on NCAP's petition submitted to EPA with support of the nine Attorney General's Offices on behalf of 180 -- over 180 actually, organizations around the country. It proposes rule-making to amend the pesticide labeling regulation, to modify the pesticide product label to include the list of all ingredients that you've already heard, all ingredients including all inert ingredients by common name on the pesticide product label. It would list the percentage by weight of each inert ingredient, and it would replace the term "inert" with the term "other." And a summary with regard to the proposal in terms of advantages, making available to all audiences all people who might want or need this information. So, it's making accessible. Available to all databases, so that ultimately this could not only be on the -- listed upon the product label, but databases through perhaps MPTN or the government, universities, cooperative extension services, whatever. And that it would not disclose any information about formulation of the pesticide product. The proposal provides for a complete disclosure of all inert ingredients on the product label in a timely and efficient manner. As the Inerts Disclosure Workgroup looked at need and the reason for full disclosure, as other people have mentioned, health care professionals was a primary category. Included in there, we're talking about physicians, emergency room doctors, people at -- physicians and clinicians at farmworker clinics, and all these have a significant need to know the inerts in the pesticide. The inerts have to be easy to access. They have to be able to get them in a timely fashion to take action. They have to be accurate, because that's one of the other things we saw is inconsistency with what was available through different databases or 800 lines or whatever. So, currently, there is a problem with regard to both access of some of that information as well as accuracy. And I know for myself, people who've worked with me with regard to trying to get this information or trying to get it personally, that using 800 numbers has sometimes led to answering machines that say, if this is a true emergency, call this other number. So, you're not really getting what you need in that first conversation, or people who are not able to fully help you at the other end. At MPTN, people answering the phone, asking what your symptom is, and then telling you that's not a symptom of pesticide poisoning, when indeed there would be no way for them to know that without full information on all the ingredients in that product. So, again, those are critical issues. We also found out through our series of discussions and invitees to the meetings that Micro-Medics, which provides the information to Poisondex, the poison database, as you've already heard, it's voluntary. They seem to suggest that there was no confidence in the accuracy or the timeliness of the information that they maintained, and I think that's pretty scary. I know -- I live in New Jersey. I've used poison control there. I know other people who have used it, and it's kind of a scary thing to think you could be exposed to something and not truly get all that information, whether it's as an individual, as a physician, as someone assisting you with a problem at that time. And the -- we also had a presentation by Dr. William Meggs, medical toxicologist and emergency room physician from Verdy (phonetic) Medical School in Greenville, North Carolina. He made it clear that he cannot evaluate, diagnose or treat patients who come in after pesticide exposures without complete information on that pesticide product. And in trying to access that information, he's had some of the same kinds of difficulties that individuals -- that have been expressed here. And, again, with the -- having the product label include inert ingredients makes it easy for somebody who has been exposed to a product just to bring that product to the emergency room, bring it to their doctor's office, give them that first step towards securing that information and making some type of medical determination. He also objected to listing inert ingredients in terms of category. So, using petroleum distillates or surfactants, because, again, they provided no specific information on what the composition of that product is. We also have issues of cumulative -- both synergy and cumulative effects when you're mixing chemicals together and so forth. So, again, in that framework, full disclosure of inerts on the product label providing for accurate databases that could be used secondarily, but I don't think that for -- certainly for emergency situations, but even for individuals making product selections, so forth and so on, that the website is where it's going to be. It's really going to be the product. Full disclosure of inerts on the product label relevant to different populations, certainly it's going to protect the public, prevent illness and disability, allow people at substantial risk of harm by pesticide exposure, whether it's an initial one or somebody who's already sick from pesticides having repeat exposure. So, people with allergies, chemical sensitivities, neurological impairments, children with autism, immune disorders, lots of folks who are going to be impacted by both active ingredients, but also clearly by inerts that are in a specific product. Our organization works with people who've been injured, poisoned by chemical exposures, including pesticides and including many of the ingredients that are -- many of the inerts that would also appear in other consumer products. And a series of Federal, State and -- State, EPA and university studies have determined that about a third of the population is -- and the term is "affected by" chemical exposures. So, we're talking about people who are affected by things like, and the list is pesticides, perfumes, fresh paint, new carpet, auto and diesel exhaust. Within that larger population, these studies have come up with roughly -- for example in California, 16 percent unusually sensitive to those types of products. There the list used bug sprays. And then up to 6.3 percent chronically ill or disabled by these kinds of exposures. The point is not that pesticides or the active ingredients are the only thing either causing or initiating this type of illness or triggering symptoms. But the point is the fact that pesticide products, and the inerts, in particular, where we don't know what we're dealing with, can initiate symptoms -- debilitating symptoms, can cause all kinds of significant medical problems for this population. The other key piece is that people who develop multiple chemical sensitivities, the characteristic of that disorder is that they react to more and more different substances and products at lower and lower exposure levels. So, to argue that inerts are just at a low level, this is just a small amount of the product, really is not relevant to the question of whether they are or are not in this product itself. And I wanted to just give a few examples of the need for inerts disclosures in products. For example, the last several years we've had -- we've seen increased use of products that I'm just going to generically call Round-Up, lots of different formulations. And with those products, we've seen more and more people experiencing symptoms from exposures to those products. But we don't know -- and I guess another characteristic is that we have a product where the inert ingredient is actually more toxic than the active ingredient. But what you have there is someone being exposed -- for example, somebody who's very sick from chemicals might call their doctor's office or might call their neighbor before visiting or talk to their school before they go there to find out what types of pesticide applications have taken place, and they might be told, well, Round-Up was applied, and there's no way to know from that generic -- first of all, if we don't know what all the inert ingredients are. Secondly, there's no way to know from the more generic term what was applied, what the ingredients are, what the risk to health or well-being or just the ability to access, go to that doctor's appointment or something, how accessible that really is. And another issue here is the question of chemicals like xylene, for example, or toluene where my impression is that if they're under a certain level, they do not have to be listed on the product label. But let's say the reverse and suppose that instead of requesting or requiring that industry include all inerts on the product label, suppose we were asking them to list every product that contains these ingredients. I know our organization clearly has people who are extremely sick at low level exposures to chemicals like toluene and like xylene. So, again, we're into products that may have these ingredients, but do not have the information available to the public. And the next issue that I guess I wanted to address is the issue of including class names rather than individual inert ingredients. So, for example, saying petroleum distillates, when petroleum distillate formulations can really vary greatly, and it can also vary greatly with regard to the impact on the individual exposed to those substances. Surfactants where, again, the comment can be, well, surfactants, they're in all kinds of consumer products, and I will tell you that there are many people who are sick from all kinds of consumer products. There's no way, again, to know how you are going to -- how this exposure is going to affect you without being able to know what those ingredients are. And another category there is the use of the term "perfumes." According to the FDA regarding perfumes, that they're sort of -- these can be, again, low level, irritant, allergenic neurotoxic, and what we're seeing is that with regard to perfumes themselves, there is actually an FDA docket right now questioning the fact that there are some perfumes out there that are misbranded, that is perfumes don't have to list ingredients at all. But they actually have found perfumes that include hazardous ingredients, but there would be low levels that require them to be on the product label. So, again, I know there's been some discussions on our group that putting perfumes on helps people know if they're sick from perfumes not to buy the product. But I think the reverse is likely true, also. That is, somebody who's reacted to perfumes, chances are is going to get sick from other products there because perfumes can contain up to 4,000 different ingredients, many of which are sort of repeat performers in other categories like surfactants or something. Then the bigger issue with both my own personal experiences, and certainly tens of thousands of people I work with and many others across the country is, what do you do when you're trying to select a least toxic, least problematic product, least harmful to people and so forth. And we can be dealing with people who are any age group, but just as a particular example, working with an 80-year old man who is extremely sick from working with solvents at RCA. He's had radiation damage to his eyes which required -- retina detachments, which required delicate surgery for that. So, he's in threat of losing his vision by solvent exposures. He has a history of skin cancers, melanoma, various conditions. So, he goes to his doctor and says, my landlord at a Public Housing Authority wants to treat my apartment and the surrounding apartments for termites. What do they do? And he is protected under the Americans with Disabilities Act by the Department of Justice. What is a reasonable response to this and the doctor has no way of knowing this because the doctor does not have the full list of ingredients on any of these products to then compare to the health situations this person is dealing with. And although that's more detailed, that's the kind of situation we deal with on a daily basis. Just to summarize, with full disclosure of inerts on the pesticide product label, it's going to make physicians and other medical personnel be able to hopefully make --


MS. LAMUEL: -- I think in the larger picture, physicians more able to recognize pesticide-related illnesses when they see them, it's a really significant issue right now because we see many people who have been exposed to pesticides, maybe children or teachers in schools, they go to the doctor, the doctor doesn't make any connection, if they sort of associate it with that exposure. And so, it's a really serious issue for doctors to either miss these situations or, you know, just, again, not being able to put the pieces together. I think it's going to make the public totally sort of be in a healthier situation. I would hope it's an incentive for industry to manufacture products that are less toxic. And -- let's see here. Oh, the other issue in terms of the use of inerts and everything, I think inerts has been -- I know when I first got involved in these areas nearly 20 years ago now, that inerts is one of those words where you hear it and you think inert, innocuous, it's a really tricky and ambiguous term and everything. And I think that many people in the general public don't think that, you know, when they hear that term, that this is of any significance to them, and the other piece here is that -- and this has to do with sort of what information do you give to the public, but I think to presume that the public is sort of stupid and ignorant and doesn't really have an interest in inert ingredients is almost to sort of dummy down the public. I think if they understood what they were seeing there, and certainly there are savvy consumers who are going to want to know, who have kids, who are going to want to know what these pieces are. But I think that presenting this information to them with, you know, sort of a background of education, certainly you have a lot of savvy consumers out there who want this, is really the best way to go. Thank you.


MS. LAMUEL: Um-hum.

MS. MULKEY: I think we need to do an agenda check. I had hoped and expected that we would be able to complete these presentations before our break, and now we're well past the time for our break. I think, however, for coherence, it would be good if we could get the last piece of the puzzle on the table, and then do a little thinking about how to manage the rest of the time. So, Bruce is going to do that. But we're mindful that we're pressing you guys.

UNIDENTIFIED MALE: The last presentation comes from page 23 of the draft document. And what it basically is is a collection of four or five additional ideas that are probably supplemental to the major proposals that you've already heard. These were put together by Brad Mitchell, who unfortunately could not be here today to present these. So, what I'm going to do is just quickly highlight the four or five ideas that he has presented there on page 23. The first is that he believes that label contact numbers for inert information would be the most direct and effective means of putting customers and others in touch with the customer service providers that could be used. A second idea is one that has actually come up in context already of a couple of the proposals. This is -- or at least in the discussion of them. This is the database of inert information for health care providers. As has been mentioned already, a couple of -- a couple of types of these already exist, but they do have drawbacks in terms of not being as complete as some would hope. And Brad is suggesting that we look further into this and develop a more robust, a more complete database, strictly for the health care providers, the emergency situations. The other -- he has two other last items. One is one that's been discussed before. This is the business of looking much more closely at the use of more general descriptors so that instead of -- so, for fragrances, instead of listing every kind of fragrance, this is the example he gives, it might be sufficiently useful to most readers just to list the fragrance itself. But there's a lot of different general descriptors that could be used for classes. Of course, the key here would be to come up with ones that actually get you to where you need to go, the kind of information that really is useful. The other is an idea that if, in fact, there's going to be a voluntary program to put a listing of inerts on the label itself, that we should be -- the agency should be looking into the possibilities of incentives for that. And there's -- these could come in a number of different forms, and Brad doesn't lay them out. But I think some of them have actually already been mentioned even today. But that's -- that's a very quick synopsis of Brad's ideas, which have been endorsed by a number of the members of the subgroup itself. So, at this point, before we get into questions and further discussion, we're going to go ahead and take, I guess, a 15-minute break.

MS. MULKEY: Well, let's try to keep it to 10. And during your break, I'd like you -- those of you who have not been engaged with this workgroup and who are hearing this report and have an opportunity to give some special thought to what you think we ought to pursue in next steps both in substantive terms, what content of a policy ought we to be looking at, and in process terms, you know, having benefitted from the work of this workgroup and from your input, what additional process and what substantive answers. So, we'd like to hear from you on that when we get back at 20 till. (Whereupon, a brief recess was taken.)

MS. MULKEY: Thank you for reconvening so eagerly and promptly. We know that you're beginning to flag a little. I know that because I'm beginning to flag a little. We have put ourselves forward with a very hard-working day. But this topic that we're spending so much time on this afternoon is an example of a topic where this committee, through a workgroup, and through its own investment, has, at this point now, invested an enormous amount of energy, hard work, information gathering, perspective airing. You could hear through these presentations references to information that the workgroup gathered and heard from throughout. You got a sense, I think, of divergence of viewpoint, but you also got a sense that these viewpoints have gone past the sort of first knee-jerk level, and that people are answering each other's arguments and answering the answers to each other's arguments, and advancing the public policy debate to the point where we have a very, very thorough airing of a set of public policy issues, for which there appears to be more than a single answer embraced within this group of viewpoints. This kind of work can be enormously valuable to the agency and, in fact, what the agency does when it tackles a public policy issue is a lot of the same work this workgroup did; try to seek out expert or resource information, try to sort through the competing viewpoints, try to be sure they're given their fullest and most comprehensive articulation, and try to evaluate the quality and caliber of those points of view and the information amassed in support of it. So, we are coming close to being able to harvest all this work and convert it into agency policymaking, having been presented with a lot of the early stages work that would go into any policymaking, information gathering, development of options, all of that kind of thing. So, we're really very excited about that. Would it be better if this workgroup had presented to you and then you to us a single consensus point of view that we could instantly then implement? Well, it would have been easier. But that doesn't, in any way, denigrate the value of what we can receive. However, this is a workgroup of this larger committee, and it is from the committee that we receive our advice. You will remember there have been some instances before when you've elected to just encourage us to take the material developed by one of your workgroups without your adding, altering it in any way, and that is an option here. But we hope -- we suspect and hope that you have some value to add, based on the work they have done, and so, we invite you to begin that process, if you will, now. And I'm glad to see a lot of you eager to enter that dialogue. And since I had a blind spot to Win earlier, I'm going to start by calling on him.

DR. HOCK: Whoa. Well, I just had a question for the group. What role do you see the National Pesticide Telecommunication Network playing at Oregon State University in disseminating information particularly on inerts? They do have a physician hotline, they have a consumer hotline. I'm just wondering, has that been given any thought?

UNIDENTIFIED MALE: Let me start on that. That was considered. There was a description of what the hotline does and I think there was a recognition that it was not probably going to be complete enough so far, as currently designed.

MS. MULKEY: Okay. I think I'm going to just go around this time. I don't always do it that way, but there are enough of you -- I think that's the way we can go. Melody?

DR. KAWAMOTO: Thanks. I'm really glad that this committee is dealing with this issue since it's been something that I've been having to deal with in training workers in understanding that inerts does not mean non-toxic to humans. I have a question for Julie about the calls to the -- for information about inerts, because one of the things that I -- in terms of public health importance, is not just frequency, but the severity of the numbers of cases that get reported. So, I was wondering, what kinds of calls were these .04 percent of calls for information in the past year, I mean, in terms of relative severity?

JULIE: These were requests for information. It was not -- this was not in response to -- this was our product information line. This was not the emergency -- we do have a -- you know, a medical emergency phone number. They have all of the inert and ingredients information available at that center that's through a contracted poison control center which has all of that information available. So, what I was referring to was more the general interest that users of the product have in this information. You know, I think the -- just to get the relative numbers that we -- this year, I think our unit sales, it was about -- close to five million actual unit sales, and so out of those five million, 14,000 people called -- you know, picked up that container and called to say, I want information generally. More often, it's they want information about, can I use this product here, can I use it there, will it hurt my -- you know, this plant or that plant, you know, those type of questions. That's -- it was just -- this was just the general product information line. That is not one of the areas where people are generally looking for information. It wasn't meant to be (inaudible).

DR. KAWAMOTO: Yeah. I guess in that case, I'd like to know more information about what kinds of calls were made to the emergency. So, I think that kind of information would be important.

JULIE: I think that most of the information that goes in -- I mean, most of that is reported to the agency under 682, as far as any severe incidents, that would be reported by products under FIFRA Section 682.

MS. MULKEY: Did the workgroup look into the 682 reporting and see if there was anything that could be identified as specific to inerts?

UNIDENTIFIED MALE: Actually, Kerry, are you -- okay, it doesn't look like Kerry is here right now. I think we did discuss, at least, the possibilities, but I don't think we did a systematic look at 682 just to look at a survey to see how many actually were related. Do you happen to have any information on that?

UNIDENTIFIED MALE: Off the top of my head, I don't know. I think Jerry Bondell (phonetic) did (inaudible) a little bit with his group and probably has some more information than (inaudible). I don't know that we've -- we didn't spend any significant time looking at the 682. Presumably, that would be because there weren't 682 reports specific that we got (inaudible) specific to inerts.

UNIDENTIFIED MALE: Right. I think one problem you've got with the 682 is that the 682 usually comes in linked with a pesticide product and it's hard to know what inert actually is the linkage. So, it's hard to do statistics on that kind of thing.

MS. MULKEY: Okay. Brad?

MR. JOHNSON: Thank you. Two concerns that seem to have been described consistently just prior to the break were the lack of detailed inert ingredient information and also the lack of timeliness, especially in getting that inert ingredient information available through FOIA. I'm wondering if the working group has looked at the releasable summary proposal from industry just to see whether or not that will really meet some of the needs that were articulated, especially with respect to what health care providers and emergency room physicians may need; i.e., does the releasable summary get you, you know, 80, 90 percent of the way towards what the need originally was?

UNIDENTIFIED MALE: I think the agency has definitely heard their proposals and has definitely got -- individual staff members and so forth, we've discussed it and so on. But we don't actually have a position on any of the proposals so far as to workability, let's say, or their advantages and disadvantages. I think that's what we're still in the middle of doing.

MS. MULKEY: And partly looking to you to -- I mean, your point, I take it, is we ought to really focus on that and see how much it gives you.


MR. JOHNSON: Thank you.


MR. NICHOLSON: Well, I had a comment, a process suggestion, and a question. First, I'd like to give my thanks to the working group. The information we were provided was tremendously helpful, as a first-time participant in this process, to have the background and read the different points of view. So, my thanks to all of you who put your hard work in putting that together. With regards to the proposals, I think one of the things that was troubling for us, especially from the industry perspective, was that farmworkers were absent from the picture. I think it's important to remember that as we talk about these chemicals, that farmworkers are the one population that are almost working in this environment that has been treated with pesticides on a daily basis. Their families often live in areas surrounded by fields that have been treated with pesticides, and their children are playing in those areas, not to mention eating those foods. So, I think when we're talking about who needs this information, I would take that to a different level and say, who has a fundamental right to this information. And if there's any populations, the farmworker population, that should know the active ingredients they're being exposed to in the workplace and the inert ingredients as a matter of basic rights. In terms of process, I would propose that the EPA merely initiate rule-making to institute labeling of inerts. There was the 1996 decision. It's been five years now. I think five years is more than enough and I think it's time to initiate a rule to require the labeling of inerts on pesticide containers. And finally, with regards to industry, I do have a question to the manufacturers. As I understand, the working group came together over a year ago. Have any of the manufacturers already institute voluntary labeling of inerts, and if no, why not? Thank you.

MS. MULKEY: Does anybody want to field that question?

JULIE: Well, I can answer to, have any manufacturers, yes, in the format that was presented that is with the more generic descriptions. In some cases, depending on the nature of the ingredient, it may be very specific. We have one product that has one inert ingredient and it's corn cob. So, it says -- the label says, other ingredient, corn cob. So, that -- you know, depending on the nature of the product, it may be very specific or in the case of fragrances, we have just listed fragrance or preservative or surfactant. So, it's -- there's no -- we have not taken a one size fits all approach, but we've tried to put what we thought was useful information.

MS. MULKEY: Do you know if any other companies have, Julie?

JULIE: I've seen it on some products. It's not -- I don't know that there's a universal approach at this point.

UNIDENTIFIED MALE: I would like to point out that, in fact, farmworkers were considered -- it may not be reflected in -- as well reflected as you would like in the paper itself, but, in fact, we did have representation and discussion of that area -- of their needs.

MS. MULKEY: Okay. Alan?

ALAN: I, too, would like to urge the agency to initiate a rule-making process that would require manufacturers to disclose fully all inert ingredients. It would seem to me that the medical profession is not satisfied with the level and the timeliness of information that's available under present circumstances. Otherwise, in the report titled, Educational and Informational Strategies to Reduce Pesticide Risk, the Council on Scientific Affairs of the AMA would not have made the following statement: "Support all efforts to list both active and inert ingredients on pesticide container labels and material safety data sheets." In preparing for the meeting, I tried to find out some information about how common pesticide poisoning was, unsuccessfully. There are a large number of cases, and most of them, in emergency room circumstances, involve either accidental or intentional ingestions by children. Erik mentioned agricultural workers. One report that I came across from the NCI said that about 16 percent of agricultural -- participants in the agricultural health study had at least one significant exposure to pesticides. Data available in the IHANES III (phonetic) report and the National Exposure Reports on reporting the prevalence with which pesticide metabolites are present in the blood and urine of everyday humans who are walking the streets of the United States indicates that almost all of us have detectable residues there. So, this is a widespread problem. Schools, agricultural institutions, state and municipal governments and other institutions are going to be interested in looking at this information when they make decisions about which products to purchase for use in their particular location. We've heard about the community right-to-know. In medicine, we call this informed consent. It's a bit more of a deliberate step where it's the responsibility of the health care provider to inform his or her patient about the course of an action so that they can make a decision for themselves as to whether or not to accept that recommendation. Without the information, that process can't take place, and I would submit that, to some extent, we're all undergoing a medical experiment without informed consent in terms of the exposure to inert ingredients as well as the active ingredients in pesticide products.

MS. MULKEY: Thank you.

MS. HARDER: I have a comment and a question. The comment is to include in your document tribes, also, as an audience or a group. For instance, in chart two on page four, you include Federal, State, Tribal, local regulatory agencies. I think that would be a really good idea. And then my question is, is for tribes who want to find out information about inerts for monitoring purposes of whatever, what is the mechanism or process that they would go through? Would it be the same as a state?

UNIDENTIFIED MALE: Could you please repeat the question again?

MS. HARDER: What would be the mechanism or process that tribes would go through to get inert disclosure on a product?

MS. MULKEY: I think that -- it's -- Don's here. Why don't you field that? Don's from our General Counsel's Office.

DON: Thanks. One of the issues that's unstated so far today is the ability of state and local and tribal regulatory agencies to get inert ingredient information. Because the inert ingredient information is frequently claimed as CBI, there may be barriers to getting that information directly from EPA. We do not, under FIFRA, as we do in some of the environmental statutes, have authority to provide CBI to states. So, there may be a means of getting it if the information is already public or -- directly from the companies. But if it is claimed as CBI and a state or tribal authority asks for it, unless we go through our process and determine the information not to be entitled to confidential treatment, we may not have the authority to give that information out.

MS. MULKEY: And that's true for states, too. I believe that in this area, you have about the same authority the states do. States regulate pesticides and very few tribes, if any, have that authority. So, states may have their own independent authority that tribes may not have. But as far as vis-a-vis EPA and the information EPA has, I think tribes are similarly situated to states. Okay? Ray?

MR. McALLISTER: One of the proposals we heard about was specifically based on a petition that was filed for a rule-making to disclose pesticide inert ingredients. I'd like to ask either Marcia or Jim to explain what happened with that petition.

MS. MULKEY: We responded to the petition by denying it, and the petition expressly requested that EPA require that all pesticide inert ingredients be released or be disclosed, and we found that we lacked the statutory authority to require that every single one be disclosed, that under the statute, we could make the finding that it was -- help me out, Don. But there's a statutory finding that we could make about hazard that could require disclosure and under the NCAP decision, we could require disclosure of all that were not CBI, but there is some universe that is -- neither qualifies for the hazard finding and is CBI, and that universe, we wouldn't have the statutory authority, and therefore, we could not grant the relief as it was requested. So, it was a very -- I'll say it right here publicly -- legal technicality denial, and we said in the response that this did not represent a policy point of view regarding the desirability of broad disclosure of inerts one way or the other. Does that answer your question, Ray?

MR. McALLISTER: Yes, thank you.

MS. MULKEY: Thank you. Did I get it right, Don?

DON: You did fine. (Laughter).

MS. MULKEY: Right enough, not to embarrass me. Is that what you're trying to say? (Laughter).

MS. MULKEY: If there's a provision you think you should add, feel free.

DON: No.

MS. MULKEY: Okay. Warren?

DR. STICKLE: Well, I was going to raise the same question that Ray had raised. The real question here is we've just heard four different proposals, and very candidly, the one from industry is asking for a pilot project to move forward on some generic terms. I think that's workable. I think it's doable within the statutory authority of FIFRA. I'm not sure, however, that the other proposals that we've heard today could be enacted under the statutory authority of FIFRA under Section 10 and the very things that you cite in the letter of early July of last year. So, I think there's potentially a conflict between some of those proposals and some of the various statutory authority that you were talking about.

MS. MULKEY: Is it your view that if there were -- if they were implementable in a statutory way, is it your view that that should be the primary way in which we sort them through?

DR. STICKLE: Well, I think it's important from the manufacturer, formulator and distributor perspective that we look at the protections of Section 10 and to make sure that information that's claimed is confidential information is treated as confidential information and not disclosed. I think that's really the cardinal principle that we're talking about here. I think, on the other hand, the industry proposal for a voluntary set of disclosures that reach a variety of different areas that the agency has had before it, I guess, for a year, a year and a half, is something that could be implemented immediately, would solve most of the problems. I think we had one speaker earlier saying, well maybe it solves 80 to 90 percent of the problems, but it's something that is doable, something that the industry would be willing to work with the agency to do, and would be within the statutory requirements of FIFRA.

MS. MULKEY: Okay. Ray, since we're -- otherwise, I have a clean slate here. I'm going to pick you up again before I turn the corner.

MR. McALLISTER: I appreciate that, going a bit out of order here. One of the other models was based roughly on the cosmetic regulation model where cosmetics regulated by FDA are not -- the ingredients are not granted automatic CBI status, but must request it and be granted on a case-by-case basis. It's my understanding, and if there's somebody from FDA here who can amplify it, it would be helpful, that cosmetics are regulated to a much lesser extent than are pesticide products, that there's not a great deal of testing, if any testing, required to be done on the product or the ingredients. Therefore, they -- in exchange for -- possibly in exchange for a lower level of regulation, they reveal their ingredients. On the -- because it's something that's applied -- obviously, it's applied directly to the human body, but where pesticides are tested to a much greater extent and are much more closely regulated, it's an argument for maintaining that confidentiality of the ingredients in order to maintain the competitiveness of the products and the markets.

MS. MULKEY: Well, I don't know if Michael's part of FDA would give him any insight into whether this represented some kind of trade-off between regulation and information. But --

MICHAEL: I don't think so. It's true that cosmetics don't require pre-market approval as do pesticides and food additives under the FDA scheme would require pre-market approval. But the food additive requirements for pre-market approval were initiated in 1958. There were labeling requirements for foods going back to the 1930s. So, there have been -- it's just a historical development type thing where, as time went on, some substances that had labeling disclosure ultimately got pre-market approval added onto it. But I don't think you could say that this trade-off is inherent in the way that cosmetics is regulated.

MS. MULKEY: Okay. Well, we'll turn the corner. Before we hear from at least three people on this side, we might note that -- I may have been wrong, but I don't think any of our commenters on the right side had actually been a member of the workgroup.

UNIDENTIFIED MALE: Other than the last two.

MS. MULKEY: Oh, you two guys were. I should have said this before I got to Ray, that, obviously, the folks who were a member of the workgroup have the benefit of having had their voices heard there, too, and also of having a more complete understanding of what the work of the workgroup was. Michael Surgan was also a member of the workgroup. He's here today at the request to substitute for the Environmental Defense Fund, participant on the PPDC, but he was a member of the workgroup.

DR. SURGAN: Thank you, Marcia, and Margie asked me to please qualify. You've already done half of my requisite qualification. Although I'm here by the indication of the Environmental Defense, I don't pretend to speak on their behalf. I'm here representing the views of the Attorney General of the State of New York. And I want to emphasize that I'm representing the views of the Attorney General and not the State of New York, which is an important point, and I think it directly leads into one of several comments I want to make and then a question I'd like to ask of EPA. In Wally Puckett's presentation, he referred to two of the supplemental papers, 8 and 8A, discussion papers that were submitted by Brad Mitchell and Eileen Mahoney, neither of whom are here. And those were surveys they conducted of certain governmental institutions and they reported the results of those surveys. Although Wally didn't specify, I think it's important to note that the surveys were of representatives of state agencies that have pesticide regulatory responsibilities, and as such, they have access to a vast store of ingredient information that is not generally available to other state and local government agencies. And, of course, that informed their answers as to whether or not they have enough information to do their business and maybe to answer public responses. I would note that in Brad's version of the survey, he did ask the representatives of these regulatory agencies if they thought that more information should be publicly available, and seven out of eight or six out of seven said that, yes, they agreed that the public should have more access. And that's in discussion papers 8 and 8A. I wouldn't want to leave the impression that those agencies speak for government agencies any broader than I do. It's also interesting to note that in Massachusetts, while the representative that Brad spoke to of the Massachusetts Regulatory Agency, said that they thought they had enough information. When the states filed the petition, both the Attorney General of Massachusetts of the Executive Office of the Environment, which is an independent gubernatorial agency, joined in that petition asking for the general release of -- the general labeling of inert ingredients on pesticides. So, even in Brad's own state, there's a significant difference in opinion. Talking about government agencies, but perhaps generalizing a little broader as to institutions, when Julie spoke about the Consumer Labeling Initiative, I think it's important to note that that represents the findings based on an inquiry of a limited segment of what are, in the broad sense, consumers, government agencies, institutions, be they Boards of Education, school boards, Departments of Transportation, housing departments, law departments, all have to, A, conduct their business and whether that's a legal prosecution or making a decision about pest management in their own agency. And those government agencies do not have access to this information any more than, as Lori pointed out, the tribes do not have access to that information. So, we're all in that same boat and it's very dangerous for people to generalize about institutions, about consumers and about government agencies. I do want to ask one question, and perhaps I'll direct it to you, Marcia, although I realize it may be answered from my left. When Cameo gave her brief overview and in discussion just a moment ago, it was stated that the agency has authority to make case-by-case determinations when disclosure is required, and you pointed out that the Court set certain limits on that. Is there anything in the statute that dictates the point in time when that decision is made? Is there anything that would prevent that decision from being made during the registration process rather than some time down the road when we're trying to respond to, perhaps, an emergency situation?

MS. MULKEY: You want to answer that, Don?

DON: We could have a private little discussion here, but the answer to your question is no. The -- there are a number of authorities involved for the case-by-case determination. One of them is whether disclosure of the identity of inert ingredients is necessary for there not to be unreasonable injury to human health and the environment, and that, of course, is a decision that can be made during the processing of the application for registration. It's also a decision that can be made with respect to an existing registration. So, no, there is not a time limit on that.


MS. MULKEY: That's also true for the CBI determination as well I take it.

DON: Right.

MS. MULKEY: It could be structured so it's made at any time. Is that right, Don?

DON: That is correct.

MS. MULKEY: Okay. Julie?

JULIE: Just to clarify, I think, an earlier point that was made with regard to a 682 reporting, and then also about not knowing the effects from products. One of the differences, I think, with pesticide products versus cosmetic products is that the products are tested as a whole. The whole formulation is tested or a surrogate of a very similar formulation is cited. Sometimes a product that's maybe a lot more diluted may cite a more concentrated product. But in that manner, the products are tested for their effects, and I think some of the effects that you see -- the reason you can't discern necessarily what is from the inert or from the active is because it's really coming from the formulation as a whole. I think we see -- a lot of the incidents that we will be reporting are things such as eye irritation because somebody got the product in their eyes. That is not necessarily -- it could be a result of the inert ingredient, it could be the result of the active ingredient, but it's really coming from the product as a whole, and that's what is tested. That is also what we are -- that we put our label precautions on. Unlike cosmetics, as well, there is a requirements for all FIFRA products that based on the toxicology categories and irritation categories for the products, that certain precautionary language be on the label. They also require first aid information as mandatory on pesticide labels, based on the toxicology categories. So, instead of having to make those decisions or those determinations on an analysis of the ingredients, that information is directly provided on the basis of the formulation as a whole. And going back to -- you know, I don't think I elaborated on it too much, but the -- consumers indicated the information that's most important to them, that is precautions and the first aid information were two of the areas that they deemed was the most important, and that is something that is provided on our products that isn't necessarily on other types of consumer products. I guess just one last comment. I don't think that I represented -- tried to misrepresent the information that we were providing as being indicative of any -- beyond the consumers that we surveyed. We were looking at consumer users of these products, and so, I apologize if there was any -- that was misrepresented as trying to indicate it was any audiences beyond that.

MS. MULKEY: You were looking at household type consumers, I take it, rather than institutional?

JULIE: The three -- yeah. The three product categories that we specifically surveyed were lawn and garden pesticides, household insecticides and household cleaners, hard surface cleaners in particular. Now, some of those same products might be used in an institutional setting, but they would typically be used no differently than the consumer would use them, I would think.

MS. MULKEY: Is the next card Jose or Janine (phonetic)? I'm sorry.

JANINE: A comment, actually, on the idea that consumers should drive what's on the label, which has been brought up repeatedly. I think if consumers were driving these kinds of issues, then consumers would eat organic, because I would consider that the more informed choice. I think that to continually say how many consumers want inerts on their label is really a moot point of .0001 percent of consumers are in a situation where their child is the one who swallows the pesticide and they need to go to the hospital, or they have multiple chemical sensitivities, or their child is the child that has some kind of severe allergies and they need to know what the inerts are when they purchase or when there's some accident or when there's some accidental exposure. That's enough of a consumer group to consider it important to have that information readily available, immediately available and not by FOIA. Also, with regard to -- I think it was a very interesting distinction that the phone number that you had cited actually, Julie, is not your 1-800 hotline, which I would consider the more important indicator of how many people in a situation need to know more than what's on the label, and not in terms of what the conversation spun to, which is whether they're sending Section 18 reports or 682s on whether there's a known inert that caused a problem. I think what's interesting is that there are consumers who phone in who need more information than what's on the label. And even if those are very few, they deserve that information. That's important. I mean, I think when the thimerosal issue hit the front page and actually four days before the thimerosal issue hit the news, when it actually hit the awareness of the Federal agencies and emergency meetings were called all over the place and all the doors were closed so that nobody was talking about it for four days, there was, I think, an understanding that inerts are really important. The thimerosal issue was the mercury in vaccines, which turned out to, in some situations, be as high as 40 micrograms per deciliter, which is four times the allowable limits that children would be getting, and these would be infants.

MS. MULKEY: The mercury in vaccines?

JANINE: Vaccines, yeah.


JANINE: It was considered an inert. It was considered a fungicide, and the vaccines were being shipped in non-refrigerated or in storage containers where there were multiple dips, and it was never labeled for the 20 years it came out. So, I just think that to point out that I don't think that consumers should be driving these labels as a whole, I think that the consumers who need that information should be driving this decision, and there are definitely people who need this information and have a right to it.

MS. MULKEY: Just -- those of you checking your watches, the good news is that, as far as we know, we have no public commenters. We may have, because we lost the sheet after the last time we checked. (Laughter).

MS. MULKEY: It had no names on it, but we clearly don't have 30 minutes worth of public comments. So, while we know that we want to have and we will have a discussion about topics for future PPDC, we do, I think, have an opportunity to conclude this dialogue. Sean?

MR. GRAY: I'd just like to support the idea that we need -- EPA needs to undergo rule-making immediately and there needs to be full disclosure to whatever extent to the law of all inert ingredients on the labels. And I just want to bring up the issue of CCA-treated lumber and the "voluntary" program which never was implemented on these consumer information sheets for 15 years. And it's just -- it's another situation where the agency can make the right decision and not support a voluntary program. It would end up just in utter failure. That's basically no to voluntary.

MS. MULKEY: Okay, thank you. Adam?

MR. GOLDBERG: Yeah. A quick question for clarification. I just want to make sure I understand this. Is there anything in the current law that prevents the pesticide manufacturer from listing the inerts on the label?

MS. MULKEY: Don, do you know of anything?

DON: No, nothing that I know of. The only possibility that I could think of is, if the registrant has an agreement with the supplier regarding the identity of the inert ingredient, the registrant might be violating its own contract by putting that information on the label. But other than that, I can't think of anything.

MR. GOLDBERG: So, basically what we've had is we've had the pilot project and the manufacturers have volunteered not to put the information on. So, if you believe that consumers have a right to know what's in these products, which we do, then there should be labeling and a voluntary program, then get to the labeling, because they already have the ability and the right legally to voluntarily label. So, we would certain think that it's time for a rule-making.

MS. MULKEY: Okay. Lori?

LORI: Actually, my major question was answered previously. But I do have a question and since I'm new to this discussion, I just was wondering, what kind of information is available on the reported incidents of problems in this area? If someone could address that, I'd really appreciate it.

MS. MULKEY: Do you mean incidents reported to EPA under the Section 682 requirement that registrants report incidents of -- is that what you mean?

LORI: No. I'm talking about people becoming ill or having symptoms that they suspect are due to inerts.

MS. MULKEY: Did the committee -- was it Cameo? Do you know whether there was enough information gathering on that issue to --

MS. SMOOT: We touched upon that just for a moment. Unfortunately, Roseanne Solliway (phonetic), of our American Poison Control Centers, who was on the subcommittee, is not here today. I don't think we ever got into a white paper, so I can't give you a statistic per se. It was discussed. There are some that feel that if you have at least the name of the inert ingredient, you would have a place to start, by process of elimination. There are those that say, most of the time, it's the active or it's the symptoms. So, it led down a different path --


UNIDENTIFIED FEMALE: -- particular question.

MS. SMOOT: I wouldn't -- we never went down that path. So, we don't have a discussion paper that talks about that specifically.

UNIDENTIFIED FEMALE: I would be really interested just to have that statistic. I think it would be a valuable piece of information as part of the whole discussion.

MS. MULKEY: And what you're asking is, what indication poison control centers have that they are seeing episodes that are associated with pesticide inert ingredients?


MS. MULKEY: Okay. Steve?

STEVE: Actually, just a quick follow-up to that question. It's fairly important -- one would think that would have been actually the first thing that we would have looked at as, actually, what is the incident rate of inerts being a problem. And I have no clue other than anecdotal information that we've heard here. Secondly, this is a serious problem that I think -- I'm glad you guys are trying to make the decision and not me.

MS. MULKEY: Well, this is why I said, those who don't have a defined point of view because of your job, you might be real helpful to us. (Laughter).

STEVE: Well, I can certainly understand the issues because as a manufacturer of food products, we have the same kinds of things. We are users of others' ingredients and we want to know what's in those ingredients, particularly with concerns for allergenicity and those kinds of things. At the same time, we need to protect those business confidential pieces of information, those trade secrets that we might be able to -- canned food doesn't have a whole lot of trade secrets, I'll admit to that. (Laughter).

STEVE: But such as they are and we are certainly protective of processes that gain us some difference and some value that some other company, if they took advantage of, it would be a major impact on our company's ability to make that difference. So, we're stuck here between those kinds of issues, and certainly, no one wants to do this at the expense of someone else's health. So, the question becomes, there's a fairly -- it seems, a fairly narrow limited group of people, although we -- again, we don't know how many people. But a limited group of people who need to know about inerts and what those inerts might be, so that judgments can be made about their sensitivity. Is there a way in which, and I think maybe this compromised piece that was presented by Shelley, I think, sort of guessed at some of that. Are there some compromised ways to provide information, make your information available, without a full statement of all ingredients to protect confidential business information. I guess one of the questions is, did EPA or did anyone take a look at what that might cost to be able to go through a sort of hazard identification for all inerts and the cost to both EPA, to make that judgment, and to the companies to develop that information?

MS. MULKEY: Well, I'm not sure I understood that last question. Did you guys who were closer to it understand that last question? (Laughter).

STEVE: Well, maybe I didn't state it exactly --

MS. MULKEY: Are you asking about --

STEVE: There would clearly be a cost to identifying hazards that are among the list of inerts you have. If you were to say, we want to maintain a certain number of these as confidential business information and show why you wanted to do it, and you had others that were clearly designed as hazardous and you had to identify, there is a cost to regulating that. There's a cost to you guys doing the work and there's a cost to the manufacturer developing the information. Do you have any sense of --

MS. SMOOT: No. We, obviously, have not gotten that far. Part of why we're here is to help you help us pick a direction. So, it's certainly a question that we could ask. We have Kerry Liefer here, who's known as Mr. Inerts. He certainly can tie some of the hazard information -- I don't know how much cost he's actually familiar with regarding inerts. But that's --

MS. MULKEY: I think I, at least, understand the question now.

STEVE: Yeah.

MS. MULKEY: There are really two governmental exercises that might be undertaken. One is an across-the-board evaluation of CBI claims and whether they're valid or not, and that would clearly have a governmental cost, a fairly substantial governmental cost, if claims were broadly made. Obviously, if a lot of them were waived, that would be a lower governmental cost. So, I know there's been some thinking about that. The issue of evaluating the inerts, those that are food use will go through tolerance reassessment. So, we will have to invest in that exercise for tolerance reassessment purposes. Do they also go through reregistration? Help me out here, somebody. Not per se.

UNIDENTIFIED FEMALE: Well, they do at (inaudible).


MS. MULKEY: And then, of course, new inerts that are authorized for food uses also go through an exercise. So, there is, to some extent, for some significant subset of inerts, that price has to be paid anyway, sometime. Now, maybe that's a partially helpful answer to the question.

STEVE: Yeah, yeah.

MR. KELLNER: Marcia? Marcia?

MS. MULKEY: Yes. Who's speaking?

MR. KELLNER: Marcia, this is Steve Kellner. Can you hear me?

MS. MULKEY: Yes, Steve.

MR. KELLNER: I didn't hear all of what you just said, but I just wanted to see where we are on the inerts policy regarding repositioning of the list. Is that what you just referred to? In other words, at one point the agency was going to take a look and move the inerts on the appropriate list, list one, I guess, or list four. And --

MS. MULKEY: We are working on it.

MR. KELLNER: -- I was just wondering, is that still in the cards?

MS. MULKEY: That's a good question. It's very relevant to Steve's. We are working on issues about -- especially ingredients that we think ought to move to list one and ingredients that can move to list four, list four being the very benign and relevant to the biopesticides and others who want to qualify for use -- for exemptions or for use in organic certification. But that doesn't really get at this issue that Shelley was talking about, which is she identified a substance that was actually on list four that was a potential allergen. So, I'm not aware that any costing has been done of what it would take to look at all of these inerts fresh with an eye to allergenicity. I mean, that particular question, which is lurking inside what you asked --


MS. MULKEY: -- I think is a harder question for us. And that may make it make sense to call on Shelley, whose card happens to be next anyway.

SHELLEY: Just a couple of quick points. One is that on our committee, we did have Sheldon Wagner and Roseanne Solliway who work for, respectively, the EPA Oregon hotline and American Poison Control Center Association. So, we had the benefit of folks who handle these emergency situations and they felt that the generalized description that the industry proposal includes, like saying surfactants, for example, would not be adequate for handling an emergency situation. I don't know where the number 80 to 90 percent comes from, but in all the year plus that we've been deliberating, I never saw anything that would remotely indicate that a voluntary program would get us 80 to 90 percent of the information we need. Far to the contrary, I think, as Adam pointed out. If voluntary would have done it, we should be there already, and we're not. I think that it's also important to reiterate that the statute allows for the process -- the flip-flopping of the process, which is what we're proposing. Have an upfront determination that there be disclosure or that the CBI be substantiated, and this did come up very specifically with OSHA, because in their MSDS process, inert ingredients, amongst other things, are disclosed and the OSHA folks said, when it really was time to put up or shut up, basically most manufacturers basically folded and put the inert ingredient on the MSDS. I wanted to -- one more point. On the question of incidence -- and this is -- I'm not a doctor, I'm a lawyer, so the doctors out there can probably be more helpful, but this was my general understanding from the issue of are there incidents related to inerts? Sheldon Wagner specifically said that he had seen some cases that he believed very strongly were related to inerts. But it's a very difficult thing to know when you don't know what the inerts are. All you have as a doctor are that people have some symptoms and those symptoms do not appear to relate to the active ingredient. But not knowing what the inert is, you can't really say if it's related to the inert or it's just not related to the pesticide. And, as Sheldon has said, there are many things in pesticides for which there are not definitive tests. It's not like you can say, well, we'll give you X test and that will show that you are being harmed by an inert. So, I, a little bit, think that although that would be a great fact to know, that it's unknowable, and just, as an aside to that, I would just say that, in general, we don't really have accurate national statistics on how many people are harmed by pesticides -- by pesticides active ingredients. So, generally, our statistics in this area are very weak.

MS. MULKEY: After we hear from Ed, we will have left only cards from folks we've heard from who also were on the workgroup, and while we will try to hear from them, we will ask them to try very hard not to repeat just to be sure that we heard what they said. But we will get back to them after we hear from Ed and then I am hopeful that all of you who feel you can really participate -- those of you who were not on the workgroup, because we do have the benefit of their work product, but the rest of you will really feel you can participate in our deliberations. We'll either take the opportunity now, or this is a particular area where I think we want to try to benefit from your point of view through some additional mechanisms over the next brief period while we turn to -- and you've offered very little by way of advice for us in terms of process. So, while we don't want to start a whole new wave of dialogue, if you have some thoughts about that, we'll try to find some way to get those beyond this meeting, too. Okay. Ed?

DR. ZUROWESTE: Well, I'd like to thank the workgroup also. It was a great education for me to read over all this material, and I think my preference would be to have total disclosure of the inerts. That would be my preference. But if that becomes impossible, or if it becomes so problematic that it's going to take years, I think I would be comfortable with endorsing the proposal that Shelley Davis presented to us. I think it is a good compromise between the right-to-know and to protect the true CBIs, and I'm getting the sense -- I'm very naive to this, but I'm getting the sense that there are a lot of CBIs that aren't really true CBIs, and if we really melted that down, that it would not be that tremendous amount of number. I really don't know. As a family doctor who's worked for over 20 years with farmworkers, and in talking to my colleagues all over the country, inevitably, it's 8:00 at night on a Friday night when we get this patient in, either our office or the emergency room, and I'll tell you, the 1-800 numbers are very problematic. It's certainly -- you know, there's nothing more beneficial than having every ingredient on an exposure right in front of you. If you have to start doing that second step and the third step and the fourth step, and you're in a situation like that, it becomes very problematic. Even if it's just irritation of the eye or a rash or whatever, once you have to go through several steps, it becomes more problematic. I also just -- and Julie already pointed this out, but I just wanted to make one comment on the consumer focus groups, you know. We all do consumer focus groups, I've done a lot of that. I think if we did a consumer focus group -- and Erik kind of alluded this. If I did a consumer focus group on farmworkers after they left my office or the ER after being exposed, I think the results would be much different than what Julie had, and she's already pointed this out. But I think you have to take that data in perspective. And I think we already have -- and I'm a little unclear about the FDA and the cosmetics, but it seems like there's already been a program established where you could have this sort of compromise. So, it seems to me, in the interim, at least, maybe that's what the EPA should be looking into.

MS. MULKEY: Okay. Ray?

MR. McALLISTER: Just some comments on issues that have been raised since I had a chance to speak. Adam brought up the fact that theoretically we've had a pilot program going on ever since pesticides have been registered. While there may not be a legal prohibition against listing inerts on the label, what is required by law and regulation clearly channels ingredient statements in one narrow direction, and that is what is on the labels right now. You are required to list the active ingredients and the percentage of -- the total percentage of inert ingredients. And there are some bureaucratic, if not legal, impediments to listing the inerts. We've had to deal this -- with this in review of some labels where a review will say, if you're not going to list all of them, you can't list any of them, and if you're not -- if you can't fit them on the front label, you can't put them on the back label. So, these are some bureaucratic things that we would like to resolve. On hazard -- disclosure of hazardous inerts, the MSDS requires disclosure of all hazardous ingredients in that product, not just those which EPA has put on list one of inert ingredients. There are a number of other EPA programs that identify hazards for various purposes, and if those ingredients occur in the product, they have to be listed there. And just one final comment on the burden that would be -- we would have if we had to defend, not just the industry, but EPA, if we had to defend the CBI status or define and defend the CBI status of the inert ingredients, of all inerts. It's not just each of some 2,000 inert ingredients, do it once and you're done. It's each use of each inert in each of perhaps several formulations in each of 20,000 plus products. So, it's a tremendously time-consuming and complex process.

MS. MULKEY: Okay. Warren?

DR. STICKLE: I think one of the questions that we were alluding to was the possible upfront substantiation of confidential business information dealing with inerts. The bottom line on that is the agency has been working on that issue, going back to 1995 and 1996, when they did a notice and comment back at that point in time, and then came back in December of 2000, just at the end of the Clinton Administration, and put another statement in the record trying to address that issue. The problem with dealing with upfront substantiation, as Ray has just alluded to, is that you've got roughly 20,000 products out there, and if you're dealing with Fuji's products, you're dealing with an average of maybe 10 or more inerts. Non-food products, you're dealing with up to 20 or 25 inerts in there. If you follow the regular procedures of the FOIA right now, they ask, basically, nine questions with multiple questions, leading to about 13 questions for each ingredient in each product. You start multiplying that out and you have an enormous amount of information that's more than five million questions that have to be responded to by registrants. Much of that information would never be needed or used. The system we now have for FOIA, where you request it on a need-to-know and you get industry comments back, the registrant's comments back, seems to work. Otherwise, you're requesting literally millions of pieces of information that will never be used and never wanted and never needed.

MS. MULKEY: Okay. Michael?

DR. SURGAN: Warren just raised the point of -- and I won't check his arithmetic on how many millions of information bytes would be required if EPA required every manufacturer to defend a confidential business information request for every ingredient and every product. But that's not a requirement by EPA. That's a choice by the registrant. And if we learn a lesson from FDA, when FDA came to speak to our group, FDA said that they get relatively few -- and I can't remember the number -- but they get very, very -- relatively few petitions asking for confidential business information. And I think that while we can't, at this point, guess, Warren, no more than I, how many registrants are going to petition for confidential business information on how many ingredients and how many products, I can't subscribe to the theory that it's going to be every registrant for every product for every active -- inert ingredient. I'd also like to just sort of extend focus on something that I've heard as we go around the table. There has been a focus on the importance of providing information to the medical community in response to poisoning incidents or suspected poisoning incidents. I don't, in any way, want to minimize the importance of that, and I support -- and any efforts that will get the information to the medical community. However -- and I've said this many times before -- in the IDSW, we all learned, at our mother's knee, the first principle of public health science and public health practice, and that is that an ounce of prevention is worth of pound of cure. When we talk about providing information to physicians in emergency situations, we are providing cure. When we talk about providing information so that individuals and institutions can make informed choices, we're talking about prevention.

MS. MULKEY: Okay, thank you. Go ahead, Julie.

JULIE: First of all, just to answer one of Lori's questions with regard to -- I think we did have, on one of our calls, we had Rick Kingston from Prozar on the call and, again, I think one of the things that the poison control centers look at, they don't necessarily -- even though they have ingredient information, generally they -- looking at a product and a call coming in to a specific product, what the poison control center provides is a treatment protocol, which is based on the route of exposure and the product. So, they may -- what they will offer is a treatment protocol saying, if it got in your eyes, do this. If it was swallowed, do this. And so, they really base it not on the ingredients, but on the route of exposure by the product, you know, for that product specifically. That's the general -- you know, a call to a poison control center, that's generally how those are handled. It's more based on the route of exposure. Just a couple of comments with regard to the upfront substantiation. Again, finding one of the differences with our pesticide products versus cosmetic-type products is because of the registration process, the confidentiality of a product or any information with regard to a product is not static. At the time, when a product is submitted for registration, essentially every component of that registration package is -- including the label -- is confidential until the point that the product is registered, and then after registration, some of the confidentiality status of certain information does change. The label now becomes public information, and even a disclosure of ingredients in a product at the time when the registrant submits it, all of that information is confidential because the fact that they've even submitted it, to some degree, there's some confidentiality there. You know, once they go to market the product and they put out a MSDS, again, that confidentiality status may change and it may change through the life of a product. So, I guess just from a process standpoint, I would question kind of how we would, from a process, make an upfront substantiation when -- at the point when everything is confidential and how do you deal with it as that might change. And then, I guess, the last question I would have, if labeling -- if under that scenario you are required to label those things you can't claim confidentiality of, but not the things you have, is there any representation on the label then for those things that are not -- that do -- for confidentiality is claimed, and could that potentially be actually more misleading to a user of a product than if there was more of a generic description given that if everything -- let's say if everything in the product is confidential except water, and so, the only ingredient listed is water, then it seems like that that may actually lead somebody to a different conclusion than if they had some generic description. So, that's just, again, kind of a process as we look at any of these.

MS. MULKEY: All right. Well, I think what is evident to us at EPA is that the -- this workgroup has surfaced many, if not quite all, of both the factual and policy considerations. They have prepared what is yet in draft, but quite a comprehensive report. They've submitted it to the full committee now in writing, as well as through a series of verbal presentations today. We have now heard some of the thoughts of members of the full committee who were not members of the workgroup, as well as some who were, and the next steps for us will be basically to complete the receipt of advice from the PPDC and then attempt to react to that advice and do our job. In the interest of an appropriate completion of the advice for the PPDC, I suggest that for a brief period tomorrow morning, I ask from the PPDC your feeling about whether you're prepared to encourage us to receive the report as it is finalized, and obviously maybe subject to looking at it again, maybe not. We can talk about that. To receive your comments here. Whether you want some additional process and what you feel would be an appropriate way for this committee to conclude its advice to us on this topic. But this is an example of one where we tackled a very difficult topic, about which frankly there are some quite strong feelings. There was plenty air of civility, but I understand there's been plenty of passion in the dialogue of the workgroup, that notwithstanding that, what surfaced has been a lot of useful information and advice and recommendations. So, we will aim toward that. Now, we have remaining -- we have no public commenters. We have remaining a plan for another half hour approximately of this committee, and I know you're very tired. But we really do need to begin to understand and plan our next steps. We have some time tomorrow for this topic, too. What we thought we might accomplish today, there are three topics which individuals here are prepared to identify with a little bit more than just the name of the topic, what you think we would benefit from tackling these particular topics. So, with that, we'll take a minute to hear from those three points of view. I think I'll go left to right this time, and ask Dan and Larry if you've worked out a way of articulating the worker risk assessment, which is my understanding of the topic, but maybe you want to frame it a little differently, and talk about why you think we ought to tackle it and how you think we ought to tackle it.

MR. BOTTS: Larry's delegated this to me, so I'll cover it the way I understand it, and this goes back actually to the initial aggregate risk assessment for an OP that was important in Florida where we didn't understand, as they went through the process, that the worker risk associated with the product came up to a level where, even with 100 percent engineering controls, which you would assume would take the exposure side out of the equation, you still ended up with an MOE, at the end of the day for workers in the field, of levels that would lead to some kind of regulatory action. This was mixer/loader/handlers. So, we had asked the agency, even though a decision -- the regulatory decision had already been made on this compound, to sit down and walk through this product with us, a very limited number of worker exposure sites, so that we could understand the risk assessment process, much like we did on the dietary exposure assessment when we first started the tolerance reassessment process. What was scheduled to be a one-hour meeting turned into a four-and-a-half-hour meeting, which benefited not only the industry representatives in the group, but also both the HED people who were explaining the process they went through and the regulatory decision-making people from SRRD who had gone through the process. At that point, we felt it would -- the whole universe of people would benefit from an explanation of how these MOEs are arrived at. We've all seen them, we've all attempted to deal with them in risk mitigation discussions, but it's still a fairly significant black box. And this has come up both in the context of a CARAT effort, as we've moved through the combination of the OP assessments to get the RED documents where you folded in the tolerance reassessment with the regulatory decision process on a RED, and also those things that have occurred outside of the OP risk assessment process. At the last meeting of this group, there was, at least, a discussion of putting together essentially a two-day workshop or a one-day workshop similar to the technical briefings that have taken place on some other issues as we've gone forward on the cumulative exposure, and quite frankly, the whole cumulative exposure issue, I think, more or less, came in and took precedence because the same people that were going to be working on this particular process were also engaged in that. But we had taken it to the point of actually outlining a program, trying to set up a steering committee, which included a subgroup of representation of PPDC members to kind of guide the program. Those people were identified, and at that point, because of other pressing issues, that kind of, more or less, fell off the table. Having gone through several processes over the past several months, it's still not clear to us, in the user community, how some of these MOEs come about. And there's been an awful lot of effort that's gone into discussions with the registrant community on the PHED, Pesticide Handler Exposure Database, and how that product's used, and these that need to be enhanced in that particular data set. Also, some of the things that are coming forward through another industry task force on the Ag Reentry Task Force. And as the Resident Exposure Task Force or the Outdoor Residential Exposure Task Force comes forward, I think you're going to have some of the same type of black box questions on how the actual risk assessment takes place. So, we had hoped to, at least, create a process where we would have a workshop, where the agency would, more or less, go through a technical briefing type process to lead the discussion at a later date by PPDC on what needed to be done to enhance that process, what information needs to come forward, what actually needs to be done so that we could actually start framing a workgroup effort similar to what the Inerts Disclosure Workgroup was working on to help refine that policy and decision process within the agency.

MS. MULKEY: So, your vision is first, some form of technical debriefing or briefing or information, and then a PPDC focus on reacting to the issue in light of what you learned?

MR. BOTTS: In light of the workshop. Because right now, there's all different levels of understanding of how the process works and where the numbers come from and how the action actually -- how the actual decision process comes forward. One of the things that surprised me in the discussion as we went forward, was the level of -- I don't want to say surprise because that's not the right word.


MR. BOTTS: Well, actually, everybody in the room after it was over with, they said it was one of the best discussions they'd ever had because there were questions asked by the user community and the people who were there who had to deal with the actual use, and there's more of a handler application scenario than it was reentry workers or those types of situations. And the engineering control aspects of the questions that we asked on why the numbers ended up doing what they were doing forced a deeper --

MS. MULKEY: Is your focus on mixer/loader/ handler or --

MR. BOTTS: I think it goes to a whole universe of --

MS. MULKEY: Also reentry work?

MR. BOTTS: As it moves forward, I think it's a whole non-dietary occupational and non-occupational exposure scenario. Take drinking water out of it. It's that whole how you come up with the numbers that end up with an MOE that leads to a regulatory decision at the end of the day. Until we get an understanding of how that process works and understand how the inputs go into it, where there's actual exposure components that need to be done, I just, quite frankly, am inclined to work through it to come up with a scenario on how to deal with some of the issues that we feel like just are absolutely so overstated from a risk standpoint for our membership trying to come up with a methodology to come up with the information to determine what the actual risk number really is. And quite frankly, the only way I know to do it right now is going out there and doing a whole bunch of biological monitoring of workers in the field, under controlled circumstances, under non-normal use patterns to come up with something that would even fit into the type of risk assessments that supposedly we're doing from a cumulative exposure standpoint to come up with the overall risk drivers for these products. That's the only way I see getting to the point, because everything else is extremely low-tiered, worst case, worst case, worst case scenario that's perfect for doing initial registration, regulatory decision process, but we're reevaluating products that have been involved in agriculture for a tremendously long time, and taking them away represents, in some cases, a more significant hardship than others, and we're trying to regulate those on less than an adequate scenario, in my opinion. But that's me as one person. But I think there's a whole universe of people that need to be involved in that discussion, not only the registrants, but the worker advocacy groups, the medial community. Everybody needs to sit down so that we come to the decision-making process, or the advice-making process with a common understanding of how the actual number that you get at in your data, where it comes from and how it's arrived at and where the process starts.

MS. MULKEY: Okay. And then Bob Holm.

UNIDENTIFIED MALE: There are at least four of us who don't know what an MOE is over here.

MR. BOTTS: Margin of exposure.


MS. MULKEY: It's an estimate of how much gap there is between the dose you're worried about and the exposure you think you have.

UNIDENTIFIED MALE: Can I just say one thing to that? The underlying assumption on this is that there was a great deal of good for everybody involved in the process the agency went through on tolerance reassessment, the process of articulating how the decisions are made, how data's used. And we think that a similar process on worker assessment could provide the same benefits in terms of for people who might submit data, having a better understanding of how it's used, what data's useful, public policy outcome for the agency, and really increase the level of public confidence in the decisions.

MS. MULKEY: Okay. Bob Holm was going to tee up another subject that we thought there might -- some thought there might be some interest in.

MR. HOLM: Thank you, Marcia. This came about really a couple weeks ago when EPA Biopesticide and Pollution Prevention Division, in cooperation with IR-4 and Canada's Pest Management Regulatory Authority and California's Department of Pesticide Regulation sponsored -- co-sponsored at NAFTA Biopesticide Registration Workshop, and we had almost 200 people there, and I think a lot of excitement and interest in the registration of biopesticides. But Marcia challenged me, and I accepted the challenge. If you look at the reality of what's happening in the industry, we're all looking for safer alternatives. That's one of the mandates of FQPA. Biopesticides are, admittedly, one of those alternatives that can be used, but yet the industry is struggling right now. There are a lot of new products in the pipe line that are being registered and are registered, and from our program, look very good, but they're not being used to not being used to a very large extent. You look at the growth of the organic food market at 20 percent for a year and, you know, the real interests in IPM program and IRM programs -- you've got to ask yourself, why aren't there products being used more than they are? Basically, the industry has been static for the last ten years, at less than 1 percent of the global crop protection sales. So, what's going on. And what I -- I'm not going to tell you the answers because I'm not sure I know them, but what I would volunteer, if it's the group's -- committee's pleasure is to, at a future meeting, come prepared to discuss this topic in more detail and give you some pros and cons and focus on maybe how this group might encourage the broader use and implementation of biopesticides in production agriculture.

MS. MULKEY: I think we'd be particularly interested in whether the agricultural interests that are here would like to have some meaningful dialogue about what are the barriers to this, what are the issues with these kinds of products, what are their values and so forth? So, that's -- obviously, there might be others, too. But if the folks involved in production agriculture are not of the mind that this would be useful dialogue, that, alone, would tell us something, although we might -- so, that's part of what we -- and let's go ahead with the third topic, which (inaudible) brought to our attention. These were not the only topics, but they were some of the ones where the fuller suggestion of them is desirable.

UNIDENTIFIED MALE: Well, I guess we're trying to decide what we should talk about in the future, so I'm going to try to give some background, but I would need some help from other folks here because I'm not greatly knowledgeable, but just trying to learn about it. I know enough to think that it's probably important and we should discuss it, but I'll need some help. So, the topic is pesticide management plans. There was a proposed rule back in '96 for that and it was the intention of the last administration to promulgate that rule by the end of last year. They submitted it to OMB as one of those that OMB never finished with, so they sent it back to EPA. Now, it's in the new administration's consideration. It is a priority issue from OPP in terms of what -- the kinds of things the EPA would want to look at in the future, and it is not something that has been dropped, but they are looking at in terms of, you know, three basic options. And that is resubmitted as is, drop the issue, or, of course, improve or revise it. But what is the pesticide management plan, what is it about? So, that's something I need some help on. I'll try to explain it a little bit. Basically, it says that if you're in a situation where in a state a certain problem has been identified in terms of groundwater contamination from a particular active ingredient, you must come up with a plan to manage it, the idea being that you're not going to prohibit the use of that product any longer, but you're going to continue the option for the growers to use it, but rather they're going to have to have plans that end up with -- so that in the future, the amounts in the groundwater decrease. And, of course, you could apply this to surface water. In discussions that the EPA was having with the state regulators yesterday and today, they were already talking with the surface folks that have a surface water interest. So, it could be applied there. In the past, they were proposing that we look at only four particular active ingredients, metolachlor atrazine, of course, and alachlor, and I think one other. And, of course, one of the possibilities in the future is that we maybe could broaden that and include other active ingredients, or give the states the ability to determine which ones they would want to work with. The states already have some experience doing this. I'm not sure under what rule or what auspices they're doing it. But, for example, certain areas of Iowa, atrazine is prohibited or they have to apply it at rates that are below what the label allows them to do. Wisconsin has had some similar programs. Other states, Florida, Maine and others, have had different active ingredients where they say, for this particular area, it may depend on the groundwater, the swell types and so forth, you have to change the way you're using the product. Use it in lower amounts, lower application levels, or use certain types of BMPs to limit exposure to the groundwater. I'm not sure what happens over a period of time when that level -- the level decreases enough so that it's within safety limits and how they do away with it or what the procedure is there. But obviously, the idea is that you've got ongoing monitoring, surveillance of what's happening in a particular area, so that you make sure that you get out of the problem that you were in. So, I hope that gives a --

MS. MULKEY: I think that tees up the issue. We do have one public commenter and we will all listen courteously to him, I'm sure, at exactly 15 after. So, in the 10 minutes between now and then -- and that will conclude our program today. What we'd like to hear from you is your feeling about these topics, not the substance of these topics, not what your position is on them, but whether you think we ought to tackle them and in what way, or about other topics. And as I said, we will have some time tomorrow, also, to talk about how the committee will work and how it should tackle topics and even what topics. But we want to take the remaining time today. Okay. Let's -- yeah, that helps. If you'll put your cards where I can see them, I'm still struggling with first -- in some cases, I have the first name and not the last name down and so, at least you'll keep me from being embarrassed and showing, for example, that I'm not sure I know Larry Elworth.

MR. ELWORTH: Nice try, Marcia.

MS. MULKEY: So, why don't we start with you, Larry.

MR. ELWORTH: Okay. Just a quick question for John. Are you talking about the state management plans? That's that rule --

MS. MULKEY: Yeah, that's what he was talking about, um-hum.

MR. ELWORTH: One thing that -- I won't speak in behalf of Dan's brilliant suggestion, but one issue that I'd like to see tee'd up in addition is the issue of fee for service, for registration fees. It's an issue that came awfully close to being in statute five years ago and it ties into some of the stuff that people have been talking about as far as getting alternatives registered. I know there's been discussion with industry as well, so it will be interested to get industry's view on this also.

MS. MULKEY: Um-hum.

MR. ELWORTH: But I kind of like to, at least, know where we are and whether the ball's been advanced any.

MS. MULKEY: At least a status report you're saying?

MR. ELWORTH: Yeah, at least that.


GARY: I would like to reaffirm what Bob Holm said. I think that it's very important for this group to talk about the future of biopesticides now that we have an opportunity to be on PPDC. I think it's extremely important for all these groups just to discuss, why aren't there products not being used, and what can we do. There's been some discussion internationally -- I know there was a meeting two years in New Chatel, Switzerland. I was at that meeting, where we were actually driven out to the vineyards to show how these biocides can be used as part of an IPM program and so on. So, we're not talking about not using synthetics, we're just talking about in addition to the synthetics.

MS. MULKEY: So, maybe the committee can go to New Chatel. (Laughter).

GARY: That's fine with me. (Laughter).


MS. MULKEY: Just to Napa Valley, that might be easier to rationalize anyway. Margie always reminds me that the (inaudible) this favors meetings outside Washington, which seems to me to be a pretty perverse disfavor considering how much one can learn from departing from Washington, especially about the subject matters that we're dealing with. Alan?

ALAN: I know there are a number of people around the table who are interested in the issue of the use of human testing models for pesticide toxicity. I understand that there is some urgency in terms of dealing with this issue.

MS. MULKEY: You guys are not interested in tackling any of the difficult questions, are you? Okay, Erik?

MR. NICHOLSON: I had two points I'd like to put on the table. One is a review of the Section 18 program, specifically kind of evaluating what truly constitutes an emergency, and also in Oregon, we've had numerous cases where the Section 18 approvals have exceeded the EPA limit in reviewing the regulatory authority under which extended approvals -- we had a case of 14 consecutive years -- how that is happening and what is EPA's current position on that. The second point I'd like to put on the table is there's been several GAO reports criticizing the agency about protection of children, particularly farmworker children. I'd like to hear a review from the agency where the agency stands on a broad range, from REIs to tolerances to worker protection standards on responding to GAO and protecting farmworker children.

MS. MULKEY: Thank you. Brad?


MR. JOHNSON: -- I'll just generally categorize as work-sharing/mutual recognition. I think, in part, this stems from a presentation that we heard from Frank Sanders a few weeks ago at the biocide workshop where he talked about, you know, from a resource efficiency standpoint whether agencies could jointly work on packages for review, agencies here and abroad, or whether there could be mutual recognition of reviews already done. If, for example, there could be further cooperative discussions between California DPR, for example, and Canadian regulators in PMRA or TPP, again, just throwing this idea out for possible discussion. And I know I was at the OACD Biocide Steering Group meeting yesterday and the secretary had also -- had an online web presentation of a database of reviews that had been conducted throughout all of the OACD countries and there are some access mechanisms where for a particular product or a particular active ingredient, perhaps, there could be access to reviews already done abroad. So, again, just a possible discussion item for PPDC. The second that I would like to bring up is animal alternatives and whether, with respect to data requirements and registrants needing to address the wide variety of end points, both for active ingredients and also for products, whether there could be further discussion and kind of institutionalizing some thinking around methods that might depart from those methods -- methods that are used today that might have been validated in a much earlier time, but whether we can step ourselves ahead into some technologies, some opportunities for either reducing the amount of animal testing or moving to ex-vivo or in vitro type models. So, again, a topic for your consideration.

MS. MULKEY: Okay. Troy?

MR. SEIDLE: Well, Brad beat me to it. So, let me just, for the sake of time, second that very strongly.

MS. MULKEY: Okay. Ed?

DR. ZUROWESTE: Yeah, I just want to put my two cents worth in for both the worker risk assessment -- I think that would be very beneficial for me personally and for our group -- and also the biopesticide, I think would be very, very important for us.

MS. MULKEY: Thank you. Lori?

LORI: I would like to talk about the worker risk assessment, the biopesticides, and also ecological risk assessments. So, if we could include that, I'd appreciate it.


MS. MULKEY: And a ditto to what? That last one in particular?

UNIDENTIFIED MALE: Yeah, sure, yeah.

MS. MULKEY: You will remember that a predecessor of this committee engaged a lot in the whole notion of probabalistic ecological risk assessment and some other things. So, there is a history with regard to this committee and that subject. Julie?

JULIE: Just to -- you know, I guess if we're putting in votes, I would also vote for the worker risk as a topic for further investigation.

MS. MULKEY: Okay. Steve?

STEVE: One quick thought about the biopesticide issue. In some ways, I don't know that we're really talking to the right audience. The issue, I think, might -- I think your concern, Bob and Gary, with biopesticides is the lack of implementation, and what are the barriers to implementation for that, and I think we need to get out and speak to growers about that and speak to consultants about those kinds of issues more than this group here. I'm sure we're all going to pat each other on the back and say, it's a great idea, but we're not the ones that are actually trying to implement it. So, maybe --

MS. MULKEY: Could the dialogue be about who and how those activities could occur?

STEVE: Sure, that could --

UNIDENTIFIED MALE: And, Marcia, that was exactly what I was planning. I've kind of got a preliminary outline of, you know, looking at the history of the industry, where we are, where things are going, and looking at the barriers to implementation. I totally agree with Steve. There's a real reluctance in the user community right now to try the products for a variety of reasons, and I think if we look at that and dissect it and then look at some solutions to -- you know, to go address that group or those various groups which, I think, some of these people in this room could have some impact on, would be valuable.


DR. HOCK: Yeah, I'd like to just comment about the biopesticides as well. I think we need to look at it as well from the extension standpoint, the educator standpoint. We deal with these people, we deal with farmers, we deal with users all the time, and we're finding the same thing, they're reluctant to use them. I can go through a whole litany of reasons, but there's no question about it, they're hesitant because they don't feel as confident about the value of those products, that they're going to control the products. They're concerned about cosmetic damage and not from the biopesticide, but the fact that they may be a little slower in their activity. So, I think we could go right to the -- let's say to the extension area, to the user community and get some good information.

MS. MULKEY: All right. Well, this was very helpful to us. We have Jay Feldman (phonetic) from NCAP, who is our public commenter tonight, and then we will have a well-earned social hang-out opportunity.

MR. FELDMAN: Thanks for the opportunity to comment today. I am Jay Feldman, Executive Director of Beyond Pesticides National Coalition Against the Mis-Use of Pesticides, and here today in support of my colleagues, environmental, public health and some pest management colleagues ont he panel who believe that this agency needs to be very clear on issues of transparency and what better place to embrace transparency than on the labeling of product ingredients, those which could be biologically and chemically active on product ingredients. We believe that that concept can be embodied in a regulation and must be embodied in a regulation by EPA that mandates full disclosure product ingredients. To argue that it is too complicated for consumers to understand, I think, belies the argument and the believe that this agency is (inaudible) under other circumstances that transparency is essential to good public policy. The proponents of a voluntary strategy for releasing product ingredients are proposing a strategy that has failed numerous times in the history of the agency. First of all, the agency typically, in voluntary agreements, doesn't have sufficient enforcement authority. Secondly, you know, the agency has numerous case studies that this panel should look at in which it has simply failed to carry out or enforce those agreements. One of the ones that they're dealing with now, as you're probably aware of, is the Consumer Awareness Program in the Wood Preservatives Program, which requires consumer information sheets and labeling. The program was a terrific failure and has been since the very beginning, and if you trace the regulatory history on that, what you'll find is that the agency never enforced against the failure of the program, as it said it would, when it issued the final regulation on the voluntary agreement. So, for instance, if you were to go with a voluntary strategy and you said, as a caveat in that voluntary strategy, should there be a lack of compliance with the strategy, the history of the agency enforcing against those failures under voluntary agreement are terrific and troublesome. This committee will be judged by its recommendation to get behind right-to-know. Right-to-know is a concept that is embraced by many in the pest management industry. Although not embraced by the chemical industry, it is certainly one that is embraced by the environmental community, public health community, medical community, people that are either using pesticides or are exposed to them by virtue of their use. It's an easy concept, it's one that this panel should get behind and should vote to support. The concept that the industry would agree to releasing hazardous ingredients is, to cut to the chase, bogus since EPA already requires that list one ingredients be released on the product label. So, anything beyond that would be voluntary and reverts back to the argument that that's not transparency. If this panel is unable to reach an agreement on this, my organization and others, I'm sure, sitting around the table there, will be pursuing a litigation strategy or will support a litigation strategy that seeks to expand the findings in NCAP v. Browner, in which the Court very clearly denied the agency's position that inert ingredients, as a matter of fact, were CBI, and, in fact, does require that the registrants make a determination or justify a determination that an inert ingredient is CBI for purposes of FOIA requests. The purpose of the litigation will be to expand the findings of NCAP v. Browner to the label, specifically to the label. I think that's a winnable case. It would be nice if the community sitting around this table were able to get behind both the concept and the policy that all consumers today, at every level of government, embrace, and many, many, many in the pest management industry embrace, that consumers have a right-to-know. So, let's get behind that. Thank you.

MS. MULKEY: Before we split, I should have mentioned that John Ward from Region V has joined us, and that Jim Jones, who is our Deputy Office Director, has also joined us. So, they will be available for you to get to know during this informal social period. I know it's been a hard-working day. I hope that you have felt that we've gained some ground, I know we do, in our effort to understand these issues better. (The meeting was adjourned.)

Day Two

December 5, 2001 PROCEEDINGS

MS. MULKEY: We don't seem to have lost too many after yesterday's hard work. Even before I introduce Steve, but while final seat taking occurs, I want to start by thanking everybody for your patience with the long hard working day that we all put in yesterday, and to assure you that we felt your engagement with us during the course of the day was of a great deal of value to us. And we're hoping that you feel that your time was well spent today, and we trust you will find that to be the case -- or yesterday -- and find that to be the case today. Well, since we all last convened, Steve Johnson has not physically, or I think maybe even emotionally, changed, but his job certainly has and in more than just title. I'm sure he'll give you a little insight about the difference it makes to have been requested by the President -- nominated by the President -- submitted to the Senate, advised and consented upon, and appointed, as part of this new administration in Washington, Assistant Administrator for OPPTS. So, Steve?

MR. JOHNSON: Well, thank you, Marcia. One of the most noticeable things -- and for some of you who have known me more than -- more than a few years -- that this job has -- last time we met, I had dark brown hair. For some of you, I won't go there. But it is -- I mean, it really is a pleasure and a wonderful opportunity to be able to join you for a few minutes this morning and to say welcome, and particularly to say thank you, because I know that each of you around the table lead a very busy and active life, and that it is in many ways a sacrifice for each of you to spend time grappling with the issues that we collectively face. But I wanted to say that from certainly my perspective, and I know Governor Whitman's perspective, and from the administration's perspective, we really value committees -- advisory committees -- such as this. Because I think that in the end, certainly we at EPA will make better decisions having had an open dialogue with all of our stakeholders -- our partners -- before making a decision. And so really I just wanted to say thank you and add my welcome, even though you're now on your second day or the ending day, and hope to in the future be able to spend a little bit more time with you. There have been a few pressing events of recent days keeping me busy. I just wanted to comment on a few things. One is sort of one of the general themes of the new administration. And for those of you who have heard me speak have probably gotten a little bit nauseated hearing some of these, but bear with me. Because it does bear repeating that for the new administration, and certainly at EPA, we're very interested in really sort of three things. One is the theme of partnership, that our experiences have led us to realize that we can accomplish more through a partnership effort than an adversarial relationship. And so that's our goal, is to establish partnerships to achieve the intended results. Second is innovation. One of the other things that we soon realize is that, you know, Washington is not the holder of all wisdom and all knowledge and that there are many outside of Washington that have a great deal of knowledge, a great deal of wisdom and, in fact, have some very innovative and good ideas and that we need to listen. And if we can through a partnership fashion take on some of these tough issues, coming up with some innovative solutions, we can get -- which is the third theme -- results. Because at the end of the day, we will be judged. I will be judged for my time as Assistant Administrator, of what difference did you make. What are the results. And so those are three themes that as we think about, and as we tackle issues, that certainly are the approach that we would like to pursue. Well, clearly for me when I got the call from the White House and asked to come over, what an honor and a privilege. And as many of you have heard, my first response was, am I being called to the principal's office or is this something good. And of course it turned out to be something good, and what an honor and a privilege to serve both the President, the administration and really everyone in this room, I in this position. But I think for all of us, that no matter where we sit, 9/11 has changed our lives and certainly impacted our program, in the pesticides program particularly me and also other parts of OPPTS. And certainly we've been facing some enormous challenges. And I know as you heard yesterday, we have been in the thick of things with anthrax and how to deal with that. It's certainly fair to say that way back when when I was head of Registration, no one ever came knocking on my door asking for a label claim against anthrax. And so now we find ourselves dealing with anthrax and, of course, other potential bio or chemical threats. So those challenges have created both some new challenges as well as new opportunities, and also have consumed a fair amount of -- a number of our collective personal time. But having said that, there is really important work that is sort of the mainstream of our work that we need to do, and I would just like to comment on some of -- certainly what are my priorities for the pesticides program. I couldn't probably emphasize enough one of the principle, primary activities, which is the continued implementation of the Food Quality Protection Act. Still that landmark piece of legislation, we're very much in the middle of implementing that piece of legislation. Of course, as you heard from Lois yesterday, we met another milestone, and that was the release of our draft preliminary cumulative risk assessment for the organophosphates. A major milestone, both when you think in 1996 no one knew how to do one of those assessments, and that through a cooperative effect with the scientific community and many of you around the table, we have come up with methodology and approaches. We have improved our data to be able to issue a draft cumulative assessment. And so what a major milestone. But we have much work to do, both of understanding that methodology, focusing on the science techniques and understanding through sensitivity analyses the tail ends of those distributions. And so we have certainly work to do there, and continued work to do in the reassessment of each of the individual chemicals, whether it be the remaining 12 organophosphates that we have yet to finish the individual actions on, or the next class of compounds -- carbamates -- and other compounds as required by FQPA. Of course, as we know that FQPA being an important piece, one of the other is that you don't have to sit on one side of the issue or another to realize that for dealing with these older products that you do need to have, and we need to have, processes in place to move along the new products, particularly those that are safer kinds of products. So I'm very interested in seeing how we can continue to strengthen and improve our licensing processes. And again, whether that's an active ingredient or whether those are inerts are issues that I know we're going to be talking about, such as experimental use permits and the issues surrounding those. Public health and pesticides, again, sort of in this day and time those take on new meaning, and antimicrobial products as well. So the licensing program we need to continue to strengthen. We need to also continue to look for ways -- innovative ways -- that we can accelerate to get those products on the market sooner to help us in the myriad of issues that we have. There are just a whole host of issues, both policy and science, as well as practical issues. Issues such a methyl bromide. Methyl bromide is subject to a phase out in international treaty. And there is an agricultural exemption process for particular situations. And so working with our AIR office and with USDA to try to construct what kind of process that the United States will use for dealing with those critical ag uses that still may be needed as we move through the methyl bromide phaseout. Worker protection issues. Continued -- certainly as we have learned in our re-registration efforts, worker issues continue to be ones that we grapple with, both from the data availability as well as mitigation measures and outreach and education. And so we need to move forward in that arena. Again, a myriad of labeling issues. Issues that I certainly look forward to hearing what your thoughts and ideas are with regard to inerts and inert labeling. Very controversial and a very difficult subject. And so how do we as an agency move forward and do the right thing with that. And, of course, as some of you couldn't help but notice if you've read the paper of recent days, issues like human studies and what is the agency going to do with that. One of the clear issues for me is that it is very, very clear that it is complex. It's very controversial. There are ethical issues, there are scientific issues and there are legal issues associated with the use of human studies. And what we are doing right now within the agency is having some very serious discussions as to what approach we want to take. And I expect by the beginning of the year, we will be announcing what kind of approach we intend to take with regard to human subject testing, and specifically what have been referred to as the NOAEL or NOEL kinds of studies associated with pesticides and human subjects. So we don't lack for controversial issues. We don't lack for -- there is no lack of really thorny, public policy issues. And certainly as we work through those that I have mentioned and many others, we really look forward to your input as we formulate what the agency should or shouldn't do in that case. So I certainly look forward to a continued dialogue. I do apologize for only being able to spend a few minutes today. There are a number of things -- most of the topics which I've mentioned are taking me to a variety of places today, including the White House. So I'm glad I was able to come over and spend a few minutes with you. I look forward to a continuing dialogue. And again, I just want to say thank you for your commitment and participation in the PPDC. And I do have a few minutes, I think, and I would be happy to answer some questions, if you have any. Yes?

MALE SPEAKER: I wonder if you could outline how you foresee the role of this committee in interacting with the agency on the human testing issue.

MR. JOHNSON: It's undecided as to what is the role. That's one of the issues that we are talking within the agency of what steps we want to take to sort this issue out. And certainly this advisory committee, as well as other advisory committees, may be employed. So the simple answer is we haven't figured it out, and that's part of the serious discussions we're having. Given the complexity of the issue, given the controversies of the issue, whatever process that we undertake will have to be one that will have adequate opportunity for public input, whether through advisory committees or through other public opportunities. That's going to be essential. Other questions?

MS. MULKEY: They all know you so well they feel like they'll get a chance to talk with you.

MR. JOHNSON: Yeah, that's it.

MS. MULKEY: And I think that's a good sign.

MR. JOHNSON: Good. Well, I do apologize. I am going to run. But I look forward to continuing to work with you, and hopefully the next meeting will be able to spend a little bit more time together.

MALE SPEAKER: Are you planning to run the meetings or just run, Steve?

MR. JOHNSON: I'm just running. I'm just running. So thanks.

MS. MULKEY: In Washington when you say you're running it has a special meaning.

MR. JOHNSON: That's true.

MS. MULKEY: I don't think he's running for office, anyway.

MR. JOHNSON: At least not that I'm aware of, anyway. See you later. Thanks.

MS. MULKEY: Thank you. Well, thank you all, again. I wanted to affirm, as I did at least one other time, that we do maintain a record of everything that you say, so that we can summarize it and be sure that people like Steve and others are mindful of the kind of input we get from you. And we'll talk a little more later about the ways in which we will attempt to make this more effective in terms of your feedback. But we'll go immediately into the next item on the program, inert risk assessment methodology. My name is on the program, but that's because we thought Jim was going to be tied up again today in a hearing. It was always planned that Jim, who has a wide range of lead responsibilities on behalf of our front office, and among them are the matters relating to inerts risk assessment, so that's why he's going to frame and chair this section of the program.

JIM: Thanks, Marcia. Good morning, everyone. I want to mention a few things in terms of context before Kerry Leifer and Kathryn Boyle walk us through the presentation. Some of you in the room, I think, are very aware of the concept, because you're intimately involved in the inerts business. For those of you who are not, I'll spend a minute or two just giving you some context. The Food Quality Protection Act pretty dramatically changed the standard -- the legal standard -- for the reassessment -- or actually created the reassessment. But reassessing and approving new inert food use ingredients, those inerts that ultimately may end up in foods. They have always required a tolerance or exemption from tolerance, but now they are required to meet the same rigorous standard that is applied to pesticides in food. That is, the reasonable certainty of no harm finding in FQPA. And we in the Office of Pesticide Programs have struggled mightily since the passage of FQPA in developing a methodology that will allow us to evaluate them against this standard prior to FQPA. Not only were we not doing water assessments for inerts, but we weren't even considering water assessments. We were not asking for the kind of data that you would use to do a water assessment. We were not aggregating food, water and residential, and we had basically a relatively narrow database that we were relying on that was articulated back in 1987. So in our efforts -- now we've not only got this new standard, as I said, to new approvals for inert ingredients, but inert ingredients are also subject to tolerance reassessment, so that by 2006 the 800 or so food use inert ingredients will need to be reassessed. And, of course, the FQPA standard applies there, as well. There are no additional resources that the program has to make these assessments. So we have been working for the past several years to develop a methodology that will allow us to evaluate inert ingredients -- food use inert ingredients -- in a manner that will allow us to make an assessment under the Food Quality Protection Act. And that's the basic context within which we've been operating. And this morning Kerry Leifer and Kathryn Boyle from the Registration Division and the group that evaluates inert ingredients are going to walk you through our current thinking on this inert ingredient methodology. You are getting a preview here -- a true preview. We still have got some work within EPA before we ultimately put something forward to the general public, and that's likely to happen in the coming weeks and months. But you're getting really a first look at what our current thinking is on this inert ingredient methodology that we will ultimately apply after some process. And that may be -- some of the discussion we'll have afterwards will be about your ideas of the process we should be using, as well as the content of what you hear. So with that, I will turn it over to Kathryn Boyle, and then I think Kerry Leifer is going to follow Kathryn.

MALE SPEAKER: Jim, can I ask a point of information?

JIM: Sure.

MALE SPEAKER: Does RD do the risk assessments for inerts that come in with BPPD submissions as well?

JIM: Well, for the most part -- there have been exceptions. For the most part, for inert ingredients the regulatory management occurs in the Registration Division. The science assessment, just like in synthetic chemicals, occurs in HED and EFED. AD and BPPD have typically relied on the Registration Division to manage that process for inerts. There have been some -- few exceptions to that. Okay. Kathryn?

MS. BOYLE: Good morning. Kerry and I are very glad to be here to present this to you. The presentation will consist of two parts. The first part we're going to explain, well, what is the methodology.

MS. MULKEY: Move your mike a little closer, Kathryn.

MS. BOYLE: Okay. All right. The presentation is actually going to be in two parts. The first part is going to be, well, what is the methodology. And the second part Kerry will present, and it will be how this methodology might be implemented. And as Jim was saying, this is our current thinking on this, and this is actually being given in advance of any kind of roll out of the methodology. And it has been a long term effort. For the past two years, we have looked at various methodologies, thought a lot about what we wanted to do and tried some pilot processes. We learned a lot from these attempts. The active ingredient paradigm just does not work for the inert ingredients. It just did not do what we needed it to do. So we went back to the beginning, and we really thought a great deal about what we wanted the approach to do. And I would like to tell you some of the things that we considered. Eventually we needed to develop a process that could do everything. It had to serve as the framework for when both a petition was submitted requesting a tolerance exemption for a food use, or when someone requested the approval of an inert ingredient in a non-food use formulation such as a bathroom cleaner. It had to be used for the tolerance reassessment process. Currently we have 870 tolerance exemptions that need to be reassessed. We've done about 75 or 80 of them. And it also had to be used for List 3 classification. Right now there is a great deal of interest from the organic community about List 3 to List 4 reclassification, but we also will need to use this for List 3 to List 1, List 2 to List 1 or List 1 to List 4. But just what is an inert ingredient and why is it different from an active ingredient. Well, the inert ingredient is actually intended to be part of the delivery system. A lot of active ingredients just simply cannot be used in their pure form. Okay. Quite a few of them don't mix very well with water. So the purpose of the inert ingredient is to do the delivery. Inert ingredients are emulsifying agents, propellants, stickers, surfactants and carriers. They carry the active ingredient essentially in a consistent manner at the specified rate to the target organism. By themselves, the inert ingredients -- they do not kill or repel the target organism. And most chemicals have some biological activity. But there are widely varying degrees of biological activity, and the activity of an inert ingredient is just not that of an active ingredient. But then, some chemicals can function as both an active ingredient and an inert ingredient. You have here isopropyl alcohol -- isopropanol. It can be an active ingredient in an antimicrobial formulation, but it's also a solvent. You could dissolve another chemical in it and then put that in the formulation, and it would be in a much lower concentration that could not work as an active ingredient. Ethanol would have the same exact pattern for this. There are also chemicals like FD&C blue, which is a dye which is certified by FDA for use in your food, in your drugs and in your cosmetics. It is also an algicide. But all inert ingredients are not the same, either. We have sand. We have sugar. We have salt. We have taurine. We have chlorobenzene. Okay. How would we look at these. How would it be scientifically justifiable to use the same database for all of these. They're dissimilar. They're not alike. But what database should we be asking for. Now, it would seem that if we could use the database for the active ingredient, well, to make the finding for the active ingredient, it would work for an inert ingredient, also. But we kept coming back in our discussions to the range of toxicity and the biological activity, and it just didn't seem to make sense. Inerts can be different, and we just do not believe that we necessarily need the active ingredient database. So eventually the question became, to evaluate the toxicity, the exposure and the risk, must it always be done in the exact same manner each time for each chemical. There are regulatory bodies who use tier data requirements, and generally they do this by doing a Tier 1 database. Based on the results of that Tier 1 database, you can move on to Tier 2. Okay. The concept behind this is to balance the need for effective regulation with efficiency. FDA has the responsibility for direct food additives, indirect food additives, color additives, dietary supplements, pharmaceuticals and cosmetics, and each of these has a different regulatory scheme and the additives had tier data requirements. Over in the Office of Pollution, Prevention and Toxics in the Pre-manufacturing Notice Program, they review the information submitted in the PMN, and then they can make, if necessary, an exposure based finding. This finding, which says that there is significant or substantial exposure, can be the basis for requiring more data. And in OPP, we've used tier data requirements for years. We have bio-pesticides, antimicrobials, food use and non-food use active ingredients. The use pattern can very definitely determine what data is necessary, and within each of these, there can be tiers. But what does our statute tell us. Essentially the Food Quality Protection Act amended both FIFRA and FFDCA. When you have a food use inert ingredient, and when you're establishing or reassessing a tolerance or tolerance exemption, you have to make the FQPA compliance safety finding. And this safety finding includes the consideration of exposure through food and drinking water, as well as from residential uses, as well as any other information we have on the non-pesticidal uses. The statute also requires that there be extra protections for infants and children. When you're considering whether to remove, reduce or retain the factor that is especially for the protection of infants and children, is there only one way that you can make this determination. But what kind of data should we use. Some of these substances have been in use for years, okay. Given this long history of use, what do we already know. There is a lot of data out there. It's in journals. It's on the Internet. Can it be used? What about other agencies -- parts of EPA -- that also regulate some of these chemicals. FTA grass chemicals are analyzed under the same statute, FFDCA. Okay. They're used in food. Some of these evaluations are 25 to 30 years old, but they were based on data and they were peer reviewed. We want to use these assessments. How do we use these assessments? But what about our statutory mandates to consider exposure through drinking water and residential uses. That's not in the FDA evaluation. And what happens to these substances in the environment when they're sprayed on an agricultural field.? Do they degrade or do they go to the ground water. Over in TOSCA, the PMN Program examines over 2,000 chemicals a year. They do this sometimes without any data. They do a process called SAR -- structure activity relationship -- okay, in which they compare the structure of the molecule that they're assessing to structures for which they have known data and they make predictions about the toxicity. And they're very good at what they do. There is also the HPV, the high production volume challenge program. This is a voluntary program. Those sponsoring chemicals under the program submit summaries of existing studies or they generate new studies to complete a screening data set of information which is called SIDS. Okay. Now, what about that data. Could it be used for regulatory purposes? It seems that a screening approach that incorporated elements of the tiering would be a workable approach for inert ingredients. But it needs to be a very carefully structured approach. It has to be scientifically sound and transparent. It has to provide us with a rigorous assessment. And at the same time the process also has to be efficient and it has to be effective. The easiest thing to do, at least for the agency, would just be to require one set fits all. Everybody do the same data. But it just doesn't make sense. It lacks a sense of logic. Okay. The screening approach with the inclusion of the tiered approach will be harder to implement, but it's a much more logical approach. The screening approach means that the low toxicity inert ingredients will go through the process faster and thus be available for use. The real value to this process is the ability to move forward the lower toxicity inert ingredients while continuing to evaluate the higher toxicity ones. The tiering approach reflects the fact that there is such a wide range of toxicity for inert ingredients and would allow the agency to focus its resources on the chemicals that are greater risk concerns. And now we'll talk about the tiers. Tier 1 chemicals are those of minimal toxicity. They can be confirmed using the available data. The 1-As are those chemicals that are of low toxicity. The logic, the justification and the rationale to confirm the low toxicity can be made in a very common sense manner that will rely greatly on the long history of safe use. Examples of these types of chemicals would be atmospheric gases. These are the gases that we breathe every day of our lives. Commonly consumed foods, excluding the known allergens. These are how we acquire our nutrition. The 1-Bs are of low toxicity, or maybe what we could refer to as a low moderate toxicity. This would be that when we look at the profile, it does not exactly fall into low toxicity, but it's just a little bit off of low toxicity. It's most definitely not a moderate toxicity. The rationale for these chemicals cannot be made in the same fashion as that of the 1-A and there will need to be some data, but this data should be already out there. There should be the data that is on the Internet and in journals. No data generation should be necessary. Examples of these would be most of our grass chemicals, fatty acids in their salts or the allergens that were excluded under 1-A. But what if there isn't any readily available data out there, or what if the existing data is just not enough to complete the evaluation. Tier 2 data generation would be necessary. Most Tier 2 chemicals will be those for which for one reason or another they're just not in Tier 1, but they also don't belong in Tier 3. Tier 3 are going to be the higher toxicity chemicals. These are going to be the carcinogens. The Tier 3's will be those already known to be of higher toxicity, or those which have structural similarities to chemicals of known toxicity. But what data will we need. For Tier 1, no data needs to be submitted. For Tier 1-B the necessary information should be on the web in an FDA assessment, in a SAR assessment that would be performed over in OPPT, in open literature or a combination of these. For the 1-A and the 1-B, the risk assessments will be qualitative. It will basically be a description of what is known and how the low toxicity is confirmed. For Tier 2, there will be a three pronged approach. There will be the information in the web or in the open literature. There will be the SAR assessment as performed by OPPT. And this will be integrated with the data set, okay, and the data set will bear a striking resemblance to the internationally known screening information data set, the SIDS. For toxicity this means that we will need mutagenicity information and the combined repeated dose developmental reproductive screening study. In evaluating the information using the weight of the evidence approach, there needs to be a consistency. The results of all of these will have to match. The power of this three pronged approach lies in the integration. It will tell us whether or not there are special concerns for infants and children or if there is an effective concern. The risk assessment will be quantitative, but it will not be like that of an active ingredient. It will be more bounding levels and levels of concern. Okay. If there is still a concern and it's just not possible to move towards the risk assessment, then there are two options: targeted testing for the effective concern or this is probably a Tier 3 chemical. Tier 3 is a food use database, the complete data set as required in 40 C.F.R. Part 158. It will be equivalent to an active ingredient risk assessment. There will be some chemicals, such as your carcinogens, that are just going to start at Tier 3. And now Kerry will describe how we might implement this methodology.

MR. LEIFER: So far our discussion has been focused on the philosophy of the inert risk assessment model. Now, I would like to turn our attention to looking at how OPP might operationalize such a model -- the risk assessment process itself. The key element of this process is the establishment of the inert ingredient focus group. This is an interdisciplinary group of senior scientists and risk managers that will have primary responsibility for making risk assessment and risk management determinations for inert ingredients. This group will consider all elements of the inert risk assessment and could be considered as being comparable to the various science peer review committees that are used in the Health Effects Division with regards to the review of active ingredients. So how might this process work. What I'm going to attempt to do now is to use an example and to kind of step through a process and an approach that we think may be viable here. The example we'll use is the submission of a tolerance exemption petition. This is where a party is petitioning the agency to establish tolerance exemptions so that they can use an inert ingredient in food use pesticide formulations. The petition and the accompanying data would first be screened by the review manager. This screen would determine if the submission is complete and whether it can be considered for further review. Any data or other information that was submitted and judged to be complete in the screening process would be reviewed by the appropriate risk assessor. So there are a number of ways this could be done, but there would be a review component here. If needed, the structure activity relationship analysis would be performed. And again, this would be done by the office of Pollution, Prevention and Toxics, the experts in the field of SAR, at the behest of OPP. So we would essentially request that OPPT perform this on a chemical by chemical basis as needed. Finally, when all the above steps are completed, the action -- in this case, the tolerance exemption petition -- would be scheduled for consideration by the inert ingredient focus group. What does the inert ingredient focus group do. At the inert ingredient focus group meeting in which a given action is being considered, the inert ingredient focus group would review the hazard and expose the characterizations developed by the assessors. And that would be a combination of the existing data, structure activity analysis and any submitted data. The group would then determine the appropriate tier placement. Is this substance Tier 1-A, 1-B, Tier 2 or Tier 3. Additionally, the group would determine the sufficiency of the data considered and whether any effects of concern have been identified. The group could then either perform a risk assessment or make a determination that specific additional data are necessary, the concept of targeted testing. How would the risk assessments be performed. For Tier 1 substances, the assessment would take the form of the affirmation of the rationale that was developed and that Kathryn had previously spoke to. For Tier 2 substances with no significant effects of concern, a bounding level of concern estimate would be utilized as part of the risk assessment. The inert ingredient focus group would in the course of its evaluation identify worker risk and nontarget organism concerns, and would flag these concerns for additional consideration as part of the product's registration process. For example, if worker risk issues were potentially involved with an inert ingredient, this might trigger the need for additional PP on product labels that would incorporate this inert ingredient. We've discussed the term the bounding level level of concern estimate. Exactly what are we talking about here? This is a form of risk assessment which uses the doses and endpoints from the toxicity data, along with conservative estimates of dietary and residential exposures, to determine whether there are any risk concerns. We also mentioned targeted testing. And exactly what do we mean here? If the data suggests specific toxicological concerns, then additional studies would be needed to address these particular concerns. For example, if the data suggests the potential for reproductive effects, a full reproduction study would be necessary to satisfy that particular endpoint. We want to just emphasize that substances that fall into the Tier 3 category would basically fall out of this particular process. There would be no further evaluation through the inert ingredient focus group, but rather they would enter into the same process used for our synthetic and conventional AI's. The focus group would establish a decision database, which would contain all of the essential elements of the individual chemical specific assessments and would serve as another data point when conducting future assessments. We could consider this information to ensure that our approaches are consistent, and it would provide us with feedback on the decisions that we do make that could be used to adjust or correct the process. OPP recognizes that the value in terms of savings and costs and in the amounts of testing that may be necessary, as well as overall improvements in the efficiency in the inert evaluation process of the concept of chemical clustering or grouping. This approach is where closely related chemicals are considered as a group or category, rather than testing or assessing them as individual chemicals. In the category approach, not every chemical needs to be tested for every effect. However, the data compiled for the category must be adequate to support each of the members. These groupings may be either OPP initiated or submitter initiated and they may be based on chemical structure. For example, linear alkyl benisons may be potentially one group of a chemical structure. It's closely related and could be considered as a group. Or they may be based on more functional or use categorizations. And one example -- and again, this is only an example -- is the grouping of dyes in pesticides. There are many other ongoing EPA activities that we have identified and are cognizant of, and realize there is much value in some of the efforts that are ongoing in other parts of the program that could help inform decisions related to pesticide inert ingredients. We've already eluded to the high production volume test challenge program. There are about 2100 chemicals that are being sponsored for data development under the HPV challenge program, and a significant number of these -- over 500 -- may have inert ingredient uses. So there is a significant overlap here. We are working with OPPT to determine the best way to kind of coordinate our efforts in terms of the data gathering and assessments for these substances. Another program is the voluntary children's chemical evaluation program. And this program -- another voluntary program -- is intended to provide data to enable the public to understand potential health risks to children associated with certain chemical exposures. EPA has asked companies which manufacture or import 23 chemicals which have been found in human tissues and the environment through various monitoring programs to volunteer to sponsor their evaluation. And this is set up as another kind of tiered program. Again, there is an overlap here. A number of these 23 substances are also pesticide inert ingredients, and we're looking to see how we could maximize this effort as it relates to our inert reviews. One other item is the endocrine disrupter screening program. And here a process is being developed to identify substances that might have endocrine disrupting effects. Again, we're looking at some of the activities that are ongoing here to see what utility they may have for inert ingredient assessments. Where are we in this implementation. At present, we have utilized a pilot program, and we have looked at selected chemicals through the process that we've outlined. In fact, we have recently established a tolerance exemption for a surfactant from a Huntsman that went through a very similar process here, and we were able to use that process to make the FQPA safety finding in the risk assessment determination. We have about a dozen inert ingredients on the FY 2002 work plan. We are looking at these substances to see which may be amenable to be considered for evaluation under this approach. Now, we've already mentioned the tolerance reassessment. There are some 870 inert ingredients that are subject to tolerance reassessment. We are taking a look at particularly now those that may fall into the low toxicity Tier 1 type categories to see how many of those that we can begin to make tolerance reassessment determinations on. And we're in the process of working up a schedule for inert ingredient tolerance reassessment. Obviously of great interest to this group and many other people is the actual methodology itself. As Jim mentioned, this is an ongoing process. What you're hearing today -- what you've heard today -- is kind of a preview of where we are at this point in time. Further work still needs to be done. There is still ongoing consideration to this approach within EPA, but we hope to in the not too distant future be able to release both methodology for public comment. Thank you.


JIM: -- talking about this session. I want to make a couple of points before we start doing that and frame a couple of questions, although we certainly won't be limited to that. First and foremost, this will not be the last proverbial bite at the apple for anyone or all of you on this issue. We're going to definitely do some significant amount of public process and participation before we ultimately go with a final methodology. And that is an area where I think it would be good to get some feedback from this group. The other point is that there definitely is on the PPDC a number of individuals who have a very keen interest in what we are doing here. And while I do not want to discourage that group, who has a far more keen interest than many of the others of you in the room, I do want to make sure we're balancing those, the participation of those with very keen interest and those who may have less of a stake. Because I think frankly all of us have a stake in the outcome here. So I'll try to balance the need of those who really have a lot of keen interest in giving us some feedback now with those of you who may not be so involved in that, and certainly signal to that group that we want to hear from you as well this morning. A couple of areas for specific feedback that I think would be useful to get, one is very general in the sense that as a new PPDC, as you all are thinking about how you want to operate, what we heard here today you could think of for this afternoon's -- or later this morning's feedback session, is this the kind of presentation that you would like the PPDC to be receiving throughout its course. Is this the kind of way in which you want us to present information. Not only the kind of information, but sort of the time and when we are presenting it to all of you. So it's sort of a general question for everyone, and just a little talking ahead for you. More specifically, on the presentation itself your general questions are certainly welcome. This is new, I think, for most of you. General questions about what Kerry and Kathryn presented, as well as some feedback. Some general feedback or specific feedback. Things we didn't think about that you think we should have included in our thinking on this methodology. So with that, why don't I just open this up. And I will start actually at this end and I'll work us through that way so we'll mix up the way in which we're engaged in. The first card that was up was Julie? Was that you? Julie?

MS. SPAGNOLI: Just, I guess, a question just for clarification. On the existing tolerance exemptions, as well as, you know, I think when tolerance exemptions are proposed, usually those are done with kind of a -- there is a specification included with it as far as the level that will be used, or the type of products that will be used, and the function of that ingredient. How will those kind of work into the assessment that will be done?

MALE SPEAKER: Well, we could have -- really, the same approach will follow through. We could have very broad based tolerance exemptions if the data and the analysis support that. If for some reason we can't make the safety finding on the very broad basis, then the limitations that sometimes appear in there may be appropriate. Some of these inert ingredients, for example, have limitations in the percentage formulation. Sometimes use limitations. Sometimes the timing of the application. And sometimes limitations to specific active ingredients. And we would see that as continuing. This is not in any way, shape or form going to dismantle that.

MS. SPAGNOLI: So that the safety finding may not be based just on the chemical, but may also have -- with those specifications. So you wouldn't necessarily be saying this chemical is safe in all circumstances, you know, but we'll make a safety finding that it's only used at less than a tenth of a percent on these specific pesticides. Is that the kind of finding that the agency would make then? Is that what you're saying?

MALE SPEAKER: Yes, certainly that could be the case.


JIM: Jennifer?

JENNIFER: Thanks for presenting a good presentation in a rough form. I mean in terms of early in the process. It's nice to see. You mentioned a couple of the volunteer programs which my guess is going to be where a good deal of the volume of your data will be coming from, only in the sense that they're going to generate a huge volume of data. In the HPV Program you mentioned that there was about 2100 chemicals. How many of those have you received data on so far?

MALE SPEAKER: We don't receive that, because that would have been through OPPT.

JENNIFER: How did EPA receive it?

MALE SPEAKER: I don't have that information.

JENNIFER: Can you make a guess?

MALE SPEAKER: Actually, Oscar Fernandez from the Toxics Program is here. Oscar, if you could venture an answer?

MR. FERNANDEZ: Yes. To date we have received in the neighborhood of 700 chemicals as part of the challenge program.

JENNIFER: Data on 700 chemicals?


JENNIFER: Thank you. And do you have an idea with the voluntary children's chemical evaluations, how much data you've received so far?

MALE SPEAKER: Again, that's not -- that's another toxics. Oscar, if you could?

MR. FERNANDEZ: Yes. We have received none at this point. The program is scheduled to begin sometime in early spring.


MALE SPEAKER: Thanks, Oscar.

JENNIFER: Thank you. My guess is you're going to receive a lot of data, just clearly in terms of dead forests, I mean, if you could measure it in stacks of paper. Do you -- does the EPA see its role primarily as a data manager of this information, or is there some role and does EPA have the resources to do some kind of a quality control on the data coming in?

MALE SPEAKER: Jennifer, are you referring to our role in inert ingredient assessment versus our role in these other programs -- HPV and the children's?

JENNIFER: Well, I'm bringing it up now because it sounds like a good chunk of the data that is going to be used in this inert program is going to come from these voluntary testing programs.

MALE SPEAKER: But are you asking about our role in inert regulation specifically? What we see our role in inert regulation?

JENNIFER: I presume it's the -- I presume it would be the same. I presume that if you're going to be able to go through a quality control for the data of the inerts, it's going to be the same process to look at the quality control of all the information coming in from these programs.

MALE SPEAKER: Well, I think we see our role in the inerts program as using this information to make regulatory decisions about the safety of inert ingredients.

JENNIFER: So then this data that comes into the agency will already undergo some kind of a quality control screening, or will it just undergo a data management type of process before it gets used in the regulatory process?

MALE SPEAKER: Oscar, could you?

MR. FERNANDEZ: Yes. For the challenge program, we have established criteria and published guidance to determine the adequacy.

MS. MULKEY: Let's give him a mike. There's a hand held mike.

MALE SPEAKER: There's a mike right there.

MR. FERNANDEZ: I was saying that for the HPV challenge program we have developed criteria and published guidance to assist submitters in the determination of the adequacy of their packages. The data adequacy ranges from physical chemical properties, aquatic effects and selected -- the mammalian endpoints that are part of the SIDS base set.

JENNIFER: So then what the agency has done is put out a list of -- a generic sort of guideline. These voluntary programs will then submit data that is compliant with the guidelines. And then that data will then be used by the agency -- managed, because it's going to be huge in volume, and used in regulatory processes in these different kinds of subgroups like inerts?

MR. FERNANDEZ: Yes. I should mention that there is an additional resource or tool that we developed to help us in the data adequacy step. And that was the preparation or development of particular formats -- (inaudible) summaries they're called -- which are endpoint specific templates, if you wish, that identify the critical descriptors for that particular study. And those data elements are presumed -- are looked for in the (inaudible) summaries. The absence of one of those descriptors does not itself invalidate the study, but it raises a flag and it makes you ask questions about the quality of the study. We have found that tool to be extremely useful in expediting the data adequacy determination.

JENNIFER: Thank you. JIM: Gary?

MR. LIBMAN: First of all, an excellent presentation, Kerry and Kathryn. It was excellent. My question is regarding one of the statements you made about reclassification. And I would like to give a sense of urgency to the reclassification of some of these category three to category four. We're under a severe time line because of the organic standards. Some products that can now be used for organic farming cannot be used if they are using category three inerts. And I know that -- I think it might be April -- next April -- where we have to have these only List 4 products -- inerts -- in some of these biological certainly that can be used -- that can be listed by Armory and other certifying agencies. What is the urgency within the agency to get these List 3's looked at in order to get them properly categorized in some cases to List 4?

MALE SPEAKER: Well, we have been working with the National Organic Standards Board and USDA. They have identified a group of substances that are classified as List 3 that they would like us to consider for List 4 reclassification. So there is an ongoing effort to look at a specific group of substances. We have given them some preliminary indication as to which of those we may be able to consider in the time frame that that's necessary and which ones we think are most likely to meet the kind of criteria we walked through here in terms of meriting a List 4 reclassification. So we're certainly aware of that, and we're trying to work with NOSB and Armory and others in that area.

MR. LIBMAN: Okay. I just wanted to --

MALE SPEAKER: We go -- every quarter we go to the NOSB's meeting and we give a status report on how we're doing in that very effort. And I think it's November of '02 we have -- or you have, really, to have it -- if it's not on List 4 by then, it can't be in an organic product. And I think we'll be going in January again to give them another status report. They identified, I guess, about 40 of them, Kerry, that really were caught in this bind? And we're trying to work through them. We obviously are not going to have reclassified all 40 of them by that time frame, but we hope to have a good chunk of them reclassified.

MR. LIBMAN: Okay, thank you, I appreciate that. And whatever we can do to help the urgency of that, we would appreciate, because otherwise we're going to lose some good organic products.

JIM: Bob?

BOB: Again, my compliments to the group for an excellent presentation. I think an excellent start for a process. I just have a comment. The current list or categories go from one to four, with one being the most toxic to one being the least toxic -- or four being the least toxic. The proposal on the tiers here, 1-A and B and 2 and 3 go the other way, with three being the most toxic. I was just wondering if there had been any consideration to whether this might cause some confusion and whether it might be more appropriate to reverse the process?

MALE SPEAKER: We are looking into that. We recognize that we have the tiers and the classification. So as part of our consideration in this kind of implementation, we're taking a look at that. These tiers do not necessarily translate directly to List 1, 2, 3 or 4. And this will be further explained when we present the full package.

JIM: Thanks, Bob. Steve?

STEVE: Well, first of all, thanks Bob. I was wondering the same thing. You can't help but wonder the resources something like this effort might consume, particularly in the time in which we're trying to get new registrations through and get through all the reassessments. I understand that through the HPV and some of these other processes you'll be able to collect data from other sources. I'm wondering if there isn't more information available. Presumably a lot of inerts might be commonly used in other products. We spoke yesterday about, you know, household cleansers and things like that. Are there ways in which these items can work together so that there is some more efficiencies that can be had in this whole process to try to streamline some of this?

JIM: Kerry and Kathryn? I think that when you're referring to literature searches and use information, that's what you're speaking to. Is our ability to understand based on past history what is commonly known about these ingredients.

MS. BOYLE: Right. One of the things that we struggled a great deal with, which will be articulated better in the actual methodology, is what kind of data did we want to look at. And what we were trying to come up with was a scheme for something that has been peer reviewed that is fairly recent, but not necessarily just a year ago, that essentially when you look at it, we can run with it. Okay. We do not essentially want someone to dump a truckload of data on us. That would just burn our resources to go through it. So what we're trying to do is identify resources that when we can pull that data, that essentially we can use that data immediately because it's already been through the processes. That's why the FDA grass assessments are so great, because they have been through a peer review process.

STEVE: And nothing like this is being done by any other agency within the federal government currently, other than the standard FDA process?

MS. BOYLE: Not that I'm aware of.

MALE SPEAKER: An analogy of the FDA indirect food additives. That might be the most --

STEVE: Well, maybe Bill can answer that question.

JIM: Good segue. Thank you. Bill?

BILL: Thanks. I have a couple of questions. The proposed program is primarily designed to establish acceptance or establish a tolerance for these inerts -- for use inerts. Is that kind of the idea here?

MALE SPEAKER: Well, we developed this -- I mean, as Jim mentioned in his opening remarks with FQPA. That was really the sticking point. So consideration was given clearly to coming up with a process that would be FQPA compliant. But really we see this as being -- having utility for all inert ingredient determinations. It's really the basic premise of what we put forth here in making determinations related to low toxicity, to considering the exposures that would apply to basically any inert assessment.

BILL: So the idea is that an inert would go through this process and you would then -- the outcome would be perhaps a tolerance, perhaps which list it's going to go on. You know, one, two or four, I would presume. Right? Are you coming out with a determination or not?

MALE SPEAKER: Yeah, right. Yes. You're exactly right.

BILL: Okay.

JIM: Bill, anything that gets approved is de facto List 4. List 4 means we've made a safety finding for it.

BILL: I see. Okay. So it becomes a List 4 inert. And my final question is that FQPA seems to be the driver for this process, and I'm not seeing the consideration of the other aspects of FQPA in this inert evaluation. You know, the cumulative, the aggregate and all those complicated -- and the drinking water considerations. Is that going to be part of this?

MALE SPEAKER: Well, we didn't go into great detail here. Again, this is kind of the broad overview. Yes. Many of those -- I mean, we've considered the relevant parts of FQPA and how it might impact the inert process. So that again would be something that we would speak to in the definitive methodology.

BILL: Okay. And I guess I would echo Steve's comment, then, that the resources required to do these full kind of FQPA analyses, I would think, are going to be, you know, huge. It just depends on the degree to which you want to complicate your life, I guess.

MALE SPEAKER: Well, that definitely is one of the factors that we've used in attempting to develop the methodology. And we're trying to balance the needs for making a safety finding under the law with a resource constraint, which is why we're relying so much on data that has been generated for other purposes, structural activity and assessments. That's the balance that we're trying to strike, is meeting the safety requirements under the law with the -- making logic good sense and resource considerations.

BILL: Yeah, I can -- and I see that on the tox data or the data generation side. I guess it's the other aspects of what you do with that data and what you plug it into in terms of like the drinking water or cumulative and aggregate stuff on this. I just -- it would be huge.

MALE SPEAKER: Well, it is, I think, useful, although it shouldn't be relied -- as I was mentioning to some inert manufacturers last week -- for people to look at the assessment that we did for this Huntsman product. The reason why it's useful is it gives you a sense as to how we actually aggregate, because we did aggregate, drinking water and residential with food. But its limitation is that because everything now under this approach is go tailor made, it doesn't give you the answer to every possible solution that we'll come up with. It gives you how we solved one specific scenario situation. So it's useful to look at an example like that, but at the same time, it is limited because it was -- you tailor -- you have to tailor pretty much everyone as to the particulars around that inert ingredient. But we did an aggregate assessment that was very -- wasn't, I don't believe, as expensive as you might think. It certainly wasn't free, though.

BILL: Thanks.

JIM: Troy?

MR. SEIDLE: Thank you. Yeah. I would like to echo the comments that have been raised so far. It's very helpful to get this type of presentation early on in the process. And representing the animal protection community, I can tell you that we're certainly pleased to see considerations like data grouping and clustering being considered. But there are some concerns, particularly when you move beyond List 1 for potential massive animal testing. Even a standard SIDS dossier, assuming that there is no existing data on a chemical, you're looking at up to a thousand animals per SIDS dossier. And considering the number of inert ingredients that could be examined in either a Tier 2 or a Tier 3, there is enormous potential for animal use here. So my question is, what is OPP, and for that matter OPPT, doing to work with the EPA's Office of Research and Development to encourage or to promote the development and validation of non-animal methods that could potentially replace some of these in vivo endpoints? Because essentially all the SIDS, with the exception of mutagenicity, are in vivo and the Tier 3 assays would be as well.

MS. MULKEY: Well, I'll take a crack at trying to answer that. We have an ongoing effort -- not just in this context, but across the board -- in a lot of cases involving international forums like OECD and others to identify opportunities to reduce or eliminate either an animal test or animals in a test. And that's as applicable here. And in fact, there may be some additional opportunities here, because we are attempting to think through how we can use valuable information a little more aggressively than we are able to do, frankly, in the active ingredient context. How we can use available data, things like structure activity analyses, which generally do not require the use of any animal testing. So we do have a generic investment in that. Ann is a little closer to the particulars, if you want to ask some.

ANN: Just not in great deal, Troy, but you'll remember that our Office of Science Coordination and Policy in this AASHIP is sort of spearheading the whole AASHIP's efforts on animal welfare and animal testing issues. And so we're working with them, and Sherri Sterling in particular, to take a look at all of our test requirements. Not just for inert ingredients, but across the board to see what are the opportunities for actually not only satisfying our need to know certain things about the chemicals we regulate, but what are the effective ways that we can reduce the testing implications. I actually believe, but I haven't seen this in writing sort of on my desk yet, that there was some direction of resources in our appropriations process this last year towards animal welfare issues. And I think the agency is still sort of sorting out how that will be managed and used. But I would expect that through OSCP we will be working with ORD to employ that most fruitfully.

MALE SPEAKER: Just to follow up very briefly, we have had ongoing discussions about this. But the one impression that still rests with us is that we have -- it's just, I guess, the lack of coordination between ORD and OPPTS, where on one hand we have the HPV endocrine children's health and potentially significant animal testing for inerts and other pesticide products on a day to day basis, and on the other hand there don't appear to be any focused efforts to go after specific animal endpoints to develop non-animal methods through ORD. And we talked to Bill Farland and others in the Department. And I think there is fairly -- a fair bit of agreement that there needs to be more coordination, and that's something that perhaps to come from a higher level.

MS. MULKEY: Well, we would agree with that. One thing that would be helpful is as you focus on the details of this particular proposal, if you were able to identify specific tests or science questions that you think are particularly ready for a focus on an alternate test. If you are aware of work going on on an alternate test, or if it's the kind of science question that lends itself to the development of alternate tests, comments that are very specific are particularly helpful to us. And we are also going to be proposing our pesticide data requirements as a rule over the course of this year, and that's another place where if folks who are interested in seeing these alternate tests develop for whatever reason -- for animal conservation or for resource conservation in general -- are able to focus in on particular tests, that makes it easier for us to really react to this concept.

JIM: Thanks. Winand?

DR. HOCK: Yes, thank you. An excellent presentation. A couple of the members have already eluded to the fact about the tox categorization kind of being switched. I just also want to point out that our current AI's -- active ingredients -- the classification starts with tox category one and goes to tox category four. So, again, it's kind of switched around. I just wanted to ask a question, though, about the synergistic or additive effects. I think Bill brought some of this up already. But I'm just curious about, are you going to be looking at synergistic or additive effects, particularly, let's say, of Tier 3 -- what is currently Tier 3 -- tox groups with the AI's themselves? Are you going to be doing any of that?

MALE SPEAKER: As I understand, the only testing that we have and we'll continue to do under this proposal on that point is the product specific testing, where the product itself which has the active ingredient and all the inerts in it get a battery of acute tests.

DR. HOLM: Okay. Thank you.

JIM: Bob?

BOB: Well, I'm thinking it's taken me five years to, I thought, figure out how this process all works, and now I'm just completely confused again. This is a question -- I'll always be confused. This is a question. What is the regulatory endpoint? After you've gone through this entire process and if you've characterized the risk appropriately, what happens? Do you just end up on a list, or do you revoke a tolerance, or say it can only be used up to a certain level?

MALE SPEAKER: We will exempt it from the requirements of the tolerance, establish a tolerance, or conversely deny the establishment of the tolerance or the exemption. Or we will say -- and if we're exempting it or establishing a tolerance, you are automatically put on List 4. If it's a tolerance reassessment, we'll basically be affirming that we can make the FQPA safety finding for an existing tolerance, a tolerance that is subject to tolerance reassessment under FQPA. Or we'll be taking some regulatory action to bring you into compliance, whether it's modifying it or revoking it.

BOB: And if it's not an inert with a tolerance, then what?

MALE SPEAKER: If it's not a food use inert ingredient, then it's not subject to FQPA. And the process that we used pre-FQPA is the one we're using today for non-food use inert ingredients.

BOB: Okay. And I guess the final question and one that really confuses me and follows on Bill's question, when you use the term cumulative risk assessment as it relates to inerts, does that mean that you evaluate all formulations that contain that particular inert or other inerts that have a common mode of toxicity irrespective of the active ingredients?

MALE SPEAKER: That, Bob, would be the aggregate part of it, where you're looking at all exposures through pesticide products, and one of the harder parts is non-pesticide products, of that chemical. Cumulative would have to do with inert ingredients that may share -- or inert ingredients and other chemicals -- a common mode of toxicity.

BOB: Well, and that's like staggering.

MALE SPEAKER: That would be staggering. And we have yet to stumble across one, but we're relatively new in our evaluation of food use inert ingredients. But the aggregate issue you'll find most of the time.

BOB: Okay.

JIM: Melody?

DR. KAWAMOTO: Thank you for the presentation. I find that the model -- or the process that you've put up is quite good theoretically. And as a couple of the other members here have mentioned, the logistics seem a little bit unwieldy. And my concerns are more in terms of the quantity of the inert ingredients that have to be assessed. And when you think of the depth of review that each one has to have, then there is probably a finite amount of time, or maybe an infinite amount of time, that would be involved. And I just wanted some clarifications on a couple of things. You had mentioned the IFFG. I was wondering how many of these focus groups were you planning, because this mentions one.

MALE SPEAKER: Well, the concept here, we would have one group. One interdisciplinary committee that would be like a standing committee that would meet on a regularly scheduled basis to consider inert ingredients. This is very much modeled after the focus group that is used in the OPPT and the Toxics Program as part of their PMN process. And they're looking at, you know, 2,000 chemicals a year. I don't know if we'll meet those kinds of numbers. But, you know, we're hoping to get -- obviously one of the goals of this whole approach is to increase our (inaudible). And by the use of chemical groupings and identifying those substances that really fall into that low toxicity tier that we don't have to have an extensive AI type risk assessment, you know, should help us out there. Obviously, there will be substances that will require much more in depth analysis that will be resource sensitive, and part of this process is really designed to kind of, you know, make that distinction.

DR. KAWAMOTO: Okay. That actually addresses one of the other clarifications that I wanted. It seems that an assumption that I made from what you had presented is that you assumed that there is sufficient information available for most of the chemicals, and not that many will really need risk assessment or, you know, further data generation for risk assessment. And I wanted to know whether you have any kind of estimate of the numbers needing risk assessment. And the other thing is, if this group is reviewing, you know, how will they be able to work on the risk assessment as well, because part of it implies that this group may be doing the risk assessment, although they may have the option of recommending someone else do it.

MALE SPEAKER: Well, in answer to your first question, we haven't yet really made absolute calls in terms of where the existing chemicals or potential new chemicals -- new inert ingredients -- would fall into this. But we have looked at some of the chemicals that are subject to tolerance reassessment, and we think out of those 800, perhaps fully half or maybe two thirds may end up in these lower tiered categories. Obviously, that would help us out a lot in terms of being able to move these things through. But we don't yet have any firm numbers, so that's something obviously as we move through and adopt this process that we would be looking into. The second question was the -- the second part of your question?

DR. KAWAMOTO: Whether the focus group will be doing the risk assessment?

MALE SPEAKER: Again, this, I think, is part of the problem when you just present a very broad overview. The assessments themselves would typically not be done by the focus group. The focus group would be kind of a decision making body which would make kind of the final bottom line determination. They would be acting upon the information that would be presented to them by others in the organization, so they would essentially be kind of, you know, the judge and jury, if you will.

JIM: Fred?

FRED: Just a question to follow up on the dialogue between Melody and Kerry just a moment ago. From a registrant standpoint I understand our obligation to supply the data -- the scientific information -- but we often work with outside experts. There is a highly evolved community of risk assessment expertise out there that we commonly work with. Would the agency accept not only the data as part of a petition, but also a preliminary exposure characterization and risk assessment as part of a package that might go into the agency, obviously subject to further review and examination? But again, can we take some of the heavy lifting off of the agency by our work with outside consultants and toxicologists who are in the practice of doing risk assessments and exposure characterizations?

MALE SPEAKER: Are you asking if the agency would be willing to entertain the manufacturer submitting not only the data that may be appropriate, but also the risk assessment?

FRED: Yes.

MALE SPEAKER: I think that we're comfortable -- as a matter of fact, in our work with OECD dossiers have implicitly endorsed manufacturers submitting risk assessments. We find it very helpful. That doesn't mean that we are going to rely on that as the risk assessment. However, we find it very helpful as we're doing our risk assessment to have some sense as to what the manufacturer thinks the risk is. It helps us to troubleshoot, frankly, when we begin to diverge and quickly begin to engage in a discussion as to why do we have different answers. So we find it to be useful and resource savings, but it's not that we're just going to then rely on the manufacturer's submitted risk assessment. FRED: Yeah, I understand. I wasn't proposing that that would be accepted de facto. But it helps at least jump start some of those discussions in the risk assessment's next step.


FRED: Thank you.

JIM: Erik?

ERIK; I had a follow up question. You mentioned in your presentation which I thought was very helpful about special sensitivities to infants and children. I was wondering if you could describe or elaborate a little bit more how that will be extended to the different tiered inerts.

MS. BOYLE: Well, essentially it will be different for each of the tiers. Generally for something that is low toxicity, we have been able to say that a safety factor analysis is not necessary just due to the low toxicity. When we get into the higher tiers what we start doing is -- remember I said that the three pronged approach, the value of it, was in the integration? Essentially what you do, is you look at the SAT analysis -- the SAT report that has the SAR analysis in it -- and they have essentially -- if there are any developmental or reproductive concerns, they will so state. We look at the data then that has been submitted. We need some kind of developmental or reproductive data, and we're also looking for a match there that says there is not any concern. All right. And then we look at the literature that is available on the open web. Okay. And again, we're looking for the absence of finding any information that says that there is a concern, and you start then putting all those three parts together. Okay. That's the value of using three different sources for information at that point. And then for the Tier 3, it is exactly like in the active ingredient paradigm.

JIM: Ray?

MR. MCALLISTER: My list of questions here is spilling off of one page, so let's see if I can keep this brief. I understand the goal of the tolerance reassessment and any other reassessment done on the inerts that are already on our lists one through four is to move everything to List 4 as having been evaluated and a safety finding made, or it ends up on List 1 where it is still useful, but it has to be listed on the label because of tox concerns. In getting there through this process, I would like to understand a little better how this process will move them among lists. For example, if a product or an ingredient ends up on Tier 3 in the review process, does that automatically boost it to List 2, it needs more data?

MALE SPEAKER: No. No, we would -- List 2 is -- as we identified in our policy in 1987 for compounds for which we have -- we know that it is structurally similar to a compound that exhibits --


MALE SPEAKER: -- auganagenicity (phonetic), developmental toxicity, reproductive toxicity or some other endpoint. So, I mean, the scenario you've described could lead to it being reclassified.

MR. MCALLISTER: Because you're doing the SAR, yeah.

MALE SPEAKER: But it wouldn't necessarily.

MR. MCALLISTER: Yeah. Your SAR analysis in this process might put it there.


MR. MCALLISTER: Okay. What about the situation where you have a compound that has gone through review and it ends up on List 4, but does not have a tolerance. Does not qualify for a tolerance. Is that a compound that can be used in non-food use pesticide products?

MALE SPEAKER: Yeah. It's for a product that's got no tolerance or tolerance exemption and can only be used in a non-food use pesticide. Wouldn't that be accurate, Kerry or Kathryn?

MR. LEIFER: Yeah, that's correct.

MR. MCALLISTER: Okay. But the only way you know that, then, is look on List 4 and try to find it among the tolerances and it's not there?

MALE SPEAKER: Right. Looking at the Code of Federal Regulations --


MALE SPEAKER: -- for tolerances. For tolerance exemptions.

MR. MCALLISTER: We might consider making a clearer classification of those. It's on here, but it's not a food use.

MS. MULKEY: He's asking about an approval for a non-food use. Where would you find the fact of its approval.

MALE SPEAKER: Ray, your question is, where would you find that?


MALE SPEAKER: You would find that on List 4.

MR. MCALLISTER: Uh-huh. But List 4 will have food use and non-food use chemicals?

MALE SPEAKER: That's right.

MR. MCALLISTER: And the only way you tell which is which is by comparison to --


MR. MCALLISTER: -- the Code.

MS. MULKEY: But if that's a comment that you would like to see some other --

MR. MCALLISTER: Yeah. Yeah, I would like to see a clear designation, this is not for food use. It's Code but it's not food use.

MALE SPEAKER: So in List 4, for example, you give some indication that it has a tolerance associated as well.

MR. MCALLISTER: Yeah. Buried deep within the Pesticide Program as part of 40 C.F.R. are some listings -- categorizations -- of inert ingredients, which I think have been there for a long time and aren't necessarily coordinated with Lists 1 through 4. And I would like to recommend that those be coordinated. If what's in 40 C.F.R. is outdated, can it either be removed or replaced by the listing process so that it doesn't lead to confusion. The database mentioned -- the decision database -- is that something that is going to be publicly accessible as it is developed and added to?

MALE SPEAKER: I believe we're thinking of it as an internal decision making tool, not external.

MS. MULKEY: But again, if we have comments.

MR. MCALLISTER: Yeah. Well, I haven't thought that through. It was just a question at this point. A couple of questions have been raised about aggregate risk assessment of the inert ingredients, and many of these are chemicals where their use in other industries processes, or even in other consumer products, dwarfs their use in pesticide products. How would you coordinate an aggregate risk assessment with other offices within EPA, or even other agencies who have regulatory authority over those chemicals?

MALE SPEAKER: I think that that's hard to answer in the abstract. We would have to have an example in front of us, and that would help us sort through how to -- whether to -- and the need for that kind of coordination, or whether it could be done in a qualitative manner, as Kathryn sort of walked through.

MR. MCALLISTER: But have there been any discussions with the other offices or other agencies about the need down the road to do this?

MALE SPEAKER: Yeah. We've certainly been talking with FDA and with OPPT for sometime.

MR. MCALLISTER: Well, I want to compliment the agency on the approach they're taking. Several folks have expressed concern about the magnitude of effort that is going to be required. But from what I know about the active ingredient registration process, what you're doing greatly reduces the magnitude of effort compared to a similar effort. You know, rather than doing them one at a time and getting all new data, you're making efficient use of the data that already exists, kind of in some sense farming out review of that data to other programs in EPA that are already doing it. Do you have any idea, even with this streamlined approach, how much time this is going to take for the nearly 800 tolerances -- exemptions from tolerance?

MALE SPEAKER: Two thousand and six is our statutory requirement.


MR. MCALLISTER: -- in public opinion research. And it's hard for some of us to shake that when we're thinking about this. You might want to call this an inert ingredients review committee so that there isn't that confusion.

MALE SPEAKER: That's a good point, Ray. Thanks.


MALE SPEAKER: Warren, is your card up?

DR. STICKLE: Yes. I, too, had four or five questions I wanted to raise. I think, Kerry, you mentioned that the methodology was going to be ready for public comment. Are you looking at two or three months, or do you have some idea what kind of a timetable you might be working on?

MR. LEIFER: Well, as we mentioned it's still undergoing some internal review further, so at this point I can't give you a definite date. Obviously, we would like to get this out as soon as we possibly can to solicit public comment.

DR. STICKLE: One of the really important things ultimately will become the determination of what inerts are in List 1, 2 and 3. Or I should say Tier 1, 2 and 3. What kind of a timetable do you have -- I realize you've got several years to do this. What you're really doing is setting the list of priorities. How long do you think it's going to take to begin publishing a list of those, let's say, that are on List -- Tier 1, for example?

MR. LEIFER: Well, I think some of those determinations have yet to be made. We have begun preliminary work with the body of inert ingredients that are subject to tolerance reassessment, and have given some consideration primarily to those that we think may fall readily into the lower tiers that we can move through more rapidly. What we haven't done as much is to kind of predict at this point which ones may fall in -- in some cases we just don't have the information as of yet. So I think that's going to be an ongoing process to kind of scope out where these things may fall and what the resource implications may be.

DR. STICKLE: At one point the agency was giving consideration to doing a data call in on List 2. Given what we've heard this morning, where does that put that project? Does that get incorporated into this, or does this get postponed to a later time? I'm trying to understand the potential status.

MR. LEIFER: Certainly as we mentioned, we're going to be using this process to make all those determinations. But certainly there may be cases where data call ins are the way to go. This doesn't, you know, obviate the need for DCI or would eliminate that. So that's still on -- in the works, I should say, where needed. We certainly will be taking a look, you know, once we've operationalized this process concerning exactly what our data needs may be and make the appropriate determinations.

DR. STICKLE: One of the real potential log jams deals with trying to reassess 771 food use inerts other than those that are on the grass list. And Kerry and Kathryn did a very good job of outlining the process. The creation of an inert ingredient focus group, or whatever you might want to call it, obviously is going to tap into some of the scientists and some of the risk managers in the agency. I guess my question from a relocation or allocation or resource point of view, are these scientists and risk managers going to be assigned to this particular project, or is everything going to get routed through ATD? And what are the implications for a backlog? In other words, are they going to be working and focusing on this issue?

MS. MULKEY: Well, obviously the work we do on this issue is work that is using people and resources that we're not working on something else. That is sort of true by definition. That's one reason why we've worked so hard on this, is to try to be sure we can be as cost effective with our resources. How we organize ourselves to be sure that there is some -- that we get to all the things that we've chosen to get to varies somewhat. For example, within our Health Effects Division we have separated out the scientists who focus on registration from the scientists who focus on re-registration. They're in different branches, which is one of the ways that we sort of manage. So obviously you look at those kinds of issues when you're putting together a structure like this. In this case, we're talking about fairly senior people doing this last piece of it. They're not likely to do this work exclusively. On the other hand, the actual review personnel may turn out to be exclusively dedicated to this work. But those are the kinds of things you look at in managing an organization so that you're confident that you have organized yourself in a way that facilitates your getting to the work you intend to get to and in the order in which you intend to get to it.

DR. STICKLE: The only reason I raised the question is that there is just the massive amount of work to deal with 800 inerts and it's going to take a lot of resources to get that done. Will there be any kind of fast track for the Tier 1 low toxicity list? Kerry, you mentioned that potentially maybe two thirds would fall into that area. Any kind of a fast track for processing that and working on that?

MR. LEIFER: I think, again, we're kind of working in that area to identify those that may fall in there and to see what can be done. And some of these -- the nitty gritty details of the operationalization of this process, you know, still need to be worked out. But obviously if we can make those kinds of calls -- if we can make those determinations -- we would like to report on them.

DR. STICKLE: Okay. And lastly, there are 176 FDA approved grass products that are already listed on List 3 inerts, and they make a potential candidate to look at for possibility of moving from List 3 to List 4. I wondered if that might be one of the early considerations of product groupings out there.

MR. LEIFER: Well, we're looking at prioritization in a number of ways of the new inert ingredients tolerance reassessments, and certainly we'll be taking a look at those substances where we think there may be sufficient data, be it FDA data or other data, to run through this process.

JIM: Thanks. Michael?

MICHAEL: Thank you. I had several questions, but I thank Ray and Bob Rosenberg for shortening my list down to one. Kathryn, in your presentation you mentioned the allergens -- the well known allergens -- would not be in Tier 1. Tier 2 talks about further data generation, as does Tier 3. But for many of these, there is ample information in the literature. What I was wondering is what sort of consideration -- what sort of data -- do you think that you might either consider or request in looking at those allergens, and how do you think that might translate ultimately into reclassification of the lists for those substances?

MS. BOYLE: Actually, I don't think we would need any data at all, okay. These are not Tier 1-As, because essentially we can't make just a very broad rationale that says these are the foods we eat and there is no problem. Because of the allergic properties that these have, they're going to have to be 1-Bs. What we're counting on for these is that we will be able to establish use patterns for them, okay, that we will be able to say that when you use one of the allergen containing foods, okay, but you use it according to a specific use pattern, that there shouldn't be any problem. And then we can make our safety finding that way. So that's what we're planning for them.

MICHAEL: And you would envision that for allergens you would be able to establish use patterns that would not require label disclosure?

MS. BOYLE: Essentially it would be -- I don't think that we've gotten into the issue of label disclosure yet. Okay.

MICHAEL: Well, label disclosure in terms of the requirement for labeling of group one.

MS. BOYLE: Uh-huh. You mean List 1 ingredients?

MICHAEL: One, I'm sorry.

MS. BOYLE: Okay.

MICHAEL: Between tiers and lists and groups.

MS. BOYLE: I know.

MICHAEL: Yes, List 1.

MS. BOYLE: Okay. Well, I don't anticipate that these allergens would be List 1's, okay. That's not anything I have heard of, okay, at any time in the past. What we believe that it would be is that it would have very specific -- a very specific use pattern, okay, and essentially that it would be taken care of that way.

MICHAEL: Okay. Thank you.

JIM: Julie?

MS. SPAGNOLI: I think I can add to what Michael's issue is. I know like peanut butter is used as a cockroach bait, and so if peanut butter was in an enclosed bait station, I think that would be the type of thing that you're referring to. That you wouldn't expect to have a child, you know, to eat that peanut butter. So that would be the -- I mean, is that the kind of situation? That's not my question. I just -- you know, hearing that I think that's what I envisioned that you were referring to.

MS. BOYLE: Right.

MS. SPAGNOLI: I really appreciate the tiered approach, and I think to those of us that are in -- you know, registrants who utilize the tier approach all the time, there is no confusion to me between what is a tiered approach versus a categorization. That a tiered approach gives you a point where you can make the decision, and Tier 1 is a decision made without further -- you know, without needing further consideration. So I think that this is a very good and sound approach where you say at what point can we make a decision that we don't have to necessarily generate, you know, active ingredients worth of data to make a decision. So I think this is a very, very sound approach. The question that I had, and it's probably kind of in this, but it wasn't specifically addressed. That a lot of tolerance exemptions are granted on the basis of a Palmer exemption. They have in the past. Is that still going to be one of the criteria under which a tolerance exemption would be granted, and how does that fit into this process? Do those become -- is that considered a 1-B type of decision, then?

MS. BOYLE: No, actually it will be a 1-A.

MS. SPAGNOLI: It will be a 1-A. Okay.

MS. BOYLE: Because all we are looking for in that case is that somebody makes those certifications to us, that they go through the criteria list and they say yes, yes, appropriately.

JIM: Lori?

LORI: Thank you very much for your interesting presentation. I have a few questions. From a toxicological standpoint, can you please explain to me, or clarify for me, the difference between toxicity and sensitivity that you'll be testing for, and will you be incorporating probabilities as to, you know, the likelihood of certain individuals or populations having a sensitivity?

MS. BOYLE: Not being a toxicologist, I'm probably not the person to answer that, but I'm wondering if Pauline back there could handle that?

PAULINE: Well, sensitivity --

MALE SPEAKER: Pauline, do you want to come up?

JIM: Tell them who you are.

MS. WAGNER: Okay. I'm Pauline Wagner and I work in HED. The sensitivity is for infants and children under FQPA. And that would be -- an example of that would be if you had a developmental study where the children are more -- that the pups had a lower NOEL than the moms for maternal toxicity. So you would say that the children would be especially sensitive to chemicals. Nitrates would be a good example. Children are very sensitive to nitrates in water, but adults are not.

LORI: Okay. Okay, thank you. My second question is, it's my understanding that the average time for review of a new AI/formulation is between 24 and 40 months dependent upon whether it's reduced risk or not. How much time do you anticipate this process adding to the normal review process?

MR. LEIFER: Well, for a new active ingredient it wouldn't per se affect that time frame. They very much are independent time frames, so that the new active ingredient time frame should basically remain the same, other than it potentially gets affected by resource crowding.

LORI: But I thought that that has been a concern that has been voided?

MR. LEIFER: Yes. And that's -- okay. So you are referring to sort of will it affect the time because of resource allocation issues?

LORI: Right.

MR. LEIFER: Okay. Not because you have to have the inert approved before you can do the active ingredient?

LORI: Right.

MR. LEIFER: Okay. Sorry. I think it's too early to tell what -- how it will affect, since from FY '96 until FY '01 we hadn't established a new food use inert ingredient. This will be the first year that we begin to do so, other than with the exception of Palmer exemptions. So this year will begin to inform us as to how the time is or isn't, or the extent to which the time of new active ingredient reviews and new use reviews are affected by our work on inerts. FY '02 will be somewhat telling in that respect.

LORI: Okay. And then my last question is -- because I work a lot with the fresh produce industry and there is a lot of exchange between different countries. Once we get these regulations in place on down the road, how will we be testing produce coming into the United States? What kind of program do you foresee on us testing produce coming into the United States for residues of inerts?

MR. LEIFER: That's a good question. It's a FDA responsibility.

MALE SPEAKER: Frankly, we haven't thought far enough ahead at this point as to how it would change our existing monitoring program. Yes, it is a FDA responsibility and, you know, perhaps at a future PPDC, if we have some preliminary thinking along those lines, we can share. We can come prepared to do that.

LORI: Well, this is an area that would be of great interest to the people that I'm working for. Just as we do open up more markets both ways, I think if we're building this process, we need to build that into it. Thank you.

MS. WAGNER: Can I -- thinking about your question, I think there is another -- FDA has got the responsibility once a product has been exported to the U.S. to design and run monitoring programs. I think one of the things that we would be able to do when we get our inerts methodology and sort of refurbished inerts assessment program up and running is actually to be able to share the methodological approaches that we have developed, and results, with certainly other developed countries who are about the business of regulating pesticides which include actives as well as inert ingredients. So I think that the opportunity to sort of transport what we're doing here, and what I think are some pretty big strides, exists. I think we've got the sort of international framework to do that. And I would think that that would actually help FDA as kind of a -- I'll call it prevention. So to the extent that we're able to translate what we're doing here with major trading partners, that lessens the burden for FDA to have to design a specific monitoring program with specific inert ingredient components.

MALE SPEAKER: And I can see some other factors not working in the favor of having to rely on monitoring it as much as for active ingredients. We can use multi residue methods. And over the years we've become more reliant on methods, you know, that give us more analytical power through multi residue capabilities. I don't know how amenable that approach would be to inerts. You don't want to go back to a lot of monitoring where you're depending upon a method for a compound and then just multiple that throughout everything that is coming into the U.S. So that's a good suggestion. The more that we can rely on educating in the source countries, yes.

MS. MULKEY: This is obviously a topic that deserves some additional attention. One thing that occurs to me, that if we were to in our reassessment reject -- find that an inert fails to meet the safety standard and therefore revoke the existing exemption, that would be an important candidate for thinking through these questions on. Because we would have removed it from our food supply if domestically produced. Removed it from authorization for imported foods, but then you raise the question of what about compliance. And I think -- I think that will be a pretty small subset of the universe at the end of the day. So it may not be as difficult a question once we know where we're most focused on.

LORI: Thank you.

JIM: Steve?

DR. BALLING: Well, I have a very similar spin on the same question. We import some food from overseas for processing, and we typically provide a list of legal or acceptable, to Del Monte at least, pesticides that can be used on any particular crop. If it's based on formulation as well, are we going to have to track what formulations are available in other countries to be able to know what inerts might be on those products?

MS. MULKEY: Well, in theory you have to do that now. I mean, the inerts are either subject to a tolerance exemption or they're unauthorized. So this doesn't change the legal framework about whether inerts are lawful on food or not. That was true --

MALE SPEAKER: Five years ago.

MS. MULKEY: -- in 1995.

MALE SPEAKER: Twenty years ago.

DR. BALLING: You're not testing for them. We're not testing for them. There is no list. It's a strange concept.

MS. MULKEY: Well, there is a list of what is exempted.

DR. BALLING: That's true. What -- if there was a tolerance set, would it be a measure of legal application as we currently have tolerances for pesticides, or would it be a health based tolerance?

MALE SPEAKER: It would be a health -- it would be expressed in terms of if it's a tolerance, parts per million or parts per billion. And it will be a health based standard.

DR. BALLING: And it would be based on after we know the maximum application rate and maximum timing.

MALE SPEAKER: Right. So that we would be assured it would be valid.

DR. BALLING: So it would vary from crop to crop, so you would have to have a different tolerance for each crop for each inert?

MALE SPEAKER: Yes. But again, that has to be from --

DR. BALLING: Depending on PHI and --

MALE SPEAKER: -- pre-FQPA. The vast majority of what we do we're exempting from tolerance.


MALE SPEAKER: You get into the tolerance setting mode if you really had concerns about some degree of toxicity and risk. So you wanted to make sure you were --


MALE SPEAKER: -- achieving some upper level that was below which was safe. Yeah, it would be crop based potentially.


MALE SPEAKER: And that has not changed either since before FQPA.

FEMALE SPEAKER: Bob? BOB: Yeah, I just have one question. Who -- have you guys thought about who it is that submits these tolerances today and ongoing? Is it an inert manufacturer or is it the registrant?

JIM: Kerry, do you want to handle it?

MR. LEIFER: Typically when we get the tolerance petitions, it's generally from kind of the manufacturing community, but it's not necessarily limited to that. It can be basically anybody who has an interest in seeing that a tolerance or a tolerance exemption is established. So it's not limited to any one particular --

BOB: So this would be an inert manufacturer primarily, who then has responsibility for kind of knowing -- or they'll just settle in that regardless of the formulation and the crop or the use site and everything, right?

MR. LEIFER: Well, again, it can very much vary. In some cases this is kind of at the really early stages of pre-marketing. Many times companies who think they may have a product that could be utilized in food use pesticide formulations will come forward and ask to establish a tolerance exemption, and they may not have a lot of information on the specific uses that may ultimately occur. In which case, we have to consider it rather broadly. In some cases, they may have a very specific application in mind, and they may want to use it with a very specific active ingredient for a very specific purpose for a product that is already on the market where you can really discern exactly, you know, the use patterns. Again, it can really vary. What we hope to do with our methodology is to be very transparent and clear in terms of the types of information we would be expecting to be provided by whomever it is that provides that information, so that we could give guidance as to what we would be looking for in terms of not only the toxicity data, but on kind of exposure based information as well.

BOB: Okay, thank you.

JIM: We're going to need to wrap up. I see two more cards. We'll take those and then close up this session. Phil?

MR. BENEDICT: If you're talking about monitoring and compliance, it means there needs to be an analytical method for the inert. Are you going to require that as part of this process? You know, if not, we're going to be in the same problem we were with ground water with a bunch of AI's, to be perfectly honest.

JIM: Kerry?

MR. LEIFER: Well, generally, as we kind of eluded to earlier, if we establish an exemption from the requirement of a tolerance, we wouldn't have an associated method. Again, that has not changed. That's always been the practice. If there was a finite tolerance in place, then there would be a need for a method. Obviously, one of the other issues that come to bat with inert ingredients is the fact that these things aren't unique to pesticides, so potentially you could find these substances in the environment from their many other non-pesticidal uses.

JIM: Dan?

MR. BOTTS: I don't mean to keep beating a dead horse, but I think you've opened the door to a whole new regulatory concept in non-tariff trade barriers out there that I don't think anybody, quite frankly, has thought about, because we've been so concerned about active ingredient tolerances. But what you've just said in the way you've described this process, unless that exact same product as approved in the U.S. is used on that product that is imported, unless you can guarantee that the inerts that they formulate those products in other countries aren't on this list, you created a tremendous problem for a whole universe of people that are sitting around this table. And I need some clarification on that, either from FDA or from you guys.

MR. LEIFER: Well, I think that -- instead what's happened, is you've just looked at a window that has always been there. This really has not changed for 30 years. This reality has always existed. What we're talking about here is how we're going to evaluate pending applications to inert ingredients.

MR. BOTTS: Well, that -- that makes it even worse, because there are agreements that we have signed, or our members have signed, that have guaranteed these guys that the product we supply them meets every regulation and standard by the federal government. And if we cause that product to go in interstate commerce, then all of a sudden we're subject to all kinds of rules and regulations and laws that become criminal violations. Not the traditional process of maybe having a product that is deemed unsalable. All of a sudden the CEO gets a potential to go spend some time in the federal pen relative to these issues. It's a real issue and somebody needs to clarify this.

MR. LEIFER: It could be that that -- and it's very much a separate issue from the methodology used to evaluate new and old. But it may be an issue that this group wants to talk further about.

MS. BOYLE: And I guess I would -- I know that in theory it creates -- having now looked out that window that you didn't know that was there, it looks like there is a very big sort of drop off. But I actually don't think the picture that you have painted for yourself is one that actually has to happen. I think it's a manageable issue. JIM: Well, we're going to spend -- we're going to spend some time --

MR. BOTTS: And I want legal counsel to put that in writing, so I can go back to my membership and tell them they don't have a problem.

MS. MULKEY: I think that there is no new problem. There is no problem that occurred as a result of FQPA, and there is no problem that occurred today. It's not clear that there is a problem. It has always been the case that if inert ingredients show up on food, they have to have an exemption from tolerance or a tolerance. And that's just been the law for --

MALE SPEAKER: Over 30 years

MS. MULKEY: -- over 30 years.

MALE SPEAKER: Marcia, if I could --

MS. MULKEY: And that's not new.

MALE SPEAKER: If I could just add to that. We wouldn't approve a product formulation that contained inert -- for food uses if it contained inert ingredients for which tolerances or tolerance exemptions did not exist.

MS. MULKEY: So there would be no U.S. registered products.

MALE SPEAKER: That's the scary part.

MR. BOTTS: That's the scary part, because there are products that are formulated for other regions of this country. And it's not the developed countries that I'm worried about, because there are products that go into those markets that aren't formulated by the traditional people who are putting products together in the U.S. that have all kinds of different inert ingredients in it. And they're relying on an active ingredient tolerance to be able to import that into this country, because that's what's expressed. And unless you know every single inert that is going into those products that are used in those other countries, I don't know how you created a process that didn't create tremendous barrier potential from a non-tariff trade barrier type standpoint for imported products. I don't know how you do that.

MS. MULKEY: Well, the only thing I'm thinking --

MALE SPEAKER: Through inerts disclosure.

MS. MULKEY: It's not a new process, and it's nothing that we've created in the last two decades. I think that's the message, that if there is a -- it's sort of untended to issue there. It's not a new one.

FEMALE SPEAKER: And I guess I actually think the international framework is there to sort through and figure out where are the real problems as opposed to the places where there is perhaps a theoretical problem, but it's not going to be a real problem.

FEMALE SPEAKER: But is that in a timely fashion. I mean, there is like just a framework with Kodaks, but it's very, very slow.

MS. MULKEY: But nothing has happened on this topic for the last 30 years. Nothing.

MALE SPEAKER: Is there a tolerance currently for an inert?


MS. MULKEY: There are exemptions.

FEMALE SPEAKER: You mean a finite tolerance. A numeric one.

MALE SPEAKER: There are some.

FEMALE SPEAKER: I think that there is like maybe a handful over the years where we've had a specific number. The vast majority are exemptions, which means any amount is okay. I think that if there were in fact a monitoring program in place today, it seems to be like you -- one thing that you would have to sort of figure out, is are there products where the active ingredient is approved for use there. An active ingredient tolerance is in place. But it's got an inert ingredient that has no approval at all. It's just totally different than anything that is currently on the books. If there is an exemption for the inert ingredient, even though the formulation in the foreign product is somewhat different than the U.S. formulation, then you don't have a problem. You don't have a trade problem, because the exemption authorizes any amount. I haven't persuaded you. I can tell by the beady look in your eye.

MR. BOTTS: Didn't you all put out a list not too long ago of inerts of concern, and all of a sudden there were changes in formulation of U.S. products to take those inerts out of the formulations that were going into food crops? Can you guarantee that those same products have been taken out of the same products that are being sold to our competitors in other countries? If you can answer that question yes, we don't have a problem. If you can't answer that question yes, we have a problem.

FEMALE SPEAKER: I think what you actually heard today is that neither EPA nor FDA, separately or working together, has actually historically looked at the issue of inert ingredients in food moving in trade. The methodology that Kerry and RD have presented today doesn't -- what I think this is actually doing is making us all look at inert ingredients with fresh eyes. And it think it's clear that there has been a lot of -- I don't know, probably just because people weren't thinking about it -- misunderstanding about inerts somehow being different in many ways from the active ingredients, when in fact that legal framework has been in place for a long time and these problems theoretically have been there. We're not -- because Michael told you. FDA is not ready at this point to sort of mount a monitoring program. I don't think that there is an immediate specific trade issue, and I think there is lots of time to sort of try to sort out what are the most effective ways to make sure that it doesn't become a trade problem, even if FDA should have to amend their monitoring programs at some point to include looking for an inert ingredient. They might not have to do that.

JIM: I think I'm going to wrap this session up. And we have a break coming up, and we also have some time later this morning to talk about future topics.

MS. MULKEY: We will come back at 11. (Whereupon, a brief recess was taken.)

MS. MULKEY: -- and then we have some important planning work to do together, and we trust you will join us for that. I'm glad Bill is back. This next topic is of particular interest to the agriculture folks on the committee, and they're all hanging out.

MALE SPEAKER: Well, we turned Pete into a cowboy out on our ranch.

MS. MULKEY: Did you? I bet you Pete makes a pretty good cowboy. He's a pretty good athlete. All right, please reconvene. I want to make some announcements that will be important, but I don't -- I might as well wait until we have -- it's really disappointing that we're having so much struggle getting people back to your table.

LINDA: Let's go, PPDC'ers.

MS. MULKEY: Linda is our star cat herder.

LINDA: You know you don't want me to come out there and get you.

MS. MULKEY: Okay. As of now, we do not have anyone signed up for public comment, so that's our relief valve for our timetable. But even with that relief valve -- oh, excuse me. We have one. And we're always happy to have whatever public comment there is demand for. We will make it happen. But we do have still, even with one, a little bit of a relief valve there, but only a little bit. I think you owe it to yourselves to invest some in this discussion about next steps and planning for future PPDC meetings. So we don't want to lose that. So we will ask that this next -- unlike the previous topic where you got a preview, sort of a first look -- a first look by anybody -- at an idea, this next item is one in which there have been previous presentations to the predecessor organization of this group. There has been a lot of effort to have informal communications with various stakeholders about this idea. So this is an idea that should not be new to those who have been following it closely. There obviously will be some of you who won't have heard this, and that ought to lend itself to an expedited segment of our agenda. I'm going to ask Jim also to help with this end, but we're actually going to have Pete lead and chair this whole session discussion. Peter Caulkins is currently acting as Director of our Registration Division. He is the Associate Director of the Registration Division and has worked with these issues for a very long time. Thanks, Pete.

MR. CAULKINS: Thanks, Marcia. This exercise that the Registration Division has been involved in in terms of developing an expedited experimental use permit process reminds me of a similar though less successful effort I'm undergoing with my 12 year old son. He's a baseball player. It's the only team sport he still plays, and each year he plays against tougher competition. Last summer the pitching he faced with overwhelming and his batting -- he's in a slump. Or was in a slump. Like any father, I was out in the batting cage with him trying to help him. He was discouraged. He was frustrated. And he said, dad, I'm just never going to be able to hit a home run off these guys. I really don't have the technical expertise to change his swing. But I tried to work on his attitude adjustment, and I basically said that, you know, stop thinking about what you can't do. That doesn't help at all. Think about what you can do. So let's not focus on home runs. Let's focus on line drives. I think this exercise that RD has been involved in has been an exercise in positive thinking as well. We are not -- we have not focused on what we can't do with our limited resources, but rather what we can do. And to extend the analogy one step further, I think this expedited review process for UP's is not a home run, but it is a solid line drive single. Let me get on to what we are actually doing. We're creating an expedited review process for certain experimental use permits. We're talking about, first of all, only conventional pesticides that come through the Registration Division. We're not talking about antimicrobials, and we're not talking about biologicals that go through the Antimicrobials Division or BPPD. We're initiating guidelines and providing criteria that potentially will increase the number of food use EUP's that we'll be able to issue. And this expedited review process will be able to take place without a registrant burning up one of their precious priority slots, so that if a compound qualifies -- meets our criteria -- we'll do it and the registrant does not have to displace one of their other high priority actions. Why are we doing this? One, I think we clearly recognize that the information that is gathered through experimental use permits is very valuable and helps the registrant to fine tune their use instructions on the label, optimize application methodologies and application rates, and that maximizes both the efficacy of the compound as well as minimize the environmental and human health risks associated with that. We also believe that it is extremely useful to growers to have the benefit of this additional information. How are we going to go about doing it? Well, we have a Federal Register document that is ready to go out. It will be signed this week and will hopefully be in the Federal Register before Christmas. It will open up a 60 day comment period on our draft process here. After those 60 days, we will review the comments, make those changes that we deem appropriate, and move into implementation. So this thing is -- this is not an early preview. This is -- we're about ready to hit the ground running on this one. I want to give you a little bit of background about the EUP situation. How we got to where we are. Prior to FQPA we were issuing about 20 food use EUP's a year. Two things happened just before FQPA passed or at the time FQPA passed. One was we went to a priority system. Prior to that, we were basically doing registration actions on a first come first serve basis, and we didn't feel that we were doing the most important things first. We implemented a priority system. The registrants identified their top priorities, the agency identified its top priorities, and we basically did the highest priorities first. EUP's became something that a registrant would have to prioritize, and they would have to make a choice between doing the EUP or the new use or the new AI. And many of them chose to do without an EUP. That's always too expensive. At the same time, FQPA passed. The requirements for a temporary tolerance were raised and that increased the cost to the agency as well. These two events conspired and what resulted was a significant drop in the number of EUP actions that we've taken. Since FQPA passed, at most we've granted three EUP's in any given year. The findings that EPA has to make for a temporary tolerance for a food use EUP, under FIFRA we have to make a no unreasonable adverse effects finding, and under FFDCA we must make a reasonable certainty of no harm finding. What do we think this new EUP program is going to do? Well, first of all, we think it's going to meet both the grower and registrant needs for more experimental use permits. It is going to allow the agency to make the necessary safety findings and very importantly with minimal additional resource expenditures. We intend in the Registration Division to implement this program with a common sense degree of flexibility. I'll get into more on that in a minute. I would like to review once again the criteria that we have developed here and some of the rationale behind our current priority scheme advantages, methyl bromide alternatives, conventional reduced risk chemicals and OP alternatives in terms of the priority in which you get into our registration queue. This EUP Program mirrors that same priority scheme. The active ingredient needs to be a methyl bromide alternative or a reduced risk or an OP alternative.


MR. CAULKINS: And the reason for this is that this date was chosen because most of the current FQPA assessment methodologies have been fully implemented by this time, and consequently the most recent risk assessment standards have already been applied to these compounds, therefore, again, minimizing the amount of additional work that would have to be done to make the safety findings for a tolerance for the EUP. And third, the application methods and use rates need to be similar or less than what's already out there. Again, what we want to do is preclude a need for further mixer loader applicator risk assessments and bystander risk assessments. Again, what we're trying to do is minimize the amount of additional agency work that has to go into granting a food use EUP. Other criteria. The registered uses that are already on the books need to utilize roughly less than 50 percent of the existing aggregate acute risk cup and roughly less than 60 percent of the existing aggregate chronic risk cup, and the proposed EUP should utilize, more or less, less than 10 percent of either risk cup. And the rationale for these cutoffs is to ensure that the new proposed EUP's would not result in an unacceptable level of aggregate risk. Like I said, we would be using much more common sense flexibility here. If someone came in with an active ingredient that had 54 percent of its acute risk cup utilized and their EUP was on kumquats or something like that, we would probably go forward with it. If the risk cup is at 80 percent full and you're coming in and the major new use was substantial, we probably wouldn't. So there is some flexibility. These are kind of guideposts and it's not a bright red line right now. We're going to limit acreage to less than 2,000 acres for a major use, less than 100 acres for aquatic or minor uses, and no more than 100 acres per watershed. These acreages in the watershed limitations have been established basically to prevent significant increases in drinking water or ecological exposures. Again, we want to make sure that the existing risk assessments will cover. Furthermore, no counties will be included in the EUP Program if EPA determines that the level of concern for endangered species risks are exceeded. Essentially no residential uses in general will be eligible under this program. And the reason here is that we want to ensure that we don't have to redo any previous aggregate risk assessments. Also, we would like to see the EUP proposals accompanied by grower and commodity support -- letters of support from those organizations. We have conducted a preliminary screen of active ingredients, so the criteria we have defined is not an empty set. We want to assure you that our preliminary screen indicated the following fungicides and plant growth regulators would likely be eligible: eshaustestroben (phonetic) eco list and heximid, phalasinam, plutioxinil, prohexidiam, calcium, trifloxistroben and sausimide. For herbicides, cupantrozone ethel, diafuphensiper, flucopperzone sodium, glyphosate and halsulfron ethel. For insecticides and insect growth regulators, peuprofenzin, indoxicarp, foxiphenicide, puraproxifen, spinosad and tebufenicide. I guess in summary I want to reiterate that these criteria apply only to conventional pesticides. Secondly, that these criteria do not preclude a registrant from coming in under our existing EUP Program. These criteria are set up for expedited -- for expedited EUP reviews. We got here by evaluating the current EUP situation and looking at establishing these proposed criteria. We have developed a draft PR notice which will -- which our Federal Register notice will highlight as being available. At this point in time, internal agency and OMB review have been concluded, so that we're ready to go out. As I said before, we're basically going to go out with a 60 day comment period. We'll review the comments that are received, modify this program and go final. So that's sort of -- that's where we are now. I would be more than happy to entertain any questions.

MS. MULKEY: Do you want to call on people or do you want Jim to do it? Jim can do it, maybe, for you.

JIM: Well, at this time we'll start down there and work our way around the horseshoe. Larry?

MR. ELWORTH: Well, Pete, you'll be glad to know that we're really interested in increasing your slugging average. When you talked about the EUP's that were granted before, were they usually major crop or minor crop EUP's?

MR. CAULKINS: They were typically more major crop EUP's. A lot of times we would see the EUP before we issued a first registration.

MR. ELWORTH: Uh-huh. Can you help me understand the rationale for 100 acres for minor crops and the difference between those and the major crop acreage, and also the rationale for 100 acres in the watershed? And could those of us who are fortunate enough not to be familiar with the USGS eight digit cataloguing units, can you give any idea what the size of those watersheds would be?

MR. CAULKINS: Well, the rationale is basically to minimize the potential for significant increases in environmental or drinking water exposure.

MR. ELWORTH: I understand that. But, I mean, the specific number. I mean, like why did you choose 100 acres?

MR. CAULKINS: They were generally a back of the envelope calculation of how much food grown on a given amount of acres would significantly contribute to increased dietary risk. And so the proposed cutoffs, they haven't been evaluated versus every single major crop or every single minor crop. It was just sort of guideposts to put us out there so that we could rely upon existing assessments without having to reopen a risk assessment. The idea is to move these things through as quickly as possible.

MR. ELWORTH: And is that the same for 100 acres in a particular watershed?

MR. CAULKINS: Again, it's so that we don't have to reopen the drinking water assessment. And those cataloguing units are a way that the U.S. Geological Survey catalogues different watersheds.

MR. ELWORTH: Uh-huh. And can you give some sense of what this eight digit -- how do acres in the watershed -- I mean, what does this mean? I mean, I just don't know.

MR. CAULKINS: Yeah. Each watershed is given an eight digit number. This is actually one of the comments that we added in response to the PPDC meeting from last December. There was -- people wanted a little bit greater specificity on what the cataloguing units were. And I think actually the draft PR notice that you all have provides a little bit more information about that, as well as a link to the USGS web site that gives greater definitions and the map so that you can see what this is all about.

MR. ELWORTH: I don't mean to be cynical about the USGS web site, but what about -- about how big is this area?

MS. MULKEY: How big is a typical watershed?

MR. ELWORTH: Right. Right.

MS. MULKEY: That's the question.

MALE SPEAKER: Are they a big valley, or is it --

MR. CAULKINS: They are a lot smaller. It's not the Mississippi River watershed. They are very localized.

MS. MULKEY: Conceptually, it's where all the water drains to a common source.

MR. CAULKINS: Right. Again, I mean, more locally. We're not talking about the Chesapeake Bay Watershed. We're probably talking about a small tributary off of --

MALE SPEAKER: No, you're not.

MR. CAULKINS: -- the Chesapeake.

MS. MULKEY: Do any of the people -- we have lots of people who know about how big they are.

MALE SPEAKER: I'm just going to estimate to the nearest water magnitude. But I would say an eight digit has to do with thousands of acres, not hundreds and not tens of thousands. So that should give you some idea. Anybody know differently? That's just my guess.

MS. MULKEY: We have lots of people that would know, but none of them are here.

MR. ELWORTH: Can I recommend something for -- if this is a PR notice you're sending out?


MR. ELWORTH: It would be helpful on these issues if done basically back of the envelope, if the preamble specifically asks for questions on these particular issues. I think that would provide the opportunity for some additional comment on this.

MR. CAULKINS: Yeah. Actually, what you were leading into, Larry, that I know we really want to get some comment on, is that the whole initiative to do this had to do with feedback we got from the user community that you needed some practical experience, and you giving us sort of feedback as how big of an acreage do you need for there to be. Practical experience is something that we're looking to hear from the user community.


MR. CAULKINS: And we can hear some more this morning, but the comment period will be a very good time to really give us that sense of how much acreage is necessary for a minor crop versus a major crop.


MR. CAULKINS: For you to feel like you have some practical experience.

MR. ELWORTH: Uh-huh. And I would be interested in hearing comments from registrants about this as well, just kind of in this forum. I mean, our goal is to -- if we get on first base, we want it to be a hit, not get hit by a pitch, you know.

JIM: Lori?

DR. BERGER: Well, I just really have a comment. We really appreciate the opportunity to evaluate the situation, because the EUP process is extremely important to our growers as we do try to move to reduced risk and other types of technologies. And when you're working with high value orchard crops, these things are much more subject to environmental conditions and pest biologies and densities, and you need this time to evaluate these products. So we will do everything we can to get you the information on acceptable acreages that we feel like we need to evaluate these things.

JIM: We appreciate that. Bob?

BOB: Well, I want to compliment Pete and the whole group. I think this is a very necessary process. At least for our program representing minor crop growers, we've seen the need in the last few years, and we've been working to speed a lot of new transition technologies to these growers. But I think as Lori eluded to, the fact that our growers are hesitant to try new technologies without some of their own experience, certainly EUP's are a way to get some practical experience on a low -- you know, on a smaller scale without having to, you know, jump right in. A question. There was nothing addressed as to whether there was a possibility for multiple year EUP's. In some perennial crops in the IPM Program and so on, that might be an important consideration. And I just wondered is that something that is open in the application itself, or are these to be time limited one year EUP's?

MR. CAULKINS: I think we assumed it might be one year, but I don't think there is anything that says it precludes us from -- because all we have to do is set a temporary tolerance for two years instead of one and grant it. Would it take two years, do you think, to get the information you need to fine tune it?

BOB: Well, I think on annual crops one year is sufficient. But I think on perennial crops, where you're looking at, you know, putting something into an IPM Program where you're looking with pheromones and other systems, I doubt whether you're going to get all the information you need during the one year period. So I would just encourage the agency to be open to considering multiple year EUP's with the appropriate justification, obviously, in the need to capture that data.

MR. CAULKINS: I don't see any reason why we wouldn't be able to. I think we've done it in the past and we would consider it. BOB: And just another comment in following up on Lori's comment. And I'm sure the minor crop industry will have some ideas on the 100 acre limitation. I think, you know, for some minor crops that we work with, 100 acres is more than sufficient. There are 200 acres of commercial red currants in Oregon, and certainly you don't need to treat half of those to find out whether a pest control tool is appropriate. But we also work with hundreds of thousands of acres of minor crops that are grown in different geographical areas. And I'm thinking particularly of perennial crops where, you know, we put something in an orchard sprayer and go out and treat a block of 20 acres. And that's not uncommon. It isn't going to allow very much use if that's the limitation. So I'm just wondering if there is some consideration of being flexible over that 100 acre limit for certain major or minor crops.

MR. CAULKINS: Yeah. I think the whole idea is that we would take that on a case by case basis.

JIM: Julie?

MS. SPAGNOLI: Just overall I think this is an excellent approach. I think, you know, from a registrant's viewpoint it obviously would give us the incentive to pursue these types of things. I guess the comment I have is maybe not even applicable to this specific process which is looking specifically at food use, and I understand the reason why residential uses would not be considered. And maybe this really needs to be kind of separate action, and probably it's not a line drive, but maybe just a bunt. But the current guidelines that the agency has drafted -- that are currently in draft form. But the guidelines that they are developing for the generation of efficacy data for termiticide baits does require -- is going to require as part of the data to support the registration data generated under an EUP. And these are actually rather long term collections of data. They will be two years or longer, and these are generally uses for which there is essentially no residential exposure once the baiting stations are placed. You know, would there -- perhaps maybe just as a consideration of even including when they issue those guidelines, would termiticide baits, you know, be also considered for this type of an approach since there is essentially no exposure that tended to be reduced risk products?

MR. CAULKINS: When we said -- I said essentially no residential. And the reason why is that if you came in with a lawn use, you're going to significantly change the exposure -- the residential exposure -- which would require a residential exposure assessment, and then we would have to redo the aggregate risk assessment. With the bait where there is little or no incremental exposure residentially, then we would not -- we probably wouldn't have to -- we wouldn't have to worry about an assessment there, and we would not have to reopen our aggregate risk assessment, either. So under that kind of scenario, as long as there is an existing use where the applicator has already -- has similar exposures when placing the bait there -- in putting it in place. If there is an assessment that already exists to cover that, then, you know, something like that would be feasible.

JIM: Ray?

MR. MCALLISTER: The criteria in the draft PR notice mentions risk cup limits for the EUP -- the proposed EUP use. And I'm curious, is this 10 percent limit -- I assume that's strictly applicable to dietary exposure, because you're not concerned -- you're not going to take the time to concern yourselves with the water exposure at that point.


MR. MCALLISTER: Is that 10 percent limit relative to the entire potential target market of that use, or is it only applicable to the acreage that the EUP would allow?

MR. CAULKINS: Rick Laranger is here. Can you answer that?

MR. LARANGER: What I personally think, I don't see why we (inaudible). I don't -- I'm not aware we discussed it.

MR. CAULKINS: Well, we'll bring it up in the comment period, then.

JIM: I'm sorry. Beth?

DR. CARROLL: You're ignoring me, Jim.

JIM: I was distracted.

DR. CARROLL: I just wanted to follow up on some of the comments that have been made on acreage and also on the number of years. I think some experience we've had at Narvaris and Syngenta over the past few years during FQPA is as we've developed products that are much more specific to certain insects -- and I'll use the example of aphids in the Pacific northwest. We have needed several years of use after registration to actually iron out how to use the product. And the product that I'm speaking of in this case is used very differently in the west than it is in the east, and it's something that we have not been able to uncover in a small test plot that had been done. So I think it will be really critical to look at more than one year on specific products. And again, too, as we move to systematic approaches to pest control in area wide type programs, we need more than one year to see what the conditions are going to be and how the product will be affected. And I just want to compliment the agency on bringing the EUP's back, because, boy, we've missed them. We really need them and I'm excited to see that happening.

JIM: Okay. I think that's it and we will wrap up this session. I'll turn it back to Marsha.

MS. MULKEY: All right, and we're back on time. We have now scheduled a discussion about planning for the next meeting. We had a discussion yesterday on proposed topics. I thought it was very helpful. I appreciated the work that the three folks who had identified topics ahead of time. I also appreciated the emergence of thoughtful, workable, additional topics, and that, I think, is a good context in which to try to have a discussion about such issues as format, style, operational approach and those kind of things. We had one other topic that we thought we were ready and would be useful for today for this session -- this day and a half session -- which we didn't include. And it appeared -- I have had the feeling at the end of the day and a half that maybe you felt -- and in fact to some extent I felt -- we jammed at least one or two topics and didn't have as full and comprehensive an opportunity to engage as might have been ideal. In fact, we still have a little unfinished business, which I'll try to get to at the end of this discussion, regarding the disclosure of inerts. Now, you don't often have a topic where you've had that kind of investment of the committee, so that was a little bit of an unusual example. So the big sixty four thousand dollar question is, deep versus wide. I mean, if we tackle fewer topics, we can do it more thoroughly, but that means we tackle fewer topics. And that's true whether we meet every month or every six months. I mean, there is still -- we are budgeting our time around that. So a really good sense of -- and it's possible to mix them up, to have some topics where there they're essentially just informational. But if you choose that, then you are foregoing some opportunity to more meaningfully engage, because it's not as meaningful. It's just an informational topic, and we don't benefit as much from your presence if it's just informational, although it may meet some of your needs, and we're receptive of that. So I would really like to hear from you about that. Second, if you have very specific suggestions about ideas. I will mention some of ours. I've mentioned a couple. One is the idea of a comment period -- and we can even do a chat room, so you could see each other's comments -- following the meeting. Like a 30 day chat room -- I think we can do that; I'm pretty sure we can do that -- so that you had sort of a structured electronic continuation of your dollar. We could have it on specific topics. We could just open it for anything the committee wanted to schmooze on. Another possibility is sort of standing subcommittees that hang out together. The difficulty -- and they could take on topics, tee up topics for the group, pre-digest group views. The difficulty with that is that you want those to be balanced and it's hard enough to get a whole committee that has all the perspectives you want. And we have multiple representatives of some points of view, but by no means all points of view in our committee, and it stresses some of those points of view to have to staff, you know, more than one or two at issue. There is the full blown subcommittee takes on a project, works it over time, may or may not consist entirely of existing members of the committee, and then feeds it back to the committee in some significant pre-digesting. That, quite, frankly, is extremely resource intensive to the agency, as well as to all the participants on that subcommittee. There may be some other creative ideas, breakout sessions or other things that we could work. There is a possibility of longer meetings. More than a day and a half. Two days. Two and a half days. There is a possibility of a pre-day where you get informational stuff and then a working day and a half. So if you could react to any of those ideas along with any of your others. The only other thing I put on the table before I throw this open is the timetable. And we've been getting -- Margie has been getting feedback from all of you about just timetable availability. It appears to us that the earliest practical data for a next meeting is late April. And I'm sure that at least three or four people at the table said oh, no, no, no. I don't like that either. There is not ever going to be a date that is perfect for everybody. But that's the earliest practical next date. We have typically tried to meet approximately quarterly, with an exception that that would tend to work out to three times a year. We could be somewhat more aggressive about that. But I will tell you that if the CARAT Advisory Committee is as active as many think it can be and should be, that frankly creates for us and for many of you some crowding around that. So I think I've done enough to set the stage. I would just now like to invite your participation in a dialogue around this topic.

MALE SPEAKER: Marcia, I have a clarifying question.


MALE SPEAKER: As a returning member, I think one of my frustrations from the last go round was sort of lack of clarity about PPDC's role to the agency. And I'm thinking about the struggles -- and unfortunately I wasn't here yesterday for the inerts presentation. But, you know, we have a working group that has been struggling greatly with this issue in presenting it to the committee. And the clarification I need is, is this a decision making body? I mean, I don't think it is. But, I mean, are we looking for -- on controversial issues where there is a lot of quality work and a lot of effort made by individuals who then present it to this committee, what is the ultimate purpose of that? And then what weight would that carry? Would consensus among the dialogue committee carry any kind of weight within the agency as far as execution of a resulting decision?

MS. MULKEY: Well, let me try this. And my view is not the only one that matters with regard to what the committee ought to be. There are some things that -- first of all, it is an advisory committee. By definition it is advisory, not decision making. We cannot by law turnover our governmental function to a group like this. So by definition, it's advisory, number one. Number two, this was named the Pesticide Program Dialogue Committee. That committee -- that name predates my involvement in the pesticide program. But I suspect it was chosen carefully, because there was an anticipation that dialogue, that hearing directionally government to you, you to government, and across all of you, was part of what it was intended to do. Now, having said those two things, both of which are sort of low balling the expectation, let me tell you that if a group is diverse as this had consensus on an issue, and especially an issue that didn't happen to be a major stakeholder that is not represented, that would go -- that would carry enormous weight in terms of the agency's responsiveness to that. If consensus were to emerge around one of the issues that we're trying to tackle, we would be very, very, very, very likely to adopt that consensus as the government's approach to that issue. But our experience has been that that is a pretty rare phenomenon. What can happen is that some coalitions can build that are not obvious, and some convergence between otherwise disparate positions can emerge. And that is also very helpful, so that moderation -- if all we hear are people who take the most extreme version of what they think of as their self interest and advocate that to us, then we are forced to do the moderating away from those positions on our own. And often we don't do it in the way that the people whose positions are being moderated would have chosen for us to do it. If only they had chosen to moderate it themselves, they would have gotten a little different twist. So anything that happens in a dynamic like this that moderates people toward consensus, even if it is quite a far piece from it. And I think it would be interesting whether people think they saw any of that happening in this work group. But to my eye, I saw some of that happening in this work group which clearly was a failure of consensus. I mean, it was overwhelmingly a failure of consensus. But it was not, I think, a complete failure of communication and even moderation of views, at least in some parts and to some extent. So that's helpful, too. Now, I don't -- I don't know if that answered your question. Others may -- that was a good provocative question that I hope others will reactive to as they put their cards up. And I'm glad to see some cards emerging. All right. Why don't we start with Troy.

MR. SEIDLE: Okay. Just general comments. I think the range of issues that we've dealt with on this agenda, I think, is good. It's manageable, as is the day and a half meeting period, and I think the amount of time that has been allocated to each item is also fair. I particularly appreciated the presentation and the opportunity for discussion on the risk assessment of inerts. I think it's a good approach to get hopefully very advanced heads up on agency decisions like these and have the opportunity to discuss and reflect and hopefully influence early on before it goes public. In terms of more contentious issues like the inert disclosure, an issue that -- or two issues that I feel strongly about, and I think would either merit a subcommittee or some sort of broad reflection, are animal and human testing. And if we could somehow farm that out and have a committee, or have a subset of this group examine the issue in more depth and then report back, I think that's one way to deal with important issues that are controversial without eating up a lot of this committee's time early on. So I would like to make a strong pitch for that.

MS. MULKEY: Thank you. Win?

DR. HOCK: Well, I think I share some of the comments that Troy made. But one of the areas that I think we could benefit by is -- and this may be a sore subject for some people. But I think we need a longer meeting. I know people are meeting to death. But yet at the same time, a lot of you people probably spend a whole day traveling here, and you're going to spend a whole day traveling back to your homes. I drove down in four and a half hours, so it's not so bad. But when you think about it, you may be two days -- a minimum of two days on the road and you have a day and a half meeting. I think we could be more productive if we extended it. I'm not saying a week or anything, but maybe like two and a half days, because, again, we're coming into D.C. We're coming into this area. And I really think that, you know, there is a lot of meat, if you will, and I think we could utilize our time a little more effectively. I do like the idea of maybe some breakout groups. Troy mentioned one. Bob Holm mentioned one yesterday about the biopesticides. I think that is a good topic that we could actually have a working committee on and report to the overall committee. So I think that's positive to have some of what I call topical committees or breakout committees. I think that's a positive approach. Again, I think we just can utilize our time better by maybe having a little longer meeting, taking into consideration the amount of travel that people do.


BOB: Yeah. And is it too late to go back to the topics?

MS. MULKEY: No. No, that's part of this discussion, too. BOB: Okay. Well, I guess I have one comment on process and two on topics. On process, it strikes me that these serve two useful purposes. One is it creates very public opportunity for the agency to be more transparent, which is to say it's a lot better for me, for instance, to sit through these discussions than it is to read Federal Register notices. And I suspect others would share that view, and in that sense, I think it's just per se a good exercise. But secondly, I think the usefulness of the group -- and I think the correct question isn't so much is it useful to us as much as, is it useful to you and in which way is it useful to you. You know, I think there is a range of things we would all like to talk about, but it is the things, I think, you feel like you need the most input from people outside the agency that are the things that we should be devoting the most amount of time on. So I guess that's kind of -- I'm saying it's your call more than it would be our call. As far as topics go -- and I'm kind of mixing things up -- there are two things that I would like to see. One we sort of talked about briefly yesterday morning when we were talking about bioterrorism and some of the related topics. We spent a lot of time talking about how we measure risk and how we take regulatory steps to mitigate risk. And yet it strikes me that probably the largest source of adverse health effects that occur as a result of exposure to pesticides occur as a result of the misapplication of products by people who are either untrained or inadequately trained. And I think it is an issue that merits some attention. The last time I think the agency went through some sort of a formal process. I know there has been a CTAG effort recently. But the last formal exercise was a 1988 rule making that was withdrawn, I think, probably in the early '90's. And I think it's something that warrants a whole lot of attention. I would love to see some sort of group discussion about, you know, how we can enhance the quality of training and certification and related issues. The second topic actually arises out of this last discussion -- or not the last discussion. The next to last discussion about the risk assessment process for inert ingredients. And I think this is attributable to either my low I.Q., poor education or a combination of the two, but I was thoroughly confused. It struck me that it's as if you're creating a parallel process -- registration/re-registration/reassessment process -- for inerts that sort of resembles it, but really isn't quite the same thing. And it raised a whole host of what I thought were very complex, interesting, tough questions. It seemed there were science issues, process issues, regulatory issues, legal issues, trade issues and enforcement issues. One of the things that I think was a good byproduct of the TRAC process was the elaboration of science policies through papers and things of that nature. Maybe it would be useful, either through the development of a paper or through some kind of process, for us to try to better understand what that whole inert risk assessment process is.

MS. MULKEY: And by the way, I think the draft is about 100 pages, somebody told me, to try to describe it. Did I get that right? So that's well under way. I shudder a little bit when folks want us to generate a paper we haven't already got almost done. But in that case we agree, I think, and so hopefully that will be part of what we do. But it may not be the vision you just had for it, and so we welcome to hear your vision for it. Brad?

MR. JOHNSON: First of all, I would like to agree with your comment that convergence is an ideal in an PPDC dialogue and that as future task groups and subcommittees get chartered, they keep that spirit in mind. I think the most useful tool that can be generated in such a group is one where there is true convergence and consensus built around specific themes. So just to echo your thought that that is certainly an ideal in future PPDC dialogues. I wonder if it might be appropriate to kind of think of criteria in place, or principles, if you will, on how to select -- you know, which items to pick up and begin to work next. And one that comes to mind is using PPDC as a forum for those issues that really transcend all nooks and crannies of the FIFRA landscape. And obviously there would be some topics -- anthrax, for example -- that might be more specific to antimicrobials and farm worker related issues perhaps more specific to ag chemicals. And I wonder if we could think of those issues that really transcend all types of pesticides as being the issues to work. And perhaps lastly, then, to pitch the ideas that I suggested yesterday. And to echo Troy, I think the issue of test methods, and animal testing and human testing, I think, do transcend all aspects of FIFRA. And especially with part 158 waiting in the wings, this might be really an opportune time to advance a dialogue in PPDC on that. And again, the other which there seems to be precedence for, and that is mutual recognition, or recognition, at least, of other reviews of chemicals or active ingredients or inerts or even entire products that might have gone on in other jurisdictions, whether at FDA, whether in the TOSCA program, or whether abroad. Mutual recognition of those data reviews through OECD, I think, is already moving forward or portends to move forward. So I would encourage perhaps the PPDC to look at ways to develop strategies or principles around what that kind of program would look like. Certainly, no compromise in data quality or the integrity of the review process. But I would just offer that up as a given issue that might transcend all pesticides.

MS. MULKEY: It would be helpful to us to know how others feel about this idea of trying to focus on issues that are generic as opposed to issues that are particular. You lose a lot if you rule out particular issues relating to, for example, antimicrobial pesticides or biopesticides, but then you gain the fact that everybody at the table is interested. So it would be nice to have some reaction to that suggestion. We have gone the other direction and picked several things that are pretty particularized for this session. Phil?

MR. BENEDICT: I don't see how you can extend the meeting more than another day. That's two and a half days worth of commitment. I wonder, though -- and it puts more work on the agency -- if you couldn't do more briefing papers or those kinds of things ahead of time, so that people could read about what we're going to talk about and spend more time talking about it here.

MS. MULKEY: That's a fair suggestion.

MR. BENEDICT: It puts a lot of work on the agency.

MS. MULKEY: It's a timing problem as much as it is burden. To have us identify an agenda and prepare papers sufficiently ahead would require us to start working almost the day after this one. Maybe that's okay.

MR. BENEDICT: Well, we all got the inert paper ahead of time, and we still spent a lot of time just going through it here again. And we could have read that. Some of us probably did.

MS. MULKEY: Right. That's a good point, at least where we can do that to take advantage of that.

MR. BENEDICT: And talking about that, yesterday it appeared to me that people staked out positions on the inert issue. There was kind of the industry perspective and the other perspective. And I only wonder if the agency shouldn't do something with both. It appears to me -- and I've been around about 25 years on some of these things. It appears to me that rule making takes about three years, anyway. So if you were to initiate a rule on inert disclosure at this point, nothing would happen really for about three years. It appeared to me that the industry came forward with a proposal which basically said we don't need a rule. So why not initiate a strategy that allows -- where the agency goes forward with some kind of rule making. Give the industry an opportunity to show that they can do it without rule making. And if they can put a program in place in this three or four year period that it's going to take to do this anyway, you won't have to finish the rule making and it would be a win-win for everybody.


MR. BENEDICT: And I honestly think, again, if the industry steps up to the plate and creates a program where you don't need rules, you can stop rule making at any point in the process.

MS. MULKEY: Okay, thanks. We will take one more stab at this group sort of either closing the book or closing the chapter on inerts disclosure before we depart today, too. Julie?

MS. SPAGNOLI: Yeah. I think this -- a value that comes out of this, and I think why maybe we need to give the depth instead of the width, is that a lot of times the positions tend to evolve based on as you get more information, as you get more understanding, that sometimes like hearing the background or hearing why somebody took a position, you might not still agree with your position, but you might be able to think of another approach that will address their concern. You know, I think that's the value sometimes of having the -- getting the feedback as we try to come to -- you know, we don't necessarily have to come to a consensus, but maybe to come to an understanding sometimes. And I think that would be much -- I think especially if the role of this committee is to provide feedback to the agency to help them in that process, to help maybe them get understanding, that that is of more value. You know, I think the informational aspects are good, but I think only when coupled with, okay, we need to get the feedback so that we gain an understanding that might help us develop something better. And I think that's what I would see the role is. And I think as far as timing, I think, you know, the length of time -- you know, if you go to two and a half days, I guess I would recommend that then you kind of have to maybe mix it up with some breakouts or some other things, because I think if you just go to straight two and a half days of topic discussion, you know, it would probably -- people would probably start to burn out a little bit by the end.

MS. MULKEY: You think maybe? Yeah, I'm feeling a little tiny bit of that -- and I bet others are -- even after the day and a half. But I took that comment to be intertwined with some format changes. Jose?

DR. AMADOR: Well, after so many people it begins to be repetitious. But as far as the deal of the electronic comment period, I think that's a very good -- a very appropriate way to kind of hold off the meeting. I guess we all have that opportunity. Those people that wanted to, they could always send their comments in. But maybe it could be formalized a little bit more. I don't know how, but just by maybe during the meeting assign a certain time in which you want to hear comments from the people. Maybe even privately or publicly indicate who are the people you would like to hear from. I mean, you can balance, you know, the groups and get comments from everybody. But again, that's an opportunity we all have, but maybe if we can formalize it a little bit better, I think it would be good. And I do intend to follow up by sending one as soon as I get back. As far as the longer meetings, I kind of second what Phil said. Again, we talked about it a little bit last night. Maybe if we get more material to review ahead of the meeting, we can make better use of the time here in discussion rather than presentation by the staff. The staff presentation is always good. But a day and a half seems to be just about right. You know, longer than that, the people -- particularly the people that have to travel, and the time that you invest in getting here and then going back would make the meeting long. So maybe the idea -- we talked about breakout sessions. But if we could have some subcommittees, like some of the ones that have been mentioned for biopesticides and subcommittees where everybody is represented, there could be an opportunity after the meeting -- those people who belong to any one of the subcommittees, maybe they can stay for the afternoon and solve the problem, and then report back to the group, either at the next meeting or electronically. We could send the information to you or Margie and she can make it available to the people. That way the whole committee would not have to be here for the long time. But those that are here, you know, we're already here. We might as well -- if you have anyone of the subcommittees -- then go ahead and do it. I think the topics that were presented were very good. I think I like the one about biopesticides, because I think that we're going -- we're going that way. As far as the timetable is concerned, I think that three times a year is probably appropriate. If we go quarterly, that will be four times and that -- I mean, I don't know whether you mean three meetings a year or four meetings a year. I think three meetings a year would be just about right. More than that for you people would be a tremendous burden, particularly if we go to preparing more of the material ahead of time to have shorter presentations when we're here. But I think three times a year would be just about right, and late April would be a good time for the next meeting. The week of April the 15th or the 26th seems to be a good time. If it's on April the 15th, then I can deliver my income tax check in person to the IRS, which might be a little heavy this year.

MS. MULKEY: Thank you. Sean?

MR. GRAY: First of all, I think that if you prepare documents before a meeting and send them around to everybody, they're either going to need to be web resources or they need to be PDF. This whole idea of Word Perfect files and Word files is a little bit confusing, and then having 17 files come into my in box and 17 files in a different format.

MS. MULKEY: Well, you can tell he's in a different generation than some of us. Some of us still want to get the paper in the mail.

MR. GRAY: Well, I'm also happy with the paper, but it's just a little bit difficult to try to piece back together on my screen the 17 files and there are formatting issues.

MS. MULKEY: Sure. That's a fair point.

MR. GRAY: Yeah.

MALE SPEAKER: What is he talking about?

MR. GRAY: That's just one suggestion. Another thing, I think the electronic list would be really helpful. It would provide everybody a chance to comment post-meeting and perhaps actually this discussion alone could be even more properly identified when people have some time to reflect and think about what we've talked about today and what might go on in the future. It might also help you all to understand what it is we would like to discuss at a meeting and what depth of information we need to hear about. On that, I think it's really beneficial, and I think in that whole sense of dialogue it's really beneficial to hear things like what we did -- like we are today in these presentations from EPA. I know from conversations with other parts of the agency that's sort of the best part that you ever get out of these sorts of meetings, is that little heads up on what's coming down the pike. And I also think perhaps breakout sessions might be helpful, and more than a day and a half might be a little bit much.


MR. GRAY: And the last thing I have is that this subgroup that we had -- or this work group -- for inerts, it might be nice to sort of always have some work group like that which exists and be some topic which is in depth, which is in compliment to the mean body of the meeting covering all of the broad issues. So we can sort of do both at the same time. And, you know, this electronic discussion might help us to find what that next topic would be, because we don't define that until our next meeting sort of when we finally wrapped up the inerts issue.

MS. MULKEY: Okay. Bob?

BOB: Well, as a first time panelist, I really appreciate the opportunity. I've attended a lot of the TRAC and CARAT meetings, and sitting in the audience is different than sitting at this table. I think it's an awesome responsibility that I think all of us take very seriously. As far as the topics, I think I agree with Bob. I think a lot of us have different ideas of what is important, and it's important to put those on the table. But I think as an advisory panel, it ought to be at your pleasure as to which topics you think are of the most importance to the general public, and then prioritize those so that they fit your, you know, regulatory and public policy needs. So I think it's a two way street. I'm glad to suggest topics, but I think the agency should select the ones that we should actually address at the meeting. I think three meetings a year are appropriate. I think a day and a half is a little too short. Even though I only have a two and a half hour train ride down, a lot of people have a lot more -- as Win said, a lot more travel time than that. I think two and a half days would be ideal. I would like to see a day and a half meeting like today, a half day of breakout sessions where we maybe get four or five groups around specific topics, and then come back the next morning and address those and recommendations that the whole group could talk about, because, you know, things are immediate in your mind. You go away from a meeting. You get back into your day to day job. And then you get something in the mail and you're supposed to read it and e-mail. And then, you know, most of us procrastinate until a week before the next meeting to start to think about it again. And I think while the group is here and we're all tuned in to this and can address particular topics, I think is an ideal time for breakout sessions and feedback.

MS. MULKEY: Okay. Allen?

ALLEN: The benefit of going last is everybody has already articulated what you wanted to articulate, so you don't have to figure out how to do it. I absolutely agree that the idea of getting us all together three times a year or four times a year creates a situation where we can cover a lot of topics, but it has to be the topics that you think are of most importance, in addition to what we think needs to be covered. And I think that your explanation earlier, Marsha, was very good for explaining what this committee is all about. It's the best explanation that I've heard. So I really appreciate that. Whether we do it three times or four times a year doesn't really matter so much to me, as long as the schedule is somewhat regular. For various reasons, we haven't had a real full CARAT meeting for a while. And I understand that, but we do need to try and get these things on a regular schedule so the committee has more meaning and more currency. You know, it doesn't matter whether it's exactly four months or it's five months, but we do need to try and get that a little more organized. And in terms of how we do it, I think the agenda this time was very good. But without being critical of the presenters yesterday, I think maybe if you could tighten up the presentations a little bit. The size of the agenda, I think, was manageable. It's just that we packed it a little too tightly. This is an experiment. So if we can tighten it. And as far as breakout sessions or work groups or what have you, I think we ought to experiment on those sorts of things. And I think Bob's idea of the breakout sessions in conjunction with this, and then coming back the next day with recommendations or that sort of thing, sounds very good. I am a little worried about subcommittees that might meet at times other than when the full group is meeting. It is difficult for some of us to get to all of those things. I would like to know what everybody else is doing, and if you create a subcommittee that I'm not on, maybe I go and maybe I don't go. Whereas with this and breakout sessions, or subcommittee meetings that are done at the same time as the full committee meeting, then I can keep apprised of what's going on. So that would be helpful.

MS. MULKEY: Some very helpful feedback. Lori?

LORI: I just would like to add that the sooner we can get the meetings on our calendars the better. We would really appreciate that.

MS. MULKEY: Okay. Larry?

MR. ELWORTH: I don't think there is anything wrong with a controversy that doesn't lead to a decision. I like seeing presentations by people who have different points of view and the more controversy the better, as far as I'm concerned. On the issue of subcommittees, having been on the Eco whatever it was --

MALE SPEAKER: Environmental.

MR. ELWORTH: Environmental -- I can't remember what the name of it was. Maybe this is -- John, this is my comments. I think that the subcommittees ought to be made up of people from the PPDC. If other people want to hear about what went on, they can come to these meetings. I think it's a really good way to have that balance between depth and broad discussion. But I know on ours we had a lot of people who weren't PPDC members, and at any one time two or three people would be on one call. Two or three totally different people would be on another call. It really made it hard to have any continuity in the discussion. The discussion went all over the place and there was -- we revisited issues over and over and over again as people moved through. So my recommendation would be to have the subcommittees limited to PPDC members. The meetings can be open, obviously, but I think that would add some continuity and some structure to it. On the issue of a longer meeting, my only concern with a longer meeting is knowing how busy everybody probably is here, that you can make a longer meeting, but people would fall off on either end of it. People would have to come in late or drift off towards the end of it. So the functional time in which a committee like this might be able to actually meet and discuss things might not be much longer than that. And one issue that I haven't heard discussed except a little bit by Bob -- but this isn't a Rosenberg intervention support.

MR. ROSENBERG: Nor did I need it.

MR. ELWORTH: But the guys our age -- Bob, we're going to be confused a lot more as time goes on. I really think that it would help a lot to have some background on the issue from a regulatory point of view. Some of the discussion today on inerts, there are a lot of people who didn't know what that regulatory -- that this had been an issue that existed for a long time. I think that would help. And also as I look around, there are 15 or 16 people on this committee who may or may not have a whole lot of background on the regulatory structure of FIFRA. So if you're going to talk about a risk assessment, I think you still need to talk about what the background is, because some of it is a little esoteric. But esoteric or not, it's likely to be unfamiliar for a while to lots of people in the room.

MS. MULKEY: Other than paper, do you have any other ideas about how to achieve that?

MR. ELWORTH: I think in this situation maybe not for the EUP's, but on the inerts, talking a little bit about the regulatory structure in which --

MS. MULKEY: Just make it part of the presentation.

MR. ELWORTH: Yeah. Yeah.


MR. ELWORTH: You don't have to go into any great detail. If they've got questions, they can ask them.

MS. MULKEY: Okay. Has?

DR. SHAH: Okay. I've got a process question. The minutes of these meetings will be taken, but is there also a transcript?

MS. MULKEY: There is.

DR. SHAH: There is.

MS. MULKEY: It's recorded and there is a verbatim transcript.

DR. SHAH: Okay. And do you share those transcripts with the people within the agency who may have particular interest? Like this morning there was a presentation on inerts risk assessment and methodology. Lots of good questions came out. It's hard for everybody to remember all of those good questions that came out. Do you share those particular sections of the transcript with relevant people within the agency?

MS. MULKEY: Well, we do. I think that there -- one of the things on my mind is better follow through.

DR. SHAH: Yeah.

MS. MULKEY: And it has to do with the way we use your advice. It also has to do with the way we feedback to you how we use your advice. So, yes, we do, but we could do more and better, I think. And so I'm translating your question into a comment.

DR. SHAH: Okay.

MS. MULKEY: And we need to be sure that we take advantage of what we achieve here.

DR. SHAH: Right.

MS. MULKEY: Including treated almost -- I'm not going to commit to a response to a comments document. But something that sort of is comparable to that in terms of some sense that we really paid attention, that the right people looked at for a given topic.

DR. SHAH: Okay.

MS. MULKEY: I will tell you that on the inerts disclosure, where at some point before too much longer we're going to move into policy decision mode, I think we will not only take the work of the subcommittee. But we will definitely go back to see what kind of feedback we got out of the rest of you, because that -- now whether we do that on every topic, you know, some of them. But I suspect that on these latter two -- well, the other thing that we try to do, of course, is have the people here who are going to do the follow through so they hear it.

DR. SHAH: Right, yes.

MS. MULKEY: So it's not just Jim and me who hears it. But I think we can get that --

DR. SHAH: Yeah. The whole thing was that there are lots of good questions come out and it's hard to take notes of everything. But if they have that in front of them while they are re-working those initiatives --

MS. MULKEY: Right.

DR. SHAH: -- they know everything.

MS. MULKEY: And we will -- we do that and we will definitely renew and enhance our commitment to making that meaningful.

DR. SHAH: Okay.

MS. MULKEY: Good question.

DR. SHAH: The other question I have is -- I like the format of this meeting. When the agency wants to take an initiative -- make the presentation to the broad based community or the different stakeholders, I would encourage the agency to continue that practice of any new initiatives that they are taking to put it forward and get some feedback. And the last thing is, in terms of the subcommittees, I've got one subcommittee that I can recommend for your consideration. And that would be on the non-contentious, non-controversial list, the results, identification and sharing of the results, following up on Brad Johnson's idea. Because agency has so many things, and you have got very limited resources. If there is a subcommittee which looks into what are the things that other related agencies do -- FDA, CDPR, PMRA or OCED countries -- or even within the agency -- Office of Water -- all those things. And how do they do those things and what are the standards that are being used by these things, so that you can feel comfortable at the end that if you go add up the reviews by certain countries which have been done, we feel comfortable doing those. So if there -- and ultimately it is going to help you in minimizing your results utilization.

MS. MULKEY: Okay. Resource issues. And Melody? And Ray. I know Ray's been up a while.

DR. KAWAMOTO: Yeah. I think that this has been a really good opportunity to bring out a lot of different kinds of issues. I was thinking that sometimes there would be -- for me -- although these are very complex issues, it would be really good if we could identify some -- you or us could identify some key questions or some key points that we want to get out. You know, something like expected results out of the meeting. And I like the idea that Brad had pointed out about, you know, looking at concepts. I like the idea of key concepts, but I understand that the concepts are only helpful if you have particular problems. In that case, it could either come from an existing problem. Of if you have a concept that you like, that you're interested in, for example, with regard to animal testing, it would be good to, you know, work on specific examples so that it's grounded in reality. The other thing, I appreciated Larry's suggestion that for those of us who are very new here. One thing that really gets me is the use of acronyms. But I want to contribute a new one. It's called TETT, which is too early to tell.

MS. MULKEY: Thank you for the most insightful comment. Ray, I think we'll let you have the last word on this issue.

MR. MCALLISTER: Okay. I just wanted to suggest a possible topic for a future meeting, and this is probably more in the vein of an update from the agency as opposed to a topic we would come back with recommendations. And that deals with the status of 40 C.F.R. Part 158. Now, between now and then maybe events will overtake us and we'll see some progress there. And along with that, what might exist in terms of parallel requirements for pesticide registration that may be outside of Part 158 that maybe aren't very well documented. Now, the system for inert ingredients, you might tell us at that time is this going to be appearing in Part 158 or be outside of it. I think there is a fair amount of confusion, because what's now in Part 158 is very old and not what we're really following.

MS. MULKEY: Okay. Well, that's helpful. All right.

MALE SPEAKER: Can everyone know what Part 158 is?

MS. MULKEY: Yes. It's a section of the Code of Federal Regulations in which we elaborate the requirements for data that's for registration. But since -- it was last promulgated many years ago, and since science moves forward on a case by case basis, Ray's point is we routinely identify things that go well beyond or different in some way from what's in that draft. He was talking about both the need to refresh it and the need to be transparent at a minimum when some of this other is going on. I think -- is that right? Is that a fair translation of your point?


MS. MULKEY: All right, very good. You can tell I hadn't heard that point for the first time. I also happen to agree with it. All right. Well, what we have, we have one public commenter and we have one piece of old business. I would like to do the piece of old business, which I think won't take very long, and then we'll do the public comment, and then we'll be -- oh, she's -- we no longer have one public commenter? All right. We have a piece of old business, which is we still have to sort of wind our way through this committee's advice on the inerts disclosure. What we have is, we have a work group which I do not believe anticipates further meetings. They have produced a document which I think they want to take -- to do some activity to finalize it, which should happen quickly and, I presume, is not a major level of effort. We have the feedback that each of you more or less individually gave us about your own views around the topic that followed the presentation. We have generally asked the committee to opine on whether they would like the agency to receive the advice of one of these work groups. That doesn't mean that you think we should accept it. It does not mean that you agree with it. It is really just a proforma requirement of the Advisory Committee Act that we receive any advice from work groups through the full committee, because the work group is not itself chartered and so forth. So I need to do that, but I also want to take an opportunity for any of you to sort of have your last say to the agency about either -- and I'm hoping nobody will fill the need to repeat yesterday, because it is all recorded. But I would like to sort of seek ayes and nays about whether we should receive the subcommittee's work. And before I do that, I want to take one shot at hearing you out about next steps, because I would like to not feel like we have to return to this topic. Okay. So does anybody want to individually make some comment on that? Okay. Dan, Allen and Julie. We're try -- and Ray.

MR. BOTTS: I didn't make any comments yesterday, basically because I did receive the document prior to the meeting. I read through it, and quite frankly with the positions that are staked out in that document, I don't know how -- what we were being asked to do to make a recommendation. All I could do was listen to the presentations. And I apologize for being pulled out for at least a small part of it on another issue. But I heard enough that I think that I understand that those positions as represented in that document are not going to change in any major degree as a result of discussions we had yesterday. What would be presented to the agency would be essentially the same document that you have to go forward to lead you in the very same position that you were before the work group ever started. The work group did a good job of capturing the diversity of opinions around a very complicated and complex issue that has a big long history associated with it within the agency. And from that standpoint, I think it's a very valuable document to have to inform the agency as they move forward in the process of making whatever final decision the agency has to make. That's a long way of saying I would recommend that you accept the work group document as essentially a definition to set the preamble of whatever you're going to do to move forward in the endpoint process. But the end gain is up to you guys. You're going to have to do the regulatory process. And I'm not sure that we picked up anything yesterday in the discussion during the process that would make us lean toward any one of the individual recommendations in there more than we would have before we had the discussions yesterday.

MS. MULKEY: Okay. Allen?

ALLEN: Well, I, too, would second what Dan just said about receiving the document and proceeding onward. And I hope this comment is in line with what I thought I heard you were saying about other comments. And that is, just very briefly, that if pesticide labels had full disclosure of inert ingredients, some of the inst I heard you express earlier this morning would disappear.

MS. MULKEY: Julie?

MS. SPAGNOLI: I think one of the things that became apparent out of this, regardless of what proposal would even be adopted, is I think where we came to kind of identify what are some of the barriers for label disclosure, regardless of which approach we took. And I think, you know, some of those barriers had to do with location. I think we did like a little bit about location of ingredient information, and how that could impact the practicality and also the incentive if we went from a voluntary approach. And I think the other bigger issue that really needs to somehow be tackled before we could get to any real -- I want to say -- mutually agreeable type of disclosure is nomenclature. And I think, you know, we've skirted about it, and I think anybody that would go look at, you know, the inert list would say this isn't necessarily what we want to have on the labels. And so I think maybe what can come out of this, instead of, you know, we have to pick one approach or another, is before we can -- you know, what we need to do before we can do anything is kind of work out some of those type of issues. So maybe instead of a decision, there is just some future work that needs to be done.

MS. MULKEY: I actually think the -- I personally think that the work group did a good job of analyzing many aspects of the issue. Not just the policy aspects, but as you said, just some of the legal, practical, literal aspects. Ray?

MR. MCALLISTER: I think the discussion on the inerts ingredients disclosure might benefit from a finite period following this meeting for comments -- electronic comments -- by the work group. In particular, a couple of subjects that didn't come up during the discussion because they're in such earlier stages are some efforts the industry has just begun. Just started, which I think will be very helpful. Julie mentioned the nomenclature. We have an effort ongoing to expand and standardize the terminology for ingredients information. We have initiated a very preliminary pilot project on the idea of releasable summaries. We've been working with Kerry Leifer. That needs to be expanded. A lot more work needs to be done there. And we're looking at ways of gathering medical information needed about a product formulation in order to inform those who might have to treat someone who was exposed. And these are things we can put forward in the comment period.

MS. MULKEY: Are all these exercises of your trade association or are there some of the other products?

MR. MCALLISTER: It's a cooperative effort amongst all of us.

MS. MULKEY: Amongst all of you?


MS. MULKEY: Okay. Michael?

DR. SURGAN: I will resist the temptation to incorporate by reference everything that was said yesterday.

MS. MULKEY: You can assume that it is already in the record.

DR. SURGAN: But I would point out that in fact there were new proposals put before the PPDC that were developed during the course of the working group. There was the major compromised proposal on the cosmetics, and there were also a number of proposals put forth by Brad Mitchell that were read into the record. And so in defense of our group, I would like to say that we did move off this part and did generate some new work beyond what was before us at the time that we were first convened. In response to Ray, I think that if industry is now going to raise new issues and provide perhaps new input and new discussion, that should be heard by the working group as an extension of the working group's work and not funnelled directly into the PPDC at this time.

MS. MULKEY: Okay. Bob?

BOB: Well, as a new panelist, I appreciated the opportunity to be updated on this issue, because it wasn't a hot button on my radar screen. And I do appreciate all the efforts over the past year or year and a half of the working group that went into it. It was obvious, as Dan said, there is a diversity of opinions, and I don't think people are going to -- I don't see any convergence around the central issue. What I saw was several proposals that in them had given the agency an opportunity to reach some convergence around some common goals. I think there is a lot of meat there. I don't think any group is going to get their own way completely, but I think there is some opportunity for compromise that would allow for information to be passed on that would be appropriate to the people that needed it. And I don't envy the job of the agency in coming up with rule making, but I think the groundwork has been laid for a public policy that can be adopted.

MS. MULKEY: Okay. And Adam. He has the last word.

MR. GOLDBERG: I think now is the time to move this forward to the agency. I wasn't sure whether we should give that advice now or at the next meeting. But the point that the work group feels like, or most of the work group or EPA feels like, the work group is done, that they don't want to meet again, and that this has gone on for so long. I think it leans towards the direction of it is time to forward this to the agency, with the understanding that the work group and the PPDC didn't come to a consensus. We've come up with several different ways of doing this, several different suggestions, that are being forwarded for EPA's consideration. So while it's a productive product, it doesn't come to a conclusion. And that's okay. And if that's the manner in which we're forwarding it to EPA, then I think maybe now is the time to do that. But taking off on what Ray said earlier, I do think that it may still be productive, at least, for you to hold the record open, so that if there are further comments by PPDC members, given the limited amount of time we had to read the product and the comment yesterday that we have the time to forward those to the agency in the next week, month, two months or whatever it is, so that we can get those out on the table. And then there is going to be a process on inerts anyway, so we're all going to be back at this as individuals and groups.

MS. MULKEY: Right. Too many of us are lawyers. We're getting in the habit of talking about leaving records open and so forth. This is, of course, much more informal than that, and we will continue to listen to people on this topic throughout any policy development. All right, Shelley. We'll hear from you and then I was going to suggest a wrap up. But we're happy to hear from you.

SHELLEY: Okay. I promise only 30 seconds. I also hope that the agency will receive this report and move forward as soon as possible, because we have been at it for a long time, and the agency has been at it for a long time. It's time to make a decision. But one thing I just wanted to throw out -- I know this is a little out of your time -- in terms of things to think about for the future. This doesn't -- solving the inert problem doesn't solve all the right to know issues from the label. And one more that I would like to raise, and maybe this could be, you know, work for the group on a subsequent occasion, is the need to put information about chronic health effects. The label only now talks about acute effects and that's a big gap, and we can't really say that this label apprises the consumers of all they need to know without that information. So I just put that for your consideration at a later time.

MS. MULKEY: Well, we can -- our John has decided we need one more. And that's fine. J

OHN: Just briefly. Regarding the working committee's report, are you asking today's group to vote on it?

MS. MULKEY: Well, let me -- I'm about to get to that.

JOHN: Okay.

MS. MULKEY: I suggest -- I'm inclined to the following course of action. To ask you today, just by ayes, to indicate whether you think we should receive the report. In other words, whether the committee is prepared to have us receive that, not as the content of the advice of the committee, but on the recommendation from the committee that we factor this report into our deliberations. And I'll ask you to do that in a few minutes, and you can say aye or nay. In addition, I think we are going to go back, and it will probably take us a week or two, especially since I'm going to Rome with my husband for a few days. But Margie and I will work at trying to see if we can set up a chat room, and try to figure out when we want to leave it open, and how we want to use it. And as part of that, we will identify some topics that we would encourage and also some kind of time frame, although I think we need to think it through whether we want to experiment with it just being open indefinitely and so forth. But as part of that, we will expressly invite you to add any information that you think would really be material to our deliberations on this topic, and we'll give you a time frame so that we don't have sort of an open ended indefinite for that topic. That -- and then the combination of the receipt of this report, the transcript from this meeting in which many of you did actually offer some additional thinking, and whatever comes out of that chat room will sort of conclude the advice of this committee on that topic. It doesn't mean you can't individually speak again or that we can't collectively decide that it belongs -- you know, that the committee needs to focus on it again. But it at least allows us to bring some closure to that topic with regard to the advisory committee and, of course, leaves squarely in our lap the issue of how and where to go forward. But I think we all know that industry has an opportunity to seize the initiative and to move some of the kinds of things they're doing, and that they don't need to wait for us -- and I presume will not wait for us -- in working through some of the kinds of things that they are doing. But that otherwise it does appear now to have -- as most things do -- come back to rest with our responsibility. And this would allow us to say we've finished this phase and it's time for us to move to our operational phase. Bill, do you need to comment?

BILL: I have a clarifying question.

MS. MULKEY: Uh-huh. Sure.

BILL: I guess this is to Julie and Michael. Is it the working group's recommendation that this be forwarded to the agency?

MS. SPAGNOLI: You're asking the report as it's been drafted?

BILL: Yeah.


BILL: Okay. Thanks.

MICHAEL: Speaking from my viewpoint, yes.

MS. MULKEY: And we do have a federal person. I understood -- hey, there you go. He's been here long enough past lunch. So all of those committee members in favor of our receiving this advice in the manner in which I've described it -- with the caveats I have described -- aye? (Ayes.)

MS. MULKEY: All opposed, nay? (No response.)

MS. MULKEY: All right, very good. We've played by the rules of the Advisory Committee Act as well. Thank you all so much for your hard work with us today. I suspect you will underestimate the value you have been to us. I know I feel enriched just personally in the part of the job that I do, and I believe that all of our people do who are working on these topics. And we look forward to hanging out together for whatever period of time we choose to next time. (The meeting was concluded.) - - - - -

CERTIFICATE OF TRANSCRIPTIONIST I, J. K. Tennyson, do hereby certify that the foregoing transcription was reduced to typewriting via audiotapes provided to me; that I am neither counsel for, related to, nor employed by any of the parties to the action in which these proceedings were transcribed; that I am not a relative or employee of any attorney or counsel employed by the parties hereto, nor financially or otherwise interested in the outcome of the action.

J. K. Tennyson, Transcriptionist

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