Transcript of the Pesticide Program Dialogue Committee
Hilton Crystal City - Crystal Room 2399
Highway Arlington, Virginia
December 4-5, 2001
ATTENDANCE LIST PRESENTERS
Marcia Mulkey, Director, Office of Pesticide Programs
Jay Ellenberger, Associate Director, Field & External Affairs Division,
Jeff Kempter, Senior Advisor, Antimicrobial Division, OPP
Michele Wingfield, Chief, Product Science Branch, Antimicrobial Division,
Arnold Layne, OPP Public Health Officer Chief, Insecticide Branch, Registration
Dr. Kathryn Aultman, National Institute of Allergy & Infectious Disease,
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
Phillip R. Benedict, Director, Plant Industry, Vermont Department of Agriculture,
Food & Markets
Dr. Lori A. Berger, Director of Technical Affairs, California Minor Crops
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,
Adam Goldberg, Policy Analyst for Pesticides Consumers Union
Dr. Michael Surgan, New York Attorney General's Environmental Protection
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
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
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
Brad Johnson, Product Safety & Regulatory Affairs, The Procter &
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,
John Ward, Waste, Pesticides & Toxics Division, U.S. Environmental
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
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.
UNIDENTIFIED MALE: Yes.
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.
MS. MULKEY: Okay.
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
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
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,
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.
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
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.
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.
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.
(END OF SIDE A, TAPE 1)
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
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 --
MR. ELLENBERGER: Right.
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.
MR. ELLENBERGER: Right.
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
MR. ELLENBERGER: Absolutely.
MS. MULKEY: Bob?
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,
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
MS. MULKEY: Bill?
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
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.
(END OF SIDE B, TAPE 1)
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.
MS. MULKEY: Win?
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
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.
MS. MULKEY: Jay?
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
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.
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.
MR. ELWORTH: Okay.
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.
MR. KEMPTER: They have used -- my understanding is they have used both
the foam and the liquid chlorine dioxide.
MR. ELWORTH: Okay.
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?
MS. MULKEY: Jeff?
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.
MS. MULKEY: Okay.
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
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 --
(END OF SIDE A, TAPE 2)
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
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
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
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
DR. CARROLL: Can we provide you with some additional information on the
DR. AULTMAN: Yep.
DR. CARROLL: Okay.
(END OF SIDE B, TAPE 2)
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
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?
DR. STICKLE: Sure.
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
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
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,
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?
MR. CHANON: Yeah.
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,
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
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.
MR. ELWORTH: Okay.
MS. MULKEY: Bob?
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.
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,
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.
(END OF SIDE A, TAPE 3)
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.
MS. ROSSI: Yes.
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: Sorry, Al.
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
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.
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?
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
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
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
MS. MULKEY: Pat?
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.
MS. MULKEY: Alan?
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
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?
MS. ROSSI: Yes.
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.
MS. MULKEY: Okay.
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.
UNIDENTIFIED FEMALE: Okay.
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.
UNIDENTIFIED FEMALE: Right.
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?
UNIDENTIFIED FEMALE: Um-hum.
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.
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.
(END OF SIDE B, TAPE 3)
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: Nine? MS. SMOOT: Yeah.
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 --
(END OF SIDE A, TAPE 4)
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.
UNIDENTIFIED MALE: Thank you, Mary.
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
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
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
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.
UNIDENTIFIED MALE: Yeah.
MR. JOHNSON: Thank you.
MS. MULKEY: Erik?
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,
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.
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.
DR. SURGAN: Okay.
MS. MULKEY: That's also true for the CBI determination as well I take
MS. MULKEY: It could be structured so it's made at any time. Is that
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.
MS. MULKEY: Okay.
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
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 --
(END OF SIDE B, TAPE 4)
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
MS. MULKEY: And what you're asking is, what indication poison control
centers have that they are seeing episodes that are associated with pesticide
UNIDENTIFIED FEMALE: Yes.
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
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.
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).
UNIDENTIFIED MALE: Marcia?
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 --
UNIDENTIFIED MALE: Yeah, right.
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
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.
UNIDENTIFIED MALE: (Inaudible).
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.
UNIDENTIFIED MALE: Thank you.
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
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.
MS. MULKEY: Gary?
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).
UNIDENTIFIED MALE: Napa.
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
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?
(END OF SIDE A, TAPE 5)
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
UNIDENTIFIED MALE: Ditto.
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
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.
MS. MULKEY: Win?
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
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.)
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
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.
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
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?
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.
(END OF TAPE ONE, SIDE A)
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
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.
MS. SPAGNOLI: Okay.
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
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?
MR. FERNANDEZ: Right.
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
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
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
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
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.
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
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
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.
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
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.
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
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.
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.
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.
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?
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
MALE SPEAKER: Sure.
FRED: Thank you.
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.
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 --
MR. MCALLISTER: Okay.
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
MALE SPEAKER: Might.
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 --
MR. MCALLISTER: Yeah.
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?
MR. MCALLISTER: Yeah. Yeah.
MALE SPEAKER: You would find that on List 4.
MR. MCALLISTER: Uh-huh. But List 4 will have food use and non-food use
MALE SPEAKER: That's right.
MR. MCALLISTER: And the only way you tell which is which is by comparison
MALE SPEAKER: The Code.
MR. MCALLISTER: -- the Code.
MS. MULKEY: But if that's a comment that you would like to see some
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
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
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
MALE SPEAKER: Two thousand and six is our statutory requirement.
(END OF TAPE ONE, SIDE B)
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
MALE SPEAKER: That's a good point, Ray. Thanks.
MR. MCALLISTER: 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
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
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
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
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.
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,
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.
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?
MR. LEIFER: Okay. Not because you have to have the inert approved before
you can do the active ingredient?
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
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
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
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.
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
DR. BALLING: Right.
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 --
DR. BALLING: Right.
MALE SPEAKER: -- achieving some upper level that was below which was
safe. Yeah, it would be crop based potentially.
DR. BALLING: Okay.
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
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.
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.
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
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.
MALE SPEAKER: Is there a tolerance currently for an inert?
FEMALE SPEAKER: Yes.
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
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.
(END OF TAPE TWO, SIDE A)
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
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
MR. ELWORTH: Can I recommend something for -- if this is a PR notice
you're sending out?
MR. CAULKINS: Yes.
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. ELWORTH: Okay.
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. ELWORTH: Okay.
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.
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.
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
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.
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. CAULKINS: Uh-huh.
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.
MS. MULKEY: Sure.
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
MS. MULKEY: Bob?
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
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
(END OF TAPE TWO, SIDE B)
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.
MS. MULKEY: Okay.
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
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
MS. MULKEY: Other than paper, do you have any other ideas about how to
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.
MS. MULKEY: Okay.
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
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
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?
MR. MCALLISTER: Yes.
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
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?
MR. MCALLISTER: Yeah.
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.
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?
MS. SPAGNOLI: Yes.
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