Transcript of
Pesticide Program Dialogue Committee Meeting
Georgetown University Conference Center
The Leavey Center (Salons G & D)
3800 Reservoir Road, NW
Washington, DC
May 9 - 10, 2002

Day One
May 9, 2002
PROCEEDINGS

MS. MULKEY: Thanks for being here to do this work together today. We are delighted to see you all. We're very pleased at the attendance, and it is, believe me, better than it looks like this moment. We have an expectation of a very full attendance of this hard working group.Our real opening ceremony, if you will, is going to happen in just a few minutes, because Adam Sharp and Burleson Smith have agreed to kick us off with some remarks. And we'll do that. I wanted to spend just a few minutes reviewing the day and talking through a little bit about the committee and the philosophy. We'll come back to some of those topics. We are working very hard to make this committee more user friendly, more effective and more interactive, and we've implemented some small and some not so small efforts towards that end. One effort is that we have worked on -- and we started this at the last meeting -- sort of spreading the duties of the Chair within EPA. And as you will see, we have -- each segment has a chair, and for the most part that person is not I. In fact, the segment this morning that shows me as the segment Chair, the Updates in a Minute, was intended to be Jim Jones, Deputy Office Director -- but we discovered that one of us had to be somewhere else this morning and he drew the straw. So Jim will be at an undisclosed location for the morning, and I will try to chair that session along with the updates that he had planned to be responsible for. But as you see throughout the rest of the program, we have asked folks who are closer to the subject to work with you, and we hope that builds relationships between you and our key leadership team. So that's part of the reason for that. Second and perhaps more importantly in terms of things we're trying to do with the way we do business, is we are attempting to work through a relatively finite number of topics that we believe are important to us, and which we have some indication are important to at least some of you, and to do so in a way that really taps into what you have to contribute to the topic.

So we've asked folks among you to actually participate in presentations relating to those topics. We've asked you to prepare for and in a more structured way participate in panels around the dialogue for those topics. And we're hoping that all of that leads to everybody's capacity to participate meaningfully on each of those topics. So that's another thing that we work for.The third thing we've attempted to do is build our agenda in significant part around issues in which you show an interest and to avoid agenda building in areas where you don't think it's a productive way to spend your time, although obviously we're mindful of our needs and interests as well.There are many topics in which some of you are interested in some measure of dialogue. For those topics where we cannot or should not for some reason -- and we would try to explain that where appropriate -- develop a more comprehensive dialogue around the topic, we have tried to be sure that we at least provide basic information on the topics. And that's the idea behind a series of Updates in a Minute.

Many of those are topics where there is either some other forum for stakeholder involvement or they're not exactly ripe right now. In a couple of cases, they're in litigation. But for whatever reason they're not well suited to a full dialogue, but we want to meet your needs and ours for an information flow. And so that's the idea behind that, and leaving then some topics for needier and fuller development.We have also implemented now our electronic -- PPDC forum, and we have found that very useful. And many of you are actively participating in that, and that, I think, develops a way for you to understand each other's perspectives as well as for us to have a continuing dialogue with you. And we are working -- we're looking forward to your feedback as to how well that is working as a means of continuing our dialogue. And finally, we are receptive to other developments involving this committee to make the dialogue more meaningful. So we look forward to your feedback on that.

I wanted to just spend a little time on that overview. And now I think we've got pretty much as full a seating as we're going to get, and so it's my pleasure to turn the microphone over actually to two key people. Adam Sharp has joined EPA since we last met in the Office of Prevention, Pesticides and Toxic Substances as a Senior Political Advisor. He is, other than the presidentially-appointed Assistant Administrator, the senior person and political person in our AA-ship and provides in that role the kind of leadership that we all need in a participatory democracy in which the Executive Branch moves through the political cycle and has political leadership. In addition, and at least as importantly, Adam brings to us significant expertise and experience especially in agriculture, and he brings that to the whole agency, not just to our AA-ship. And as a result, he adds to our ability -- the political leadership's ability -- to work through agricultural issues.

So it's really a pleasure to have him. I think he is -- he insists that his head is not spinning, so he's obviously a very quick study, because the depth, scope, breadth and challenges of the issues with which we're working remains, as you all are well aware, substantial. And then Adam has told me that he will give Burleson a proper introduction, but I want to say that we're also very pleased at this committee to have Burleson Smith, who has newly joined the Department of Agriculture, again, as part of their senior political leadership team. And he also has agreed to make some opening remarks.Adam?
MR. SHARP: Thanks, Marcia. My head definitely is spinning. That's for sure. But, you know, I don't know how anybody could actually come into one of these political positions and start cold without knowing something about the issues that they're going to be dealing with.

And I guess from that standpoint, at least, I do feel fortunate, because having a background in agriculture and dealing with many of the issues that you're going to be discussing over the next couple of days, and also many of the issues that are going to be kind of at the forefront of the program's challenges over the next couple of years, it's nice to be able to say that coming in I have a little bit of groundwork in these areas. And that helps a lot.Also what helps a lot, is that I look around the room and I think I know most of the people at the table. There are very few of you that I don't know. So I look forward to continue to work with most of you -- and all of you. We haven't filled all of the seats yet. But all of you who are sitting here at the table that I do know, and then for those of you who I don't, I look forward to getting to know you over the next couple of days. It is a very full couple of days' agenda, but I'm sure there is going to be some very good discussions. Let me talk a little bit about a couple of the issues that you're going to be discussing over the next two days and just make some real brief comments on those. Biopesticides, of course, is one of those, and I think that's on the agenda for later this afternoon -- or actually through the morning session and into the early afternoon session.

Biopesticides. There have been some challenges there, as many of you know, as we move into kind of a post-FQPA era, which is interesting to say, because we're still kind of in the midst of FQPA, of course. But as we move into that era, we're going to be looking for more reliance probably on reduced risk products. Biopesticides can fill that nitch. Of course, they've had a number of challenges, and we're going to be discussing those and looking for your advice on those topics. Section 18 process. As many of you know, I think the Section 18 process has worked wonderfully. And, of course, I'm actually happy to talk about this past year's performance, in that the granting of Section 18's was actually back to a pace that was better than even prior to FQPA passage. So that's good news for the program. It speaks well to the Section 18 process. Of course, you can always improve good programs, and that's what we're looking for today. And actually I think tomorrow morning we're going to discuss Section 18's and get ideas from you all and what we can do to further bolster the Section 18 process.

The last issue I want to talk about is pesticide misuse. Pesticide misuse is another issue we're going to be talking about tomorrow. And this is a very important one. This is one that does have a lot of challenges. I think we can also come up with a lot of good solutions for dealing with some of these issues. There is going to be, I believe, two panels that are going to discuss not only the topic and some of the situations that have unrolled over the last year or so. But also then we're going to talk about some of the ideas that you have for what the agency can do to address these issues. So with that, I look forward to hearing what you have to say over the next couple of days. And I'm going to turn it over to Burleson Smith here, but I have to say something real quick about Burleson. Burleson and I -- and this is the second time that we've sat at a table together since we both started our new jobs.

I have to say it's a pleasure to be at this table versus the one we were at about two months ago. Burleson and I and a few of you in the room had the pleasure of travelling to northwest Ohio to Bolling Green to testify at an FQPA field hearing in a blizzard. And after that terrific experience, we of course -- well, during that terrific experience we had the pleasure of sitting at that table and testifying before the Commerce committee folks, and I, of course, had been on the job a full three weeks. Burleson had been on the job a full week. So we dazzled them with our knowledge and expertise of the program and returned back to Washington, D.C., hopeful that the next field hearing on FQPA will take place in a nicer state in the winter, like California or Florida. But nevertheless, it was a good hearing and a good process. But I look forward to your comments over the next couple of days. I'm going to apologize actually for myself this afternoon. I'm going to have to step out for the second half of today. I'll be back again tomorrow, though. I have to sit in on a few meetings for Steve Johnson. Steve does send his regrets as well. He has to testify this afternoon on the Senate side at a POPS hearing, so he's preparing for the hearing, as I know at least one other individual, and maybe a few others in the room, are also going to be testifying. So there are a couple of events going on here, of course, today that we're trying to spread our time amongst.

But I look forward to hearing what you have to say. And with that, I'm going to turn it over to Burleson Smith with USDA. Thank you.
MR. SMITH: Adam, thank you. As he said, I'm Burleson Smith, and I am Special Assistant USDA. I had almost forgotten about the hearing -- thanks for bringing it back up -- in Ohio. In fact, before that meeting I thought white out was actually an office product. But after driving through the blizzards up there, I found out it's something else. As Adam mentioned, I came aboard about two months ago shortly after the last CARAT meeting, so in this respect it's the first official meeting that I've had a chance to sit in. And I certainly welcome all of you and appreciate your participation in this.

As a newcomer to the process here, I certainly am looking forward to the presentations today and tomorrow, especially from a personal standpoint looking at the progress on the cumulative risk assessments. Because for the most part, at the department we hear a lot from growers these days, and there is a fairly continuous line of questions wanting to understand and anticipate what is going to happen. Certainly I know that as this process is developing, some of those answers are not yet available. But we have a very strong interest in looking at what the alternatives may be as this process works its way through, and what the impacts are going to be on such programs such as management. So these are all areas that within the department we are working closely, trying to work with our colleagues at EPA and understand in advance where some of these will end up. We also expect to work with EPA to tailor the outcome on many of these decisions that they're coming up with, so that we meet the objectives of the Food Quality Protection Act, while also considering the needs of many of the crop entities.

On another matter, one of the other presentations I'm certainly looking forward to is the area of biopesticides. My background of having worked with Ag Chem and fertilizer dealers, also fertilizer and agri-chemical manufacturers, I have had some experience working specifically with biopesticides. And so I'm interested in hearing the panel's discussions and their views today on the adoption of these products. I found it very personally challenging to see how these products work, particularly looking at the challenge between delivering a balance between their performance under typical use conditions, as well as looking for economical treatments. So it is an area that certainly offers promise, but is an area that has many challenges as well. So I look forward to those views. I really would like to thank again the Office of Pesticide Programs for the invitation to join you today. As Adam mentioned, I will also be here this morning and then I'm afraid I will have to step out for the afternoon. But I look forward to joining you again for tomorrow morning. So, again, thank you, Marcia, for the opportunity to be here today, and I look forward to a very productive meeting.
MS. MULKEY: Well, thank you both. I think that probably everybody on this committee was eager to get to know both of you and are glad to have heard some of your perspective. And we'll welcome any participation you want to share with us as we go through the morning.

It seems like a good time now to have everybody introduce himself or herself to you, if to no one else. Although I know many -- you know many of these folks as well and to each other. We have a very strong public attendance today, too, so it's very -- it's neat to see that. I wanted to add that Steve is going to make an attempt, notwithstanding his daunting schedule, to find some social window time. And when he hears about how good the food is over here, that may help. But, you know, either at the end of the day, or maybe at lunch, or as we break tomorrow, or even first thing in the morning. So I don't know whether he will succeed, but I know he's really trying to do that. Well, let's spend a few minutes saying who we are. I'm Marcia Mulkey, Director, Office of Pesticide Programs.
MR. JONES: I'm Jim Jones, the Deputy Director of the Office of Pesticide Programs.
MS. LINDSAY: Anne Lindsay, Director of Field and External Affairs Division.
MR. CAULKINS: Peter Caulkins, Associate Director for the Registration Division.
MR. LAYNE: Good morning. Arnold Layne, acting Associate Division Director for Services and Resources Division. It's been week number three for me, so forgive me. I'm also the Public Health Coordinator for the program.
MS. FEHRENBACH: Margie Fehrenbach. I am the Designated Federal Official for the PPDC, and I'm also a special assistant to Marcia.
MS.BERGER: Lori Berger, California Minor Crops Council.
MR. QUINN: I'm Pat Quinn with the Accord Group, a government relations firm here in Washington.
MS. POPOWITZ: Jennifer Popowitz with the Proctor & Gamble Company.
MR. ROSENBERG: Bob Rosenberg with the National Pest Management Association.
MS. DAVIS: Shelley Davis, Farm Worker Justice Fund.
MR. HOLM: Bob Holm, IR-4 Program.
MR. TRACY: Bill Tracy, California rancher, representing the National Cotton Council.
MS. BRICKEY: Carolyn Brickey, Institute for Environment and Agriculture.
MR. BENEDICT: Phil Benedict from the Department of Agriculture, Food Markets.
MR. ELWORTH: Larry Elworth, Center for Ag Partnerships. And I would like Arnold to repeat his job title.
MS. HARDER: Lori Harder, York Tribal Pesticide Program Council.
MR. HOCK: Win Hock, American Association of Pesticide Safety Educators.
MR. GOLDBERG: Adam Goldberg, Consumers Union.
MS. SPAGNOLI: Julie Spagnoli, Bayer Corporation.
MR. BALLING: Steve Balling, Del Monte Foods.
DR. ZUROWESTE: Edward Zuroweste, the Migrant Clinicians Network.
MR. BOTTS: Dan Botts, the Florida Fruit & Vegetable Association.
DR. LOCKWOOD: Alan Lockwood. I'm a neurologist and a representative of Physicians for Social Responsibility.
MR. SHAH: Has Shah, American Chemistry Council.
MS. THAYER: Kristina Thayer, World Wildlife Fund.
MR. VROOM: I'm Jay Vroom with Crop Life America. And I can't believe that we've gotten all this way around the table and nobody has said this, so I'm compelled to. Make the observation that I'm now getting to be relieved to realize that you were speaking figuratively about Adam's head spinning being here on the Georgetown campus.
(Laughter.)
MS. MULKEY: Oh, dear.
MR. LIBMAN: I am Gary Libman, Emerald Bio Agriculture.
MR. SEIDEL: Hi. Troy Seidel, People for the Ethical Treatment of Animals.
MS. CARROLL: Beth Carroll with Syngenta Crop Protection.
MR. JAMES: Allen James with Responsible Industry for a Sound Environment.
MR. STICKLE: Warren Stickle with the Chemical Producers & Distributors Association.
MR. MCCORMICK: Bill McCormick, Clorox.
MS. LEWIS: Nancy Lewis from the University of Nebraska in the nutrition area.
MS. KAWAMOTO: Melody Kawamoto. I'm from the Centers for Disease Control and Prevention, National Institute for Occupation, Safety and Health.
MR. TROXELL: Terry Troxell, Food and Drug Administration, Center for Food Safety and Applied Nutrition.
MR. JENNINGS: And Al Jennings, USDA.
MS. MULKEY: Oh, and we have several key EPA folks behind us. Is there a mic back there? Well, we'll introduce them as they appear. But I did want to take a minute to introduce Debbie Edwards, who is the newly acting Director of our Registration Division. Debbie, if you would stand up. I think a lot of folks know you, but from other roles.

Well, it's time to go to work. The first set of topics we have here are basically that we recognize that you -- oh, I need to back up. I should have mentioned that there are a handful of you -- and actually quite a small number -- who are here substituting for the regular member. And so if you saw some faces you didn't recognize, in all likelihood that's what was happening. We'll try to identify that if it's necessary a little later. But we have most of the actual principals here with us today. This set of topics we spent some significant time on at our last PPDC meeting. And one of the things you've told us is that you would like a little bit more continuity around topics. A little bit more sense of what we've done or what's happened, or how we reacted to what we learned last time. And so this is an effort to provide some continuity around the topics that we've invested in previously. And these are intended to be short updates, where the issue has evolved since we last met.

My experience in government is in some ways, if you go away for a month, say, in some ways you come back and feel as if nothing has changed, and in other ways it's just like, oh, you know, what happened here. So I think you'll feel a little bit of both of those feelings. One is that, oh, that's exactly where we last talked. And then you'll begin to realize that things -- especially as you begin to look over a little bit longer time frame, that there has been some real maturation of issues. So with that in mind, you'll remember we discussed two aspects of inerts: the disclosure work group and the whole issue involving our risk assessment methodology. And Anne Lindsay, Director of Field and External Affairs Division, is going to give us an update on both aspects of that.
MS. LINDSAY: Okay. I had this moment of horror when I looked at the actual words of the agenda this morning, because when I did, it looked as if we had decided to combine the issue of inerts disclosure with risk assessment methodology. And to me, that seems like a very volatile mix. So the first thing I want to assure you is I'm really talking about two things. And then the other thing, I looked at it and I thought, oh, it sounds like this is very passive, lifeless. In other words, an inert set of activities. And that's not true, either. This whole area -- actually I think there has been quite a bit that has been accomplished since December.

In the December meeting, you were actually, I think, briefed extensively, both on the work of the inerts disclosure stakeholder work group, and you had a copy of what we were calling their interim report, and you also had, I think, a very extensive briefing from the agency on where we were with the methodology development for inert ingredients. Both of those activities have now reached sort of a major milestone. In April -- April 23rd, to be exact -- the inerts disclosure stakeholder work group issued its final report. In many respects, it's quite similar to what you saw in December. It has a first section that just sort of describes its basic charter, mandate process and identifies the principal audiences for better improved information about inert ingredients. A second section that deals with the proposals that the individual members of the group developed for improving disclosure. A third section which was a whole series of discussion and information papers that the group developed in the course of educating itself. And then the newest piece is actually what is listed as Appendix A.

And so I think you all -- Margie actually sent you copies of the report in advance of the meeting. And Appendix A, I think, is actually a very good summary of what I'll call two principal perspectives on the topics and sub-topics related to inerts disclosure. I'm not going to go through them. But there were two groups of people from the full work group who spent significant time putting the two pieces that are in Appendix A together, and I think they represent a very good summary of both the issues and the different perspectives on those issues that the group had to contend with.

At this point, since you basically accepted the work group's report in December, and simply urged the group to finalize the report and complete their work, the group is officially sort of de-commissioned. It has done its job. You've got the report. And I think that the ball is now actually in our court at EPA to take a look at all of this material -- and actually we have been taking a look at it. It's not that we've been silent partners in the process. And develop some proposals, which I would expect at some future PPDC meeting might be a topic for discussion with you and your advice and input as to where we think we might go on the topic of disclosure. On methodology, just a short reminder. We started working on this methodology in order to really be able to accommodate the requirements of FQPA as they applied to inert ingredients in pesticide products. And also, frankly, to really improve the effectiveness and the efficiency of our internal review process so that we could make ourselves more productive. It's a policy. Or not a policy, actually. A guidance document that is evolved from the documents that we put out in '87 and '89 trying to articulate where we were with inert ingredients. It is based on a belief, a scientific judgment that for many of these inert ingredients they are of low or moderate toxicity. The safety finding that FQPA requires can credibly be made with significantly fewer data than we might have for a chemical that was of higher potential toxicity.

So the paper which is actually in your packet explains the evaluation process that we're actually now using for chemicals that are of this low or moderate toxicity. We're making chemical by chemical decisions with it. It's got a screening approach, which you heard described to you at the December meeting. And using basically the process outlined in this document, we have made, as I understand it, two tolerance exemption decisions for new exemptions, and also 200 plus tolerance reassessments. So it's guidance. How we actually apply it in any given case may be modified from what you see in the paper itself to fit the particular circumstances associated with an inert ingredient. And we also are open for comment on it, and I think if I understood Pete correctly, the document -- there may be a Federal Register notice issued shortly that will specifically invite comment on the methodology. So you've got sort of a pre-Federal Register notice copy of the methodology, but it's -- it's it and it's in use. So that's it for inerts.
MS. MULKEY: Okay. Pete, I'm going to make a little minor timing change here. Jeff Kempter, as it happens, was unable to make it and Jim Jones is going to deal with the anthrax issues. But for timing reasons, he needs to go next and then we'll come to you, Pete.
MR. JONES: Thanks, Marcia. As many of you, I am sure, recall, Jeff gave a -- Jeff and Michelle Wingfield, actually, from the Antimicrobials Division talked at out last meeting about the kinds of activities we're involved in as it relates to anthrax decontamination and registration.

Since that time, a fair amount has happened on both the decontamination front as well as the issues surrounding registration. We have at this point, working with our colleagues in the Office of Solid Waste and Emergency Response, as well as other federal colleagues from the Postal Service to the FBI to the State Department, issued a total of 13 emergency exemptions for antimicrobial pesticides to decontaminate a significant number of facilities around the country. We are continuing to work with officials in the state of Florida in our Region 4 on the AMI building down in Florida.

And interestingly enough as a side note to one of the compounds that is being looked at for that decontamination, it not only includes the compounds that have been used in and around up here, like Chlorine Dioxide Gas, but Methyl Bromide as well, which has brought in a whole different group of people from our office to help look through that. Sort through those issues as well. So we continue to -- even though you're not reading as much about it in the newspapers as you were at our last meeting, we're working with a number of federal and state officials around the country on facilities that still remain contaminated. In particular, the Brentwood facility here in Washington, D.C. remains closed and has not yet been treated, and that's taking a fair amount of our time and energy in the Antimicrobials Division.

As it relates to registration issues, just to remind you of what I'm referring to in terms of registration issues, a number of companies have sought to register products for making a claim that it controls anthrax, and that has raised a number of very challenging issues with the appropriate microorganisms task. The surrogate. Should you be using a surrogate or should you actually be asking that anthrax be tested, two issues that I refer to as sort of the scope of the registration. If you've tested in a petri dish, is that enough to say that it can be used to decontaminate a 300,000 square foot building and everything in between. And we have been working with the industry, and we're beginning to reach out to some experts in the area of microbiology who are not necessarily in the industry to try to get our arms around these issues, which are -- they're quite complex. The surrogate issue, in particular, we've made a fair amount of progress on. We've gotten a fair amount of help from our other federal partners, in particular the Department of Defense, who have, no big surprise, been working with anthrax and potential surrogates for some time. Unfortunately, as of right now I cannot report that we have figured out or decided as an agency, or I think as a government, what is the appropriate surrogate for anthrax, nor have we completely sorted through the appropriate -- the issues I referred to earlier as scope. What exactly do you need to test to be able to have a claim of controlling anthrax on a pesticide label.

So we will continue to work these issues. We've got an industry, government -- sort of an industry and government. It's largely a nonprofit group looking at these issues, both the surrogate issue as well as the registration labeling issues, and we'll continue to keep this committee posted as we sort through these complicated issues. Thanks.
MS. MULKEY: Okay. And now Pete will update us on the experimental use permit initiative that we also talked about at our last meeting.
MR. CAULKINS: Thanks. At the last meeting, I did propose -- I walked you through our proposal for expedited EUPs. The process. We put it out for comment. The comment period closed the end of March. I received nine comments: four from industry, three from grower groups and two from other stakeholders. I think to summarize the comments, the majority of them expressed a concern that the criteria were too restrictive. We will be reviewing the comments, deliberating, making those modifications that we deem appropriate, seeking out upper management's concurrence and going final hopefully by the end of the summer. So that's the status of that.
MS. MULKEY: Hold on. I'm listening to -- I made the mistake of listening to the whispering behind me. Don't do that.
And now you will remember we had quite an extensive presentation from NIH and some information from some other sources about what's going on with public health pesticide research and related matters. And so Arnold Layne is going to update us on development on that topic.
MR. LAYNE: Thank you, Marcia. As Marcia indicated, at the last PPDC meeting we shared with you some of the information that we gained from a meeting that was held less than a year ago with a number of governmental agencies -- Centers for Disease Control, the National Institutes of Health, Department of Defense and the USDA's IR-4 Program. Today I hope to briefly update you on some of the activities that have happened since then.

Here at EPA we still stand ready to expedite any pesticidal new chemistry or technology for use in vector management. We have taken every opportunity to encourage industry and others to pursue these new chemistries for vector management. We have a number of new chemistries in house for our consideration. I'm aware of at least two companies that are exploring the use of these new chemistries for vector management, including mosquito control. We recently issued a public health emergency exemption under Section 18 of FIFRA to a couple of states, which enables them to use a novel product to combat and control ticks which may carry the causative agent of Lime disease. Although this product contains a previously registered pesticidal chemistry, it's the technology and the approach that they use that was quite creative and quite different. And what's nice about it is there is very little, if any, environmental exposure to this chemistry. We granted that Section 18 in less than two weeks after receipt. We also have a full Section 3 registration pending and we hope to have that registered very shortly.

At the last PPDC meeting, Dr. Kate Autman from NIH briefed you on a number of activities NIH was pursuing in the fields of vector biology, resistance, pesticide development and orphan pesticides. In December of last year, NIH published a request for proposals seeking partnerships for the development of novel vector control strategies and infectious diseases. That was also linked to a number of proposals for -- a request for proposals for bio-terrorism. Hopefully this did not get muddled in the bio-terrorism proposal. It's my understanding that there were two rounds for submittal of applications or proposals. The first round closed March 20th. The second round closes June 20th. During -- late this fiscal year NIH expects to fund three to 10 of these projects totalling six million dollars in the form of grant money. According to NIH, these proposals sort of run the gamut. And unfortunately, NIH couldn't provide me any specific information regarding the proposals. I think it's illegal for them to do so. So I don't have any specifics regarding what types of proposals they have received.

The Department of Defense has been primarily focused on developing personal protection products and equipment for our troops. DoD is currently developing a new insect repellant in collaboration with USDA's ARS. EPA registered a camouflage paint -- face paint -- repellant containing a pesticide which DoD is gearing up to begin using. DoD has also created and formed a number of development planning committees for repellents, for dengue control and also for West Nile Virus. EPA participates on those committees, and we also participate on their Armed Forces Management Board. And lastly, you heard a little about our activities with the World Health Organization by our own Keith Chanon, who actually spent some time with the World Health Organization. In about a few weeks, EPA and CDC and FDA will begin working with the European Center for Environmental Health of the World Health Organization's European Region on a project in the field of urban pest management which encompasses many public health pests of concern, including cockroaches, which as you all may know, is one of the causative agents of asthma. So that's what we've done. Thank you.
MS. MULKEY: All right. Now, we have an opportunity for both questions on these topics and any feedback you might offer about whether this kind of update and continuity from our previous topics is along the lines that you have been recommending in terms of having this committee's work feel more meaningful and continued. Bob?
BOB: I just wanted to ask Pete. Did you mention a deadline by which the EUP guidelines would be coming out? I'm sorry.
MR. CAULKINS: End of the summer.
BOB: End of the summer. Thank you.
MS. MULKEY: Pete, I take it if we were to receive EUP applications now, we could -- I mean, it's not like we're waiting.
MR. CAULKINS: Right.
MS. MULKEY: So if things are in align with what we proposed and there is an interest, we can go ahead and start movement.
Larry?
MR. ELWORTH: I was going to ask Pete. You mean that you would use the guidelines on applications that would be received now or not? The guidelines that -- because this isn't an FR notice thing necessarily. These are guidelines. So you could use the proposed guidelines now on EUP applications that come in like tomorrow? Is that what you're saying? Okay.
MR. CAULKINS: Correct.
MR. ELWORTH: Okay. Okay. The other question I had was for Anne on the risk assessment methodology. I was interested in the presentation at the last PPDC meeting. What I wonder is whether the agency is planning to look back at the impacts in terms of registration, either for biopesticides, reduced risk pesticides or all the other registrations, and look at what impacts the inert risk assessment is having on registration, either the speed at which registrations are coming out or any difficulties you have in getting registrations out the door. For new registrations, I would actually be interested in where the industry is on that as well. Are you all going to look at that at some point?
MS. LINDSAY: I'm actually going to let Pete --
MR. ELWORTH: Okay.
MS. LINDSAY: I'm the deliverer of the status, but Pete is the --
MR. ELWORTH: Okay.
MR. CAULKINS: At this time -- your question is whether we're going to look back at --
MR. ELWORTH: Well, I'm interested in the -- it's interesting enough to look at the risk assessment methodology and everything. I'm interested in what effects it is having in terms of registrations.
MS. MULKEY: Resource diversion, right?
MR. ELWORTH: Not -- no. Not just resource diversion. Whether in fact inert concerns are holding up registrations in some cases and the speed at which things are coming out in terms of the output from RD and BPPD.
MR. CAULKINS: Right. I think right now we have a very substantial backlog.
MR. ELWORTH: Okay.
MR. CAULKINS: I would say it's a three to five year backlog, so obviously we're having an impact, I believe. So that's why we've been piloting this methodology. We'll be taking comment and we'll be revising as we go. But, yeah, we need to address that backlog.
MR. ELWORTH: Yeah. That's the issue I wanted to raise, if that in fact is an issue and whether, you know, you all can report back to us on kind of how things are going and so forth as part of this update.
MS. MULKEY: Okay. Dan?
MR. BOTTS: I apologize if I missed this in the introduction to this methodology issue. But is this -- can we interpret this as being part of the noncontributors discussion that we had on the other stuff? This is not modeled or not -- a totally different program process? I'll save my follow up question for later, then.
MS. MULKEY: Al?
MR. JENKINS: Arnold, I wanted to follow your comment about the work on cockroaches with the European Group. Could you repeat that just briefly for me?
MR. CAULKINS: I'm sorry?
MR. JENKINS: Your comment about working with the European community --
MR. CAULKINS: Huh-huh.
MR. JENKINS: -- on cockroach control. Could you repeat that?
MR. CAULKINS: It's actually a great number of urban pests included: rats, roaches, mice. WHO approached us early last year about us engaging with them and some other governmental entities on a pest management -- urban pest management project that they're hoping to begin early this year. And the objective of this project is to sort of look at pest management control mechanisms with respect to controlling these public health pests, and hopefully come out of there with some measures that governments or industry or the pest control technology industry can use when combatting these pests that are in urban settings.
MR. JENKINS: Who is involved in that? Is --
MR. CAULKINS: The Centers for Disease Control.
MR. JENKINS: Is it just governmental agencies?
MR. CAULKINS: The Centers for Disease Control, the Food and Drug Administration, EPA. There is the Center for Environmental Health that I think WHO works with quite regularly, and they're involved as well. I think possibly the Brits are working as well on this project, and I think they have pursued some other countries as well.
MS. MULKEY: Okay. Warren?
MR. STICKLE: First of all, I want to thank the agency for moving the methodology for risk assessment for inerts through the process. It has taken, I realize, a great deal of work to get that done, and a long time ago you set a goal of trying to have that done by the PPDC meeting today. So thank you very much for doing that and getting that done.
Is this paper available on your web site at this point in time?
MS. LINDSAY: Warren, I don't think it's on the web site yet. It will be very shortly.
MR. STICKLE: It will be. Will there be a 90 day comment period for anyone who wants to comment on it?
MR. CAULKINS: Yes.
MR. STICKLE: Are you going to put in a Federal Register notice?
MS. LINDSAY: Yes. There will be a notice available (inaudible).
MR. STICKLE: Okay. And then a 90 day comment period? Okay.
MS. MULKEY: You're actually getting an early copy.
MR. STICKLE: I see. Okay.
MS. MULKEY: And it's conceivable -- I don't think it's likely -- that the actual draft that is put out for comment will have a little additional editorial work on it.
MR. STICKLE: Okay.
MS. MULKEY: So this is basically because you're the committee that you're getting this copy. But we're ready. I mean, we're days away.
MR. STICKLE: That's very good. With that in mind, I wanted to just take a moment to make an announcement that Crop Life America and the Chemical Producers and Distributors Association are going to be putting together a joint workshop on this issue on June 12th and June 13th. And we would really appreciate the support in working with EPA on this project. Thank you very much.
MS. MULKEY: Thank you. All right. Do we have any more questions or feedback about this? I'm assuming that in the absence of griping that you are finding this level of continuity about previous topics useful, and we will commit to continuing so that once you have invested in a topic, that you have a sense of some continued engagement with us on it.

We now go to a set of what we are calling Updates in a Minute. They're not literally 60 seconds, but we are -- our aim is to keep them pretty close to that. In some cases, these are topics where some of you wanted a much more substantial involvement in the topic, and for a variety of reasons that didn't seem to us to be appropriate at this point in time. Nevertheless, we wanted to meet the need -- at least the basic informational need that you may have had regarding these topics. In addition, we are mindful that this is a wonderful opportunity for us to clarify the status of matters, and we have picked some topics where we wanted to take this opportunity to be sure that everything was understood. Is Randy here and ready? Okay. The first topic, the OP revised cumulative risk assessment, of course is one in which there is extremely keen interest. There is, as you know, another advisory committee co-chaired by the Deputy Secretary of Agriculture and the Deputy Administrator of EPA related to tolerance reassessment and transition, and this subject has been very actively worked with stakeholders in that forum and will continue to be. So the reason for raising it here is solely because we didn't think we could get away without giving an update on a topic of that interest. But it's not to bring that topic into this forum, although actually we do anticipate that a work group of that committee will be meeting around issues related to this topic in June. So we're not far away from an actual active committee related meeting on this topic. But Randy is going to give us a status update for this group.
MR. PERFETTI: Thank you, Marcia. Good morning, everyone. As you all know, the OP cumulative risk assessment public comment period closed in March. Since that time and even as we speak, we're looking at the public comments and the SAP comments and revising the assessment. In June we plan to issue a revised assessment and put it out for public comment and yet another SAP review.

Also in June, there will be a technical briefing for anybody who is interested on this revised OP CRA. Also in June -- June is going to be a busy month for us -- there will be another SAP review. Sometime in July, the public comment period will end for this, and we plan to take those comments, as well as, again, the SAP comments, and incorporate them into the revised assessment and issue it in August. That was much less than a minute, I think, Marcia.
MS. MULKEY: Very impressive. And then the agency's determination regarding the Triazine class of pesticides and how and whether they operate by a common mechanism has also happened since we last met. And so Randy is going to give us a little information about that.
MR. PERFETTI: Yeah. The Triazines actually had sort of been linked to a common mechanism a long time ago, but we have relooked at the whole thing. Based very much on the industry information received -- but also I have to put a plug in here for ORD. They have done a tremendous job in helping us understand the mechanism by which the Triazines work.

The preliminary document was released for public comment April 2nd, and that comment period closes June 2nd. The document concludes that Atrazine, Simozine and Promazine and several of the metabolites share a common mechanism of toxicity based on a hormonal mode of action. And that's about where we stand. I certainly hope everybody read it and comments on it.
MS. MULKEY: Okay. Thank you. I'm going to -- we're going to work through the remainder of these, and I think if we keep them at or near a minute, we'll have some opportunity at the end of this session for anything of interest. The human studies topic here is, of course, focused on actually quite a narrow set of studies that some companies have conducted on some compounds and submitted to the agency involving the use of human volunteers in experimental tests to evaluate the toxic endpoints or the toxicity of pesticidal compounds.

None of EPA's data requirements require that particular kind of studies in human test subjects. There have been for some years now some extensive and controversial issues relating to both the science and the ethics of this particular type of experimental study. And the most recent development in that regard occurred in December when the agency announced that it will seek the advice of the National Academy of Sciences. And not only the advice of the National Academy, but ask the National Academy to engage in an open public and participatory process in the development of its advice about the appropriate use of these studies. Now, this is sort of an arcane area, and one has to speak with a lot of precision. There are studies conducted in human volunteers under funding by or directly by the federal government for certain purposes. Those studies are covered by what is called the common rule, which is a federal government regulation governing the ethical elements of the conduct of these studies. The third party studies submitted to EPA, whether on pesticides or on other substances of this type, are not by law governed by the common rule.

And so the set of questions we have asked has been narrowed to the subset of studies which are third party studies submitted to EPA and sort of by definition not governed by the common rule. In addition, we've tried to make it clear that it is this group of human studies that involve experimental direct dosing for the purposes of establishing toxicity. There are a number of studies that are conducted in human test subjects that we have long and quite routinely considered, and some of them are even contemplated by our guidelines. Things relating to such things as the efficacy of insect repellents, relating to pharmacokinetics analyses and so forth. All of those, because they involve human test subjects, can raise ethical issues. And in fact, FIFRA has an express provision that no pesticide may be tested on any human subject for any purpose in the United States unless there is full informed consent. I don't have the exact words in front of me. But there are some specific statutory requirements with regards to pesticides. We continue to work with those studies, and we continue to evaluate those studies. And should we obtain any information that raises questions about the ethical conduct of those studies, we will of course pursue it.

But with respect to this subset of studies where the ethical evaluation issues, as well as some key science issues, remain so unresolved, we have also stated that we will not be actively considering them in connection with our regulatory work unless they give rise to some information that would require us to take steps to be protective of the public health. Now, this is now the subject of litigation. There was litigation brought by Crop Life America and two of their member companies alleging that the announcement relating to the agency's approach to this and referral to the National Academy of Sciences represented an action -- a rule-like action -- subject to review. And one of the things that happens when you have a lawsuit, is you can go read the briefs and see what people think in that context. So you're welcome to -- there's been one round of briefs as to whether the matter warranted expedited consideration. And so you get to see the kind of things that the industry was saying about it. You also get to see the kind of things that EPA was saying about it in that context. In fact, the court ruled and determined that the matter did not merit expedited consideration.

But that matter will continue in the NAS forum, which is supposed to be open in public. It will continue in the courts. And the third forum that there is some interest is a federal government advisory committee on human test subjects, which has held one recent public meeting in which there was some discussion of this issue as well.
So that's the human studies issue. Atrazine is just -- happens to be one of many pesticides in which there is a broad interest. It is very widely used, and so that is certainly one of the reasons why there is a lot of interest in Atrazine. Atrazine has been going through our six step process. It's in reregistration. It's in tolerance reassessment. We have just published the revised risk assessment, so it is pretty advanced in its consideration in that context. And I just wanted to call your attention to the fact that it is in that posture. In other words, we're sort of pretty much to the end of the open public dialogue about risk assessment, and we are beginning to move into the dialogue and the agency deliberations about risk management. So it's in that posture.

We are mindful, as I'm sure some of you are, about recent public indications of study and information that we had some knowledge of and continue to work with relating to some testing of the substance in amphibians. And actually, Atrazine is an extremely frequently tested substance, both by the company and by our own Office of Research and Development and by other researchers. And we are, of course, as we always do, paying attention to all available, reliable information on that compound. The next topic is what we have listed as the false and misleading names PR notice. For some time, EPA had regulations that define what constitutes false and misleading claims. And in addition, we have always paid a lot of attention and have regulations relating to certain particular kind of claims that we're concerned about, like public health claims for pesticides where there has not been the necessary documentation of public health effects and so forth. It has become clear to us over the years that there is some moderate but meaningful expansiveness of the use of either company names or product names to convey messages very much like claims or in some cases actually containing claims.

And this PR notice is designed to address the issue of those problematic claims, or claims not permitted under the regulations, or claims that are not committed under the FIFRA prohibition on false and misleading claims, that may be contained in company names on products. Obviously if the company name is not on a product and not associated with the product, it doesn't raise issues about claims. But company names and product names. And that is out for public comment, and we've just extended the public comment period, if you're interested. And my final piece of this is Metolachlor and S-Metolachlor. This is also the subject of litigation, so I will say relatively little about this topic. But for those of you who have not been following it -- and I know some have been following it very closely -- for a number of years there was a product marketed -- Metolachlor. It's a herbicide.

And at some point, the company, which is Syngenta, developed a way of refining the molecule so that it lost one of its arms in extremely simplistic forms, and that what remained was a molecule which retained all of -- or virtually all of -- the herbicidal activity of the fuller molecule. But because it was a smaller molecule -- and I'm probably mixing up the science a little bit here. But essentially was capable of serving its herbicidal purpose in lower absolute volumes of the material. And they brought that to the agency seeking registration of this refined molecule as a new active ingredient, and indeed as a reduced risk ingredient, arguing that it was reduced risk because it involved less volume. But also stating that all of the data on the toxicity -- environmental FATE -- and other properties of the original molecule were relevant and appropriate to support the registration of this new ingredient. EPA essentially agreed with some subtle involvement involving analyses as to whether that was correct and also engaged with the company in discussions about the phase out and eventual voluntary cancellation of the original product.

During the ensuing period, and after the company had asked for voluntary cancellation but before it had been effectuated, the agency received me two applications on the original molecule. The agency considered those for some considerable period, and earlier this calendar year granted me two registrations to now I think it's three different entities for the original -- based on the original -- the registration of the original molecule.
And all of that actually has been the subject of litigation. It was the subject of litigation last summer and there is now additional litigation. And again, one can read the briefs and learn all you might ever want to know about what the company and EPA thinks about the legal proprietary and also some of the technical, and increasingly, I think, more of the technical and policy considerations. But I don't plan to talk about them freely today, primarily because they are in litigation. And that leaves us with three updates in a minute, Anne. All yours.
MS. LINDSAY: In one minute?
MS. MULKEY: No, each, and actually a little more.
MS. LINDSAY: The first one is spray drift. Most of you probably know we actually put out a draft PR notice on improving labeling of products with regard to spray drift and spray drift mitigation last August. The comment period closed at the end of March this year, so you can see we had quite an extensive comment period. And we got quite an extensive set of comments, actually 5,249. We've counted them all. I would say a vast majority of them, about 3,500, are standard comments, but there are still about 1,700 individual comments, principally from growers and ag retailers. And in general, I would say growers and ag retailers had a very unfavorable response to the proposal. But we also got what I thought was a significant number from private citizens, mostly because in my experience ordinary people don't usually comment on agency documents. They're not deeply engaged in the process. So about 6 percent of the comments that came in actually were from private citizens and most if not all of those were actually in favor of changes that would actually mitigate risk. And I think this is because many of them were involved at some point in their life in drift issues, and so it was an issue that resonated with them.

In terms of the types of issues that the commenters are raising: concern about the wind speed recommendation being unrealistic, height of application, some issues around orchard application methodology -- don't ask me questions about that, because I'm not an expert on that -- and economic hardship concerns that farmers and growers would need to get new equipment to comply. And then finally, I think primarily from AAPCO and individual states concerns about whether the new proposed language was really going to improve enforcement where it was necessary to actually take enforcement action. So what we're doing currently is analyzing what we got in a little bit more detail. And although we got a lot of, like I said, standard comments, there were about 50 submissions that really had additional data, real information or analysis of their own that require us to really go through and see what is there. So there is a substantial amount of just internal work to deal with those 50 submissions that have got lots of meat to them.

So we're going through a period of analysis this summer and fall. We're also going to be looking at what I would call other opportunities to dialogue around the issues that the draft PR notice raised. And we may be doing some workshops in different parts of the country. We're already trying to take advantage of as many just existing meetings and opportunities to talk with people. So that's my update on spray drift.
MS. MULKEY: We've committed to repropose?
MS. LINDSAY: Yeah, sorry. We committed to repropose. My second topic is on worker risk and in particular a worker risk seminar. At the most recent CARAT meeting -- actually at the end of the CARAT meeting, the agency made a commitment to find some mechanism or venue way of coming back to worker risk issues. And we've done some what I would call just very early preliminary thinking about how we might start that process, and that's what I would like to share with you right now.

First of all, in our minds you'll see we're calling this at this point a seminar, and that's because we think the place to start is with education. We have identified what we think are four what I'll call principal topics around which a seminar might be organized, the first of which would simply be how does EPA currently do worker risk assessment. I think some of --

(End of Tape 1, Side A.)

MS. LINDSAY: -- worker protection standard. The different ways in which we're trying to upgrade the field programs. Hazard communication issues, for instance. The third part would be -- I don't have as good a title for it. But it's kind of what I would call broader science developments. There will actually be an international meeting this summer in July, the Society for Occupational and Environmental Health. It's a very scientific meeting. There will be lots of people presenting different scientific papers on bio-monitoring, epidemiological work and that kind of issue. So this third part of our seminar, I'm currently envisioning as perhaps being the highlights of the type of work that will be presented far more extensively at the July -- we call it SOEH. That's how you pronounce the acronym. The Society of Occupational and Environmental Health, SOEH.

And then the final part for the worker risk seminar would deal with application technology. What's there? How extensively is it really being employed? What does the future show in this area? So those would be the four broad pieces. Obviously, EPA would have a large role in being presenter in various of these sessions. But we're also going to be looking for outside presenters, because we know that we don't contain all of the expertise within ourselves. And we're envisioning that this would be set up in such a way that there is both ample time for the presentation education part, but also ample time for questions, discussion and dialogue. And so the end result, if this plays out well, is I think everyone who has a concern and a stake in worker risk issues would leave the seminar with kind of a common base understanding of principal areas that relate to worker risk and worker risk mitigation.

We had originally thought we even had found a time for the seminar, which would have been in mid-July following the SOEH conference, but that proves not to be such a good time. There are a number of different stakeholders who we really want to have attend the seminar who had prior commitments that can't be rearranged at all. So we're now in search of a different date, and I don't know that Margie has yet found a suitable date. No, she hasn't. So we will be getting back with more specifics about time frames. But in putting the actual -- in moving from these sort of broad concepts that we've got right now, we'll be working with USDA, and I think actually with a lot of others of you around the table and outside this meeting, to actually put the details of the seminar together in terms of individual topics within the sessions and who might actually be good presenters for different perspectives on the topics. And, of course, if you think there is a major area that doesn't fit neatly into these four parts that we've identified for ourselves, we need to know that. Because I think we're at the place where we have quite a bit of flexibility as to what the seminar would be like.

And then finally, NAFTA. A little bit on NAFTA. You probably -- or most of you know that we do have what's called the NAFTA Technical Working Group on Pesticides. This is a government group that was established shortly after the NAFTA treaty itself went into effect, and it was to look broadly at issues affecting pesticides in the three countries -- Mexico, U.S. and Canada -- that may inhibit trade, but also at the same time to look at how do we actually maintain or even improve the levels of human health and environmental protection in the three countries. So it had the sort of balance of trade, but also public health protection. To start the work of the NAFTA Technical Working Group, the group actually developed a five year plan. You don't have it in your packet, but out on the table there is a milestone report from the NAFTA Technical Working Group that describes the original five year plan. We're coming to the close at the end of this fiscal -- or calendar year, rather, of the first five years.

And so the NAFTA Technical Working Group is in process right now of developing a second five year vision for itself, and I would expect sometime this summer there will actually be an opportunity to have some kind of consultative process around that second five year proposal. It will be built first and foremost on the first five years worth of experience, and so a lot of what you would actually see in the milestone report will be a basis for the second five year plan. But we also had a meeting in Mexico City last November in which we had extensive stakeholder involvement. It was actually done in kind of a work group style, so there were breakout sessions. Some of you were actually there and contributed to that. So we'll be taking input from that meeting in Mexico to build the next five year plan. And then most recently, we have gotten submissions from two industry groups. The official NAFTA Industry Working Group, which represents largely agricultural chemicals and uses, and the newer nonagricultural working group, that represents nonagricultural issues from an industry perspective. So we've got two very, very meaty submissions from those industry groups that we'll be using to develop our next five year plan.

And we're open to other input. So if others of you who have not had a chance to think about this and feel that you have something that you want us to consider, there is very much an opportunity to do that. And then the draft will be available sometime this summer. All three countries will take comment on it, and we would hope to have it finalized by the next full meeting of the NAFTA Technical Working Group, which will be in December in New Orleans. So that's it.
MS. MULKEY: And I should wrap up this segment by saying that on these topics, I think on virtually all of them, we are involved in working with USDA to some extent and where appropriate. But two of them, the one on the cumulative risk assessment -- at least the part of it that has to do with engagement in the stakeholder process and related matters -- and the worker risk seminar, both are under the rubric of the CARAT, and therefore there will be a particular effort to plan our stakeholder involvement jointly with USDA on those matters.

All right. Well, we can take a few questions and still stay on time, and if there is a lot of interest in a dialogue, we'll accommodate that. Let's start over here. It works, especially since the first card is over here. Jay?
MR. VROOM: Oh, thanks. One question about one of the one minute updates that I wasn't clear on from Randy. When is it that CARAT or the CARAT subgroup will meet following the cumulative technical briefing? Do you have those dates set?
MR. PERFETTI: Normally it's the day after. I'm sure it will be the day after.
MS. LINDSAY: It's July 19th.
MS. MULKEY: No, no. It's not July 19th.
MR. VROOM: June 19th.
MS. LINDSAY: The day after.
MR. VROOM: Okay.
MS. LINDSAY: And it will be at EPA's offices in the Fishbowl. It'll be in the Fishbowl at our offices in Crystal Hall.
MR. VROOM: Okay.
MS. LINDSAY: And the technical briefing is at the Holiday Inn in Old Towne. Oh, I'll send that out to you all.
MR. VROOM: Great. Two things that I think have emerged since we dialogued and provided input on the agenda for this meeting that I would hope that we might find some time to address in this forum briefly. One is resources for the Office of Pesticide Programs, given the failure of a fairly comprehensive group of stakeholders who tried to convince the Congress to include something with regard to that in the farm bill. I think that's important and timely for us to find some time to add to the dialogue here if we can squeeze it in. he second is a trend that we have noticed emerging with regard to public objections. And all the ones that we're familiar with have come from NRDC with regard to new tolerance approvals on new chemicals. It seems to be a significant trend, given the volume of those objections that have surfaced. And I'm not sure where that topic could be added to or incorporated into the existing topics that are on the agenda for today and tomorrow.

But I'm curious to get some idea from the agency as to what sort of transparency and due process steps may be added or provided to allow for other participation in that -- in the follow through on those comments and objections.
MS. MULKEY: And maybe I can answer at least a little piece of that. I don't know that we've yet done it. But we are preparing to publish the objections that were filed at least with respect to -- and what I'm a little unclear about is whether it's every tolerance or whether it's like the first one. But we're mindful that this issue, like all others, needs openness, transparency and process, and we are publishing those objections. And I don't know if there is anybody here who can be more specific than I've just been about that publication of those objections?
MS. LINDSAY: I think the answer is no.
MS. MULKEY: Okay.
MS. LINDSAY: Our state of knowledge is about yours. I know that the actual publication has been drafted, so I would expect it to occur shortly.
MS. MULKEY: Okay. Gary, since we're over here.
MR. LIBMAN: Do you have resources, do you think?
MS. MULKEY: Well, I'm going to think about that. We have, at your request, a discussion of the sort of sub-issue of our current operating plan as it relates to registration resources. And Joe Merenda is going to be here, and he sort of works budget issues for us. So that may be an opportunity. I want to think about that, if I may.
MR. LIBMAN: Just a real fast one on the math, then, from your perspective. As a stakeholder, I can say that there has been some substantial progress in the last five years. When is the next meeting?
MS. LINDSAY: The next meeting will be the first week in December in New Orleans. And I can't actually now remember the specific dates of the first full week in December. Warren, you may actually.
MR. STICKLE: It's the 2nd, 3rd and 4th, in the middle of the week, Tuesday, Wednesday and Thursday.
MS. LINDSAY: Yeah.
MR. LIBMAN: And that will include stakeholders as well?
MS. LINDSAY: Yeah. Yeah. It's a public meeting. It's a public meeting.
MR. LIBMAN: Okay. Do you find that in the past Mexico had kind of lagged a little behind Canada and the U.S., certainly? Is that changing a little bit?
MS. LINDSAY: I think we're seeing actually very active and significant participation and real leadership from Mexico. They're actually, I think, very straightforward that they do not have the kind of capacity that the U.S. does, for instance. But frankly, I don't know another country that has the sort of capacity that we do.
But they are very bright. They are very sharp. They're very committed and dedicated, and I'm real pleased with the sort of participation and leadership that we're experiencing.
MS. MULKEY: All right. Well, there are several cards up. That's good. We're past time for the break. So I suggest we work through a couple and that we regroup at that. So, Dan?
MR. BOTTS: Thank you. Mine deals with topic number eight on the worker risk seminar. Having been engaged on this issue, specifically on trying to figure out how the worker risk assessments are done in that process, the original discussion that we had with the agency about the need for this was to develop an understanding across all stakeholders exactly how the process works. I applaud the additional issue items there. But having attempted to dig through this to really get to the bottom of it at the detail that we need to on exactly how those risks are done, I think this agenda is way too big to do what I think we were asking for in the original discussions that we had. I still think we need to get that base understanding of how the worker risk assessment process works. What the inputs are. How they're utilized by the agency. How that discussion takes place. And that's a full two day meeting to get through those kind of details if we want to open it up to the level of transparency that we need to get to to be able to effectively deal with the worker risk mitigation issues at the end of the day as the IREDs and the cumulative exposure assessments and everything are coming to the end.
MS. MULKEY: Well, why don't we look into it.
MR. BOTTS: And I would be happy to serve on the steering committee, just because I thought that there had been a steering committee put together at one time to work on developing the agenda for this meeting.
MS. MULKEY: I think we have time to work through that issue. I think our goal is to try to be sure that we do have something that gets to the level that it meets people's needs. So I think we're very open to working through that issue. Julie?
MS. SPAGNOLI: A couple of questions regarding the spray drift and the PR notice. Are there plans to issue a draft -- a new draft or a revised draft for comment, or is the plan to try to go to a final PR notice?
MS. LINDSAY: No, no. I think I said that too quickly at the end. We are going to actually put out a reproposal at some point.
MS. SPAGNOLI: Okay. So it will --
MS. LINDSAY: After we slough our way through the analysis and other dialogue.
MS. SPAGNOLI: So there will be an additional comment period?
MS. LINDSAY: Yeah.
MS. SPAGNOLI: And then my second question with regard to the spray drift, I think in some cases that there has been requirements for label language on products based on that draft. Are they going to kind of, I guess -- do registrants who maybe have been asked to put label language on, do they have some recourse at this point, knowing that it's going to be reproposed or revised?
MS. LINDSAY: Well, I actually believe that what we've tried to say is that we're not requiring anybody -- we had not required, and we currently are not requiring anybody to actually take the label statements in the draft PR notice and put it on their label. We were, I think at least early on, approached by some registrants who had an interest in using some of those label statements, and in those cases we thought it was appropriate to basically give the flexibility to do that.

I would assume, since this seems -- I think it's always our posture that if there is a registrant who has some current statements on there that you would like to reconsider, the Registration Division is always open to that.
(Laughter.)
MS. LINDSAY: I don't know. Pete is not looking open. I was expecting an open look on his face. Now he's looking more open.
(Laughter.)
MS. MULKEY: Larry?
MR. ELWORTH: I just want to reinforce what Dan said. I think it's a good idea to have a seminar. I think it really is two days on risk assessment at least. And I think it's good to engage a lot of people in working on the agenda. I would recommend that given the intensity of interest on this issue that it might be useful to pull together a set of people who actually work rather intensively with you on the agenda, especially since I think you're going to be looking for a lot of interaction and a lot of opportunity for people to ask maybe some fairly detailed questions. So getting at least some either formal or work group to work on that would be real helpful.
MS. MULKEY: Shelly?
MS. DAVIS: Well, I first want to talk about that, too. In our view, the issues of risk assessment and risk mitigation are intimately entwined and really cannot be separated. And so I would really like at least those two pieces of this puzzle to be put together. I also think that there has been a lot of interesting studies in recent years in the area of epidemiology. There has been a recent cancer study and exposure, and I know there is more data in terms of sensor data. So we really should have the best picture we can of what we know about what is actually happening, as well as the theory of how you figure out risk assessment, so we some sense of, you know, the validity of these risk assessments. I would actually agree with Dan and Larry on the idea of the validity of a steering committee. Because since this is supposed to meet the needs of the CARAT, it would probably be helpful to have some of the CARAT members be part of the folks putting it together, so that our questions really get answered.
MS. MULKEY: Okay, thanks. Thanks to all of you. And it really is helpful. That's why we raise these issues in this forum.Well, we did, I think, pretty well about getting this many updates in very few minutes. But we have lost 10 minutes, and we don't really want to limit the full comprehensive discussions that we plan. So the answer to that is for all of us to be back in our seats and back in business in exactly 15 minutes. (Whereupon, a brief recess was taken.)
MS. KNOX: We'll use the usual process. Put your name tag up and we'll go around the room to try and record additional barrier constraints or issues. After the lunch break, we'll come back and have an hour, during which time we really want to do a brainstorming on possible solutions to the issues to the problems. Are there ways we can overcome some of these things.

For just an hour. It will be pretty much only a brainstorming session, and then Janet and I will take back the results from this and basically go through not only the barriers, but the possible solutions, and put together a report that we will send back out to the committee. We may use the on-line chat room to publish it and to get comments back and forth, and hopefully in the near future use those results to come up with some kind of an action plan that we can bring back and present to the PPDC. That's the format. The panel is Janet Andersen, who is the Director of the Biopesticides & Pollution Prevention Division, Bob Holm, IR-4, to talk about their biopesticide program, Gary Libman, who represents the biopesticides industry, Al Jennings from USDA, Win Hock, who will represent the land grant university perspective, Lori Berger to represent grower groups -- grower agricultural user groups -- Steve Balling, who will represent food processors, and Carolyn Brickey, who represents the environmental and public interest groups. So Janet will start. I think overheads will be projected in both directions.
MS. ANDERSEN: And this microphone -- okay, it's working. Overcoming barriers of not having (inaudible), we brought our backup slides. I want to thank everybody at PPDC who has been so interested in this topic, and especially the panel members who are making presentations today.

Pineapple, the first one. We're going to start off and look at what are biopesticides. To us they are microorganisms, both the naturally occurring and the genetically engineered one. They are biochemicals, which are natural compounds, or they are synthetic directives of that same compound which have a nontoxic mode of action to the target pest. They are biochemical like. That means that they are natural substances or something like that, where we know already a lot about it and we ask for a reduced data set. We bring those into BPPD on a case by case basis. And they are the planned and incorporated protectants, or those compounds produced by plants that are pesticidal. And we aren't going to be covering those today, as Marcia said. The history about pesticides, and probably lots of people don't realize, but their registrations go back clear to the '40's. There were both biochemicals and microorganisms registered as pesticides in the '40's. That's biopesticides that were in the '40's. But BPPD, a division just to look at biopesticides, was not established until 1994 as a pilot, and it had the mission to expedite the registration and reregistration of biopesticides and to encourage the adoption of safer pest management practices, including the use of biopesticides.

Next. But today the biopesticide active ingredients -- as we started out, we had about 125 active ingredients that we classified as biopesticides in 1994. We have registered 90 new active ingredients to date. So the idea of expediting the registration, in seven and a half years we've done 90 compared to many other first years of 125. We have expedited the process. Currently there is 197. You can quickly do the math and realize that we've lost some of those biopesticides over the last few years, unfortunately. I'm going to cover several examples of what our biopesticides are. I thought I would start out by saying that -- I often say we do everything from baking soda and vinegar as biopesticides all the way to cutting edge biotechnology products in a small division. We're the smallest division in OPP.

So reduced data set products like vinegar and baking soda, we know an awful lot about these compounds already. We don't need the full data set that you do for conventional and synthetic chemical pesticides. But baking soda works by changing the PH on the leaf surface. And fungi like acidic and this makes it very basic and the fungi don't grow. And vinegar, it doesn't take much to imagine that it can work as an over side, and it does and is registered for that use. It obviously won't replace Atrazine, but it has its uses. Carbon proteins are a genetically engineered product. This is a case where a genetically engineered bacterium produces a natural plant protein that is grown in a fermentation system. The bacteria is killed. They harvest the protein and they use it on the plants as a fungicide. It's a very interesting new system where it is stimulating the plant's own immune system in order to work as a fungicide. And compared to a B2 carcinogen, we're pretty excited about this kind of technology.

Probably the classic biopesticides are the pheromones, which are nontoxic and used at very low application rates, and many of them are long chain fatty acids which we have very little risk concern. They work often by mating disruption or as an attractive, and many of these products are actually used in combination. In your packet, you have a list of all the active ingredients that are biopesticides. Lots of long names. When you put those in combination and you do one at a 20/80 combination and another at a 40/60, you will affect a different insect. So it's quite a specific and interesting technology in chemistry. We have gone through a process of pesticides to really streamline the registration process, especially for these long chain fatty acid pheromones. And this process we have worked through Canada, and now we have worked through OECD. And for OECD countries, our approach to how we regulate these products is what they're all using. Next one. For microorganisms the oldest one we have registered was Bacillus Papillae back in the '40's. It is for milky spore disease and controls Japanese beetles. The most common one people know about is Bt. It's probably the most commonly used biopesticide. But there are lots of other ones that are very interesting and quite widely used. The Forest Service especially uses Jibcheck, which is an insect virus, a Bacilli virus, as they're called.

We recently just registered a new Bacilli virus, Indian Meal Moth virus. Have you ever seen those little moths flying around in storage product food sets? That's Indian Meal Moth, probably, and it is a Methyl Bromide alternative where they are using it for stored fruits and nuts. But those microorganisms actually that we use are also competitors of other organisms out there -- other pests -- whether they be fungi bacteria or insects.
But we don't do just agricultural ones, and we thought we would highlight a bit of it. For mosquito control, we have a Bt version called Israeliansus that controls insect black flies and mosquitos. We have Methaprem. We have a fungus called Lagenidium Giganteum. We have another bacterium called Bacillus Thuringiensis, and then Optinal, which is actually an attractant. It brings in the insect and they have some mechanism to kill it, whether they're using a toxic mechanism or another one. But there is quite a bit in that area, and there comes to be even more on the area of repellents. I've started off my list with the classic Citronella as an insect repellant. But we've also recently registered both Diallyl and IR35-35, which are insect repellents -- very effective -- and they are based out of Eucalyptus products.

The next one I have on the list is Methyl Salicylate, a very interesting insect repellant, but it's also been long registered as a repellant for dogs and cats. But Methyl Salicylate at very low doses in packaging can repel storage product insects and certainly beats -- to be, beats the idea of using DDDT. Methyl Anthranilate is a bird repellant. So just to show you we go all cans of ways, we also have several repellents for mammals, too, like Blood Meal and other kinds of things. I just want to end up by telling you that we in BPPD are very interested in ways we can encourage the adoption of biopesticides and some things we are actually doing. We are doing a number of things to improve our processes. Little small improvements always make up for having not -- at least it overall makes up for a bigger chunk of seeing results in improving your process.

We want to have a program where we assist registrants. We do a lot of work this way. But we had a workshop last fall, and we'll be putting out proceedings and going to a real workbook for biopesticide registrants. We have lots of material on our web site, and we're often praised for the web site and the material we have on there.
We do joint reviews not only with Canada, but also we're working on one right now with California and hope to do more. They're recognizing how important California is to the biopesticide industry. Our PESP activities are often aimed at having grower groups learn how to use biopesticides or other safer pest technologies and really having growers encouraged to use those products in the future. And not to steal what Carolyn may be talking about, but just to say that we have a program where we're looking at the national organic standards program, so that we can have a designation on those pesticides that actually meet the requirements for the national organic standards to have a designation for use in certified organic production. And with that, I'm going to turn it over to Bob Holm. And he wanted a stand, I think.
MR. HOLM: Thank you, Janet. That was an excellent introduction, and I think Pineapple's got my slides. So to start out, I thought I would give you a little background about the industry, because a lot of people aren't really familiar with the industry and what's going on. As Janet mentioned, the products have been around since the '30's and registered by the EPA in the '40's. You've got to look at the global market for biopesticides. It's about 300 million dollars. Microbials is a little over half of that. Pheromones and biochemicals. I guess for a strict purest, the insects or the predators wouldn't be classified as part of this in the U.S., but they are globally classified in this market. But strictly for the biopesticides, it would be about a 260 million dollar market. And put that in context with the global crop protection market, you have about 28 billion dollars, which is down about 10 percent or about three billion dollars in the last three or four years. That's about 1 percent of the market, so it's still a pretty small part of the overall crop protection market. About 90 percent of the total microbial sales are Bt's. So although there are a lot of other products registered, they are still mostly in the Bt area.

Just to note that none of the major crop protection chemical companies, or the top six which have about 81 percent of the global crop protection market, are in the biopesticide discovery area. So although number seven, Sumotomo Arvalent, is in that market, most of the Japanese companies now have gotten involved in the biopesticide market. Sumotomo, Mitzui, Nissan and Arvesta are the current global sales leaders. And, Pineapple, next slide, please. To give you an idea of the estimated sales, Sumotomo Arvalent bioscience is about 100 million dollars and Mitzui Sirtus about 30 million dollars. So right away, you've got two companies that have about half of the global biopesticide market. And there has been a lot of consolidation in that industry, as there has been with other industries. If you look at the current number two company, Mitzui Sirtus, it has a long history of products that have come from Thermo Trilogy, WR Grace, Biosis, Crops Genetic International and AgraQuest, and products from Norvatis, which came from Zilicon and Santos, mainly the Bt products.

Emerald Bio Agriculture is a recent company formed by Oxine and Mycotic. Valent Biosciences is a result of Valent purchasing the Abbott biopesticide business. So there has been a number of consolidations. But what I note in the next bullet point, even in spite of the consolidation there is still probably about 50 companies that are still involved in biopesticides worldwide. Thirty some -- 32 or 33 -- and Harry will mention in the Biopesticide Industry Alliance. So it's really to point out that most companies are very small with sales of less than a million dollars, and I think that has a lot of impact on how these companies can survive and be part of the overall process. And again, about 90 percent of the sales of Bt's. Of the global market, the U.S. has probably about 100 million dollars of that total. Europe with several countries there -- France, Italy, Portugal and Spain -- also heavily use biopesticides. And then Asian countries -- Japan and China -- are also very heavily involved.

I would like to just mention a little bit about how these products are used mainly on high value fruit and vegetable crops, both in field and greenhouse situations. We won't talk about the plant incorporated proteins, as Janet mentioned, but the fuller use of a lot of Bt's were really truncated by Bt cotton and Bt corn and other crops. So there are some markets that were taken away because the plants were expressing the proteins rather than having them put on their plant surface. Many of the products are not discovered by industry, but are discovered in public institutions like USDA, ARS and so on and are patented and licensed then to companies for development. So I really put -- in that previous case, really products are in search of a market or use, because a lot of these products are discovered, but then the market potential hasn't been defined. There are a few companies -- and I just mentioned AgraQuest. It's not the only company. But some companies are doing targeted screening for market targets. So there is a little discovery work out there.

Just to mention a little bit about the IR-4 Program. We've had one now for 20 years supporting biopesticide companies to help them in the registration process. But even before that, back in the '70's, IR-4 was involved in helping companies to get the Foliar Bt's registered in the '70's and '80's. Over the last six or seven years, we've supported over 2.1 million dollars over 140 projects through our biopesticide research program to help -- through a competitive grant program to help get these products out in the field and get the exposure. As Janet mentioned, there have been several workshops that we've been involved in. The most recent one was the NAFTA Biopesticide Registration Workshop. Thanks very much to BPPD and PMRA and California DPR for helping us co-sponsor that. About 192 people attended, really a lot of interest in registering of biopesticides, and we had people from NAFTA counties and across the world. We have involved biopesticides in our food use workshop discussions to try to get them considered mainstream. And I personally have been involved as an ad hoc member of BPI since its formation, and I'm now a member of their steering committee. So I'm very supportive of that industry, and Gary will talk about that a little bit later.

Next slide. Just to -- I'm not going to get into a lot of the challenges when time is really pressing, but I know the other speakers will. But I think an opportunity is to look for USDA researchers and land grant university extension specialists support for use of biopesticides. And I talked about IPM and IRM. IRM is integrated resistance management programs. And I think there are some great opportunities to use biopesticides with the newer chemistries to help avoid resistance development. I think there are a lot of opportunities, and hopefully this group can start to address them to look at policy changes and incentives to change behavior, attitudes and perceptions of biopesticides and their use. I think there are some opportunities to educate key influencers, researchers, extension agents, pest control advisors and so on on the value of these products, and really to demonstrate that biopesticides can offer cost effective and reliable alternatives to chemicals, and again especially in IPM programs.

One of the things that we're trying to do -- and you may or may not be aware of it, because the initial publicity is just coming out. But there is going to be a national IPM conference coming up in April of next year in Indianapolis. Jerry Barren on my staff is on the organizing committee, and we're certainly trying to get biopesticides included as a major component of that discussion. We have looked at increasing our funding in our research program. And I challenge the industry this year, because we actually were going to put another $100,000 in our research program, and we didn't have enough proposals to fund. So I put out a challenge to university systems and so on to make more requests for our grant funds. The biopesticide companies, I challenge them to leverage their funding at the university system with ours so that we can really get more done with our combined funds. I think it's probably too late, and I'm not sure whether there is any opportunities -- or were any opportunities in the farm bill for biopesticide funding. But I think that's an opportunity that should have been looked at but wasn't.

And then finally, really look at possibly BPPD focusing some more of their resources on biopesticide registrations. I know there is always a conflict in all the EPA agencies to look at how resources are focused, and of course there is the competitive issue -- BPPD with plant incorporated protectants. We're looking at sponsoring tours that focus on biopesticides. Lori Berger, our panel member, is not here right now. But they organized a California minor crops tour. We're looking at participating in that tour this year with several sites that would focus on biopesticide opportunities, and looking at sponsoring seminars associated with these tours. And I think Gary may talk about this more. The is an opportunity for BPI to complete their standards and certification program so they can really promote the effective use of biopesticides in integrated programs. So thank you, and I'm going to turn it over to the next speaker.
MR. LIBMAN: Hi. I would like to thank first of all the PPDC for allowing this excellent presentation to this whole subject to be put to the forefront. It's very important for us. And also to thank Kathleen and Janet for inviting me for this.

What I'm going to be talking about is just an overview of the Biopesticide Industry Alliance, BPIA, and then talk just very briefly during my short allotted time about missions, focus and goals, and then talk really what is the main subject here today, which is the barriers to the market and breaking down the barriers. If you notice the picture, that's just a template from Power Point. But those mountains are not arbitrary. That's my view from my home, and if we don't get biopesticides on the market more, I'll have to give it up and go back to Chicago.
(Laughter.) So it's very important for me. Next. Okay. So who are we, the Biopesticides Industry Alliance. We are a coalition of members of the biopesticide industry. There are also ad hoc members, such as IR-4 which Bob Holm was just talking about. We have representatives from USDA, the Forest Service and a couple of regulatory consultants who do some key work for us, too.

We have 32 voting members right now and seven ad hoc memberships in the BPIA. And the criteria for the company is that greater than 50 percent of the business has to be in biopesticides, which is not to say sales, because in some cases there are no sales for some of these small companies. But at least 50 percent of the R&D or some type of expenditure has to be in biopesticides. Our mission is very clear. It is to improve the global market perception -- global market perception, not just the United States -- that biopesticides are effective products, which they are. There is a commonality of thought certainly from the past because of some products that were not so -- or not very efficacious that some of these biopesticides are snake oils. Well, we're putting together things to make sure that that will not happen in the future. We also want to help facilitate the successful registration process of biopesticides. And really a third mission, which I didn't put in there which is part of this thing now, is what we're doing here today, which is trying to reduce some of the barriers for the use of the biopesticides in the United States.

I just indicated the focus being two classes of biopesticides. Janet Andersen was talking about her division, but we're just part of that. We're just microbials and the biochemicals. We do not get involved with the plant incorporated pesticides, the PIPs. We are strictly involved -- we are not genetically modified. We're strictly biopesticides -- microbials and biochemicals. One of our key goals is to develop an industrial seal of approval, which Bob Holm had eluded to, and we want to demonstrate that biopesticides are effective and very high quality alternatives to traditional crop protection products. And not necessarily stand alone. In some cases stand alone, obviously, but also to be used as part of the integrated pest management programs -- I think that's very important -- and to weed out some of these snake oils, if they still exist. We want to make sure that they get out. So we want to have some type of a seal of approval.

We also want to develop -- and I believe we've been quite successful in this -- a good working relationship with the U.S. EPA, PMRA, Canada, the IR-4, certainly, the California BPR and other agencies globally. We want to work also to disseminate guidelines, policies and procedures to the industry and other stakeholders. We had our first meeting a little over two years ago and with about nine people. And we now have three meetings a year, generally one in Washington. We've had one in Canada, and also -- we also tried to have one in California as well. We have five different committees, two key committees and a regulatory committee, which I'm a member of, and we've had regular meetings with BPPD, as well as PMRA and Canada, and the California DPR as well.
Then we have the Standards Committee, which is working towards a set of criteria for the seal of approval. And I feel strongly, and I think everyone will agree to this, that we've had some very open dialogues and discussions, and they have benefitted all of us as well as the regulators. So what are the barriers? Well, the skepticism due to snake oils and products which don't work as promised. We have to make sure that we get rid of those things, and that's what we're working towards.

Also -- and I'm glad there is USDA representation here, too, because you're going to hear this several times. We need help from the USDA. Right now there is a lack of grant -- land grant extension specialist support due to the long successful history of the chemicals. And also there is dwindling resources obviously at the extensions, too, and the testing regimes at the land grant universities tend to be over weighted on stand alone silver bullet types of products rather than some types of IMP approaches which is what our -- our products fall into that nitch. The university testing protocols at these land grant universities tend to be designed for chemicals, and we need to work towards that, again with help from the USDA. We have a very short time frame for development, and because of that a lot of these products are launched without the usual grower experience of years and years of people using these products. So that's -- we're hoisting our own (inaudible) in that. And we also -- there have been increasingly longer time frames for approvals within the U.S. EPA and California. It's certainly better than it has been, but there are problems.

And Janet can go into that, too. I'm not sure what the average time is right now of getting through. Some of the fault is our own fault, because the registrants may not do things correctly, just like on the chemical side. But certainly there has been an increase in the long time frames, and that is a concern for us. And that's regarding Section 3's and Section 5's. And the other thing is that we tend not to be considered as alternatives to the Section 18's, the emergency exemptions. So how do we break down these barriers? Awareness in forums such as the PPDC. And our standards will be very important to get rid of the snake oils. Faster EUPs in Section 3's with help from Janet Andersen and her people to get products to the growers quicker and without crop destruct, because these are mostly products that have exemptions from tolerances. We need help from the education incentives from the land grant universities to support these biologicals. We need more USDA dollars targeted to the adoption of biopesticides into these ecologically based IPM programs. Thank you.
MS. KNOX: Al, you're next. Do you want the --
MR. JENNINGS: No, that's all right. Being this far deep in the batting order, everyone has said everything already. So I'll just break tradition and sit here. Besides, I only get five minutes. I think when I hear barriers to adoption, or barriers in an open marketplace, the question really is, is there something wrong in that marketplace. Is it functioning correctly. Is it functioning as we expect or is there, as I said, something fundamentally wrong that government needs to address. And certainly Bob and Gary have identified what they see as a number of those issues that could be worked on. And I think it is important to go back and point out, as Janet did, that EPA has already intervened in that marketplace by making entry into the pesticide market easier, quicker and cheaper for the biopesticides, and certainly that provides them with a great advantage. So I guess we're faced with the question of, why aren't farmers using them in greater volume.

Back to basics. It seems to me for the most part, with the exception of a few specialty growers, farmers really don't care what their pesticide product is made out of. They don't care whether it's biological, biochemical, organic, inorganic or imported from Mars. What they care about is does it work and is it cheap, or at least affordable or cost effective. And that is ultimately the criteria that farmers will use in deciding what products to use in this marketplace that is fairly competitive. Of course, as was pointed out, they also have to know that there are other products out there, and that really involves marketing and sales. I come from the midwest, Missouri, and this time of year on you're constantly bombarded on radio and TV with ads for pesticides. I don't recall ever seeing a biopesticide product advertised. We see lots of conventional advertised. Marketing is critical if you're going to get people to use your product. I think the old adage of build a better mousetrap and the world will beat a path to your door is true only if you spend 25 million bucks in advertising these days. It's just not going to happen if people don't know about your product.

It's also not going to happen if people don't have confidence in your product and know you're there. Brand name recognition and company recognition are important factors for farmers. If this stuff doesn't work, where do I go. Who do I call. Will there be somebody there who will come back and reapply or someone who will reimburse me. Again, if we've never heard of you before, it's going to be hard to make that connection. Land grant scientists and extension agents have been mentioned, that we need to do more with getting them familiar with the products. And there are probably some things that we can do there, because again, if they don't know about the product, they can't really talk about it. Our specialists out there don't really do pesticide recommendations any more, but they will answer questions. So if you ask them, have you ever heard of product X, they will be happy to tell you their experience with it in their field trials or their small plot studies and that sort of thing. If they've never heard of the product, chances are they're going to say I've never heard of it and I can't tell you anything about it. And that automatically is a big strike against the product.

Who makes the decision? Again, we were talking -- or I was talking earlier about marketing. Certainly farmers make the decision in lots of cases, particularly in the midwest in the row crops, but when you switch into fruits and vegetables, 70 to 80 percent of the fruit and vegetable production in this country is under contract with processors or packers and shippers. And in many cases, the farmers -- the growers -- are not making their pest management decisions. And your marketing target really has to shift to the processors, the packers and that sort of thing, because they will be dictating to the farmer what they can and can't use or what the preferred products are. So, again, it's important to think about who you're trying to reach. I guess finally, just in the area of trying to start a fight, it seems to me that many of the biologicals and biochemicals sort of start off as here's a really good idea. It's kind of good science. It's good biology or whatever. And products are put onto the market and then they go searching for somebody to buy them.

I think you need to look at this the other way around. You need to do your market research up front. Does the farmer/grower have a need for something, and then can you create a product that fits into that need that satisfies the need. Gives the farmer/grower what he/she needs, and is it cost effective, and does it fit in with the agricultural production process as it currently exists. The pheromones and the little strips that you go out and tie on apple trees and pear trees? A great idea and it worked well, but it would have been accepted much quicker if you could just spray it, because everybody has a sprayer. And tying those little twistees on trees is a real pain.
So again, I think looking at the market and looking at the production system and trying to figure out where the product fits are really fundamental in having market success. Am I finished with my five minutes?
MS. KNOX: You are. Okay, fine.
MR. HOCK: Okay. I'm supposed to discuss the issue of extension perspectives in relationship to microbial pesticides. Now, Gary and Al already eluded to some of the issues, and I just -- I think all of you know who extension is and our clientele. Our clientele are the growers. Really the citizens of the states that we represent. So in essence, my clientele when I was at Penn State for 27 years, they were the growers. They were the citizens of the Commonwealth. So these are the people we have to interact with. And I can tell you, the cooperative extension strongly supports the use of safer pesticides such as microbial pesticides, insect/roach regulators, pheromones, floral attractants and naturally occurring repellents. To us, these are essential elements in a finely tuned integrated pest management program. They're essential. But the problem is, as I see it, it is often difficult to sell growers that these biopesticides are as reliable as the synthetic chemical pesticides that are most often used in their pest management program. I think it's what Al said. They are familiar with the chemicals. They're familiar with those synthetics. They're familiar with those old reliables and that's what they will go for. It is a matter of selling biopesticides to the grower.

As I mentioned, my 27 years at Penn State, I can't count the number of times that I've heard grower say to me, you know, I need something that is a good insurance policy against a broad scale pest outbreak. A broad scale pest outbreak. In essence, growers want a reliable insurance that their crops are protected against a wide spectrum of pests. Many growers have used the term or said to me, I just want to be able to sleep well at nights. I want to get a good night's sleep. I can't tell you how many times I've been told that.

Now, I see several problems to broad scale acceptance of biopesticides, especially the microbial pesticides. Microbial pesticides are usually highly specific to a single pest or a related group of pests. Crops like apples, peaches, tomatoes, citrus -- and I can go on and on and on -- are attacked by many different insects and diseases, not just one or two. So even if a grower were to use a microbial pesticide, the grower will almost certainly use a synthetic chemical to control all those other pests that aren't being controlled by that specific microbial product. So they're still going to go to the broad scale product that will give them that good night's sleep. Now, I mean, there are certain exceptions. You all are familiar with Bt or Bacillus Thuringiensis. It's a notable exception. It controls a large group of lepidopteran insects. But there again, timing is extremely critical. For example, we have a serious problem with gypsy moths in Pennsylvania. If the grower -- or I should say if the state. It's usually not the grower. But if the state puts on the product when the insect is in the third or fourth instar, it doesn't work. It's got to be put on early for it to work. Timing is critical and that doesn't always work. If you miss that particular critical stage of development of the insect, you lose your ability to control that pest.

I personally think the insect sex attractants and mating disruptors have probably had a more widely accepted -- or have been more widely accepted by growers than the microbials. Pheromone traps are rarely used to control a pest, but rather to monitor the pest and alert the grower when it is time to spray. In other words, here we go back to the issue. The pheromones will tell the grower when to put on that reliable synthetic chemical to give that grower the control that he or she is looking for. This might work well with insects, but let's take it one step further. What about fungal diseases? There are very few micropesticides that really will give the kind of control that a grower is looking for when you're looking at plant diseases, whether they be fungi, bacteria -- well, we don't have viruses anyway. But we really don't have products that are reliable in controlling most fungi, so what does a grower have to do. He's got to put on -- he or she has to put on a fairly wide spectrum product.

As I said, Cooperative Extension supports the idea of using microbial products or biopesticides in general. I mean, we endorse this. We have it in our recommendations. Al, we still publish in Pennsylvania ecommendations for tree fruits, for small fruits, for grain crops and for vegetables, and most of what we recommend quite frankly are the standard synthetic chemicals. Very few biopesticides. Sure, we'll include Bt where appropriate. But by and large, most of the products are still the synthetic chemicals that the grower relies on. The bottom line, Cooperative Extension has to give the grower a wide array of options to choose from. We can't be biased for one product or another. We include everything. But again, most of the products that we include are the ones that are out there, and they're the synthetic products. So again, growers will adopt new pest control measures if they can be shown to be effective, cost efficient and, again, if the grower can get that good night's sleep.
MS. KNOX: Thank you.
MS.BERGER: Good morning. My name is Lori Berger, and I'm going to be giving the grower perspective on the use of biopesticides. You might want to -- would you make that a little bit smaller so the rest of my boards fit in there? Because I think my other slides are going to be as broad -- or as wide.

Anyway, I'm with the California Minor Crops Council, and this mainly includes trees, vines, vegetables and so forth. But I've been -- I'm an entomologist by training, and I am going to be speaking a little bit on behalf of some field crops -- cotton, alfalfa and rice -- that I have had some experience in. But I've had the opportunity for this five minute talk to be able to sum it on one slide. And if you could pull off the little tab there, Pineapple, it all relates to efficacy, efficacy, efficacy. Next slide, please. But I will expand on efficacy. The current situation that we have with biopesticides in our crops mainly boils down to one organism: Bacillus Thuringiensis. Bt. There are a lot of pheromones used as mating disruptants and bait and trap type of material. There are very few used as frost protection material. We have them listed in our packet, some growth regulators. But basically we've got one product -- one main product -- and that's the Bacillus Thuringiensis -- which in a lot of the row crops has now been built in or stacked into the gene sequence of these plants. So we're mainly looking at insecticides. So as consumers, the grower really doesn't have a wide spectrum of these products from which to choose.

Next slide. Okay. What do growers want? They want efficacy. They went a technical fit. And they would like something that is broad, but these products tend to be very narrow in spectrum. Consistent performance. They would like to have longevity of control. They would like to work with products that don't make their job harder in terms of labor. And some of these materials and techniques are much more labor intensive and they do cause people to be out in the field more. The example was brought up about tying the pheromone ties up in the trees or putting these new puffer devices out in the field. So at lot of these do add a lot of labor cost. The materials -- growers want materials that are compatible with other IPM tools and aren't going to have to make them apply more materials because they're only getting efficacy on one test. They would like environmental stability. And I believe that this is an impediment to the use of these materials in places other than California, because there are issues with rain. We don't have that issue in California, unfortunately. But also UV protection. These kind of things cut down on the life in the field of these types of materials. And finally, growers do want a reasonable cost.

Next slide, please. Okay. In general, what has the growers' experience been? With Bt's, generally good efficacy. One thing that I think is very interesting, and for you nonentomologists out in the field, the way these Bts work, the Bt is consumed and in the mid-gut of the larva a crystalline protein is formed. And this basically gives the larva a stomach ache. Their mouth parts are paralyzed. And so what happens is you have a larvae out there, and if you're a scout, you actually see live larvae out there. You don't get the satisfaction of seeing them dead right away. So growers have had to adapt to the fact that these things are not killed immediately. And that's been kind of a shift in thinking with materials and how they work. So they take a longer time to work in a field, and you need to train people of what, you know, just a sick larvae looks like versus a dead one.

More scouting is needed with these materials. We need backup products in case the Bt does not work or the biopesticide does not work. These can be labor intensive. And one thing we have seen that was mentioned, some of the formulations are improving. We've gone from tying up pheromones into trees to sprayable formulations. This really helps out growers a lot if they can use the equipment they have, or if they can cover a wide area as well. Next slide. Where are the new products? And I'm looking forward to hearing more about this. Through FQPA we've been asked to transition two reduced risk materials. The California Minor Crop Council has been in the process of developing several pest management strategic plans. And these are long range plans to help us move out of high input, highly toxic materials to lower risk, and these are the crops that we've been working in thus far. We've had IR-4 and EPA participation at these meetings, and through all these meetings we've only had one new biopesticide mentioned as part of a possible solution to our growers' problems.

Okay. So the new product introductions, there is not a lot of data. There is a perception that there are snake oils. Technology transfer and support? Both the companies -- there is not a lot of technical support in the field by the companies. And in California specifically, we have fewer and fewer Cooperative Extension people that can help us work with the more difficult to work with product and show the growers how to work with them. And this is an area where the expanded EUP could really help us at the field level. Growers are being asked to take greater risks, but they're not being rewarded for taking those risks. When it comes down to a highly valuable crop, it's kind of a no brainer. The growers need incentives. They need to see these things in the field. Okay. So I want to say in conclusion that growers are open to bio -- to new technology. Efficacy is a reasonable expectation of these folks. They will pay a fair cost, because they recognize the value of these materials. They want choices. They want more than one product. There is not a lot of things coming through the pipeline. We need technical support from both the companies and from Cooperative Extension. And we need on-farm incentives to help us to reduce -- to transition to reduced risk.
MS. KNOX: Thank you, Lori. Steve?
MR. BALLING: First of all, I want to thank Pineapple for turning up the lights. I thought I was going to have to start my second half century of life with cataract surgery or something. I was struggling seeing anything, so thank you, Pineapple. Five years ago Del Monte tested a revolutionary new product on some snap beans in the midwest. This product was meant to not only control European corn borer on snap beans, but also to control white mold. It sounded pretty exciting. So we ran it through tests that were provided to us -- the protocol that was provided to us by the company -- and the results were really interesting. They were statistically worse than the untreated check, which suggests that in fact they were attracting insects and disease instead of controlling them. Obviously that's not hopefully a common occurrence with most of the biopesticides, but you can imagine that it does tend to shake confidence occasionally. This is not new. There is a history of these kinds of experiences which we battle all the time.

Nonetheless, as a processor who wants to minimize pesticide residues in our foods, we are constantly searching for opportunities -- options -- for biopesticides to work in our programs. And in fact, I would argue that so are our growers. And I might disagree with Al to some extent. I certainly understand the economic issue, and certainly for growers who are teetering on the edge, economics are pretty critical and efficacy obviously is important.
But they do want to move to softer chemicals. It's a better program. You would rather have that on your land and be able to send your workers in it any time you feel reasonably safe, including you and your own family. So not unusual. One of the things I would like to state, though, if you look at this list that BPPD provided, I have 197 biopesticides.

(End of Tape 1, Side B.)

MR. BALLING: -- coming out all the time are very exciting. But it's still a much smaller population of real usable products than we think. It's not 197, and for that reason then, let's not think that there is a lot of failures out there. We're looking at a fairly small world yet, and a growing world that will improve.

Del Monte -- in vegetable crops we do our own applications, so we have to work with about 90,000 acres of peas, beans, corn, cabbage and spinach around the U.S. And we're constantly trying to test new programs. But in that testing process, we require a couple of things before we'll get a new compound. It has to -- it has to not be a numbered compound in the context of conventional chemicals, but at least be a registered compound in the context of biopesticides. It has to have some replicated data that we can look at and say it's worth our effort to go in and look at that product. And it costs us about $1500 a replicated test to look at a compound, so it has to be worth the effort. One of the areas in which biopesticide companies have fallen down is that they don't have that replicated data. They rely on grower anecdote and that doesn't work for us. I mean, it's just too expensive for us to go in and try to spend three years working on a new product if we're going to base it on anecdotal material with pictures of, you know, fields next to each other. We've done it. I don't deny that. But we tend not to.

When it is commercialized, there are some serious barriers to commercialization. Some of these have been discussed. We're working at 90,000 acres. We have to be able to apply this typically by air, because we're on an IPM type program and we make snap decisions. We only make applications where we have to. A lot of these products are not helpful in a large scale situation. Tank mixes are cost effective. It's expensive to make any kind of application. You can't tank mix. A lot of these products are difficult to tank mix. Dealers drive adoption in the fruit crops, and many of the dealers have not yet adopted this, so that's the exposure issue for a lot of folks. There are often novel problems. Kaolin clay in pears and apples are being used somewhat extensively up in the Wenatchee Valley area in Washington state, but they end up with little white dust in the cracks and crevices of the apple and it doesn't look good. And so you've got a fundamental problem with how they're going to keep those things clean.

When growers are teetering on the edge, they tend to look for things that are as effective as possible. And one of the real interesting ironies of this whole situation with biopesticides is that as new compounds -- or new biopesticides come out, the only growers who tend to look at it are the biggest growers. The ones that have the available land and available capital and the willingness to try something new. Our smaller growers typically can't do that. And then so the irony is here we're trying to support family farms and smaller farms and worry about consolidation. But they're the ones that relied most on conventional and had the most difficulty adopting. At least in a more conventional kind of situation the most difficulty. All that being said, I would just like to say we will continue testing. We think there are still wonderful opportunities out there. Hopefully what I've given you is the historical context for the barriers and not a future context. Sell it on REIs at preharvest intervals, because that's where the sell will be. Thanks.
MS. KNOX: Carolyn?
MS. BRICKEY: Yeah. I guess I don't want to repeat anything that has been said so far, and I probably don't need to, because I'm going to talk mostly about the outlook for organic farmers in using biopesticides.
First of all, if you think about everything you know in the conventional world about resources, about networks, about knowledge bases on these materials, you take that and divide it by a thousand. So we're talking about a small resource base. We're talking about small farmers. And you're talking about a much smaller knowledge base about these materials. So that you've got to accept and understand. You're also in terms of scale dealing with a lot more small farmers than you are in the conventional setting, obviously, and you're dealing with a group of growers who don't fit into traditional pesticide networks. Groups like this. They don't work with the dealers primarily. They don't -- you know, they're not involved in EPA activities. Many of them don't -- are not active in commodity groups, although that is starting to change, I think, which will be helpful. And you're obviously dealing with people that are working on fragile margins economically.

These are people who primarily are not knowledgeable about the pesticide registration process. So the fact that EPA issues a press release and says hey, group, we're, you know, registering this new biopesticide, that wouldn't penetrate the groups that I'm talking about. And, you know, that's all pretty much bad news. Let's face it. But we have some good news. Here it is. We have a new rule that is going to become final in October. October 21st to be exact. That is going to focus a lot of attention on the organic marketplace. Not all of it favorable, but most of it I think will be.

And as part of that process, I've just completed a five year term on the National Organic Standards Board, the last two years as Chair, in which we were tasked very specially with the role of reviewing materials that can be used in organic production and recommending to the Secretary of Agriculture which of those materials should be placed on what we call the national list. And we certainly involved Janet Andersen in that process and also Jim Jones to work with us on educating the folks in our community about how the registration process works. How we can analogize to the registration process in terms of the work that our Board had to do and is doing to look at these materials. Just one interesting piece of information I can report. I've just come from a meeting of the Board in which Spinosad was recommended to the Secretary to be used on organic crops. So it's a different world. But in some ways, the world is getting -- that world is getting closer to this world. Much of the history of dealing with these materials as in the conventional world is trial and error, and that does not lend itself to a dynamic marketing situation, as you know. More good news is that there are some very well known networks that are dedicated to organic production that both this group and the new trade association can work with. And I would be happy to talk more about that process off line.

When Janet called me -- I guess -- I don't know when this was, Janet, maybe a year ago -- and said this new group had formed, I have to admit at the time I thought, well, okay. Now, I see some real value in working with that group, and I see why you were excited about the formation of it. Working obviously with the Organic Trade Association is one opportunity. There are trade shows -- there is one going on in Austin right now -- where these products can be talked about. However, I think it would be really important to follow up on what Steve said about the universe and materials we're talking about. If we're really talking about 30 materials or 40 materials, if we can match those up very specifically to the uses that they are available for and would be recommended for, I think that's the way to approach the organic community. Seeing this list that you've given us, which is of course just for informational purposes, would be a daunting list for a grower to look at it and say well, I don't know what this means. What are these things. So I think really connecting those viable products to their uses and educating the organic community about it would be valuable. And, you know, I can offer a lot more suggestions about that when it is appropriate to do that. Thank you.
MS. KNOX: Thank you, Carolyn. Now, we started a little bit late, but we, I think, made up part of the time. Maybe if we just take the next 15 minutes, and if anyone else has any additional barriers, constraints or issues that they want to raise, and then after lunch we'll try and talk about potential solutions to the issues and barriers.
FEMALE SPEAKER: This is just a quick question, I guess. A lot of the reservations that I'm hearing about introducing biopesticides into a wider market -- a more feasible market -- I think apply to introducing any new pesticide or chemical. There are market issues. There is cost. There is how widespread it is. There is nobody has ever heard of it. There's maybe not enough testing. Your neighbors never used it, blah, blah, blah. And I wonder if we couldn't have this same conversation, but also in the context of an integrated pest management, so that it was the kind of more feasible conversation in line with the long term goals of the EPA in terms of introducing more integrated pest management strategies, so that the bio sides fit in with conventional chemicals in their role, bio sides in their role, no chemicals or organics in their role.

And that might not be for whole farmers, but it might be for periods or for seasons or for weeks so that we don't need a constant barrage of chemicals on the crops. And then also with tilling and with rotation of crops and things that we know about, so that in a more integrated conversation, these bio sides might be more feasible and have a role.
MALE SPEAKER: In fact, one of the things that I think is that some of the successful microbial biopesticides have been used in IPM programs in part, because I think cotton probably would be one case where they look for the use in an earlier season. I think some of the vegetable crops as well. So I do believe that they are being integrated into IPM programs, and I would say -- earlier I think I heard the statement that really no insecticide is a stand alone. They're all part of programs, and if you are managing it properly, I think they do qualify as IPM programs in that respect.

But one of the things that -- I guess that I take some exception to some of the things that I heard is that -- the perception that there is not an active interest on industry's part to try to bring some of these to market, even at the larger companies. And I say this from experience, because for four and a half years I worked in product development on five different biopesticides trying to bring them from basically a laboratory setting to market. And any of these are still subject to the biology that underlies them. As with any successful product, you're looking for something that is going to work reliably time and again. So what you have to look at in that respect is efficacy is not only a one time situation. But it goes back to the risk whether or not it's going to give you the intended control or management often enough that a grower can rely on it, and if not, what is their backup to come back in for a rescue treatment if the biological or the bio control method doesn't work. So I would say that I'm aware of a number of programs that were ongoing several years ago. I've been out of this for a number of years now. But in looking at it, where the research can take place and where it is taking place, is often at a very basic level. (Tape malfunction.)
MALE SPEAKER: -- come up with something. Once they come with a product that looks promising, it often is then looked at by larger companies that might be able to have the background to bring it to place. So again, I think they are part of IPM and that's a wonderful place to consider it. And secondly, there is, in my perception, very much an ongoing effort to look for them and to try to commercialize them. The lack is just a matter of giving it enough opportunity, with exception of, say, the Bt's. And I would make one other comment on the Bt's. They're actually not one product, but at least three, and I would say some would say there are four different subspecies of Bt's that act very differently from one another.
MS. KNOX: Thank you. John, Shelley, Julie and then Dan, Ray and Larry. And then I'll see how many others are still up.
MR. RICOR: Yes. Good morning, all. John Ricor here. I just want to follow up on some of the opportunities that were mentioned earlier. I think Lori referred to the need for incentives at the farm level, and I believe Robert talked about the farm bill and looking at what the opportunities might be there. And since Al is here from USDA, I would just ask you to maybe characterize the opportunities there. I believe there is a lot more funding for EQIP in the new farm bill and that's probably where the opportunity lies. Even if there is no specification for biopesticides, obviously it would just fall under innovative pest management and integrated weed management. And, of course, that means there are opportunities for us to make sure that the way the rules are written, both at the national and then each individual state, that there is a little bit more emphasis on biopesticides.
If you could address that.
MALE SPEAKER: You're correct. I guess the Senate passed the farm bill, the conference version, yesterday. I think EQIP went from a billion to nine billion -- are those numbers about right -- with it being a 60/40 split between animal and other ag. And there are a lot of challenges trying to figure out exactly what that means and what the money can and should be spent for. That will be addressed. But certainly the whole idea of how you get whole farm management systems in place that have less impact on the environment is really fundamental to that program.
MS. KNOX: Shelley?
MS. DAVIS: I had a question, because somebody mentioned that cost was a big factor and that's obviously understandably so. I was wondering if you could give us some examples of how the more widely accepted biopesticides, like pheromone disruption or Kaolin Clay or something like that, would compare in cost to conventional approaches, and whether you see these costs coming down in the near term.
MR. BALLING: Actually, it has been disappointing that the costs haven't come down more. In pears, we've been looking at mating disruption for about 10 years now. And the figures in the early 1990's were three applications of goothion typically cost about $60 per acre. Two applications of pheromones being tied, including labor costs, were around $260.

Now, if you make four or five hundred dollars an acre off of pears, and you sink $200 more in a pheromone program, and then may have to spray early on with one application of goothion, it gets pretty expensive and you lose a significant portion of your profit. What most of our growers have gone to is a single application of pheromones and a single goothion application that seems to work. We're very anxious to see how sprayable pheromones may turn out, because we think that might put us in a much more cost effective situation, particularly because of the labor issues and depending on how long those sprayables work. So those numbers could work out quite well, and I hope bode well for the future of sprayables -- or of pheromones.
MS. KNOX: Julie?
MS. SPAGNOLI: I think when you're looking at -- you know, we talk about biopesticides and conventional synthetic pesticides. I think one of the things that needs to be recognized is how biopesticides actually have a role in the development of new synthetic pesticides. And in many cases, there may be a biopesticide or chemical that has some shortcomings, and a lot of new chemical development is developing synthetic -- basically synthetic versions of a biopesticide that maybe overcomes some of the shortcomings.

And I can think of one example, you know, that we were involved with, which was the new insect repellant, where they actually analyzed the molecular structure of a number of natural repellant chemicals, such as Citronella or the Eucalyptus, and determined the mode of action. And then they actually designed, you know, through molecular modeling to develop a molecule that had the benefits there. And, in fact, enhanced some of the benefits of that chemistry and overcame some of the shortcomings, so that you actually ended up with a molecule that had a better -- was better toxicologically and better efficacy than the natural version. And so I think one of the -- you know, do we need to look at the role that biopesticides play also in the development of new synthetic chemicals. And I think you're seeing that a lot of new development is based on trying to improve on, you know, the natural versions.
MS. KNOX: Dan?
MR. BOTTS: I would just like to jump in on one issue on the restraints or constraints on adoption of biopesticides. And it's a historical perspective, but it seems to be repeating itself.

Going back to my initial exposure to biopesticides was with the introduction of Bt's in the vegetable crops back in the late '60's and early '70's, where there was a tremendous education curve to get growers to understand the mode of action of a product. How the test worked. What it took to make the appropriate decisions to be able to use that product effectively. Those compounds went through the various iterations. There are at least five different races of the Bt toxin that were developed and targeted in the specific markets that we find into efficacy levels which made them at least as effective as most of the grower standard, hard synthetic compounds at that time. And that educational process took a while to get done. It's not something you snap your fingers and do. Just because EPA deems it as a biological pesticide and registers it doesn't automatically mean everybody in the marketplace knows it is out there. It's a better mousetrap and it works.

I think we're facing truncation of the educational process to allow the growers to adopt these products. And I go back to the classic example of one of the items that Janet put up on the screen as one of the new areas that they were looking at that they were very enthusiastic about. And I don't want to call it by name, but it is a situation where we were actively engaged before that product ever came out of the laboratory to go to the field to look at it because of its abnormal mode of action. We were promoting that development into our conventional commercial systems. There were indications that the efficacy was there, similar to what Steve was talking about on some of the compounds he has looked at. We encouraged the company to go through the traditional university system route to do the testing and to get the replicated trials to give us a basis of comparison into the standards that were there. They did some of that.

They got registration because of an expedited review and all of a sudden it became the greatest thing since grits. It was going to be used in every crop site known to man, and was oversold and over marketed by the company. And all of a sudden -- when it actually reached commercial fields and it didn't live up to the hype and the perceived standard that was out there, all of a sudden the whole group of compounds that were being developed around that particular system all of a sudden has a black eye. That doesn't work to anybody's advantage. And part of that is because of the licensing process, and the fact that you've got start up companies that are sitting there. They have venture capital behind them trying to drive a marketplace, the initial leverage offerings and public offerings, and all of a sudden have a bunch of people they have to answer to. And sometimes reality, because they don't have the basis of information because it's been pushed so fast, to make the transition to the marketplace it needs to be. So there are issues on both sides of the process.

But I would like to emphasize something that Lori said. If a product works, our growers will adopt it, even if it's not 100 percent efficacious, if it fits into a program that minimizes our need for other pesticides. If it's efficacious and it fits into our program, we'll use it. We're not going to go out there and redesign a total production system that has got a three to $4,000 cost per acre before you ever harvest the crop, and another 3500 to $4,000 in harvesting and packaging costs at the end of the day, just to fit a new product because EPA says it's a new safer product. If it fits into our system, we'll be glad to put it into our program. So you need to talk -- in addition to the regulatory community -- USDA -- you need to talk to the growers as you go into product development.
MS. KNOX: Thank you, Dan. Ray, then Larry and then Gary, and then I think we'll have lunch.
RAY: Much has been said about the marketplace, and I think the marketplace works very well. If your product works, they'll buy it. The point was made earlier that none of the major crop protection companies are involved in biopesticide development, and I don't think that's strictly true. At least a few of them have in the past had very active programs looking for biopesticide products. And Burleson Smith mentioned this from his previous experience in such programs.

Some of the issues that they come up with, or difficulties they come up with involve, you know, a number of factors. Manufacturing costs are typically -- can be much higher if you have to deal with fermentation technology. There are a number of efficacy issues. Some of the fungal products generally are affected by weather conditions affecting their efficacy such that they're not consistent. There are quite a number of formulation issues. Some of these products are environmentally unstable. They need UV protectants in the formulation. And getting inert ingredients approved can be very expensive. They may require multiple applications p-- that has been mentioned -- whereas the alternative -- the competitive conventional products get by with fewer applications. Rain fastness, because the product must stick on the leaf to be active. That can also be a concern. The major companies individually test tens of thousands of chemicals, perhaps more each year, in looking for viable commercial products for pest control. They're not going to leave any stone unturned in finding those products that have --
(Tape malfunction.)
RAY: -- intellectual property protection. It takes a great deal of investment to --
(Tape malfunction.)
RAY: -- when you're dealing with natural products, you may have --
(Tape malfunction.)
RAY: -- intellectual property --
(Tape malfunction.)
RAY: And as Julie mentioned --
(Tape malfunction.)
RAY: -- natural products can become very effective pesticides. And so there is going to be a lot of research into the natural products in order to find those that can be adapted. The synthetic pyrethroids are an obvious large example of what started out as a natural product and had been derivitized to make them more effective to overcome those shortcomings. The incorporation of the Bt proteins in genetically engineered crops. While we're staying away from genetically engineered crops in this discussion, they all start out as natural products.

Spinosad was mentioned, and that was certainly developed by one of the major companies. I remember in graduate school looking through some very old literature and coming across the chemical structure for a fungal pathogen which looked quite familiar. And so I looked back through some other --
(Tape malfunction.)
RAY: -- put in a single --
(Tape malfunction.)
RAY: -- herbicides. And I've always wanted to follow up and see if that was where it was found. So the natural products do become sources of the chemistry that are developed into a conventional pesticide.
So there are barriers. I think the products that are found simply need to be competitive. And the major companies are going to be involved in that and aren't going to leave any stone unturned in finding good products.
MS. KNOX: Larry?
MR. ELWORTH: Thanks. I just want to say a little bit about this issue of Extension. I think the role of Extension is involved from direct involvement with growers to providing education and information to a wide set of people. So I think -- well, there is only one way to say it. Extension is not going to get any more money. I mean, with all due respect to Extension. And I was a client of Win's for a long time. So if the balance --
(Tape malfunction.)
MR. ELWORTH: -- biopesticides or any pesticides on huge infusions of resources --
(Tape malfunction.)
MR. ELWORTH: I mean, I'm sorry. I know this is a shock to you, Win.
(Laughter.)
MR. ELWORTH: So in that case, if the role of Extension is in information education, then implementation is going to have to happen at the private sector level. And I didn't hear a whole lot about interaction with either PCAs or private consultants. And I think in terms of implementation as the primary market or knowledge about the availability and efficacy of any materials, particularly biopesticides, that's an important linkage to make, which I didn't hear much about. I think not having those people either aware of or well versed in using those materials is a huge barrier. And the other thing I would point out is that to the extent that there are regulatory barriers for --
(Tape malfunction.)
MR. ELWORTH: -- and conventional materials, they are the same, except slightly more intense, or maybe a great deal more intense, for the companies that register biopesticides. And I know, Janet, you and Kathleen are very aware of this. Examples that I'm most familiar with recently is with pheromones, where people have -- and Steve mentioned it -- the advantage of a sprayable pheromone over hand applied pheromone. It could be significant.

But all of a sudden, small companies who had never dealt with tolerance issues, because now there are residues on the trees, or at least concerned about residues on the trees, are dealing both with tolerance issues and inert issues that they've not dealt with before. Everybody has to deal with that. Julie's company has to deal with that. For these companies in particular, they are not over capitalized, so delays in registration can actually do in the material before it actually gets registered. In addition, they have relatively limited regulatory steps. So I would just make the same argument that I'm sure the other companies -- that companies would make as well, that understanding what the regulatory requirements are and having them clearly set out as soon as possible. When things are changing, to provide information so that companies can anticipate the changes and develop the data in time for the agency to use them. All of those are important for any company getting a new registration or tolerance, but especially true for these companies. And for a lot of these companies, if you can't -- if you can't work through the regulatory system pretty quickly, either your venture capital or your support within the company, I would assume, would dry up fairly quickly.

Finally, I would just make an observation, that where these materials work well and are adopted well, it's basically where they get a key pest, whether it's codling moth or any of the pests of the major crops. Where you get a key pest, you have a market incentive to use a new material, and that's where these things tend to be most successful.
MS. KNOX: Gary and then Bob Rosenberg wants one little minute after that, and then we'll have lunch.
MR. LIBMAN: Just two things. Number one, we talked about the financial thing. We talked about the fact that there is not a lot of money to advertise, because most of these companies are small companies. We're really right on the brink, to say the least. Bt's are successful. Bt's were -- and I worked for Abbott Laboratories for 23 years. Abbott Laboratories, Sandos and the big pharmaceutical companies put money aside for the Bt development, and that's why it became so successful. These companies and as part of this BPIA, we don't have that kind of funding. And it is a problem. It continues to be a problem.

The other thing -- and we heard an example. There are always examples that my microbial don't work. And I'm sure there are chemicals that don't work, too, and people don't say well, therefore, chemicals don't work. But I think there is a tendency that this microbial didn't work. Maybe all microbials don't work. And we have to make sure we don't get into that negative thinking. And I know you don't feel that way. The other thing is, we're talking about insecticides. We need to also talk about the biochemicals -- the plant growth regulators. Those are quite successful. They're quite efficacious. Anything that has gotten registered certainly within the last five years in California you know that there is a tremendous amount of efficacy data establishing that it really works quite well. So we're not just talking about insecticides here. We're talking about fungicides and the plant growth regulators.
MR. ROSENBERG: Understanding that everyone knows that as long as I go they're being deprived of their lunch, I'll just say one thing. In the area of nonagricultural use of biologicals, which there are quite a few, the single biggest deterrent or barrier to wider use is the inability of PCOs to advertise the fact that they're providing a less toxic, safer, healthier service or something that is different than a conventional service.

And while that's not an EPA issue, if a pest control operator uses reduced risk products, or lower toxicity products, or biologicals, they are typically prevented by State Attorneys Generals from making any health, safety or environmental claims about the type of service they provide. If you can't say that you're providing a different type of service, there is virtually no incentive for trying to provide it. So to the extent that the agency might want to once again take another look at that issue, which it last did back in -- I believe it was 1992 when it adopted draft lawn care advertising guidelines, which though they were never finalized have been taken as gospel by State Attorneys Generals, that might be a worthwhile endeavor.
MS. MULKEY: Well, let me take a moment to thank this panel for incredible time management, a rich dialogue and giving us something to think and talk about over lunch. Because they plan to come back and use their remaining hour to work through some practical meaningful next steps. And I've formulated in my own mind a few sort of thoughts from an EPA perspective. Questions to pose, which I'll either talk with Kathleen about or take the opportunity to do so that we can get the most useful advice from you.

But I really invite everybody to spend time with each other, and inside your own head working toward the hour that we anticipate. We -- you guys were amazing. So we're able to come back from lunch at the planned 1:30, which is a nice ample lunch hour. But what you need to give us is to actually make it back exactly at that time.
Thank you. (Whereupon, a lunch recess was taken.)

AFTERNOON SESSION

MS. KNOX: -- really talk about any thoughts or any ideas about what either EPA can do, what the industry should do, what USDA might be doing, what land grants or whatever. Again, brainstorming is fine, but certainly practical solutions would be nice, too. And then we'll go back, take all that input and report back to you on it and try and identify some things that we think might work. It may be short run or long run. So that's the plan. Hopefully, we'll have a real good discussion. As part of that, what really should EPA's role be. What should USDA's role be. Not just what can any group do, but what should the role be. Is it our role once we've registered them to have further support in some way, or is it sort of, you know, they're registered now. It's up to other parts of the community.
MS. MULKEY: If I may just in order to frame that question while Kathleen goes to -- a little bit more with regard to asking your advice to us. In particular, anything that you may want to suggest about the aspects of our registration activities, anything particular to EUPs, anything particular to analysis, or anything particular to priority setting in this arena that you want to put forward, we're receptive to hearing in this area of biopesticides.
And also partnering. What kind of partnerships can EPA engage in and how in a meaningful way. So those are some things. Al, is there anything you want to frame in terms of advice you would like to hear on behalf of USDA?
MR. JENKINS: No, I don't think so. I think it's pretty wide open. There have been lots of good ideas, so reinforce some of those, if you please, or expand upon them.
MS. MULKEY: Okay. Janet, are you --
MS. ANDERSEN: I'm ready.
MS. MULKEY: I think you've got Steve and Gary and Ray all started.
MS. ANDERSEN: All right. Well, let's start with Steve.
MR. BALLING: Good. Actually, one of the reasons -- I think maybe to help set the stage here -- and, Marcia, you actually spoke to the issue. It's really kind of a process issue. Julie had mentioned and got me thinking about this, about all the synthetic analogues there are to biological compounds. Spinosad is a good example. There are a lot of examples.
MS. MULKEY: Pyrethroids.
MR. BALLING: Pyrethroids in general. So is the same level of -- I've always made the assumption that the biological pesticides are in fact safer, because they're biological, right? But the scientist in me says, well, gosh, you know, there are a lot of unsafe biology out there fairly self evident. Are the biopesticides subjected to the same level of tox requirements and those things so that in fact we can safely say that, yes, they are safer products? That's sort of a basic question, I think.
MS. ANDERSEN: Well, let me divide it into two groups: the biochemicals and the microbials. There are -- in case you don't know, there are a set of data requirements in part 158 of the regulations that we work under. There is a set for conventional chemical pesticides, a set for biochemical pesticides and a set for microbials.

With microorganisms you're asking rather different questions than you are for chemicals, because these are things capable of reproducing in the environment, first of all, so that makes them inherently different. And second of all, the question we more often ask is not toxicity, but insectivity and pathogenicity. So considering that, it's a slightly different question that you ask with a microorganism. But, yes, they are subjected to a set of tests. We don't have a carcinogenicity test for a microorganism. But for a chemical -- biochemical pesticides it's a tiered approach. If you can go through the first tiers and you reach no toxic endpoint, then you don't have to go on to the other tiers. But the tier is set up such that you can go all the way to requiring a full two year feeding trial for carcinogenicity or whatever else it is you might need if you have a biochemical pesticide.So they can be, but with a tiered approach you don't have to ask for all of the same data for baking soda that you do for some of the others. And with resort to -- you know, if I talk about Spinosad and the history of it a little bit, it did come from a microorganism.

If the company had come in as they started out with a microorganism with BPPD, it would have stayed with us there. But when they refined it and made it a chemical pesticide, it is toxic to the target pest. It therefore fell outside the definition of a biochemical and it went to the Registration Division. And indeed, there were toxic endpoints to that product as they went forward in the registration process.
MR. BALLING: And presumably there would been in the natural compound as well?
MS. ANDERSEN: There might have been. We never got that far.
MR. BALLING: And you would have discovered that, presumably?
MS. ANDERSEN: We would hope that our tests would pick that up, yes.
MR. BALLING: Okay.
MS. ANDERSEN: My next one on the thing is Ray.
RAY: Well, my question was very similar, so there's just a little bit to add to it. You know, we have to be careful about those potential tox concerns. We don't want to discover the next nicotine the wrong way or the next cocaine.

I'm a little confused by your describing a nontoxic mode of action. Except for return, I don't see how that is a proper description, because if you're going to kill the pest, it has to be toxic.
MS. ANDERSEN: Many of these things don't do it by toxic mode of action. They might suffocate the pest. Now, to the insect that may feel just as bad as if it was done by a toxin. But it is a different mode of action.
Gary, you're next.
MR. LIBMAN: Also, by the way, the biochemicals usually are not insecticidal or the plant growth regulators.
MS. ANDERSEN: Right.
MR. LIBMAN: So there is nontoxicity there as well, at least to the target organism, we shall say.

Two things that came up over lunch, and some people kind of cornered me and asked me a little bit about the certification program of the Biopesticide Industry Alliance. What we're trying to do is set up some standards so that when it meets these rigorous standards over a two year time period out in the field, that when -- you know, if there is some kind of seal of approval or whatever we decide to do, that people will be pretty well guaranteed that that is a very efficacious type of product and we can eliminate the problems that people have seen in the past. And in fact, the newer biopesticides coming on the market, you're seeing really good efficacious products. And obviously as you know, in the case of public health type of products, they have to go through efficacy trials within -- I mean, they all have to have efficacy data. But it's required to be submitted to the U.S. EPA for public health products. One question that we were talking about a little bit is -- and maybe you can all help me on this one. We would like to know in the biopesticide industry what we can do to help independent crop consultants. Would a web site help? Would a listing help? What can we do so that we can help get the word out?

I didn't go into -- there is a survey that we're doing right now. Some of the people in the Biopesticide Industry Alliance have commissioned a survey. And I can't go into the details of it, other than to say that in the PMCAs of places like California or Florida, we're finding that just about half of the people have no awareness of biopesticides at all. They just don't have an awareness, and that's the single biggest barrier to our products. They do not have that awareness. And that was brought up very well from Al and so on. And another issue. We're not as high a percentage, but there's also the cost. We talked about the cost. The costs tend to be a little higher until you can get things like the Bt's when you get the fermentation process down pat, and you get these things to be almost commodity types of products rather than specialized ones, if you will. But we would like to know really what we can do. What we can do to help these independent crop consultants or PCAs and so on.
MS. ANDERSEN: Marcia, should -- just a word of -- Marcia, would you like me to ask Lori, or do I wait until it's her turn? What is the typical protocol you use in these meetings?
MS. MULKEY: Well, I think that's the kind of an open ended question that as you get around to it, we'll get it answered. Or if not, we'll come back to it.
MS. ANDERSEN: All right, great. Win -- I have Lori on the list. So Win? Win is next.
MR. HOCK: Well, I would like you to address the education issue. In fact, this kind of goes along with what Gary was raising the question. What can you do to promote or at least make people aware of your products? I don't think it's EPA's position obviously to promote a biopesticide any more than they should promote, let's say, a synthetic chemical. But, you know, there are a lot of educational institutions out there that can do that. You know, in my own position, I can go back many, many years. I would get information on pheromones and possibly on some PGRs and IGRs. But, you know, most of the products -- most of the microbials that came out, I never saw anything about that. I mean, we just didn't get the information even at the university level.

Your comment about -- or your question about a web site. Yes, that would be helpful. But if we're going to promote -- if we're going to encourage growers to use these products, to use microbials or at least think microbial -- I don't say they're going to use them, but at least think about it. What they need to do is have information. And how do they get information? They can get it through Extension. They can get it through their state lead agencies -- the regulatory agencies. You're right. They can get it through private consultants as well. Pest management consultants. Obviously, you've got to reach out to those people. But I think part of the problem, at least that I've experienced, I don't think the industry -- and I'm talking here, you know, biopesticides, if you will. I don't think there has been an outreach program to really get to the key players to promote or at least encourage growers to think about these products. So again, to me it's education, and I just feel very strongly about that. If you're going to have people become aware of the product, you have to have a mechanism to get the word out. And it's an educational process.
MS. ANDERSEN: Okay. Thank you. Christine? Christina? Is that the right -- I'm sorry.
MS. BEAR: Chris is fine.
MS. ANDERSEN: Chris, okay. I can do Chris.
MS. BEAR: I had a question more on the tier one -- or the tiered approach for toxicity testing.
MS. ANDERSEN: Uh-huh.
MS. BEAR: I guess the first question is, how does that work? I mean, my interpretation of what you said is that if you would do something like acute high dose studies and you didn't see problems there, then you wouldn't go on to more chronic studies. And so the specific question I ask is, what is the criteria for an effect? I mean, if you don't see anything, or if you see something but you determine that it's not relevant or it's not appropriate to justify further testing? I guess I'm sort of wondering how that interpretation is made that this is where we stop. And the second part of that is, do you have any idea when the endocrine disruptors screening program is in place if they would be subjected to tier one screens for endocrine activity?
MS. ANDERSEN: Okay. I think it would be useful if you actually looked at the tiered process in the -- what is in the first tier, and maybe we can provide that to you to understand that. But there are a number of tests that are there. So you are looking through several different essentially modes of looking for toxicity, and if you end up with no toxic endpoints at those levels -- typically these products are actually tested at a higher level than are conventional chemical pesticides to determine that. But you can, indeed, come and look at -- you know -- like Methyl Salicylate is the one I had up there. You know that at high levels that's a very toxic compound. Yet we also know that it's in chewing gum and all kinds of things. So if we also have a concept that the level of it is going to be extremely low -- for example, it's much lower in these boxes than it is in gum, or your corn flakes would taste like gum.

But it's at extremely low levels, so you consider that and you can do a -- you know, again, we use a safety factor. Often 200 or greater. That if you know you're way below that before you see any toxic effect, then you don't have to do all of the higher tier testing, which again is, you know, just using animals that don't need to be tested, etc. But the scientists do look and do a risk assessment for every one of these products and determine whether or not they have to go on to higher levels of testing. But I'll be glad to provide you with that list of studies. It's not actually -- all of them are not on the tip of my tongue. But all of these products require the standard six pack you do for every end use product and a number of other testing -- immune testing and some -- typically a repo study. Actually, probably Gary can tell you better than I can. He's probably had to do more of them. But there are often even a 90 day feeding study. I think that that's required for a lot of these products.
FEMALE SPEAKER: Janet, are you going to speak about endocrine disruptors?
MS. ANDERSEN: Oh, endocrine disruptors. Yes, some of these products will be subject to endocrine disruptors, especially if you're thinking about things like insect growth regulators, etc. They will go through part of that. It is envisioned they will. But many of them will not because of the large understanding we have of those products already.

So some of them will and some of them won't. I do not believe it's envisioned that any microorganism is going to go through that testing. Partly I think they wouldn't know how to approach it. But that's the concept. I have Alan Lockwood as the next person.
DR. LOCKWOOD: I have a question about the safety testing of the microbial pesticides. How does one assure oneself that agents are not going to be pathogenic in certain populations? For example, an immune compromised host?
MS. ANDERSEN: It is considered -- I think the literature is fairly well described of what that is. But it doesn't mean you don't have issues that come up, and we handle them in the same kinds of ways we do when issues come up with conventional chemical pesticides. An issue has come up with the microorganisms we have regulated called Burkelariasapacous, which when we registered those products back in the early '90's, the agency thought -- and so did the medical community -- that we knew well the taxonomy of those products.

Even though this is an extremely common soil microorganism, it's now known that there are -- there are strains -- well, it was already known. There are strains that can infect people who are immune compromised, especially with cystic fibrosis. And the state of knowledge has changed enough that there are now questions about all of that genomics assigned to it. Where they belong and which gene of ours, etc. We have required of that company tremendous data call in to try and resolve some of those issues. And the company is just about to decide what to do, whether or not to support that use or not, and we should have that answer this week or next about it. Because we have those questions and have to have them resolved. So when questions arise, we look at it. But we certainly are asking those questions and considering that when we look at those products as we register them.
Alan James is next.
MR. JAMES: My comments --
MS. MULKEY: You need a mic -- I'm sorry -- because we're recording.
MS. ANDERSEN: Oh, I'm sorry.
MR. JAMES: I thought I had it there for a second. My comments have to do with the handout material. I wanted to point out a couple of issues based on conversations we had this morning. The one that is called, Your Explanation Sheet on Biopesticides, and I call your attention to it, if you have it convenient, on the second page. We were speaking this morning of the agency's concern about overstatement or misleading statements. On the second page, based on the conversations we had this morning, there are a couple of areas I would like to point out that maybe we could think further about and possibly reword or at least consider it. The first bullet point under what are the advantages of using biopesticides. Biopesticides are usually inherently less harmful than conventional pesticides. I think that statement is an indictment of the EPA's registration process in general, and it just doesn't seem to fit very well with what we're trying to accomplish.

The second one is the fourth bullet point. When used as a component of integrated pest management, biopesticides can greatly decrease the use of conventional pesticides while crop yields remain high. I don't think there was too much support for that statement from the experts around the table this morning. They play a valuable role in integrated pest management, but I think that statement might -- we ought to look at that statement and see. If it's going to be on the Internet site, maybe it needs some minor wording. The third one, however, I would like to commend the agency for writing, and I appreciate it, Janet, if you wrote it. It's on the right-hand column, the second paragraph, where we point out that the EPA always conducts rigorous reviews to ensure that pesticides will have -- not have adverse effect on human health or the environment. For EPA to be sure that a pesticide is safe, the agency requires a lot of data. We do appreciate, finally, the acknowledgement that the agency assures that pesticides are safe. Thank you, Janet, for that.
MS. ANDERSEN: Okay. Lori?
MS.BERGER: I hope I can remember the question I'm trying to address. But it had to do with Gary's comments about PCA awareness in the field of biopesticides. And I'm really surprised, at least for California, that number is 50 percent. I would like to look at that information. And it might be a nomenclature type situation, because we have so many people using Bt's in California very effectively. I think that they might be thinking of them more in terms of microbials versus biopesticides. That's just kind of a newer term. The Bt's have been very effectively used in California, especially the stone fruit. This has been a super tool especially at bloom time, and we've been able to significantly reduce the uses of organophosphates in some cases up to 60 to 75 percent with the use of these tools. And so that's been just extremely valuable and we wish we had more of these types of materials. So I was just surprised that over half of the people are reported as not knowing what they are.

And I would like to underline what Win had to say, that education is the key and where is that education going to come from. Larry eluded to the fact that Cooperative Extension -- and we've got some great Extension folks out in California. But that system is just not being funded. They're not replacing people. The folks are overloaded. And at the same time, we're getting technologies that are requiring more time on the part of these people.
So it's either going to come from the private sector, the companies themselves, and that's looked upon not very credibly in a lot of cases, but that's what a lot of folks are doing. And then also there are some collaborative projects in California -- the Pest Management Alliance programs. Whatever we do, we need it in the field for people to see. For growers to see. For pest control advisors to see. I think the web site and those types of materials are very helpful when you're talking to people at levels where they're interested in web site based information. But, you know, seeing is believing, and the most success we've had is seeing these things in the field. And so we need to expand the demonstration type projects. Again, this is where an expanded EUP -- for using things like pheromones and Bt's, or even with plots that are four trees big. It's just not going to work, and we really need to see it in the field. So those are my comments.
MS. ANDERSEN: Can I just ask what the Pest Management Alliance program is? I don't think you covered that for.
MS.BERGER: Okay. That is a program in California that is sponsored by the Department of Pesticide Regulation. It's a grant program. These grants are up to, I think, $100,000 per year and they can go up to four years. And these are collaborative projects with people from the university level, farm advisors -- that's what we call Extension agents in California -- pest control advisors and growers. And it's kind of a start to finish, let's look at the pest management systems and see where we can adjust. Use more biologically based materials. We might specifically want to cut down on, let's say, OPs. It's just looking at IPM systems and trying to make them more reduced risk. So those have been very helpful. Again, seeing is believing. There have been a lot of grower meetings, and there have been a number of commodities -- strawberries, prunes, pears, peaches, grapes. Just a number of these. Those have been very successful.

We're running into some budgetary programs in California, and we might be seeing a slow down of that program. But it has been a model and it's been very effective. And Larry Elworth is doing a project for DPR this year, where he is basically reviewing these programs and reporting back to how effective they've been to adoption of IPM and reduced risk. You might want to comment on that later, Larry.
MS. ANDERSEN: Well, Larry will like this, because he's next. Thank you.
MR. ELWORTH: How much time do I have?
MS. ANDERSEN: You're not constrained so far.
MR. ELWORTH: Right. Right.
MALE SPEAKER: I'm sure you'll fill it.
MR. ELWORTH: I'm sure I can fill it, right. A couple of things. One is, if performance is a key issue in the acceptance and obviously the use of these materials, has BPPD required efficacy data as one way to at least help move the issue of performance along? And recognizing this would be an additional burden, is there a linkage that could be made to IR-4 or other funds? That's one question.

The second question is, if in fact there is a backlog -- and kind of a recent backlog, maybe one you haven't deal with before -- and if you also know there are certain situations in which biopesticides are more likely to be used -- let's say there is a new pest, a pest that people are having trouble controlling and there is a lost of existing materials -- has BPPD looked at a priority setting process which would look at where the most important opportunities were from EPA's point of view, with the hope that the opportunities that EPA targeted would also be the opportunities where growers or grower groups would be most likely to adopt these? You know, I know priority setting is done in other parts of the agency. That would both deal with the backlog and also might make it more likely that the more widely used materials got registered relatively quickly. So those are -- that's two questions.
MS. ANDERSEN: Okay. So we'll do the questions and then maybe then you'll answer Lori's point, if you wanted to, or talk to more about what you're finding in that system. If you want to.
MR. ELWORTH: Okay.
MS. ANDERSEN: Let me say we do not require efficacy data for biopesticides outright. We have -- like all groups in all the different registering divisions within OPP -- the ability that if we do not believe a product is going to work that we will ask for that data. And we have at times asked for it up front where we really -- you know, we thought we were looking at snake oil and we wanted them to show us that it wasn't.
And I know that there are a couple of products which never did come to market because we asked those questions before we really went forward. So there have been -- there has been some of that. But on a routine basis, we do not ask for it. And let me just say that the argument is often why should they be put to a burden that we don't require for the other side.
MR. ELWORTH: Sure.
MS. ANDERSEN: And I think there is some merit to that discussion.
MR. ELWORTH: Uh-huh.
MS. ANDERSEN: I think though we will find that as we partner with Canada, Canada requires efficacy data, so we see some of it in that case. But also California always requires it, and I think there may be some move in California to change that. But given that this is such an important market for biopesticides -- the California market -- that we often can look and make adjustments that way. And California is -- they have no compunction of calling us up and telling us that we ought to be able to do something here or there or whatever. So that's quite an open relationship between the two organizations. But we have not required efficacy data, and for that reason I think more than anything else. We don't think it's fair to put an extra burden on them.
MR. ELWORTH: Is it something that then you and your trade organization certification issue might consider in submitting efficacy data to the agency as part of a certification program?
MS. ANDERSEN: Well --
MR. ELWORTH: Not by whereby you would certify it. But where you would have reviewed the efficacy data.
MS. ANDERSEN: Well, let me say first something about the certification. Maybe that hasn't been required. In order to be certified under the program they've been discussing, it has to have been registered with EPA for two years before it can even be considered for certification. So in that sense, it wouldn't work.

But I think it's again like all of the other kinds of ideas that you've brought up as potential solutions. Here is one to look at and one for us to think about with our partners with IR-4. Is there something more that we could do there. And certainly hearing repeatedly the importance of demonstrations for really having growers see how well these products work, you know, the demonstrations maybe speak louder than a number of piles of studies that show whether or not things work. I can't imagine why a grower is going to very often use a product that doesn't work, so that makes sense. BPPD does indeed have a backlog and it has come -- we had a very difficult year last year within this small division, and it had to do more with those plant incorporated protectants than it did with most of the things that we're talking about. But we had -- we convinced our office director that we really needed some more contract money, and she was terrific. She gave us a lot more money than -- frankly I can tell her now -- that I ever expected we got.

And it takes a while to do it. We've had it a little over a year and it's starting to make a difference, I think, in what we're seeing how much time it takes. So we're having contractors now essentially do all of our primary reviews and where we did virtually all of it in-house up to now. And this will make a difference in our backlog. You actually ran into a problem that we had this year, where we ended up with a problem. We really wanted to meet a deadline that you had, and you were working with a group of growers to be able to put a product in the market. And I think -- I can't actually speak to the Registration Division, since it's one of the organizations where they -- that I actually never worked in. But in our organization we are small, and we are -- I know. Kathleen and I both personally worked very hard to try and resolve that issue and trying to get people in parts of other organizations to help do the reviews, etc., to make that product work.

So where we know we've got a critical demand like that and we're really trying to put a demonstration in place, and where it really does, we think, make a difference, especially if we're replacing organophosphates and other kinds of products like that, we really do try to go that extra mile to push it along. As far as a priority setting, what we are trying to do is much more on a risk basis. Because we recognize that all of these companies -- almost all of these companies we deal with are very small, we try to not put -- (End of Tape 2, Side A.)
MS. ANDERSEN: -- realize that there is a potential -- a product there in the market -- or in our queue that we could really use to try and replace, or to meet an immediate demand, we will work to bring that up in the queue and try to make that happen. We do have a lot of active ingredients before us, and we have some issues in trying to balance it. But we really do try to look at those issues as we go through the process.
MR. ELWORTH: Well, just to answer briefly Lori's question. The thing that distinguishes the Pest Management Alliance projects from lots of other projects is they're very much driven by the commodity groups. And I don't know how many times I've talked to people who have either had conventional materials or reduced risk materials or biopesticides. I'll talk to them, and they'll say, well, what should we do, and I'll say have you talked to the commodity group and the growers. And the answer is usually no. And where the projects have been successful for the Pest Management Alliance is where they have relied very heavily on the grower groups to be involved from the beginning. So I would -- that's one lesson from PMA that I think is applicable to this situation.
MS. ANDERSEN: Thank you. Let's go on to Phil.
MR. BENEDICT: I would like to go back to the education issue for a minute. USDA NRCS -- our Natural Resources Conservation Service -- is charged with helping farmers put conservation on the farm. EQIP came up earlier. And with a big influx of money into EQIP, there is going to be a lot more opportunity to do that. And this is really I think a message to the industry. I really believe that that's another field force with 3,000 offices out there. There is basically pretty near an office in every county, where there is somebody charged to help a farmer write a conservation plan to solve that farm's resource problems. And pesticides are considered a resource problem. There is a huge field force in Natural Resources Conservation Service that is untapped today from an educational point of view. So I honestly believe there is another field force, but I think your organization would have to begin to work with the leadership there. They work on waste management systems a lot. They do a lot of work with integrated crop management. A lot of that has been our management issues. But pesticides are certainly part of that. So there is this other huge field force that nobody is using today. And they would need a lot of education and a lot of information, but there is a delivery system to help farmers write management plans to deal with resource issues and that's what you're going to need to do if you're going to get EQIP funds. With that said, I guess I can begin to work with them.
MS. ANDERSEN: I thought EQIP was an interesting idea, and we might -- if we seem to have a little more time, Al, if you could -- might describe -- I had several people ask me what EQIP was and how it works. Can you provide us a little bit more background on it?
MR. JENNINGS: Very little bit. You want that now?
(Laughter.)
MS. ANDERSEN: Yeah.
MR. JENNINGS: Okay. Environmental Quality Improvement Program. As I said earlier, it's been in the farm bill and funded to, I think, half a billion. I probably said a billion, which is too much. But the money has largely gone to animal agriculture. It is a direct funding of farmer built or farmer deployed pollution prevention. In the case of the animal agriculture, a lot has been with manure management. Essentially keeping the manure out of the water. There are various ways to express that. But anyhow, under the new farm bill with the vast increase in money, we are looking at it as, yes, it is going to remain important for animal agriculture, and those people do have a major claim on the money. But we're hopeful we can move it into other resource management.

Comments are very well taken. There is a large work force out there, and I have just begun discussions with NRCS about how to help them spend all this money they're going to get. They, of course, are always appreciate of help on how to spend money. But anyhow, we will be working on trying to set up a system. Right now one of my priorities is trying to integrate our land grant system into that process. As Phil pointed out, there are a lot of people out there in NRCS. One of the problems is, they're kind of the old soil conservation types and now they're the, you know, how to build a manure pit type. And we need some additional training and expertise, and I look at the land grant system as being well positioned to provide that. Exactly how those details will shake out, I don't know at this point. The only thing I can is we're working on it. It's a good thing to report back on next time.
Was that enough, Janet?
MS. ANDERSEN: Yeah. Well, that helps me. I think we'll be talking to you about that.
MR. JENNINGS: You would like to help spend their money, too.
MS. ANDERSEN: Yeah, sure. Why not. Steve?
MR. BALLING: I wanted to make one other comment about education. Another hat I wear is the Chair of the National Foundation for IPM Education, and we have been talking with Janet at EPA and the Biopesticide Industry Alliance and IR-4 about doing some regional workshops. So I think that has an opportunity to begin to find ways to break through some of these barriers, particularly with consultants and Extension to begin to talk through how do we break those barriers down. I would mention, though, that of all that we've discussed thus far as a potential user of biopesticides, there are three things that I would say that I need more of. One is -- and I mentioned this one already -- replicated data. Lori said efficacy, efficacy, efficacy. When it comes to selling your product, it's data, data, data. We have to be able to see that this stuff actually really works in a replicated situation. That's real valuable.

The second thing is, don't over hype the product. Dan mentioned that in one of his -- in his comment earlier. That is so often -- in the desperate attempt to sell some product to try to fund your next set of data or your next product, these products are oversold and they fail. And guess what. They get a bad rep. And to be honest, if you look at Bt's, we talk about Bt's as a success story. It was the failure story for 20 years. So it's only recently that Bt's have overcome the failure of their original disaster back in the '70's. And then the third thing is, sell the product on flexibility and safety. And I mentioned this. Reentry intervals and preharvest intervals typically on these products are very short or nonexistent and that provides to us as users a real benefit. And that's, I think, one of the great ways to sell the product. So those are the three things I think are important.
MS. MULKEY: I would like to pose a couple questions to see if anybody can help with them. One is that in talking with industry -- Julie and Beth will be interested to hear that they put a lot of energy into talking about how they need us to move faster and regulate -- register their products more quickly.

But one of the reasons we hear from them that we don't often hear from you guys is that their source of venture capital is dramatically intertwined with the receipt of the registration. And one of the things that struck me, is if I were a venture capitalist and understood this industry, I'm not sure that I would tie it to receipt of the registration. I think I might tie it to some measure of sales. A successful EUP might thrill me even more than a registration, etc. So if anybody around the table has any insight into the money market around this kind of thing and any intersection between those. Now, I know we don't have any venture capitalists on our PPDC committee. We'll work on that next time. So I wanted to pose that question. And the other thing I wanted to do was ask Bill Tracy if he has any insight from cotton culture land on this question, if he feels like putting up his card, he should feel free to. I don't want to put him on the spot. But I think it's been especially useful to hear from people who are engaged in production of agriculture.
MR. TRACY: As Lori had pointed out, in the cotton industry we've used Bt's for years and it has worked out exceptionally well, especially in the deep south. It's just starting to come into California. But what crossed my mind when the discussion was about how should we advertise or how should we get the word out to the ultimate consumer, which is the in-field agriculture, if this stuff works, it sells itself. There is nothing that spreads faster than coffee shop talk about a product that works. You don't have to advertise it. You have to show in the field that it works through replicated trials and all.

As indicated in our state out west, we have an excellent Extension Service. I use it. I got very interested when Dr. Benedict mentioned the RCDs. I forgot the resource conservation districts. That's one of the real untold success stories of USDA -- the RCDs -- and they have not been used, unfortunately, since 1986. They've been converted into writing farm plans -- conservation plans. They used to be the old Soils Conservation Service that really taught us how to stewart our soils and all, and a lot of those people were discouraged from the Service when they turned them into secretaries to write farm plans for folks. But this might give them new energy, too.
But to get back to your original question, nothing sells like success in a capitalistic society.
MS. ANDERSEN: Marcia, you all right to go on?
MS. MULKEY: I'm finished with my questions.
MS. ANDERSEN: Thank you. Lori?
MS.BERGER: Yes. I wanted to comment on the -- what had been said about the resource conservation districts. I think that they are more widely understood and used in the midwest. But it is a network out there, and kind of amongst the minor crops people, we've been having some questions and discussion about the possibility of using EQIP funds to assist in transition.

And, of course, people are saying, well, it's an old system and it's water and soil and they just aren't going to want to do it. But all of us are going to have to make changes, and I think it might be a shot in the arm, like Bill said. It is resource oriented. I can think of a lot of issues in California -- and I'm sure elsewhere -- air, water. These are resources, and the components that are important to a successful IPM program are resources. And this is a network that is already in place. One thing I do have a concern about, and with all due respect to the land grant systems, which I'm a three time product, it really concerns me that there might be this huge pot of money out there and the land grant might take up to 50 percent of that in overhead when we need it in the field. And I think that there would be a benefit to having a land grant to be -- we need them, and we've got some excellent out in the field. But if we can keep that money within the USDA framework, I think it will get to the people that we are really trying to encourage to make changes. So those are some comments on the RCD and use of NRCS.
MS. ANDERSEN: Thank you. Carolyn is next.
MS. BRICKEY: I had just a couple of quick comments about the organic sector just to kind of close the loop on that, and then I wanted to comment on what Lori just said about EQIP.

I have lots of ideas for Gary Libman and his group that I won't go into in this group about things they could do. But one of the obvious things that I want to make sure you're aware of also, Janet, is that after October 21st when the rule goes into effect, there will be a list of people who are certified agents of the federal government who will be certifying organic production. That will be a finite group of people with names and addresses that can be contacted about these issues. The other thing about Lori's earlier comment about how farmers want to see how something works in the field, I think is also true in organic. And I would encourage contacts with some of the large growers in the sector that the company may be trying to contact, and get them to grow a plot of whatever it is with that material and get some feedback from the field about how it works. Also, I want to encourage you to continue your work, Janet, with the Board in terms of matching up the national list with the biopesticides that you have registered. I think that's really important to do.

With regard to your comment about EQIP, I think it's important if you want to be effective and get something done with regard to the use of that money, that you be very strategic and very quick, because that's going to start happening, I think, pretty soon. And Al is certainly geared up to work on that process, but I would encourage you to move sooner rather than later, if that's what you want to do.
MS. ANDERSEN: Thanks, Carolyn. Beth, I think you're next.
MS. CARROLL: I just wanted to make a suggestion. I heard a couple of times this morning that the growers want to be able to sleep at night. And one thing that we tried at Norvatis -- and we're still back at the drawing board, because we had some problems with it -- was a solutions package that was an integrated pest management package for citrus. We introduced it in Florida. And you basically would pay for one of a couple of different levels of protection from diseases and insects, and there was weed control in one of the levels.

So if it was a bad pest pressure year, you know, we bought the farm and had to put out the extra application. If it was a light year, pesticide did not go out, because the farmer had already paid that amount and it didn't need to. We trained scouts. We put them on real time scouting systems that the growers could look at and see what the pest pressures were. And I would just suggest this was labor intensive. But if you have a biopesticide that you can integrate into a program, and you would be willing to take on the coming in and doing the clean up if it was necessary, then that might go a long way toward getting the growers to take a look at it ahead of time.
MS. ANDERSEN: Thank you. Wow. Marcia?
MS. MULKEY: How about that for timing. Well, I learned a lot from this dialogue. I wanted to just take a minute to talk about the resource issue. We have actually deployed quite modest resources toward biopesticides, and we actually combined that work with biotechnology.

And so the infusion of some -- in spite of Janet's gracious remark -- actually quite modest resources in contract dollars was -- although we are spending it on biopesticides, it was primarily to accommodate the increased demands on our total resources from biotechnology. And that's really the area where we've experienced a draw down from our original programming of resources. That is also an area where I would -- I think people need to begin to think about all of these products in an integrated way. And the last thing I wanted to say is for reduced risk pesticides -- conventional pesticides -- for certain kinds of biotechnology and for many biopesticides, the complexity of the pest management system is increasing. And many of the points you all are making are not limited to biopesticides. Some of the special limitations involving the sort of industry resources and some of that may be specific to this. And so I think we are learning that collectively if we want to have an impact through our registration program, we have to pay attention to adoption questions and not stop our horizon at the issuance of a registration.

But it's not an obvious role for us. It's not easy for us to figure out how to be constructive players, and it can undermine our credibility if we're not careful in terms of our attempting to play a particularly comprehensive role. So we will continue to seek input about the adoption question and about things like resistance management, which as you know, we've treated as extremely important for the bio-engineered Bt producing because of the very things that we've heard around this table. The importance of the Bt products. Not the plants, but the actual products. So we will continue to try to solicit input from you that help us understand our role. But we are interested in making our -- we are making choices about resources. Making it in a way that is results oriented and not just symbolic. And toward that end, I think this has been extremely helpful to us and we value it.
But Ray has his card up, and we still have a little time. So I'll turn it back to you, Janet.
MS. ANDERSEN: I'm sorry I missed that one, or maybe it popped up at the end.
RAY: I just put it up.
MS. ANDERSEN: Okay.
RAY: I just have one quick statement. I think it would be interesting for the agency to compare -- or to gauge its success by the commercial adoption of the products it registers across the board.
MS. MULKEY: Right. And Joe Merenda will talk about this a little bit in the update in a minute. But we are beginning to track a measure of adoption for reduced risk pesticides, which includes most of the biopesticides, but also the reduced risk conventional, as percent acre treatment as an effort to try to get a handle on that.
So we're in agreement. We need to measure real world results and not in addition to our activity levels. Obviously, activity levels are important to making sure we're, you know, doing something with our money.
MS. ANDERSEN: So -- oops. A couple more up here.
MR. BENEDICT: I would be concerned about that. There are lots of ways -- you know, we've talked pretty much about agriculture today. There are success stories with microbiologicals. There is Bt-I, which is used in mosquito control districts across the country. It's all we use. And there is lots of nitch markets. I think there is a lot of specialty markets out there where these products, I think, can play a much bigger role than they can in the commodity areas. The commodity areas pay the bills, unfortunately.

So I think you need to be careful how you define what Ray is talking about. I think Bt-I is a huge success story. I think it's -- it has changed mosquito control dramatically. And I think it's been very successful, and we really never mentioned that today.
MS. ANDERSEN: It was on my list of one of those things, and it is important. And we have several strains, and we have some interesting new varieties coming along.
MR. BENEDICT: Well, it's a new strain to deal with Killex mosquitoes basically.
MS. ANDERSEN: Right. Yeah.
MR. BENEDICT: Which is the West Nile Virus issue, which is going to be -- you know, from a turbid water point of view, it's going to be extremely important. It may not have a lot of use, but where it's going to get used, it's going to be extremely important from a public health point of view.
MS. MULKEY: I didn't mean to leave the impression that's the only measure we're interested in.
MR. BENEDICT: Well, I want to make sure it's not, because I think a nitch market is going to be very important.
MS. ANDERSEN: Thanks. Lori, you haven't spoken yet, so we're glad to hear from you.
MS. HARDER: I just kind of had a question. The federal government has a lot of different agencies and a lot of different land holdings, and they do use pesticides and other controls on their land and in their buildings for various reasons and activities. And I'm curious to find out how the biopesticides play out in your agencies with, say, the National Forest on using herbicides, and if that is considered a reduced risk pesticide. And is there some kind of policy that can come out of that, so that the federal government maybe has a little bit more leeway in doing research projects and testing these products on land where they're not necessarily getting any kind of revenue from it.
MS. ANDERSEN: Well, let me talk about two agencies. You mentioned the U.S. Forest Service. I'll start there. And then the Department of Defense that we have worked with quite a bit. The Forest Service has a pest health management group. And one of that is a group in West Virginia, and they are responsible for trying to find pest management controls. And they really have a philosophy that they want to use biological pesticides wherever possible. We work closely with them. They have -- they worked with IR-4 to help us. They actually have a regulatory person on staff. And, you know, I know these people extremely well. We're back and forth with them. So we have done some products specifically for them. But they're really the holders of Jibcheck, which is the insect virus control that is used quite a bit, and also for Bt. And it's interesting. They and others -- state and local agencies -- who use Bt have often a very difficult time explaining to the public why they are spraying anything out of a helicopter, whether it's Bt or, you know -- which I frankly consider a lot safer than Demilune -- or some of the other kinds of products that they use. But they're very committed to that in all kinds of areas. And a number of these agencies are looking especially at invasive species especially. So they're looking also to find ways to help use safer products to control their pests on landscape like that.

Now, I've not worked with BLM at all, but I know the National Park Service has a strong IPM program. The Department of Defense has done a terrific job of trying to reduce their reliance on chemical pesticides. And when we started what is now PESP for us, but what was originally called the Reduced Risk/Use -- or whatever way it was -- Initiative. The Department of Defense stood up and said we'll commit that we'll have 50 percent reduction of our chemical pesticides by the year 2000, and they made that 18 months earlier. They have just done a fabulous job. And we have some really interesting work we haven't talked about here. But really important pests are fire ants, if you live in the south, and they've got a fascinating program that we have helped work with. And we often work in cooperation with some USDA scientists and FDA -- I'm sorry. USDA, DoD and EPA trying to find some innovative ones, which if it can work on those kinds of sites, then you can, you know, take them out. So that's a real good point and an important point for us to work with our other federal partners.
MS. MULKEY: Janet, Alan is offering to --
MS. ANDERSEN: Okay.
ALAN: Yeah, just kind of a broader perspective is that all federal agencies and departments have this thing called the National Environmental Policy Act that we must comply with, which requires on any program that you look at the environmental consequences and the options. And there is great pressure in any pest management program that we do or any other federal agency does to select the least damaging control options. So that really is driving, as Janet described the Forest Service, which is one of the USDA agencies, towards adopting safer products and biologicals when they exist and work. So the pressures are there to make it happen.
MS. HARDER: I experienced, though, that the need for process doesn't necessarily apply to pesticides because of the registration process that pesticides go through. So therefore, they don't have to do an assessment of the pesticide on the environment through NEPA, which is in court right now in litigation.
ALAN: Yeah, it's probably -- it probably does vary from agency or department. But certainly in USDA, all of our programs -- you know, there is a heavy emphasis on selection of the chemical or chemicals of choice and evaluation of those.
MS. MULKEY: Okay, Janet, we need to wrap up.
MS. ANDERSEN: Yeah.
MS. MULKEY: So we can move on to the remaining topics.
MS. ANDERSEN: I was going to say Bill and then Bob and we'll go from there.
MR. TRACY: I have an additional comment from the cotton industry, and I really don't know where this program fits, except for the fact you don't use pesticides. In California we've had a successful program for 35 years keeping the pink bollworm, which is an extremely devastating pest if it ever invaded the industry. In fact, it took cotton out of the southern valleys of the state for a long time. But in the 35 years that this program has been in place -- and it's been totally grower funded by a per bale assessment -- my calculations are we've kept about 150 million pounds of pesticides from being used by this program. And what we do is a triad of issues.

First of all, we -- you can imagine selling this to farmers back in the late '60's. We propose to drop five million sterilized pink bollworm over the valley on a daily basis. Every day of five working days. So cast your mind back to 1968 and saying, hey, we're going to take this pest and we're going to drop it over. But what happens if you sterilize the male bollworm, the female only mates once, so you're saturating the area there of any potential female of mating with a sterile. Secondly, we have an extremely aggressive pheromone trap system to check and see if indeed there are critters in there. If there are critters and we have a hot spot, we use a pheromone based insecticide to go in and trap just the pinky and not any of the other critters -- the good critters that are out there.
And the third leg of this triad is that we have a mandatory plow down day. You can't plant your crop before a certain date. You have to have the crop plowed down by a later date. And that disrupts the life cycle of this critter. If some of them happen to come up during that host free period, it's a suicide emergence.

This has worked extremely well for 35 years. It doesn't work on every critter. It works on this one and it has been very successful and totally grower funded. So I'm not sure if it fits into this debate --
MS. ANDERSEN: Sure it does.
MR. TRACY: -- where the mix is. But it is an intriguing program.
MS. MULKEY: What you've added is this idea of working together and having a funding mechanism and so forth, so you can go beyond the individual farm for some projects.
MS. ANDERSEN: And last but not least, Bob, do you want to finish it up quick and we'll move on.
MR. HOLM: Yeah. I just wanted to mention that IR-4 puts together what we call a new products transition solutions list, and I'm going to circulate this around. And if you're interested I have a copy of the roster, so if you check it, I'll be glad to mail it to you.

But I thought I would comment on our list. These are all new chemistries. We're tracking 300 total new chemistries and 72 of them are biopesticides. So that's a fairly high percentage, about 25 percent. But it's interesting that the percentage by classification ranges from only about 7.6 percent for herbicides up to 39 percent for nematacides and then insecticides and fungicides are about 30 percent. So I heard people mention about bio-herbicides. There is not a lot of talk about them, because basically there aren't very many products on the market, and those that are on the market are very narrow spectrum. But there are certainly a lot of bio-fungicides and biological insecticides out there, but the herbicide area seems to be so far to really escape very broad use or broad interest from the companies as far as developing new products. But I'll circulate this around and certainly if you're interested, I'll be glad to mail you a copy.
MS. ANDERSEN: Thank you all very much. I really have appreciated. I started off by thanking for the interest in the group, and I really do appreciate all the comments and diversity of opinions and ideas that we got. We will put this together as a report and be back to you all for you to see it, and hopefully we'll have ability to even do it through the chat room a bit and get some dialogue back before we actually come back to this dialogue committee. Thank you.
MS. MULKEY: All right. Now, we're going to shift gears. When we floated the idea of spending some time on e-issues, some of you said, ho hum. We're hoping that before we're finished with at least these two, you won't think they're ho hum. But actually, I think all of us of a certain age have a little more trouble getting this, at least than my kids seem to, about just how much this next set of topics really is critical to our future. Lin Moos, who is now acting Director of our Information Resources and Services Division, is going to chair this segment. Some of you may remember Lin as one of our people in BEAD in the '80's that was involved with some key -- people, you know, who get started in pesticides always come home. It's just too interesting not to.

But Lin is going to chair this segment. I want to mention that the two topics we've keyed -- I want to just mention two facts about each of these topics. With respect to e-commerce, I think that there is increasingly an e-market in pesticides whether we like it or not. We're seeing the beginnings of some problems in that market. And probably nothing yet of the potential of a really broad scale version of that market, but it's time to start thinking about it.
With respect to electronic data submission, I will tell you that those who have some -- more experience of it than we do, like Canada, are really convinced that this has the potential to save EPA processing time in the registration arena by 25 percent or more. So those of you who are worried about our registration resources, and about our productivity and our production, this is a topic you ought to sit up and listen to, because there is some evidence that this can make a huge difference. So without more introduction, I'll turn it over to Lin.
MS. MOOS: Okay. As Marcia said, our topic for discussion for the next hour and 15 minutes is the electronic media issues. Margie had sent out a package to you folks last week, and that package included 401 pages on electronic issues. It included the e-commerce paper, the electronic submission paper, and it also included an e-FOIA paper and an e-dockets paper.

We're going to talk about the electronic submissions and the e-commerce today. But if anyone has any questions about the e-FOIA or the e-docket, I'll be around the rest of the day. And Sherri Street, who runs those programs, is also here, so feel free to ask any questions on those topics as well. So let's move forward for today's discussion. We've got about 35 minutes. I still believe we have about 35 minutes for each topic. And what I would like to do is limit our presenters to a maximum of 15 to 20 minutes, so we've got at least 15 minutes for questions and dialogue with you folks from the advisory committee. Our first panel will discuss e-commerce. The panel participants include Karen Angulo from OPP. Karen chairs the OPP e-commerce committee and she is a Special Assistant in SRRD. Tim Creger is going to be joining us by telephone. That's the noise you heard over there a moment ago. Tim is the head of the AAPCO Information Technology Committee, and he's in the Nebraska Department of Agriculture as the Program Manager for Pesticides, including both field programs and pesticide registration.

We also have both Jack Neylan and Paul Meehan here. They're from our Office of Enforcement and Compliance Assistance. Jack works from the compliance end and Paul is in the enforcement end.
And so I'm asking that each of our presenters here limit their presentation to about four minutes, so that we've got plenty of time for dialogue. And Karen -- Karen is going to start off.
MS. ANGULO: First I would like to make sure that Tim can hear us. Tim, this is Karen. Can you hear us?
MR. CREGER: Yes, I can.
MS. ANGULO: Great, okay. I'm going to start. What we would like to do is give you an update on the agency's effort to date in the area of pesticides in e-commerce. As you probably know, pesticides are being sold over the Internet both legally and illegally by a variety of companies and private individuals. In EPA and our state partners, we've been investigating whether this is a cause for concern and the extent and the nature of this type of commerce.

What I would like to do is give you a quick snapshot of how EPA views pesticides in e-commerce, our efforts to date in assessing the state of e-commerce, and very quickly the current activities and a picture of the future.
I've actually heard someone say that the old rules don't apply, that this is a totally new way of selling pesticides, and so FIFRA just doesn't even apply to any of this any more. And that actually is not true. This really is just a different way -- a different vehicle -- for selling pesticides and buying pesticides, very similar to, you know, catalog sales, phone sales and magazine sales and FIFRA really does continue to apply. So as I was saying, all of what we were doing before, all of the programs and all of the information, all of our outreach efforts, need to be tailored to this new way of selling pesticides. But we really believe that we have a current, good set of tools and that the laws are appropriate.

We have the Office of Pesticide Programs involved, as well as the Office of Enforcement and Compliance Assurance, and the Association of American Pesticide Control Officials -- AAPCO. They have an IT committee that is getting very active in this. And I'm going to be passing this off very shortly to Tim, who is with the AAPCO IT committee, and Jack and Paul in OWECA, and they will be giving you an update on their activities. Very briefly, though, we have started off by trying to establish a base line. I mean, what really is the problem. And the very innovative solution of establishing that base line was surf day, where we went out and looked for web sites and tried to get an idea of what the problem was. And Jack is going to be given you an overview of that. But my favorite, the one that I found, was a product that claimed to kill computer viruses. It was a little pump bottle, and it instructed you to open the disk drive drawer and spray this liquid in the disk drive. And it would kill computer viruses and harmonize the electronic forces in your computer, and I bet you it would work. I bet you it would. It was a very interesting exercise, and Jack is going to give you an update on it.

EPA and the states are developing compliance and enforcement strategies. And Paul is going to give you an overview of that. And AAPCO has been very innovative in their exploring ways to identify web sites that may be selling pesticides illegally and thinking about ways to contact them and monitor their compliance. And lastly, we're thinking once we understand the nature of the problem, of developing a web site that would provide very helpful information, very similar to our ombudsman service now, and tapping the information that is currently up on our web site. This would help people who are in the business of selling pesticides, and those people who don't know that they are actually in the business of selling pesticides. There are a lot of folks, we believe, who have no clue that they're actually selling a pesticide product. So this web site would be a very good way for us to share lots of good information about how to register and sell and purchase a pesticide. So with that, what I would like to do is hand it over to Tim, and he's going to give a brief overview of the AAPCO IT committee's activities. Tim?
MR. CREGER: Thank you, Karen. The AAPCO IT committee was conceived and started in August of 2000. I've been the Chair since it got started. The initial focus of our committee work was on e-commerce issues. One of the largest projects that we worked on in cooperation with EPA was development of what we call the notification document, which is available for review by anyone that wants to access the AAPCO home page. They would select the e-commerce hyper link button and it would immediately take them to the document, showing them the full document as it was finished off and published on that page. The next step that we had identified is how we get that information -- that notification document -- out to the public. Out to the web sites and purveyors on the Internet. There are a lot of different ways we can do that. I believe that EPA as an agency is moving forward with ways to do that. What AAPCO chose to do is to post this particular document on an electronic bulletin board called the Pesticide Regulators Forum. That's actually part of the AAPCO web site hosted by Perdue University. But it's a secured site for pesticide enforcement and regulatory officials only. That document will be archived there.

And we're in the final stages of programming the site so that any state lead agency or federal enforcement official can enter the site using our password protected access. They would then be able to enter the Internet address -- the URL address -- for the web site in question. And the site will be programmed so that it will pull up that address. It will tell the regulator whether that particular Internet access address has been a recipient of the notification document yet, and if not, it will automatically send that document to that site with a cover letter that explains why they're receiving it and what to do in response to receiving it. And then it will archive any responses that that web site has back to that AAPCO Perdue site, the Pesticide Regulators Forum. And it will archive those responses. It will also archive every time a state sends that notification document out, so that it will reduce the amount of redundancy that the states have sending those notification documents out to the same site constantly. It will also track the responses and allow the states to decide if there has been an adequate change in compliance by that company. And if not, then additional action can be considered.

That actually is supposed to be done by mid-summer or so. Vicki Kaysons with the Perdue site there is going to finish that up, and I've been in contact with her. If there are questions of me, I can answer them at the end. If not, Jack Neylan also is aware of that operation and can help answer those. Karen, that's about it in a nutshell.
MS. ANGULO: Okay, Jim. Thank you. Hang on the line, because we're going to have some discussion and there may be some questions for you.
MR. CREGER: Will do.
MS. ANGULO: Okay. Jack is up.
MR. NEYLAN: Okay. As others have said, you know, my office tends to be the place where a lot of the complaints end up for us to deal with, and we started seeing more and more complaints about Internet web sites showing up. And because of the nature of the Internet, I think -- we think of it as a little bit different. The breath of where you get information out is wholly different. I think we're used to dealing with pesticides in a way on a more local basis. You might have something being sold in a state and it doesn't get beyond the state. Advertising doesn't get beyond the state. But the Internet is a wholly different thing. We decided to pick up a theme that we saw some of the other federal agencies doing, and as Tim and others mentioned, we conveyed a surf day last June. We had about 60 participants. They were EPA headquarters, regional and state people. And we gave those participants some direction. We gave them specific surf engines and surf terms to look through. So we tried to direct it in a little bit in that way. And we gave them some forms and so forth to fill out to collect information if they identified a site that they thought was problematic, and we set them loose for a day to just basically go ahead and surf and collect information. I guess we got back about 600 plus forms that were filled out where the participants identified problematic web sites in some form or another.

And Karen mentioned her favorite one. I had one that was 911 relief, and I find that a little sleazy coming from when it did. But it basically was advertising supposedly an antimicrobial product that would kill anthrax topically and on hard surfaces. That's really the kind of things we ran into. In any event, we found -- through this surf day we found lots of different types of sites. I mean, we have your registrant, producer web sites. You have pesticide distributor web sites that are in the pesticide trade. You have general retail sites selling pesticides. Commercial users and applicators have sites. There are auction sites advertising pesticides, like E-bay and Yahoo, the general commercial sites. Plus there are agriculturally oriented ag auction sites now and there are foreign sites. Recently, for example, I've noticed a number of people sending me e-mails where they're getting direct solicitations from China on pesticide products. I've got this product. Come buy it. They are very short and sweet, but they -- you know, they're somehow or other broadly doing this.

We found virtually every kind of compliance issue you could imagine on there. We're finding unregistered pesticides. We're finding restricted use pesticides being sold there. They're unfettered. There is no information about the fact you need to be a certified applicator to get this. You need to be licensed and so forth. They're just out there selling them. There are unbelievably different claims from your registrations found on these web sites and minimum risk pesticides. So we found lots of different things. Even this little bit of a surf day, we also asked people to figure out how many hits we got. We got like 82 million possible surfings if you went down those things. So, I mean, it's a huge thing. And we excluded government and education sites. We're developing a compliance strategy. We're pretty close to doing that. We're going to work it up the management chain so people get an idea of how we intend to do this. Tim gave you one of the examples of things. I might close with saying that we've been working pretty closely with the Federal Trade Commission and FDA, because they have similar issues and have been addressing it in similar ways.
MS. MOOS: Okay. Thank you, Jack. Paul?
MR. MEEHAN: Sure. As other people have discussed, the Internet presents some new challenges from an enforcement perspective, but really the basics of enforcement remain the same. Within the enforcement office, e-commerce is becoming an increasing priority. We expect -- EPA expects to play a major role in e-commerce enforcement, in part because we believe EPA is especially well positioned due to the interstate nature of much of e-commerce. We also think states will play a large role, as they always have in pesticide enforcement, and we've basically been trying to make connections with them whenever possible. And Tim Creger obviously plays a large role in that, and we think ultimately that any successful program will have to have close coordination between the states and EPA. As other regulatory agencies who looked into e-commerce found, the Internet does open up a new arena for people who are unscrupulous. The most important issue this presents from a pesticide enforcement perspective is the potential threats to public health that marketing of pesticides that are ineffective or in fact toxic present. But it also presents issues of a level playing field, because people who don't follow the rules and sell their products over the Internet are basically getting a leg up on the majority of the vendors who are following the rules. As Jack described, there are many types of sites just as there are many types of products and vendors. In a lot of instances, I think that what is needed is education, but in other instances what is needed is enforcement. So far most of our efforts have focused on building an enforcement program infrastructure. As Jack's office is doing, we're working up a guidance to provide guidelines for our regional offices for the National Enforcement Program. We've also been working to digest the information from an enforcement perspective that was collected during surf day. To date we have issued three stop sell orders, two of those being against companies that were selling anthrax -- unregistered anthrax products over the Internet. And that was in part an action with our relationship with the FTC. These sites were referred to us by FTC. Their authority -- they thought that our authority to issue a stop sell was a quicker remedy to the problem than the authority that they have under their statutes.

We also have issued a stop sell against a marketer of a product that was advertising itself as effective against hoof and mouth disease when it was not registered for use against hoof and mouth. So at this point, we're, as I said, trying to build our enforcement program and working with the other offices at EPA to get a handle on what our priorities should be and where we should move from here.
MS. MOOS: Thank you. I would like to open it up for questions or comments or other experiences that folks may have had. I'm having trouble reading names that far away. That's Win, right?
MR. HOCK: Okay, a number of questions. You mentioned about the sales from overseas such as China. How do you regulate something like that? I can understand where you can issue a stop sell for an agency or a company in the United States. But when you start getting them from all around the world, you know, I'm curious how you handle that.

And the other question, or I just want to make a comment, I guess, is you mentioned about some of the problems. We in Extension and the state lead agencies are very concerned about RUP sales via the Internet. Obviously, if RUPs are getting out there, how do you regulate them? How do you get those people certified? I mean, there are all kinds of room for hanky panky, if you will. The other issue is -- and I don't think anybody brought it up. I'm real concerned, and I know a lot of my colleagues are concerned, about the security issue. If you can bring all kinds of wonder cut products in, what -- I mean, you talked about some toxic materials. Toxic, yes, to the individual who receives and who uses them. What happens in terms of the security issue. The terrorism issue. We're concerned about that very much at the state level.
MR. MEEHAN: Well, I can say -- I guess I'll take them in order. The international issue is something I was hoping no one would ask about. That is a problem for us. Our first line and maybe our line of defense is really Customs. We do have a working relationship with Customs, but it's very difficult to police that, as I'm sure anyone would understand. If we don't know it's coming, you know, it might as well be drugs. If you don't have luck or advance knowledge, it's very difficult to know. Now, if this is a company that has an existing presence in the U.S., then we have a way to get a handle on them. But if it's just a random maker, or even a large maker that is located in a foreign country and is sending large quantities to, say, individuals, that is very thorny problem for us. FIFRA just -- I'm not sure. And on the RUP front, that is one of our -- that is one of our priorities. In fact, when we went through the surf day materials, that was one of the first things we looked for, if not the first thing. We didn't find as many as we thought we might. And we've had at least one inspection. We sent out inspectors to the address of the site that was offering all sorts of pesticides over the Internet, and it turned out to be sort of a haphazard operation.

But that is sort of immaterial, because if you're selling dangerous products, it doesn't matter whether you're sophisticated or not. If you get them into the wrong hands, it's going to be trouble. This site is no longer operational. They shut down. Enforcement action is pending. The state asked to be able to move forward first. So the RUP issue is a big one, and we feel that that is one of the first things we go after when we have the chance. And as far as the homeland defense issue, I can't speak to that. That's not something I'm knowledgeable about. Maybe Jack is.
MR. NEYLAN: Well, we are -- we actually are taking -- and related to what Paul said early on. I mean, we're trying to harmonize our data systems with Customs so that they -- you know, one of the problems before was just the way they look at chemicals as more macro and ours are finer level of things. And we're trying to match that up better. So that's -- and they're clearly on the alert for that sort of thing, and not just pesticides, but other chemicals as well. So there is a lot of work going on in that area.
MS. MOOS: Okay. How about Julie Spagnoli, Beth Carroll and then Bill Tracy.
MS. SPAGNOLI: I think another area of concern, at least from a registrant standpoint, is general use products. They're not restricted use, but they're definitely not intended for nonprofessional use. In particular, it would be commercial termiticides. And I think we -- you know, we know we've seen it where there is this, you know, do-it-yourself pest control, where they can buy commercial termiticides because they're general use, even though the products clearly state on the labels that they're to be used by professional applicators. And I think the concern there, you know, is knowing that generally there is very -- I think probably very few homeowners who are going to have the equipment necessary to use that product according to its label directions properly to actually get efficacy. And I think that opens up some concerns for registrants, obviously, that your product is almost going to, you know, be misused or is not going to be efficacious and you have potential liability from there.

And I don't know if that's another area that is being investigated, because, again, it's not restricted use, but obviously not going to the intended, you know, users when it is specifically being directed to, you know, do-it-yourself.
MR. NEYLAN: I think that that's a problematic area, because we don't have restrictions on the sale of those products to those kind of people. I mean, FIFRA is absent that authority. So you're really dealing with people then that -- you know, trying to deal with stopping that. One of the things I think we're going to try and do is send advisory letters to web sites like that to sort of suggest they might want to change their language if they're supposed to be directed to people that are licensed to use termiticides, for example. And probably, you know, put them on that kind of a thing. But, you know, that's -- there is a problem with FIFRA in really dealing with a sale.
MS. MOOS: Beth?
MS. CARROLL: I wanted to ask a question and then make a comment. Do you have someone dedicated to monitoring the Internet as far as looking for these illegal sites, or is that a potential position that would be filled?
MR. NEYLAN: I don't think we're going to have anybody necessarily dedicated. But I think we're going to have -- there are a lot of people who periodically do this, and I think we'll continue to do surf days as a way of pulling these up. But we really aren't quite staffed up to be able to just do that overall. But as we've said, you know, we have 50 states and some tribes that are interested in this, as well as our regional offices. So there are a lot of eyes kind of looking at it, plus, frankly, you all supply a lot of eyes, too. We get a lot of tips from people.
MS. CARROLL: And that was going to be my next comment, just to say that. The industry is very interested in making sure that these illegal sales don't go on, and we're working through Crop Life to assure that. And one of the reasons it's really critically important to us is we can't steward these products if they're being sold illegally. And that's especially true when we look at it from the standpoint of resistance management. And so I just wanted to bring that up as well. It's definitely a stewardship issue, not only an illegal sale issue.
MR. NEYLAN: Well, we're more than happy to take your complaints.
MS. MOOS: Thank you. Bill?
MR. TRACY: Did you give any consideration to phone solicitations? As a grower, I receive a lot of phone solicitations for pesticide sales. It seems to me that it would be a lot more difficult to monitor that as opposed to the Internet.
MR. MEEHAN: We've -- the Internet we consider to be sort of like catalog solicitation as well, and phone would be another example. All require attention. We don't have, you know, a solution to that now. But like Jack said, we're more than happy to take tips and complaints. That's how we found out about several of the sites that we have pursued. And again, that's something that if we don't know about it, we don't know about it.
MR. TRACY: That's a concern, especially as a Californian who cannot apply without a PCA recommendation. And that's what I always ask these solicitors and, of course, they're solicitors and they don't know what's going on.
MR. MEEGAN: Okay.
MR. TRACY: They're just getting paid their minimum wage.
MR. MEEGAN: Yeah, that's a problematic area.
MS. MOOS: Melody?
MS. DECALAMARLO: Thanks. I have two questions. One is when you had mentioned the haphazard situation at the address that you had investigated, it just reminded me that in my work when we deal with people who make a lot of claims about different things -- and I know that this happens to the FDA, too. That when people do this, if they tend to get caught, they close down and move kind of like hit and run. And I was wondering if there was a way that you're going to be trying to, you know, track certain people, especially repeat offenders. That's question number one.
MR. MEEHAN: We would certainly like to be able to track it. One of the things that we've spent a lot of time on as we started to try and build our Internet program is looking at ways that we can track the sites. Looking up, you know, ISPs and web site addresses who actually owns the site and who runs the site.

We haven't run into yet any situations where people have ceased to sell and then set up shop under another name. But certainly you could easily envision it happening, because it certainly happens in other instances. In the particular instance that we did look into, I don't think that has happened, simply because it was such a small scale operation. It was somebody who was essentially selling leftover pesticides from the place where he worked, which was an actual pesticide dealership. So I don't think he's done that. But it's easily enough to envision it happening in other instances, and that is something that hopefully the methods that we have developed will help us deal with.
MS. DECALAMARLO: Okay. And then my other one was -- is more of a comment. I noticed that -- actually my mother was a victim of mail fraud. I noticed that the Postal Service has a web page where you can report these things, and I guess the FDA must have something.
MR. MEEHAN: FTC has done a lot of work in that broad area.
MS. DECALAMARLO: So it would be really good if you had a page on the -- on your web site where it would make it easier for people to report such instances.
MR. MEEHAN: Yeah, that's an excellent idea. I agree.
MS. MOOS: Let me ask Tim if he has things he would like to add, and then I think Dan will be next. Tim, have you been able to hear us?
MR. CREGER: I'm still here, but I couldn't hear the question.
MS. MOOS: I didn't have one. I asked if you had anything you wanted to add to any of these other discussions that have gone on.
MR. CREGER: Oh, I'm sorry. No, I really don't.
MS. MOOS: Okay.
MR. CREGER: No, I'll take that back. I have one thing I would like to add. There was a question about whether there was any full time staff that was doing constant monitoring of web sites. Jack answered there really wasn't on the federal level.

I am aware of a couple of states that have actually added staff in order to do this. An issue is with the California Department of Pesticide Regulation. They collect a mill levy for registered pesticides. And they have actually taken two FTEs and added them to their internal staff, and they monitor web sites that might sell products in the State of California. And then contact them in order to collect mill levy for sales. And so in a way that's monitoring of web sites in their activities. I don't know how much success they've had with that. They just started that last fall. And I'm also aware that there has been some shifting of some state FTE resources from traditional monitoring of sales, say in the dealer field level, to, say, a quarter time or half time FTE, so that they can spend part of their time looking at Internet sales, mostly on auction sites like excessag.com and things like that. So there is some going on on the state level.
MS. MOOS: Okay, thank you. Dan?
MR. BOTTS: Yeah. I was actually going to ask Tim a couple of questions from the state level, because we've got a pretty good overview from the federal side. I know just from working in Florida, we've got -- our state pesticide rules and regulations and law that govern distribution sales and those things are different than other states as far as exactly how -- what protections you have from where you buy your product. If you buy it in state, there are certain requirements. But if you actually buy it out of state, there are certain things that you can get that may or may not be regulated at the state level because of what's on the federal label. And a lot of the stewardship issues that Beth was raising, and some of the other things that have been tailored to 24C's, are specific use instructions for specific geographical regions that may or may not show up on things that are sold in a more international level basis. How do you even attempt to try to track that? Is there a licensing process contemplated for being able to identify all these sites, and then for the states where essentially it's an open ball game to go into, because it's an Internet access type state where there are those types of requirements to have any kind of tracking system to follow that?
MS. MOOS: Is this directed to Tim or to?
MR. BOTTS: Anybody who wants to answer it. If Tim wants to try it first.
MS. MOOS: Okay.
MR. CREGER: Jack?
MR. NEYLAN: We have 24 --
MR. CREGER: Well, I'll go ahead and jump in the fire. The simple answer is, it's a nightmare.
(End of Tape 2, Side B.)
MR. NEYLAN: -- that deals with this kind of an issue, where this is the sort of thing we think if you're in the business of selling pesticides or commercially using pesticides, you know, that you ought to think about. You know, you ought to -- if you have sales restrictions or other things, you ought to make that perfectly clear on your web site and so forth. Maybe we ought to -- we'll be probably talking with the Pesticide Office about how to do something like that.
MR. BOTTS: Just to follow up on that a little bit, because one of my primary roles is ensuring that my membership doesn't get into trouble from the pesticides they use, from an educational standpoint we have tried to push them -- or our members -- into looking at the labels and supporting those people that are actually doing the things in the State of Florida that prevents those products from becoming a problem. And if that same level of action is not taken at the national level, there is a tremendous educational outreach effort that Win and the rest of the people that are involved in those kind of processes -- Crop Life and everywhere else -- and the problem is not with registrant web sites that they're talking about. They are individual products, because I can tell you most of them have their 24C backups for state specific labeling and those kind of things. But the few things that I have seen just in passing and some of the e-mail solicitations that we get as a trade association in attempts to go to our membership, the classic was the one I got two weeks ago, the guy from China who claimed to be the plant manager of the new Methyl Bromide factory over there. He sent an e-mail and said we understand that there is a phase out of production in the U.S. scheduled for a certain time. We would like to establish a business relationship for post-2005. (Laughter.)
MR. BOTTS: Which I don't think is quite legal. And there is a whole universe of other groups that are going to have to be engaged in that and Customs and other divisions. But there needs to be some education back from you guys on how we can deal with those kind of solicitations and requests, so if we get something that is patently obvious on the surface of it that it needs to be dealt with by somebody other than us just hanging up on them, we need a name and a place to go to.
MS. MOOS: Yeah.
MS. HARDER: I think Dan brought up a good point. But I'm also concerned that this is a problem in the nonagricultural pesticide use where I think there is a lot less control. So it's something to be concerned about. And I don't know how you go about educating them, because a lot of the structural pesticide misuses that I've seen have occurred with people who weren't really licensed.
MS. MOOS: Okay. With that, I would like to close this session. I particularly thank Tim for being on the phone and being available, but also Karen and Jack and Paul. I want to move on to the electronic submission topic.
MR. CREGER: Thank you. Bye.
MS. MOOS: Bye, Tim. Our two presenters are Clive Halder from Bayer and Kate Bouve from OPP's Information, Resources and Services Division. We're pleased to have Clive join us. He has pioneered the first full electronic submission with EPA and PMRA, as well as the first electronic SES transport file pilot with EPA. To date, Bayer has made two full joint review electronic submissions and two comprehensive SES transport file submissions. Clive has been with Bayer for 15 years. Kate has been with OPP since 1989, and she is Chief of the Information Services Branch of IRSD. That branch is the receipt point for all of the studies that come in to support the registrations. Kate has been working with both OPP staff and the registrants on electronic submission activities. Again, I'm going to ask that Clive and Kate keep their presentations to about 10 minutes each so that we've got 15 minutes for discussion. And, Kate, you're up.
MS. BOUVE: Good afternoon. It's good to be with you this afternoon and to have the opportunity to talk with you about our efforts on electronic data submission and review. What I would like to talk about briefly is give you some idea about what got us going in this area in taking on some of this new work. Give you some idea of some of the communication efforts that this entails. Describe briefly the pilot efforts that we've had underway in the program. Tell you want standards we have accomplished in the program. And let you know what the status is of our program, and then we'll turn it over to Clive. First, a little bit of clarification. There have been essentially two areas in which we've been doing piloting in OPP. One has to do with the electronic submission and review of study reports themselves. And then we've had -- and the work on piloting that is essentially finished.

The second area we were looking at was looking at detailed animal data in support of the chronic toxicology studies that we receive in the program. That piloting effort is still underway, and Clive is going to be going into some detail on that. Okay. With that out of the way, why did we take this work on? I'm looking back to the summer of 1999, and by that point in time, I think both industry, data submitters and EPA reviewers realized that we had to find more efficient ways and more effective ways of handling the arduous tasks of assembling and submitting data and then reviewing all that data. Also at that point in time, certain technologies had emerged and were evolving and were providing better tools for us to use as we tried to attempt this work. We also were able to benefit greatly from work that had been done especially by the U.S. Department of -- the Food and Drug Administration, which has been doing very good work in electronic data submission and review for a number of years. And also our counterpart in Canada, the Pest Management Regulatory Agency, had been working in this area as well. We were able to learn a great deal from one another, and it became a priority for OPP managers who urged us on.

As we tried to decide what principles we should apply in setting our standards, we knew that we had to strike a good balance between the needs of the data submitters and the needs of our reviewers. For the data submitters, they needed a standard that would be inexpensive and easy for them to apply to their work. Our reviewers needed a set of tools that would be easy to learn, but powerful enough to help them do their job of reviewing studies more effectively and more efficiently. We also focused our attention on the studies, because this is probably the most resource intensive aspect of the work in the program. I think it's something like 40 percent of our resources are tied up in the work of reviewing studies in one way or another. So we felt that we would get the most bank for our buck in this area.

Obviously, communication is essential in being able to introduce a new way of doing work. First of all, we have benefitted, as I said, from the Food and Drug Administration. They have shared freely all the documents that they have developed for guidance. They've trained our users. Our scientists have visited there. My staff has visited there to see how they handle some of the technical aspects of the work. They've been extremely generous and helpful to us. In March of 2000 we had a very successful workshop with ACPA, now Crop Life America. We had great participation from industry folks, labs, FDA and Canada. It was very successful, and it was a great leap forward for us. We're planning another workshop in November of this year. Individual registrants were fantastic. There were some specific individuals who were -- within these companies who were real champions of this effort and really helped us move forward. And we also take advantage of opportunities to do presentations like this to your group and to trade associations and others.

In the international areas I noted, we're working closely with Canada, and we have a project under way with PMRA as one of our NAFTA efforts on electronic data submission and review, and harmonizing the standards that we're setting, and sharing our experiences back and forth. Also, we're working now in OECD, and we have a workshop that is planned in Ottawa in October of 2002 to compare notes with North America and the European community primarily. And, of course, there is a lot of communication that has to go on within OPP itself. We have an office wide work group that has been working diligently to keep everybody together and be moving in the same direction. We have to continually do these briefings for managers and for staff. This is new work. It's a big organization. People are busy. You have to keep communicating these messages over and over. Change in large institutions is not easy. We also have to make sure that when a reviewer finds themselves ready to do an electronic -- review of an electronic study, they get training and user support just in the nick of time. But we also have to be collecting feedback from the reviewers and from the industry folks, so that we can refine our guidance and the tools that we're using.

In the fall of '99 we started our pilot. Of course, we built a web site so that we had a way of communicating to data submitters for the purposes of our pilot. What our technical specifications were. What our guidance was on how to format their studies. We had ready, willing and able registrants who stepped up and took on this new work. We worked with both our reviewers, who are federal staff, but also contractors who help us in this area. We made a point of trying to do work with different scientific disciplines so we had a good cross section of studies in electronic format. And we developed an evaluation form so we could collect the impressions and experiences of our pilot reviewers, and they were uniformly positive. So what are our standards? For study reports and for the submission of those studies, we're using Adobe Acrobat PDF. This is not brilliant. It's a pretty practical way to go. The submissions are required to be coming into us on compact disc, and they're coming in through the Information Services Branch. That is my branch and that's the branch that does all the in processing of all the studies and all the applications. So that way, we're able to account for these officially.

And then from the reviewers' perspective, again they're using Adobe Acrobat, but it's the full software package. Not just the reader -- the free reader -- but the full software package. And then in combination with our word processing software and some other tools, they're able to evaluate the studies and be able to meet all their criteria in terms of functional requirements, and then it also helps them to prepare their review documents. At this point in time -- in fact, in the fall of 2002, we felt that we had been successful enough with our pilots -- we were satisfied with the standard that we had used for the pilots -- to then announce to industry that submissions in PDF are encouraged. They're not mandatory. We can't make them mandatory, but we very much encourage this new way of submitting the information. So far to date, we've gotten almost 800 studies. We have another hundred expected soon. There are six more big submissions that are planned for receipt later this summer. And in fact, we've been working with some registrants that are looking in the out year. They're starting to build applications and data submissions for like 2003 and 2004, and starting this work with this electronic submission technique in mind. So I think that does it for me. Now, we'll hear from Clive and hear about it from the industry perspective.
MR. HALDER: While we're waiting for the slides to be set up, I just want to recognize Kate and her staff in the Information, Resources and Services group. Projects like this need more than one partner. There are two elements of that and involve the customers of each other. And it's close to four years now, I guess, Kate. Time goes, but it's been a good three years where we've been working with EPA. And because of the perseverance and innovativeness of Kate and her group, in large part that has propelled the stuff forward. And I appreciate that, Kate.

To keep within the time frame, I will be fairly superficial and just give you the highlights of what I want to cover. But basically I have three main objectives to cover. One, to give you an industry perspective on electronic submissions. You heard from Kate from the agency side. And basically the problems I would say are almost identical, as I'll get into. I mean, the resolution is a little different, but the problems and concepts are the same.
I'll highlight some of the internal challenges and that's what I eluded to. There are some, and the pharmaceutical industry has certainly faced that ahead of us, and we are finding that we are no different in that regard. And then I'll give you an overview of the latest step in the development of electronic submissions. And that deals with the supplemental files. Basically, in order to make electronic submissions a reality, there has to be a business benefit from both the agency's and the registrant's side. And in analyzing those, going to the agency's side, some of the key things that they are interested in is certainly an increase in the speed of review. That doesn't mean less intense. It just means increase in efficiency in the review. Increase in access to information. And I think what we've seen for the experience we've got so far, these two elements are certainly -- we've seen the benefit from these two elements.

Increase in quality of submissions. The jury is still out on that. That would be hard to know that just because it's electronic the quality improves. But I guess it depends on how we see it, and it will take a little more experience before we know that that's a benefit. And certainly the efficiencies in the review time. The backlog that the agency has and all that. Any tool that will help with the review process will certainly help with the resources.
Similarly, the registrants have some business need, and for us it's to have an easy tool or set of tools to be able to create these electronic submissions. Because if you don't, all you've done is added to the workload. To be able to create electronic and paper from the same source. Again, if you don't, you're just doubling up your work.
And as we go through what we're discovering at the moment -- or going through at the moment because we're in this interim phase, we actually are doing double work, because we have to take paper reports, a lot of times scan them, convert them into electronic PDF and submit them that way. But ultimately the goal is to have all studies generated from scratch electronically, and then you're dealing with an electronic source and then you don't have to worry other than print.

And this is important -- as important with any media, and it will continue to be something that we have to watch, and that's harmonizing and keeping stuff harmonized. If FDA had a different standard or Canada had a different standard, we don't care if it's paper or electronic. You end up going every which way and that just creates extra work. So one thing that we would be very sensitive to is making sure that we stay harmonized to the extent you can be harmonized. And, of course, it has to have economic value. Any time we can get a speedier review through the agency efficiencies, obviously the registrants gain from that. My goal within Bayer was -- in order to set this process into place, I put this goal as my basic tenet goal. And that is, I wanted to get the work flow and the change made, so regardless of whether I submitted electronically or not, I would get the efficiencies from electronic handling of documents and preparation of reports internally. Because without that, all you've got is additional work. I mean, the submission part alone is insufficient to carry the value of that, because there was a lot of hard work and rearrangement of work flow.

And basically that is the number one issue, and it's no different from the pharmaceutical industry. Overcoming resistance to change is phenomenal, because an electronic tool is really latent. I mean, just because you have PDF loaded onto your desk top doesn't make you more efficient. It's how you use it, and generally how you use it efficiently means you have to change your work flow, and that's when you get into the resistance area. It has taken about three years, but at this stage we've got the process down to where people generate the reports from start as an electronic -- what we call --deliverable. Also of a lesser but still important issue is the changing of the paper mind set paradigm. Before with paper, you know, you may have your word processing and you write your text and then you get a printout from some data collection system. You put the thing together and you hand stamp the page numbers. You have to change that process, because now you have to build interfaces to make sure that you get all the other supplemental additions in electronic form so you can pull all of this stuff together.

Some of these resolutions are expensive and hard to get. I'm going to skip this due to time concerns. Kate had mentioned that PDF is the EPA and Canadian and FDA standard. The Europeans use a slightly different format called Tiff. Tiff is a little less robust and has little -- has fewer functionalities than what we see in PDF, and the basic deliverable would be a bookmarked and hyper linked PDF file. Some of the functionalities that you can get out of PDF are cut and paste, particularly if you optical character recognize the document. That means they can -- instead of having to retype portions of the report when they're creating it, they can literally cut and paste and then rework it as they see fit. You can link, so the navigation is speeded up. You can go logically and say see attachment A. You can go immediately to attachment A and then go back. And the other thing that the agency likes is the annotation feature of PDF. So they can write little notes to each other, and then you can get a coordinated review of the report or the document and be able to keep those annotations and keep track of what you want to see.

Going to supplemental files, the reason where we saw a benefit for making electronic supplemental files electronic -- and I'll give you an example of a chronic study, which is probably around 3,000 pages long. Of that, about 500 pages or less is the text part and the summary. The rest are tables. A summary and tables and individual animal data. It is this part of the data -- we know that the agency rekeys certain files -- certain data sets of those so they can rerun and analyze it statistically in the way they want. So using SES transport files, it is just in a format that allows you to easily integrate the SES transport files into SES routines so you can run statistics. So instead of spending time rekeying data, they can take this data immediately, because it's live, reorganize it the way they want, select the sub-data set that they want, and run their analysis. So it would significantly speed up the agency's review. FDA has used that -- that file format -- and EPA has adopted it. Canada has not. Canada at this stage does not use SES in their organization at all, and so they're looking at Excel.

I'll give you an example of what a SES transport file looks like. It's not important that you see the detail there. But it is an organized structure of all the data points that you would have in your data collection systems. And there is a tool out there called DBMS Copy that we were told about by FDA that allows you to take different formats from your different data output -- databases -- and convert them to a SES. So you can get something in Excel and convert it to SES. You can get something in ASCII and convert it to SES. And then we provide these. This is what we've been working with Kate and her group for a long time. It's to get the organization in the format of these such that the agency just needs to put them directly into their SES routine. The types of studies that we have been able to do is basically all of the toxicology studies of four weeks or longer. We don't think there is an efficiency value on doing acute studies, because you can look at the data in one page without having to go through all the rigmarole of creating SES transport files. But we have created SES transport files for all those study types.

And I'll give you an example of the types of data sets that we have. At the moment since we're in a pilot, we kind of are doing a grand sweep. We are anything that is -- anything that is gathered, we are putting into a SES transport file. Once the agency has some experience behind them, they will be able to come back and say, look, we're not interested in food consumption any further. You know, we'll do body weight and mortality and micro pathology. The number of data sets vary according to the study. Reproduction studies normally have the largest amount. But they can range from seven to 54. These sets -- some of them are quite large. As you can see, 31,000 lines or about six data sets per line. So that's a lot of data. And generally our pilots to the EPA range around 250 studies, and we only do the toxicology studies at this time. And that's it.
MS. MOOS: Thank you very much. Asking for questions or comments? I can't -- yes.
MR. HOLM: I just wanted to comment that IR-4 has been involved in this process for a couple of years on the pilot part of the program, and we've been very, very pleased with the agency's response and working with us. We have one of our study directors that is really -- Jonas Carley -- who has gotten quite excited about this. And I think we've submitted -- or planning to submit 15 this year, and we continue to see this as an opportunity to work with the agency on approving our efficiencies and yours in our data reviews. So we commend you for the hard work and effort and look forward to working with you on the payoff.
MS. MULKEY: Bob, what -- do you all have any sense of what kind of efficiency gain you are seeing? You hope to see?
MR. HOLM: Well, I don't think there are any efficiencies internally that we perceive so far as far as us putting the information together. But we're really trying to come up with a -- you know, we still have to do the paper copy to the CD and so on. And maybe we can gain more efficiencies and, you know, as the previous speaker mentioned, then getting that -- you know, working with it completely electronically.

But as far as review on your end, I think, you know, we've been working with Jim and obviously people in the Registration Division for the last couple of years and trying to have more IR-4 petitions reviewed with the same amount of EPA workload. And I think, you know, we've been able to go from about, you know, 25 to 50 percent of your workload without any increase in resources, which tells me that this component has had something to do with increased deficiency within the agency in being able to do that without any additional resources. So it certainly appears to me that it's having a positive impact already.
MS. BOUVE: I want to just acknowledge IR-4's work and participation in our efforts, and I apologize for not mentioning you all specifically, because you really have been very enthusiastic supporters of what we've been doing.

And I would also like to point out that Clive has been sort of one of those individuals in a company who has been sort of a champion for this idea and the whole idea of SES transport. And he's had to deal with labs in the United States and in Germany in order to get that information -- that data -- pulled together, which is no small thing. So it's been a tremendous contribution.
MS. MOOS: Jennifer?
JENNIFER: Is the data coming in a form that you can break it down and regroup and do your own statistics and make your own -- you know, break the data into different groups and start to look at it?
MS. BOUVE: The studies that come in, of course there is a very large text component, and then along with it maybe tables of information embedded in the studies themselves. And with electronic submission, if it's developed in a fully electronic way, our reviewers can expert data and tables and slice it and dice it in other ways and sort of challenge the assumptions that are in the presentation or results.

And then, of course, for the supplemental files, the massive amounts of data behind those large feeding studies, we can organize and reorganize that data in a wide variety of ways. And that's part of what we're piloting, is what is the most effective kinds of analyses that our staff are using, and so that we can then make sure that others are using some of the same tools or techniques so that there is a consistent approach at analyzing this data.
We're still in the early stages of learning to work with this, but that is one of the things we hope to be able to do.
JENNIFER: Well, it's not really so much working with the electronic data, because that's -- I mean, I haven't done anything but Nialock electronic data since, I think, '92. So I would imagine any data that is ever generated has to be converted to paper. Printed, so to speak. And it's all done -- like everything is done electronically, because how else could you do large scale statistics on it. So I don't see working with the electronic form is the new part here. I see working with the data. So I guess my question to you is, are you getting it in a more raw form? Or maybe in a finished form, but are you able to break it down to the raw form and manipulate it more?
MS. BOUVE: Well, if data is presented to us in a study report in a series of tables -- for example, say, the results or the final conclusions or something like that -- in the past if the EPA reviewer wanted to analyze that information in different ways, they would have to rekey all that information --
JENNIFER: Right.
MS. BOUVE: -- into their own spreadsheet --
JENNIFER: Right.
MS. BOUVE: -- software which is very time consuming. And yet if you really want to do a good job of analyzing the study, and as part of your review and your assessment of that study, you needed to do that and it was a very time consuming tedious kind of a task. That step we are able to bypass now by virtue of getting it in an electronic format.
JENNIFER: That's true.
MS. BOUVE: So even that is a very big savings for us.
JENNIFER: That is. That's great.
MS. MOOS: Terry?
MR. TROXELL: Yeah. I don't know that my comments are going to add too much to this. But it's good to hear that FDA has been so helpful in EPA establishing this process. You know, I guess it's not going to be too many years until we won't have really any paper around at all. But it's a matter of people getting used to electronic format. I mean, we had the days of filling in libraries full of paper and having to check these petition parts in and out one at a time. One reviewer, you know, at a time. To now with the electronic version, the efficiency is that multiple users can be looking at the same item at the same time. You can have teams of reviewers looking at the items together on different computers. And, you know, in the Washington area -- those of you who don't live here -- we have, you know, kind of a traffic problem. And there is a lot of desire for people to telecommute, whether it be from centers or from home, and this really facilitates working on projects from the home, saving all that time -- travel time. And actually, you know, making people's lives better, but also more productivity for employees because they can get -- you know, a few of us bureaucrats, by the way, actually -- only work 40 hours, so we can actually get more time on projects.

But then there is the other side of the coin, and that is the security of the documents. Because once they're electronically accessible, one has to have very secure systems so that they don't get lose on you because they're flying around the Internet and on people's computers, you know, working at home and so on.
MS. BOUVE: I think the security issue is certainly one that is a big challenge for anybody who is dealing in this arena. We -- that's why we have the studies coming in on compact discs, because we don't -- the agency is not prepared to handle electronic submission via Internet or some sort of telecommunications mechanism. Plus, I don't know how many registrants would feel really warm and fuzzy about trying to send over the wires an enormous submission of, say, 230 studies or something like that. That would be sort of nerve wracking and a scary way to submit data, I think. But teaching people about how to do the secure -- to handle these documents securely just as they would with paper is a challenge. It may seem different because it's a different media. It's certainly a heck of a lot easier to walk around with a CD than it is with a 4,000 page study. So it is a real challenge for all of us.
MS. MOOS: Are there any other questions or comments? Oh, I'm sorry. Alan?
MR. JAMES: On a related area, there is progress being made at the state level as well. It is enormous what we have to submit to EPA. But there are 50 states out there, and all 50 seem to have different requirements for registration of our annual registrations, and also the many, many thousands of label changes of that nature that go on at the state level each year. There is some progress being made there. Most of it is real good, but the issue of security has come up. How the data is going to be electronically transferred to the states. There are efforts now in some cases to have a central organization provide the software and handle the processing. Some legitimate questions have come up about whether moving your data through third party networks is an appropriate and secure way of doing that.

So there are some issues that will need to be addressed at the state level. I think the concept of doing it all by diskette probably is -- for the short term, at least, gives me more comfort than the kind of descriptions I've received so far of what is being proposed at the state level.
MS. MOOS: Julie?
MS. SPAGNOLI: Another area that I know was talked about as far as electronic -- I guess it's not data submission so much, but the electronic labeling -- electronic label submissions -- and being able to do comparisons for, you know, label amendment review. There was an effort underway in that. Is that still underway in looking at -- trying to find some standardized format, or some standardized way of submitting labeling as well to ease review?
MS. BOUVE: Yeah. Yes. Tom Harris in the Registration Division has been the leader of the effort there. The idea is to get the text of an existing label in PDF and then a PDF version of the proposed amended label language. Adobe Acrobat gives you the capability to do a compare function, which will spike up any differences in the language between the existing label and the new proposed so there is no confusion about exactly what change is being requested.

Our Registration Division has done a lot of good work in trying to promote that, but unfortunately a lot of companies haven't taken them up on it. We wish they would, you know, do that, so chat that up.
MS. MOOS: Alan, did you have something to -- oh, okay. Steve. Thank you for the prompt.
MR. BALLING: Well, actually I just wanted to comment. That was an interesting issue from the user perspective. One of the things that we do -- and I know a lot of other companies do. It's something that anyone who uses pesticide compounds needs to be aware of. And that is trying to manage label changes. Every year we put together an approved pesticide list for each of our crops. We run through -- we have to look through every label and try to see if there are any differences in that label. And you've got to compare for each crop, each use, all the timings and all of that. It's a tremendous effort.

We've been trying to move to something more real time, where we have on our own intranet site all our pesticide lists. If every time there is a change in the label, that information is readily available so that we can go onto a site and look for label changes that were easy and you could do a compare function or whatever, then we could have a real time approved pesticide list available at all times for our field men and growers. That kind of information is really valuable as opposed to trying to get hold of labels from, you know, Internet sites that the companies have and they're always out of date and who knows what is timely. That would be a wonderful opportunity.
MS. BOUVE: As we look ahead -- I mean, obviously we still have a lot of work to do in the study arena. But as we look ahead to what would be the next really smart opportunity for electronic submission. But also exchange. Sharing information. And it probably -- we haven't, you know, consulted with all our internal or external customers yet.

But our thinking from preliminary discussions is that label -- detailed information about what's on the label -- the sites and the pests -- in a structured way that feeds from our database to our database -- hopefully to the databases of the registrants -- we feel that there is probably tremendous potential there in being able to share that information. Being able to process it quickly. Keep our databases up to date and the like. So that's probably --
MR. BALLING: That would be better.
MS. BOUVE: -- the next opportunity to explore.
MR. BALLING: If it's in a database format as opposed to trying to compare labels, so much the better.
MS. BOUVE: Absolutely. Absolutely.
MR. BALLING: That would be fabulous.
MS. MULKEY: It's nice to see some energy forming around this issue. In our view, it warrants it. But we're past our break time. I think we're okay on time. If you opt not to come back, you won't get to have a part in the discussion about where we're going to put our attention in the future for this committee. So we hope that's enough of an incentive together with the good goodies that are still out there.

If we come back at five after, then we're back on time. We can end in plenty of time. We can have our -- admittedly out of our own pocket -- happy hour on time. And so we'll come back at five after. We'll use that time, if you folks can stay, for a little wrap up of this topic when we get back, because it warrants a little bit.
(Whereupon, a brief recess was taken.)
MS. MULKEY: My take away message from all of you is you share our unease about the implications of the Internet for safety, lawfulness and security involving pesticide products in the United States. And we would be interested in your feedback as we go forward about whether there are any networks, partnerships, follow along projects or other activities that this group could or should facilitate. You see -- you've got some sense of our level of effort, the level of effort in the states, our attempts to partner with the Federal Trade Commission and other federal agencies, and our effort to facilitate your tips and other engagements with us. But I suspect you also got the sense that we are extremely limited in our capacity to manage this, and that frankly it will not be successfully managed if left to law enforcement as the only tool that we all employ.

And so there is some possibility that something beyond the information exchange we engaged in might be a possibility, and we'll look forward to some further engagement on that, and our chat and the possible follow up.
With respect to the second topic, I know even my eyes cross a little bit when we get to this SES format stuff. But I will tell you why I stay awake in this. Of all the issues that have come to my attention in the time I've served as Office Director, this is the single most dramatic and it has the potential to impact our efficiency and our quality, and to impact it at a level that will be noticeable in terms of real results. Now, I would be startled if the 25 to 30 percent efficiencies that we have gained in the IR-4 submissions are primarily attributable to this factor, because this factor came fairly late in the game. But I would not be startled if at the end of the day we learn that this when fully implemented is gaining us those kinds of efficiencies. That, folks, is dramatic, and it has positive implications regardless of where you're coming from as you sit around the table.

If your interest is in newer, safer chemistries, it has positive implications. If your interest is in -- is a business interest in the registration production flow, it has positive implications. If your interest is in more tools in the toolbox, it has positive implications. So I think it is -- if your interest is in more rigor in our science and more care and a greater soundness in our science, it has positive implications. So I'm hard put to see how it is other than good for everybody, and I believe that as companies go fully electronic, rather than dual track, they also will gain some of the kinds of efficiencies that may lower the price of these tools to all of us, or raise their stockholders gains, or something good for somebody. Make for better bonuses at the end of the year or whatever.

It just seems to me it's one of those things that nobody loses and everybody can win. And so again, there may be some opportunities, maybe for parts of the industry that are not the big R&D. Maybe some of Warren's members, or some of Alan's members who are nevertheless in the registration application business to get engaged. Certainly some of Gary's colleagues and so forth. So there may be some opportunities around the table to learn from this, but we wanted all of you to get a sense of it. And so I want to thank Lin and to express my delight that she is back in the pesticide fold, and to offer you one last chance to speak to this topic before we move on. Okay. Thanks a lot. We now are scheduled to spend about half an hour on four topics that have been identified, either by you or by us or both, for potential future consideration. And by that, I mean more comprehensive consideration. Consideration beyond updates in a minute and with a special focus on this forum as opposed to other forums as an appropriate place for some extended dialogue. These topics, as I said, are identified in part because some of you identified them, and in part because we had some interest in them. I want to spend a minute or two on our vision of what these topics -- what their scope might be, which is not to limit that, but at least give you some sense of where we would be coming from.

Alternative testing issues can be very broad spectrum in terms of what people mean. They can go all the way to -- this was a new word I learned and now I've already forgotten it. Something toxicology. Think. Basically figuring out a way to do toxicology without animals. You just do it on a machine. What is it?
FEMALE SPEAKER: Computational toxicology.
MS. MULKEY: Computational toxicology.
(Laughter.)
MS. MULKEY: Which I think is way beyond the scope of this group of mostly nonscientists to discuss. All the way to the more nuts and bolts kinds of things about alternatives to animal models that are either had been validated or in the process of being validated to questions about how to be sure that the testing that is done is necessary and that we have things like tiering and workable waiver processes and so forth. But the reason we put the topic here was to focus on alternatives to the animal models in sort of a practical, available in the near term, operationally possible within our program. So that was the scope we had in mind, but I'm just acknowledging that this is a topic that has an extremely broad scope.

There is a lot of interest in biotechnology, genetically modified organisms, and there are a lot of other forums for that, including USDA has an advisory committee that puts -- well, I thought you already had one.
MR. JENNINGS: Soon we'll have it recharted.
MS. MULKEY: Oh, it's recharted. Okay. I didn't think I dreamed that. But there is a federal advisory committee that works on these issues. We have SAPs on the science of these issues. There seem to be some special interest in the allergenicity issues. There are some really difficult, hairy, medical, science issues around allergenicity and biotechnology. We have had very dense, rich SAP meetings. This is, again, not a forum for a discussion of the science. But within our agency, there has been more lay interest in sort of just generally, how do you think about allergenicity. So there is a possibility of having a dialogue aimed more at a lay understanding of this issue. So that's what we had in mind for that, rather than a forum in which we try to understand what kind of models, animal or otherwise, there are to fully and comprehensively analyze allergenicity and genetically modified organisms, or anything else for that matter.

Ecological risk assessments is something we've always done. There was a subcommittee of the PPDC which put a great deal of work into probablistic risk assessments. We continue to do these risk assessments. They continue to create results that we struggle to understand how to implement and risk management. We continue to have relatively infrequently pesticide analyses where the ecological risks are sufficiently compelling that they are an important component in our risk management decision making. And so the idea of an update on where we are on ecological risk assessments and where we're going -- again, not the detailed science of it, but the thrust and approach -- is there. And then registration review is that part of FQPA which basically says when you finish
reregistration, or independent of reregistration, for all of those products not subject to reregistration -- in other words, for everything post-84 and for the next cycle after you finish reregistration, we anticipate an approximately 15 year cycle of updated testing and review of the continued appropriateness -- safety standard -- of registered pesticides.

And that we are beginning -- it's time for us to begin to have in place that program. We've done an advance notice proposal. And we could have a discussion about our thinking and next steps and get input on that.
So that's what those four topics are. But we can talk now about those four or any others, and also use this time for a little bit of feedback from you about format, approaches, or how to make this committee the real working, useful committee that we all want it to be. So I'll stop now and let you guys talk a while. Steve?
MR. BALLING: One quick question on the genetically modified area. Does EPA get involved in the issue of advantageous presence?
MS. MULKEY: Yes.
MR. BALLING: Because obviously that's a very hot issue right now, or becoming a hotter issue, not just related to allergenicity, but the fact that it's presumably unregulated. I think that seems to me like it would be an area of great interest to this group.

MS. MULKEY: But one of the difficulties in talking about anything about genetically modified organisms, the EPA's role is with the ones that have pesticidal properties, and all of the rest of the responsibility for looking at the impacts of genetically modified organisms lies in other federal agencies.
MR. BALLING: Well, the two I'm aware of that have hurt the food industry are pesticide related.
MS. MULKEY: All right, fair enough. Two?
MR. BALLING: There is this current canola issue out there.
MS. MULKEY: With respect to the ones where we are doing -- we do look at it. And in fact, our registration for Bt cotton limits growing in areas where wild cotton plants are known to grow. So that's an actual regulatory choice based on advantageous presence. The difficulty is that the science questions -- and a lot of the public policy questions -- around advantageous presence go beyond the plant pesticide issue, and even the ones that have to do with advantageous presence in the food supply. There is some -- and I'm not close enough to it to know the details. There is some interagency work on this issue.

So I think the real question is, how expansive ought the Pesticide Program Dialogue Committee try to get around biotechnology issues that are not pesticide specific. And frankly, my --
MR. BALLING: Well, we have Terry here, of course.
MS. MULKEY: What now? Yeah, we have Terry. We have Al.
MR. BALLING: He would actually wake up.
MS. MULKEY: We have both the other federal agencies with responsibility for this. But I think this might be an odd forum.
MR. BALLING: Okay.
MS. MULKEY: Okay. But there is this other forum.
MR. BALLING: I'll abide by that. A couple of other things I would add. One that has come up recently in some discussions with commodity groups in California and with the western region pest management center is the issue of these pest management strategic plans and how EPA actually uses them. Whether they're used, because they are a tremendous amount of work and fairly costly.

And we don't have a real sense -- I mean, some people say, oh, yeah, we use them all the time, and other people say, oh, they never use them. And so it would be nice to have a report from your HED and R&D and whoever else.
MS. MULKEY: BEAD.
MR. BALLING: BEAD and everyone else on how those are used. And then another one that came up yesterday, and maybe it's -- I don't fully understand how it is being dealt with. But I would be curious if it's being dealt with by some work group that I don't fully understand, maybe a report from that. And that's reentry intervals and the concept of activity based reentry intervals versus just the single REI per crop. That's very important as these REIs get extended when, you know, you've got a 45 day REI based on something that is going to be machine harvested. Those are big issues for us.
MS. MULKEY: Well, that issue is a risk management -- it's like a refined risk management issue and that's something we probably could have a discussion on.
MR. BALLING: Okay.
MS. MULKEY: Okay. I know -- I don't know in what order, so I'll just go down the line. Gary?
MR. LIBMAN: Thank you. I think we had some great discussions earlier today about pesticides and maybe we beat it to death. I don't know. But I think we didn't, and I love to see in a follow up meeting some further discussions. Maybe a follow up discussion. There were some great ideas that were given to me by the panel members, as well as the agency people, and I think that I would like to see this pursued. I would not like to see it dropped at this point in time, because I think it's a very important subject. And because of the key issues that came up with USDA and the EQIP and so on, I would very much like to see some type of a follow up on this.
MS. MULKEY: Ray?
RAY: Thank you. I also appreciated the discussion today on the biopesticides and the fact that a substantial chunk of the meeting was dedicated to that with the presentations. And I would suggest a similar format for alternative testing issues at a future meeting, perhaps the September meeting, particularly to focus on some areas where short term replacements might be a possibility. There is an extraordinary amount of work being done in other countries and other jurisdictions, which have in fact accepted replacement alternatives to animals for some of the endpoints which OPP requires. So that sort of discussion taking place at a future meeting, I would strongly encourage. I would also strongly support a review of the data requirements for various classes of pesticides to ask the question whether we could possibly get by with less data or different types of data, as well as an ongoing review of some of the longer term replacement options. Some of the R&D that is going on in other jurisdictions for nonanimal methods, be they in vitro, computational or other sorts of technologies that could reduce or replace animal use further down the road.

This would need to be an ongoing discussion and it's not really amenable to an update in a minute kind of format. So it had been discussed at the last meeting, and I would like to revisit the possibility of establishing a work group that could review these issues on an ongoing basis, that could be more technical in its focus to explore the technical aspects of it, looking at in-house activities through the EPA's Office of Research and Development, as well as efforts in other jurisdictions to develop and validate some of these methods and serve as an ongoing coordinating capacity for the agency.
MS. MULKEY: Beth?
MS. CARROLL: Just to follow on a little bit with data, presumably by the next time we meet -- and I don't -- if it is September, that would be perfect timing. The agency will have received feedback on the draft document on how it plans to comply with the Data Quality Act. And I would like to see that added to the discussion for the next meeting. MS. MULKEY: Warren?
MR. STICKLE: I would like to raise two or three questions. First of all, the inert risk assessment model for inerts that we've just gotten today, perhaps you'll have a 90 day comment period which will bring it sometime into perhaps early August. At some point, the agency is going to need to look at the 800 food use inerts that are up for tolerance reassessment. So perhaps after we've gotten through the comment period and we begin moving into the next phase, perhaps we could put that on the agenda to discuss how that might be implemented and where it might head. I would also agree that the Data Quality Act -- the comments are due on May 31st for EPA and has to be implemented by October 1st -- is a real ripe timely topic for discussion. In other words, what are the implications for data. What are the implications for OPP, for R&D, for AD, for endocrine and a whole variety of other issues and how that might all fit together. And not for the next PPDC meeting, but perhaps for the one that follows that. You mentioned earlier that the NAFTA TWG group is getting together in December in New Orleans to talk about the next five years and plans for both agricultural and nonagricultural issues. So at some point in early 2003, I would recommend that as a discussion point on what the issues might be. But only after you have gone through that annual report in New Orleans.
MS. MULKEY: Okay. I'm going to go to Lori.
MS.BERGER: Okay. I just had a few things. First of all, I really appreciated the advance notice of this meeting, and maybe that's one reason why we had really good attendance. And I also liked the update in a minute format. I thought that was very interesting and kept moving. I really liked that format. I would, like Steve said, like to hear from EPA folks and USDA about these pest management strategic plans. How they are helpful to you. How we can improve them, because we are putting a considerable amount of effort into developing these, mainly for you guys. We feel a lot of benefits for our commodities, but we want to optimize that process and product.
And two other things. The activity based REIs, this is a critical issue that we need to visit. And then finally on biopesticides, I did enjoy that discussion. And this might be way off, but it sounds like there is a lot of commercial limitations to these smaller companies that are using these products.

Are there any government programs that could help some of these companies or projects of this nature if this is really a way that we want to encourage pest management to go. I mean, are there any opportunities within the system to encourage entrepreneurs in this area.
MS. MULKEY: You mean like the Small Business Administration launches?
MS.BERGER: Yeah, something like that. I mean, I know that there are other -- I know with manure treatment and water treatment there have been similar programs, and I wondered if maybe there might be something along those lines for biopesticides.
MS. MULKEY: (Inaudible).
MS. POPOWITZ: Yes. I'm really encouraged by your interest -- by the agency's interest in pursuing short term replacements for the animal testing required under FIFRA. And to that end, would like to propose that Proctor & Gamble, that has a lot of experience in doing nonanimal risk assessments, would be willing at your next meeting to give a presentation on our methodology for doing that in the acute tox endpoint area. Basically, you know, what we do for our nonFIFRA products, which essentially, you know, is what you do when you look at a six pack.

In 1996 we made a commitment on our nonfood and nondrug products not to conduct animal testing any longer unless required by the government. And as a result, in the U.S. our FIFRA regulated products are the only products that we still conduct animal testing on. And in many cases, it doesn't make a lot of sense to us, because often these are household cleaner formulations previously regulated under CPCS for which we didn't need to do animal testing to commercialize. But moving them to add an antimicrobial claim, puts them under FIFRA and causes us to generate animal testing. So we're very interested in the issue and have a lot of experience, as I said, in not only conducting the nonanimal risk assessment method, but have spent almost to the figure of a hundred million dollars on research in this area. So we have a group of research toxicologists who have focused on in vitro methodologies. And the state of the science has moved considerably since your data requirements were established, and I think there are some methodologies that could be readily accepted if there was a good process for reviewing them.

I would also be interested in the agencies articulating what OPP's animal welfare policy is. There are statements of policy in the OPPTS acute toxicity guidelines, for example. OPPT, as part of their high production volume challenge program, has animal testing principles. It's not clear whether OPP's are consistent with that, and the implementation clearly of those principles is made more difficult by the fact that they're not codified. And in discussions we've had with the agency in the past, it has always come up that codification of those principles would enable more ready acceptance of alternative test methods.
MS. MULKEY: Thank you. I'll answer one little part of your question. We hope in this year to propose
-- well, propose an update for our data requirements, part 158, and in connection with that proposal, we expect to highlight this issue of animal conservation, and welfare considerations, and minimization and appropriate reduction of animal models where appropriate.

There will be some -- a few, quite frankly. Very few specific provisions in which we may be able to point to a proposed change. But we're going to invite comment and also articulate our general principles. So that is a forum we hope that we'll have this year in which we will have a more systematic opportunity to speak to this issue.
We do -- on occasion you will see a PR notice we did on duck Hepatitis B virus testing and some other places where we stated -- we have made public statements.
(End of Tape 3, Side A.)
FEMALE SPEAKER: -- than on nonanimal risk assessments.
MS. MULKEY: Well, I was just going to wait until we got around.
FEMALE SPEAKER: Okay.
MS. MULKEY: Because several people have raised that. I just wanted to answer just that narrow point.
Bob?
MR. HOLM: I would like to support Steve and Lori's comments about the pest management strategic plans. I know the commodity groups have spent a lot of time and effort. I know Al's group has gone out and helped organize these meetings. Usually 20 to 30 people attend for one to two days. IR-4 has been sending members for about a year.

And one way we've hooked into the program is that we've told the commodity groups that if they prioritize and come up with a list of priorities, then we will take the top priority at our next food use workshop for an IR-4 project. So that's provided a good hook to the system. But I think there may be a lot of information that comes out of those programs that could be used more broadly, and I would like to maybe have this group explore it, and certainly have the agency look at it. I agree with Gary. I think there are some opportunities for following up with the biopesticide presentation. I think Janet and Kathleen and Pat have done a good job of capturing a lot of information. But if it just sits there without any recommendations for implementation, it won't go anywhere. And I think if we've got some momentum going, it would be good to follow up.

And then the final comment I would have was -- and I know it's sort of in the purview of TRAC and now CARAT to look at FQPA transition. But I'm just wondering if this group might play a role in the transition process, whether we could have some participation in the transition working group or whether somehow this group could support that effort.
MS. MULKEY: Larry?
MR. ELWORTH: I may be the only person in the room that is really interested in registration review. I think -- I'm actually interested in how you all have been thinking about it. Maybe we can talk separately.
MS. MULKEY: I'm not sure about that. A lot of people in the room have taken our side.
MR. ELWORTH: Okay, right. I think they do. I'm just kind of -- it seems like it's an esoteric issue that, you know, nobody paid a whole lot of attention to in the statute. But one of the ideas behind putting registration review in there was to give the agency a backstop on granting registrations. So where registrations were -- I know there had been concern within the agency about granting a registration, and then if problems appeared in the future, it would be very hard to get it back off the market.

DISPRA provided a way for the agency -- a regular place for the agency to review decisions, so that if problems did come up, there was a way to deal with them, both on the back end, but also to provide some comfort level on the front end in granting registrations.
MS. MULKEY: There is also the issue of systematically updating the data.
MR. ELWORTH: Sure. Right, right.
MS. MULKEY: So that there is sort of a level playing field.
MR. ELWORTH: Well, sort of to avoid the FIFRA 88 kind of crash. So I'm interested in that.
I would like to put this issue of the pest management strategic plans in a slightly larger context while they're important in and of themselves. There are things that the agency does besides the risk assessment in BEAD for looking at what the impacts are, both in terms of the pest management strategic plans, where the alternatives are, and also maybe to some sense the way in which the agency assesses risk mitigation options, both on the risk side, but also on the BEAD side. So I would like to actually put the pest management strategic plans in that context so that we can understand that in terms of BEAD's activity.

The other thing I would be interested in, while I'm interested in the biopesticide piece to this, I am interested in the discovery side with the -- I don't know what we call them now -- conventional chemicals to the extent they're reduced risk. But I'm actually interested, and I wonder how many people have actually had a chance to look at the way the larger companies do their discovery process and how that actually takes place. Maybe all the people from the registrant side know it really well. But I think it's pretty interesting the way in which that takes place and how registrants actually decide to bring compounds to the agency and how they make those cuts. It would be really interesting to me. And also I think that computational toxicology is -- when you said that I thought, god, that's the way I feel at the end of every day in front of my computer.
(Laughter.)
MS. MULKEY: (Inaudible).
(Laughter.)
MR. ELWORTH: Right. Anti-virus.
MS. MULKEY: And computation. Win?
MR. HOCK: Yes. If you will indulge me just for a moment, I want to just read something. In Merced County, California, thieves intent on stealing from agricultural operations deliberately trigger an alarm on the premises and then flee. They wait until after the Sheriff's deputies have investigated and left. Then they quickly return and take the agricultural chemicals, equipment and hay they had originally targeted. This is just one of many examples of a growing problem in agriculture in California and elsewhere. Crime aimed at agricultural perations.
And this comes from the Gimbler's Alert Newsletter that I get electronically and it's kind of enlightening. After I read that, I just was wondering. I would like to see someone, maybe from the Office of Homeland Security, discuss this whole issue of security of pesticides. I have no clue. Are they doing anything? Are they addressing the issue, the movement, the sales, the transportation, the storage of pesticides? Are they concerned at all about e-commerce?

Another example would be that we do not -- or at least many states don't ask for a positive I.D. if someone works into a dealership and buys pesticides. Anybody can go in as long as they have -- if it's an RUP. If they have a certification, they can get it, but they don't ask for any kind of identification. And I'm just curious. Is the Office of Homeland Security doing anything in terms of -- and I'll put it in quotes -- "pesticide security management." And I know from a previous meeting I attended, Steve Johnson, I believe, has visited with Governor Ridge and his staff about this very issue. And I'm just curious what is going on. You know, how does EPA or how can we interact at the state level with the Office of Homeland Security. So that's an area that I am particularly interested in. I just throw that out as food for thought.
MALE SPEAKER: Excuse me, Marcia. Marcia? Could I add a comment to that.
MS. MULKEY: Of course.
MALE SPEAKER: In fact, the Homeland Security office on Tuesday and Wednesday of this week here in Washington at the Rand Building held a two day conference on security issues and safety issues, and we spent two days talking about chemical issues and pesticide issues. In fact, there were a number of people from EPA, as well as a number of people from a variety of different parts of the industry. All the trade associations in the pesticide industry were essentially represented there.
So, yes, they are doing a great deal. And I would be happy to provide the information to you, and perhaps someone in your group could get plugged into that.
MR. HOCK: Okay.
MS. MULKEY: And when we come back around, I was going to mention a few things.
MR. HOCK: Thank you.
MS. MULKEY: Julie?
MS. SPAGNOLI: Larry, there are other people interested in registration.
(Laughter.)
MS. SPAGNOLI: And in fact, kind of a combined maybe even -- you know, Beth brought up about the Data Quality Act. And I think maybe even to see how the Data Quality Act may relate to registration review.

I think the other issue with registration review would be -- you know, we know we are still going through tolerance reassessments. There are still a lot of tolerance reassessments left to be done. And, you know, how could they tie in some of the tolerance reassessment activities with, you know, registration review on products that will be undergoing tolerance reassessment. You know, is that part -- you know, would that be considered part of their registration review and how does that -- you know, how does that process interrelate. Just like reregistration and tolerance reassessments where they kind of intertwine. And then I think in the area of alternative testing issues, I think another area to be investigated is alternatives to testing. You know, we worked with the agency on a policy for basically a blanket waiver on acute toxicity testing for products on granular fertilizers, that, you know, there was no reason to keep testing fertilizer over and over again with this products that had low levels of active ingredients on fertilizer.

And, you know, are there other opportunities to look at. Classes of products where there is enough data available on -- you know, almost on an entire class of product to kind of make a judgment that would allow us not to, you know, have to continue to, you know, reevent the wheel of continuing to test to see the same effects.
MS. MULKEY: Okay. I think I'll just run again and pick up Pat.
MR. QUINN: No. What Julie just said, I think that's something that companies that I'm working with would be very interested in as well. And just so, you know, Proctor doesn't appear to be alone here on the industry side as advocating a focus of this group on alternative testing, I know two, maybe three, companies that I'm working with that will be very interested in participating if there were a work group of some kind, Marcia.
And then just a follow up on your comment about 158. I think that's a great opportunity to go ahead and sort of reinforce what I guess we could call the Whalen letter principles within that document, and also perhaps institutionalize some way for the agency to look at validated alterative tests and then put them into place, which simply doesn't exist right now.

And that may be -- that may sound ambitious for a rule that is as far along as it is. But I think quite a bit of thinking has been done about that, and I would be happy, you know, to chat about that if there is still an opportunity.
MS. MULKEY: It is a proposal.
MR. QUINN: Right.
MS. MULKEY: So if we tee up the issue adequately, it will be possible to go final around some things that may not be fully fleshed out in the proposal. Bill?
MR. FREEZE: Yeah. I would like to encourage the group to look at the pesticide producing plants and allergenicity, one of the topics here. As everyone probably knows, allergenicity has been one of the main concerns of genetically engineered foods for a long time with the main health concerns. And there have been lots of workshops and papers on the subject dating back to -- I believe the FDA had a big workshop in '94. Scientific Advisory Panels have looked at it, as well as, of course, it was the issue with Starling corn.

There have been several protocols that have been put forward, most recently at the UN level. The Food and Agricultural Organization and the World Health Organization came out with the most detailed protocol to date which has international support. And I think it would be a good idea if -- you know, I think we really need to begin to apply such protocols for, you know, these new pesticide producing crops that will be, you know, coming down the line. There were four Bt crops reregistered last year, and unfortunately none of these protocols were used. They basically were not assessed for allergenicity. There was a lot of new evidence that came up that wasn't really considered. So I think it's -- you know, it would be a really useful topic to address and to come up with some firm standards hopefully that the EPA can apply in future assessments of Bt crops. And my name is Bill Freeze. I'm with Friends of the Earth. And I have some comments that I submitted to the EPA that I would be glad to share if anyone is more interested in this subject.
MS. MULKEY: Bill Tracy, I think yours will be the last word for this session. There will be time tomorrow to talk about this, and I'll be able to give a little bit of reaction to these.
MR. TRACY: This is a footnote on the pesticide security issue. As mentioned, it was addressed at the federal level. But there is a program -- a pilot program -- in California. It's into its fifth year. A real crime task force, where the state has been funding the local sheriff's department, and they in turn work with agriculture through Fax Net and E-mail Net. It's been extremely successful in disseminating information on suspects and pinpointing where thefts are going on. That's the good news. The bad news is that the State of California had an energy crisis last year and we spent way over budget. And so this program is in real jeopardy, and so we will be looking for other funding sources to get a very good and viable program, not only for pesticide securities. But just in general, being out in a rural area when you have an $80,000 to $300,000 tractor part there, and you're just waiting on the good graces and honesty of the people around there. It doesn't take long to snap one up and then head it south across the border pretty quick.

So we are looking for additional funding sources and if anybody can help us in that direction. Maybe the Homeland Security might be one direction to look.
MS. MULKEY: All right. Well, let me give you just a little bit of general feedback about what we're struggling with to try to make this committee work for you and for us. The work group model, where you have multiple ongoing, pretty high level of effort meetings and produce a work product, is available to us, and I think we can select over time a pretty small number of projects. And quite frankly, there is a fairly high level of transaction costs in that model. Now, there are some payoff that comes from that transaction cost in terms of people working out their differences, or at least reaching a higher level of understanding about their differences and some of those kinds of things, and the potential for some more sustained alliances and collaborations and so forth that go beyond the mere dialogue, if you will. And then there is the just come around and everybody says their piece with their card up and go away model.

What we're trying to do is struggle to find something between those two that works for you and works for us for most topics. And we can opt for the work group model on some topics, and we can opt for the once around and done model on some topics. And we are -- last time, as you will remember, we had used the work group model for inert disclosure, and what has resulted is a very thoroughly worked through set of issues, which then comes to us much more prechewed than it otherwise would have, but not, I might note, preresolved. There is the risk assessment, which is essentially informational and we're trying to keep you updated, but there doesn't seem to be a lot of energy around them. You need to have the group keep working it. You just want information over time, for now anyway. There is the EUPs. That was largely informational. There was anthrax. That was public health pesticides. Maybe a little more than that, which is why you had a little more robust update about information, and if we get to a critical stage, we might go further than that.

Today's topics so far, my take on e-commerce is that maybe some of you will begin to want to put together some kind of network among yourselves on this. But that's not gelling yet and there is not a lot of energy behind wanting to do that. Electronic data submission. We hope we've motivated and informed. That doesn't seem to lend itself. Biopesticides, on the other hand, I sense some interest in some kind of continuity of work together. Sharing ideas. Building ideas. Maybe even developing some alliances to work some issues. Helping each other and helping us and advising us. But I don't sense that you want a multiple meeting work group on that. And so the challenge there is to find a way for us to keep that going, whether it's the chat room or whether it's you guys taking the initiative, to form, you know, sort of off line some connections and so forth. That is all by way of reacting to the ideas you've now presented us with. Let's start with the pest management strategic plans. The only reason I would see why we wouldn't give that at least the level of attention that we did for biopesticides, which is to put together some of you who have knowledge of it. Have you do some work ahead of time. Have you provide something meaty and meaningful to the rest of us, including our part of it, and then see where we go from there.

The only reason I can think of not to do at least that much is the question of whether that overlaps too much with what we hope will soon be an active transition work group of CARAT. So subject to checking that out and making sure that we're comfortable with consistency across the table, that seems to lend itself to this model that we're using, which is put people together to work on it. Have them do some homework. Have them do some work here and see where it goes from there. It's interesting, pesticides and security. We floated it as a topic for this meeting, and the only feedback we got was please, no. And we got that from a small subset, admittedly, and everybody else was silent. So I think there is some question about whether there is a broad enough sense that this is the forum, but certainly it's open to update in a minute kind of thinking. And if we had gotten anything other than please, no, to it, we probably would have included it in updates in a minute. We do have some information we could share.

The Data Quality Act. Probably update in more than a minute, but unclear yet in my mind whether that is something that a lot of people have a stake in and an opportunity to discuss. But we'll definitely keep it on our list. Overall how companies do R&D and what the implications are for the future pipeline. I think we've only heard now one or two people mention. Let's see if that gains some momentum. That seems to have some potential. Inerts methodology, we have continuity. So that leaves out of all the ones registration review. Carolyn before she left sent word she was into ecological risk assessments, but nobody else has spoken to that, both of which gathered some interest. Allergenicity. But all with sort of one or two -- so we need to look into it. Is this more an update in a minute or a short informational presentation kind of question. Leaving us with the one that there seems to be a lot of energy around for now, which is some scope tackling of the alternative testing.

I think the question for us to think about is, how to launch into that, and at a minimum, I think, we would like to put the most interested folks from the committee together to do some homework in anticipation of the next meeting on that. Now, whether that means convening an actual work group, it feels to me a little premature to think about that, because the question is just what is the scope. What is appropriate for this committee as opposed to -- some of this is just science questions. You know, how to validate these tests, or what kind of information is necessary. So I think we are receptive to working that one in a more interactive way. Those are just immediate feedback. We'll listen more. We'll hear you more. I just wanted to give you a little bit of what I'm hearing. What initial thinking. The whole point in this electronic forum is to allow these ideas to bounce between you, so that we don't -- aren't limited to just this dialogue.

That's how I process what I heard on behalf of the agency. My views are not the only ones of the agency that mattered. In particular, the ones where there is a heavy USDA role, such as pesticide strategic plans, we very much, you know, look around to see how they think this kind of forum fits. But those are some short term reactions, which apparently prompted some thoughts on your part. So, Lori?
MS.BERGER: Forgive me if I'm wrong. But were activity based REIs part of your list?
MS. MULKEY: I'm sorry. I missed that. And I heard it, and I heard it twice.
MR. BALLING: Three times, actually.
MS.BERGER: And I honestly think if Shelley was here, she probably would have chimed in on that.
MS. MULKEY: Right. No, you're right. Yeah. I think that lends itself quite well to at a minimum sort of a full informational dialogue. We could at least explain what we think we're doing and why we think we're doing it, and maybe we could have a panel to talk about what are the implications in the field. I know we've had some discussion. We've actually had some pretty robust discussions with California about this, because it raised some real issues in their minds about enforceability and other issues. So, yes. No, I'm sorry.
MS.BERGER: That's okay.
MS. MULKEY: I'm working too fast.
MR. BALLING: Let's get California here on that.
MS. MULKEY: Yes, right. That's the point.
MR. BALLING: If Toby is the one that wants to fight that, let her come in with all of us, too.
MS. MULKEY: Well, that's sort of what we're trying to do here. And as you noticed, there were some folks here who you wouldn't otherwise have seen. Because what we tried to do was plan these topics in a way that we had really valuable resources here on a topic.
MR. BALLING: Great.
MS. MULKEY: And not just our own people or the members.
MR. BALLING: Great.
MS. MULKEY: So, yes, I think we would want to include California if we were to discuss that topic. Larry?
MR. ELWORTH: One of the reasons that I feel participating in this committee is valuable is also to be of use to the agency. So one of the things that I would hope you folks would feel free to do is to give us feedback on the kind of information that we were able to provide back to you whether it's any use in the program at all, and maybe things that this committee can do, either in terms of issues or in terms of participation, that would make our time here more valuable to use. I would just encourage you to look at things like --
(Tape malfunction.)
MR. ELWORTH: -- and get back to us.
MS. MULKEY: You said that before, and actually we -- we're trying to accomplish that while we accomplish making you feel productive. I mean, it really is about our needs. And that's why this issue about biopesticides adoption -- actually, I think the idea of doing that originated with us, and it's because we're struggling with the question of what role should we play. How does it fit. And the work that was done to prepare, as well as the work that went on today, I can tell you right now was and is of considerable value to us. And so I think we are finding -- and in some ways that's vastly more an efficient way for us to gain the value than a full blown work group that would -- you know, really eats up a lot of our effort as well as yours. Julie?
MS. SPAGNOLI: This is in reply to, I think, Larry, you know, wanting to know more about the process maybe for development of products. I think, you know, that could be something that could just be a short presentation. I don't think we would get into, you know, the full details. But maybe it would be useful --
MS. MULKEY: And tell us all your trade secrets?
MS. SPAGNOLI: No, we wouldn't tell. But I -- you know, I think -- and I'm not even here to speak to -- you know, I don't know that our process specifically -- I think it's very -- probably very typical. I would say probably all the companies have, you know, a similar type. And it might -- I think it might be useful just to get an understanding of, you know, I think, some of the issues of why is it important to know when you're going to get a registration and those kind of issues, and how a decision is made to, you know, choose to develop a product and what goes into that.

And I think it could probably be, you know, done in a fairly short presentation. Just kind of an overview of the decision process and the development time lines. And I think it could probably help everyone have a better understanding of it from that -- from the product development point.
MS. MULKEY: Well, one of the things we're learning as we work in this committee is that putting you to work in doing presentations -- and this offer from Proctor & Gamble and other industry participants on their experience with alternative testing, for example, is an excellent example that we can gain -- all of us can gain by having the talking heads come from a variety of places. And we worked very hard for today and tomorrow to maximize that. And we've had some in the past. Do you remember the time we brought in ORD and had this talk about all their research?
MR. ELWORTH: uh-huh.
MS. MULKEY: I think we're looking for more opportunities to make this less about -- just about what we in OPP have to say.
MR. ELWORTH: Yeah. And actually what Julie said I would support. I was really surprised -- and I'm not easily surprised -- about pesticide issues. But I was really surprised at what the companies do in that kind of discovery. It was pretty interesting.
MS. MULKEY: I think that the R&D part of the pesticide industry is fascinating, and I'm sure drug would be, too, if I had had the opportunity to learn that. I remember when I first learned about it in the early '80's. I thought it was fascinating, and I still think so.
All right. Well -- so this is not -- it wasn't meant to be a conclusion. You know, we're going to look into these issues beyond this. We're going to use our electronic forum. But I wanted to give you some sense of our reaction so you didn't feel like you just spoke into empty air.
Well, Margie, could you help us understand what the story is on the cash bar? Is it just for us, or is it just -- we can all use it, if we want to?
MS. FERENBACH: That is correct. It's Hoyas. It's right -- if you got out to the main hallway and make a left, you see it. It says Hoyas. It is a pretty big bar, but we have to share it with the students. And tonight -- Thursday night I think is student bartender night, so we had better get there soon.
MS. MULKEY: But anyway, it is an opportunity for some social time. And then we will meet in the morning at 9:00, and we'll be able to break by one, maybe even a little earlier if we don't have any public comments again tomorrow. And think about, you know, how to make this more workable. I'm feeling very good about the process we're making, but if you're not, we need to hear that.
(Whereupon, the meeting was adjourned.)

Day Two
May 10, 2002
PROCEEDINGS

MS. MULKEY: -- really comprehensive discussion about our budget, because the President's budget is presented to the Congress. The Congress often has a different point of view than the President's budget. It's part of the Executive Branch. Our role is always to advocate the President's budget. And so the kind of dialogue that I think Jay had in mind about the range of issues relating to our funding is awkward for us. But I think if Jay wanted to give a report of the industry's perspective on the budget issues relating to this, there would be no reason why he couldn't do that in this forum. So -- and I did see him this morning.
MALE SPEAKER: He's here.
FEMALE SPEAKER: He's here.
MS. MULKEY: So what we can do, is at that point if he would like to do a little five minute update on industry's take on what's going on with regard to the budget, that is possible.

I will also ask Joe Merenda -- good morning, Joe, just to say hi to you -- when he goes over the registration resources issue to just give the barest outline of the status of the maintenance fee issue, the registration fee issue and the tolerance free rule issue. Just the barest outline. And so that's the way we can deal with that issue.
I wanted to take a minute this morning to say a special thanks to Margie Ferenbach, who is not only our Designated Federal Official and who makes sure we play by the Federal Advisory Committee Act rules, but who leads the team. Who does all the work to plan and execute a meeting like this, everything from the meeting arrangements to the paper distribution to the communications.
Is Margie in the room?
MALE SPEAKER: Yes, she is.
MS. MULKEY: All right.
(Applause.)
MALE SPEAKER: Speech. Speech.
(Laughter.)
MS. MULKEY: I also wanted to take a minute to mention the electronic forum that our Information Resources and Services Division -- whose Director, Lin, you met yesterday -- has worked so hard to make viable, and invite you to also feedback on that towards the end of the session when we do the rap up to see what your feeling is about that as a tool. I see it as making advisory -- bringing advisory committees a little more into the electronic age. And we actually worked quite a lot with our Office of General Counsel to be sure that that system also plays by the FACA rules so that we could make it meaningful. So that -- that's also part and parcel of what I wanted to acknowledge.

I will tell you what's being distributed. Then I have one more remark and then we'll go into the program. What's being distributed is a new FR notice that we expect to publish shortly. It was signed either yesterday or today. Those of you who have been involved in the CARAT will recognize it as the first of what we said would be tolerance reassessments under a theory of early noncontributors to the cumulative risk. So it's the first group of the OP tolerances that are not revoked, but are deemed by us to be reassessed. It covers 275 of the approximately 1,050, give or take -- at one time I thought it was 1066, but it turns out that's not the exact number. So it covers 275 of over a thousand OP tolerances. So you can read that at your leisure. And it demonstrates our belief that it is possible to reassess certain of the OP tolerances prior to completion of risk -- a final cumulative risk assessment and risk management. But it is based on consideration of cumulative risk as well as the individual chemical risk. So you can have that. And finally, but definitely not least, I wanted to on behalf of all of us and the committee thank Adam Sharp and Burleson Smith for the time they spent with us yesterday and for coming back and hanging out with us again today. I think it means a lot to the committee and its members, as well as to us, the career leadership in the program, to have their advice and availability, and to offer both of them a chance to say a quick hello to you before we plunge into the agenda.
MR. SHARP: All I heard was there were good discussions yesterday afternoon. I'm looking forward to hearing a little more about some of the things that got discussed yesterday, and especially this morning on the Section 18's. I guess this is the -- this is something I mentioned yesterday, and it is a very important program, of course. And I'm looking forward to hearing the discussion on the Section 18's, because I guess in my former life I know how important the Section 18 process is for all those involved. And all those involved being all those around the table and many, many folks across the country who depend on it. So I look forward to definitely hearing your remarks and taking a lot of notes. You'll see me scribbling a lot of notes. I'm a notetaker. I love to listen to what people have to say, more so than -- more so than always giving my opinion. So in that note, you'll see me taking a lot of those notes and bouncing ideas back off of you during breaks and everything else. So I look forward to working with you on this process. Thanks. Burleson?
MR. SMITH: I was going to say I really don't have any comments to make, other than I certainly found a lot of very spirited discussion yesterday. I appreciated that. I'm sorry that I missed the follow on to the biopesticide area, but I look forward to hearing more about it. The one thing I would like to say is I would be happy to make myself available, since I was not around yesterday during the follow up, to listen to any perspective you may have. I'm certainly interested in hearing more individually, and I hope to get the chance to talk with more of you during some of the break sessions today.
MS. MULKEY: Thank you. And, Jay, you can catch up on what I said about the funding.
MR. VROOM: I heard.
MS. MULKEY: Okay, good.
MR. VROOM: Three times.
MS. MULKEY: All right, great. Very good. Well, let's move then into the Section 18 reform. And Pete Caulkins is going to be our segment Chair and work us through this session.
MR. CAULKINS: Thanks, Marcia. For the next hour and 15 minutes we're going to talk about the Section 18 proposed reform. There are three of them. My panel members are Rob Forrest, who is Chief of the Minor Use, Inerts & Emergency Response Branch in the Registration Division. To my right, I have Dave Widawsky. He's Chief of the Economic Analysis Branch in the Biological & Economic Effects Analysis Division. To his right is Robin Rosenbaum. She is from the Michigan Department of Agriculture. She's the Program Manager for their Pesticide Registration Program, and she also chairs the AAPCO work group on Section 18 reforms. She will be representing sort of state perspectives on this. Bill Tracy is here as a cotton and carrot farmer in Butingwell, California. He will be representing the growers perspective. And Adam Goldberg here is going to be -- from the Consumers Union will be representing the public interest perspective on this. The format is going to be, we're going to walk through some of the most recent trends in the Section 18 program -- Rob will be doing that -- and walk through the three proposed reforms. Then I'll go to my panel members for comments, and then we'll open it for comments and questions from all of you. Rob?
MR. FORREST: Thanks. There are three proposed reforms that we're going to be discussing today. The first is renewable exemptions. Second is exemptions for resistance management. And the third is defining economic loss. And before I get into the specifics, I first want to, as Pete said, go over some of the trends that have occurred in the Section 18 program over the last six years, as well as I would like to give you some background information explaining why we're talking about these three particular reforms. When we're dealing with the Section 18 program, I think a good place to start is to discuss volume. This graph depicts the receipts that we have had on a yearly basis for the last six years. Nineteen ninety seven was the first year of impact, I should say, coming from FQPA. Before FQPA our average receipts were about 400 to 450. After '97 they went up substantially. In '98 and '99 they hit about 600, and in 2000 they did start to decrease. Last year we ended up with about 540.

Another way to indicate volume is to talk about chemical/crop combinations. To give you an example of a chemical/crop combination, you might think about Spinosad on peas, for instance, and the multiple requests that we get for Spinosad on peas turn out to be the number of 18's for that particular year. Before FQPA our chemical/ crop combinations averaged about 160, and you can see the receipts were much higher, obviously. In '98 and '99, they hit about 220. Since '99 they have again started to decrease. We're up to about 190.

Section 18's that are granted. Although the trend does appear that we're increasing as the years go by, the percent of 18's that we grant each year remains pretty constant at about 80 to 85 percent. Denials. The percentage also has been pretty constant. About 2 to 5 percent of our receipts are actually denied. The majority of the denials are due to lack of emergencies. There is maybe 1 percent that we deny because we can't make the safety findings, and that was true also before FQPA.

This is a comparison of receipts and turnaround time. The time that we get the application and issue a decision. Historically our turnaround time, we've always shot for 50 days, and we've always felt that that was an effective time frame for us to do the assessment that we need to do and get a response back to the grower, whether that's a positive or a negative response. In 1996, the year before FQPA, we had a 53 day turnaround time. It was one of our best. That started to increase by 2000-2001. We got down to 34 days. The number of crises. I wanted to put this chart in because before FQPA, we averaged about 60. There is a good definition of crisis in the background material that you have. After FQPA -- '97, '98 and '99 -- our crises went up to about 125 a year, and there was a lot of criticism from external groups that they did go so high. And we took that very seriously. We worked very closely with the states. And in 2001 our crises was down to 59.

Just some findings that we have observed in 2001. The minor use program, 52 percent of Section 18's went to minor use crops. That's about 300 Section 18's that went to minor use crops. Twenty-two percent of the 18's were for conventional reduced risk chemicals, and 56 exemptions were eliminated for FY-02 growing season, primarily due to new uses and most of those new uses were minor use crops. This is a chart that depicts new uses versus the Section 18's that we received. There is a logic in the assumption that if new use registrations increase, then there must be a decrease in Section 18 receipts. And in 1995 and '96, where our new uses were about the same, the receipts were in the range that we would have expected, 400 to 450. However, in 2001 our new uses went up to 204, and our receipts were still relatively high, higher than we would like them to be. So from this chart, I think at least right now it's hard to make a correlation between new uses and how many Section 18's we might eliminate that particular year. So it appears that there is some progress. There has been a decrease in our turnaround time, there has been a decrease in crisis exemptions, and there has been a decrease in the number of FY-02 Section 18's due to new use registrations. And again, these were mostly minor use registrations.

So with such progress, why reform? Well, a couple of reasons. Back in 1995 there was a government wide effort to streamline regulations and EPA began to evaluate the Section 18 process. Also around the same time, we received a resolution from NASDA and AAPCO, NASDA being the National Association of State Departments of Agriculture and AAPCO is the Association of American Pesticide Control Officials. We received a letter from them. Their resolution is outlined in the background material. They supplied eight reforms that they would have liked -- that they wanted us to consider. Aside from these two being the obvious in terms of moving us forward, in terms of reforms I would say that because of the nature of Section 18's, we need to respond quickly and, again, either positively or negatively. And we're always looking for ways to improve the process and to expedite decisions, and that was one of the ways that we got a response time down to 44 and 34 days.

With the letter from NASDA and AAPCO, we decided that in November of '96 we were going to hold a two day workshop to discuss the reforms and to solicit comments. The workshop was widely attended. It was very much of a diverse group. State lead agencies were represented, environmental public interest groups, pesticide companies and academia. The reforms back in '96 were put on the back burner for a while. Three months before the workshop, in August, FQPA was enacted, and this certainly changed the dynamic of the workshop in that we spent at least 50 percent of our time discussing the impacts of FQPA on the Section 18 program. And it was clear at the end of that workshop that the attendees thought at least at that time that it would be best for us to focus on addressing the FQPA issues, which we did. Having said that, we tried to keep the reforms somewhat in the public eye. In 1999 we put out a proposed rule setting tolerances for Section 18's, and in that rule we also solicited comments. We asked for comments on the NASDA/AAPCO recommendations. In 2001 we began to refocus on the reforms. The states did as well. AAPCO formed a task force. We met with the task force back in August to discuss the feasibility of all eight of the reforms, and at the conclusion of the meeting, these were the reforms that there was a consensus on in terms of going forward.

So the first reform is renewable exemptions. EPA authorizes a Section 18 by no longer than one year, and quarantine exemptions are for three years. This proposal is that if certain criteria are met, the agency would allow states to recertify an emergency situation up to two years following an initial authorization. Why are we doing this? Well, approximately 70 percent of our Section 18's are repeats, and given the high level of repeats, we feel that this approach would help conserve some resources. Certainly the state resources.
And how would it work? The first year the request would come in and we would do an assessment. Assuming that it's a renewable exemption, the assessment would be based on risk, which it always is -- dietary -- because we need to set a tolerance, ecological, environmental and occupational. We also have to determine progress towards registration. We also have to validate the emergency. And since this would be a renewable exemption, we would have to determine whether the emergency met certain criteria for a renewable exemption.

Possible criteria. The pest has developed resistance to alternatives and that's been documented. Alternative products aren't available due to cancellation. It might be a new pest. Documented loss of efficacy of registered alternatives. The key to these particular alternatives is, I think, predictability in that there is probably a good chance that these requests would last. The emergency would persist for two to three years. When would a renewable exemption be unlikely? A new crop. Weather related pest outbreak. That's not to say that someone wouldn't get a Section 18 because they had a lot of rain, but there is not a lot of predictability that they're going to have rain the next year. Poorly documented emergency situation. Sporadic pest outbreak. Again, there is not a lot of predictability there. Or where the alternative product is unavailable due to a supply shortage.

How would this process unfold? EPA would do their assessment, and at the end of their assessment if we conclude that this would be acceptable and we grant the exemption, this would be, again, a renewable exemption and it would be a one year exemption that could be renewed for two subsequent years pending EPA's review and approval of the state's confirmation that the emergency still persists. Again, the states would be required to recertify the emergency to EPA each subsequent year after the initial authorization. In terms of quality controls, recertification of the emergency would prompt the agency to reevaluate the situation each year. If any changes in the status of the exemption occur, if we receive new information, the agency would have to determine how that new information would impact the continued use of the exemption. We would notify the state. Let them know what the changes are and how those changes might impact the exemption.

Another quality control measure would be that if EPA receives new information at any point during the renewable exemption. We would inform the states that recertification is no longer an option. If, for instance, in year two the state recertifies the emergency, we approve it and six months later we have new information that impacts the exemption, and the state still wants to consider that use prior to the next growing season, they would have to then submit an application and inform the agency how our particular argument is -- makes sense to them or not and how they would rebut our arguments. So that's renewable exemptions. Next is exemptions for resistance management. Currently, the agency's position is that Section 18's may only be authorized for resistance management in cases where documented pest resistance to the registered alternative has already developed and is expected to result in significant economic losses. The proposed reform is that if certain criteria are met, we would allow the issuance of an emergency exemption for an alternative to be used in conjunction with the registered pesticide, again where there is documented scientific evidence that resistance has developed to the currently registered pesticide, even though the degree of resistance may not have resulted in significant economic loss.

And how would these reforms work? As I mentioned, we would grant the exemption for the alternative in cases where there is documented evidence that shows that resistance is happening to the currently registered pesticide. Now, having said that, criteria would need to be established to provide guidance as to when a requested alternative could be granted under a Section 18 for reasons of resistance management. One example might be that the requested pesticide must be of a different chemical class, or a different mode of action from the currently registered pesticide. Specific criteria would need to be developed. We're in the process of doing that. Certainly, any ideas that you might have regarding criteria to resistance management would be most welcome.
MR. CAULKINS: Thanks, Rob. Now, Dave Widawsky is going to briefly explain the proposed reform on defining economic loss.
MR. WIDAWSKY: Thanks. Thanks, Pete. Well, the first question that we ask ourselves, and reasonably you ought to ask us, too, is why do the criteria need revision for determining significant economic loss. And I'm going to introduce three ideas about our reasons why we want to consider revising the criteria for determining significant economic loss.

The first one is the point that Rob made earlier, that the states have asked us to please think about are there ways to reduce the data burden that we currently have that is required in order to make our determination. Some of the states believe that the data that we're requiring can be onerous and can take a fair amount of time to collect, and we've been asked to reflect on whether we can responsibly make our determination of significant economic loss with less data. The second reason to consider revising the current criteria is a systematic difference in agricultural production systems that may lead to what we might call an unlevel playing field in some cases. And I'll talk about that when we talk about the limitations of the current criteria. And a third reason is that if we can actually make our reasonable determination and be responsible with less resources from the states, it's also going to require the agency to spend less resources on analyzing this data, so it would be a win/win situation for everybody involved.

So what I'm going to do, is I'm going to quickly recapitulate what are the current criteria for determining significant economic losses and what are some of the limitations of those criteria in relation to what I've just mentioned, and then talk about what we would like to propose for new data requirements, new methods for determining significant economic loss, and what some of the implications of this tiered system of data would be.
The current system for determining significant economic loss is based on normal or observed historical patterns of crop variations. What we've been asking for is for historical data. Five years of data on the production of that crop, the prices associated with that and the cost of production. And what we do with that is try to determine -- we make a determination of what the profit would -- the normal profit -- the historical pattern of profits would be.

When we look at the base line, we compare that base line to what the emergency situation would be in terms of potential losses and yield, and in addition to losses and yield, potential changes in quality from a particular pest or insect disease or weed. And then how the -- in addition to the potential revenue impacts, what cost impacts would arise from changes in pesticide costs, pesticide application costs, potential changes in operating costs from making different -- using different equipment, or making additional applications, or changes in harvesting costs. And then we estimate the level of profits and what the difference in profits would be. If the impact of the emergency situation leads to profits that are outside that five year pattern that we have observed from the historical data, then we make a determination of significant economic loss. This has worked for us reasonably well, but there are some limitations to this method for determining significant economic loss.

The first is that, as most agricultural producers can attest, the profits don't fluctuate the same for all crops. My background is in agricultural production economics. And there is a lot of data to suggest that rain fed crops have -- because of the dependence on -- it depends on the rainfall in a given year, have profits that fluctuate much more widely -- or I shouldn't say widely. But much more substantially than crops that have a more controlled water control system like irrigated crops. And so the result of that is that the pattern of historical variation is going to be wider for rain fed crops and require the emergency situation to lead to a profit loss that is greater in order to fall outside that pattern of historical variation. And we've been asked to consider whether that is something that we want to reform or consider revising our criteria in order to take that into account. The second limitation is that the historical data may be affected by the emergency condition if we're relying on historical data and we have a Section 18 situation that has been occurring year to year. Over time we start to see impacts on profits and costs and pesticide use that is incorporating the Section 18 exemption, and it becomes more difficult to separate out the emergency condition from the base line condition when we're relying on historical data.

And third, the historical data may not be available for minor crops for five years in a lot of states. Those data can be hard to come by, and when we can get them, they're not always as well documented as we would like them to be. So what are we proposing? We're proposing to go to a tiered system of data requirements for determining significant economic loss. And the idea is that we would start off at a lower tier with a smaller data burden, and then depending on the findings at any given tier, increase the data requirements as we go -- if we can't make the determination at a lower tier. The first tier that we call tier one is yield based, and it's based on the presumption that if yield losses are high enough, then you can reasonably make a determination that significant economic losses are going to occur. If somebody is anticipating that they're going to lose 50 percent of their revenues, you don't have to get detailed -- we believe that you don't have to get detailed information on every pesticide application to realize that, hey, that's going to be a problem and we're going to realize significant economic losses.

And so that one of the challenges becomes how do you determine what the threshold would be, and that's something that we're working on, and I'll get into that in the case study I'm going to present next. But I just wanted to introduce that to you at this point. And what it does, it allows to even a threshold among crops and so you're not trying to downsize the historical variation, but we're setting the same threshold for different kinds of problem systems. In some cases, the economic loss isn't going to come from yield changes, but it may come from changes in the quality of the produce -- the fruits and vegetables. That's often the case for emergency situations. And so in that case -- in those kind of cases, we would like to be able to go to a second tier, and that considers economic loss as a percentage of gross profits.

In that case, we're taking into account the yield loss, but we're also accounting for price and quality effects on the changes in pest control costs. And we would compare an economic loss defined as total revenue plus changes in pest control costs as a percentage of gross profits, and that allows us to take those price quality effects into account, and make a determination with more data than we would need under the yield based tier, but still a lot less than we would require under the historical variation method. And then increase in the data requirements. If we're not finding significant economic loss in tier one and tier two and the application reports that there is an economic loss, we can consider a third tier which would look at economic loss as a percentage of operating profits. And that's getting us closer to the analysis that we're doing now in terms of data requirements for the current year, but it's basing the determination on the base line versus the current year without necessarily going to a historical variation method and setting some kind of a threshold or standard for what that percentage would be to come to a determination of significant economic loss. So those are our tiers. And what we did is a case study, taking 89 Section 18's analyses that we did in the 1998-1999 season, and considering the analysis that we did under the current criteria, we are reanalyzing those data under our tiered system to see what would happen if we -- would we get different answers. Would we -- are we completely out of kilter here in proposing these.

What we did, is we estimated based on these 89 applications what would be -- what was the yield loss that was associated with it and under the current system did it lead to significant economic loss or not. We did the same calculation for tier two, economic loss as a percentage of gross profits. And then also for tier three, economic loss as a percentage of -- gross profits and then the tier three operating profits. And what we found was that there was no noticeable difference in the likelihood of determining significant economic loss. And what that told us basically is that we could use a lot less data -- and require the states to provide a lot less data -- and relieve some of our burden in making the determination and basically come up with the same likelihood of determining significant economic loss.

In a substantial number of the cases, about half the cases, where there was a finding of significant economic loss under the historical or the current method, yield data alone would have sufficed to come to that determination, and that suggests to us that there is a real potential for reducing the burden to states and the agencies for collecting and analyzing these data. Now, this was a real quick jog through our proposed changes for making significant economic loss determinations. If you want more information, we do have a -- there was a handout at the front on the proposed methodology, and we'll get a chance to talk about it more in the discussion section.
MR. CAULKINS: Thanks, Dave. Rob, do you want to do the next steps?
MR. FORREST: We're going to close with going over some next steps. What we're going to be doing is issuing a proposed Federal Register notice for public comment. We hope that that would happen in the summer of 2002. On an interim basis, we will be implementing the reforms in the 2003 growing season. This would provide us an opportunity to gain some experience, to test what works and what doesn't work. At the same time, we would be considering public comments, and we're going to pay very close attention to how these proposed reforms impact on the Section 18 process. After that, we'll gather up our experience and we'll report back to this committee and we will revise accordingly. Okay. Now, I would like to have Robin's -- one of our panel members -- presentation.
MS. ROSENBAUM: Thank you. As Peter said, I am here to talk to you about the perspective of the AAPCO Section 18 Task Force, and also the perspective of the sole Section 18 submitter for the State of Michigan, which has particular impact on this first Section 18 revised procedure recommendation. I've got a Power Point up there somewhere. Well, I'll get started. On the renewable Section 18 exemptions, we believe that EPA should allow states to recertify the emergency situation for the second or third year based upon the state's confirmation that the basis for an emergency situation continues to exist.

Most of the Section 18's that we request are due to the fact that the registered alternatives are no longer efficacious or not efficacious enough, or perhaps there has been a cancellation of a key pesticide, and the pesticide that we've requested under Section 18 is the best in the pipeline, if not the only product in the pipeline. So it's our feeling that if the product doesn't get registered during the year in which we've asked for the Section 18, then the urgent situation still exists in the subsequent year and would therefore warrant another Section 18 exemption. Another reason why we are supportive of this revised procedure is that data from the current season are difficult to obtain early. In Michigan where we have a single growing season, we harvest into October and oftentimes it takes, you know, a month or two or three perhaps for the growers and the Extension specialists to compile the data necessary to update the Section 18 for the subsequent growing season. That's not mine. I'm trying not to look at it. Okay. It just says PPDC, Robin on there. That's okay. There are only six of them.

So, anyway, what that does is it delays my ability to get the Section 18 into EPA until perhaps January or February or March, when I barely speak to anybody else in the office. All I do is have my head down working on these, and this year, 18 Section 18 exemptions.

So you can see that the timing issue is a problem, that by the time EPA gets the application -- and I had to put a plug in for EPA. I mean, they've done great in terms of streamlining their end of the process and the turnaround has been great. It's just that we can only get the applications in to them so early. And this pushes us right up against the growing season, and oftentimes the situation is that the growers don't know until the height of the pest occurrence whether or not they're going to have a Section 18 material. So that creates some obvious difficulties for the grower. If we could get the -- if we could certify the Section -- recertify that the emergency situation continues to exist and give the growers an extension of heads up earlier, we would have a lot more time for the growers to strategize their spray schedules for the summer, and there would be a lot more time for product stewardship. Our Extension specialists are out all -- you know, in their winter meetings all year, and they've sort of got their hands tied when they can't talk about whether or not the Section 18 products will be available in the subsequent growing season.

So if we could recertify in Michigan, for example, in December -- or even January -- that they're going to have the product in the upcoming growing season, then clearly that creates a much better situation, and particularly when you're talking about resistance management and development of a resistance management plan.

And the obvious one, better utilization of resources for the growers, the Extension specialists, the state lead agency and EPA. I think it would give us more time to focus on the initial applications and do perhaps a better job of putting those applications together. But we're continually being asked to do more with less and less and obviously need to prioritize our tasks. Michigan -- or the Governor just announced an early out package and told us that those of us who are left standing for the next 20 years can only rehire one in four positions. So we just lost 16 people. We get four back. That just tells you what our work environment is like.

And last but not least, on this one, of course EPA retains its authority to rescind or deny the emergency exemption for cause should additions to its risk database warrant such a decision. So there is always that fail safe. So we really feel that this is a win/win revised procedure recommendation. Resistance management. We feel EPA should support Section 18 exemptions for resistance management where there is documented scientific evidence of resistance to currently registered pesticides or valid research demonstrates the dynamic process of resistance is developing. As you know, resistance management is the process of prolonging the useful life of a pest control tool by delaying the selection of pest populations that are resistant to it. Resistance management programs are seen philosophically in the context of integrated pest management, where in IPM programs pests are held below economic injury levels by utilizing optimum combination of strategies which offer the most minimal adverse effects. To require growers to use up all of their effective pest management tools before the situation is considered an emergency as defined by Section 18 regulations seems to not be in accordance with IPM.

The future success of resistance management depends upon the continued availability of a diverse arsenal of efficacious pest management tools. The benefits of this would extend to the consuming public and to the environment as a whole through the increased availability of wholesome produce at affordable prices and reduced pesticide load to the land, water and air. And I have to throw in the Colorado potato beetle example in talking about reduced chemical load in the environment. Several years ago I put together Section 18's for use of a few products for the Colorado potato beetle. And in going through that process, we surveyed the Michigan potato growers and asked them to submit a list of the chemicals they were using to try and control this pest.

I mean, it was pretty incredible what they were doing. Basically, we saw the word cocktail on their spray list many, many times, that they were taking several insecticides and throwing them in the spray tank and hopefully some combination of those sprays were going to kill this persistent pest. So we eventually obtained the Section 18 exemption for Metaclopred and, you know, hugely reduced the pesticide load on the environment.

So while it's unrealistic to expect the emergency exemption process alone to provide the solution to the pest resistance problem, we feel that its judicious use in a proactive manner could offer a significant contribution to the resistance management effort. And lastly, significant economic loss. We feel that EPA should support the use of yield loss and/or other economic indicators instead of or in addition to the five year production cost averages for crops with a high variability. And I won't spend a lot of time on this one, since David did us such a nice job of laying it out.

But most of our Section 18 exemptions are for use on minor crops. Seventeen of the 18 I processed this year for Michigan alone were minor crops. Current agency guidance says that loss is significant only if it exceeds the normal variation of profits over a five year time frame. States and growers feel that this practice discriminations against minor use crops with high variability, because a much higher loss is required to fall outside of the normal range and it doesn't take into account a number of factors outside the control of the grower, which cause fluctuation in profits and losses and mask the emergency nature of the situation. An example of a situation that wouldn't fit the classic economic scenario is powdery mildew on watermelons. It is a serious late season disease, where the disease defoliates the vines exposing the melons to sunburn. Sun exposure turns the melons pale, almost white, resulting in a poor quality product. The yield numbers don't reflect the loss, because the grower can still harvest the sunburned melon crap. The powdery mildew stunts the plants and the melons, so the grower will feel the losses in the grade. Grower pack outs are the best way to analyze crap loss. The pack outs reveal the fluctuation crap grade as a result of the disease pressure. So basically that's it. Thank you.
MR. CAULKINS: Thank you, Robin. I'm going to ask Adam Goldberg from Consumers Union now to provide us with a public interest group perspective.
MR. GOLDBERG: Thank you. On the renewable exemptions, we certainly don't want EPA or the states to be wasting any resources. However, to us this proposal seems to be more about making it easier to get Section 18's that may or may not be warranted. It is one thing to streamline the process, but not if it takes the emphasis away from the real reason behind the Section 18 program. Our problem is that the whole idea of Section 18's is that they are for unpredictable, unusual and nonrecurring pest management emergencies. If the agency is asked to grant a two or three year Section 18 because of solid evidence showing that an emergency will exist for the next two or three years, the pest problem justifying the Section 18 seems well outside the definition of an unpredictable emergency.

If the goal of this current Section 18 reform process is to develop a new category of temporary limited registrations, let's be honest and up front about it and retain the Section 18 program as is, since it clearly does serve a vital, although too pliable, purpose. If there is a continuing need for a particular pesticide to be used on a particular crop year after year, then there is no longer an emergency use and the resources should be put into getting a permanent tolerance or registration in place. In fact, if the goal is efficient use of resources, why not speed up permanent registration for reduced risk, low exposure products and uses. If you look at the numbers that were presented, there are far too many Section 18's granted and the numbers seem to be going up every year. And there are very, very few denials, and while the denial numbers are higher in 2001 than in 1996, it's not an appreciable difference really. It's a very small number of the overall numbers of submissions. Basically from our perspective, the Section 18 process has gotten too routine and that's really a problem. EPA should tighten up the Section 18 process. Figure out a way to speed up reduced risk registrations and get on with some other pressing business.

On the resistance management exemptions, we think that this proposal makes more sense than the renewable exemptions. The agency has registered a few dozen very promising effective reduced risk and biopesticide products in the last five or so years, yet many are highly vulnerable to resistance problems because of their specific mode of action. It is a good idea, indeed essential for EPA to pull out the stops in an effort to head off resistance problems to key active ingredients. The Section 18 program can play an important, albeit a limited role in achieving this goal. Section 18's in the name of resistance management should only be approved by the agency, however, when there is solid evidence showing that both registrants and growers are doing everything they can through other means to responsibly manage resistance. Accordingly, if EPA accepts resistance management as a criterion for approval of Section 18's, the applicant should be required to document that all other recommended proven resistance management strategies are being used to the full extent possible, and that still resistant populations are growing more common and/or levels of resistance are growing. In addition, explicit and strict resistance management language should be incorporated onto the labels approved covering resistance management driven Section 18's. Plus, the label should specify acceptable rotations of active ingredients as well as unacceptable