Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

October 20 & 21, 1999

ATTENDEES

John Ehrmann, Meridian Institute

Gary Guzy, EPA's General Counsel

Susan Wayland, Deputy Assistant Administrator for Prevention, Pesticides and Toxic Substances, EPA

Jim Aidala, EPA

Steve Johnson, Deputy Assistant Administrator for Prevention, Pesticides and Toxic Substances, EPA

Marcia Mulkey, Office of Pesticide Programs, EPA

Margaret Stasikowski, Director of the Health Effects Division in the Pesticides Program

Bill Jordan, Office of Pesticide Programs

Bill Spencer, American Farm Bureau Federation

Elin Miller, Dow Chemical Company

Steve Balling, Del Monte Foods

Robert Keifer, Chemical Specialties Manufactures Association

Mark Whalon, Michigan State University

Mark Greenwood, Ropes & Gray

Wally Ewart, Northwest Horticulture Council

Paul Helliker, Director, Department of Pesticide Regulation in California

Bill Lovelady, National Cotton Council

Mark Miller, American Academy of Pediatrics

Steve Pavich, Pavich Family Farms, California and Arizona

Nancy Rachman, American Cyanamid

Robin Spitko, National Alliance of Independent Crop Consultants

Mark Trostle, Texas Department of Agriculture

Dave Whitacre, Novartis Crop Protection

Bob Rosenberg, National Pest Control Association

George Wichterman, Lee County Mosquito Control District, Fort Myers, Florida

Jose Amador, Texas A&M University, Research & Extension Center in Weslaco

Jay Vroom, American Crop Protection Association

Margaret Wittenberg, Whole Foods Market

Rick Jarman, National Food Processors Association

Dan Botts, Florida Fruit and Vegetable Association

Mike Linker, North Carolina State University

Jon Jessen, Gowan Company, Yuma, Arizona

Jamie Clover Adams, Secretary of Agriculture from Kansas

Lois Rossi, EPA

Jack Housenger, EPA

Therese Murtagh, USDA

Al Jennings, USDA

Keith Pitts, USDA

Richard Rominger, Deputy Secretary, USDA

Larry Elworth, Program for Strategic Pest Management

Henry Anderson, Wisconsin Bureau of Public Health

James Czub, National Corn Growers Association

PROCEEDINGS

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MR. EHRMANN: I would like to welcome you all to this proceeding of the EPA/USDA Tolerance Reassessment Advisory Committee, affectionately known as the TRAC. What I would like to do first is go around the table for introductions, so that folks in the audience can get a beat on who is where and put a face to a name, et cetera. I would ask that the folks who are here sitting in for others as official designees just indicate the TRAC member for whom you are sitting in, so that folks, again, can kind of recognize who is here in terms of organizational affiliation. Then we will turn it to the co-chairs for some opening comments, and then I will review the agenda and we'll get into the day.

Let me start the introductions by saying I am John Ehrmann from Meridian Institute. Gary?

MR. GUZY: I'm Gary Guzy, EPA's General Counsel.

MS. WAYLAND: I'm Susan Wayland. I am the Deputy Assistant Administrator for Prevention, Pesticides and Toxic Substances at EPA.

MR. AIDALA: Jim Aidala from EPA.

MR. JOHNSON: Steve Johnson, Susan's Deputy.

MS. MULKEY: Marcia Mulkey, Office of Pesticide Programs at EPA.

MS. STASIKOWSKI: Margaret Stasikowski, Director of the Health Effects Division in the Pesticides Program.

MR. JORDAN: I'm Bill Jordan. I work in the Office of Pesticide Programs.

MR. SPENCER: I'm Bill Spencer. I am an Arizona citrus farmer, and I represent the American Farm Bureau Federation.

MS. MILLER: Elin Miller of the Dow Chemical Company, representing Dow Agri Sciences.

MR. BALLING: Steve Balling, Del Monte Foods.

MR. LUCKEY: Brad Luckey. I'm a farmer from southeastern California.

MR. KEIFER: Robert Keifer with the Chemical Specialties Manufactures Association, sitting in for Ralph Engel, President.

MR. WHALON: Mark Whalon, Michigan State University.

MR. GREENWOOD: Mark Greenwood, Ropes & Gray.

MR. EWART: Wally Ewart, Northwest Horticulture Council.

MR. HELLIKER: Paul Helliker, the Director of the Department of Pesticide Regulation in California.

MR. LOVELADY: Bill Lovelady. I'm a cotton producer from Texas, and I represent the National Cotton Council.

MR. MILLER: Mark Miller, American Academy of Pediatrics.

MR. PAVICH: Steve Pavich, Pavich Family Farms, California and Arizona.

MS. RACHMAN: Nancy Rachman, American Cyanamid.

MS. SPITKO: Robin Spitko. I'm an independent crop consultant from New England, and I'm representing the National Alliance of Independent Crop Consultants.

MR. TROSTLE: I'm Mark Trostle of the Texas Department of Agriculture, representing the Association of American Pest Control Officials, which is all the State lead agencies.

MR. WHITACRE: Dave Whitacre, Novartis Crop Protection.

MR. ROSENBERG: Bob Rosenberg with the National Pest Control Association.

MR. WICHTERMAN: George Wichterman with the Lee County Mosquito Control District in Fort Myers, Florida.

MR. AMADOR: Jose Amador, Texas A&M University, Research & Extension Center in Weslaco.

MR. VROOM: Jay Vroom, American Crop Protection Association.

MS. WITTENBERG: Margaret Wittenberg, Whole Foods Market.

MR. JARMAN: Rick Jarman, National Food Processors Association, for John Cady.

MR. BOTTS: Dan Botts, Florida Fruit and Vegetable Association.

MR. LINKER: Mike Linker, North Carolina State University.

MR. JESSEN: Jon Jessen, Gowan Company, Yuma, Arizona.

MS. ADAMS: I'm Jamie Clover Adams. I'm the Secretary of Agriculture from Kansas, sitting in for former Secretary, Allie Devine.

MS. ROSSI: Lois Rossi, EPA.

MR. HOUSENGER: Jack Housenger, EPA.

MS. MURTAGH: Therese Murtagh, USDA.

MR. JENNINGS: Al Jennings, USDA.

MR. PITTS: Keith Pitts, USDA.

MR. ROMINGER: And Rich Rominger, USDA. Well, I want to welcome all of you to this last scheduled TRAC meeting. I think since we began this process a year and a half ago that there have been a lot of changes, and I think we've made some significant progress in implementing the Food Quality Protection Act.

We've had some new and difficulty science policy issues being developed in an open and public process. We've had risk assessments and risk management processes that have been put in place that have ensured broad stakeholder involvement and the opportunity to help shape the regulatory decisions that EPA must make. And I think we've all learned a bit more about the various perspectives on pesticide regulation in general and FQPA in particular.

Both EPA and USDA have profited from your advice and your insights, and we want to thank you for your participation. Thanks to your efforts, FQPA implementation, I think it's been a success, or certainly at least not the disaster that many predicted.

EPA met the first deadline for tolerance reviews. There are many continuing concerns, however, in the agricultural community and by others, and I think we must acknowledge that FQPA does have the potential to have some major impacts on farmers as well as other sectors. However, EPA and USDA have worked together to implement the Act without the kind of severe impacts that many believed were inevitable.

But we are far from finished. Many issues remain, including the requirement to consider cumulative risks. However, I think we have established the framework for working together, and we've identified and adopted processes that work. The challenge ahead of us to maintain the momentum and the spirit of cooperation that we've had.

So I think it's important to establish a process for the future. EPA and USDA, and I personally, are committed to do so, and this is one of the important topics for this meeting. So we need your input and your advice.

On the agenda for tomorrow is a proposal to take some additional steps to improve the process. The proposal will capitalize on the expertise available from the many interested stakeholders, including our land grant partners and our farmers and ranchers, those who face the very real problems of managing pests. In many cases, I think these are the people who can best tell us how to mitigate the calculated risk through changes in pesticide use patterns.

Finally, on the subject of transition, there are several interpretations, I think, of what constitutes a transition strategy. To some it's the development and implementation of a plan of action to alter pest management tactics and move toward a biologically based system. Others look at transition as a contingency plan to be implemented only if certain events occur. Still others have a transition strategy and believe that a transition strategy can only be successful if it's focussed on a specific chemical pest issue and is a short term effort to fill gaps created by some regulatory action.

Well, I suspect that transition strategies will be a hybrid of all of those above characteristics.

I think as in the past TRAC meetings, I'm confident that we will have a lively discussion, and we certainly look forward to hearing from all of you over the next day and a half.

I want to next turn it over to Gary Guzy, the General Counsel at EPA. Gary, I hope you know what you're getting into. You know, your two previous predecessors no longer work for the federal government.

MR. GUZY: Yeah, there seems to be a certain pattern here.

MR. GUZY: Which I think speaks well for this committee, actually. I would like to welcome you on behalf of EPA to the final Tolerance Reassessment Advisory Committee. We know that you're busy. We know that many of you have come quite far. We know that Washington's roads don't make it easy to get here. And we know that you've come often, and that you've given a lot of yourselves in this process.

And our view very firmly is that we, the federal government, have benefitted tremendously from the collective advice that this group has been able to provide to us throughout this process.

As you know, and as Rich mentioned, and as is obvious, there have been a number of changes in the agency's senior leadership throughout time. You all worked closely with Lynn Goldman, Fred Hanson and Peter Robertson. And I'm here this morning to make it absolutely clear that the senior leadership at EPA remains strongly committed to this group, to the processes it has developed, and is looking forward to a continuing working relationship that would be productive with all of the groups that are represented around this table and those who may not be here today.

Administrator Browner has asked me to make clear that we continue to devote a significant degree of senior leadership attention to the issues that this committee considers. Along with Susan Wayland, Jim Aidala and Steve Johnson, our team from the Office of Prevention, Pesticides and Toxic, we will continue to respond to the concerns raised by this group and others as we go through the important work of implementing the Food Quality Protection Act.

I look back and try to assess what have been the benefits of this group, and as we as an agency sat down to think about it, it seems that there are a number of absolutely critical steps that have occurred in our work as a direct result of the kind of thoughts that have emerged from this process.

One of the most significant is the degree of transparency that now permeates our entire approach to tolerance reassessment to implementation of the Food Quality Protection Act. The public has the benefit of understanding what we do. The interest groups who are represented here I think have a far clearer picture of what we do.

When we engage in risk assessments, it should be now much more obvious the approach that we're taking. We now have in place policies and standard operating procedures that really benefit, as well, from input from these groups.

We have a timely process and a meaningful process to assess tolerances for organophosphates. We have made remarkable progress in developing and issuing for public comment science policies that revolve around nine critical issues that this group has identified that are important for our work in the tolerance reassessment area.

And in addition, and this should not be under estimated, we have developed an unprecedented cooperation with the U.S. Department of Agriculture in this work and as a direct result of this process as well. And that's a critical component of our continuing work in this area and has benefitted all of us tremendously. We're very grateful for that.

In short, since our first TRAC meeting in May of 1998, we've made tremendous strides in our ability to work cooperatively with all of you to conscientiously involve all stakeholders in the regulatory decisions that EPA is making.

We went back and looked at five ideas that we sought the advice of this group on that were set out in a memo from Secretary Glickman and Administrator Browner to the Vice President when this work commenced. And let me briefly run through the objectives that we specifically asked this group to think about as we committed to the principles of sound science, transparency, stakeholder involvement and a reasonable transition for agriculture.

First, we wanted to know what process was appropriate for tolerance reassessment that would ensure public participation and transparency. And as a result, we've worked with you on a pilot process for review of organophosphates that has promoted public involvement and, we believe, public acceptance of the results, to review and comment on risk assessments, technical briefings that promote better understanding of the technical bases for EPA's thinking and actions, and opportunities for stakeholder involvement in risk reduction efforts as well, all in a manner that is appropriately docketed and reflecting that input.

Second, we asked what is the proper policy framework for deciding if there is adequate scientific information for making tolerance reassessment decisions. When should we be seeking new information? When is it appropriate to use science based assumptions. When is it appropriate to use exposure scenarios? What is the best methodology for actually making risk assessments?

Again, through the TRAC process we identified important public policy, scientific issues that were critical, and in fact have identified the areas where we believe that we can make the most accurate and the best estimates of potential risk from pesticides. These are complex policies, as you all know better than anyone. They're at the forefront of the ideas of risk assessment methodology. And we have committed to an ambitious public process for setting out EPA's approaches and refining these principles.

Third, we asked to have input on ways to speed the pace of decision making to make newer and safer pesticides and new uses of existing pesticides that meet FQPA requirements available to growers, so that there would be safer substitutes. And we believe we have put in place a process where alternatives to older, more risky chemicals can be identified. They can be given a higher priority for review. Safer chemicals can be brought into the marketplace as rapidly as possible. And we have a new partnership with USDA in order to work with growers to foster the dissemination of chemicals such as this.

And for the past year, the agency has registered 26 new pesticides, 19 of which were bio-pesticides or conventional chemicals that are considered to be reduced risk pesticides.

Fourth, we sought appropriate common sense strategies for risk reduction, while retaining pesticides of high public value and then implementing phase out schedules that are reasonable for those pesticides that may require action.

And today in partnership with USDA and FDA, we are working more closely than ever to determine the most reasonable ways and the most reasonable time frames to make changes to pesticide uses that will help to reduce risks that pose concerns.

And let me point to -- and we'll speak about this later -- as an example the action that was taken on Methyl Parathion since the last TRAC meeting, where we targeted approximately 10 percent of the use, but were successful in eliminating approximately 90 percent of the risk posed by that pesticide.

And lastly, we asked about determining priorities in considering the challenges that were posed by implementing the Food Quality Protection Act in considering organophosphate pesticides such as those most likely to lead to exposure in children's food. Exposure and risk to kids, which was one of the motivating factors for the Food Quality Protection Act.

The agency has developed and announced publicly a rigorous schedule to complete tolerance reassessment and to review individual organophosphate chemicals. And we fully intend to meet those schedules and are very firm and serious about that commitment as well.

The previous six full TRAC meetings, combined with a significant number of subgroup meetings, provided a successful forum for us to consider and discuss each of these issues to attempt to reach consensus on a process that would achieve the goals of FQPA implementation effectively that would involve all of us, all of our stakeholders, on equal ground and equal footing. And through the hard work of this group, we believe we have laid a very solid foundation on which EPA and USDA can move forward with the task of completing the assessment of tolerances required by the Food Quality Protection Act.

But one of the main goals for us here at this final TRAC meeting is to discuss -- to receive your input on options that will allow us to build a firm foundation to continue the work on the foundation that's been put in place so that we can move forward with the requirements of future reassessments of tolerances, review of pesticides, continuing to assure that we have the safest and most abundant and affordable food supply in the world.

And we certainly look forward to your advice on this critical, important issue of what should be the structure of engagement with stakeholders on these future issues. But let me assure you that it is our firm commitment, regardless of what kind of structure emerges, that we continue to follow sound principles of sound science, transparency, public involvement, and a reasonable transition for agriculture as we move forward to ensure an even safer environment for ourselves and our children.

Let me also point out that since the last TRAC meeting EPA has taken a number of important steps, and we hope that during the course of this meeting, you'll have the opportunity to learn even more about them. But they include the publication, either in the Federal Register or for public comments, of some six science policy related documents, some eight technical briefings held on organophosphates, and approximately 14 revised organophosphate risk assessments or risk management options that have been shared with the public, where we have solicited public comment. Again, an unprecedented degree of work to ensure that we have the views of you and your colleagues as we go about carrying out these responsibilities.

And in August of this year, we took action -- that I'm sure we'll talk about further -- to mitigate risks from Azinphos Methyl and Methyl Parathion, and we believe very clearly that these important regulatory actions embodied the principles that we've outlined and committed to.

In sum, the TRAC process for EPA has been critical. It has been educational. It has allowed us to move forward in a way that we believe is responsible and responsive to the public and to the concerns that have been expressed around this table. We believe it has afforded the members of this advisory committee a far better understanding of how EPA regulates pesticides and approaches its responsibilities. And we certainly believe that it has given EPA a far better perspective of the needs and concerns that have been expressed by this group and that are important to the stakeholders here and your constituents.

Mr. Rominger and I and our team at EPA would like to thank you again for the incredible commitment of time, energy, talent, professionalism and enthusiasm that we believe have been critical to the accomplishments of the TRAC, and we look forward to hearing your ideas and comments in the next day and a half about how to move forward from here.

Thank you.

MR. EHRMANN: Thank you, Gary and Rich. Let me just spend a couple of minutes walking through the agenda, so we're all clear about how we're going to proceed over the next day and a half.

The first item we're going to turn to in just a minute will be updates, as you can see on the agenda in front of you, on a number of issues that have been talked about by the TRAC through the course of the meetings that Gary and Rich just described. And as usual, we'll have a short presentation from staff on each of those issues, and then an opportunity for you to ask questions and interchange thoughts with the folks who have made those presentations and other resource people who are here from EPA and USDA.

So we'll go through those presentations. We'll take a short break at 11 o'clock. Following that we're going to have an opportunity for a more detailed update and status report on where we are in terms of the organophosphate reviews. And you can see a number of sub-issues that Lois will be touching on in that update.

Then following the lunch break, we'll have a couple hours to discuss the transition issues, and Al will lead us in that discussion. USDA has done a lot of work on transition since the last time the TRAC met, so there is quite a bit to be updated on there and some new thoughts that I know they'll be sharing for discussion.

And then following the afternoon break, we'll discuss the issue of tolerance revocations and channels of trade. This is an issue that has come up and has been touched on in some earlier TRAC meetings, but we've never delved into it in any depth. And we've got three folks, as you can see on the agenda there, folks you're familiar with, who will be discussing that issue from the various agency perspectives. And, again, obviously opening that up for discussion and soliciting your advice on how to proceed in that arena.

We'll have an opportunity for public comment at 5:15. I would ask anyone here in the public who wishes to make a comment to sign up on the sign up sheet outside, so that we can gauge how many folks wish to make a comment and apportion our time accordingly at the end of the day.

Tomorrow we'll start off with a review of the current status of the public participation process, the so-called pilot process as we've referred to it, and discuss some potential modifications or options that might be incorporated into that process based on the experience that has been accrued to date.

And following that then we will have a discussion as the co-chairs have referred to about post-TRAC activities. There is, I know, a lot of interest in what's going to happen next. What are some of the approaches that might be used by the department and the agency to continue interaction with all of you in one form or the other. And we want to solicit your thoughts on that, and we have some thoughts that we will be sharing in terms of some of the criteria and issues that should be thought about as you all give your advice on how to proceed in that arena.

And then we'll have another opportunity for public comment, and we will adjourn no later than one o'clock based on this agenda. As always, we hold open the option of modifying the agenda as we go forward, if we need to in terms of these time lines. And I'll do my best to keep you apprised if we see any changes in the time lines based on the amount of discussion we need to have. But this is the guidelines we'll be following at this point.

So that's the overview of the agenda. Any comments on that before we -- I turn it over to Bill and Margaret? Yeah, Bob?

BOB: I think my comment -- well, it's not a comment. It's a question.

MR. EHRMANN: Sure.

BOB: There are some of us, I think, who would be of the opinion that there are issues that this process has not adequately addressed or discussed and or not contained on this agenda.

Is there some opportunity in these next two days for us to raise those issues? How do we do that?

MR. EHRMANN: Well, a couple of ways. One, I think if you have any -- and I know someone shared some thoughts in writing about some unfinished business, and those have obviously been received by the department and the agency. I think also when we discuss the post-TRAC activities, I think that needs to be a process discussion, but also it could be substantive in terms of, you know, raising issues that you think need to be addressed at some point in the future.

So I would say let's try to have that discussion at that part of the agenda, and that can be both substantive and process. And any other written communication that anybody wants to forward to the agency and the department obviously would be helpful as they consider the next steps.

Other questions or comments on the agenda before we get into it? Yes. You are Steve Balling.

MR. BALLING: Just checking. How come we don't have our names on the back?

MR. BALLING: I keep forgetting.

MR. EHRMANN: That's why I wanted to confirm that you had the right name tag.

MR. EHRMANN: Six meetings we've had and he's still trying to figure it out. Let me turn it over to Bill Jordan and Margaret to introduce us to the current state of the science policies.

Bill?

MR. JORDAN: Thanks, John. The agenda item says, cumulative risk assessment and other science policies. I'm going to start off talking about the other science policies as a way of setting the table for the one that is a culmination of the risk assessment process when we're looking at a group of chemicals with a common mechanism, the cumulative risk assessment.

Margaret will be making that presentation, but let me just wet your appetite a little bit by talking about the science policies, where we've been and where we're going. The information that I'm going to be speaking about is contained for the most part in TRAC paper number 41. And if you want to pull that out and look at it while we go along, that might be helpful. But I do have some late breaking news that I'll weave into this presentation.

The science policies are pretty comprehensive. We put together -- and you'll see in the TRAC paper 41 an overview of the nine different issue areas and how they all fit together. When we did that for ourselves, and we offer it here for you, what is apparent is that the science policies that we are presenting for public comment and advising and issuing as part of our commitment to transparency, covers -- these science policies cover everything from the beginning of the process to the conclusion at the risk management stage. And they look at all of the key cutting edge issues that come up as we are going through the tolerance reassessment effort.

We made a lot progress, I think, thanks to the work of TRAC in identifying what are the issues that we ought to be looking at, and then thanks particularly to the hard work of the folks in the science divisions, health effects division and environmental effects division in EPA, as well as other parts of the Office of Pesticide Programs.

The paper -- the two page paper that has schedules on it shows you which documents have been issued. And since the last TRAC meeting, we have issued papers relating to 10X. There were actually four of them grouped together under two different headings. We've issued the paper that explains our approach to taking the residue data we get from USDA's pesticide data program and de-compositing it to translate back from large five pound or ten pound samples to the possible residues that might be present in the amount of food that a person would eat at a single sitting.

We've also issued a paper on the way in which we take pesticide use information and put it into our risk assessment and risk management process. We've issued two sets of guidelines, one on how to bridge from high application rates to lower application rates, and the other how to characterize residue decline over time. And those both have significant implications for the way that we do our risk management.

And I might just say a word about those two documents. We issued them and so far the comment period is closed and nobody has commented on them. And I was amazed by that. I thought perhaps nobody noticed, but that was wrong. I did in fact check with folks and they said, as we believe, that they were good papers and that there really wasn't much in the way of comment or critique that people wanted to offer.

We probably will be keeping the comment period open and may be getting in some comments a little bit late. But I think there is a reflection of the really high quality of science that the folks in the Health Effects Division and Environmental FATE Effects Division are doing here.

The last document that you see up there, the Threshold of Regulation, is the most one. It has not actually been announced in a Federal Register notice. That will be published next Wednesday, and it is one that I think is significant because it represents our moving through the process of reviewing public comments, revising the paper in light of those public comments, and issuing the revised policy document. So look for that one to come through a Federal Register near you.

The next slide in this fast breaking world that we're dealing with is actually out of date, to be completed. The drinking water exposure assessments actually have been completed. They are being signed today and will be announced in the Federal Register either next Wednesday or the Wednesday after that, the 27th or the 3^rd.

It, too -- the paper on the drinking water exposure assessments is a revision reflecting the public comments. And we have moved ahead to combine several papers in the chart. Numbers 8, 18 and 19 will all be -- in fact counted as completed because we've concluded that they are appropriately covered in this last document.

The aggregate exposure guidance is in the hands of the folks in the AA's office, and we're confident that they will review it and endorse it and sign it shortly. And it, too, could be published as soon as the 3rd, but probably no later than a week after that.

Cholinesterase inhibition policy is also one that is scheduled to be signed in October. And we're working away diligently on that and have gone through virtually all of our science review on it and are in the final stages of the formal review process, which we hope will wrap up pretty soon.

The 99.9 percentile policy and residential SOPs are also revised documents that are scheduled for this December, and we're making good progress on that. I'm very confident that we will get the 99.9 percentile policy out toward the early end of the month, and the residential exposure SOPs are close on its heels.

And then finally the list up here includes a cumulative risk assessment, which is one which is scheduled to be published in January, following a review by the Scientific Advisory Panel in December. As Margaret will be discussing, we've already been doing a lot of work on this one. It will be put out for public comment, and then following the public comment, revised as are the rest of the documents.

I guess I want to just wrap up by saying that when the drinking water and the aggregate exposure guidance are -- or when the aggregate exposure guidance document is issued, we will have covered and put out for public comment all of the documents identified in the initial TRAC effort, except the cumulative risk assessment guidance. We will have done 18 out of the 19 papers that we originally said we would put forward.

Counting the drinking water paper, the threshold of regulation, we will have finalized, when those are published, five of the 19. And we have also, as you can see on the chart, identified a number of additional related papers that we'll continue to be working on and moving ahead with.

The progress that has been made in this area has been steady. It has been good. And I think it really -- and I've said this before and I want to just reemphasize how much we in the agency appreciate the input that we've gotten from the public. The comments that have come in have really been of exceptional quality. They have been thoughtful. They have been thorough. And they have been constructive.

And as a result, when our folks within the agency sit down to work with the documents, we're able to make some pretty clear and direct improvements in the documents. And we hope -- we believe and we hope you will agree that when they are eventually issued that they represent significant progress.

Before introducing Margaret and the cumulative risk assessment presentation, maybe I'll stop and see if there are questions.

MR. EHRMANN: Elin?

MS. MILLER: Well, I guess I would say there has been a tremendous amount of progress made, but I think there is still some outstanding science policies that have dramatic implications on the end result of the decision.

And I just want to give an example here. Just last month the World Health Organization met and deliberated on one of our compounds, Chlorpyrifos. And in that deliberation, they had the same set of data EPA has and took a look at that collectively.

The end result of that deliberation was that they determined that the risk cup for Chlorpyrifos was a hundred times bigger than what EPA is assuming for chronic, and 60 times bigger for acute. The only differences in what WHO is doing and what EPA is doing is science policy.

And so even though I think we've come a long way and there has been a lot of progress made, there are some critical science policies that have dramatic implications on the ultimate decision making process that have not yet been dealt with. And when you've got an organization like WHO taking positions -- and EPA was at the table in those deliberations. They made their case at the time in those deliberations, but this is the result.

So there is some significant things that have some pretty severe ramifications on what is happening here in the U.S. I know there's been progress, but we have some debates to still go on.

MR. EHRMANN: Bill?

MR. SPENCER: Well, I just want to follow up a little bit on what Elin said. You know, the agency met its first statutory deadline in August, and we've got another three years before the agency, you know, bumps up against the second statutory deadline of FQPA.

And according to the schedule that has been laid out, virtually all of the 19 science policies will be finalized in some way, shape or form by some time in the middle of the year 2000.

If we don't have another statutory deadline coming up until the year 2002, my question as a grower would be, why would we continue to rush to judgment on a lot of these products that I and other growers out there are using when we don't have a statutory deadline that doesn't come up until the year 2002, and why some of these science policies may in fact change.

We've already got two products out there, Azinphos-Methyl and Methyl Parathion, where the agency has made some pretty tough decisions for a lot of growers out there. And what if some significant changes are made in some of those science policies. You know, what if we decide that we're not going to regulate it 99.9. What if we decide we're going to regulate it 99.8. What if we decide that the endpoint selection is going to be something different than what it is in one of the science policy papers that are out there.

A number of the science policies that have not been finalized can affect the ultimate tolerance reassessment of not only the organophosphates, but all the rest of the crop protection materials that we're using out there.

And so I would say, I would like to see the agency come to a screeching halt here until these science policies are in place before we go on and do something drastic like we did with Azinphos-Methyl and Methyl Parathion.

MR. EHRMANN: Any comments on that? Gary?

MR. GUZY: I would be happy to make a comment. Certainly it's a point that we're well aware of that there are essentially two paths that we're moving on. One is the refinement of science policy issues, as we also are continuing to work on individual chemicals and completing the responsibilities that we have there.

But our view of the intent of Congress was that we not simply wait until our deadlines and then get really busy. And in fact, as a practical matter we can't manage our program that way. But to really set out a schedule and make steady progress to meet the obligations to ensure that in fact we are in a reasoned, rational and responsible way going through the significant amount of work that is required to actually have done all of the reassessments that are required.

In addition, we believe that it's our public responsibility, as we've set out numerous times, to do our best to address the potentially riskiest pesticides first. To look at the ones that may pose the most significant risks, and to try and move those early into the queue of action, so that in fact if there is a public risk that's posed, then we're able to work to mitigate that.

So our view is that it really is not appropriate to just come to a grinding halt. In addition, I think we've said this many, many times, and I think most people are very well aware of this. The science policies that we're stating in many instances reflect very longstanding practices that the public has been well aware of that are well supportive practices. In many instances, they've been through peer review, either through our Science Advisory Panel or Science Advisory Board. In some instances, that might not be fully the case. But in many instances that's the case as well.

And we've also said that in the event that this science policy work that we're doing to refine and complete these reveals that somehow we got it significantly wrong, then we will go back and look at those decisions again as well.

MR. SPENCER: But the problem, Gary, is you look at the agency's decision that they made on Azinphos-Methyl, and the decision that they made on Methyl parathion. If in fact one, or more than one, or many of the science policies are changed in their final form, the agency is liable to go back and reassess Azinphos-Methyl, or reassess Methyl Parathion, and say at the end of the day, gee, guys. We made a mistake.

Before August 1, 1999, these two products were safe. On August 2, 1999, now these products aren't safe. Now that we've got these science policies in place, we went back and we reassessed the tolerances on these two products, and now they're safe again. But in the meantime, you've already gone out and told the public and all of us farmers that they're not safe.

And I don't think that in a channel of trade situation with a registrant that the registrant is going to go back and start making that product. Or that a farmer is going to take the chance of using that product once the federal government has told the consumer that I'm selling my fruit to that those products weren't safe.

So I have a problem with the agency continuing, you know, when again they've already passed the statutory deadline. They don't have another one coming up. We know all of the science policies are going to be in place by the middle of next year. Let's not rush to judgment on the rest of these products and take a chance on scaring the public that some product is unsafe when you may find out that it's not unsafe. That's all I'm asking.

MR. EHRMANN: Jim, do you want to make a comment?

MR. AIDALA: Yeah, just a couple of things, because obviously, Bill, these are things that we all considered as we've moved forward in the last three years. I think unwittingly you may have said it best. I think your words were, I would like to see the agency come to a screeching halt. And that's a concern of ours, because I don't think we agree with that part of some of the statement.

For example, we've approved over a hundred new active ingredients since FQPA started. Otherwise, we would have no new active ingredients since 1996. I don't think any of us have an interest in that, and I don't think that's where you're going with that, anyway.

But I'm just saying for the record, that's one of the tensions we have, which is if these policies all have to be finalized before we can move forward at all, well that also applies to many different things that we do.

Most directly in terms of -- are there pivotal science policies underneath the decisions that we make on an ongoing basis. That's really our key question and our concern when we're wrestling with this. And whether that be a particular case like Azinphos or Methyl or just in general.

And so specifically one of the things we looked at is whether or not those decisions would change given any of the comments we've received and the kinds of things we know: it's relatively a smallish community and the kinds of things that people have been looking at on these issues.

So, for example -- let's take one very specific example. On Methyl, would it have made a difference if we come out differently at 99.9 versus 99 versus something else. In Methyl's case, we would still have the same kind of concerns we did, unless you went all the way down to close to 90 percent. And we're pretty confident we're not going to say that a 90 percent level in the Monte Carlo is an acceptable way to do business.

But we thought about that. We asked that question, does that make a difference. In contrast with Azinphos, we know that can make a big difference. Because as you all heard at a TRAC presentation, 99.8 would make a huge difference. Suddenly it's not a problem. Well, that's also why we were looking for some kind of mitigation measures that weren't the same kind of drastic measures -- from some points of view drastic -- of trying to figure out what mitigation might make some sense. And that's why you went more towards the notion of increased PHIs and some label amendments as opposed to elimination of a use.

And that's the kind of thinking that we do. Given the set of issues underneath, is our pending decision likely to change in light of the ongoing science and science policies behind any decision. Because we don't want to go back and say, oops, we screwed up. Oh, we said 98. It's not. It's a big problem now in 2001. Oh, go ahead, fine. Not a problem. Because it's gone.

MR. LOVELADY: Well, a lot of the things that the two previous speakers have spoken about, I agree with. However, we realize that the agency said up front -- last year I believe it was, about last summer -- that they were going to continue to make decisions even though everything wasn't finalized.

And so we kind of understand that. We may not agree with it. But we understand the process that you effectively can't come to a screeching halt, even though many of us would like you to.

But I agree that there has been a lot of progress made in the last year and a half. And as I was going through the documents that were sent to us for this meeting, I thought, you know, this looks really positive. I wish that -- I wish that what happened on August 2nd hadn't of happened then, because I think we would have more confidence in the progress we've made. But I do acknowledge that progress is being made. Good progress is being made.

I don't want to be real redundant in all the comments that were made. But we do continue to be concerned that decisions continue to be made when these science policy issues have not been resolved. And here's where I would like to take a little different track. I think that the fact that decisions continue to be made without the finalization of these issues is the most compelling argument that I can think of for having some continued stakeholder -- organized stakeholder involvement in this process.

I think that logically it would be very difficult to convince someone that this process of stakeholder involvement should stop today. I mean an organized effort should stop today when we still have so many issues that must be resolved. So I think -- the fact that that has happened, I think is the most compelling argument to do something to continue this process.

MR. EHRMANN: Thanks. Nancy?

MS. RACHMAN: I would like to request some clarification on what is going on with the drinking water policies. The merging of certain new issues with the existing issue paper which has already been out for public comment I think needs a little bit more transparency. Just because the additional policies have been presented before the SAP, I wouldn't count that as equivalent to a public comment period.

And so I think those -- the new revisions that have been molded into the existing policy that has been commented on deserve some wider discussion. And the reason I say this is because I'm very concerned. If you look at the chemicals that have been through their technical briefings at this point, there is a common thread, that I see anyway, is the presumption that there is a risk from drinking water. And that presumption is based upon the modeling that the agency is currently doing, which in turn is related to these policies, some of which have not been out for public comment.

So could somebody address that for me?

MR. JORDAN: Yeah. The paper that we handed out at the last TRAC meeting discussed this, and I think that most of the text is repeated in TRAC paper 41 on page two.

Basically to summarize that, when we put out the paper number eight, entitled Dietary Drinking Water Exposure Estimates, we flagged in it a couple of ideas that we had for making our exposure estimates of residues in drinking water using models more realistic. The two particular changes were to move from a small, contained farm pond to a reservoir, which would have sources of surface water and would have some sort of movement of the water through the reservoir. And using the index -- using that reservoir we thought would be a more realistic estimate of the kinds of residue levels that were being encountered in source drinking water.

The second change was to reflect the -- and this change was discussed in the paper number eight also when it went out for comment. Was the idea of incorporating a factor that reflects that not all of the land surrounding a reservoir or drinking water source is crop, and therefore not all the land is likely to have been treated with pesticides.

By reducing the land area that's actually treated to reflect the percent cropped area, and possibly also percent crop treated, we would reduce the estimates to a level that was more realistic. What we did was to take some more refined analysis that had been done by our EFED to the Scientific Advisory Panel. We looked at the comments that we got in and basically said, yes, index reservoirs were the right way to go. The use percent of cropped area is the right way to go.

The material that we took to the SAP supported the notion that these were appropriate modifications to make. The comments that we heard at the Scientific Advisory Panel, both from the public and from the panel members themselves, were yeah, these are the right things to do. Here are some fine tuning and adjustments that you might make in it.

So what we have said is, rather than take those ideas out, go through a public comment process and delay including them in any way in the model estimates, we're going to announce in the paper that's being issued as the revision that we are doing those things. We are putting them forward. We're incorporating them into our models. And we're confident that the model outputs will be realistic estimates.

Now I'm sure that there will still continue to be controversy about the use of modeling versus monitoring. That is something that we recognize and acknowledge. We know we need to continue to work on it and include that. That's the subject of subsequent papers that we're planning to issue next year.

We know that there is plenty of room to argue about any number of aspects of the risk assessment process. Maybe people will have questions about the details of the index reservoir choice that we made, or the percent cropped area. But those are things that I think we can deal within the context of individual products and individual chemicals. And if people want to raise them as they go through the review of the preliminary risk assessments or the revised risk assessments, that's something where I think we can continue to make progress.

FEMALE SPEAKER: You might want to elaborate on the two drinking water papers that are still to come. I know you mentioned them.

MR. JORDAN: Right. We have identified papers number 25 and 26 which relate to, first of all, factoring drinking water treatment into the assessment of drinking water residue levels. We know that monitoring results that are taken in rivers and streams measure the source water. The water before it goes into a water treatment facility. And in some cases, the water treatment techniques or technology that is used will have an impact on the level of pesticide residues. In other cases, the technology may not have an effect.

What we are doing in the paper number 26 is describe the kinds of information that we want to get in order to be able to reflect the impact of treatment on pesticide residue levels in the water that folks are actually drinking as opposed to the level that might be present in the stream or reservoir.

The other paper number 25 is quantitative assessment of uses of concern for drinking water. When we've done our screening, when we've looked at a quick cut at monitoring and it still looks like there may be a concern about the residue levels and what people are actually getting when they drink the water, then we need to move beyond it. We need to go beyond the screening effort.

And this paper will describe the directions that we're moving to improve our ability to do a quantitative assessment, an assessment that recognizes and takes into account the fact that residue levels vary around the country. They are impacted by the effects of treatment, that people's consumption of water varies depending on the age and that sort of thing. All of these characteristics mean that there is going to be, much as we see for food, a distribution of exposure for drinking water residues, and therefore a distribution in terms of the risk.

And this paper will outline where we're headed in order to get a handle on the quantitative risk assessment for drinking water in a way that may not be quite as good yet as where we are for food, but certainly is a lot closer to that than we are today.

MS. RACHMAN: Bill, it sounds like what the agency is trying to build is a tiered assessment scheme for drinking water sort of similar to what we have for dietary.

MR. JORDAN: Yes.

MS. RACHMAN: And I applaud that. I think that's really terrific. But here's a case where this is new policy. This is not one of the cases where the program has had longstanding scientific policies that have been peer reviewed and so on and so forth.

And I'm just wondering -- I guess maybe I could really welcome Gary to the group by putting him on the spot right off the bat. FQPA says drinking water, and yet what we're doing is kind of going at this backwards. We're talking about models that are far from validated with respect to drinking water sources, whereas the agency needs to assess drinking water.

I wonder if you have any thoughts on that, Gary?

MR. GUZY: I do. Keith, I don't know if you want to take this first?

MR. PITTS: Well, there is another tier we're talking about in this approach, and that is PDP monitoring of drinking water. We've still got to dig through our budget, but it does look like PDP got all that we requested. So we will be in the process of initiating a PDP residue monitoring program for water.

And the other thing that I wanted to point out, and we've said this in a few other fora, these models will be used as screens, and we could very well reach a point with a screen where a chemical continues to be a problem. And that's where we would intend on having PDP and perhaps industry generated data if we get appropriate protocols put in place, and I think we will, to fill in those gaps.

And, again, as we've gone through the regulatory decision making process to this point where a model has been a issue around drinking water, there has not been a regulatory decision directly tied to that. Again, we are looking at the food use issues primarily in many of the decisions we've made at this point.

MR. GUZY: Yeah. I think that's really critical to stress, which is the agency is obviously cognizant of the evolving nature of the work on drinking water. And I think as you fairly say, some of it is new ground. And so that the actions, for example, that were announced on August 2nd were really tailored to look at dietary risk primarily, rather than to involve some of these less certain areas. And that's a very conscious approach on the agency's part.

MR. AIDALA: Yeah. And then basically, again, as you said before in response to Bill's question, I mean this is the kind of thing -- try to think of it in terms of the decisions that come up to the decision makers and/or when you're done looking at a decision, ask yourself the following kinds of questions.

If the model says there may be a problem, compared to there is a model that says there may be a problem with real monitoring data -- real -- is it finished water? Is it source water? These are the kinds of questions we ask, you would ask or you should ask, and that we ask our staff before they're presenting sort of the options before us in a particular decision.

And then you also get into further questions, even if it's, quote, real monitoring data of finished water. Is it sort of a point source kind of problem? Is it one particular region that, gee, we didn't know and someone goofed in whatever sense of the word, regulatory wise or by misuse? Those are the kinds of things. How many people are involved? Is it one detect out of 2,000 samples, or 200 detects out of a thousand samples?

And, again, these are the kind of real world things we ask and we look for, and that people as this process goes on, either from input from, again, the stakeholder -- the stakeholders in general and registrants in particular obviously have an interest in that, that we factor into the decision making. And that's really the real time. Work backwards from some -- somebody, hopefully intelligent and responsible, sat in a room and thought about all of this stuff, and that's one of the majors to hold us accountable to. I think we do that, but, again, if someone says we're not or we should be thinking about things, that's what we would like to hear more about.

MS. RACHMAN: Well, yeah, I'm feeling better. Thanks a lot. But I just want to make one other small point. And that is that we've learned a lot about water impacts from pesticides over the years, and where some of it is chemical specific, some of it is going to be use pattern specific, or a combination of use pattern and geography or, you know, environmental characteristics.

And I would hope that, you know, you wouldn't be singling out one active ingredient. If you really have a use pattern, it has to be dealt with, you know.

MR. GUZY: Do you mean like all herbicides? I mean, what are you asking for?

MS. RACHMAN: No, no. Start with something else, would you, please?

MR. GUZY: Okay.

MS. RACHMAN: Thank you.

MR. EHRMANN: Okay. I've got three folks who have asked to be recognized, and I would encourage them to keep their comments brief so we can get some quick answers, because we've got a number of other topics that we want to cover here.

Jon? Get a mic for Jon. Thanks.

MR. JESSEN: I wanted to use this -- right now I wanted to share a prospective from really the Arizona/California area. Unless we get too -- you know, too self important here, I wanted you to know -- to tell how it is in the field.

Now I've been in the field in this business for about -- in the plant protection business and with the farmers for about 40 years. And the last -- the first 20 of it was actually checking the fields. The last guy in before a field was sprayed, and the first guy in after it was sprayed. So it's not like I'm -- and you people talk on the science, I can barely following what you're saying.

So I pretty much have to talk from my experience, and I can bring that to the table of what the feeling is out here. Now my observation is -- are largely carried from the worker safety side, but that has somehow become involved with food quality. I really don't know how they totally got pulled together. But they're different. The quality of the food and worker safety wouldn't seem to me like they would be the same.

But anyway, I do know a lot about worker safety, and I wanted to share some observations on that. I don't know –

MR. EHRMANN: Jon? Jon, can I ask just a question? We've got the worker risk piece specifically a little bit later after a presentation. Do you want to make these comments then?

MR. JESSEN: I would just as soon finish this.

MR. EHRMANN: Okay, go ahead.

MR. JESSEN: And pick up the time on me later.

MR. EHRMANN: All right, that's fine.

MR. JESSEN: I don't know where the problem on this perception really originated, but it's not visible in the California/Arizona agricultural environment. I personally have 300 people that work for me full time. Most of the operations go day and night in formulation. These are just people in formulation and application that are actually handling either the pure quill or handling the formulated pesticide. Not going into -- you know, what we found to be the toughest parts of the deal.

And the records from these people -- and I checked this just before I left. I had them go back -- in the formulation area, I had them go back ten years, and that's not been a single toxicity incident. And this is in the formulation of 20 million pounds a year. We formulate for Novartis and DuPont and many other people in our plant. And this is 20 million pounds a year. It hasn't always for the last ten years been that way, but certainly for the last three or four it's been large amounts of product without a single toxicity incident. Now that's not that we didn't have somebody with an eye irritation or maybe a skin irritation and we don't know quite what it was. We might have moved him from one operation to another. But we checked like workman's compensation and OSHA records and anything we could find back ten years to get this.

In the application, we haven't had an application -- we haven't had an incident since 1984, and we do about 40,000 acres a year in application. And really in this time of year, by far the majority of the applications have Cholinesterase Inhibitor in them.

So I'm trying to get this into perspective. As far as worker safety is concerned in California and Arizona, if people follow the rules, we don't see the problem. None of us in agriculture see the problem. If you have an enforcement problem, I would say deal with it. But more laws and making it more difficult to get these products in the field to deal with our problems is not the answer.

Certainly in my own operation -- and anybody is welcome to share -- to look at the records -- we haven't seen a problem for a decade or more. And a lot had to do -- I'll have to hand this to you. A lot had to do with getting rid of fosner (phonetic). But once that was gone, really the rest of it was easy.

I wanted to say -- another thing is that my daughter, Gowan, is a pediatrician in Yuma, and she has been in practice there for six years. She did her internship and residency in the Children's Emergency Hospital in Phoenix, so she got the acute cases from all over the state. And then she came to Yuma and she has practiced there for six years.

And she has not had a single incident of pesticide poisoning. She says she's had incidents of kids drinking Clorox and drinking antifreeze, and that could have easily been pesticides. She pointed out it could have easily been a pesticide as anything else. But as far as -- and her practice spans the society from the well-to-do to the workers. Plenty of her people are on Access and come in from that level, too.

So I guess what I'm trying to tell you is that from those of us that live in the deal, let's not let our hubris carry us away here, because we probably are doing something. but it's certainly not -- it's certainly not one of the most pressing needs that we're addressing here, one of society's most pressing needs from our perspective.

So that's about what I had to say.

MR. AIDALA: Well, Jon, if I could just respond on the front end of that. First of all, what you may want to suggest as a risk mitigation option in some cases then is that we only use your company as the people who can apply. Applauding your record so far, but the front end of that or why worker's matter, this is taking place in the context not just of FQPA per se, which is driven by the residue issues and safety factors and all the stuff we've talked about.

But this also takes place in the context of re-registrations started back in the '70's and still going. And so that's why it's basically a matter of, again, common sense that we're not going to go through an FQPA dietary, including water and all those other issue kinds of things, an analysis, and then suddenly go back and say, now what's the FIFRA re-registration requirements.

And that's why. That's the short answer why. The standards are different in some cases. For example, the food and drug provisions vis-a-vis the tolerance setting. Do you say that it's non-occupational exposures that are taken into account there. And we fully know that and acknowledge that and operate that way. But at the same time under FIFRA, we do need to take a look in terms of meeting the re-registration standards for whether or not workers are an issue that you need to have mitigation and all that.

So that's just on the front end of what you're saying. We're very cognizant of that distinction between the dietary residues and what's this got to do with workers, and then why we're looking at workers as we go through these assessments of the older materials.

MR. JESSEN: Good. Well, it's not -- I don't know how it is in other parts of the United States, but certainly California and Arizona, we see it everyday. We live there. And we in agriculture don't really -- we think the problems are behind us. Certainly we don't -- it's not part of our everyday life any more.

MR. AIDALA: I hope you're right. I mean, and the key thing there is -- again, we may want to, as Jon just mentioned, get back to that when we talk about the worker risk, that we don't see incidents or how do we get that information in. Or we have an experience base given all your work that your outfit does and all that, and how do make sure people are aware of that when we're looking at whether or not there, quote, truly is a worker risk thing.

MR. JESSEN: Thank you.

MR. EHRMANN: Okay. Dan, quickly.

MR. BOTTS: Quickly.

MR. EHRMANN: Quickly. You'll get other chances, but let's keep it to the -- if we can keep it to the issues that Bill has talked about to this point, that would be helpful.

MR. BOTTS: That's the whole intention, because I think I go back to the very first meeting when Bill made this presentation and said he would lose his job if he didn't meet the schedule. And you've done a very good job of being resilient in the face of schedules slipping and time lines not going out.

MR. EHRMANN: And he's got a little more gray hair than when he started.

MR. BOTTS: I also asked him earlier today what he was going to do when the science policy issues were over with. And I'm going to suggest that as we move forward in this process and look at the science policy issues that are currently on the table, with the exception of Cholinesterase endpoint in the hazard evaluation part of it, most of these are geared specifically toward the tolerance reassessment, dietary and non-dietary exposure requirements associated with those specific provisions in the Food Quality Protection Act.

As this process has matured over the past three years, a lot of these very same policies or other policies are also coming to the forefront relative to new product registration and the registration eligibility document process that we know and love as the re-registration process.

Any my question, number one, is how are we going -- or as a TRAC process or a stakeholder process, how do we float those issues in the context to get them on the table, and then the process to be looked at in the same type of format and openness and transparency? Some that come quick to mind are the occupational health and safety issues that Nancy raised. Some of the issues on the new cancer guidelines. Some of the other issues that are out there that are going to really impact not only FQPA tolerance reassessment, but also all the other parts that have to come together to make a successful transition work.

And I'm suggesting that Bill have a permanent office called Science Policy Director, but there are about 10 or 15 other issues that we need to float in regard to that. But in a specific context, the only model that we've had so far that has come out, other than the one that's coming out next week, is the common mechanism with toxicity paper, where there was a very good section in there that described exactly the agency's thinking relative to the comments received and how the policy changed.

Is that the same framework and plan that we're going to go through where those issues that were identified? How they were addressed by the agency and how those policies are changed? Or how the process is intended to reflect those changes as it moves forward going to be part of the new revised documents as they come out?

MR. JORDAN: Yes, it will.

MR. EHRMANN: Dave?

MALE SPEAKER: Let's go back to the first question. How long are you going to be working on science policies?

MR. WHITACRE: John, I have a fairly short question, but not necessarily an easy one. So first a comment and then a question. First -- and it's specifically about the cancer issue.

But in the context of the science policies, there is no question in my mind that EPA over the course of the last year has done an excellent job in responding to the input of this committee and the public in dealing with the science policies that are critical to be able to move forward in an appropriate way and regulate under FQPA.

But I do believe that there is an issue that we interestingly have not touched on in this committee, and if we have, it's been from the side, and that EPA has not raised that really is quite critical. And that is, what is happening on the side of the cancer policy.

Recently within the last two or three weeks, I went back and looked at some of the decisions that have been made. In 1997 EPA did not make too many decisions as regards to cancer classification. And the issue here is not only the general policy, but in specific how one decides whether a product should be regulated with a threshold or a non-threshold mechanism. It's not an easy question, but I think it's still critical.

About 20 percent of the decisions made in 1997 were to regulate by linear extrapolation. About over 60 percent in 1998, by linear extrapolation. More decisions were made in '99 which disclosed that over 80 percent of the time EPA decided to regulate by linear extrapolation.

Now we've spent an enormous amount of time talking about an extra 10X fold safety factor. But when you jump to something like the choice between threshold and non-threshold, the risk cup doesn't shrink by -- to one tenth. It can shrink by 10,000 times or 50,000 times, depending on the particular data at hand.

A critical question and a difficult question, all of us agree. My point is that in 1996 the draft policy for cancer was published in the spring, and then a PR notice on July 17th signed by Penny Fenner-Crisp, basically saying we're going to use that policy when we can. EPA has continued to make decisions. You must make decisions.

The question, though, that comes out of all of this is, what's going on? There's been too much silence, and I think we need the same standard for transparency and sound science applied to this policy as others. Even granting the fact that it's difficult and difficult to get at in a difficult scientific question, it has so much leverage against the interest of agriculture and other users that we need to -- we need to come to grips with it.

And we can't wait much longer, because some of the decisions that may be made on products, or are being made, or will have to be made soon, may result in damage to certain products that should not be damaged that in fact cannot be later rectified because the products will be gone.

MR. EHRMANN: Jim?

MR. AIDALA: Yeah. Dave, I mean, I think there are two issues. And it probably goes back to what Dan was raising, which is how do we -- as new issues emerge, ones that we can kind of think of now, or six months from now we may think of other issues. And I think that's something that we need collectively to talk about, and tomorrow morning, about the sort of post-TRAC follow up and activities.

I'm not trying to defer or to evade it, but, I mean, I think that's where we plan to get into those issues. Either how do we continue on, again as Bill said, with the current set of issues already here or any new ones. And that's kind of what you're talking about. That's number one.

Number two, the threshold and non-threshold cancer assessment business is mostly being played out on a larger stage, agency wide specifically. And so we've got the Science Advisory Panel -- or excuse me -- the Science Advisory Board. Again the agency wide peer review process. And they've had meetings. I think recently they've been meeting on this. All that is subject to the same sort of, you know, openness. You know, it's a public meeting. I think you all -- some of you or most of you probably are more familiar with all of that than I am on this particular issue.

And that's where that process plays out. If you've got a separate question about how then it applies to pesticide decisions, does it change a PR notice we had or have, etc., those are again somewhat the sort of follow up issues on things.

But we agree that obviously -- and your example, Dave, is exactly right. It's not going to be in some cases a tenfold difference. It can be not even two orders back. It can be three orders of magnitude. You know, with a Q-star approach you've got an unacceptable risk, and with a threshold approach you've got -- you know, and then we're at 3,000 in some cases.

And we know that. And that's one reason we're as anxious as you are to figure out exactly what that may mean as we go forward with the decision making, following this agency wide process of whether or not the cancer guidelines are revised, should be revised or they're constantly being revised and all the rest.

So, again, just try and separate out the issue from the agency wide process from the whole. Okay. So whatever is going on over there, and I may or may not have an opinion, okay, what does that mean for pesticides. And if that's part of your question, that gets into the question of how we're going to deal with those issues over time as this or anything else gets identified post -- from here on out. Post-TRAC or whatever you want to call it.

MR. WHITACRE: And, Jim, I realize there is an agency effort in this -- on this point. But there may be some specific FQPA related issues, and I'll illustrate one that I almost fear to raise, because it may be empty. There may not be anything here.

But just for example, in the 1996 draft guidelines, if one reads it carefully there is an intimation that EPA wants -- probably properly -- to move toward a direction that says if we understand the mechanism by which some of these rodent, timberingen (phonetic) products produce their effects, then we're more likely to be able to gracefully and appropriately classify these products as -- they should be regulated as a threshold rather than non-threshold effect.

Okay, fine. Guess what? When you do this, you get to define the mechanism. And you look at FQPA, and FQPA says when we get to the cumulative risk side, if we understand that there is a common mechanism, we should lump everything together.

Now I realize it may or may not fit. But we've got to address the question. Do a series of different chemistries produce timbers by the same -- in rodents by the same mechanism or not. So in a way it's counter intuitive, and there are risks that are specific to pesticides.

And excuse me, I'll say it again. I now it's tough. But it's so important that we can't just let it lay. We've got to talk about it. And I don't know if the public can help, but you're owed that help if it's there. So I really encourage you to get it out so we can talk about it.

MR. AIDALA: And we agree. I mean, a few things the agency does are referred to as graceful, number one. But the other thing is, as Margaret will talk about, how we're going to be doing cumulative. That may shed some light on some of that, although most of that is mostly for non-chronic effects, although it still applies per se.

Again, it's something that we're very well aware of. I mean, for example, the words common mechanism versus mechanism in terms of how we talk about threshold. They're again the same word, but they can have very different meanings. I can assure you that we're very conscious of this when we were advising Congress and taking our own positions as an administration.

When we wrote that distinction in the statute about threshold versus non-threshold, it was cognizant of the fact that there is a large group of scientists and other constituencies that believe there are thresholds for carcinogens, and there is a counter point to that, and that that was something that we're going to have to wrestle with. So that was why the distinction was put in in that part of the statute for threshold and non-threshold as opposed to using other nomenclature.

MR. EHRMANN: Jay?

MR. VROOM: Hi. Just to put kind of a reality spin on what David is talking about, which is very complicated and is sort of burdened by the over arching cancer policy glacial movement review, is that if you go look at Therese Murtagh's mid-Atlantic Apple review document, almost every one of the to do lists under the individual chemical scenarios is dependent on getting something through the pipeline that is either a new use, I presume, of an existing active ingredient, or a new active ingredient.

And we think that a lot of those chemicals can be easily caught up in this cancer policy question that Dave just raised. So that's where kind of the nexus of reality comes in.

MR. EHRMANN: Let me turn to -- oh, Gary, go ahead.

MR. GUZY: I just want to comment on it, because I believe it's an important point. It's an important point in the critical science issues that the agency faces. And I think it really does reflect this administration's commitment to using sound science in our approaches.

And one thing that has been so telling, we thought we had kind of a basic relatively straightforward but new and evolving cutting edge approach in our proposed guidelines. And that was three or four years ago. This is extraordinarily difficult science, and what we're committed to is ensuring that it goes through the right kind of public process, the right kind of peer review scientific process, before we leap to any decisions. And I think you would criticize us, appropriately so, were we to do otherwise.

So it's difficult to wait for the clarification of that guidance. On the other hand, it's critical that we do so, that we take the time to get it right, you know, just as some of the mechanisms of action issues are very difficult. Some of the pediatric community has a set of their concerns about are we appropriately focussed in our work on that. And that's been the subject of some Science Advisory Board work, and we're waiting for recommendations on that as well.

I mean, these are very, very fundamental and important issues that we agree with you have a significant potential consequence on the work that we're doing in this arena. We have to continue to be aware of that. On the other hand, we're committed to using the right scientific and public process for concluding that work.

MR. EHRMANN: Okay. Margaret, let's hear about the update on cumulative risks.

MS. STASIKOWSKI: Good morning. Today I will give you an overview of the progress that we have made to date on development of cumulative risk assessment methodology. It is the most complex science issue for us yet. For us it all started in August of '96 with the passage of FQPA, as the law requires that for tolerance reassessment we consider cumulative exposure and common mechanism of toxicity.

I will briefly discuss the process that we've followed so far in development of the guidance. I will discuss the goals and the nature of the guidance, the recent Science Advisory Panel review, and the next steps that we're planning.

From the earliest steps in tackling this issue, we consulted with the stakeholders, held workshops and worked with other agency offices to complete the first phase that we just took to the Science Advisory Panel. The guidance builds on methods that previously have been released by the agency: chemical mixtures assessment guidance, risk characterization guidance, grouping of organophosphates and carbamates, and aggregate exposure and risk assessment guidance.

In September with the Science Advisory Panel, we discussed selection of chemicals for cumulative risk assessment: selection of key toxicity points that would trigger cumulative risk assessment, risk estimation methods and how we will apply uncertainty and safety factors in cumulative risk assessment.

There are some key points about the methodology that I would like to discuss and emphasize. First, in cumulative risk assessment, we cannot and will not add reference doses of individual chemicals. What that means is that individual chemical risk cups cannot be simply added.

For example, let's say we have a chemical A that takes up 80 percent of its RFD risk cup. We have a similar chemical B that also takes up 80 percent of its risk cup. This does not mean that in a cumulative risk assessment of the group A and B that there is 160 percent of the cumulative risk cup taken up. Also, the cumulative assessment may be based on different toxicity endpoints than was used for individual chemical risk assessments.

Let me illustrate this in more detail. On the left hand side of this table, you see toxicity endpoints used in individual risk assessments for chemicals A and B. For chemical A we used a 90 day mouse study. The most sensitive toxicity endpoint in this study that we used for derivation of the RFD were eye lesions. For chemical B we used a two year dog study. The most sensitive endpoint that we used for derivation of the RFD was red blood cell Cholinesterase. RFDs were derived for those individual chemicals.

Now we are moving onto cumulative risk assessment, and we have a group A and B. The first thing we do is we search our entire database for the two chemicals and find studies that are comparable. In this case, it's a 90 day rat study. Then we look at an endpoint that is common to both chemicals. In this case, brain Cholinesterase Inhibition. This endpoint may be less sensitive or just as sensitive as the endpoints found for individual risk assessments.

To summarize, in a cumulative risk assessment chemicals in a group must be compared against the same toxicity endpoint. The endpoint is derived from toxicity studies of similar duration, conducted on similar species, strain and preferably the same sex.

The uncertainty factors and safety factors will be applied to the entire group when appropriate. What I would like to stress is that uncertainty and safety factors from individual chemical risk assessments will not be used in cumulative risk assessment. Uncertainty and safety factors will be applied to the group.

The recent Science Advisory Panel review was very supportive, but we are still waiting for a complete report from the Science Advisory Panel. In December we will be taking the exposure assessment, risk characterization and a complete case study to the Science Advisory Panel.

The guidance will then go for public review in the spring, and we anticipate the revised guidance in August of 2000.

MS. STASIKOWSKI: Thank you. Questions?

MR. EHRMANN: Questions? Comments? Yeah, Mark?

MARK: You just made the comment that uncertainty and safety factors will be applied to the entire group when appropriate. I wonder if you could illustrate that, so that we could see it maybe using some of the safety factors that have been dealt with in the OPs and how that would actually play out so I would have a better understanding of it.

MS. STASIKOWSKI: Okay. Bill, can you go to the table that has the numbers?

MS. STASIKOWSKI: -- had an uncertainty -- for chemical A with eye lesions, we have an uncertainty factor applied for intra-species of ten, and intra-species extrapolating between humans and animals of ten, for a total factor of 100.

For chemical B we had the same situation, except for red blood Cholinesterase we never reached a no effect level. So we may have an additional uncertainty factor of three. So the uncertainty factor for A -- the uncertainty factors for chemical A would be 100. The uncertainty factors for chemical B would be 300.

Now when we move to cumulative risk assessment, since we are looking at a different study now for chemical B, it would no longer make sense to apply the uncertainty factor of three, because we didn't reach the no effect level.

MALE SPEAKER: Assuming that the no effect level and brain Cholinesterase is the same?

MS. STASIKOWSKI: Right.

MALE SPEAKER: So you would use 100 for the cumulative?

MS. STASIKOWSKI: Well, there are probably several possibilities. We will use a factor of ten for extrapolating from human -- from animal to human. A factor of ten to extrapolate for sensitivity within human population. We may apply an additional uncertainty factor to account for the quality of the overall database. And we also recommend that consideration of the FQPA's safety factor be done on the group following the risk assessment.

MALE SPEAKER: So would you use a 150? Use a 1.5? Would you average it?

MS. STASIKOWSKI: No. When you think about cumulative risk assessment, you think about an effect and about the group as a unit. So we would be applying -- we may be applying in this case an uncertainty factor of 100, if we have a sufficient database. It may be 300. And then we may -- we would be considering the need for an FQPA safety factor.

So it may be 100. It may be 300. It may be modified by an FQPA factor.

MALE SPEAKER: It seems to me like that's a policy issue that ought to be addressed in more detail, so at least we can understand how it would be applied.

MS. STASIKOWSKI: This issue is going to be addressed in the cumulative risk assessment paper that will go out for public comment in the spring.

MALE SPEAKER: So you'll lay out all that methodology?

MS. STASIKOWSKI: Yes.

MALE SPEAKER: The way you're going to handle those assumptions?

MALE SPEAKER: I guess from my perspective this is probably one of the most significant things that FQPA is going to address, and I don't think TRAC is done until we address that.

MR. EHRMANN: Okay. Jay?

MR. VROOM: It seems like you're making great progress on the toxicity side of this and thinking very logically. I wonder if you could comment on the development on the exposure side, and in particular have you thought about whether, as it seems to me, that there is going to be a very different kind of demand for exposure data in order to complete this entire analysis and make decisions in the end, different from the chemical by chemical and aggregate kind of exposure data that is required.

Because in some places, especially on acute risks where you may have -- made a scientific judgment that there is a common mechanism toxicity, but the exposures may not be such that they really are additive kinds of risks that could be cumulated.

Is it time now to start thinking about that? Is that part of what SAP has talked about, and what additional thinking is going on inside the agency?

MS. STASIKOWSKI: We will be taking the issues of exposure assessment methodology to SAP in December, and it really would be premature for me to speak about them right now. But, yes, they are very difficult and complex issues that we're struggling with right now.

MR. AIDALA: And, Jay, for example -- I mean we know, for example, say in the class of OPs and the common mechanism, etc., that if you've got the same kind of pest problem, you've got three choices as a grower. Well, that means you're not going to use all three. You're probably use A, B or C, and then some use one and some use another, etc. And those are the kind of issues that will be underneath and wrestling with as this thing goes forward.

We were just talking about this yesterday with the staff just in general. Shall we say it's going to be difficult. And of course it's something that as we try to figure out a way to see our way through it, that will be subject to the open peer review process, etc., etc.

MR. VROOM: It seems to me that there may be instances where we can show that, you know, simultaneous exposures are not occurring. But you're going to have to get a lot closer to the dinner plate in terms of residue data and exposure projections in order to demonstrate that.

Or, you know, chemical A might be used on the west coast and chemical B on the east coast. And, you know, there's not likely commingling of those kinds of food supplies that would represent a potential common mechanism exposure. But that requires, it seems to me, a whole different approach to exposure data collection, and in particular for the task forces that are working on market basket and data collection.

Should we be thinking about how to factor that in the work that's being done right now, the sooner the better perhaps?

MS. STASIKOWSKI: Right.

MR. EHRMANN: Okay. Bill Lovelady?

MR. LOVELADY: Yes. This is kind of a question. What exactly did SAP say about the common mechanism? Didn't ILSI say that there wasn't sufficient evidence to say that they didn't have a common mechanism -- didn't work by common mechanism, but they didn't say that they do? Is there -- could you clarify that, what they actually did say? SAP said?

MS. STASIKOWSKI: You are not talking about the most recent review of the methodology, but you're asking a question about organophosphates?

MR. LOVELADY: Yes.

MS. STASIKOWSKI: I do not have the exact language of their report in front of me. But the comments from the SAP were supportive of our and ILSI's conclusion that we look at organophosphates as a common mechanism group.

MR. EHRMANN: Go ahead.

MR. GUZY: Bill, I think we can certainly pull the language for both the LC as well as the SAP. I think the important point here is that the agency has concluded that based upon the LC comments and based upon the SAP comments that they share a common mechanism.

MR. LOVELADY: I was just wondering what it specifically said. That's what I was asking, what did it specifically say. Did it say there was not sufficient evidence to say that it didn't, or did it actually say that they do?

MR. GUZY: We'll pull the information. But as I said, again, you know, certainly for the next steps the important piece is the agency has concluded based upon those comments that they do share a common mechanism.

MR. LOVELADY: Because it does sound -- I mean, there is a subtle difference there, and it may be -- I'm just not convinced that it's -- even though it's subtle, that it's not substantive.

MR. EHRMANN: Let's get the language. We'll get you the language so you can take a look at the exact wording. Bill Spencer, and then we'll take our break. Go ahead, Bill.

MR. SPENCER: A brief question. I notice that the SAP report in September recommended grouping not only the organophosphate class of pesticides together, but grouping that particular class with some of the carbamate class of pesticides.

Can we expect down the road that there will be other classes of pesticides? Other classes or groups of pesticides that you'll be looking at to group together and look at one pesticide in cumulative?

MR. JOHNSON: Do you mean with the OPs and stuff? What do you mean? Yeah. You know, obviously as we continue down the tolerance reassessment road, obviously we know that there are groups of chemicals -- synthetic pyrethroids, the carbamates, the triazines. You know, whatever the class might be.

And in each of those instances, we are going to be looking at taking to seeking public comments, seeking science advice as to where -- whether in fact individually within that group they share a common mechanism, and obviously if there is any crossover.

I think most of us, you know, entering this fray of several years ago in '96, particularly with the OPs and carbamates, suspected, since they both fall in lines of Cholinesterase Inhibition, that it certainly raised the issue. And as you have noted, in at least the early indications, that there may be some carbamates that share a common mechanism with OPs. Or looking at it the other way, there are other carbamates that don't.

As we move through the other classes, that is certainly going to be a question. Certainly the agency is aware of some efforts that industry and others are doing with the synthetic pyrethroids, that at least what I understand of the early research, and certainly we've not evaluated it, would indicate that they may not share a common mechanism among all the synthetic pyrethroids. But, again, that's early data. We haven't made any evaluation of that ourselves, but we are going to be looking at that as we march through.

MR. EHRMANN: Nancy, a quick one?

MS. RACHMAN: Yes. Steve, I think I heard the word crossover? Do you mean by that that the agency may consider that some chemicals are members of more than one class and could be part of two different cumulative assessments, or three or four?

MR. JOHNSON: Now you've just gone beyond my base toxicology knowledge, Nancy.

MR. JOHNSON: I mean, I'm not sure about crossover. You know, I think the simplest one was the carbamates to the OPs. The simplest in the fact of there may be some relevancy as far as common mechanism.

With regard to other chemicals, I just don't know the answer. I'm not aware of any specific where there is a triazine that acts like an OP that acts like a carbamate that acts like a colore. But it's probably going to be a great chemical if you could ever develop it. But I'm not aware of any.

MR. EHRMANN: Okay. Let me note that we're slightly behind on our agenda. But I think given our TRAC experience, we know that in the initial hour or two there are a lot of comments that need to get made that apply to multiple topics. So I'm going to trust that we'll pick up the pace here as we move forward. But I think it was important to get a lot of those initial thoughts out on the table.

So let's take a 15 minute break, and we'll come back and pick up with the human study topic.

MR. EHRMANN: Take your seats, please. All right. I want to move to Marcia's update on the human study issue. But first I want to recognize Bill for a short comment. Bill?

MR. SPENCER: Just for two seconds. I had an opportunity to set up a little lemon display out there in the lobby that you guys might enjoy taking a look at over the rest of the day. But unfortunately as I was doing my little pin ups to explain what it was out there, I left one piece of paper out.

And that was a piece of paper thanking EPA very much for the first two boxes of fruit that you see, U.S. number one well within and U.S. number one average within. Because without EPA and without Bi-methylate and Carzol (phonetic), I couldn't be able to show you those two boxes.

MR. SPENCER: So to all my friends in EPA, thank you very much.

MR. EHRMANN: All right. Thanks, Bill. The next item on the agenda is an update on issues relating to human studies, and Marcia Mulkey is going to provide that for us.

Marcia?

MS. MULKEY: And this will be quite brief. As you all know, EPA has never required the use of human test subjects to evaluate toxicity of pesticides. It's never been a general requirement. It's never been required on any specific pesticide.

You will also probably remember that last summer it became clear to many of us that a number of the pesticide companies had decided to, and embarked upon the conduct of these kinds of studies. And EPA at that point announced an interim approach to its consideration of these studies. And its interim approach had to do with the way it would handle the studies, and it also embarked on a major effort to consult with key experts in scientific ethics in order to inform our longer term approach.

Specifically the agency announced last summer that it will not base any final regulatory action on these studies -- these human test subject toxicity studies -- in the absence of a policy and approach which would allow us to fully evaluate the ethical acceptability of each such study.

At that time the agency also set about to convene a joint panel of the Science Advisory Board and the FIFRA Scientific Advisory Panel. This panel was composed of regular members of both of those advisory committees, along with a number of special members -- invited members -- who were eminent science ethicists. And this group held a two day meeting in December, a very lively, open discussion of these issues. It involved presentations by the agency and others, and there was also participation by some other federal agencies with expertise in this subject matter.

After that meeting, the group embarked on the preparation of its report, through which it would advise the agency, and apparently discovered that this was a particularly difficult issue to work through in a way that they all could feel comfortable with in a report. And after working toward the presentation to the agency of a report for a number of months, the panel came back to the agency -- or at least a number of members of the panel did -- and said that they believed that they would benefit from our convening them again for a further open meeting.

They believed that that would allow them to work through, because it had been difficult for them through the passing of papers back and forth and other more informal means to engage each other on the issues that they were struggling with. And that they believed they would benefit from a further -- the convening of a public session. So we agreed. The agency agreed and has reconvened that panel, and that session is now scheduled for November 30th.

So we continue to proceed with our interim approach, which is that we have not, and are not, relying on any of these studies for any final regulatory action. And we are eagerly awaiting the conclusion of this important consultation with these folks whom we've always relied on, the two science panels, and the special infusion to that process of the specialists in this area.

So that's my report.

MR. EHRMANN: Okay. Thank you. Elin?

MS. MILLER: I just have a general question on timing of things. One of the things that at least just has come to my attention recently is EPA had finalized regulations on neurotoxicity testing. And I think those regs were final on May 14th -- or the guidelines were final on May 14, 1998. The drafts were peer reviewed. Environmental organizations were involved. The industry was involved. Academia, etc.

And just to read a couple of things on this, there was a specific session, 3.1.1.4, Human Laboratory Exposure Studies. And it says neurotoxicity assessment has an advantage not afforded to the evaluation of other toxic endpoints, such as cancer or reproductive toxicity, and that the effects of some chemicals are short in duration and reversible. This makes it ethically possible to perform human laboratory exposure studies and obtain data relevant to the risk assessment process. And then it goes on to deal with that.

That was issued as final guideline, May 14, 1998, by the agency. Then one month later, the statement was made: no human tests would be accepted. Organophosphates are neurotoxins.

So that just -- it just does not make sense of how the agency could have gone through a three year process of deliberating on neurotoxic risk assessment guidelines. And understanding the ethical natures and all those things -- and we -- I mean, our own process internally is so rigorous, it's almost unbelievable to get there.

But how could that process have ended and one month later the rules get changed? And by the way, some pesticides, the risk assessment had historically for 15 years been based on human testing. It's not like this was something new. So why?

MS. MULKEY: It's important to remember that throughout this issue, the exposure -- human exposure studies have been -- have not been the subject of this intense focus with regard to ethics issues. That's not to say that there are not ethics issues associated with human exposure studies. But studies designed to evaluate levels of exposure are -- is a whole different universe than those designed to establish toxic end points.

So, I mean, I heard you read that. I don't have the document in front of me. But it may very well be that the kind of studies that that guideline speaks to are the exposure studies. And there have long been a number of exposure studies.

MS. MILLER: No. It's specific to toxic endpoints. That's what they were working on.

MS. MULKEY: In any event, I think there -- the focus, I think, is on the notion that a number of these are being conducted, and that there was a widespread sense within the agency -- not just the Pesticide Program -- that it was time to take a good hard look at the ethics associated with the conduct of these studies.

MS. MILLER: Well, you know, once again, how do you finalize a guideline on May 14, 1998, and one month later say no after three years of deliberation? So that's -- I mean, it's just confusing to us.

MR. AIDALA: Well, we all are part of -- well, part of it, too, is we know the history. This was raised as a TRAC issue and that was what -- I think there's a distinction between time out and we're not accepting. And I think at some point we all face this, and it's something that we've dealt with internally on. So how are you doing -- again, one of these sort of unfinished science issues, and what are you going to do in the meantime. And that's been the wrinkle that's been the hardest one to sort out over time in recent times.

We would have all liked to see this -- for lack of a better phrase -- concluded by now one way or the other. And Marcia went through some of the background and where it was in terms of the panels reviewing it and all that and what's to come. And, you know, ideally we would have liked to see that, and almost every other issue that we already know about or any future ones, resolved on August 4, 1996. But, you know, that's one reason we're all here, because some of these issues are still in play.

So, again, I would just say make a distinction, responding to your point about time out versus we're rejecting it. And, again, functionally that may not seem like a big difference in the meantime, but that is important to us.

MS. MILLER: I guess was it a time out only for pesticides, or is a time out for the entire agency has now voided this guideline, or what's the situation?

MR. AIDALA: My take on it, I'm not sure -- and the oral dosing studies are the ones that are most sort of at issue, for lack of a better phrase, and I don't think there are other parts of the agency where you would use oral dosing.

But I'm not trying to say I know everything about the air program or other places. It is an agency wide look, and an agency wide issue, if that helps.

MR. EHRMANN: Okay. Cindy?

CINDY: My question is just probably one more of clarification, Marcia. In your comments when you began talking about human studies, you talked about a concern that the agency had when you thought that -- and I'm over simplifying this, I'm sure, that chemical companies were out there generating human studies, and you had an ethics concern, and you're convening an ethics panel and all that.

And I guess my question is, has the agency decided that the human studies, like Elin mentioned, that prior to FQPA had been the basis for selecting an endpoint or whatever, are now no longer reliable? I guess my question is that it seems to me you have some reliable and available data in these human studies that would tell you exactly how a chemical reacts in a human, which we've heard over and over and over these six TRAC meetings as what you want to know. That there is all this uncertainty about how these chemicals react and why the agency wouldn't use that data.

I just want clarification. Do you have a concern about its reliability, or is it more an ethics issue? Where is the differentiation?

MS. MULKEY: Well, those issues are not totally unrelated to each other, of course. But with respect to studies that we have long had in our files not recently received, we do think it's appropriate, in addition, to deferring the reliance on those studies for any final regulatory action, until after we have a policy that would allow us to sort through whether to rely on them and how for ethics purposes.

We do think it's appropriate to try to understand how valuable they might be in terms of just other scientific principles. And in fact, upon closer scrutiny, some of them do not lend themselves at all well to continued use, for reasons that are independent of ethics. And where that is the case, we've tried to identify that and make that clear and be as transparent as possible.

Others of them do not sort of readily contain problems or issues that allow you to reach some sort of determinative conclusion independent of an ethics kind of analysis as well. And for those, we have on occasion done calculations both ways, as you know, and other kinds of things to sort of try to keep -- to be as transparent as possible about the impact of this interim approach and where it's having an impact.

But it is -- we have discovered that some of the circumstances in the past, where we have used and relied upon some of these studies to set reference doses, that just as a lot of times when you revisit the way you looked at a science issue sometimes years and years ago, that in some of these instances our better scientific judgment now is that they're just not appropriate to rely on in any event.

CINDY: So is it somewhat of a case by case basis? I mean, I can think of an example of ours that is recent in 1993, prior to FQPA but not years and years ago, that an endpoint was selected based on a human study. So in those cases, you're going to go case by case?

I mean, right now you're not going to do anything until you get a policy. But once you have a policy in place, am I reading into the fact that you're going to go case by case and look at the reliability issue?

MS. MULKEY: Well, it depends on the policy.

CINDY: Of course.

MS. MULKEY: So, that's what I mean that these things are intertwined.

CINDY: Yeah, right.

MS. MULKEY: So it's a very hard question to answer. What I was trying to say is that we are attempting where it is in front of us. It's on our plate and active now.

CINDY: Okay.

MS. MULKEY: To take a case by case look at these old studies. And if we -- or if we discover that they're just not -- they don't have enough scientific rigor to even reach the questions of ethical acceptability. There are occasions when we in that case would say that is the end of the issue for that study.

CINDY: And one just quick follow up. Could I read into your comments then also that possibly you would be considering them for worker exposure scenarios? If it's not an oral human feeding? If it's, you know, a worker exposure?

MS. MULKEY: The issue of studies that are conducted to help understand exposure, the most common of which are these so-called skin patch tests designed to determine sensitivity, although there are ethical issues for those studies -- and I don't mean to imply that there are not and they are covered. But they do not, we believe, raise the kind of challenging dilemmas that our science panels are struggling with. We have continued to evaluate those, accept or reject them, on a case by case situation.

MR. EHRMANN: Okay. Bill Spencer?

MR. SPENCER: Let's get this down to the drawer level again, guys. You already heard me talk about 99.9 earlier. And I would remind you that the world that I live in in producing my citrus is a very small world. When I got into this business almost 28 years ago, it took a vessel three -- a little bit over three weeks to sail from the port of Long Beach to the port of Tokyo in Japan. Now 28 years later, it takes that same vessel ten days, and they're working on nine days now. And this is a boat that floats on the water. So they're figuring out how to get across the ocean faster.

I'm not the only one in the world producing lemons, like the lemons that you see out there. I can compete with growers in Argentina, in Chile, in South Africa, in Morocco, in Italy, in Australia, and a number of other places around the world that are producing lemons.

In the European union where a lot of these countries look to see what their pesticide regulations are, you know, they regulated 97.5, and we're sitting here -- you know, we talked a little bit this morning about 99.9.

You know, I listened with interest when Elin made the point that the World Health Organization, you know, just set the reference dose for Chlorpyrifos, you know, utilizing human and animal studies, and that it is 60 times greater for acute and a hundred times greater for chronic than what we set, you know, because we're not using human or animal studies.

And I just want you all to know that making decisions like this, and if the agency chooses to walk down a path of being worried about ethics, when other countries in this world have already fought their way through that and are making decisions based on human studies and have found that they can set reference points 60 to a hundred times higher based on what actually happens to a human being as opposed to some computer model or something like that, you are going to put me out of business.

Because you're going to put me at a competitive disadvantage with the rest of the world. The rest of the world is going to be following World Health Organization guidelines, not guidelines set by my federal government. And I think you have to take this into consideration, not only when we're talking about human studies.

But I'll go back to 99.9 again. You can't put me at a disadvantage to another grower. We can't have an un-level playing field. And we haven't talked about it, but one of the policies is level of detect, right? I mean, when does zero equal zero? Well, zero will never equal zero for me, because I grow -- what I grow in the United States, and if you can't find a residue in my lemons, you're still going to apply a half level of detection.

But the Chilean fruit that comes in here and competes against me at the beginning of my season in July and August and September, and seven tenths of one percent of that that gets inspected by the FDA and they don't find it because the residue doesn't exist, zero equals zero.

So I'm just begging you as a grower. You know, I need to be at a competitive advantage with the rest of the world. We live in a small world. You know, we're not just exporting. There are other people that are exporting to us and we're importing fruit. And I'm just begging you to find your way past it. If the rest of the world found their way past an ethics problem with human studies, go talk to them and find out how they found their way past it. And let's find our past it, so that you don't put American growers at a competitive disadvantage