of the National Advisory Council for Environmental Policy & Technology
U.S. Environmental Protection Agency & U.S. Department of Agriculture
October 20 & 21, 1999
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 FoodsBrad Luckey, Farmer from southeastern California
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
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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.
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.
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 3rd.
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.
(END OF TAPE ONE, SIDE ONE)
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?
(END OF TAPE ONE, SIDE TWO)
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.
(Whereupon, a brief recess was taken.)
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.
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, 184.108.40.206, 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.
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 against foreign producers.
MR. EHRMANN: Bill, quickly?
MR. LOVELADY: Yeah. Marcia, just a point of clarification. The interim policy is that no final determination will be made based upon human studies? That was the wording, right?
MS. MULKEY: That's correct.
MR. LOVELADY: Is it implicit that –
MS. MULKEY: Reliance on human studies.
MR. LOVELADY: Okay. Is it implicit in there that it can be considered as part of the preponderance of the evidence? You say final. When you say that no final decision, is there a place in there that sometimes it's considered in the context of all data?
MS. MULKEY: Well, I think that this is somewhat like -- it's not entirely like. But it's somewhat like the issue of how much difference would it make if it weren't 99.9. How much difference would it make if we, you know, had a different approach to estimating drinking water.
And you sort of -- you want to know how big a role this issue is playing if you're on the cusp of making a decision, just because that's a smart way to proceed. You want to know how big a role any of these kinds of issues are playing. That's not quite the same thing as saying you consider it in weighing the evidence that you do rely on, because our policy is not to rely on it, and we don't.
I know that's probably a little too much discussion about what it is for your taste.
MR. LOVELADY: Well, I was just trying to get past the final word there. You know, the word final.
MS. MULKEY: But I think what we're attempting to do when we take final actions is to do it with our eyes open with regard to every issue.
MR. EHRMANN: Okay. Let's move on. Thank you, Marcia, for that update. Let's move on to the tolerance reassessment progress, the piece that Jack Housinger is going to review with us.
MR. HOUSENGER: Thank you. I think I've got probably 30 seconds to go through this. But unless you've been asleep for the past -- or the prior TRAC meeting, you'll already know that FQPA establishes time frames for us to get through reassessing all the tolerances that were on the books as of August 3, 1996. And it directs us to complete a third every three years until August 3, 2006, when we're suppose to be done with it.
We grouped in accordance with FQPA, we've grouped the tolerances into three groups. We're supposed to complete the reassessment for the tolerances that may pose a potential -- a greater risk first. And as you can see from this chart, group one includes the OPs, the carbamates, the carcinogens, RFD exceeders and the high hazard inerts. There are priority one -- or priority group one, you should note, contains the largest number of tolerances. It contains 50 percent -- 57 percent of all the tolerances that we're suppose to reassess.
On August 2nd Administrator Browner announced that we had already met our goal, I guess one day early.
MR. HOUSINGER: Of the one third. Now there are 9,721 tolerances that we have to reassess. If you take one third of that, there are 3,240. We actually reassessed 3,290. So we beat that third by a little bit.
The next slide shows what percentage out of the 3,290 came from each group. And as you can see, group one -- 66 percent of those tolerances were in group one, which is consistent with what FQPA directs us to do, which is consider those tolerances first.
The next chart shows specific numbers on how many have been completed. For example, for group one 2,178 tolerance reassessments have occurred. We still have 3,368 to go.
And finally, if you will take your handout, the bottom of the second page of the tolerance reassessment handout, it shows that we have made additional progress since August 2nd. As of mid-October we've completed over 35 percent of the reassessments and continue to work toward our goal of 66 percent by August of 2002.
And I'm done, unless there are any questions.
MR. EHRMANN: Okay. Bill Lovelady, a question and then Jay.
MR. LOVELADY: Yes. At the risk of sounding like a broken record, my first comment was that I wished that what happened on August 2nd had not happened. And I was asked to testify before the House Committee -- House Ag Committee on EPA implementation this summer.
And Charlie Stenholm -- Congressman Stenholm asked me specifically -- he said, how do you feel about our progress in the TRAC. He said, how do you feel now compared to a year ago. And I testified that I thought that we had made a great deal of progress, but that I was extremely disappointed, and I thought that we had actually taken a step back when we did more after we had already -- after you had already reached the one third level, to go back and to make some decisions on Azinphos-Methyl and Methyl Parathion that appeared to many of us to be more in the nature of political science than in real science.
And so I would like to urge the agency in the future to be a little bit more sensitive to the people that are involved in agriculture, and not make the same kind of mistake for what appeared to us to be political reasons. Why we needed to do that when we had already reached the one third goal, then for just a -- at the last minute to throw in these two products.
And you can't -- it's very difficult to undo wrongs. But I think that this was -- I think it hurt the credibility to do something like this at a time when it wasn't absolutely necessary with as little input from everyone, from registrants and users, as we had.
So I would just like to encourage the agency to be more sensitive. And I think it will help the credibility of the process a lot if we don't make the same mistake. And I do consider that a mistake.
MR. EHRMANN: Okay. Jay?
MR. VROOM: FQPA's section 408(Q), Publication of Schedule, required an initial Federal Register notice not less than 12 months, which was done, but I think it's been changed more than once since then and in August of this year.
I wonder if there is a plan to put that in the Register, or would it be done for comment. I mean, the law specifically says it's not rule making, but is that a place that the schedule and a list could be a little better clarified?
MS. MULKEY: I think that we think that that is still valid. In other words, what that -- as I understood the list, what would we put as our first priority. What would we devote our energies to first. We're still doing that. I mean, it is the case that some of this first third included things that were not in list one. But that's not because we set aside work on list one in order to free ourselves up to do these others. It's because other work, such as the registration of an additional use for a list, led to the reassessment of some of those.
So I don't think it's our view that what we published is inaccurate or has been changed.
MR. JOHNSON: It wasn't changed. What do you mean? When you say it's changed, Jay, what do you mean?
MR. VROOM: My recollection was that there was sufficient detail in the original 12 month deadline list of priorities that would not be accurate today.
MS. MULKEY: Okay. Well, it's worth looking at that. We certainly don't -- we don't want to be inaccurate and misleading in any way. We have published, as you know, a good deal of information about our schedules and about our plans of action since then. I think it's fair for us to be sure that we don't have anything out there that is misleading.
MR. VROOM: Sure.
MR. EHRMANN: Let me just comment, too, on Bill's remarks relative to the August 2nd decisions. We are going to touch on that a bit more directly when we get to the part on the agenda about the OP update that Lois is going to lead.
MR. LOVELADY: And I just brought that up because –
MR. EHRMANN: I know.
MR. LOVELADY: -- you were going through the schedule.
MR. EHRMANN: No, no. I think it was good you brought it up. I just want to let you know that there will be some response or discussion on that from the agency, since they didn't respond right at that moment.
MR. BOTTS: Yeah, real quick. In the tolerance reassessment process, after you complete that there are several different options provided as far as what can be done with those tolerances. One is revocation, one is modification and the other is continue as it goes forward.
And I was just wondering, have you done any kind of analysis on exactly what the actions were relative to the tolerance that you reassessed as far as what percentages met which criteria? That's the first point. And then the second point deals with a different issue. Do you want to try to get that one first?
MR. HOUSENGER: Yeah. We have analyzed how many were revoked, how many need to be raised or lowered or otherwise -- and how many stayed the same. My eyesight is going. Out of the --
MS. ROSSI: 1498.
MR. HOUSENGER: Yeah, 1,498 have been -- Lois is reading these for me -- 1,498 have been revoked. Out of the RED actions, the tolerances have been reassessed with REDs: 143 need to be raised, 133 need to be lowered, 584 remain the same, 93 need to be revoked, and 46 need yet to be determined.
MR. BOTTS: And the second question deals with - is probably more directed toward the RED process rather than other processes that might have been involved in those discussions. It has come to light in at least some of the technical briefings that there are labels out there that aren't currently in line with negotiations on uses that have been brought relative to negotiations with the technical registrants and others -- some of the following registrations on other things.
Could somebody outline for me the process by which the agency goes through a label validation process to ensure that when those use restrictions that are negotiated to meet the risk numbers are actually carried out to all labelled end use products, rather than just being with the initial technical registrant?
Because it creates a real dilemma out in the marketplace, both from a marketability of products standpoint, as well as putting growers at risk for sometimes having products that maybe in the eyes of the agency are not appropriately labelled, even though the labels have been approved by the agency.
MR. EHRMANN: Do you want to comment?
MALE SPEAKER: Yeah. After we make a label modification to the technical registration, we usually do two things. One is have the technical registrant communicate that down to their customers. And then we also follow up and communicate it down, asking for voluntary cancellations, recognizing that at some point in time there is not going to be any product out there for those people to manufacture that product into.
(END OF TAPE TWO, SIDE ONE.)
MR. HOUSENGER: But we try to make that clean up at the time of re-registration.
MR. EHRMANN: Did that -- yeah, go ahead.
MR. BOTTS: I would just suggest that maybe the process needs to be looked at again to come up with some clarification process on exactly how that process works. And just a case in point, for a compound at a technical briefing -- or not technical briefing -- but a stakeholder meeting was held. There were some real interesting differences in the labels that still existed out there, based on a negotiation that had taken place. Not for dietary concerns, but worker exposure and aerial application information from several years ago that created the distinct marketing advantage, because the labels weren't verified to the technical registration that was there.
And I'm just -- I'm wondering whose responsibility it is -- it's certainly not my growers' responsibility to know when those negotiations have taken place and what those label changes are. But I've been given the impression that sometimes the agency doesn't necessarily feel it's their responsibility to get into that discussion either.
But somebody -- if those are going to be the way these things are handled, especially in light of what's coming forward with Methyl Parathion in December, it may not be an issue. But if there is a product that's labelled out there that carries two different sets of use instructions, it creates a real dilemma for our growers to deal with things -- the actions you've taken to mitigate risks.
MR. EHRMANN: Good point. Steve, did you have a question?
MR. JOHNSON: Just a comment. I think there are perhaps at least two issues to bring up. One is sort of the federal licensing process to make sure that the primary, and then through all the various distributor labels, that that is properly accounted for.
And then raising a second issue, and that is, one of label enforcement. And certainly for other issues where we have, for example, worker protection regulations, or other -- I'll call them events -- where we have asked our enforcement arm of the agency to focus on that as a priority to make sure that those labels are in full compliance with, you know, whatever that particular action was.
So I think there are a couple of things that we should think about, and certainly comments or suggestions to use, both in the process of making its way through the channels of trade, if you will, on one hand, and on the other hand from an enforcement standpoint.
MR. EHRMANN: Mark Trostle, is your comment on this point, the labelling point, or something else?
MR. TROSTLE: Yes.
MR. EHRMANN: Okay. Why don't you go ahead, and then we'll move on.
MR. TROSTLE: Well, I was kind of going to step forward for our state lead agencies. Steve talked about the enforcement arm. That falls back to us, the state lead agencies, doing the enforcement. And labelling registration issues are a real pain, because, yeah, you can negotiate. You change here, but where the wheel meets the road out that, it's us. And we're the ones that are taking the burden of making sure these labels get changed, and all the decisions are being made every day that's impacting every state on what's happening out there.
So it's a real -- it's a real issue. And many times the states aren't being included in these meetings, or even being advised of these meetings. This stuff comes down and then poof, there it is, and you've got to take care of it.
We still today find DDT on the shelf. Now don't say that just because you passed a rule that you remove all those labels -- Paris Green, DDT, Sodium Flora acetate and other things are still out there. You walk in these drugstores and old feed stores, and you're still coming across it. It's not just selected to Texas. It's every state. You can go out and find it. I can probably find some here today in this town right here.
So it's one of those issues that you've got to be careful when you start changing labels. It's also a work issue. If you've got a product registered, a lot of the states have gone to multi year registrations. That product is going to continue to be registered out there in that state. You come out with a new label and the state simply makes that company register the product again. So, again, a monetary burden for them. It's a paperwork burden for everyone involved.
So when you start making these rules, as Bill said over here, you impact lots of people, and you start impacting not just the grower. But you impact a consultant, you impact an extension service or experiment station, and the state lead agency out there. So when you start restricting labels, you start causing lots of problems.
MR. EHRMANN: Okay, one more. Mark?
MR. MILLER: I just have a question about the rigorousness with which the tenfold child data uncertainty factor is being applied. You know, how it's being applied, particularly in light of limited studies of neuro and developmental effects.
What is the percent of reassessments to which that factor has been applied?
MR. EHRMANN: Marcia?
MS. MULKEY: Yeah, why don't I take that. We have a -- we do maintain records of each circumstance under which a chemical is considered for the tenfold safety factor. We can provide that. I don't have it with me today.
You need to look at it in terms of which sets of chemicals are in the denominator. And obviously it depends on whether you're talking about new chemistry or old chemistry or a lot of other things in terms of what you think it means to look at those numbers. But we can provide them, and have provided them.
With respect to that whole approach, that is the subject of a major science paper. It was published, I believe, in July, and the comment period ended recently. We also had a -- we've had multiple presentations to the Science Advisory Panel on that.
So there is an enormous amount of information in the public domain about how we're doing that, what procedures we're using and the approaches we're using. As well as we have been entirely open about its application to particular chemicals.
With respect to the organophosphates, each of the risk assessments -- and only a handful of them now have not had at least the preliminary risk assessment published. And in each of the ones where we've published, we have a detailed discussion of how we did the FQPA safety factor analysis.
MR. EHRMANN: Okay. Nancy, I really would like to -- is this quick? Because we need to move along.
MS. RACHMAN: Yeah, very quick. Just since Mark brought up 10X, I thought I would just tell the group that the issue of additional safety factors for children is another science policy issue, and it has a nexus back to the international community and competitiveness issues that Bill raised before.
The WHO, FAOJ and MPR was asked to consider whether their current methods for setting maximum residue limits are adequate, or whether additional safety factors for children developing organisms might be necessary. They reviewed, as far as I know, a complete dossier of information, including the National Academy of Science reports, the various LC's reports and so on.
And their conclusion, which was recently published, said that there is currently no basis for changing the current approach to addressing the susceptibility of developing mammals as compared to that of adult organisms in the toxicological evaluation of pesticides.
MR. EHRMANN: Okay. Let's go to the worker risk assessment update. Margaret and Therese?
MS. STASIKOWSKI: Okay. Therese and I will give you an update on the expanded public participation process in occupational risk assessment. You do have a handout that corresponds to these slides.
At the last TRAC meeting, members indicated that EPA needs to engage in more explanation of how we do occupational risk assessments -- our methods -- and solicit more participation earlier in the process. And here are some of the specific activities that we have done over the summer.
The land grant universities' staff have become involved in risk assessments -- in our preliminary risk assessments -- serving as reviewers. EPA scientific staff gave a short briefing on occupational risk assessment methodology at the July PPDC meeting.
MS. MURTAGH: Also, our land grant university people have served as reviewers for the OP risk assessments, and they've looked at a number of the occupational risk assessments as part of this work. And as they reviewed the occupational risk assessments, our reviewers came to agree that they could better serve EPA as contributors rather than reviewers. That it just, you know, fit, you know, their background and what they were able to contribute.
Well, they did ask for two things. They wanted to learn more about the risk assessment process. They needed to know how -- what data was needed and how it fit into the assessment, and they wanted to learn more about PHED, the pesticide handlers exposure database and how that model works. The second thing that they asked for was a process for their early involvement.
So we got to work. We met first in July. A group of land grant people who had served as risk assessment reviewers got together with some of the EPA risk assessors, and we had an all day session talking about the risk assessment process.
There was a second meeting in August, where a group of land grant specialists from our North Central Region met with EPA and again went through the risk assessment methodology and discussed possible improvements.
And then last month in Louisiana, Lois and Margaret brought an excellent group of EPA-ers to our USDA Southern Region annual meeting. And Margaret will describe that meeting. but it resulted in our land grant people becoming even more enthusiastic about working with EPA, and they would like me to emphasize about their becoming contributors rather than reviewers.
MS. STASIKOWSKI: Presentations at the meeting were extensive. There was a lot of questions, a lot of back and forth discussion, and I believe an improved understanding of the way that EPA does its risk assessments.
We made detailed presentations that covered all facets of human health risk assessment, looking at dietary and drinking water assessment and methodology and occupational risk assessment. We discussed our pesticides handlers exposure database and presented a case study of a worker risk assessment for Azinphos-Methyl.
We also discussed worker protection standards, re-registration and tolerance reassessment, risk mitigation and the REDs, use and usage of data needs -- as you can expect, we spent a lot of time discussing that -- and the pilot public participation process.
MS. MURTAGH: Well, I think we're, you know, well on our way of addressing the land grant universities' first request, which was to get smarter about the occupational risk assessments. We do need to take the second step, which is to set up a working process for their involvement as contributors.
Later in this meeting, this group will be discussing the revised -- a revised public participation process. And one of our USDA goals for that process is to have an earlier on opportunity for involvement by land grants, but we would also like to take extra steps and work out ways that they could make connections and contribute even earlier.
Larry Olsen of Michigan State University has been a leader in advocating a multi day workshop for land grants and possibly others as an expansion of the excellent meeting that we had in Louisiana. We haven't scheduled this meeting yet, but we hope to hold it -- certainly, Larry, who is here today in the audience, we hope to hold that meeting before there is a thaw in Michigan, which should give us enough time to do that.
MS. MURTAGH: There are also a number of other meetings that are scheduled for this spring. There will be a presentation -- EPA presentations at the Northeast Pesticide Applicator Training meeting, and also at the North Central meeting, and another presentation planned for the western states annual meeting.
MS. STASIKOWSKI: Okay. I would just like to emphasize that the Louisiana meeting, for example, was open to the public. We had some members of the TRAC, in the person of Paula Paul at the meeting. We also had some farm worker representatives at the meeting. And the meetings that we are planning on will be open to the public.
I would like to also add that USDA has joined industry and the EPA task force for further development of the pesticides handlers exposure database, and we already know that USDA will be providing additional data for the pesticide handlers exposure database.
MR. EHRMANN: Great. A good example of some good team work there, in the presentation as well as in the work you're doing.
MR. EHRMANN: Let's take some comments. Yes?
FEMALE SPEAKER: I just wondered if you could comment on what parts of the country are the land grants that you're working from -- working with. Do they represent all of the different regions of the country and the different agricultural practices that would be in those regions?
MS. MURTAGH: They certainly do. At the meeting that we had in Louisiana, we had representatives from every USDA region. Even though the meeting was held in the Southern Region, there was a lot of interest and participation.
MR. EHRMANN: Okay. Cindy?
CINDY: I have just two quick comments. One is that I think it is very beneficial that you're going out and explaining some of these scenarios. I think the worker risk assessment scenarios, all the ones that are in there, are very complex. And the comments that we got from some of the land grant people that were looking at Bensulide, for example, and its ag uses were that they didn't quite understand what those scenarios meant and what those things are. So I applaud you for the efforts of opening up those scenarios and explaining how they go and all of that.
And my second question is really, I guess, for EPA, which is, are you guys looking at probabilistic risk assessments for worker exposure scenarios? Is that something like with dietary that we're looking at? Is that something that we're entertaining the possibility of looking out for worker exposure?
MS. STASIKOWSKI: I think as we develop -- as we have more information, as the information comes from the industry task forces, if we have their appropriate information, we definitely would like to move to probabilistic.
CINDY: I think -- I know that some companies -- I know we've done one for ours, for Bensulide. And I know other companies have looked at them. Are those being accepted then? What is the status of those?
MS. STASIKOWSKI: I don't know about the particular Bensulide.
CINDY: Well, I don't mean Bensulide specifically. Just in general, if someone like Novagen were to do a probabilistic risk assessment with maybe data from CDPR or CDMS or other -- you know, in Bensulide it was a easy case because the particular use was in California. And so we had very good data about what the use pattern was.
But if there are other scenarios -- I'm just asking in general. Is that something that you're accepting?
MS. STASIKOWSKI: Yes, definitely, and we would like to see more of those.
MR. EHRMANN: Bill?
MR. LOVELADY: Yes. I guess this is sort of a question. Worker protection is in FIFRA, right, and not specifically in FQPA. And doesn't FIFRA require a risk benefit analysis and FQPA doesn't.
Would somebody kind of comment on how you resolve these two different laws as far as that is concerned about the risk benefit analysis?
MS. MULKEY: I think you said it almost exactly correctly, that in the situation where you have risks opposed to workers, if you don't have risks, you know, then you don't have the issue. But where you do have, then you have to ask yourself, are these unreasonable adverse effects taken into account the benefits.
And so it is absolutely a part of the analysis in terms of evaluating whether to take risk management measures and which ones are appropriate. There are some things that are sort of built into that, if you like. I mean, the sort of levels of risk that are generally regarded as to be regulated for workers tend to be a little bit higher in general. Cancer risks, for example. The sort of operational level of projected cancer risk for workers we think a little differently about than we do for the general population.
So there are some senses in which sort of even at the risk level, you take account that statutory difference. But it absolutely requires that you take into account the benefits. The same thing is true for ecological adverse effects.
MR. AIDALA: Also, Bill, just a 30 second seminar on it, just so it's clear, FQPA was a set of amendments to both FIFRA and Food and Drug. But that part of FIFRA, that was part of FQPA as amended. FQPA amendments to FIFRA did not change the benefit considerations for worker risk and things. But FQPA was amendments to both laws, just to clarify which is which.
MR. EHRMANN: Dave and then Nancy.
MR. WHITACRE: In a case where a product is regulated for a non-threshold effect from the dietary standpoint, is there any bright line for handling the safety assessment for workers on that same product?
MS. MULKEY: I think the right answer to that is no. And I don't think we would say there is a bright line for handling the general public safety. I think we all know that the legislative history around FQPA indicated that the ten to minus six range was generally expected to be.
But I don't -- but for workers there is -- we have a range that we sort of do as a point of departure. And that's what I was referring to when I said that the benefits analysis was to some extent almost built in at that point of departure level. That's all I was trying to refer to.
MR. WHITACRE: I thought so, but you've clarified it. Thank you.
MR. EHRMANN: Nancy did you -- no? Okay. All right. Anything else on the worker issue? Let me suggest or propose the following in terms of the agenda. Rather than have Lois do the presentation and not have time for the discussion, because everyone will be getting hungry, why don't we -- let me suggest we go ahead and take our lunch break now, but keep it to returning at 1:15. We had more than a hour on the agenda, but let's keep it to an hour. And then we'll come back for Lois' presentation. There is enough room in the agenda this afternoon to keep us on schedule.
There are restaurants over in the -- there is a good court over in the Ballston Commons, kind of through the lobby of the hotel out into the metro area there. There are also several restaurants here in the hotel, but I would encourage you to do more of the food court kind of thing, so you can make sure you do get back within an hour, if at all possible.
So let's reconvene at 1:15. Thanks.
(Whereupon, a lunch recess was taken.)
MR. EHRMANN: If anyone has anything to say about Azinphos or Methyl, you have two minutes.
MR. EHRMANN: Time's up. Okay. What we would like to do at this point is turn to the update -- status report on organophosphate pesticides, as it's titled on your agenda. There are a number of sub-issues there that Lois is going to touch on and open this up for discussion for a period, and then we'll move on to the transition issue discussion that Al will lead off for us.
FEMALE SPEAKER: John?
MR. EHRMANN: Yes?
FEMALE SPEAKER: On the handouts to be provided, were there any comments that we could make on the data call-in for neurotoxicity studies or some of those other things that were up on the agenda this morning that we never talked to?
MR. EHRMANN: I mean, those were just meant to be, I think, other papers to support the earlier discussions.
FEMALE SPEAKER: Okay.
MR. EHRMANN: But if you have any comments on those –
FEMALE SPEAKER: I just have a question. I just have a quick question on the data call-in for the neurotoxicity studies.
MR. EHRMANN: Yeah.
FEMALE SPEAKER: There are some cases where OPs have been farther along through the process, where we've gotten documentation from the agency that says, you know, looking at the preponderance of data, there is not a need for a developmental neurotoxicity study.
Does this overrule that or do those –
MS. MULKEY: Yes.
FEMALE SPEAKER: Yes?
MALE SPEAKER: Aren't you glad you asked the question?
FEMALE SPEAKER: Yeah, I'm really glad I asked it.
MALE SPEAKER: Science marches on.
MALE SPEAKER: Science is a wonderful thing.
MALE SPEAKER: Science marches on.
MR. EHRMANN: Okay. Any other comments on that? All right.
MALE SPEAKER: You'll know when you get your data call-in letter, you know.
FEMALE SPEAKER: I know.
MS. ROSSI: All right. I'm going to present the status of the agency's review of the organophosphates. In the presentation today, I will be presenting a status report that reflects a great deal of work on the part of the agency and the department, and all of the many stakeholders that are at this table here, and those that you represent that aren't here, as well as those stakeholders that aren't here today.
While a lot remains to be done, and that will be the focus of much of the discussion today and tomorrow, I ask that during these remarks over the next several minutes you at least think about the progress that has been made over the last year to accomplish the goals discussed over a year ago at the TRAC meeting.
I've got three major areas I'm going to cover: the overall status of the OP review, including the schedule for review of the individual OPs, a discussion of the technical briefings and stakeholder meetings that we have held to date, and lastly I'm going to cover highlights of several OPs, including the status of the implementation agreements of Methyl Parathion and Azinphos-Methyl, work on three OPs that are at or near closure, and recent work on the first three public health OPs, which we have not talked about a lot at TRAC until now. And I would like to have some remarks on those three Ops.
In your package there is the status of the OPs in the pilot process. It's basically the same chart we have been showing for the last few TRACs. It's the one on the Internet. You'll see that the agency has released a large number of preliminary risk assessments into the docket and onto our Internet web site. Thirty five OPs are now in this pilot process. We have four more to go.
The whole process started last year, specifically on August 10, 1998, when we issued nine preliminary risk assessments. They were placed on the docket, followed by an additional seven assessments that were placed on the docket on September 9, 1998. So it's just a little over a year ago that we've been doing this.
The first page of your handout provides counts of the number of OPs that are in each phase of the process, and the second page provides more detail by listing which OPs are in each phase.
The current activities on the OPs and how we are refining the risk assessments. The agency has worked very closely with the department over the last year to ensure that several important refinements are made to the risk assessments. And I'm going to just highlight some of these refinements, because they not only play an important role in refinement of the risk assessment, but they are considered very definitely in the risk management thinking when we're faced with making a risk management decision such as the ones we made on Methyl and Azinphos-Methyl.
First of all, we have routinely -- we have developed a methodology to use composite PDP data to estimate for single servings in probabilistic risk assessments. We have been continuing to use the best data we have available to get the most refined exposure estimates.
We have been determining the risk contributors, which we call drivers, in looking at the underlying assumptions for the drivers, such as if a particular commodity is driving it, if it's the food consumption data, if it's food residues, if it's nondetectible food residues that we assume at half the level of detection, or if any of the science policies could play a particular role and the risk assessment is particularly sensitive to these, such as the 99.9.
And for occupational risks, which we do as part of re-registration, we have received a lot of data from the agricultural reentry data call-in task force, and we're using that as it comes in.
For the public health uses, which we're just beginning to get into the risk ssessments -- the refined risk assessments on -- we've been working to refine them using the best information and assessment tools that we can.
To briefly summarize the status of the 39 OPs, 35 -- again, 35 have entered the process. We have four chemicals that are still in pre-phase one of the pilot process. We have not done a preliminary risk assessment. We have four chemicals in phase two and three chemicals in phase three. Twelve chemicals are currently in phase four, and these are the ones that are next in line to have refined risk assessments released to the public via the docket and the Internet.
We are planning technical briefings in the very near future over the next few months on Acephate, Methamidophos, Dimethoate, Disulfoton, Methidation -- or some people say that a different way -- Oxydemeton Methyl and Phosmet. We have eight chemicals in phase five and eight chemicals in phase six.
To date we have released 16 revised, refined risk assessments, and these chemicals are listed in phases five and six on your handout. The same day we released these revised risk assessments to the public docket and the Internet, EPA opened phase five, which is a 60 day public participation period. And we start counting the public participation period from the day it goes in the docket and on the Internet.
We have had a few times where we've had technical briefings on one day, and we haven't been able to release the assessment or get it posted on the Internet until a couple of days later. It does not start from the technical briefing. It starts from the day it is made available to the public.
The 60 day public participation period is the opportunity to submit risk management ideas to the agency and meet with us to discuss assessments data, methodology and risk mitigation proposals. Minutes of meetings with stakeholders have been placed on our public docket.
With regard to the technical briefings and stakeholder meetings, I think we've learned a lot from having these technical briefings and stakeholder meetings. Early in 1999 we modified the pilot process to include a public meeting, which we termed a technical briefing on refined risk assessments. The whole point behind that was to provide another opportunity to allow stakeholders to meet with the agency and hear verbally the presentation of what went into the risk assessment and ask questions. And, again, it was on the whole basis that unless we have a common understanding of what went into the risk assessment, it's very hard to start a discussion on risk management proposals.
The technical briefings were conducted by EPA with input from USDA, and they are scheduled at the end of phase four after the revised risk assessment is completed. With regard to the technical briefings, we have held eight technical briefings where details and methodologies of risk assessments of the eight organophosphates were discussed.
The agenda included a slide presentation describing the risk assessment parameters, executive summaries and chemical overviews summarizing EPA's findings and that were to be made available to the public.
Those in attendance typically included representatives from industry, commodity associations and growers, and other nongovernmental organizations. And I am pleased to say that at every single technical briefing we had, we had at least one representative from a major constituency. Briefings always included question and answer periods, where participants were allowed to ask questions on any aspect of the presentation.
The first technical briefing we had was on Azinphos on May 19th with approximately 125 outside stakeholders and interested parties in attendance. Bensulide and Profenofos were the subject of the second technical briefing held on June 16th with approximately 20 stakeholders in attendance. Methyl Parathion was the subject of the third one we held on August 2nd with approximately 125 people in attendance.
And the most recent technical briefing was held on September 2nd, where we actually had the stamina to do four risk assessments in a day on Ethoprop, Fenamiphos, Phorate and Terbufos. And approximately 80 people were in attendance throughout that day.
In preparing for the technical briefings, the review teams have had to work very closely together and with management, and this has resulted in better quality of the risk assessment, as well as preparing to explain the risk assessment in plain English, which has been a challenge. We have had to closely examine what goes into the risk assessment.
Thus we believe that the technical briefings have been a successful internal process for the OPP review teams and the management team. Because we've had to review the assessments, analyze the results and then explain them and defend them and stand behind them, which was going to be the basis of any risk management decisions that we would be making.
The agency believes that the technical briefings have also been beneficial to both the public and the agency in other ways. The collective wisdom produced as a result of the interactions have helped ensure sound decision making. The agency remains committed to the public participation process and will ensure that the process remains flexible and fluent.
We'll continue to encourage public participation by providing notice of the technical briefings and maintaining good communication with the stakeholder communities. We are organizing efforts and resources to more efficiently incorporate public involvement as a result of the experience from the past briefings and stakeholder meetings.
For example, the first technical briefing to be held outside of Washington, D.C. is currently being planned for early December in California, which is where two of the chemicals that will be the subject of that technical briefing, Oxidematon Methyl and Methidathion, are mostly used. The majority of the use -- since the majority of the use of these chemicals is in California, it certainly makes sense to have the briefing in a locale where people with the most interest are located, and it's also an area that a lot of stakeholders from the different constituencies can attend.
Other chemicals, again, which we're planning in the near future, include Acephate, Methylamidofos, Dimethoate, Disulfoton and Phosmet. We're not planning to hold technical briefings on Methyl Parathion, Fosterbupren, Permaphos Methyl, Propetumphos (phonetic) and Tetra Chlorethoxyphos. However, we have always said in these that we will stand ready to meet with any stakeholders that are interested.
The reason we have elected to not hold technical briefings on some of these chemicals is mostly based on a limited use pattern. We found that in a couple of the briefings we had where we only had 20 people that it probably was not worth the resources that it takes to do these. But we would do stakeholder meetings, which is what we have done on a couple of the chemicals.
Again, based on the small attendance at a couple of the technical briefings, we considered not holding them for all the chemicals, but always offering to make staff available to meet. We did not have technical briefings for Sulfotepp, Cadusafos, Ethion and Chlorethoxyphos, as well as the three insecticides that have mostly public health uses, Fenthion, Naled and Temephos.
We were asked for Ethion to hold a stakeholder meeting in Florida, which is where if not all, almost 99 or 95 percent of the use is. And we did hold a stakeholder meeting in July -- on July 27th, to be exact -- where about 40 stakeholders attended. And with a group of that size, we were able to have a great deal of dialogue throughout the meeting on the different results of the assessment and what went into the assessment. So it was a very interesting meeting, I think for the agency as well as for the people who attended.
The second stakeholder meeting we just held October 13th, also in Orlando, on Naled, Fenthion and Temephos, and it was sponsored by the American Mosquito Control Association. There we had about a hundred people attending. And this was extremely interesting, because many of these people were involved with controlling some of the problems -- the mosquitos that are causing some of the problems in the country, the encephalitis outbreaks and stuff like that. So it was a very interesting group of stakeholders, and we had also a very valuable exchange on those three chemicals.
Now I would like to give some highlights on decisions on organophosphates that are very close to closure and then end with a discussion on Azinphos Methyl.
Three OPs, Bensulide, Profenofos and Cadusafos, have been very early on in the process along with Azinphos, and we have been working with the registrant and the user community on these decisions. For Bensulide, the issues have most been non-dietary concerns. And it's interesting to point out that besides being in a pilot process, these three chemicals -- well, Bensulide and Profenofos are in re-registration. So, therefore, we have been working on re-registration eligibility decision documents for these chemicals, and that is why we are discussing risk management strategies on the non-dietary concerns. For both Bensulide and Profenofos, we did not have dietary concerns.
On Bensulide we have worked a lot with the issues on the turf use, and we worked a lot with our PSP partner, the Golf Course Superintendent's Association. I think I have that right. And for Profenofos, which is only used on cotton, we have worked a lot with the cotton growers on the mitigation measures that we're concerning, again to mitigate non-dietary concerns. Cadusafos is only an import tolerance on bananas. We had no dietary concerns and so we will just -- we will just say that.
So for these two, Bensulide and Profenofos, we are preparing a RED document -- a Re-registration Eligibility Document -- that will stipulate that the tolerances will not be reassessed until a cumulative risk assessment is done on the organophosphates. So it will have all the mitigation measures, all the decisions and all the documentation that normal re-registration eligibility documents do, but it will reserve that final assessment on the tolerances pending the cumulative tolerance reassessment exercise.
Another OP -- and those decisions probably are expected within the next month.
Another OP, which was a non-food -- it's an OP for greenhouse use only on ornamental -- is Sulfotepp. And this has been undergoing re-registration for many years. And the outcome of that was to declare it ineligible, because it essentially had a lot of data gaps. We recognize the importance of this chemical in the production of ornamentals, particularly poinsettias and chrysanthemums and stuff like that, and we came to an agreement with the registrant that we would do a five year phase out on that one.
And with regard to the OP public health on Fenthion, Naled and Temephos, I again want to specifically these, because they are the first ones with major public health uses that are in phase five. And we have just begun that phase, where we're going to discuss risk mitigation and management. And we had the successful stakeholder meeting, as I said before.
Now on the two chemicals, Azinphos and Methyl Parathion, that have been brought up today, I will discuss a little bit of the background that went into these chemicals. And having lived through the experience moment to moment, day by day, week by week, I will certainly take questions after I finish.
First, I would like to point out from a process standpoint that while both of these chemicals have food uses and tolerances that are required to be reassessed under FQPA, they're OPs in the pilot process, and they're also in the re-registration program. And, in fact, if we didn't have either FQPA or the pilot process in our lives, the review of these chemicals would have occurred anyway, and probably almost at the same time, as part of the re-registration program that was mandated in 1988.
With regard to AZM, the review of Azinphos actually began prior to the passage of FQPA. A preliminary health effects assessment was released on August 10, 1998. It was one of the first nine for public comment. And we had -- we did not have a 30 day registrant error correction phase, because the assessment had already been reviewed by the registrant prior to the start of the pilot process, probably even prior to TRAC. The EFED chapter did go through a phase one and two in December of '98 and placed on the public docket in January of '99.
Both of these chapters went through a phase three, which was the public comment period, on a preliminary risk assessment. And at that time in the preliminary risk assessment, there were dietary concerns.
From October of 1998 through May of 1999, about six months, the agency in consultation with the department worked on revising and refining the human health risk assessment. This is the point also where we started using PDP data. Azinphos, I think, was the first chemical we used PDP data and used the de-compositing method. The refined human health assessment showed that, again, the chemical would not meet the FQPA safety standard.
A technical briefing was held on May 19th and initiated phase five, which was the public participation period, where we focussed on a risk management strategy. That period ended on July 19, 199. The FATE and ecological effects risk assessment lagged behind the health effects assessment. And phase six was a phase where the agency develops a risk management decision. It officially began on July 19th, but in fact the agency began working with stakeholders throughout phase five, and began discussing with USDA different ways to mitigate the risks.
We used a lot of tools in this assessment for the first time: the probabilistic risk assessment, the PDP, and the whole sensitivity analysis to identify drivers in areas to mitigate. Very similar to the way we handled re-registration eligibility decisions in the past. However, our tools are a lot more sophisticated.
And in thinking about what would be an appropriate decision, we went through so many different adjustments to variables, like rates and PHIs and all kinds of -- and where it was really needed and what was the critical use. And we also looked at the same time at the different the factors. The fact that at 99.8 it wasn't a level of concern. The hundred percent of the RFD was not utilized -- or the PAD, I guess, as it's called now. It was not utilized.
And these all factored into the overall decision that a modification of the use pattern, with data to support the decision, would probably be the appropriate risk management decision for this chemical.
We engaged in discussions with the registrants over a series of weeks, culminating in some very intensive discussions over the course of a weekend. I know some of you got a briefing on this from the attorney from the registrant side, so I know you all have been told that already. So I just thought that I would verify that yes, in fact, that happened. And we also were in close contact with the affected commodity groups, as was USDA.
And, in fact, we didn't even have that old gossip game that you play, when I would talk to the apple growers, and Bear would talk to the apple growers, and then Bear would talk to me. We all had the same story. It was pretty amazing.
We ultimately reached an agreement with the registrant, and the discussion –
(END OF TAPE TWO, SIDE TWO.)
MS. ROSSI: -- dietary risk and still allow critical uses to remain. Very briefly, we reduced the application rates to pome fruits. We canceled some uses. We canceled the uses on cotton east of the Mississippi River, and sugar cane and some ornamentals. We believe that use modifications and cancellations did result in a reduced risk to workers, but we are continuing a dialogue with the registrant on types of data that we can require to better assess the risk. And the same thing with ecological risk. Because of the reductions in the use patterns, we believe that these also reduce the ecological risks. We didn't quantify these, but we believe that common sense would dictate that conclusion.
Where we are with this, is we have approved revised labels in accordance with the agreement, and they will be in place for the next growing season. And that was one concern that we did have that we wanted to be able to get this done early enough so that we could have an impact on the next growing season. And there is that window of time that you have to be able to do that.
We will be announcing cancellation of the sugar cane, eastern cotton use, shade trees, Christmas trees and a number of ornamentals in a NACEPT notice, and that will also provide another comment period on those dropped uses.
And we are continuing to meet on data, because the agreement does hinge on generating residue data to show that these modified use patterns will in fact result in reduced residues. And that's a very important part of the agreement.
So that was Azinphos, and Azinphos presented a different risk management problem than Methyl Parathion. With Methyl Parathion we had preliminary risk assessments that were sent to the registrant for error correction in October of '98. And Methyl Parathion actually didn't have as much pre-TRAC, pre-FQPA work done on it as Azinphos did. It came up later in the queue -- in our re-registration queue -- and so it didn't have as much work as Azinphos.
The preliminary risk assessments were released for comment in December, and they showed levels of concern. They showed very high levels of concern, but it was a very unrefined risk assessment. However, even with an unrefined risk assessment, if you have a very high level of concern, with a refined one you're likely to have the same concerns, unless there is some very quirky thing going on.
From February through early August, the agency worked on refining and revising the risk assessments on Methyl Parathion. The refined risk assessment -- and, of course, by the time we got to Methyl Parathion, we knew how to use PDP. We knew how to use decompositing. We knew at least how to start thinking about drivers. So Methyl Parathion certainly benefitted from all the work we had done on Azinphos.
And it showed that the dietary risks were orders of magnitude above the levels of concern, and that no further refinement was possible using currently available information. And we believed that it would not meet the FQPA safety standard. The agency consulted with USDA, starting in late May and June, on the risk assessment and began a dialogue to identify drivers and mitigation measures with USDA and growers and registrants.
A technical briefing was held on August 2nd announcing the results of the risk assessment and incorporating the measures that we had agreed to with the registrant and the agency. And, again, the canceled uses accounted for about 90 percent of the acute dietary risk to children, and yet it's only about 10 percent of the Methyl Parathion use.
The risk management decision included the cancellation of use on a variety of children's foods, fresh fruits and vegetables, and we did have some non-food uses that were also offered up to be deleted. We believe, again not quantitatively but qualitatively, that the reductions in the use will have an impact on reducing worker risk and ecological risks.
Where we are with implementing that agreement, all the Methyl Parathion products with the old use pattern were canceled by August 25th, and the new products with the revised use pattern were all approved by the agency on October 8th. You'll hear later today the issues concerning the tolerance revocation that are a result of this agreement.
The agreement also calls for a lot of generation of data, particularly addressing worker risks, as well as opportunities to develop other data that may continue to support the other uses of Methyl Parathion.
The next steps for both of these chemicals, there is a lot of follow up activity, including on Azinphos Methyl a commitment on the part of the agency to convene a group to discuss production caps. I failed to mention one of the parts of Azinphos Methyl, which was putting a production cap on it. And we agreed to discuss that whole concept, and we will start that effort in the near future by calling for interested parties to participate.
We will continue to follow up on the specifics outlining the voluntary cancellation agreements. We will begin to put together re-registration decision -- eligibility decision documents -- REDs -- for Azinphos and provide a complete discussion of the mitigation and rationale for the actions taken by the agency.
We are still taking comments on the refined risk assessment for Methyl Parathion. That public comment period ends -- well, actually it ended Monday, on October 18th.
So this is a summary of the status of the organophosphates in the pilot process that was developed as a result of TRAC discussions last year. There has been a tremendous amount of effort on the part of all of us to get these 35 OPs to the state they're in today. The pilot process for the OPs has been used to carry out the re-registration process for many of the chemicals, as only four OPs actually are not subject to re-registration. Four OPs were registered after 1984, and they're not in the re-registration program, as well as the tolerance reassessment requirements under FQPA.
Many of the steps in the process are characteristic of our re-registration decisions, yet the process has been opened up to allow for participation by all stakeholders and the transparency of our decisions.
So with that, I will stand by for questions. Thank you.
MR. EHRMANN: Lois standing by. Bill?
MR. LOVELADY: Okay. Lois, I want to go back to the technical briefings just a moment. And they're an enormously important part of the process and do a lot for transparency.
I do have a question, though, and I don't know, maybe I just missed it. But if I didn't, the Terbufos. Did we have a technical briefing on that? Because that is an extremely important chemical for cotton.
MS. ROSSI: We did not. We did not have a technical briefing on that one. But if you feel that that was not the right thing to do, we would certainly be willing to have a stakeholder meeting at your request.
MR. LOVELADY: Well, we were kind of concerned about that, that it didn't happen, because that apparently is not one of those things that has a very minor use. It's an extremely important product –
MS. ROSSI: Um-hum.
MR. LOVELADY: -- in cotton production, especially in areas that are low input areas.
MS. ROSSI: Um-hum.
MR. LOVELADY: In the high plains of Texas, it's an important part of the cotton belt. So we were concerned about that, skipping that step in the process.
MS. ROSSI: Well, again, the rationale was just that it was one use, and that we did have the experience with Profenofos. And maybe it isn't the same level of importance to you as Terbufos is, but we decided because of the limited use pattern in that it's one commodity, we elected not to have the chemical briefing.
However, you know, we certainly -- again, like we did for Ethion and the three OP public health ones, we would certainly be willing to meet with stakeholders.
MR. LOVELADY: Okay, good.
MR. EHRMANN: Thanks, Bill. George?
MR. WICHTERMAN: I've got one comment and a question that I would like to ask. And the comment is that I would like to say to both Gary and Marcia that Lois Rossi and Margaret Rice and their staff performed a stellar last week in the stakeholder briefing that we had in Orlando. We had over a hundred people in attendance at the meeting, as she eluded to, representing over ten states from across the U.S., from California down to Florida as well.
And it was very informative. And this was our first exposure to any kind of activity like this, and it was encouraging to see the support that we're getting from EPA on these respective issues. My only regret of the whole day was -- and they were conspicuous by their absence -- the Department of Health and Human Services' lack of support on our issues. They had been invited to the meeting. And we constantly do not hear much information in regards to that. But I would say that EPA did a very nice job.
And my question would be, when are the technical briefings going to be held for these three OPs relating to public health?
MS. ROSSI: Well, George, we're not going to have the technical briefings. The stakeholder meeting we had basically was the equivalent of the technical briefing.
MR. WICHTERMAN: Okay. Well, in regards to Fenthion, we were not privy to the risk assessment at that point in time to even comment.
MS. ROSSI: Right. Well -- well, the technical briefing releases -- or in your case the stakeholder meeting was the event that started the period. The risk assessment is released at the time of the technical briefing. So no one ever has the risk assessment before the technical briefing. We have the overview and the summary on the web.
MS. MULKEY: From your point of view, what happened in Florida was the exact equivalent of a technical briefing, followed by the release of the risk assessment, and there would be a 60 day comment period. And if it had been a technical briefing, there have been several where the risk assessment was put on the web later in that day, a day or two later. Not literally handed out, the full body, at every technical briefing.
MS. ROSSI: Right. Right.
MS. MULKEY: So what you experienced with these three compounds, in terms of what it would look like to you, was exactly the same thing as a technical briefing preceding the opening of the 60 day comment period on the refined risk assessment.
MS. ROSSI: Right.
MR. GUZY: George, we appreciate your comments and the constructive attitude with which that meeting was approached.
MR. WICHTERMAN: You're welcome.
MR. EHRMANN: Jay? Wally and then Jay.
MR. EWART: I would like to compliment Lois and her staff on the cooperation that she showed during the Azinphos negotiations. We also appreciate the efforts of the registrant. But I must say it was difficult for a number of reasons. One was that we -- certainly we're on a different time table than we had anticipated. And getting grower comments that are accurate and reflective of practices and needs really does require more time than some of these short time tables that we were pushed into.
And so that's one of the things I want to, you know, bring forward, to get meaningful grower comment. If you put out schedules and you shorten them at the last minute, you will not get the same kind of comments from growers in accuracy and thoroughness as you would otherwise. So that's a concern I have going forward. But under the circumstances, we think, you know, as that one came out, it probably was quite reasonable, and we appreciate the efforts of EPA and also the registrant.
The other point that I guess I want to make is that for growers to have an impact in this process, we do need a clearer way to get the information in. And in these cases where your particular crop is really at the forefront, perhaps it's easier for you to get your voice in.
But sometimes you have some minor crops that may not be at the top of the risk driver list, and those are ones that sometimes really need the material, but it hasn't been identified because they haven't had an opportunity to find that out. And I think that's a challenge to USDA and to we in the grower community to work with other people.
But getting back to the issue I brought up, if you put out schedules, stick to the schedules. Don't move those up for other reasons, or you're just not going to get the same kind of quality of grower input.
MALE SPEAKER: If I could just –
MR. AIDALA: A little bit, and then Lois and I want to fill in a little bit, too. To telegram a little bit about tomorrow morning's discussion on sort of lessons -- not just lessons learned now. But also some of the things that we take away, may want us to adjust some changes. Because exactly -- first of all, to encourage any kind of discussion like your comments, Wally, they're helpful. We've heard some of that. We've all had sort of side bars and other things along the same lines. But that will be the basis of what we think -- what worked and what didn't work, given the pilot process up to now.
So, for example, to give a little bit of a flavor of tomorrow morning's thing -- and, again, Lois and I want to amplify further -- is the front end people just sort of seem not to know what to do with it, or frankly don't take it seriously. Whatever phrase one might want to use.
And the middle part needs to be sort of amplified on more. And that's something that Lois and Al have talked about a lot in terms of the way the two agencies can work together better, and having conversations with many of you around this table in various forums and capacities. And that's exactly the basis -- we would like to hear more now, but then also form the basis of what we have some suggestions for tomorrow morning.
And, Lois, do you want to add anything?
MS. ROSSI: I think the early involvement is one of our big lessons learned that we're going to talk about tomorrow in the revised process and how to get everybody on board earlier and up to speed so that we can have a better dialogue.
MR. EHRMANN: Thanks. Jay?
MR. VROOM: I would like to echo what has just been said, particularly Wally's comments, and go back to, I think, Gary's remarks at the beginning of the meeting this morning that suggested that Azinphos and Methyl actions embody the principles of TRAC. And yet I think reality is that there was a time table, whether we want to call it political or not, that was the reality around those decisions and the certain limitations that came about because of those time constraints.
And I think Lois has given us a really good recap of things that happened in sort of chronological and process way. Maybe it would be helpful if we could ask the registrants, the agency and other stakeholders to get together and maybe construct it on the basis of the four TRAC principles that Gary enumerated this morning, so we could take a look at sort of that lessons learned approach from that sort of matrix, rather than sort of a stream of chronology.
One specific question, and, Lois, maybe you mentioned this and maybe I should have known this anyway. But the FIFRA 6(F) voluntary cancellation provision says that it can't take effect within -- until 180 days after publication of the Register notice unless that is explicitly waived.
Was it waived in the agreements, or how was that handled?
MS. ROSSI: It was waived in the agreements to 30 days.
MR. VROOM: And was that in the Register?
MR. EHRMANN: Repeat the question, Jay. I don't think she heard you.
MR. VROOM: Was the waiver of the 180 day FIFRA requirement published in the Federal Register?
MS. ROSSI: Was the waiver published? The whole thing was waived and we don't publisher waivers.
MR. EHRMANN: I don't know if people heard that. You may want to -- I think you drew an inside baseball a little bit, so you might want to amply a little bit and not mumble quite as much.
MS. ROSSI: I can mumble if I want.
MR. EHRMANN: Lois?
MS. ROSSI: The agreement included a waiver of that comment period for the 6(F), and we typically don't publish the fact that it was waived.
MR. EHRMANN: Okay. Gary?
MR. GUZY: I just want to make a few points in response to both Jay's comment now and a comment that Bill Lovelady made before lunch about the particular actions. And I thought it made sense to wait until in fact there has been the opportunity for Lois to go through the time frames and the like, so we were all clearly operating from the same set of facts.
There were a number of factors that influenced the agency's approach to this. But one is our belief that there had been a lengthy and public process involving substantial public review of the risk assessments for both of these substances.
In the case of Azinphos Methyl, we believe we adhered to the time frames that had been clearly spelled out through this process. In the case of Methyl Parathion, we certainly adhered to the time frames for developing the refined risk assessment. And then consistent with what we believe to have been articulated where there was a showing of significant exceedance of the risk cup, the agency really always reserves the right or the opportunity to move forward on the risk management side upon completion of that work.
So it's our sense that we really did respect the science process here, as well as the meaningfulness of public participation and in forming our risk assessment work.
Let me point out a few other things. Some people who are not around the table think that we in fact have failed to meet our requirements and deadlines of August 3rd, and that we failed to address the key priority chemicals that we specified in the notice that Jay referred to last time. And they have sued us on it. That doesn't mean that we agree with that position. We don't and we'll vigorously defend that litigation.
But I think it's also part of the reality that we all operate in that there are some who believe that the requirements aren't being respected and that we're moving too slowly. And that is something that I just want everyone to be cognizant of.
We also thought that it made sense to take early action to provide information to growers as early as possible. As early as we were able to, to avoid rumors and to avoid confusion.
But the last thing I would ask is that you judge what we did and the appropriateness of it by the character of those actions. There was not a lot of grand standing that happened associated with that event. There was not an action to simply suspend the chemicals, which in some respects may have been the easiest approach. There was not an action to grandstand on food safety concerns and risks posed by application of those chemicals or those specific uses in our food supply.
We decided to work closely with the registrants, and I think in a kind of unparalleled way to achieve agreements, and also with growers, so that we would best understand, with the help of USDA, what were the uses that were absolutely critical, where there were viable alternatives, and where you could achieve the most risk reduction bang for the buck, essentially, so that we were being smart about it, so that we weren't just applying it across the board kind of an approach.
And we think those are agreements that will stand the test of time, and ones that are -- that make sense in being particular and being carefully honed and being sustainable also based on the science. So, I mean, I understand that there is some concern, and maybe it was a communications concern on our part, or a sense that we had deviated in some way from what was understood to be the projected course for those chemicals.
But we very much believe that it is consistent with the kind of spirit that we've been working with this group and the principles that we've all come together on this.
MR. EHRMANN: Bill? Thanks, Gary.
MR. SPENCER: I would like to know from the department if on Azinphos Methyl and Methyl parathion whether (1) economic alternatives for the uses that were lost were identified, either at or before the time that the particular uses were either canceled or they were reduced, and (2) I would also like to know what the transition strategy is for the uses that were lost or the uses that were reduced.
MR. EHRMANN: Al, do you want to take that one?
MR. JENNINGS: Let me take a shot at it. Bill, I think for the most part we were comfortable that the decisions -- we fine turned some of the Azinphos decisions to make sure that we had covered southeastern peaches, for example, and the cotton needs east and west of the Mississippi. I think you probably know there was one case of a quarantine use for ornamentals that we just didn't pick up, and we did have to do a lot of scurrying around later with EPA's cooperation getting that use restored.
But we looked at the decisions coming down. We felt there were alternatives available for the most part. Again, there may be a few minor things we missed. I haven't heard about them yet. But other than that ornamental one, I feel pretty comfortable that we covered everything. Maybe you know of some things we don't. Oh, forestry uses was another one of those that we kind of picked up late in the game. But we preserved it, because there were no alternatives.
MR. AIDALA: And just from our perspective, Bill, I mean, we did. That was a lot of the particular questions that we were getting, not just in conversations with -- the registrant is not always the best person to ask about what the alternatives are, but also the growers and the department.
For example, another question is, when they say, well, one alternative may be another chemical. Another OP right now. Well, hold it. Or is that looking like a RQ. Because the only thing -- you know, out of the pan into the fire kind of problem. Are we going to have that? There was a concern early on about some of these compounds, but that resolved itself out in real time as we were deliberating.
And those are the, you know, exact questions we were asking and getting some answers. What would have happened if they had said, no, even though your number is really big, there is just absolutely no alternative. I don't know what we would have done per se, but we were happy in terms of hearing back that, yeah, it looks like -- with these modifications.
Given what we might have initially put forward, what Al just said, the kinds of things that they, you know, hold it. You need to tinker here or not do that there, you know, to move forward. And I don't know, again. And Al and Lois were the ones doing most of the heavy lifting on that. Lois, do you have any other –
MR. JENNINGS: Yeah, we did talk to a number of rural organizations and our state people. I think we had pretty good information. Granted, some of the alternatives may not be exact plug ins, and they may be a little more expensive. But I think pest management options are there.
MR. SPENCER: And as far as the transition period is concerned?
MR. JENNINGS: Again, I don't see a major transition need with either one of these. I think the one you were involved in more recently, Carzol, was one of those where we had to get all of our heads together and be more creative about the transition, about how to maintain some critical uses through some fairly innovative approaches.
But, again, I don't think with either one of those that we had a serious transition issue.
MR. EHRMANN: Okay. Cindy?
CINDY: I guess my stomach is kind of churning, being the only registrant who actually did participate in either one of these positions. And I feel a little bit awkward trying to address it, as I am not the primary registrant for Azinphos Methyl. I certainly have nothing to do with Methyl parathion.
But, Gary, after your comments, I just can't hold it any more. And I'll have to tell you that I hope that the process that we went through on Azinphos Methyl is not the process that you intended, because to have in a 48 hour period a settlement agreement imposed is not a process that I hope is going to be the norm. And I don't think that it is. I mean, I have to say that I have not seen since that action that that is the pattern.
But to characterize it as a process that we laid out through TRAC that we all agreed to, that we all understood was going to be this way, simply wasn't the case for us. I never anticipated in looking at phase five or phase four in the process that that's how it would play out.
And so I hope that what I've seen since then is more the norm of how these things will play out, because I have seen some real cooperation and understanding in talking to stakeholders since then. But I don't believe that Azinphos Methyl is a model case for what we intended the phase process to be.
MR. EHRMANN: Steve?
MR. JOHNSON: Yeah. Cindy, I think one of the sort of issues that we face, particularly on the Azinphos -- and there are other ones that are in the queue and, you know, some that belong to you all -- that actually they have been in the queue, and that they have been worked on and refined, literally for years. I mean, years.
And so in one sense, you sit back and look at the whole process, and you say, well, yeah, 48 hours seems like a short time period. But when you take a step back and look that in fact a number of these chemicals have literally been in the process, and have been refined, have been discussed, have been refined and have been discussed endlessly for years, the 48 hours takes on a different meaning.
And that certainly is, we believe, the case for Azinphos. Maybe not specifically for your company. But certainly from the technical registration, that's certainly our belief.
In the case of Methyl, as we've said all along, we've always reserved the right that if we felt that there was a risk that we needed to take action more quickly than the six step process, that we would take that action. And we felt in the case of Methyl that it was necessary for us to do that.
And we also felt that it was a very constructive and deliberative process. And all the things that certainly Gary said, that we thought that, you know, judge us certainly by the outcome. We think that addressing 90 percent of the risks with 10 percent of the uses and not invoking a food scare, and all of the other things associated with that decision, we think that we collectively did a very good job. And I really mean that collectively.
And I think the other thing to keep in mind is that as Lois has gone through the number of the organophosphates that have gone through the process, we've really only had two where we've had a dietary risk exceedence, and that we have taken what we believe appropriate action. One quicker than what the six phase process dictates, but we reserve the right in that kind of circumstance to do that. And then the other was a very deliberative process. And in the case of that chemical, again as others, there is -- there has been a great deal of history associated with it.
And, again, many of the other chemicals -- one of which you have and others around the table -- we have been, you know, working our way through to try to come up with an appropriate, acceptable plan to address the risks.
And I guess I would ask you, how do you think we're doing on Bensulide?
CINDY: Well, let me say two things. One is that as I stated in my comments, I have absolutely no knowledge of Methyl Parathion, and I wouldn't begin to question either side. I mean, that's up to the registrant. The only reason that I even make a comment on Azinphos Methyl is because we were engaged -- we were involved. It's a product that was important to us. We used it.
I think it has some very different circumstances than Methyl Parathion does. You have a dietary issue that was acceptable at 99.84. I mean, all the kinds of things we've already talked about. So I think that's a different case. They're apples and oranges in my mind.
On Bensulide, and why I said that, you know, the other processes and the other things that we've gone through, I think we've had a very good dialogue. Because what we have tried to do in that is bring in the stakeholders. Lois mentioned the golf course superintendents. What do they think? How do they use it? How does it vary geographically within their use? The homeowner use. What are the impacts there? The ag use. Right in our backyard we can tell you, you know, how it's used, where it goes and those kinds of things.
And so I think that any time that we're allowed the opportunity to get realism in -- and I don't mean we the registrant. I mean we, the affected stakeholders, who use it and bring that information to the table. I think we'll get a better decision. And I think that's happened with Bensulide.
MS. MULKEY: I would like to add just one subtle point to this. I'm a little worried that this 48 hours phrase is going to take on a life of its own. And while I'm certain that the principal AZM technical registrant would not say that there was ample time for the discussion, and they would also characterize it as troubling short. I don't mean to imply that they wouldn't. They would not have said that our discussions lasted 48 hours.
And in fact, we opened -- and Lois can help me with a little bit more detail -- essentially about a two week window, at least, of active discussions. Maybe a little longer.
MS. ROSSI: Actually we had a meeting in late June with Bear and the apple growers, which started the whole thing off.
MS. MULKEY: So I just think it's important that we not allow this -- I mean, because the Gowan Company was an associated registration, and because for whatever reason, and with the benefit of hindsight perhaps not the best reasons, our initial discussions didn't include everybody with some economic or past economic or label stake in it.
I have no doubt that that is an accurate impression from within the Gowan Company. But it is not -- doesn't accurately characterize the period in which these discussions occurred. And I think it's just important to correct that.
MR. EHRMANN: For those who have, as I think most around the table do, kind of a historical sense of where some of these issues were and what some of the concerns were when this whole process started, these are very important insights that everyone is contributing in terms of how these particular examples played out. And we need to learn from that, I think, as people have suggested.
But I also think it's important not to lose whatever I've heard people from every interest say, which is, you know, a good sincere effort was made. It wasn't perfect. And there's a lot to build on here for how to learn how to do this better as you go forward. And I think that's -- and that's not to discount the problems that may have emerged from certain perspectives in the examples that just took place.
But, you know, you're talking about a range of concerns, that is at least to some degree narrower than one might have anticipated a year ago when some of these decisions started coming down, at least from my perspective.
MR. LOVELADY: Yes. I would just like to have a little clarification about how on these two decisions what EPA did to involve grower groups? I think we got our information through the registrant. Were grower groups involved in this decision making process? Were they involved at all?
MS. ROSSI: Yes, they were. As I said, with the Azinphos one we actually started with a meeting. That was actually the first meeting that we've ever tried with the registrant and the major commodity group present.
MR. LOVELADY: The apple –
MS. ROSSI: The apple people, right. We did do that. And then USDA, as their part of what we're trying to do here, they took a lead in keeping in contact with the commodity groups. We've also used our minor use team, Pat Cimino, to talk to various -- some of the smaller commodities, particularly with Methyl. She made a lot of calls to various commodity groups across the country on some of the smaller vegetables and fruits.
So that's what we did. I mean, as far as having them on conference calls, except for that one meeting that I did cite, they weren't there. But we did do a lot of the phone calling.
Al, did you have any meetings? I think you did have some.
MR. JENNINGS: I was trying to remember when you were talking.
MS. ROSSI: Right.
MR. JENNINGS: Bill, I don't know if we talked to the Cotton Council or not.
MR. LOVELADY: No, you're didn't.
MR. JENNINGS: We didn't. Okay. But we did talk to a number of our land grants as well. California Tree Fruit Advisory, sugar cane in both Florida and Louisiana are ones I remember specifically. But also we went out through our land grant system for information as well, when we had small organizations that we couldn't get to or present in a lot of states. It varied depending on what the commodity was.
But I think what you're pointing at, it was kind of an ad hoc process. And what you'll hear about tomorrow is what we want to do in the future to make sure it is more thorough and not ah hoc like it was with this one.
MR. LOVELADY: Well, I think that's one of the purposes that we have in the TRAC, is to try to learn from what we've done before. And as a commodity that lost some use in one of these decisions, I think it would have strengthened the whole process had the agency correctly involved those grower groups that were directly involved.
So let's use this as a learning process and something that we can move forward with for the next time.
MR. EHRMANN: Bill?
MR. SPENCER: Just as a point of information, Bill, a small 4.6 million member organization, the American Farm Bureau Federation, didn't know about either one.
MR. LOVELADY: Well, it's a little small group, obviously.
MR. EHRMANN: Jamie?
MS. ADAMS: I just wanted to follow up on your question. We're in this five step process -- or six phase process. Do producers come into the picture? And secondly -- or maybe firstly -- when you said your example of involving the apple growers, was that the June '99 meeting?
MS. ROSSI: Yes.
MS. ADAMS: But I would just like to know where in this phase do the actual growers -- not the registrants and not phone calls that get filtered through USDA. But actually grower groups come to the table and have a voice?
MS. ROSSI: Well, I think that's a very good question. And it's one that we've certainly talked about, and talked about with a number of commodity groups over the last year as to where in this process -- because I don't think when the process was laid out, those kind of specifics were necessarily laid down. But it's more like we've been -- it's a pilot process, and I think we've been feeling our way through it in trying different things, which we're going to talk a little bit more about tomorrow when we talk about amending the process, or changing the process, and getting the pilot out of pilot out of pilot process.
But I think we -- I don't think you're going to find a specific spot in those six phases that says commodity groups enter here. I think we've been doing it, like Al said, more on an ah hoc. And I think one of the lessons that you're going to hear, at least in my presentation, is that we need to make a -- we need to make some standard steps in the process of when we engage commodity groups. The agency and USDA.
But I think, you know, we've been -- we've essentially been trying to see what works and what doesn't, because it hasn't been nailed down.
MR. JENNINGS: No, I agree. I think my characterization is it was an ad hoc process in bringing the growers in, and we're going to fix that. We agree we need to do a better job.
MALE SPEAKER: We'll get into this in more detail tomorrow, but the thing that -- the only place -- once the preliminary risk assessments go out and the public has had a chance to review those and offer comments, the only thing that we've got officially set up is first a technical briefing that people can come in and talk about mitigation.
One problem we even had dealing with our land grants with the refined risk assessments is we've de-linked the refined risk assessment from any kind of mitigation discussion. So we've been going out to land grant extension folks. They aren't able to connect up a risk assessment with any real world action.
So one thing that we really want to talk with folks here about is how can we sort of combine all that up so that people aren't just looking at a bunch of numbers and have no clue what those numbers mean. And that's one problem that we've run into so far in this pilot process. And we're going to want to have some discussion about how we can make that final step a little more participatory and something that folks that don't have strong technical or scientific expertise can make some real world connection with the numbers that they're seeing.
MR. EHRMANN: Jim?
MR. AIDALA: Two observations, and one I'll give on my own and then I'll ask Lois for the other. And one is that whenever you see the word public, it's not just growers. It's also -- everyone has access to it as a public agency. As Gary hinted at before very politely, I mean there are those who we did far too little and far too late. I'm not defending that, but they're out there and we all know some of those points of views.
And that is one reason -- that is not to say we can't do better. But what I would ask Lois to comment on is -- and, for example, RED chapters where the risk assessments are and what our concerns may or may not be have been public for years. We've been doing REDs since 1988. We've never had any problem with people asking for them, and some measure because frankly no one ever asked us for them until relatively recently.
Lois, compare the sort of process when we went through a RED process and identified problems and how much we -- who we talked to and how much, say, for four years ago. Let's be clean about the break point. Four years ago compared to this process. Not to say that we can't do better and won't do better and have some suggestions for that.
But I think that's a real good base line comparison. And the degree to which Lois herself has been out to farms in the last two years compared to the past six, for example, might be one way to measure that. But go ahead.
MS. ROSSI: Well, I think the names in my organizer are probably the best telltale. Yeah. I mean, the difference between the way -- we did REDs even, you know, back in 1997. I mean, we basically shared the chapter with the registrant. And when we got to risk management and mitigation proposals, we did it with the registrant, and basically announced it in the RED. And that was how it got out even to the public. I mean, we did not -- we did not talk to commodity groups or other stakeholders, for that matter.
And within the last two years, I think, you know, particularly other stakeholders -- the environmental groups and the public interest groups, as well as the commodity groups -- certainly have interacted with us on re-registration eligibility decisions a whole lot more.
And you're right. I mean, really my organizer is a good indicator. I mean, I didn't have a whole lot of names, and then I've probably got every fruit and vegetable that exists in here who were the contacts. So it is a tremendous difference.
CINDY: Can I follow up just real quickly?
MR. EHRMANN: Sure.
CINDY: I would just say that I think that's great and that you all are learning. But don't ever assume, with all due respect, that you represent EPA and the growers in this country. And if you want their buy in to what you're doing, they need to be at the table, too. And the stakes went up when FQPA passed, and that's probably they could rely on the registrants. Today the growers have different interests than the registrants, and I'm sure you're aware of that.
But it concerns me greatly, and I come from a state that, you know, we have row crops, and we have wheat, and why should peaches and apples matter to us. But it matters, because the process you establish today will effect producers in my state tomorrow. And these are people whose livelihood is on the line here. We all need to remember that.
MR. EHRMANN: Thanks. Okay. I've got several folks' cards up. I would like to just take the folks who have asked to be recognized, so we can move on to the transition discussion.
MR. EWART: One comment I didn't make about timing. And after hearing that it was a process closer to what it should have been, I just want you to know that I wrote my comments on risk mitigation after I knew what the final decision was on Azinphos. So I don't consider that timing to be reliable and allow growers to have input. That was not in the pilot process. That was not a way that we could get input into the process through the official channel.
And that is another thing that I've heard mentioned was that a lot of times you don't get comments to the docket about something you have put out as a preliminary risk assessment and for the refined risk assessment for mitigation. And, you know, if we know it isn't going to be used, growers are unlikely to take the time to put those together.
I don't accept that as a good process. I want to have a process by which growers will put something into the docket that will be used.
EHRMANN: Okay. Mark?
MARK: To rejoin on Jim's comment, I never asked for a RED, because the stakes were very different under the RED process than they are under FQPA. FQPA is far more sweeping than the RED process. And FQPA is also coming as a wave and the timing is very different than the REDs. So that would be how I would rejoin that.
But the statement I wanted to make is that -- and maybe this is too obvious even to state. But we've been through a process, and certainly the pilot process, the August 3rd deadline, and the process we went through on AZM and Methyl Parathion, though engaged through the RED process earlier, I would say that is much too early to know the full impact of what has happened. Because these were late season decisions and there were trade offs. There still were OP alternatives out there in the marketplace.
Now I was talking to Jon Jessen a little earlier. I asked him the question, what happened with Phosmet. Did sales go up? And he said no. And the reason, I think, is that it was too late in the season. What will happen next year, though, is a key and where is Phosmet in the process.
And not only Phosmet, but you worked down the list of Chlorethoxyfos and --
(END OF TAPE THREE, SIDE ONE.)
MARK: It's a whole different ball game, because so much of that cumulative and trade off process depends on what EPA does for new registrations and whether they fit in an IPM system.
So as I look at this thing, and look at pest management in the short term cycle -- and by the way, there are pests that have very short term cycles, and other pests that have long term cycles. So the assessment on those long term cycle pests is a different ball game than short term cycle pests that may be more important initially.
Finally, the transition situation is very different for row crops and perennial crops and other ornamental issues. And as I look at IPM and think about what kind of system that I would try to help our growers develop and implement, I recognize that IPM is very cite specific and very information intensive.
And I go back to the point I made in the first TRAC. When we transition through FQPA, where is the information coming from to help growers transition with a system that is already curtailed by all the processes that we have put in place for extension and information transfer.
So I think state the obvious. It's too early to count coup on anything. We've just done the first notch in a long process.
MR. EHRMANN: Okay. Robin, and then Mark and Bill. Robin?
MS. SPITKO: Mine is just a quick question for Lois. There may be others that are confused as well. Just on the RED process, you were discussing Azinphos and we mentioned that there is going to be label changes for the 2000 growing season.
Were those changes based on dietary risk mitigation only? Have we gotten into occupational exposure, and how does that fit into the RED process? Because you're working on the RED for Azinphos now, correct?
MS. ROSSI: Um-hum. Well, let me answer the first question first. The changes that -- Azinphos has a lot of worker protection already on it, because we mitigated that risk a few years ago when we were starting the RED process. So most of the label changes relate to the rates that were related to the dietary risk, okay. And there are reentry intervals that are going to be changed. There is, you know, that kind of thing.
MS. SPITKO: So the reentry will also change?
MS. ROSSI: Yeah. Yeah. So there are some changes that relate to those risks.
How it relates to the RED process, in the RED -- or in the re-registration you look at everything. You look at dietary risk. You look at worker risk. You look at ecological risk. And within those you look at all endpoints. You look at all routes of exposures, all different end points and all sub-populations. For ecological you look at all different species. You look at water. So the RED is a comprehensive review of the entire chemical.
MS. SPITKO: And do you anticipate further revisions based on occupational exposure as you're going through this process?
MS. ROSSI: We didn't -- well, on Azinphos specifically?
MS. SPITKO: Yes.
MS. ROSSI: Well, we didn't really finish the Ecological and FATE, because that chapter lacked behind the Health Effects. Now whether or not that's going to need anything else, I don't know. But we didn't finish that.
MR. EHRMANN: Mark?
MR. MILLER: I'll try this again. I just wanted to throw in my feeling that I'm acutely aware sitting here that this is more of a grower/registrant/ag forum than a public health forum. I mean, I understand that. That's who is sitting around the table.
But I believe we should still be addressing those other issues. And I think -- you know, I hear the question asked how are we -- how do you think we're doing with re-registration from a registrant's viewpoint. But I'm not hearing what I think is key to what this was all started from, and that is, how are we doing from a child protective health standpoint.
Now maybe this is -- these aren't the right people to be asking that. But I think it should still be the guiding principle about what it is we're doing here. And you should be answering that. I bought that up last time when we met, and you went through the protocol for how you were going to prevent -- or present Azinphos Methyl data, and the child protective factor was just, well, we don't need -- or we have enough data.
It wasn't -- nobody went into any kind of detail about where that came from or how your thinking was developed. You know, are you going to take all this information from panels which do maybe include some of those -- you know, your Science Advisory Panels which are giving you input? But then there should be a process by which the way that is then dealt with, and how does that actually come out, just the way that we're dealing here with how does it come out for growers, and how does it come out for registrants.
Well, how does it come out on the public health standpoint at the end of the process? I mean, I heard from the Science Advisory Panel on residential exposure that essentially kids don't play on grass, so that turf exposures aren't important. So where is that going to fall in the whole level when we get to the end of this process?
MR. EHRMANN: Okay. Do you have a comment?
MS. MULKEY: Just to clarify that. Now that was an industry presentation, you're talking about having heard it?
MR. MILLER: That was an industry presentation. That's right. However, it was done at Stanford, for whatever that's worth.
MR. EHRMANN: Bill? Did they answer your question, Mark? Or did you ask a question? Or did they answer a question?
MR. MILLER: Well, I guess I -- it comes down to I would hope that as this proceeds along and in the future that the public health aspects of this are consistently considered and expressed. And I think that even though some of the people that would be asking those questions aren't sitting around the table, they are sitting somewhere and we ought to be addressing that stuff.
MR. EHRMANN: Steve, do you want to comment?
MR. JOHNSON: Mark, in response, I think first of all, thank you for -- thank you for the comment, because obviously those of us sitting at the Agency or the Department are obviously concerned and need to reach out and need to address all of our constituents' comments, concerns and issues. And obviously state the obvious that, you know, the principle behind FQPA is public health and environmental protection. Public health, in particularly, given the FQPA issues particular attention to children.
And so not only are we very mindful of that, but that is the guiding principle of the actions we've taken. And, in fact, looking at the Methyl situation, we think that is a very fine example that, you know, where were the risk concerns. The driving, if you will, sub-population of children one to six. And that we were able to collectively take measures to in fact eliminate those uses. In eliminating ten percent of those uses, we achieved overall a 90 percent reduction, but particularly for children of that particularly sensitive sub-population.
So, again, I appreciate your comments, and certainly that's very mindful in our minds. We do not only have an obligation, but we want to reach out to all of our stakeholders.
MR. MILLER: Yeah. I think that's great. And I think that you ought to take the opportunity whenever you have it to just say that over and over again, that, you know, this is how this is protective and we are considering that, and that is our base priority.
MR. EHRMANN: Bill?
MR. SPENCER: I think we already produced the safest food supply in the entire world, and I think we're trying to do a good job of taking care of kids while we're doing it. And this is not a pick on Jim -- Mr. Aidala -- but you brought up the point –
MR. SPENCER: With that lead in, and it sort of goes along with what Jamie had to say and what Mark had to say. But, you know, you made the point that the RED process has been around since 1988.
And I guess I'm going to just echo Jamie and Mark by saying, you know, because we're now applying the science policies that we're going through that we developed in the TRAC process on obviously products that are going through the REDs. That has definitely perked a lot of growers' interest out there, including mine.
And, Jamie, I would say to you that back in July I had a very frightened salesman from a registrant come to my ag extension agent and say, did you know that EPA and my company is in the process of coming to an agreement to do away with this use on citrus. And my ag extension agent called me and said, did you know anything about this, and I said no, I didn't know anything about it.
And so I proceeded to call California Citrus Mutual and CCQC and WGA and a whole bunch of people, and by late that afternoon, we got a call from Pat Cimino in Lois' office who said, gee, maybe we ought to get a group of affected stakeholders together on this particular product and talk about this.
And so a lot of times, it's no, people aren't getting a hold of you. They aren't telling you about products that really affect you. And yes, I think both the Agency and the Department have to do a better job of getting a hold of us and letting us know, you know, what's in the queue. Otherwise, it's just going to be the agency and a registrant sitting behind closed doors in a smoke filled room cutting some kind of deal and we're going to get left out in the cold at the end of the day.
And that's what would have happened on this product that I use had not a salesman, who was afraid of losing part of his revenue because he sold so much of this stuff to me and every other citrus grower in Yuma, come and told my ag extension agent, do you know you're going to lose this product.
MR. EHRMANN: Jim?
MR. AIDALA: Two real quick things. One is, again, Bill, that I think the contrast is, in 1991 -- and I use that term intentionally -- you basically would have lost that. I mean, in the early days of the RED process. And that's not to say that that was a great system or the one we have now is the perfect system.
What we're going to hear about tomorrow morning is ways to try and evolve that further and about all REDs, including a notion that the lessons learned from the OP pilot are applicable to the re-registration thing in general.
The second overall point, and my main point, is simply to say that a lot of the dynamic underneath this -- a lot of it concerns especially the minor crop growers -- are ones that are driven by re-registration and started a long, long time ago. And again, that doesn't defend any particular thing that we've done. It was just that that is the ongoing process, and with or without FQPA, a lot of that dynamic would have occurred.
Again, that doesn't justify any particular thing we've done or are doing. It doesn't mean we can't do better. And we want to hear about that.
MR. EHRMANN: Jay?
MR. VROOM: I would like to speak to Mark's comment. Number one, I would like to observe that just because most of us who are still at this table, minus the few from the original 52, now have commercial interest in food production or pesticide production or both, it doesn't mean that we don't care about children.
I have played with my children on the grass -- my lawn.
MR. VROOM: Now they're old enough that I fight with them over bagging the clippings, you know, which is probably even more exposure than when we use to play regularly on the grass. Put that into the factors.
But I do appreciate the fact that you and Steven and Margaret are still here. And I think that makes a lot of difference, so I want to thank you for that commitment and continuing the dialogue.
Bill is exactly right, and I would add that if he and I weren't both members of this committee, he wouldn't have had my telephone number so that he could call me first thing after the extension agent called him.
MR. VROOM: Which allowed me to go talk to the president of that company, and we established some communication.
Cindy's point, though, I think needs to be emphasized again. And that is that there were 48 hours for one registrant, and yeah, this has been going on for a long time before Marcia was part of the program and so on and so forth. But I also harken back to how difficult that July '98 TRAC meeting was when we first had Mr. Hanson table the idea of this pilot project, and how important it was that, you know, we ended up on six instead of three or five phases or whatever.
Again, in all due recognition of the time pressures that were faced around August 2nd and a half or whatever it was, things are going a little more smoothly now. Let's keep working at that. But I'm looking forward to the discussion tomorrow morning about what Lois called the final public participation process.
MR. EHRMANN: Okay.
MS. ROSSI: Well, I didn't mean to say final.
MR. EHRMANN: We never say that around here.
MS. ROSSI: Refined.
MR. EHRMANN: I think this was a very helpful discussion, both in terms of Lois' presentation and the thoughtful exchange of views we've had in response to that debriefing and looking forward. And we will look forward to tomorrow morning to continue talking about some of these issues explicitly.
Another kind of road from what we've just been talking about are the broader transition issues, and that's what Al is going to introduce to us at this point. Just as a time check, I understand we do need to take our break at 3:30, because some folks have some calls to make.
So we'll take -- you know, we'll start. We've got about 45 minutes on the transition discussion. We'll kind of assess where we are at 3:30. If we need to do a little more time on that when we come back, we will before we move to the channels of commerce issues. But I think we'll have adequate time to do both of those and keep to our schedule.
Let me just also remind folks in the audience, if you do want to make a public comment, please sign up outside so that I can assess how much time we need to allow to give you adequate time to make your comments.
MR. JENNINGS: Thank you, John. Those of you who have been through the TRAC process with us know we've talked about transition issues at past meetings. We've also talked about transition in several other forums -- fora, maybe. Multiple places, anyhow, including Michigan, Wisconsin, California and Washington. Basically wherever we travel across the country, we end up talking about transition issues.
What I would propose to do is keep my remarks very limited. Sort of try to introduce to you where we are. Talk a little bit about the progress we've made. But what we really do need from you is the feedback. The paper that we distributed that you hopefully all have in front of you, dealing with apple production in the Appalachian Southeast, is something that we are offering up as an example of the technical basis.
And that's where I would like to focus the discussion. That's where we really need your feedback. And Therese's note on the top of that identifies some of the key questions that we thought of, but certainly we don't want to limit you to those -- to just those questions.
As the Deputy said in his opening remarks, transition is interpreted by many people in many different ways. And basically it ranges all the way from -- a transition can be a very specific response to a risk assessment or a risk mitigation proposal, much like we went through with Carzol or a couple of the other chemicals here, where there is a problem. How do we maintain pest management in some kind of an interim period of time until alternatives are brought on line, or until additional data come in to change the risk assessment.
It's that quick response that went into the spectrum. At the other end of the spectrum, we think of transition quite possibly as a planning document with a very long range view looking at changes in fundamental pest management practices. How do we move to more environmentally friendly, more biologically based pest management systems.
So think of transition as some place between those two endpoints, or maybe if you can, help me expand those endpoints. Because right now I think it is appropriate that we consider transition very broadly and any number of valid definitions of what it is.
What seems to us to be one of the real common threads, though, throughout all of those potential definitions of transition, is the need for a firm technical basis. If you will, the information platform on which you want to change or move pest management should be fairly common when you're talking about a commodity in a specific region.
And I guess speaking of specific regions, I think Mark probably said it best earlier. Like politics, pest management issues are all local. So, therefore, one of the keys behind a good transition strategy, or the technical basis for transition, is that you have to look at the commodity, and you have to look at the production region. So we cannot talk about a single transition strategy for some popular fruit like zucchini. It has to be tailored to each of the production regions.
What we've done and what you have in front of you is the example of apple production in the southeast, as I said. This was completed some time ago. We really do need your feedback on that. Since that time, we've also talked to the California peach growers and have developed a similar document for California peach production. We hope that that can easily be expanded to include other stone fruits and many common pests because of the common growing conditions.
We recently completed the first step for southeastern peaches. That document should be available in a few weeks. Next week a couple members of my staff will be joining the California almond people in developing a strategy for their crop. And in late November we're going to be working with some people in the northwest on pome fruits.
So that's kind of where we are on developing these technical documents, so it's very timely that we hear from you about, you know, what is your reaction to what we've done so far with this southeast apple document.
I guess I should point out that we've also been meeting with our land grant cooperators and talking to them about carrying the effort forward, working with their state and local organizations on high priority commodities.
I guess I should also say the process that we've been through, and the one I envision that we will continue to go through, involves crop production experts from the land grant system, from the grower community, as well as from the Agriculture Research Service and the relevant lab people there. I think of this process as being fairly expansive. Anybody who has got something to offer can certainly participate.
The output of the process, as you'll see in the apple document, is many. It is a collection of information about pest management. But there is this -- well, throughout there are several to do lists. And Therese gets credit for inventing the to do list concept. But the idea is if you're going to change pest management for any of the identified pests, then something has to happen. People need to do things.
And the to do list ranges from the Agriculture Research Service needs to change the fundamental direction of research or emphasize some particular research element to EPA needs to register something that is our IR-4 pipeline. We need the alternatives out there. So I guess that's another thing. Look at the to do list. Give us feedback on that. Is it focussed? Do we need priorities? How do we set priorities?
I guess let me just conclude my overview. There is some good news associated with what we're seeing now in our budget. It does look like we'll probably get funding, and there is some sorting that has to be done here. But we're likely to get some funding for the two new programs that I think we talked about here before: crops at risk and the risk avoidance and mitigation program. Those will be competitive grants that I hope we'll be able to use to further the efforts on transition implementation.
And, Keith, did you want to add to anything to those programs? Or Therese?
MR. JENNINGS: Well, with that let me direct you then to the paper and the questions we asked about the needed direction tone context. Or maybe it's not fair. Maybe you haven't read the paper. We'll find out.
CINDY: I read it.
MR. JENNINGS: Oh, okay. Cindy read it, so she'll go first.
CINDY: You want me to go first?
MR. EHRMANN: Yeah, go right ahead.
CINDY: All right. I did read it. In fact, I read it a couple of times. And I guess I would say that I think it's one of the better overviews I've seen of the situation. I think you captured the whole picture in terms of what is going on with apples in this particular region quite nicely. I think you did a very nice analysis of what the particular pest problems are and what are the alternatives there. And then your to do list that goes with it I would imagine would be very helpful to people in that area.
Some of the things that strike me in terms of the questions that you asked, it seems to scream a real need for new products and new uses to come through the pipeline. And so I guess that it would beg the question of where do you think those things are, and where are they coming from, and how are the resources being allocated in order for those things to happen. Because I think it screams that.
And in terms of priorities, I think there is clearly some pests identified in here that either no alternatives exist, or new alternatives in the pipeline are limited, or alternatives that may have other questions with them. And I would think you could certainly prioritize some of those things on that basis.
Two other things that are curious to me, and I'm not sure if it's just a function of the timing that you guys were trying to put this together under, or if it's a true component of the process you plan to go forward with. There were no registrants on your work group. And I think it was Jim who said, of course, you don't want to talk to registrants about alternatives. But we might have alternatives that are -- that could be replacements in here.
And I think certainly in this case you talked about DuPont's new product, Avant. You talked about Dowagro Sciences Spinosad. I would think that there could be some beneficial discussion to having a registrant who might be able to talk to you about alternatives in the pipeline included in there.
The other thing I noted, and I'm not sure what CMS is, is that there is no food processors on this committee. And 60 to 75 percent of these apples go to processing, and it might be helpful to get the insight of a food processor, what their concerns and standards and changes would be with regard to that.
And I think -- I guess the other thing that really struck me was that this particular region of apple production is probably one of the smallest and less complex that we have in the country. And to see how complex this one is really concerns me when you start to look up in Wally's area, or over in Mark's area in Michigan, on how you're going to go through and make assessments and look at alternatives.
So I think finding a way to prioritize what the key issues are is probably going to be the key to how you'll be able to move forward on it.
MR. EHRMANN: Okay. Robin?
MS. SPITKO: I thought it was an excellent document. One thing that struck me as I was going through this was that even though this is a very different region from the northeast where I work in the apple industry, that many of the issues identified are very similar.
And if you were going into doing this in similar areas -- because as Mark said, it is site specific -- that this would be a very good basis, and you wouldn't have to start from square one again, that this document could serve as a good base for building upon it to make it specifically tailored to certain areas.
One thing that came out to me, and actually the apple people -- we had a meeting with Jim Jones yesterday looking at what new chemistries should be prioritized and what was coming down the pipeline. The thing that came up and became obvious to all of us is that there is a lack of -- there is this transition period where we're working with these alternative chemistries -- like we have a small research farm. We were doing research this year with a lot of the new chemistries.
But we're doing single tree plots and their crop destruct. We need some improvement in the EUP process. We didn't exactly decide how to do that, because if you're working with a chemical that doesn't have a tolerance, it's hard to not have crop destruct on it, obviously. But single -- as an IPM practitioner, it's really hard to base widespread recommendations on what you're finding in small plot research.
I'm real nervous about getting ahead of ourselves and jumping on some of these materials and saying, okay, this is what we're going to use as an alternative to Azinphos, say, for particular pests, when because it has performed well in small plots, when we haven't had a chance to really look at it under an air blast situation, grower situations or, you know, different ecological system situations.
So I think that transitional period from where we're just developing the original efficacy data to where we're actually moving it out into widespread use in the field is a pretty critical weak link at this point, you know, from my experience.
And just one other quick comment about, you know, really when we're looking at these transition strategies, a lot of times we just come back into spray materials that we can spray. There are other strategies, such as the red spheres for apple maggots that Ron Cocopea (phonetic) has been working with -- you all know about that -- in New England.
But unfortunately a lot of these techniques are labor intensive, and we are in such a critical state in agriculture with our labor situation that strategies that involve more labor are not going to be implemented. And what we seem to just keep going back to is alternative spray materials, because that fits into the system that we already have and it doesn't take a lot more work to make these changes.
So those are my only two comments. But overall I thought it was really comprehensive and a real good starting point for developing these in other parts of the country.
MR. JENNINGS: Thank you. And could I -- you did say single tree?
MS. SPITKO: Single tree plots.
MR. JENNINGS: Plots. Okay.
MS. SPITKO: Replicated single tree.
MALE SPEAKER: One tree replicated?
MS. SPITKO: Yeah, typical efficacy. So it's real scary, then, when you're looking at a couple hundred acres and thinking well, do I dare recommend this or not.
MALE SPEAKER: What are red spheres? Are they
-- it says here with crop circles. Could you –
MS. SPITKO: We're not quite that bad in New England.
MS. SPITKO: They're apple maggot spheres. They were originally developed -- they were red croquet balls. They're super stimulus that the apple maggot fly when it's, you know, flying into an orchard sees that first and is drawn into it first. And Ron Cocopea at the University of Massachusetts has done some excellent work with baited spheres now, actually with the Imidaclofrid in with the paint mix and was attracted to dry in the spheres.
And, you know, on a small scale it's really quite effective. But you basically need to hang one in every tree along the parameter of your orchard and then change them every two weeks. And that's -- I mean, it can be done on a small scale. But like in the northwest, you're dealing with huge acreage. I mean, that's just -- you know, it's an alternative, but it's not a practically implementable alternative.
MR. EHRMANN: Okay. Dave Whitacre?
MR. WHITACRE: Two comments. First, Al and Therese, I thought that the document was good, and it's a synthesis that took a lot more work, I suspect, than one would believe just in reading through it. Because there are multiple, multiple places you've got to go to to kind of cross check to make sure that what you're putting down makes sense. It also shows the amount of work that has to be done as we think about other crops and other uses, and it's going to be a lot of work. I think it's a good job.
I had two specific comments. One is that at one point in this document the systems approach is mentioned. And it's sort of a question. Is there a role for a systems review in the context of all the different types of crop protection treatments that might be made or needed on a crop in an FQPA context?
Because this deals with insecticides, but at the same time, there are fungicides that are needed and maybe other products, growth regulators or whatever. And maybe that was implicit in the word systems as it was used. I couldn't quite tell. But it is used back here. So that's my first question.
At some point, maybe it's further down the line, when they actually asked the question. Okay, now, across -- we have a table for insecticide, but what about other pesticides that might be affected as part of the overall program to grow these -- grow this crop? Just one thought -- one question.
And the second one is trickier. And that is, I looked very carefully at the list of alternatives or possible alternatives, and they're critical. I was also -- as I read through the list in each section, I was remembering the discussions for what I remember was work group one or two.
Now I can't remember, but Bill Spencer was very adamant in one of those work groups –
MR. SPENCER: Two.
MR. WHITACRE: Two, okay. I only had two choices and I screwed it up.
MR. WHITACRE: Very adamant about what an alternative meant. And there was a group of criteria that actually came out of that discussion. It was a good discussion. A strong discussion. An alternative is just not a particular product.
So, again, you don't need to provide an answer, unless you want to. But I wonder if this definition of alternative in here would comply with that discussion that we had those many months ago?
One other watch out. I don't believe all those alternatives are really going to be alternatives. And I don't know across the array of all those listed that I could pick out a couple that are questions in my mind, because I happen to know something about those products. As we get further down the FQPA list in review, I think some of these are going to fall out.
I don't know that. But it might be that we need a very clear prioritization of what we might think is really going to be available. There needs to be at least a back of the envelope review of USDA with some of the registrants, users and EPA to see if they're going to pass.
Just to illustrate, I brought up earlier this morning my concern of the issues around the cancer policy. I can tell you right now, there are six tumoringens on this list. And if everyone of them are queue starts, then they're going to fall out.
So very clear priorities may be necessary to have a feeling that what we may have are real alternatives and not just a list. Good job, though.
MR. JENNINGS: Okay. Thanks, Dave. Kind of approaching your questions from the last to the first, I think you do touch on something very important, which is this is a very dynamic process. It has to be a very dynamic process. We have to keep looking at that mix of alternatives. We don't know when the next pest is going to arrive and change everything.
Apples -- we've decided to limit it to organophosphates. And, of course, a month ago what happened to Carzol, not an organophosphate, suddenly jumped up as a problem. So, again, we're learning as we're going that we may need to broaden this approach.
Alternatives -- I think, yes, it would meet Bill's definition, because we think unless it's really adapted -- adopted by the grower it's not really an alternative.
And systems approach -- I guess we already talked about that. But I think to give credit where it's due, Wilfred Burr, who many of you know is the primary author, or at least the moving force behind this. So Wilfred Burr, I'll let you answer the systems questions.
MR. BURR: A couple of things. The time involved, because we had crop profiles from the states involved in that region, it helped put together the information much quicker than if we had not had crop profiles. The meeting itself involved the people that are listed in the document, and we met for a day and a half here in D.C.
And when that meeting was over, I brought the notes back, wrote up the document, sent it out for review, incorporated comments and that was basically it. So it took probably from about -- I think June 10th was the meeting, and by August we had the final document up. So that's how long it took, and the crop profiles that we've been asking for helped tremendously on that.
I think, if I remember right, the systems approach can be tied into the same comments that we've just heard on the need for improvement in the EUP program. Because currently orchard research is done on a very small scale, and there's some way that you have to bring the whole system into it. And whether that's just a systems approach for insecticides, or including herbicides and fungicides and everything else, is all part of the big picture.
The alternatives -- one of the guiding principles that we set out at the beginning of this meeting was that any decision that was made during this workshop had to consider farmers' profitability first. Economic alternatives were the ones that we discussed, and some of those may or may not be economical. They are listed there. But they were alternatives and the working group felt that they should be put on that list.
And one of the other things, other than regulatory actions and research efforts needed, the third area that we really discovered that was a needed item was education. Once the new tools or methods accepted were registered or in place, then there is a definite need for an education process so that the growers know what to use, how to use it and what to expect when they do use it.
So I think I answered all of your questions. And I really do appreciate the positive comments on this, because I was real nervous that this wasn't going to be what people thought it should be or something. So thank you for your positive comments and your suggestions for improvement, too.
MR. EHRMANN: Okay. Wally?
MR. EWART: I appreciate the opportunity to see this again. I have seen some drafts earlier. So I've got some comments that a few of them could have been made earlier, so I apologize for not doing that.
One thing I want you to know, as I read this I came away with a feeling that 60 to 75 percent of apple production is process, which is not the case. I realize you were saying of this region. But make sure everybody here knows that it really is 60 percent to 70 percent is fresh in the nature. So that is one of the comments that I want to make to make sure people know.
And with apples being a word, it was obvious USDA would have to go to Appalachia for the first transition.
MR. EWART: So this goes along with most of the regulatory actions in D.C. about apples. You know, it's pretty much –
MALE SPEAKER: Watermelon in the west didn't have the same ring to it, Wally.
MR. EWART: Right. The other thing I do want to talk about is -- and I'll raise this. It's obvious that right now we would not be doing the right job if we do OPs. It's just we're into the rest. And I think putting a transition plan together with OPs alone as we move forward is going to mean we're going to be within a few weeks or months of scrambling to do the Carbamates and the B-2s.
And so I think we've really got to look forward to not being quite that narrow, because especially on the alternatives, you have the mixing, and you have all the risk issues that are going forward about Carbamates and OPs being related. And so that would be another point.
Obviously, when you started this, you know, the Carbamates hadn't really come into play, so that would have made sense.
The other issue really is the issue of the goal being to phase out OPs. My concern with that goal is that as a transition plan, that may not be the transition plan. The transition plan is to have OPs regulated based on their risk. Those risks that need to be mitigated, will be mitigated. Those uses that come through the process, will come through the process.
And for apples, at least, and a lot of other crops as we've already talked about, the alternatives are not in view in terms of being registered and proven in the field. And a lot of the alternatives, as have been mentioned, in the pipeline have questions, whether it's the registrant not willing to go further with the new tests, or it's cancer issues, or it's other issues.
We had our meeting yesterday with Jim Jones and had a good discussion with Jim, and appreciated that opportunity. But after going through the list, I'm sure we're going to find that the number of materials that we have available coming up quickly as alternatives is very limited and also includes materials that we're not sure if they'll work in the field. They might have worked on Robin's one or two trees, but we're not sure they're going to work on the thousand acre orchard in the Columbia valleys.
MR. BURR: Thank you, Wally. I think your comments about the fresh versus the processed is an excellent example of why this needs to be done on a regional basis, because that does vary on a regional basis.
I agree with you that the OPs alone were probably not enough. But it was kind of an overwhelming task to just think about them by themselves without starting to think about Carbamates and B-1s and B-2s. And being an entomologist, it was easier for me to cope with the OPs than it was some of the other things.
So far the groups that have met, I'm sure would be very willing to get together again to discuss diseases in weeds as they relate to FQPA and any regulatory actions being taken.
And as far as the goal of phasing out OPs, I think that's kind of why we changed the name from just a -- we put in the word foundation for a transition strategy. Because we realized what this was not going to be a plan that somebody could sit down, take out to the orchard with them and change their ways of production next year. It was a foundation to point out what needs to be done, if the OPs are going to be taken away, or if the uses are going to be modified over the next few years.
So it was kind of like trying to get ahead of the game, rather than being behind the game. And maybe that was shortsighted at the time. I think when we meet with the Washington people at the end of November, it will probably be more inclusive than what the southeast one was.
But, again, I'm leaving that kind of up to the people that are organizing the meeting. And I will just go and write down what they tell me they want me to write down.
MR. EHRMANN: Okay.
MR. BURR: One other thing, too. I wanted to let people know that the National Alliance of Independent Crop Consultants played a very important role in that southeast apple one, and that the PCAs in California also played an important role in the peach process there. So it involves those groups of people, as well as researchers and growers and commodity people. And processors in California were there for peaches as well.
MR. JENNINGS: And we very much appreciate the input.
MR. EHRMANN: Bill Lovelady?
MR. LOVELADY: Okay. As someone who is not very familiar with apple production, I thought this was a very interesting paper. A very good job. I applaud you for doing that.
And I think that it points out what we need. We need to expand the role of USDA in risk assessment and risk mitigation. And I think it will give our whole process a lot of credibility if we can expand the role of USDA in this. And I applaud this right here.
I think implicit in that expansion of your role is that we need to get some money for the Office of Pest Management in USDA so that they don't have to go and try to rob money from ARS or something. They need money of their own so that they can have ongoing programs like this.
MR. BURR: Thank you.
MR. JENNINGS: We'll take it.
MR. EHRMANN: Yeah, you've got Al smiling over there. Brad?
MR. LUCKEY: I've just got a question, I guess. Other than Bill Spencer and Bill Lovelady and Steve Pavich and myself, are there any other farmers in the room? Well, guys, if you feel out numbered, you are.
I guess a couple of observations, and that's all they are, just my personal observations. If you'll look on page number four, down at the bottom it says that OPs were not available for use during petal fall. Another material would be used by default of mite scales, insects and for sale signs.
(END OF TAPE THREE, SIDE TWO)
MR. LUCKEY: -- it lists petal fall, a critical time for OP use. Again, on page 13, early cover spray is an important time for OP use. And then again on page 19, mid to late cover spray, this is the second most important time for OP use. So three out of five growth stages are definitely looking for organophosphates to get them through and provide control. And the one thing that everybody forgets is a control equals the crop.
If you miss one of those applications in any one of those stages, you're going to lose your crop. And that's what farmers are in business to do, is to try and make a crop so that they can provide that crop to you, the consumer. And I think it just -- we need to be very, very cautious as we move forward -- and I think someone, maybe Bill Lovelady said it -- in the elimination of OPs. And I think that's definitely in the plan, Bill. And we need to be smarter, and we need to get more money for research. But we in the agricultural community need to do a better job of educating the public on what we're going through, so that they are sensitive to what the risks are that we undertake every day.
And we're going to need a lot of help from Al to try to get this funding secured. It seems like we have enough problems on our shoulders right now in the agricultural community. If it's not FQPA, it's TMDLs. If it's not that, it's just the sorry economic state that we're in. But we've always been survivors, and we'll continue.
But I did enjoy reading this. And it points out some of the pitfalls that agriculture faces, and it also highlights the need for more research. And we need help. Thanks.
MR. BURR: Thank you. If you take this home and read it, and if you have comments, would you please send them to me. And you can do that on e-mail. And it's just email@example.com. And I know some of you probably just are seeing this for the first time today, so please look it over. And we really do need some comments and some help in the structure of it and what it does and where it wants to go next. So any comments would be more than welcome.
MR. EHRMANN: Steve Pavich?
MR. PAVICH: Yeah. I just wanted to bring up that I'm a little perplexed that you didn't use organic as an alternative in this system. And the only reason I say that is because I know our growers up in Washington who are apple growers -- we have 20 of them -- our acreage is double from last year and representing about a million packages of apples, which is no small task.
And these are growers that, you know, started anywhere from two to ten years ago. And at the time that they started, it was the same story. It's impossible to grow apples organically. But we somehow have a million packages that we're going to sell. And Smelt, the largest apple grower in the United States, has a very active organic program.
And I'm not here to say that these growers should all be forced to grow organically, but that they should consider it as an option. And by you not putting it in there as an option, and looking at the economic aspects of it as an alternative, I think is very important.
MR. BURR: I agree, and we did not overlook that. It's just the work group -- if I remember correctly, it was because of the size of the orchards in this area -- in this region -- and also because there were so many backyard apples that it's very hard to do organic type things without having the input from your neighbors coming in.
I'm not sure. I can't remember. These of some of the –
MR. PAVICH: Well, I will note that these million packages that we have to sell are sold as fresh, and they're not sold as processing apples, which is probably four to five times more difficult to do, because processing is not related to blemishes and other things that have to happen to it. And I just -- I just ask question. You know, to me there's something wrong here in this picture.
MR. BURR: Okay.
MR. EHRMANN: Okay. Steve Balling?
MR. BALLING: Well, I was going to be a smart aleck and ask how many processors there were in the room.
MR. BALLING: But I feel out numbered and I won't. Actually, I've seen Wilfred in action doing this, and he's a master. I think a valuable use of biotechnology would be cloning Wilfred to do these.
MR. BURR: No, no. I can't crossover.
MALE SPEAKER: I won't touch that one.
MALE SPEAKER: That may be the only business they've got left.
MR. BALLING: I was pleased to see resistance included in this, or resistance management, because as we use up all those great new compounds that are pouring out of the pipeline right now with, from what I understand, nothing behind them, we are going to be in deep trouble relative to resistance management issues. And I think it's very important that this whole process include that.
I did want to ask, who is the audience for this, specifically?
MR. BURR: The work group. I've sent it out to other commodities to see if they would be interested in doing something like that. I think it would be very important to EPA to receive this kind of information so that it gives them an IDEA of the impact of decisions being made and the efforts that will be needed to move from here to there.
And that's about as far as I've taken it at this point.
MR. JENNINGS: Yeah. Therese said that's just a so what question. But I think the audience is many and varied. In part it is the research community.
MR. BALLING: Who can say it's so what? But, no.
MR. JENNINGS: Oh, I'm sorry. I'll let you answer your own question. But it's the research community. It's within USDA. It's our land grant partners. It's anybody who wants to worry about how to transition from one particular pest management technique to another.
Therese, go ahead.
MS. MURTAGH: When Wilfred finished the final draft of this document, we asked ourselves, well, so what? You know, we have this document. It's the same question that you're asking, I think. Once you have the document, what does it mean to EPA, within USDA and to our land grants? And those are questions that have to get answered.
MALE SPEAKER: I would like to make a proposal that actually the audience is and should be the commodity group itself. It reminds me a little bit -- Mark and I at lunch were talking about modeling. Back in the '80's modelling was really hot. And we found out that predictive modelling didn't work at all. Sorry, EPA. But in pest management systems, it didn't work.
But what we did find is it had great other values. You learned what the holes in your knowledge were. And I think commodity groups, by going through this process, will have a great advantage in understanding where the holes are, where research needs to be done, and where they should be applying their energies and dollars.
That's the most important thing. You cannot do it yourself --
MR. BURR: That's right.
MALE SPEAKER: -- as USDA. There are 250 or 300 crops. There are X number of geographical locations for each crop. And what I would propose as the next step that the commodity group would take is to put together a business plan. How are you going to manage the next five years? What are you going to do? Where are you going to put your energies? How are you going to research -- put your money in research? What companies are you going to work with relative to new compounds? How do you keep your ear to the rail?
Those of the kinds of things that I really think where the greatest value can be gained for the commodity group itself.
MR. BURR: I guess that would be our pipe dream, is to have commodity groups take this ball and go with it. And we have established the format in a document that represents what goes on in these meetings. It would be real nice to have somebody stand up and say, I think that we can do this and then go ahead and do it.
MALE SPEAKER: Well, I think we've had good success. It was never formalized quite like this. But pears in California did this at the turn of the decade in '90 and '91, and we began to plan out where we wanted to be and what our expectations were. And contrary to Wally's comment that -- well, maybe not contrary. But maybe in addition to Wally's comment that we don't necessary -- we aren't necessarily phasing out the OPs. You had better be prepared in case they are. And that was part of the preparation process.
MR. BURR: Well, the model for the work group was if you're going to go for a bus ride, you might as well be the driver.
MALE SPEAKER: Exactly.
MR. EHRMANN: Mark? This Mark and then that Mark.
MARK: I hope that -- I got Steve to put his hand up. You know, he really said well what I was thinking. But, you know, we're going in a transition and you're talking about the transitional phase. But I would hope that your research monies would also be directed at the endpoint. And people that are working right now at that point have a lot to offer, and I think a lot of money ought to be going there. I mean, we can do a lot to reduce the traffic congestion by building new highways. But it's not going very far towards reducing automobile use.
MR. BURR: If you look at some of the to do lists, there are things that mention the red spheres and pheromone work and trapping work. And if I were an enterprising researcher, I might say, well, gee, these are some things that maybe I can do a grant proposal for and submit something like this to the car or the ramp program, or to the P-Map program and get some money to do some of this research. So that's another reason I see the to do list is pointing, you know, in that direction.
MARK: Well, I hope somebody goes out and rabble rouses with those people to encourage them to actually --
MR. BURR: The people in California were much more receptive to that than the southeast apple people were. And the Michigan and the Wisconsin meetings that we had, the transition also --
MALE SPEAKER: Just speaks to how much it's a mind set.
MR. EHRMANN: Okay. Mark and Margaret, and then Gary wants to make a couple of observations and then we'll take our break.
MARK: I want to be very complimentary of the effort and the process, and I think it's exactly what is needed. I don't want to address the document so much as I want to address the issue of scale. Because what we're talking about is the kind of scale change that I addressed before about Jim's comment under REDs to FQPA. We have a tremendous scale of change associated with that.
And I'm thinking about, for example, research on Robin's single tree efficacy study versus the systems plot. The scale there is somewhere around three to six K -- three to six thousand dollars for an efficacy test replicated properly and the study done, to a full systems research plot on ten acres is around 80 to 160 thousand in apples. So it's a huge scale thing.
And by the way, systems research actually found its origin in the late '70's, even early '70's, in electrical engineering, where one set out to identify a universe that you wanted to control. So it's good to ask the question about what are we trying to manage and what things are in this, and then what elements contribute to that control system. And when you talk about pests and OPs, those are part of it.
Many of those elements that we're talking about are very dynamic. And I mentioned this before, but we need to maybe hammer this home, that they require monitoring, and that's expensive to do.
And so if we know the current state, which is something like our crop profiles are current states of where we're at, and we identify where we want to go, maybe a system without OPs or reduced OPs, that's a future state. And then we design a system to get from A to B, from the current state to the future state. What I recognize in that is yes, it's going to take a lot of research, and I think it's going to take a lot more on farm research and on farm transition.
And the comment about well, you can build a new highway, but you've got to manage the traffic that's already there, I agree. And the way you get to manage traffic is that you put out stop signs, and you get directional signs, and you do lines on the roads and things like that. There are a lot of things that we can do along the way.
The last point I would like to make is an information point. When you transition in agriculture from a system as simple as an -- and I'm not putting down the simplicity of using chemical sprays. I'm not. But they extract or subtract or suppress or eliminate large areas of complexity in production. When you move away from that kind of simple system under an OP suppressed eco system to an alternative system that has much more complexity, the information that you need to manage it goes way up.
Where does that information come from and how is it purveyed?
MR. EHRMANN: Okay. Margaret?
MS. WITTENBERG: Okay. I'm going to echo, I think. This is a real terrific piece. And I think this is one thing that -- as far as me being part of the TRAC, this is what I've really been excited to have happen.
Just as Mark was saying, this is a future plan. There has been so much fear with all the, you know, previous six TRAC meetings, which is reasonable. You know, you never know -- you don't know what's going to be taken from you. You don't know where you're going to go to the next step. And this gets right to the people who are really -- who it's going to effect the most. You know, Brad, Jim, Steve -- who is the other farmer? Is there another one?
MALE SPEAKER: Bill.
MS. WITTENBERG: Bill. Yeah. And I think it's really important that they have the real processes. And I really think this is a fabulous job.
The other thing, and I've been saying this until I think people are sick hearing me saying it. But I think the public does need to hear the really good transitional success stories as well as the challenges. And I think this would help get Brad's question about do people know what the farmers are dealing with, and I think that's real important for them to know that this is not an easy task.
However, it can be done and that a lot of research is needed behind that. And then maybe the public can get behind in pushing Congress to get the types of programs that we want. And I'm really happy to hear that we're going to have those two proposed programs funded.
But anyway, the educational process for the public -- and I'm meaning the good stories. I don't want any scary stories at all. I think this is what we need to get to. And I was wondering if there is any plan for the future, the near or far future for that?
MR. EHRMANN: Yes, Therese?
MS. MURTAGH: Can I make a very belated comment? Mark, you were talking about children and the focus on children. And you know USDA, our customers, our clients and our growers. But we sure pump a lot of food into a lot of kids. And our office, you know, does stay in contact with the people who do the WHIP Program, Food Stamp Program -- what am I missing -- and school lunch program.
And two facts that really stayed with me from conversations that we had with those people is that when we talked to them earlier, it was 20 percent of kids lived below the poverty level. It's actually increased and it's now about 25 percent of kids are below the poverty level. Another fact that is very impressive is that for every dollar that the Food Stamp Program increases, it puts a 36 million dollar increase in the budget.
So our office and those offices are very concerned about having lots of nutritious food, but also about food cost and food availability. So we do -- are always concerned about kids. Millions of them, in fact.
MR. MILLER: I appreciate that, and certainly the Academy of Pediatrics is very strongly in favor of increasing fruits and vegetables in children's diet, and understands that cost is an issue there, and therefore would be strongly behind the kinds of efforts that are being made around this table to transition in a reasonable way.
However, I am struck also by when Steve did his presentation that he was able to sell grapes on the market competitive with non-organic grapes, even though he was raising them organically.
MR. EHRMANN: Gary?
MR. GUZY: I wanted to think for a minute about how we all generalize from the kind of work that's been done in this effort, and I go back to two comments that were made, one by Jamie on the importance of involving growers in risk mitigation decisions, and one that Steve made about thinking in a rational, comprehensive way about the future given what is a likely scenario on general use of organophosphates. And given, quite frankly, the kind of schedule that EPA has now put out in a very public way, and that we again stress today that we're committed to meeting.
And as we did with Azinphos Methyl and Methyl Parathion, we can make certain assumptions ourselves, or in cooperation with USDA, or working with registrants in some subset of growers, about targeted approaches and our best guess as to those about reasonable phase outs and transitions.
Nonetheless, I didn't want people to overlook what we feel is also a very important part of the announcements that the Administrator made on August the 2nd. And that was really extending a challenge, a risk reduction challenge, to pesticide manufacturers and growers to come forward with additional voluntary measures that can be taken to reduce risks from other organophosphates, the ones that were the subject of those particular actions. And really we see this as an opportunity for grower groups and others to shape future actions on organophosphates and other pesticides.
And we in that announcement set forth some very preliminary thinking on our part and in working with USDA on what would be some of the criteria that we would find acceptable in voluntary programs and challenged programs. And one would be to focus on those risks that we believe are most significant, consumption of children's foods -- children's diet.
And two, eliminating uses or achieving no detectible pesticide residues in high consumption children's foods, moving toward safer use, use of safer reduced risk alternative pesticides, and the definition of an acceptable specific time frame for achieving goals.
But we recognize that that shouldn't be done alone or in isolation by a group that obviously -- if a group is going to step up to the plate, you need support from the government as well. And we've had extensive discussions with USDA about targeting -- helping to target their resources for critical research and extension.
We have, as part of this, committed to expediting registration of reduced risk pesticides with a goal of making decisions within 18 months if there are specific needs. Expediting review of promising new chemicals and new chemical uses, and recognize that there should be some give and take if we're successful in developing these plans.
But I think this kind of a challenge program, this kind of a risk reduction challenge, has been somewhat overlooked in our announcements from August. And I want to stress that the agency is very open to efforts to put people in the driver's seat of the bus, not to have us driving it, so long as ultimately the public health and risk reduction goals can be met.
So, again, this is an invitation one more time to find those kinds of common sense transition mechanisms building upon the base of knowledge that is provided in a report like this.
MR. EHRMANN: Rich?
MR. ROMINGER: Well, I appreciate the laudatory comments that we had for this foundation for a transition strategy for southeastern apples. It is the first one that we've done, and the comments that we've had here today are certainly a big help in not only improving this one, but improving future transition strategies as we work on them.
And I think as Wilfred said, the peach growers in California are a little more forthcoming and are going to take a little more proactive part in working through this.
But it does help us. It points out where we need research and where we need to put more effort.
Bill, thanks for offering us some more money. We'll take it.
MR. ROMINGER: I think it does show that when we get the resources together, and working with the industry and the registrants and everybody involved, that we can make a difference in this process.
I want to add my thanks to the USDA crew that put this together in a fairly short period of time. But I think we have a model here that we can -- to build on and improve and will certainly make a difference as we go down the road here.
MR. EHRMANN: We will have, as several folks have noted, a discussion tomorrow morning about the pilot process and the latter stages of that, which relate obviously to the time allocated for risk management and interaction between the various groups. So we'll be coming back to some of these issues in that context tomorrow.
And what I would like to do now is take a 15 minute break, and we'll come back and pick up with the tolerance revocation and channels of trade discussion as indicated on the agenda.
(Whereupon, a brief recess was taken.)
MR. EHRMANN: -- the remainder of the afternoon. First, I want to give Robin a chance just to share a couple of thoughts she had following the discussion we had right before the break. And then we're going to turn to Jack, Bob and Al to discuss -- initiate a discussion on the issue of tolerance revocations and channels of trade. And then we will take any public comment that we have signed up, and we will adjourn no later than 5:30, as it indicates on your agenda.
MS. SPITKO: Thanks. Steve is not here, and he was part of -- Steve Pavich was part of -- the person I wanted to address. But I want to talk about the issue of organic versus non-organic, and maybe just bridge the gap a little bit.
A point occurred to me that we hadn't really discussed in the TRAC so far, and that's -- you know, we keep talking about IPM or spray programs and how specific they are. How regional they are. How tailored they have to be to each site. But when we look at organic, we're looking at organic versus nonorganic.
And what the truth is, is that organic is a very viable means of production, and a very positive way of production in specific sites. Again, I mean, there are regions of the country that are suited -- more suited for organic production than others. And I think we've kind of been missing that point in our discussions.
It's not either them or us. It's, you know, working with the different pressures. In New England, unsprayed apple trees -- I mean, there is not a single reclaimable fruit. And this is a tree that's been grown, you know, for many years in the wild or in abandoned blocks. The pest complex is incredible.
And we do have a few growers who are working with some that are trying organic production, and it's really difficult. I mean, it can be done on a small scale in New England, but it's really, really tough. And when you're working with commercial cultivars that are highly susceptible to certain pests, you just can't turn around and start growing them organically. You need to make changes regarding that.
And so I just think we need to stop talking about, you know, us versus them, organic versus nonorganic, and look at where organic is suitable and accept that in the large areas it is not suitable.
And this won't be a popular subject, but we have some cases where we have organic orchards butting up against nonorganic orchards and they're actually increasing the pesticide use in the commercial sites, because there are so many pests in the organic site that they're, you know, migrating over the stone walls and over the fences, and causing the growers and commercial production to have to increase their pesticide levels to control the pests that are coming out of the organic sites. So in this case organic production is actually causing an increase in pesticide use on the non-target site.
So I'm just saying it's a real complicated issue, and we can't look at people not doing organic because they're dumb or they have the wrong mind set. Yes, it does need to be investigated more, and I think it can be used at certain sites very well. But we have to also use the same principles we use in IPM, that there are regional differences. In some areas you may be able to do it, and some you can't.
And so maybe we should just try to develop it where we can look at it more, but not condemn people not using it quite so vigorously because they may not be able to genuinely because of the scientifically -- the pest conflicts in the area.
That's all I wanted to bring up. Thanks.
MR. EHRMANN: Okay. Let's turn to the tolerance revocation issue. And Jack, I think you're going to lead this off in terms of the three folks who we've got lined up here.
MR. HOUSINGER: Okay, thanks. I would briefly like to describe the channels of trade issue and the provision in FQPA which addresses it. After a food or crop is treated with a pesticide, as you know, detectible residues of that pesticide may result. It's harvested. It goes through various points of distribution until it gets to the store where people buy it and consume it.
It's those various points of distribution after harvest that we refer to as channels of trade. In some cases, such as where the food is sold as fresh, it moves through commerce quickly. Or where residues decline very quickly, there is a very short time that there is food with detectible residues that are in the channels of trade.
In other instances, such as where the commodity would enter cold storage for an extended period of time, or the treated commodity is processed, such as being made into juice or frozen, commodities with detectible residues could remain in the channels of trade for two, three or up to four years. As long as any residues are not exceeding the established tolerance, all is well. Where the channels of trade issue comes into play and could be problematic is in the instance through, say, re-registration where the use is canceled, or it's voluntarily canceled, and tolerance revocations may occur as a result of FQPA. Where tolerance reassessment results -- or where a tolerance reassessment results in termination of the tolerance, a revocation is the means by which the reassessment is completed.
FQPA contains a provision -- and if anyone is interested it's Section 408(L)(2) -- which states that if a pesticide registration is canceled or modified under FIFRA, due at least in part to dietary risk concerns, that EPA shall revoke any tolerance or exemption within 180 days of when the use becomes illegal under FIFRA.
However, the law also provides -- or also contains a provision designed to solve the channels of trade issue. The law provides that any food that was treated lawfully under FIFRA prior to the revocation shall not be deemed unsafe as long as the residue does not exceed the level of the tolerance that was in place at the time of treatment. This provision is contained in Section 408(L)(5) and has been referred to by EPA as a safe harbor provision.
I should note that it can be -- this provision can be overridden by EPA if we determine that consumption of the legally treated food during the period of time it takes to clear the channels of trade would pose an unreasonable dietary risk.
The agency is very committed to assuring that we support the implementation of these provisions in a manner which addresses the channels of trade problem. We have been discussing with both FDA and USDA as to how this safe harbor provision will be implemented, what kinds of information the agency has to provide in order to ensure that it can be carried out effectively, and what special circumstances need to be addressed as a result of implementing this provision.
EPA has already begun providing information to FDA on expected residue levels for commodities for Methyl Parathion, which was canceled earlier this year. All use on those commodities can occur no later than December 31st of this year. For instance, EPA has calculated the maximum level of residues that could be present at various time periods following legal treatment. We've calculated it for three, six, nine and 12 months.
Additionally, we have also identified how long the fresh commodity, as well as any processed commodities, would be expected to remain in the channels of trade. For example, we estimate that apples and pears could be expected to remain in channels of trade for a period of one year. The juices could remain for two years, and the frozen juice concentrates for a period of up to four years. We hope that this and other information will assist FDA in developing its strategy for implementing the safe harbor provision.
I'll now let Bob Lake of FDA explain how FDA is addressing the implementation.
MR. LAKE: Okay. Thank you, Jack. I appreciate the opportunity to talk about this issue with the TRAC this afternoon. A couple of points. One, let me first thank those and Jack and others at EPA, as well as Al and others in USDA, for the dialogue that we have had so far around this issue.
I think we all recognize that like a lot of issues involving pesticides, this one is important. It is also difficult. It's difficult for a number of reasons. One of them is that on the one hand there is a desire by everybody to effectuate this provision, which is to assure that food once lawfully treated is allowed to go through the channels of trade and be sold to consumers and be consumed. Even though in the meantime the use has been canceled and the tolerance has been revoked, it is really a way of getting through the transition.
Jack has said that EPA likes to use the term safe harbor. Actually, I guess I'm one of those who sees everything as kind of this big pipeline. It goes all the way from the farm over here to the consumer's fork over here. And there is always a lot of stuff in this pipeline all the time.
And so any decision with regard to any pesticide commodity combination, any termination of use or any revocation of tolerance, will no matter when you time it affect some things that are in that pipeline. And I think the congressional intent of this provision is to allow those things to continue to move, unless, as Jack pointed out, there is a particular finding that would be contrary to the public health.
Let me also simply point out that this is really not a new issue. You know, tolerances have been revoked in the past. And what has tended to happen in those, at least, you know, when it fell to FDA to figure out what do we do now, we have in fact tended to operate sort of with a presumption that up to a certain point in time, it is likely that most, if not all, of the food that would contain this residue would in fact have been lawfully treated. But that at some point the presumption sort of flips the other way, and, you know, if you get far enough down the road, you have to begin to presume that if you find this residue, it is not the result of lawful treatment.
The challenge, of course, is to try to figure out, you know, where that point is. And, of course, that can vary, depending on the commodity and the pesticide. Also a lot seems to depend on whether it is fresh produce versus processed food.
The other kind of overall factor that maybe I would kind of mention up front is that -- or a couple of tensions. Maybe I should put it that way. One is we want to provide -- we all want to provide for the channels of trade to clear. We don't want to have a policy in place that allows for continued use of a pesticide after it is no longer allowed.
The other component -- the other tension is between allowing these channels of trade to clear, but to do it in a way that does not allow foreign growers to unfairly take advantage of the situation. And let me just explain that problem a little bit.
The registration is canceled for use in the United States, but it may -- but the same pesticide on the same commodity may still be allowed, and typically is still allowed, for growers in other countries, because they have not made that decision. Our law does not extend in terms of pesticide use to what happens in other countries. It only governs what happens within U.S. borders.
On the other hand, in terms of pesticide residues on food, those provisions, which are enforced by the Food and Drug Administration, apply not only to domestically -- the residues on domestically grown food, but residues on imported foods as well. In fact, a large part of our enforcement effort is focused on looking at residues on imported food. And if they are not in compliance with EPA tolerances, then we simply refuse their entry. They are not allowed into the United States.
The dilemma we have with the safe harbor pipeline -- and actually since the statute uses the terminology channels of trade, maybe we should all agree to use that. The dilemma we have is that if we cut off
-- or if we cancel a use today and the tolerance is revoked at some point in the future, U.S. growers from the date of -- you know, they can no longer use the pesticide, are stuck with the fact that they can't use the pesticide, and are facing competition from foreign growers who continue to use the pesticide.
And as long as the tolerance remains in place, the FDA has to let in the imported food, every bit as much as we have to allow the continued movement of food in domestic commerce. There has to be absolute parity in terms of how we do our enforcement. That's the way the law is structured. And further more, if we did otherwise, we would immediately face trade challenges that we would surely lose.
So those are kind of the parameters of how we look at this overall situation. Now as we -- and I should say that there is handout that should have been put all the way around the table. It's one page. You know, one full page and there is some on the backside as well. And I'm not going to read that. I'll leave that to you to, you know, read at your leisure. But it touches on much of what I am saying.
What we are thinking about doing grows out of what we have done in the past, which is to say that what we want to do is to have a policy to effectuate the channels of trade that assures that fresh produce goes through the channels of trade before the FDA cranks up an enforcement problem program to look at the residues.
Now let me -- and also that we want to have a policy -- a rational policy -- for dealing with the fact that some of this food is going to find its way into processed food that may have a somewhat longer shelf life and may therefore be in the channels of trade for somewhat longer.
One of the considerations is what do we know about how long the residue is likely to remain in the food at a detectible level. And let me just clarify one point here, just so there is no misunderstanding. Any time we would find in our normal surveillance a pesticide residue that is above tolerance, then we would take regulatory action against that food. And nothing about this policy changes that in any way. So what we're talking about here is the detection of residues below what has been the tolerance, even though that tolerance is no longer in place.
At some point for many pesticide residues, the level drops to a point that it is no longer detectible by the regulatory methods used by FDA. In the case of Methyl Parathion, the valuable information and data that have been provided to FDA by EPA suggests that even under worst case situations, the fruits and vegetables that go into the fresh market will probably not have detectible residues after the elapse of about a year.
So if EPA goes forward this fall with a proposal to revoke the tolerance for Methyl Parathion and then issues final revocations some time next summer, and then FDA's normal enforcement program -- the programs we write for our field enforcement people -- typically go on a fiscal year basis. So we would be sending out assignments -- I mean the next time we do it would be next October.
So, you know, there is a belief on our part that for fresh produce there is not likely to be detectible residues after the beginning of the next -- you know, once the next fiscal year begins.
(END OF TAPE FOUR, SIDE ONE.)
MR. LAKE: -- that we are in no way closed on any aspect of this policy, as a matter of fact, and what I'm saying represents our current thinking. You know, we will be coming out with guidance that we will publish in the Federal Register inviting -- it will be draft guidance inviting public comment. And we will be reviewing that comment before issuing our final guidance. So just to be clear about that.
Now for processed food containing Methyl Parathion, the situation seems to be a little bit different. EPA has advised us that with fruits and vegetables that are frozen that we would a couple of years from now likely find the same residues that we would find in the fresh product if we took a sample today. So that presents a particular challenge in terms of how to deal with processed foods.
We are open to suggestions of anyone in this room, as well as anybody else, who has any bright ideas on this as to how we grapple with that. One thought that we have had is if processors could keep track of the date on which they processed their food, and particularly I think this is an issue for frozen food. You know, when does it go in the box and frozen.
If that's done, say, within the next year, just to throw out an idea, we wouldn't ask any further questions about whether that residue was likely to be lawful or not. But there is certainly a point down the road where we would have to say, well, you know, it's beginning to look doubtful to us that this residue was lawful at the time it, you know, got in the food.
So those are thoughts. And I guess what I would do at this point, having thrown out those general thoughts, just stop and let the discussion continue. But also assure you any thoughts you have, either now or later, about how we can best implement this provision, we would welcome that.
MR. EHRMANN: Al, do you want to say anything at this point and then we'll open it up?
MR. JENNINGS: Yeah, I think just very briefly. The Food Safety Inspection Service does the job that Bob just described, inspecting for legal residues or for illegal residues in meat, poultry and eggs. And whatever system that we ultimately end up with, I'm envisioning FSIS will have a parallel system to FDA's to enforce the decisions made.
The other aspect of this, though, is kind of the export issue and the availability of the legal tolerance and that sort of thing. The Taiwanese trade agreement is key to a U.S. tolerance. So there are dimensions of this beyond the enforcement inspection that I'm sure we will get into.
MR. EHRMANN: Okay. Bill?
MR. LOVELADY: Yes. Bob, I have just a question about the way FDA works. I remember that you check a small percentage of the fresh fruits and vegetables that in. What was it, was it one or three percent?
MR. LAKE: If you're talking imports, at this point in our history, it's probably less than a percent, simply because the volume has just grown so much in recent years.
MR. LOVELADY: Okay. Well, I knew it was a very small percentage.
MR. LAKE: Right.
MR. LOVELADY: My question is -- and let me tell you where I'm coming from. I live on the Rio Grande. So I am noticing -- and this may not be a problem that you see in other parts of the country. But I am noticing in the grocery store more and more processed foods from Mexico.
Could you kind of give us an idea of what sort of percentage of the processed foods that come in that are checked?
MR. LAKE: I don't know that number off the top of my head. But the one percent number -- and maybe as high as two. But, you know, one to two percent I think is sort of across the board on foods generally. So I think that would be --
MR. LOVELADY: Well, let's say processed.
MR. LAKE: -- at least some of both. But, again, I mean you're raising an interesting point -- an important point. The level of FDA sampling, both for imported product and also for domestic product, is really at an all time low. Our program today is half of what it was at the beginning of this decade, and, you know, at the beginning of this decade, it was already half of what it was at the beginning of the last decade. So there has been a long term trend towards ever declining resources for monitoring and enforcing pesticide tolerances in food.
MR. AIDALA: And is PDP -- a question for Al and company. Is PDP domestic? I mean all domestic or domestic and imported also?
MR. JENNINGS: It's both, domestic and imported, and it's fresh as well as processed.
MR. AIDALA: And that's not enforcement monitoring. Are you saying just for --
MR. JENNINGS: But that is a good point, because when we do find something that looks like it might be a violation, either over tolerance or for something that has no tolerance, we do turn that information over to FDA.
MR. LAKE: Yeah, let me just comment on that. And that is useful in terms of intelligence. But by the time, you know, those data get to FDA -- well, in the first place they're collected in a way that you cannot identify a particular shipment, or even somebody who owns the shipment, number one. And number two, you know, by the time we know about it, that food is long gone, and we don't even have good information about who we might go talk to about it.
It does, however, provide us information on the commodity, and I think basically some information at least on where it may have come from.
MR. EHRMANN: Steve?
MR. BALLING: Well, as the outnumbered processor in this group, I have to comment. I find it ironic --
MR. LAKE: I just have to interject. There are probably even more processors than there are enforcers in the room, though.
MR. BALLING: I bet not. I find it ironic that in FQPA one of FDA's goals was to get rid of action guidelines in the Section 18 process, because you didn't feel that those were numbers that you could take to court. And guess what we've arrived at? A very similar kind of situation, where we're going to get rid of actual tolerances and have these kind of, well, we'll look the other direction, regs.
MR. LAKE: Well, let me comment on that, too.
MR. BALLING: Well, I got more questions.
MR. LAKE: Okay. Well, let me comment on your
-- you know, since I'm --
MR. BALLING: It was pointed to you, Bob, yeah.
MR. LAKE: -- blamed or credited or whatever, depending on what point of view with the Section 18. The whole notion of Section 18 was to have a number that wasn't a sanctioned number by the statute, and to have that sanction put in place. And that has been accomplished.
Here we are actually not talking about a number. And what we're saying is, that the old number continues to apply so long as the food is in channels of trade. I think the -- and in fact that was FDA policy before, too, and one that we have always, you know, been quite comfortable with, simply because, you know, from a practical standpoint, you know, I don't know what else you would do. Either from practical or equity.
The thing that, of course, always has made it difficult is knowing at what point can you really say, well, what we're now seeing really was not in channels of trade when this action was taken.
MR. BALLING: Well, I would disagree. The number is no different than an action guideline.
MR. LAKE: Well, I'm just saying there is no number here at all.
MR. BALLING: Well, that's worse.
MR. LAKE: Well, no. Well, I mean, that is, of course, an issue. But what I'm saying is this was not associated with any new number. It's simply that whatever -- you know, if it met the old number, it is still okay so long as that residue got there when the old number was in place.
MR. BALLING: You mentioned that for Methyl Parathion, at least, they've looked at the dissipation over 12 months. Does that mean at month eight you'll expecting a different level, or is the tolerance still acceptable?
MR. LAKE: I think the way we're looking at it is that at month eight we won't look. We won't start looking until we get to month 12. Or -- or if we happen to -- well, let me clarify that.
MR. LAKE: We would do the normal monitoring that we would always do, even though that's at a very low level. If we find a residue that is within the old tolerance, we would simply assume within that first year that this is something that is legitimately in the pipeline by virtue of having been lawfully treated.
And so we wouldn't look at -- you know, the only issue on the number is whether it is above or below the tolerance. If it was above the tolerance, then we would go after it. If it's below the tolerance, we would assume that it's lawful within that first year. After the first year, the same residue would be assumed to be not lawful.
So it is not -- we're not trying to titrate this down. I think that would be totally impractical.
MR. BALLING: Well, then I guess my other question is for Paul. Are you going to look the other way also next year? State harmonization is pretty critical in this whole process, isn't it?
MR. BALLING: You're not the only agency looking at pesticides in food.
MR. LAKE: I can't speak for the states.
MR. BALLING: Paul can.
MR. HELLIKER: Yeah. And for us, we haven't really come up with a policy, but it will probably look something like this.
MR. BALLING: I sure hope so. The one thing is, this is kind of precedent setting, and you're looking at Methyl Parathion here. And I have to ask, is methyl Parathion a worse case scenario, so that we can trust that dissipation studies we're looking at apply to all pesticides that will ever be appropriate to this particular issue?
MR. LAKE: No. I think we are not assuming that. I think each one of these is going to have to be looked at, at least in my assumption -- and, Jack, you can speak to this -- probably based on what we know about that pesticide.
MR. BALLING: Okay. And then my last question.
MR. AIDALA: Well, Steve, one of the things, just as staff explain it to us, too, it's not just the dissipation of the compound. It's also the -- call it dissipation of the food form through the channels of trade, and that variable will be less case by case. I mean a frozen -- and I'm making it up. But frozen broccoli is going to -- you know, if it usually takes two years from field to dinner plate, that will be sort of constant. Now whether or not -- the residue of the compound may vary, given its own particular characteristics or presses and techniques -- or something like that.
MR. HOUSINGER: Just to follow up on that, though. The residue levels that we calculated over three months, six months and nine months assumed that the commodity was treated at label rate.
FEMALE SPEAKER: Closest to harvest?
MR. HOUSINGER: Closest to harvest. So it started at that and worked its way down, rather than what was actually occurring in the field. So PDP data would tell us that the levels we're actually seeing in commerce are a lot lower than that.
MR. BALLING: Last question. What about products that are stored in volume for long periods of time? Grains, dried fruits, juice concentrate, and you mentioned frozen. We don't have dates on any of those typically. They get mixed. They could be in storage for four or five years even.
How do you -- if something pops up five years from now in raisins --
MR. LAKE: Well, my first suggestion is you sell them as quickly as you can.
MR. BALLING: Well, that's a good suggestion, Bob.
MR. LAKE: Yeah. My next -- you're right. My next point would be that -- I mean, actually you are getting at what I think is the most difficult part of this in terms of how we implement. And I would urge you and others to think about how this might be done in some reasonable way.
And I think it has to be defensible, both from the standpoint of indeed effectuating this provision and assuring that we don't take action against food that shouldn't be acted against, but also that we are looking at the other side and not operating this in a way that it becomes a cover for misuse or allows for the prolong situation where farm processors and growers are able, you know, to get food into U.S. commerce because we have a system that is not taking a hard look.
So I guess I would challenge those in the audience -- I mean, around the table and elsewhere in the audience who have an interest in the matter to give it some thought and to get back to us as quickly as possible with any thoughts you have about the best way of implementing this. We are very much open to that.
MR. BALLING: Well, I guess this gets to the fundamental problem that I think processors have, and that is that you are guilty until you prove yourself innocent. And the way you do that, then, is, say, absolutely we will not accept any crop that has been treated with Methyl Parathion, and someone is left holding the bag, and it develops a very complex, difficult situation.
Are you holding the bag, Cindy?
CINDY: Not of that. I have none of that.
MR. BALLING: So it's exactly what we were afraid was going to happen.
MR. LAKE: Well, except that -- I think again one approach to that is to say that for processed food, anything that the processor buys and processes within a certain time frame is presumed to be okay. So that all then we would be looking for -- and that's one thought that we've had -- is for the processor to tell us, all right, when did you process. And if you did it early enough, that's the only question we would ask.
Now if, you know, three years later you do the processing, then we might be -- you know, I mean at some point we have to ask a different question. And that is, well, this does not seem to us, under the policy that we articulate, that it was within the purview of the channels of trade. So if you think it is, then we would like to know what your rationale for that is.
MR. EHRMANN: Okay. Mark?
MR. TROSTLE: Well, I think we're making the full, I guess, circle here, it seems like. Because my understanding initially on -- Curt Mann in the House Ag Committee told me that one of the reasons that FQPA was passed was to appease the World Trade Organization under the Section 18 process that we did not have a tolerance established. Therefore, they could not import their commodity from a foreign country.
Now we have time limited tolerances that allows this situation to circle. And it looks like we're coming back around to that same spot we were three years ago when FQPA got passed, that we're fixing to have an unfair trade thing occurring again against a foreign country, because if we do away with the tolerance, therefore the foreign country is back in the same boat they were before. And I'm not sure the World Trade Organization might get excited again.
It also troubles me -- the second thing is that EPA is supposedly at this time doing harmonization with our neighbors, Mexico and Canada. I'm not quite sure how it's going forward. Being a neighbor to Mexico, we're seeing more and more things coming back and forth, fresh and processed, across the border. And I cannot believe in dealing with multi states and Mexico that they are going to stop using Parathion on their fruits and vegetables, particularly if they find out -- or they probably already know -- that we're checking less than one percent of them.
To take up the processors' point of view, if you look at your apple juice, I think you'll find it's blended with about everything from Canada to Argentina to China. So I guess I'm a little confused here about how we're going to revoke somebody's tolerance in the United States, and then let them continue to do their thing without impacting our growers.
I guess I always remember to take up for the processors. I had the opportunity to see 328,000 pounds of turnip greens processed and frozen that was seized by FDA. Now folks, that's a ground slide load of turnip greens.
MR. TROSTLE: And it's all because it was a Section 18 that had expired and didn't have a quote, tolerance. Now that impacted that grower, because he had harvested. The processor -- they had processed, labelled, packed and frozen it, and it sits there today, I think. It's been sitting there about six years still frozen.
MR. TROSTLE: So, you know, that's what we're getting into. It's like the Secretary of Kansas said a while ago. Folks, you're in packing or growers. They're what feeds us here every day and you're going to have to be careful. You've got to be careful.
MR. EHRMANN: Any comments in response to that? No? Rick?
MR. JARMON: Just a couple of points and possibly a question or a suggestion for some further discussion down the road.
First of all, one of the pivotal points here is the application of the tolerance revocation, which starts a lot of the discussion about how the safe harbor will work. I would like to raise the notion that there may be some discretion there, and some lawyers may need to spend some time together to figure out the provision that triggers the tolerance revocation, to see if that is an absolute necessity within the time frame, if that can't be part of the mix of the solution to this.
Partly, and particularly because with Methyl Parathion where the decision has been made that the foods -- fresh foods as well as the processed foods that have been treated that may or may not contain a residue, during this growing season and into the future, are indeed safe and don't pose a health problem, which was the decision that was made because of the allowed continued use after the cancellation decision was announced. So indeed there was a safety finding.
That poses a different situation, in my opinion, than when a decision is made that those foods are not safe. There is a residue problem. There is some real concern here and we have to take more immediate action. So I think that needs some discussion.
The other point I would raise, and others have already mentioned it, we've talked about concern over a level playing field for our growers and their foreign competitors. If a -- and it was just described. If the situation arises that either a domestic grower cannot sell his crop for this year, he's impacted. If a processor says I cannot accept your crop, he's impacted. If the processor hears from his customer, the retail store, that they will not accept that product, he's immediately impacted.
So those are some -- there has to be a little bit more open mix, and in my opinion, again, a step back to look at how this can be considered to provide minimal, if no disruption, without imposing and maintaining the safety standard that we've been talking about all along.
So I think there are some issues that need to be opened up, and it's not black and white.
MR. EHRMANN: Does anyone have comments? Wally?
MR. EWART: The are two issues that haven't been discussed too much here. One is the issue on foreign trade. We have two of our trading partners that are major trading partners for fresh as well as processed apples and pears and cherries that depend upon U.S. tolerances. They defer to them in cases where there is no codex tolerance or there is no tolerance in that country.
And I believe that if you go ahead and cancel Methyl Parathion, it would put that crop that has been treated in jeopardy. And so that's the number one issue for growers in the United States -- and packers in the United States. It would be a problem with this crop we have right now.
The second issue has to do with the concentrate issue which everybody has talked about. But I just wanted to tell you a little bit from my experience as a processor of apples. Basically apple juice concentrate is made and then it is used in blends to be put back into a single strength type juice as long as four years after it is made. And it's done because of the fact that they blend juices to get a uniform quality of color, acid, sweetness, aroma or whatever.
And because of that, you really would be looking at the possibility of having, you know, a treated juice from this crop end up in a bottle -- being put in the bottle two or three years from now and being on the shelf. And even though we've heard about the fact that there is a dissipation in nonfrozen, I don't think as concentrate it would dissipate, because it's kept refrigerated.
And single strength, I don't know if anybody has done any juice studies to show dissipation in apple juice. The registrant told me that they did not have those studies. If EPA has generated them independently, we would be willing to look at them.
But that's the kind of issue that we have here, where you have a product that is in the channels of trade that could be a problem, and we have international issues that will effect this crop. And we're really very concerned about both of those.
MR. AIDALA: A point of clarification on the first point, Wally. At least on the contracts or whatever it is, is it law of a trading partner or a policy? We've said in our contracts with those guys like it has a tolerance. What I'm getting at, is over time -- whatever appropriate time, if that's one thing to think about -- that those contracts could be changed to say meets all applicable U.S. standards or something like that that would be a benchmark.
MR. EWART: Right.
MR. JOHNSON: As opposed to a tolerance. I mean, does that help that problem?
MR. EWART: Right now it is a tolerance.
MR. AIDALA: Fair enough. But is it --
MR. EWART: A codex tolerance or a U.S. tolerance. And, you know, these countries trade with other countries who have tolerances or codex tolerances.
MR. AIDALA: Sure.
MR. EWART: And there is no provision for anything like a safe harbor being put into that. Is that possible, you know, that these countries would change their law, you know, to allow for that? We certainly don't have that at the present time.
MR. AIDALA: Well, codex MRL is not necessarily a particular individual country number, too. I mean, they can adopt them. What I'm getting at is whether it's like a law. Give me a name of a country that's one of the ones you're thinking about.
MR. EWART: Japan and Taiwan.
MR. AIDALA: Okay. That's close enough. Japan. Does Japan's law say that you must meet U.S. tolerances -- does Japan say you must have -- for example, is it a contract or a law with whoever in Japan that you trade with?
MR. EWART: I can't tell you whether it's law or regulation. But every year we have it affirmed through our embassy that Japan first of all looks to their standards.
MR. AIDALA: Sure.
MR. EWART: If they don't have a standard, they defer to the codex MRL. If there is no codex
MRL, then they defer to the U.S. standard for our product. Now I don't know what they do for other countries, if they have the same situation.
MR. AIDALA: No, fair enough.
MR. EWART: With Taiwan it's specifically with us. It's an agreement we just -- the U.S. government just concluded with Taiwan.
MR. EHRMANN: Okay. Dan?
MR. BOTTS: I would like to first of all thank Bob and his group for thinking about and looking at the issues and providing us with a document, at least to start as a token point to proceed.
But for the benefit of the group around this table, I would like to just illustrate one point that we did with Bob earlier this week relative to this issue. And it's not having to do with the actual tolerance process or how long the tolerances remain on the book. It has to do with how my growers or the people who buy their products would expect to be in the point of compliance. This acknowledges that there will be a guidance document that comes out later.
But let me just explain the process for fresh citrus juice production in the State of Florida. The packing house that we visit on our regular tour runs as many as 130 different truck loads -- semi truck loads -- of fruit a day through that processing facility. Those individual loads of fruit are segregated until the bricks and the acid content and the color are checked, at which point USDA certifies it to be able to be processed and go into the juice process.
That juice is commingled with all 130 other loads of oranges that come in that day. This particular facility has a little over -- somewhere in the high teens of stainless steel double wall tanks with a million gallon capacity to hold this juice.
My concern in this process right now is until we have some way of knowing how that processor can meet the requirements of meeting the two prong test that would allow the safe harbor to kick it -- because some of this juice could possibly be in that tank for two years. We've got a two year supply of grapefruit juice in Florida right now, because it's dirt cheap and nobody will buy it. There's no telling when that might be marketed or moved down the road.
I need to know, or be able to tell my growers, how they can meet the standard that is going to be asked of them by their processors and their vendors that will allow them to put their product in the trade to meet this safe harbor provision in those common time frames.
MR. EHRMANN: Bob, just to repeat what I think you said earlier in terms of kind of the process from here -- and to all the folks on this -- I mean you put out these ideas as ideas in process. You're soliciting people's thoughts and comments, which you're getting.
MR. LAKE: Right.
MR. EHRMANN: Give us a sense, again, of the kind of time line. I know we have some other comments. But just right now give us a sense of the time line.
MR. LAKE: We would like to put out guidance -- you know, published guidance for general public comment later this fall. So now is very definitely the time that anybody who has got any ideas, and including Dan Botts and his folks down there in Florida. I mean, I can see that that's a very difficult problem. Again, we would welcome ideas from them as well as others on how this -- you know, what is reasonable here in terms of how we implement this.
Let me also just make one other point to come back a little bit to the import problem and maybe even just some aspects of the domestic. But my idea -- you know, a thought that is in my head, but I didn't really express it clearly. Again, the kind of a notion we have is that we would not do special monitoring until some period of time elapses that allows us to make the judgment that we think the channels of trade are clear based on data and input from others.
I think, though, after that for situations where EPA has found it necessary to actually ban a pesticide for public health reasons, that what we would then do is institute, as we have in the past, a special monitoring program to look at the particular pesticide and the commodities where it previously was expected to be found but is no longer lawful. And in that situation, the monitoring right still might not be super high, but it would be higher than the very low level of monitoring that we normally do as part of our routine monitoring.
And so we would want to be clear that everyone understands that, that at some point with Methyl Parathion we will take some special looks at foods that in the future are no longer suppose to have Methyl Parathion, both domestic and import, to be sure that in fact people are not being unfair with the system.
So I just wanted to be clear about that.
MR. EHRMANN: Okay. Steve and then Jon.
MR. PAVICH: Yeah. Bob, this is a led on, but unregistered compounds on foreign produce, where are we going with that one?
MR. LAKE: Again, as the enforcement agency, really what we enforce is Section -- well, you know, it's all parts of the Food, Drug and Cosmetic Act, which includes 408 which relates to tolerances. We really have no enforcement authority over registration. And we also as a government have no authority on what pesticides or other chemicals are used in other countries.
The issue for us becomes one of is the residue on that food lawful when it comes to the U.S. border. And if we can find a residue of a pesticide for which there is no U.S. tolerance, then we take action against it. We also take action against pesticides for which there is a tolerance if it is not on the right commodity. In fact, it's a very common situation that we encounter in our enforcement that the pesticide is one we know a lot about and the level may be well within U.S. tolerances for other commodities, but there is no EPA tolerance for the commodity that we're looking at. And we treat that as a violation and simply don't let it in.
So our focus is -- and we do this by, you know, collecting samples and taking them back to our labs to analyze. And the issue for us is, is there a tolerance for anything we find. If we find something, the first question we do is look in the books and see is there a tolerance for that food. If the answer is no, then we don't let the food in. If the answer is yes there is a tolerance but it's being exceeded, then we don't let the residue in.
But it's actually not very often that we see a high residue. What's more common is that the residue simply has no U.S. tolerance. That's the most common violation we find on imports.
MR. EHRMANN: Okay. John? Pull the mike up, John, a little bit. Pull the mike towards you.
MR. JESSEN: I just have a couple of things that hurt me more than my back did while I was listening here today, and I want to make sure that I have a chance to say them before -- I don't see where tomorrow -- they're not germane to tolerances or channels of trade. And if there is time to talk tomorrow, I can do it then. It won't take long. But I can do it in a more appropriate time if you prefer.
MR. EHRMANN: Well, I think we've taken all the comments on this topic, so why don't you go ahead. Oh -- and then I'll --
MR. LAKE: Could I just --
MR. EHRMANN: Yeah.
MR. LAKE: Mr. Rominger has pointed out a typo and we want to be sure we correct it, and it's in the fourth line from the bottom.
MR. EHRMANN: A small detail.
MR. LAKE: Yeah, right. Which says tolerance revocation June of 1999. Let's change that to June of 2000. Sorry for that mistake, and thank you for bringing that to our attention here.
MR. AIDALA: EPA noticed it, too, but we were trying to be polite.
MR. EHRMANN: And once again, if you have -- before I turn it to John for a minute, if you have comments or thoughts as you get a chance to look at the paper that Bob distributed, please get those comments to him, you know, during this meeting or soon, because it sounds like they're moving towards wanting to get their guidance out in a more formal form in the next short period of time here. And then, of course, there would be a chance to comment on that more formally. But just to keep this process moving. It's obviously an important issue.
Jon, why don't you go ahead and raise your points, and then we'll take the public comment.
MR. JESSEN: Okay. Well, I'm moving back a ways in the afternoon.
MR. EHRMANN: That's all right.
MR. JESSEN: There are a couple of objectives or concepts that came into the discussion today. And one suggested that why don't we eliminate all OPs. And I didn't know if that's an objective of the EPA and had it been discussed publicly. I thought we were -- I thought we were rationalizing the ones that were available. And the discussion I heard about here was getting ready for transition. We don't have any more.
Can you tell me what is going on here?
MALE SPEAKER: It's an EPA thing. Go ahead, Steve.
MR. JOHNSON: I accept full blame for that. I was the one that suggested that preparation to that would be a wise thing, Jon, as a grower.
MR. PITTS: Jon, if you take a look at the Southeastern Apple transition strategy, one of the assumptions we used in that discussion, just to direct the discussion, was let's assume that OPs are going to be gone. And if that's the case, how are USDA and Southeastern Apples going to respond. That kind of scenario.
MR. JESSEN: Okay. I just didn't want this moved from a possibility to an assumption without full public discussion of it.
MR. PITTS: No. All it was was a tool to kind of put some structure around a discussion on transition.
MR. JESSEN: And the other thing I got, and that might have come from Steve, too. Maybe it didn't. But there was a lot of talk about the goal was no detected residues. Now I thought that that's what tolerances were about. And if we're going to scrap the tolerance system, is that -- did you hear this about no detected residues kicked around here?
MR. AIDALA: Well, two things. First of all, Jon, just on the first part. For the record, too, what we've said, and the co-chairs have said it, and whoever they may be over the months on all fronts, the goal is to meet the standard. That may or may not mean elimination of any products -- any or all. But that's just for the record, number one.
Number two, the no detect -- I mean, we would still have a tolerance, to say that the enforcement level would be at the detectible level. I think, Keith, this is again something that you all have put forth in the past, at least as a working goal. And I don't know if you want to articulate that a little more.
MR. PITTS: Again, that's just part of how we're trying to engage growers on discussions about transition. Where do you want to be three years from now, one year from now or five years from now. And certainly one of the goals that we have put out in the risk avoidance and mitigation program is if a commodity group wanted to come in with a proposal and try to achieve no detect low key residues, that's something that we would try and help them work towards.
MR. JESSEN: Okay. The concept that I would like to lay on you here is that you've got a system of control. And when you push almost any system to its limits, you start to get abuses and you don't get an optimal solution to the thing. Whether you push communism or anarchy, or you push a high police power to lawlessness, you know, you can look at those things.
And I say that when you get -- that rather than try to say they are OPs -- there are a lot of differences in OPs. Some of them are much safer than many of the non-OP products. And to just say that the OPs go, they don't look good in the system, is pushing it. I think you're pushing it to absurdity and there is going to be -- and that society is going to pay quite a price, I think, in diet and public health and things like that. If you set a goal that just because the group of people that walked out of this room a few months ago decided that that was a goal to get rid of this group of compounds, I'd say that society can be the loser in that deal. You're pushing the system to absurdity. And when you get there, something is going to -- you know, somebody is going to pay for that.
And that's the point I wanted to make. And be sure that if you do decide to eliminate the OPs, and you do decide to go to a no detection system, that, you know, I get involved in the public discussion of that.
MR. PITTS: Yeah. Absolutely. And, again, these are not regulatory tools. These are trying to start having discussions with growers about where do you want to be five years from now.
MR. JESSEN: Okay.
MR. PITTS: And I imagine you wouldn't be alone in wanting to be part of that discussion.
MR. JESSEN: I read in another context recently that Wilbur Wright said in 1901 that if perfect safety is your objective, you best sit on the fence and watch the birds.
MR. PITTS: That's probably not so safe, either.
MALE SPEAKER: That's before CPSC started regulating the fences.
MR. JESSEN: Pushing it to absurdity, you get nowhere. I mean, I would have walked back to this meeting if Wilbur's critics had had their way.
MR. EHRMANN: Okay. A couple of more things I want to do before we wrap up for today. First, just to take a look at the agenda. Tomorrow we will start at 9 o'clock tomorrow morning. We're going to have a discussion on the public participation process, the pilot process. There are a number of sub-issues outlined there. Again, I think we hit on a number of issues today as we talked about both the current state of affairs that relates to the OPs as well as the transition issues, that we'll kind of come back to in the context of the recommendations that are going to made about possible modifications to this process.
And we'll take -- we have about two hours for that discussion. Then we'll have a discussion on post-TRAC activities. And, again, I would invite you to come with your specific thoughts about that, either substantive issues that you think need more attention, or process suggestions for how you would want the agency and the department to think about post-TRAC activities.
We want that to be an open discussion, so they can collect your thinking and then make some decisions as they go forward in terms of what will happen next. And then we'll have another public comment period before we adjourn at 1 o'clock tomorrow.
Nancy, a comment?
MS. RACHMAN: John, in moving things around on the agenda today, we did not have an opportunity to talk about two of the handouts. One is the data call-in for the neurotox studies. We kind of glossed over that, and I think there are some points that some people may want to make. And the same thing for the PR notice for worker protection.
So if we could just spend five minutes tomorrow morning?
MR. EHRMANN: In the morning, let's do that. Yeah. A good suggestion. If you have any thoughts, we'll put that in that first hour and a half.
Okay. We have one public commentor. That is at least one who is registered. Adam Sharp?
MR. SPENCER: Farm Bureau.
MR. EHRMANN: Farm Bureau?
MR. SPENCER: Farm Bureau.
MR. EHRMANN: Thank you.
MR. SHARP: My comments are real brief, actually just focusing on the earlier discussion surrounding the drinking water science policy papers. My name is Adam Sharp from the American Farm Bureau Federation. I just wanted to get it on the record that we believe it is very important to preserve the opportunity for public comment on the issues regarding the drinking water science policy papers, numbers 18 and 19.
While very important, the SAP meeting is not sufficient opportunity for public comment. There are still public policy elements in those two papers. The scientific technical feedback offered by the public at the SAP, together with the panel's response to the agency, do not necessarily address all policy concerns. Those two policy papers are specifically number 18, the Drinking Water Screening Level Assessment, and number 19, the SOP for Drinking Water Assessments, including the reservoir model.
MR. EHRMANN: Thank you. Any other public comment at this juncture? Any final thoughts from the co-chairs?
MR. GUZY: We look forward to tomorrow. It's an important discussion. And we thank you all for being here.
MR. ROMINGER: It was a good day. We're looking forward to tomorrow. We've got some more important things to talk about.
MR. EHRMANN: Okay. We'll see everybody at 9 o'clock tomorrow morning. Thanks.
(END OF TAPE FIVE, SIDE ONE.)
(Whereupon, the meeting was adjourned.)
- - - - -
OCTOBER 21, 1998
MR. EHRMANN: All right. If everybody could take their seats, we'll get started with our agenda for the day. A couple of items that we want to pick up
that we did not have an opportunity for discussion yesterday, as Nancy suggested at the end of the day yesterday, on the data call-in and PR notice on worker protection.
So Lois is going to -- where is Lois? Lois is going to say a few -- make a few brief comments about those two pieces and we'll entertain any comments or questions at the outset on those. And then we'll get into the update on the OP pilot process and public participation. And Lois will make that presentation. And then we'll have discussion on that issue. We'll take a break about 10:45 to 10:50, and then come back and talk about potential post-TRAC activities, as indicated on the agenda.
Once again for the members of the public, if you wish to make public comments today, please sign up outside so we'll know how many folks wish to make a comment and can apportion the time appropriately. And then we will adjourn the overall meeting no later than 1 o'clock as indicated on the agenda.
Before we turn to Lois on those couple of items that I mentioned, any other comments or questions from any committee members that we should raise at this point? I would like to welcome Larry Elworth. Better late than never, Larry, in some people's opinion, anyway.
MALE SPEAKER: Let's take a vote on that.
MR. ELWORTH: The meeting can start now.
MR. EHRMANN: Yes. Lois, do you want to touch on those couple of topics?
MS. ROSSI: Sure. The two topics are the data call-in calling in neurotoxicity information, and the worker PR notice. Both of these were announced on August 2nd.
First with regard to the data call-in, basically EPA is requiring registrants of pesticides thought to have neurotoxic effects to conduct acute, sub-chronic and developmental neurotoxicity studies. The program to call in the data will apply to approximately 140 pesticides and will be completed in phases over the next several months.
On September 10, 1999, we issued the first phase of the data call-in notices. And there is a fact sheet in your packet -- it's two sided -- that gives this information. We issued the data call-in notices to all the registrants that had registrations for organophosphate pesticides. And there are -- they're required to respond to that notice within 90 days, as usual for all data call-in notices, indicating how they intend to respond to data requirements.
These were sent to all registrants, by the way. They weren't just sent to the base manufacturers. They were also sent to formulators who would most likely apply for formulator's exemption.
The classes that we are -- the additional classes are on the second page of the -- or the back of the handout. It lists the classes in pretty much the order that we're going to issue these in.
Are there any questions on data call-in?
MR. EHRMANN: Nancy?
MS. RACHMAN: Yeah. About how many compounds are subject to the call-in for the development on neurotoxicity studies?
MS. ROSSI: One hundred and forty compounds are subject to this battery.
MS. RACHMAN: Okay. Do you know how many laboratories are currently capable of performing that study?
MS. ROSSI: I have heard that there aren't that many. But I know -- Marcia, I think Penny did a -- is Marcia there?
MS. MULKEY: Yes.
MS. ROSSI: I think Penny Fenner-Crisp, who worked on this with us, did some investigation into that.
MS. MULKEY: We did look into the laboratory capacity issue. That's one reason why we're doing these things in stages. It's also been our experience in the past that laboratory capacity tends to grow to accommodate demands. It's happened in a lot of programs where there has been testing. Obviously to the extent that that's a limiting factor, people will be able to identify it and work it through with us.
MR. RACHMAN: Okay.
MS. MULKEY: But we believe there may be some laboratory capacity issues as we work through these.
MS. RACHMAN: Okay. The other question, which is related. This is a relatively new kind of study, as I understand it, and in any studies with behavioral measurements you have the potential for inter-laboratory variability which is not associated with strain of animal use or anything else like that.
People are trying to figure out efficiencies, also, by combining the requirements of this new study with the existing developmental studies. And I understand that there are some issues of protocol that are quite serious that need to be worked out there.
What -- you know, does the agency have some consultation process in place so that the study can be designed and we have good consistency and the scientific questions are answered before people begin to do these studies?
MS. MULKEY: Margaret can speak to that.
MS. STASIKOWSKI: Okay. We actually have a work group that is working right now to prepare for this kind of a consultation process, so that when you come and you talk to us about protocols, we can talk about these things. We also are talking about electronic submission of the information and about fine tuning some of the protocol items.
So we are getting ready for that.
MS. RACHMAN: Okay. Margaret, one of the concerns -- I don't want to get too technical on people here, so I'll try and hold myself back. Whenever a new study is done, people are worried about historical controls. The availability of a large group of control animals that people can look at so that they can make sense of the results that they're getting in the dosed animals.
That is a real concern here, because a lot of these studies are being called in all at once, and there isn't going to be the time to develop that historical control experience.
Is that part of the work group's charge to sort through that as well?
MS. STASIKOWSKI: Yes.
MS. RACHMAN: Okay, great.
MR. EHRMANN: Okay. Any other comments on that one? Okay. Lois?
MS. ROSSI: Okay. This second item that was also announced on October 2nd was a fact sheet describing -- well, the work group PR notice was issued, and you have the fact sheet, again, in your packet.
This is out for comment, also. It represents an approach that we have been talking actually about for years about leveling the playing field and putting across the board measures in place on classes of compounds such as the organophosphates.
What this does is it encourages and requires, as we're going through the risk assessments for the organophosphates, that we would request closed systems and enclosed cabs. We asked voluntarily that registrants come forward and do that to the extent that it is required by the risk assessments, and have that in place by the end of the year 2000.
In the fact sheet, there actually is a description in bullets of EPA's approach in reviewing each OP pesticide and making decisions to manage the worker risks. And it talks about the steps that EPA will be following that's presented as guidance in this PR notice. And I think that it's a fairly factual description of the thinking that's being used as we're going through the worker risk assessments.
MR. EHRMANN: Okay. Any questions on that? All right. Let's turn then to the public participation process discussion.
MS. ROSSI: Okay. As you all are aware, EPA and USDA have been using the pilot public participation process for tolerance reassessment and the re-registration of organophosphates. That was developed based on discussions during the TRAC last summer. We reported back on the results and the statistics as to where we were with the OPs yesterday. And this discussion today will focus on the process.
The major goal of the pilot process was to increase transparency of EPA's regulatory processes and to enhance our consultation with effected stakeholders by expanding the public's access to EPA's risk assessment and risk management processes.
As I reported yesterday, the pilot process has been underway for more than one year now, and it is time for us to consider whether this process or some modification of it should be adopted as a process. In other words, let's see if we can't take the pilot out of the pilot process.
We should also discuss whether the process should be used beyond the tolerance reassessment for organophosphates and applied to other pesticides subject to re-registration and tolerance reassessment.
And at the end of this presentation, I will briefly talk about the activity that went on at the end of this fiscal year on some non-OPs that were not following the pilot process, since the pilot process was pertaining to the OPs.
In using the pilot process for a year, we have all had the opportunity to identify issues associated with the public release of risk assessments and risk management documents, and evaluate how best to obtain public input into the risk assessments and a risk management development process. I know we all have thoughts, experiences and opinions on how the process has been working, the strengths and successes of the process, as well as the shortcomings and areas that could stand improvement.
Our goal for this session is to really get your feedback on what your experiences were with the pilot process, and for us to share our experiences, both from EPA's and USDA's point of view, with you. And most importantly -- and I emphasize that -- to get input on a process that will serve the interest of the stakeholders and allow the agency to carry out its mandate.
What we would like to do this morning is give you all an overview of how EPA and USDA believe the pilot process has been working, and then discuss some modifications to the process that are intended to enhance the effectiveness and efficiency of the process and produce better work products the first time around, and utilize everybody's time and input and expertise in a more productive way.
We've had a lot of participation in this process over the last year from all stakeholders, and we found that the input and the expertise was phenomenal and we've been able to take advantage of that on many of our decisions.
The goal here is to have an efficient process that allows all stakeholders to participate in a process that they know and understand and know how they can play. The goal is not just less time.
Currently there are six phases. And I've got an overhead just to remind us of what we're talking about in the pilot process right now. We don't have that? We don't have those six phases. Okay. Cool.
MS. ROSSI: It's in your packet. Okay. Phase one was the registrant error only review stage for 30 days. EPA sends its preliminary risk assessments to the registrant for 30 days for error only identification. And also at that time we send it to USDA.
Phase two: EPA considers the registrant's comments up to 30 days. Phase three: begin a public comment period on the preliminary risk assessment for 60 days. We publish a notice in the Federal Register of availability releasing a preliminary risk assessment and related documents for a 60 day public comment period.
Phase four was, again, EPA's phase, where we revised the risk assessments up to 90 days. We considered stakeholder comments received during the phase three public comment period, developed a revised risk assessment, and sent it to USDA for review. That was a modification that we made some time last -- or early spring and we announced it, I think, at the last TRAC meeting in April.
We also announced that EPA and USDA felt the need to have technical briefings to share the revised risk assessments with the public to increase the transparency and to assure that people had an understanding of the risk assessment to be able to play more fully and effectively in the risk management.
Phase five was when EPA solicited risk management ideas for 60 days on the refined -- based on the results of the refined risk assessment. We again published a notice of availability releasing the revised risk assessment to the public and opened a 60 day public participation period, during which the public was encouraged to submit risk management ideas. Again, phase five was typically kicked off with a technical briefing for many of the chemicals that we talked about yesterday.
And the last phase was the EPA risk management strategy phase, which also was designed up to 60 days. And that's like up to 60 days. EPA considers all risk management proposals received, and with input from USDA we would develop risk management strategies.
So those were the six processes. And yesterday I gave you where we were with the 31 chemicals -- or the 35 chemicals that are currently somewhere in this process.
Some of our experiences, first from a point of view of looking at what was actually received and submitted. We did some analyses. For phases one and two, 31 OPs have completed the registrant only comment period. The majority of the comments received from registrants during their error identification period were non-error comments that did not impact the release of the preliminary risk assessment.
With regard to error correction, for five OPs there was a change in the preliminary risk assessments. Overall 11 OPs had received mostly error comments from registrants, and approximately half of those comments identified mathematical errors, and some even identified grammatical and spelling errors.
With regard to non-error comments, they were received from registrants for about 20 OPs. There are some OPs -- I don't have the exact number -- where we did not receive any comments, and some of these were where the preliminary risk assessments were so old. One that comes to mind was done in 1994, and there had been so much interaction between the agency and the registrant since 1994 and 1998 that the registrant didn't even bother to comment.
The non-error comments were received from registrants for 20 OPs. Overall the large majority of the non-error comments received were general objections to the risk assessments, followed by commitments to submit new studies. And that's an important point, because I think the one thing that we did find that affected the results of the risk assessment were the submissions of new studies and not so much just comment on the risk assessment.
With regard to phase three, the public comment period on the preliminary risk assessment, 27 Ops have completed the public comment period on the preliminary risk assessment. From non-registrants comments of a general nature in support of, or in opposition to, the chemical were received for 18 OPs, and nine OPs received submissions of usage information, studies or other technical information. Registrants submitted mostly general comments on the risk assessment. But, again, for about five we received new studies and studies to confirm or upgrade existing submitted studies.
Getting submissions of use and usage data and new studies results in rework. And it would be better to get this information early in the process as possible and start out with the assessment with the correct information and the most recent information.
With regard to phase five, the release of the revised risk assessments and public participation on risk management, risk management comments and ideas were usually received by EPA via meetings and conferences calls rather than through written submissions. That's what we found.
I'm only on page four, and there is a card up already. Okay.
MS. ROSSI: Some lessons learned. Some of the guiding principles to modifying the process from our viewpoint, and again what we are here today to do, is get your viewpoint and suggestions on modifying the process.
First of all, the earlier the involvement and receipt of information, the better quality of the risk assessment. It's less rework for us. It saves resources on everybody's part. It's not just agency resources. It's the department's resources. But more importantly, it's your resources, the people who are commenting.
Less misunderstanding and confusion concerning the results of the risk assessment. And this is not to be under estimated. I'm sure everybody at this table, and maybe even everybody in this room, if they kept track of the time spent tracking down truth to rumors that we've heard about risk assessments, I'm sure it would be a substantial amount of time that is impacting everybody's productivity.
So, again, the earlier the involvement and the better the risk assessment is -- the first risk assessment is and the quality of the information, we believe it would be a substantial improvement in the efficiency, productivity and quality of these risk assessments, and in the overall regulation of this class of chemicals as well as other classes of chemicals.
We have also heard -- and Al can elaborate more on this -- that it is helpful to have stakeholders engaged as early as possible in risk management strategies, ideas and measures, and time is needed often to get information in support of these measures.
We found in some of the risk management decisions that we've done over the last few months that when there is an idea that was put on the table and you want to get information from stakeholders, stakeholders need to make some phone calls. And they need to get some information pulled together to substantiate whether the measure is feasible, practical or whether it is something that will work or not.
We have heard that more time is needed for the review of risk assessments and risk management options that the agency is talking about. And we have also heard that people would like to know as early as possible about risk management ideas that the agency is thinking about.
Now that many -- a second general lesson learned. Many of the tools that are developed that were needed to refine the risk assessments have been developed. There is little value to producing a preliminary, unrefined risk assessment based on 100 percent crop treated and tolerance levels.
We would go right to the refined risk assessment. Now that we have Monte Carlo capability, we are utilizing PDP and we have the decompositing method -- this is preliminarily for dietary -- we would go right to a refined risk assessment if the tier one, tier two showed a problem.
In fact, we've heard from some stakeholders that they viewed it a waste of time. And maybe perhaps Wally can comment on this when it comes to the time for comments, that it's a waste of time to spend too much time on reviewing and commenting on a preliminary risk assessment that everybody knows will change.
We put out all those preliminary risk assessments on the web and, you know, there wasn't a whole lot of reaction from a whole lot of people on those, because, I think, people realized that they were showing in some cases 10,000 percent exceedences, and that they would definitely be refined once the methodology was put in place and we agreed on how to refine them.
A third lesson. We realized the need to have a process that people know, and that they know how they can play effectively in the process and what information is useful to the agency. And there again I say that -- I say that again. What information is useful to the agency. That's another question that we have heard a lot over the last year. Hopefully we've made some impact on that. I still think we have a way to go, because I think there is still a link between the information that people have and how the agency is using it that hasn't necessarily been connected.
They need some degree of predictability of the process and the schedule of chemicals that is needed both internally and externally. All stakeholders want a schedule. They want to know what chemicals are coming up in the queue, and they want to know the predictability of the process.
We found this particularly true when the confusion resulted at the end of this fiscal year when we were doing REDs in our re-registration program on chemicals that were not organophosphates. The pilot was for organophosphates, and even though the bulk of our time this year has been spent on the OPs, we do have other chemicals in re-registration that we're making decisions on and that we're spending resources to review. So one of the questions is, should this process apply to all chemicals in re-registration, for those that are subject to tolerance reassessment and re-registration.
The fourth one. We learned that a common understanding of the risk assessment was needed before stakeholders were willing to participate in risk management. We needed to have some understanding of where the agency was coming from, that it was based on some assumptions that were realistic, or real data, or various other things.
We needed to work hard at making these risk assessments transparent. We worked on developing charts and summary documents with USDA and the technical briefings. And we'll continue to do this. We'll continue to develop documents besides the somewhat often 200 page risk assessment to make these clear so that people understand what goes into them.
I think we've come a long way in making the dietary risk assessment transparent. And in the last few months, and you heard yesterday from Margaret, the effort that we did in Baton Rouge to help make the worker risk assessments more transparent. And I think we will continue to work on water and what the assumptions are based on the water assessments, as well as the ecological effects.
Of course, those are all re-registration assessments done under the re-registration program. Our attention for the last year has been on the FQPA and dietary risk assessments, which I think have come quite a way towards making them transparent with regard to what data is being used and with regard to if we're using PDP data.
We have a table that we put out at the end of our overview that shows if we've used pear data for apples, or if we've used peach data for nectarines, it says it. It says the samples. It says the level of detection if we've used half a level of detection. If we've had no monitoring data and we had to use field trials, it says that we've used field trials and what the data were and the percent crop treated, which often is -- percent crop treated is probably the most common input that we get from information from growers and how it's being used.
We've also learned that broad stakeholder involvement has resulted in sounder risk management decisions and more creative decisions aimed at risk reduction. And I think we can -- we feel comfortable in saying that the discussions we've had with all stakeholders have certainly helped in making our decisions credible and workable.
Options for a modified process. I'm going to sketch out a modified pilot process -- or how we modified the pilot process, I should say, in concept. And Al and I have been working on this, and we both agree that there are a lot of details and process points that have to be worked out. But today we're coming to you with a concept. We're coming to you with a proposal for your input and for your discussion to help us incorporate what the lessons we've learned are, as well as the experiences that you've all had.
The modified process contains many of the same elements of the pilot process and enhances public participation at important stages. I'll point out similarities and improvements as I go along. This is in your staff paper number 42 in your packet. It describes the proposed modification, and the summary is in attachment B.
Again one of the major lessons we've learned from the pilot process is that we really need to actively engage stakeholders very early on in the process. What is described in pre-phase one is just that type of active engagement.
Pre-phase one, public engagement. A significant focus of the modified process is to engage stakeholders as early as possible to ensure that the risk assessments reflect actual use and usage, available data, current labelling and other information on use practices that stakeholders, and sometimes only some stakeholders can provide.
We would like to work with USDA and other government agencies, like DHHS and FDA, in the months prior to the formal initiation of phase one to organize what we've called smart meetings. And I realize that there may be people who don't know the origin of smart meetings. But we had an idea a long time ago, as far back as August of 1996, that in order to accomplish tolerance reassessments in this program under the time frames that we had, we had to start working smarter. And hence we coined the term smart meetings, which has taken on the acronym, caught on right away, and everybody has called them smart meetings ever since.
And what they essentially were were where the registrant would come in and meet with the agency once we figured out what was in the re-registration queue, and would present -- do a presentation on how the chemical was being used. And also let the agency know about data that was under development that would affect the risk assessment.
And these meetings have been done for a couple of years now, at least, and maybe even three years, I guess. And even this year we've had some -- we've had about ten smart meetings during the course of this year on chemicals that will be done in 2000 and even in 2001.
These meetings could start -- they have to start at least three to six months or more before any risk assessments are done, but even the earlier the better. And, again, if we embrace this as a phase and an activity in this process, I think the chemicals that we would be doing in the year 2001 would be the first ones that probably could take full advantage of this.
The smart meetings could include other stakeholders, as well as the registrant, and would be our opportunity to really set the stage correctly for the development of the risk assessments and encourage stakeholders to share their information with us. And at the same time, it would start the interaction with USDA, or as the case may be, with HHS.
We really want to use the months prior to the release of risk assessments to clarify use, usage, labels, data that we are using in our risk assessments, and data and information that stakeholders could submit to us. Again, these smart meetings would be an interagency cooperative effort.
Another lesson that we learned is that stakeholders need to have more current information about the schedules for pesticides in the public participation process. EPA would name pesticides that will start the process well in advance of the initiation of the process. We have done this in the past in the re-registration. We put a Federal Register notice out in the beginning of the fiscal year saying -- listing the candidates that would be candidates for re-registration review during that year.
We also really need registrants and other stakeholders to identify any ongoing studies. We have made a thoroughly ambitious attempt, and my colleagues in the Health Effects Division, who scream at me every day about this, will testify that we have tried as best we could to incorporate new studies as they come in the door. And I think there are even some registrants at this table who can say that we have incorporated studies at a very late hour into the refined risk assessment. We have been able to do that, and they have had an impact.
However, it would be nice to know that these studies are coming in, and when these studies are coming in, so that the registrants don't -- not the registrants. So that the risk assessors don't finish their chapter, only to have to go back then and review it again -- review a study and revise the risk assessment.
So we would like to have warning on these ongoing studies and when they're coming in. In this way, we will also be able to prepare for the initiation of the process, and stakeholders will be able to prepare for the process and will know when data information is needed if it is to be considered by the agencies.
EPA will announce for each pesticide the due dates for the submission of data and information.
Now onto the start of what a public participation process could be. Phase one would be the same, risk assessment registrant error only review. However, there would be a couple of additional activities going on with a chemical profile and interagency engagement. This would be 30 days. Phase one of the modified public participation process would be the same, in that the risk assessments would be sent to the pesticide registrants for a 30 day error correction period.
Registrants would be asked to identify and correct any computational or other errors that EPA has made in developing its assessment of the pesticide risks. We would also ask them again about due dates for submission of data that may substantially impact the risk assessment and information to EPA, and for an indication of how the study or analysis may change the assessment.
One process modification we are proposing is to formally release basic chemical information to the public at this stage. EPA recognizes that the public would find useful for their planning purposes a description of the pesticide that has started the public participation process. The agency would publish an FR notice announcing the availability of the chemical's profile to OPP's public docket and Internet web side.
The profile would be a document that would characterize the use and usage information and types of data and information used in the assessment, such as whether we used PDP, what we used, whether we used the Monte Carlo, and what we used to estimate water risk, for example. Just for example.
At the same time the risk assessments are sent to registrants, we're going to transmit to USDA, FDA and HHS, as the case may be, the risk assessments and overview and profile for interagency review and comment. And that would be phase one. So it's the same as the pilot, except it does have that added information getting out to stakeholders, again, early in the process to emphasize the early involvement.
Phase two, the agency considers registrant error comments up to 45 days. Again, this would be a similar phase, but there are some additions that we feel based on our experience would help the process. In phase two EPA summarizes and considers the errors that have been identified by the registrant, and works to make the changes in the risk assessments to correct any errors that are identified as appropriate.
Error correction in phase two is the same as in the pilot process, but we're proposing to jump start stakeholder involvement before the end of the phase and the beginning of phase three's formal public comment period.
Now we have two weeks in here, just as a place holder. But approximately two weeks before the close of phase two, EPA would send to USDA the revised risk assessment overview, and USDA would organize conference calls, as a suggestion, with stakeholders -- growers, registrants and public interest groups -- to review and discuss the overview. This could be one conference call. It could be several conference calls.
EPA will then work with USDA to address the comments and ideas received during the stakeholder conference calls. And Al will elaborate a little bit more on this as this modification plays into his current process that he's using with the land grant universities. EPA will also address risk assessment comments received from FDA and HHS and USDA. By the end of this phase, the risk assessments are prepared for release to EPA's public docket for the pesticide.
We believe that by adding these conference calls -- and, again, this was an experience that we had for the non-OPs at the end of the year where we did have many stakeholders -- and Bill Spencer referenced his experience on Carzol yesterday, and maybe he can comment during the discussion on this about that part of the process. We initiated mostly our minor use team with USDA and coordinated a series of conference calls on these non-OPs that we were issuing REDs on, and it proved to be a fairly successful activity.
I see a few shaking heads -- in a positive direction.
MS. ROSSI: Okay. And we could alert stakeholders on the upcoming release of the risk assessments with these conference calls to the docket, as well as expedite USDA's review, increase the efficiency of this review, and take advantage of the USDA land grant experience on the issues that we really need their input on, rather than having them slug through these enormous risk assessments.
Phase three would be the public participation period, where the technical briefing, public comment on the risk assessment, as well as risk management options, would be up to 90 days -- or it would be 90 days.
Now let me explain a few of the aspects of this and why we thought that it was an idea worth putting down in this piece of paper. Phase three is the public comment period, just as in the public pilot process. EPA would publish in the Federal Register a notice of availability, announcing the release of the risk assessment and related documents, like the overview, the summary, registrant error comments, agency's response to comments, etc., to the public docket and our web site.
The changes we are proposing include the release of risk management options for the same 90 day comment period and the holding of a technical briefing at this point in time. So, again, we envision that for chemicals with lots of uses, we would hold a technical briefing. For, again, ones that had limited uses, we would make the offer to have a stakeholder meeting.
The same FR notice used to announce the release of the risk assessments would also announce the availability of options for risk management, and, again, we would have the technical briefing and the stakeholder meeting. The technical briefing or a stakeholder meeting would be held at the beginning of phase three in order to share with the public the revised risk assessments and the range of possible risk management options. As in the pilot process, stakeholder meetings are often more appropriate for some chemicals if they are limited in use and usage, have lower risk concerns and have a small number of stakeholders or other factors.
For your consideration, the concept of the risk management option discussion could be a lot of things. And I ask you to think about this. It doesn't necessarily imply that this is the agency's decision -- that it's the risk assessment, the agency's decision and it's out for comment. It could be a range of possible ideas. And, again, I ask for input from a lot of the stakeholders on whether this would be helpful. Because we have heard that people really don't get engaged until they see the risk management idea that the agency is considering. And not only have we heard it, but that's been our experience.
Drivers could be identified to direct stakeholders to areas to consider for risk management. The discussion could be of a broad, qualitative nature, such as application rates could be adjusted, PHIs could be adjusted, or we could actually give some specific ideas, particularly when they're obvious and have been suggested by a number of stakeholders. This is a point that we really need to hear feedback on this morning.
In addition, an interagency effort would be initiated to engage stakeholders, much like we're doing now in phase five, in a dialogue on risk assessments and risk management options. This means that we would have meetings and conference calls would be organized to get stakeholders' thoughts and ideas about risk management and risk assessments. The dialogue would be expected to continue into the fourth phase of the public participation process.
And the fourth phase would be to develop final risk assessment and risk management decisions. And this could range from 30 to 90 days. In the fourth and last phase, EPA would review and consider the comments, data and risk management ideas, and proposals received during phase three's public comment period and during the stakeholder dialogue, conference calls, meetings and interactions. Again, I want to emphasize that the dialogue with stakeholders would continue through this phase, as well as being initiated in phase three.
EPA will develop the revised risk assessments, and with input from other agencies -- the USDA and HHS -- we would develop risk management documents.
We also injected in here -- although we would do this anyway, but maybe people don't realize --
that we would have an interagency senior management briefing. Sometimes it's not always interagency. It's usually each agency has their own meeting. But we're proposing to have an interagency senior management briefing to discuss revised risk assessments and risk management ideas. And, again, depending upon the type of decision -- the type of risk we're dealing with, those could be bigger or smaller meetings, or formal or less formal. And this would allow USDA's management to be informed of the risk management decisions.
At the close of phase four, EPA would release to the public the revised risk assessments and issue risk management decisions for the pesticide. And this could be in the form of a tolerance reassessment decision if you didn't have cumulative risks to deal with. If you did have cumulative risks to deal with, as we do with the OPs, it could be an interim RED, like I announced yesterday we were doing on Profenofos and Bensulide.
The modifications we're proposing in the pilot process draw on experiences that USDA and EPA have had over the last year. We went to beef up the public involvement with a pre-phase one before the start of the process in order to ensure that the risk assessments are using the right and most complete set of information. Stakeholders will also be much more informed because they will know the schedules of the chemicals we're working on, and will know when EPA and USDA need that information so that it can play and be utilized in the most effect way possible in the assessment.
And phase two would give the public advanced information about the chemicals through a series of conference calls set up by USDA. Conference calls could happen about two weeks ahead of the release of the risk assessment to the public docket.
Phase three would start off with the release of the risk assessment and some risk management ideas for public comment. The technical briefing or stakeholder meeting would engage the public in a discussion of the risk assessment and begin the discussion of risk management.
The modifications to the process do eliminate a public comment period on a preliminary risk assessment, because the assessments that are now under development -- and I think we even reported this at the April TRAC meeting -- are much more refined at this stage than other chemicals were at this stage in the past. But we want to be very clear that the goal here is not cutting time, but, again, increasing the efficiency of the process, so that the process serves all and accomplishes our mandate.
One of our lessons is that we must continue to encourage organized stakeholder communications. So we're planning for the interagency effort to continue throughout phases three and four. We anticipate a series of meetings and conference calls throughout these phases.
All in all we believe that some of these suggestions I've just gone through, or some modification, incorporate some of the lessons we've learned in the time that would enhance the efficiency and public participation of the pesticide tolerance reassessment and re-registration effort. The agency and the department remain open minded on these modifications.
And I'm going to ask Al for his comments at this point, and then we will open the conversation --
(END OF TAPE ONE, SIDE ONE.)
MR. JENNINGS: I think as usual we've let EPA carry the majority of the work on this subject. But I do want to claim partial credit for the idea of initially revising this process and opening it up. One of my jobs is to improve relationships of the department with the land grant universities. And they assured me if we changed the process, it would improve relations.
MR. JENNINGS: So that comes from basically the difficulty in reviewing a risk assessment. I don't know how many of you have actually taken on one of these 200 page documents that Lois described, but they are pretty awesome, and they're the kind of thing I think that only a toxicologist could love and understand.
So we've been sending these out to entomologists and plant pathologists who have been somewhat bewildered and have had the reaction of how does my crop fit in. I don't understand where you're going with this and what does it all mean. It's a confusing bit of numbers. This is -- despite the fact that Therese and my staff and headquarters have been trying to plow through them first and extract from them very pointed questions that we're looking for input from the land grants.
So it is resource intensive, and I guess in some ways it's been not a very satisfying experience because of the abstractness of the risk assessment. Why are they abstract and difficult? Well, if we can get our land grant person to plow through it and to answer the questions, they're left with a problem of a national risk assessment.
EPA wants to know nationally about the active ingredient, what's going on. Our land grant people are typically dealing with a registered product that may well have different label rates for a particular state or area or crop. So they're looking at a label rate that's driving a risk assessment that's not used in their particular area on their crops. So they get very confused.
They have been doing good things, don't get me wrong. There has been positive effects by adjusting some of those label rates and some of the actual application rates, but it is a confusing task and a difficult one.
I think the other problem we're trying to address is what looks to us like big chunks of down time with the current process, be it the initial 60 day public comment which tends to produce very little information, and we think we could be using that more constructively, as Lois described. She had some ideas on how to do that.
The second chunk of down time is that 30 to 60 days in which it is in the department and the land grant system for review. Not much is going on in terms of involving other stakeholders at that point. And Al and Lois and those folks at EPA aren't sitting there doing nothing. They are trying to refine and improve that risk assessment. So by the time we end up with our review, chances are there had been significant changes and a lost chunk of time in many ways.
A frustration comes up on the part of our reviewers. They see something in the risk assessment. They want to talk to someone else about it. And they can't go to the registrant, and they can't go to the grower at that point, because we've agreed with EPA that this is a closed process right now.
So what seemed like a good idea when we started this, really is becoming frustration and pretty clearly to me a need to open the process up to all stakeholders. We profit greatly from having the dialogue of people exchanging ideas and thoughts about the risk assessment and the risk mitigation options that might exist.
What else have we learned? We have certainly learned that it is of great value in understanding the risk assessment to dissect the Monte Carlo analysis. And by that I mean looking in great detail at what's going on in the tail of the curve way out there at 99.9. You can't really understand what to do about the risk, unless you understand what's driving it. And to get to that point, you do need that detailed dissection. We've made a lot of progress with EPA in getting the kind of information that we need so that you can do that kind of work.
I think this is extremely valuable when you start looking at, as I said before, the risk mitigation options that might be available. It makes a big difference of are you looking at one high end consumer, or are you looking at one consumer with a variety of substances, or a variety of commodities consumed driving the risk. It does make a big difference.
I think Lois already mentioned a number of the improvements and why we think the new process can work better. And this goes back to the revised risk assessment being much better than it was earlier on. The use of PDP data, the refinements that we've made in Monte Carlo, just getting more confidence in the dietary risk assessment part, and hopefully some of the work that Therese talked about in improving the worker risk will continue to make that a more useful document up front.
I suppose another issue talked about a little bit is the technical briefings. I think Lois and her people did a lot of work getting ready for those. Some of the initial ones I was anticipating that there would be a presentation with a lot of dialogue. Unfortunately, what does tend to happen is a good presentation, but it's talking heads, because participants -- the stakeholders -- are hearing about this revised and refined risk assessment for the first time. They haven't seen the document. They haven't been part of the discussion. So it's been pretty much a one sided exercise, and people are not able at that point really to react and discuss risk mitigation options.
We think the new process will make the technical briefing more of a dialogue and let us start engaging in serious conversation about risk management and risk mitigation. While we have all those people in town, we might as well take advantage of their knowledge.
I think Lois mentioned -- and I'm not sure what words she used. But we are talking about defining this check list. What information do we need to make available, so that you can engage in the risk assessment discussion. I mentioned how important it is to dissect a Monte Carlo. Certainly we think that some of that information needs to be made available so everybody can see what's going on out there. And there are many other pieces of information that can and should be made available in this new process.
Conference calls. Again, I would just second what Lois said about their value. In a couple of the REDs at the end of this last fiscal year, I compared the process that we laid out, which is lengthy and is a paper exchange. It's got people review, people comment. We did not do that with the REDs that were mentioned. Instead, we had conference calls. And I think it allowed us to move very, very quickly to a common understanding of what the risk issues were, and more importantly a common understanding of what kind of risk mitigation steps made sense and were workable for all the stakeholders.
So with that, I think you have the department's view of these and our support for the idea of changing, and certainly the importance of opening up the process to all stakeholders.
MALE SPEAKER: Are we ready for questions?
MR. JENNINGS: Comments. As Lois said, we need your input. Ideas.
MR. EHRMANN: Just to -- a comment on our understanding of this discussion. As Lois and Al have both said, it's an opportunity to solicit your feedback on this particular set of possibilities in terms of how to modify the process. I think -- and the agency and the department correct me if I don't have this right. But I think the plan is to solicit this feedback, talk to others in terms of understanding how people's experiences have been with the current process, and then in some defined period of time come back and basically make a decision about the process that they will be utilizing from this point.
So, you know, I think they're on a track to make some decisions about instituting a public participation process. We'll talk in this discussion also about the scope of that as it might apply to other non-organophosphates, etcetera., as Lois suggested to be discussed. But I think it's important to recognize that your input is very valuable obviously at this point in time, and then they'll deliberate on how they want to make the modifications and then announce how they're going to proceed.
Have I got that right from up here? Okay. Bill, you were first, I believe.
MR. LOVELADY: Lois, I'm really happy to hear you say that the agency has an open mind on this. I guess that means that -- that means that we can bring up something that happened last year. I think that I applaud your looking at the process after a year and trying to find out its strengths and its weaknesses, and make it so that everything is more transparent. And I applaud the effort.
I do have a question on phase one on the errors only. Is there a chance there? It said and other errors -- computational and other errors. That still does not include a registrant -- when the registrant feels like a conclusion that EPA reached was invalid, is that right?
MS. ROSSI: That's right. I think other errors were like, you know --
MR. LOVELADY: Like grammatical?
MS. ROSSI: Yeah.
MR. LOVELADY: Okay. I figured that that was probably right. My recollection of our discussion on this errors only was sort of a compromised position at best. I don't think that we can in good conscience not mention the fact that since we're trying to improve the pilot project, that I still think that it would be in the interest of truth and knowledge if there was a step there where the registrants could actually interact more than just on an error only basis at that stage.
And I think that that is -- I think that belief is upheld by the fact that on the errors only responses that you got, in many cases you saw other information besides errors only. And I think that just shows you the importance to the registrant of trying to get the best information into the risk assessment as early as possible.
And so I would like for you to at least consider that while we did have somewhat of a compromise situation in the development of the pilot project, that experience has shown that the registrants feel like that there is a need for some additional input besides just errors only. So I would like for you to consider that. That's my number one point.
My number two point is that I am -- I don't really know how -- I'm not a registrant, so I don't know exactly how those people think. But if I were a registrant, I think I would be happy to hear that we're going to put out more refined data at first and not have the preliminary. So I personally applaud you on that, because I don't think it served anyone's interest to put out this raw data that everyone knew was not correct. So I applaud you for that. I think that is really a step forward.
It was mentioned yesterday that you got no grower response on many of these risk assessments. As being a grower, and as a representative of a grower organization, I would have to say that I would think that the reason you didn't is because this preliminary risk assessment was so -- it had no bearing on reality in many cases, and I think that the grower groups probably just didn't -- they were either confused or they didn't understand or something because of the very nature of the preliminary group and preliminary risk assessment.
And so I would think that with your improved program and going directly to refined data, I think that you will see more response from grower groups than you saw in the past. And also, you have to remember this was a pilot project in the first year, and I think that you will see grower groups become more sophisticated in their response to you. And so I think your response from grower groups will certainly improve regardless of how you do this.
My fourth point, then, is that I think that with a better preliminary -- well, with a better risk assessment and not having this unrealistic preliminary, I think that it's important that everyone be able to respond to the risk assessment separately from the risk management. I think before, because the preliminary risk assessment was so unrealistic, I think that people just skipped that and they just went directly to the risk management.
But I think with this new project, I think that you will see -- I think you will see that there is a need for response on the risk assessment, and then a separate comment period on the risk management.
MR. EHRMANN: Okay. Let me suggest -- because there are a number of folks who want to make a comment. If you've got thoughts that are very similar to Bill's on certain points, feel free to say, I agree with Bill, and elaborate on those points that may be different. And if we use that approach, maybe we can make sure we get everybody in who wants to make a comment.
MR. SPENCER: One of the interesting things that I found out when we were going through the process on a non-OP -- and that was Formenate -- that in response to a statement that Lois made about getting together with the registrant early in the process, you know, to exchange information on, you know, how the product is actually being used, in my experience on this one product, it was amazing to find out that the registrant doesn't always know how the product is being used.
And early on in the process, you know, when you're talking about, you know, preliminarily meeting with, you know, a registrant, I don't think that's too early in the process to involve stakeholders outside of a registrant in the form of growers or grower groups to make sure that the registrant knows in fact how that product is being used. Because, again, it was a pretty eye opening experience for me to find out that, you know, in fact the registrant just really didn't understand how this product was being used.
The other thing relates to risk assessment and having as refined a risk assessment possible at the time that you involve the other stakeholders. Not the registrant so much as, again, grower groups and going through this process that I was involved in on a non-OP. You know, we were told during the first telephone conference that this particular item, or this particular crop commodity, was a driver and so on and so forth.
And what we found out going from the first telephone conference to the second telephone conference was that one of the things that was driving it was orange juice. And everybody woke up and said, hey, wait a minute. Carzol isn't used in Florida. Florida produces 99.9 percent of all the orange juice produced in the United States. We produce oranges in the west for fresh and everybody said, oh, really.
So, again, I think we need to have as refined a risk assessment as possible when we get to that point of involving the stakeholders in the conversation. But not only does it need to be refined. It needs to be understandable. And that goes, I think, to what Bill Lovelady was talking about a little bit. You know, you hand us this 200 page document. And, again, there are people in grower groups -- like Mr. Botts across the table from me there -- that can take a look at this 200 page document and really understand what's in it.
But, you know, there also are a lot of people that aren't like Mr. Botts, like me, who are -- are just intimated by a 200 page document. And we need it boiled down into plain English. You know, here is the high points and give us some feedback.
So those are at least my initial comments, until I hear from some other people here and see if I forgot to mention something. Thanks.
MR. EHRMANN: Okay. Wally?
MR. EWART: Since I was mentioned about one of those who didn't respond, I guess I need to explain that, and actually Bill has explained part of that.
Growers really did not see an incentive in responding to the preliminary risk assessments that we looked at, and realized that those were believed by EPA that we would be doing something different, and that we knew refinements were going to occur. And after those refinements were done, then that really is the time to look at the risk assessment and to see if risk management is needed. But I think it is really important to understand the separation between risk assessment acceptance by the growers and then the work on risk management.
Obviously with a crop like ours, that has a hundred registrations, if we were to spend our time working on risk management for all of those initially, I'm not -- I'm not enough people, and neither are other crops going to have enough people to do that. So we are relying on the risk assessment process to identify those chemicals that actually need risk management.
And that's why there has to be a separation here. The risk assessment process has to move forward. We have to be able to give meaningful input into that, and as Bill said, correct those things that aren't understood by registrants and by EPA about how we use the materials, and where the materials are going to end up as a residue, and whether it's going to be a juice, processed form or in fresh form. And identify that and get that into the assessment. Refine that assessment reflecting grower input and then look at risk management.
I just think you have to understand that growers right now are looking at this whole process and thinking that if any of those preliminary risk assessments were accurate, they can't understand how the process could really be operating at all. So there is a credibility point here. If you really want growers to commit time, we really need to know that that risk assessment reflects all the valid information and data that can be brought forward by the registrants and by the growers.
And so it's a matter of separating that. If you have them together, you're muddying the waters because there isn't the commitment by a grower to believe that this is the final assessment, or close to the final assessment, in order for them to take the mitigation actions.
MR. EHRMANN: Okay. Dave Whitacre?
MR. WHITACRE: Lois, it was a good report. It gave quite a bit of insight, much of which I was not aware of, about exactly what kind of comments you have been getting. And I think that the arrangement you've discussed is not too bad, but just some feedback on some of the questions you raised.
OPs. There are only two right now in that category, as I recall from yesterday, in the pre-phase one level. And there's not much use in building a whole process just for the OPs. I think there has to be a process for other products. What did Jim say yesterday? Six hundred or so still to go. So a process is needed, and it shouldn't just stop with the OPs.
MS. ROSSI: Well, we only -- I do want to correct that. We only have less than 200 in re-registration to go.
MR. WHITACRE: Oh.
MALE SPEAKER: And that's a number of AIs.
MR. WHITACRE: I didn't mean to increase your workload. I beg your pardon. Okay.
MALE SPEAKER: We look forward to the innovation of the industry, Dave.
MR. WHITACRE: That's why you looked like you were going into shock, I see. In any case, having a process is important, whatever that process is.
But there is also obviously some learning that's gone forward in terms of the original concept and approach for how to roll this out to the public that was talked about by TRAC, the feedback and now what you're proposing. And I can tell you the next topic on the agenda: the importance of continuing this process and in an appropriate way. I think that's also important because of this example of learning that's gone forward.
The number of steps in the process I don't think is the issue. I would like to use a little bit different word, though, in expressing the importance of working on accomplishing the level of refinement that is possible on each product before we leap to actually electing any type of risk management. One has to determine the size of the risk cup for a product before we go to that next step of how we actually tee up what -- you know, what management steps are necessary.
Back on the topic of why you didn't get comments. I just had a thought and I wanted to share it. It's kind of a parenthetic issue. It's difficult to deal with theoretical risk in some of these big numbers that we've seen, and there's a great deal of ambiguity. At any time if USDA and EPA in talking back in phase two and phase three and taking the public comments you've got, can actually talk about what's at risk, even though it's not settled, even though it's not final, that would be useful.
Somebody yesterday -- and I've forgotten which individual it was -- talked about the percent use versus percent of risk in the Methyl Parathion example. If it were possible to construct a hierarchy of at least a few examples for a product that has many uses, where is the risk, and then show that, and then a grower can see very clearly, I think, what really might be at risk. And, therefore, I think the interest would be immediate in wanting to say, wait a minute, that's very important to me, or maybe you don't get a comment and it's not important.
But teeing that up is something that is actually palpable that you can actually see what the impact might be. It's not ambiguous. It's more solid and would probably garner a lot more feedback that would be useful in making those final decisions.
I'm going to come to one other topic, which is really not -- and I'm not speaking here as my -- in anyway for my employer. But I really have a concern. I talked about it last year. I'm going to mention it again.
The difficulty of honestly reconciling disparate sets of criteria. EPA has certain obligations to the public. They need to make sure under this new law that products are going to be available that are safe. The growers, to which the registrants have a commitment as well because they're our customers, need to make sure that their needs are met by having products to control the pests that are destroying their crops.
And the registrants -- you know, everything else aside in the end, we've got to be able to have products that we can sell in return to shareholders -- what they want, many of whom are us, shareholders. So there is disparate need. But at some point this needs to hang together. The safest product in the world that doesn't work is no good. The safest product in the world that is too expensive does not help the grower. And all other permutations of that point.
And let me come to my point. My concern is that we're maybe even now not talking early enough about what the cost structures are for some of these products that are manufactured now, and what the success or the survivability of those products are relative to some of the uses. USDA and I think the growers need to understand early on what those products -- what will kill those products. And if it happens, at least it ought to be known up front.
I can tell you right now that every single product rests -- the ability to continue to manufacture that product rests on one or two or five uses. If the critical use is lost, no mater how important that product is for the minor uses, it won't be manufactured, because it's simply -- it's a reality that the product cannot survive in an economic sense.
So as early as possible, maybe in phase three -- I kind of underscored in phase three, however it sorts out, risk management options. Sometime before that point USDA and maybe EPA certainly should be getting together with the grower groups and with the registrants, and maybe there should be an honest exchange about what that product looks like. What would kill that product.
And if you know that in advance, and if there is rational or reasonable honesty, then I think at least people are forewarned about certain outcomes. There are certain things that are not viable in the long term to satisfy all the different criteria of all the groups.
MR. EHRMANN: Excuse me. Let me just comment on something I'm hearing. And that is, you know, there is a tension between the kind of how early and who gets involved when and what kind of information, I mean, that already a number of commentors have talked about. On one hand, I think people are saying -- and I think the department and the agency are trying to be responsive to -- the need to bring people in sooner. Get the growers in the dialogue sooner. That's what we heard yesterday.
At the same time, there is a concern of separating -- and these are all -- each point is rational, so I'm not saying there is -- you know, anybody's view is not more valid than anybody else's. At the time folks are saying separate the risk assessment. You know, we need a clear separation of the risk assessment, because we don't want to, you know, alarm people. People aren't really going to pay attention until they absolutely -- you know, they know that they're comfortable with what the risk assessment says and have a clear understanding of what its implications might be.
And there is also the issue of what is going to create the incentives for people to have the kind of conversations that folks think they should be having, regardless of which interest group you're in. What is the incentive for a grower group to come in early. What is the incentive for the registrants to engage in certain kinds of discussions. What are the incentives for the public to understand this information.
So I think as we think about this and you're giving your perspectives to the department and the agency about how to proceed, think about some of those -- you know, how do you weed together some of those potentially conflicting objectives. Again, they're all -- there are good reasons for all of them.
But they're trying to put together a public process that can somehow create without -- you know, this isn't about forcing people to come in or forcing people to do things. It's about the kind of natural incentives that can be created for folks to have the kind of interactions that they need to have to satisfy their own particular interests. And in some cases, you know, it may be difficult to accomplish these multiple objectives at the same time.
So help them think through how you do that as we think about how to modify this process.
MS. MILLER: Yeah. I'm glad you just made those comments. Actually, I don't see as much conflict potential here. I think one of the things that the new proposal talks about is more an earlier involvement of stakeholders. And I guess I -- maybe something different than somebody said so far is if we went back to -- even though there was a lot of pain and anguish when we came up with the process about a year ago here, we looked at what is there, and we put in some more of that early stakeholder involvement with that process that is in place -- those steps or about those steps -- morally involvement.
And then I think we heard the thing that says, gee, these preliminary risk assessments aren't worth much if its over estimations, etc. From what I've heard around the table, the more refined you can be, the absolute better. But at whatever point in time, you're going to be where you are. And I'm not sure another 60 days changes a whole lot sometimes in kind of new process, but, you know, maybe a little.
But my thought is, you get out that risk assessment as refined as possible. It's the first one out, so whether it's called preliminary or not, I think is somewhat irrelevant. It's the best data you have at the time. You get that out. You have the comments and have a separate comment period for the risk assessment, I think like we've heard from a few other folks. So then we can understand what that is, the assumptions in that, the risk drivers and those kinds of things, and I think you'll get a lot more engagement there. And then you go back, redo and then later on in the process you have the risk management discussion. I think that just has to be separated.
So maybe it's taking more early involvement from stakeholders in a real valid way early, and then doing the risk assessment separate from the risk management comment period. And then maybe we can get there without the question of the conflicts.
MS. ROSSI: But -- can I just ask a question there?
MR. EHRMANN: Yes, please.
MS. MILLER: Sure, Lois.
MS. ROSSI: A couple of people have mentioned about the drivers. I guess in identifying drivers, to me that kind of points in the direction of risk management, because you're starting to say, hey, look, if we're going to regulate this risk, this is kind of, you know, the areas you're going.
And so are you saying that -- the risk assessment right now is just totally, you know, risk assessment.
MS. MILLER: Right.
MS. ROSSI: It's total science. Are you saying that it would be -- you would add at least something to it to point in the direction of where the risk management would be?
MS. MILLER: Not necessarily where risk management would be. But an example here. If you have a certain commodity that is a risk driver, could that commodity be the Carzol answer, because you assumed that it was all for juice versus for fresh? I mean those kinds of things I think can be very educational, not only for you all, but sometimes for us registrants, especially for minor crops which we may not know very well. So you use that opportunity to just talk about the risk assessment at that time.
The other overlying factor that we kind of beat about the head a lot yesterday and I think is still on the table, is there is still some heavy science policies that have not been worked out that may be an ultimate driver in the whole risk assessment. And I think maybe a year from now, when you have all those science policies worked out and everything hammered out, we'll all have a comfort level and confidence that those risk assessments are exactly where they need to be.
But I think until then, too, that's another strong rationale for having a separate comment period on the risk assessment portion, because there is a lot yet to be decided on science policies.
MS. ROSSI: But, again, in order to figure out that the orange juice was the driver in Carzol, you have to do some analysis beyond the risk assessment. I mean, we had to take the risk assessment and tell Bill Spencer that after looking at the oranges, this is what was the driver. And that currently -- what I'm saying is, that currently isn't in the risk assessment.
MS. MILLER: So in your risk assessment, if you're even looking from a Monte Carlo standpoint, it is not obvious?
MS. ROSSI: You don't do -- you don't do like that kind of interpretation exercise. If you read the risk assessment and go through the risk assessment, like we do and we've been doing with USDA, it's obvious, but it's not pointed out in a separate part of the risk assessment.
MS. MILLER: Well, maybe that would be an enhancement that would assist, but it's not yet, because there may be assumptions that make no sense. It's not yet at risk management, and I wouldn't take that leap yet.
MR. EHRMANN: Jim?
MR. AIDALA: Yeah. I think there's -- and this is fruitful, because I think there is too much sort of worry, if you will, for lack of a better phrase, on the phrase risk management. My phrase for it is risk management directions, or driver driven. I mean, use some kind of driver direction. We're not even saying exactly what they are, because I think what you two just talked about is a good illustration of it.
What we get from the risk assessment purely from our science divisions is just the Monte Carlo at 99.9. And trying to put aside the science policies for a second -- I'm not saying they're unimportant, but just for the moment in terms of this process. That at 99.9 the risk is 103 percent of the cup, or 120 or 180, whatever it is entering into that.
Okay, now what. Again -- and I think what we're suggesting is, and what I'm hearing in this discussion internally, too, for Al and his folks, is like, well, that doesn't tell me anything. I want to know whether or not you think oranges may be in trouble, or that oranges -- and, you know, if oranges are in trouble in a really big way, well, that sort of suggests that just tinkering with the PHI and whatnot is probably not going to make it. If you're at 103, an increase in the PHI by a factor of 20 percent, it will probably do it.
And that's the kind of thing I think we're trying to say. And my version of what folks have told us is those are the kinds of things that people want to hear. That's a direction you may be going. Everyone reserving their right to argue about everything from the numbers to the science to the whatever. But, you know, that sort of tells me whether the -- and the department
-- whether or not the orange guys ought to be involved, or to bother to call Bill or whoever or not, or the cotton folks, or the whoever folks.
And I think what we're suggesting is underneath it. Al and Therese? That's my take away from it in general. Is that on target?
MS. MILLER: Well, then I think you need to not -- I mean, because risk management by its nature is, and here's our answer and we've made the determination.
MR. AIDALA: Well, that's what I mean by the --
MS. MILLER: I think you've got to have a separate risk assessment --
MR. AIDALA: -- driver direction. Call them whatever.
MS. MILLER: -- that talks about challenges, drivers, and then later on let folks talk about the mitigation and risk management options.
MR. JENNINGS: Maybe Bill's point was a little bit more fundamental. Not just whether oranges are in trouble, and whether we're sending a signal about that based on what we know now. But whether in fact the assumptions that went into our constructing those risk drivers are in fact right. And that's the opportunity for people to come in on that.
MR. SPENCER: Exactly. And that doesn't have anything to do with risk management.
MS. MILLER: Correct.
MR. SPENCER: It just has to do with the risk assessment.
MR. AIDALA: Well, I think that's kind of where we're talking past each other and we're trying to ferret it out. Because what Lois is saying, as I understand it, is that to know that orange juice is a driver in the risk assessment is the initial step towards a management direction. In other words, you need to address oranges or not.
And I think we -- the nomenclature is not totally trivial here. And part of it is so that you all don't -- and all parties -- don't think that we're trying to lock down on, or we're hell bent to leather on, oranges got to go, or even be changed, when it may be something more fundamental that says, oops, there is not a problem at all or whatever.
MR. SPENCER: And that's fine if orange is a driver, except that it wasn't, because we don't make orange juice out of oranges that are grown in California.
MR. AIDALA: Right. But you have to identify that.
MR. SPENCER: Oh, gee, we need to go back and do the risk assessment and take that out.
MR. EHRMANN: I mean, it's probably a question of nomenclature. It's also -- I mean, I think there has been -- I mean, I've had conversations with growers around this table, you know, between meetings, and we've had comments at meetings where there has been, you know, justified concern about people pointing out drivers, because people are concerned that someone will look at that and say, you know, we're going to have a food scare or whatever as a result of that.
So at the same time, if you don't know what they're thinking the drivers are, there is no way to do you know, the kind of additional data input that Bill has experienced in his case. So, you know, there needs to be some nomenclature developed and some kind of understanding/trust developed among the players, so that when the agency says, well, we think these are the drivers, the reaction is, well, let's talk about that. Let me get you some more data. You're not really correct. Rather than, what do you mean you're going to get rid of oranges, or, you know, you're going to get rid of this material.
So it's a matter, I think, of hopefully this kind of discussion helping clarify that, so that they get the information they need to be as accurate as possible before we move into the formal kind of risk management stage.
MR. AIDALA: The other point I want to make, John, is simply as people talk about this, remember that of course no one process is one size fits all. I mean, that's something we all share in terms of how any government policy usually runs into trouble that tries to be that.
But remember that there is a whole menu of different kinds of things we want this process to use. For example, things that you all -- you know, the OPs. And, again, they say we're getting toward the end of that process. For also, for example, another question on our agenda is the RED process in general. Does it make a difference if we think there is a dietary risk cup exceedence versus not. What about chemicals that are post-84. They're still subject to FQPA, but they're pretty modern and pretty complete.
So as you think about these things, again, I think mostly underneath it is this is what happened in Methyl or something as opposed to, hold it, we do a whole lot of different things, and thankfully we only get a few of the Methyls, and hopefully we'll only have a few as we go through the whole thing, as opposed to the -- you know, again, the one size fits all.
So it's a process we want to have to be able to work for a whole menu of things we have to go through under the reassessment process.
MR. EHRMANN: Brad?
MR. LUCKEY: Well, I think my comments would dovetail everyone else's. When I looked at this current proposal, and you see the risk assessment and risk management together, it's almost like there is a bias there, that there is going to be risk management when none of the drivers have even been identified. And I think there definitely needs to be that separation. And I think in the risk assessment you've got to be able to identify what is causing the problems. Only then can we go out and mitigate that risk if there is one.
Lois, down on the bottom of phase one on your attachment B, it says that EPA will ensure that stakeholders and other government agencies are informed and involved. And I'm wondering how are you going to ensure that?
MS. ROSSI: On the bottom of which phase, phase one?
MR. LUCKEY: It's on attachment B. And I want to make sure it happens. I'm just wondering what mechanism you're going to use to make that.
MS. ROSSI: Well, that is just to say -- I mean, we would use USDA. We would use the significant tools. This is if we would issue a risk management decision at any time during the process that it would warrant it. We would use our -- some of the things we did for Methyl and Azinphos. We would use conference calls. We would go through the department. We would go through our minor use team.
MR. LUCKEY: Okay. I guess I'm getting back to like what Bill was talking about. How do we get the grower groups interested and involved? And I was hoping that you had this mechanism in your mind and you knew how we were going to do that.
MS. ROSSI: Well, the mechanism that I think, you know, has worked -- I mean, again, we're trying -- we tried this out this year. I think the example of the non-OPs was pretty good. I mean, we were ready to take some -- to make some decisions on these things and they weren't part of the pilot process. So I think that's a good example of where we had to do something to get people involved and to let people know. And we used our minor use team. We used USDA. And we had a series of conference calls that were very successful to get the word out.
MR. LUCKEY: Well, it's just in my experience, and I think Bill -- both Bills and anybody involved with farmers, is that sometimes it takes a catastrophe to get their attention. And that's unfortunate, but that's the mentality, I guess, or the mind set of the people.
And I'm going to keep thinking and hopefully get with you later on how we can get these people involved in this process earlier, because that's to everyone's betterment.
MS. ROSSI: That's right.
MR. EHRMANN: Let me -- I'm going to go next to Nancy, Larry and Jim. And, again, if you've got comments that are similar to other folks, you know, indicate that, because it's useful to know kind of how many folks are where, but focus mostly if you can on those things that may be additional different thoughts than we've heard thus far so we can get everybody in.
MS. RACHMAN: Okay. I'm pretty much on the same page with everybody else who is calling for a separation in the comment period between risk assessment and risk management. But as a risk assessor, I have a slightly different spin on it, and maybe I can offer some concepts that would help us talk through it.
First of all, I'm really gratified to see the analysis of the pilot program and to hear some of these suggestions. I think that bidding goodbye to the preliminary risk assessment is -- that's just fine. I don't think that did much for anybody's credibility, really. And I think the fact that you didn't get any comments does reflect the fact that nobody really believed they were real risk characterizations.
I think the idea of the pre-phase one consultation is a really important step. And as far as incentives for people to participate there, maybe what we could do is identify some key goals that we have that are more generic than chemical specific and get some things discussed and queued up early on.
For example, in doing the Carzol risk assessment whenever that was, obviously some things came out –
(END OF TAPE ONE, SIDE TWO.)
MS. RACHMAN: -- and others who were involved with kid -- major kid foods, and let's get some of those generic exposure assessment variables identified up front. I think that would go a long way towards making things more efficient. It would also mean that people could participate just once and not have to come back every single time to tell the same story.
Secondly, I think that opening up the process so that USDA and HHS and the stakeholders and the companies can all talk to each other is a tremendous improvement. And I'll mention that that was one of USDA's goals here. And I think that's going to help a lot, because everybody who looks at those risk assessments sees something a little bit different. And that consultation is going to bring you a lot of good input and help you get more efficiency out of the process.
I think your ability to get efficiency out of this new phase three is going to require some separation. And I would say rather than separating it into comments on risk assessment and comments on risk management, what we're really focussing on is refining the agency's risk characterization. To a large extent, the drivers that EPA is identifying now, while they're very helpful, in large part I think they still reflect what kids eat, rather than specifics of any particular chemical. I mean, you could almost predict risk drivers in advance of seeing the risk assessment. And I know that's a real generalization, but there is some truth in that.
It's also been my experience that once the refined risk assessment is released, it takes a lot of work, even on the registrant's part, to get into those details enough so that we can actually do a peer review. We can recreate what you did and figure out whether there are some things buried in there that need to be changed. And I know this, because I've been cranking through this for our two OPs and working with our grower groups who are trying to figure out whether the agency has made the right assumptions.
To a certain extent I'm talking about things that are even more detailed than the sort of growth science policy levels. And my job over the last -- since September 2nd, basically, has been trying to figure out what's in those risk assessments and helping the growers to understand so that they can figure out whether they need to talk to you. That whole exercise I call refining the EPA risk characterization.
So if that was the first part of phase three, and if that were coupled with some additional transparencies, some improved communication about the risk assessment, which I think, you know, we're all getting a lot better at that, then that would queue up a real productive second part of that comment period on risk management. Until you've got some closure on the risk characterization, you can't have a meaningful discussion about risk management.
I think the other thing about having a period for refinement of the risk characterization is that's really the external peer review, and so it will help the agency to achieve those objectives as well.
I'm really struck in how this program has developed by two things. First of all, it's been painful for everybody, but it has really changed the way that we do business. The way that we talk to people. The way that we talk to our customers and the growers. And I think it's fabulous. I think we have people engaged here and we have achieved a level of transparency that is going to be helpful for all of us.
I think we have a way to go on the risk assessment side, because for a lot of people that risk assessment or risk characterization is still pretty much of a black box. And I'm personally and particularly excited about having opened the lid to that, and I hope that that work continues.
I'm also struck by the fact that with this exercise OPP is finally beginning to implement the agency's risk characterization guidance which came out years ago, which in turn flowed from the NAS report which talked about separation of risk assessment and risk management. I think we're getting to a real meaningful process.
And even more exciting is that I think we're also getting to a point where we're beginning to implement some of the suggestions of the President's Commission on Risk Assessment and Risk Management for stakeholder involvement. And this is -- this is a real first for a program like the pesticide program. And I really applaud it, and I'm very proud to be a part of it.
MR. EHRMANN: Thank you. Larry?
MR. ELWORTH: I'll summarize my comments and submit the balance of my comments for the record.
MR. EHRMANN: Thank you.
MR. ELWORTH: I think Lois and the people at the agency have done a great job with this process. I think it has not only improved public participation, but I think it has really improved the products you see out of the agency. So I think it's been valuable in both ways.
On this issue of involving growers in the smart meetings, I think if you want to do that, I think you really have to go out and identify the affected grower groups and contact them directly. If that's what you want, and I think it's a real good idea. I concur with what a bunch of people have said.
I also think in response partly to Brad's question, it would be useful to have a simple checklist or chart that you could actually put out for grower groups, have put in trade publications, so they really see what this process is, if you want them to be involved. And you can use land grants. You can use some of the departments. But certainly the grower groups in the publications they see, first of all so that they know what the process is so at least they're informed, and secondly, if they want to access it, have some fairly clear way of walking through the process.
It might also be useful -- and this is way more work for you -- as individual chemicals come up to try to make that available, even if it's only to the grower groups so that they can inform their members. But some sort of system to advertise while you're doing that. I think that would be helpful.
The other piece that I would point out on here, and this is actually in phase four that's not currently in the process. I'm not entirely sure it belongs here. As we get further down the line when we've done multiple OPs, there will have been a series of mitigation or risk management steps that will have been taken. The kind of the risk management step of the day is either increasing the PHI or reducing rates.
For the moment that may seem to be working. But my question would be, after you've done that for three or four chemicals that may have the same spectrum of activity, especially with late season pests, it would be really useful to have an evaluation loop in here as to the current effectiveness of the existing risk management measures.
My concern is that we're going to end up really -- and maybe not too far out from here -- with very few materials that we're using at the end of the season that are available. We're already seeing some pretty significant fruit moth damage in fruit this year in the county I live in. So I think that would be really useful to build that evaluation loop in here, to put a place in here for people to say, you know, there are three materials that we've already taken action on that used to be used late season. We're now going to move on another one. What is the effect of that.
And I guess the question that I would ask for Al is, you eluded to a number of issues with timing in terms of review. Is this process pretty much just the draft proposal -- pretty much a solution to a lot of the timing problems that you folks encountered?
MR. JENNINGS: I believe it is, because of the ability to open it up and talk to folks, holding the conference calls and getting away from this paper exercise, where we're holding it close and we're reviewing it and sending paper comments to Lois. That just is a little too stilted.
I don't know. Therese, do you have some thoughts about that?
MS. MURTAGH: Well, I have some thoughts about the two step process. You know, separating the risk assessment so much from risk management. I think that there are a lot of commodity groups and growers and land grant university specialists who are not sophisticated enough to look at a risk assessment and anticipate what the implications might be for their use for their commodity. And they are not going to become engaged until they see what it means to them.
And it's not just the dietary risk assessment. It's also the occupational and ecological. Like, well, if there are occupational risks, well, what does this mean? How will the mixer loader applicator uses have to change? What will the REIs be? Will they be extremely long? And until they have a feeling about what the changes might be to the label, then they're not going to become involved. Now if they only become involved at the very end of the process, they will not have the time they need to look at the assessment and see, like what you're describing, Nancy, what were the assumptions made.
So I just wanted to throw that out in the discussion so that you might look through the eyes of, you know, commodity groups that are not really well organized, but have a real vested interest in some of these products.
MR. EHRMANN: Nancy, do you want to comment on that just for a minute?
MS. RACHMAN: Well, that's a good point, and actually I guess my ideal version of a risk characterization would actually include some indication of where that risk characterization leads. In other words, the agency says here's how it looks to us based on this risk assessment, and this would logically lead to the following risk mitigation types of ideas, okay. But here are some things that might change, and in that case, here are some other things that might happen. So we get kind of a matrix approach.
And the during the discussions, people can look at how they've characterized the risk, which may include some of the inputs to the risk assessment, and that may, you know, de-emphasize certain risk mitigation options or suggest others. So part of the risk characterization, to me in this case, should be some indication of what the real world impacts might be.
MR. EHRMANN: Jim?
MR. AIDALA: One item. I think the risk characterization idea -- I'm glad Nancy followed up on that, because that may be the middle ground concept. But this will become obvious that this is unrehearsed for a colloquy with Lois and Al.
As I understand the distinction we're trying to get at, is the risk assessments right now -- and that's our term of art, and it is a term of art. We basically might come out with a document that says, by the way, world, the risk cup in this particular case or a particular chemical is 110 percent full, which includes a 3X safety factor, and by the way, it's use on cotton, oranges, cranberries, cabbages and kiwi. And that's about it.
And what Therese just said is my guys don't know what to do with that, as opposed to one I think where we're going at. Whatever the nomenclature Therese should use -- risk characterization or whatever or call it something else entirely different -- would you like to know that it's a hundred percent -- the cup is estimated to be 110 percent full with 3X, because no alteration and so on, but that oranges are 33 percent of the cup, and we think there are alternatives. And by the way, they can go pre-bloom. We think they can go pre-bloom and that will probably drive down the numbers. We don't know how much, but we think that's pretty significant, especially since that's 33 percent contribution of the cup.
But for cranberries contributing 40 percent of the cup, there appears to be no alternatives and there is no sort of pre -- you know, timing application kind of thing that's going to make a difference, because maybe it's a late season rescue treatment and so much of the crop uses it.
I think -- to me that's the kind of difference in what we would like to put out to the world and involve folks with engaging on. Is that kind of the general direction? I'm asking Lois and Therese what is behind the proposal. So that's what I'm hearing in talking to you folks.
MS. MURTAGH: Yeah, I agree with it, too.
MR. AIDALA: And that's kind of the -- whatever we call it -- and it's not an attempt to say that you still can't fight about -- you don't need the extra safety factor or there really isn't use in whatever commodity and things like that. That's the two -- whatever the nomenclature is that we use, that's the kind of goal that we're trying to get.
Because Al and company, as well as our own folks in discussing with grower folks and others -- registrants, too, obviously, have a huge role here, as to whether or not there again there are alternatives and all that. But no one wants to engage on that until we think that that matters. Because otherwise I've got this list from HED -- the HED files -- which are cotton, oranges, cranberries, cabbages and kiwi, and the cup is overly full.
MS. RACHMAN: I think the agency, though, also has to include a little more information than is currently included with respect to the dry foods.
MR. AIDALA: That's what -- well, we're agreeing with that.
MS. RACHMAN: Yeah. And I don't know, it sounds like a workshop or a separate meeting to talk this through. But I think making some improvements there might help get us where we all need to go.
MR. EHRMANN: And I want to take -- Larry I think had a follow up.
MR. ELWORTH: Well, my question is --
MR. EHRMANN: And then we're going to go ahead and take a break. We'll come back and stay on this topic, because I know we're not going to have half an hour of public comment, and there are some other things on the agenda. And this is obviously a very useful discussion.
So, Larry, why don't you go ahead?
MR. ELWORTH: And my concern is not only the substance of how you go about it, which I think is extremely important. But also that there is an appropriate time -- and I don't mean an appropriate time of constantly fading deadline for doing things. But we often come to this place where all of a sudden these key decisions have to be made and it's a Friday afternoon phone call for a Monday morning decision.
And I know some of that is unavoidable. But I think to the extent we, and USDA in particular, can anticipate and make sure the process allows you the time to do what you need to do, it will avoid the outcome where we had a six month process that at the end of it people who are most key have some of the most important effects feel as if at the last minute they weren't heard.
MALE SPEAKER: Yeah. We all want to avoid that, Larry.
MR. EHRMANN: Elin, did you have a quick comment on this? I know you were trying to respond.
MS. MILLER: Yeah. In the response, Jim, I think you were all right up to the point of saying, and this is what we think we need to do. Because once again going back, if the assumptions themselves are flawed, then you wouldn't even need to have done it.
So to me it's describing the risk assessment in a way with the drivers without saying, and maybe pre-bloom, da, da, da, da.
MR. AIDALA: Yeah.
MS. MILLER: That happens at the next phase, and we need to have that dialogue and discussion. So that -- that's where I would separate the two.
MR. EHRMANN: So you would go -- just to be clear, you would go further than the list of all the crops he mentioned --
MS. MILLER: Right, but orange is the driver or --
MR. EHRMANN: -- and you would want to know which ones seemed to be contributing which, but you wouldn't go to the point of saying, it looks like we might have a fix for this timing and we might have a fix for this that's something.
MS. MILLER: Right.
MR. EHRMANN: That would come in the next phase, just to be clear about that.
MS. MILLER: I think you'll still -- you'll definitely still get the inspiration.
MS. MILLER: No. question.
MR. WHITACRE: And you'll definitely get the feedback.
MR. EHRMANN: Right, Dave. Rich, do you want to make a comment?
MR. ROMINGER: So are you saying that we should -- it should just say then these are the possible drivers and leave it there?
MS. MILLER: Possible drivers and why. Describe.
MR. ROMINGER: Why --
FEMALE SPEAKER: So people could respond to that.
MR. EHRMANN: All right. Okay. Let's take our 15 minute break. We'll come back and I'll pick up with Dan and we'll go around.
(Whereupon, a brief recess was taken.)
MR. EHRMANN: Next is continuing with the discussion we've been having on this -- on the feedback to the potential modifications to the public participation process. Basically I'll take the cards that are up. Again, I would encourage folks to feel free to just support what you've heard from others without elaboration if the points are the same. If you've got -- which I'm sure folks do have -- additional perspectives, please that's what we would like to focus on so we can get everybody in and get on to the next topic, and at the same time make sure that we get all the feedback that we possibly can for the department and the agency on this topic.
Let me just repeat what we were saying right before the break in response to some of the discussion about kind of where -- how to handle this risk characterization issue. And I ask folks to particularly also reflect on where you see that -- how you see that playing out.
I think what I heard at the end was, it would be very helpful to know what the agency believes the risk drivers are to give a sense of the assumptions that go into those judgments and kind of the proportionality between those drivers. But not to go to the -- in the, quote, risk assessment envelope or whatever we're going to call it, which may have this risk characterization tail on it. But not get into the part where you would start to discuss, and we might be able to do this or that to correct or address those issues. That should come in the risk management piece.
So to get everybody comfortable with the risk characterization piece first, and then move on to the risk management based on the judgments that are made about the risk characterization after all the feedback and interaction.
So with that -- I mean, that's one way to do it. That's, I think, with the helpful clarification there at the end. If you've got thoughts about is that the right place to draw the line or not, or how to characterize those things, let's keep providing feedback on that, or supporting that approach, of if you have a different angle on it, that would be helpful.
MR. AIDALA: John, if I could just -- and I don't know if Therese -- I mean, Therese was the one that articulated very specifically some of the concerns that folks had that she's had to deal with and what they need. Has that helped towards that or did they need more? Because I think that they may not say things like the REI needs to go up to five days instead of three days or something like that.
I mean, and that's -- I think we have a tension here about the agency or the government looking like it has made up its mind versus hold it, this is directionally where we think it could go -- or whatever the right adjectives are -- and then allowing certainly our friends at USDA, as well as the outside world, be able to comment on kind of where the thinking is going, again whatever the right word is.
And Lois, too. I mean, Lois and Therese and Al are the folks that do all the heavy lifting on this stuff.
MR. EHRMANN: Well, let's keep hearing from others, and then we'll come back and see how you --
MR. AIDALA: Yeah, respond to it then.
MR. EHRMANN: Yes.
MR. AIDALA: That's fine.
MR. EHRMANN: Yeah, good point. Okay. I'm going to Jim -- I neglected -- his card had gone down, but he still wanted to make comments. So Jim and then Dan and then Jay. We'll kind of work this side of the room a little bit. Everybody is going to get their chance, so don't panic. Everybody's cards went up pretty much at the same moment.
JIM: First off, I appreciate the additional three to six months on the smart meetings. I think that's a great opportunity for the growers to participate in the process. But I do see kind of a lack of grower participation. In my experiences with our task force and also the task force in our state. We have difficulty finding the expertise we need to help due the risk assessments and the risk management. We do have them out there, but finding them is difficult, and finding the resources to help with them participating in the process is difficult as well. So we need to keep that in mind, and that has been in my mind one of our largest challenges as a grower organization and as an individual farmer.
And lastly, the new proposed phase three, I have some difficulty with the fact that you're putting them together. I still think we need to keep those -- the risk assessment and risk management separate, as most of the other speakers do. And please keep in mind that the change in the number of days to participate there goes from 210 to 90, and that's a significant drop for two major components of the process.
MR. EHRMANN: Okay. Dan?
MR. BOTTS: Thank you. First of all, I would like to acknowledge Bill Spencer's belief in my capabilities beyond what I think they are.
MR. BOTTS: I can tell you for a fact, and I'm sorry I didn't bring my prop, because I did go in and pull every single document off the web site on Methyl Parathion from a preliminary risk assessment and attempted to go through it to figure out where meaningful comments could be put in from my industry, especially in the environmental FATE and worker protection side of it. And I'm still trying to figure that out.
It was an impossible task from the preliminary risk assessment process, and that's why you have not received any comment from the Florida Fruit and Vegetable Association on any of the preliminary risk assessments. We felt the need to make it most efficient for our limited time, because you're looking at the one person in the association who would do all that, and that our comments were most effectively directed at the refined risk assessment process, or after the agency's best refinement came forward.
And I would like to thank the agency for participating with stakeholder meetings in Florida on the compound that had the most significant use in Florida. And we have not submitted written comments. But we did -- in the hopes of providing a better understanding to the agency of the impact of some of the risk mitigation efforts -- a tour for some of the people that would be involved in the decision process to actually see how the application process worked in Florida with the variability of the different users that would be involved in trying to implement some of the risk mitigation steps. So there are more ways than just written comments to provide input into the process, and I think those need to be recognized and brought forward.
One thing I would like to say relative to this whole pilot process and the issue of making it work better, I'm a firm supporter of opening the process up and making it understandable and bringing the user community and the stakeholders into the process as early as possible. I think what we have to remember is the initial pilot process was geared specifically in a framework of looking at tolerance reassessment for a group of compounds called the OPs.
And as we move this process into other areas of agency activity, which is the re-registration process which I wholeheartedly support, I think we need to take a little more time to sit down in a forum with the opportunity to have the type of more specific conversation that we've had this morning just in the hour and a half to try to flush out some of the holes that may not be apparent in the limited review time that we've had to look at this process.
It's a step in the right direction to make a process more efficient. I think we just need to spend some more time and work on it. Probably the single most important factor that I see this type of process doing is it creates accountability for all parties involved in the process. Not just USDA and EPA, but the registrant community and the user community to put their best foot forward and their best information forward as early in the process as they possibly can. That takes communication.
I personally don't care whether you identify a risk and mitigation steps and the rest of the things. I do want to know where the power -- or the push points are relative to individual active ingredients so I can determine where I need to push back on the process.
One thing I would like to point out at this point just looking at the process, we've concentrated on the dietary aspects and the tolerance reassessment process. I think one of the things that became apparent, especially in the RED process at the end of the year, is there is a universe of people and uses out there, and the nonfood uses, nursery, ornamentals, and right away even some of the swimming pool type process and those things that aren't necessarily as engaged in this process as those people who have food uses.
Just another point relative to that, sometimes the needs of the individual stakeholders are different, and the point of entry in a risk mitigation discussion would be different. And I go back to the technical briefing on -- and I can't remember which product it was. But it was primarily used -- the dietary concern was for bananas and the actual environmental FATE issues associated with it that led the risk assessment process were pre-plant soil incorporation uses in the midwest on corn.
So you had two different -- a totally different universe of people that probably needed to be directly engaged in any risk mitigation discussion. So if you identify dietary drivers, they may not be the same as it would be for environmental FATE or occupational health and safety. So it needs to be looked at from that context as well.
There is also -- and I think the point that Bill made -- Bill Whitacre made relative to the economic impacts of how this process worked, just as personal experience going through the process earlier this summer on the two that have led to action by the agency, there is a tremendous number of uses of both of those products in commodities that are important to Florida. But those were not the products that were driving the risk discussion.
So from that standpoint, we didn't necessarily feel like we needed to be as engaged in the process as some of the other commodities that were there. We needed to know that the product was at risk, and our uses were at risk, and come up with a process to identify to our membership to be able to explain to them whether to go absolutely bonkers or to sit on their -- keep their powder drop for a later time and what the particular ramifications were.
So that's a plea for openness in the process, but it's also a plea for understanding from the supporting agencies to us, including the people we buy the products from. We need to be kept informed of potential outcomes of what the regulatory decision process will lead to.
Again, one thing that I would like to emphasize more than anything else is that the discussion today points out the need to have a much more formal, smaller group sit down and try to come up with some more specific recommendations to flesh out some of the potential fit falls and maybe areas that the process could be enhanced.
MR. EHRMANN: Okay. I'm going to go to Jay and then Bob, Mark and Cindy.
MR. VROOM: Number one, I think it needs to be reinforced that all of us recognize and appreciate the department's and agency's commitment to incrementally improving the refinement and user friendliness of risk assessment information. There is still great vulnerability across the board here until we have more of the science policies nailed down.
Number two, I agree with all the previous comments. There is a need for a clear separation between publication and release of risk assessment and risk mitigation documentation.
Number three -- I don't think this has been said before. I would suggest that we need a clear place in this new process for benefits consideration and factoring in on ecological and worker and other kinds of FIFRA risk issues as we commit to REDs being part of this public participation process.
Lastly, I think we need to remember that we got to this because of something called Freedom of Information Act request and threatened litigation over the Freedom of Information Act consideration, all around the fact that public scrutiny -- what preceded the pilot process couldn't stand up to public scrutiny.
And I'm curious to know now or in the workshop later that Dan just proposed, can we get some understanding about what is happening with regard to FOIA volume and activity, and has the pilot sort of substituted for some of that. And also one of our continuing concerns is uniformity of FOIA response.
MR. EHRMANN: Do you want to comment on that now?
MR. AIDALA: I don't think we know. Lois may have some idea. My sense is that the key things that are subject to FOIA are sometimes the documents that are sort of for many chemicals and stuff like that. But I don't know.
Marcia, do we know? Or Lois and anybody? I don't think we know.
MS. ROSSI: I don't know.
MR. EHRMANN: Marcia?
MS. MULKEY: I wouldn't want to give a definitive answer. I do have the sense that all stakeholders have generally accepted the pilot process as the means by which they will obtain their information. So I know we have not been, for example, getting requests for the preliminary risk assessment during the registrant correction period.
So generally the process I think has been honored by people who are interested in knowing what the documents say. Now whether that translates to something you can measure in overall volume or something, I don't know.
MR. VROOM: It just seems to me that it ought to be part of the factoring in as we go to final, which the agenda says.
MALE SPEAKER: Part of the evaluation?
MR. VROOM: Right.
MR. AIDALA: Well, something like two thirds of our FOIAs come from industry, so you may have a better insight than we.
MR. EHRMANN: Bob?
MALE SPEAKER: Do you want to FOIA our FOIA list?
MR. ROSENBERG: Yeah. I want to start out and say that I concur with everybody that said that risk assessment and risk mitigation need to be separated. I've got a couple other spins on that, but I think probably enough has been said on that subject.
I wanted to focus on a couple of specific things, though. In the existing pilot process and the proposed modification of the pilot process, there is frequent mention of consultations with HHS. And I would sort of like to take just a moment to explore that issue. By consultations with HHS, I presume that means something other than FDA for tolerance issues, that there is a place in there for discussions with HHS about public health uses, number one. So along those lines I guess what I would like to do is kind of throw out a series of questions. I don't expect they'll be answered. But I would at least like to know that they're being thought about, you know.
One, have they even been engaged? I don't know that. I don't see them here. They haven't been at a TRAC meeting. That's something that is very disappointing to my organization and those of us who view ourselves as being in the public health sector.
Secondly, when and if they have been engaged, what kinds of uses have they been asked to comment upon? Is that mosquitoes? Does it include cockroaches? Does it include rats or mice? We don't know anything about that, and that's also been a disappointment for us. Has there been any respond from HHS, in fact, if they've been asked those questions, and if so, we're not familiar with or privy to any of those responses. I think that's an area -- and maybe this goes to the next topic in the program. I think that's an area that needs to be much more fully addressed in this process.
You know, I admire what USDA has done by inserting itself in this process and playing a very constructive role in the entire process. There is not a department of non-ag that is providing the same level of input.
MR. ROSENBERG: Is there room for another cabinet agency?
MR. ROSENBERG: I think we would like to have that. Secondly, I think a ditto on this whole issue of clarity on the issue of risk drivers. But what I'm talking about are risk drivers other than dietary exposure risk drivers. You know, what we've been told mostly from the registrants has been that, yeah, we get these risk assessments, and you know what? It's residential uses that are coming up hot. Residential uses are causing us lots of problems. Worker exposure associated with residential uses is causing a problem.
I think we would like to see those issues highlighted a little bit better. I think -- and, again, this isn't -- this maybe doesn't add anything to the discussion. But I think we would also, in the interest of transparency and honesty, like to see included in this process something like this.
I know yesterday there were a couple of times -- I think, Marcia, you had said, you know, in the course of making these decisions we're cognizant of the impact that changes in science policy might have on our risk assessments. Now, for instance, if we go to 99.84, that might have an impact on a decision we might make six months from now.
Is there some way in this process that those kinds of things can be identified? Is there some way in this process that we can identify where the risk assessments, particularly on the residential side, are being based upon worse case scenarios, SOPs default assumptions, where there may be data that would be useful?
I mean, as somebody who is outside of this ag process, I can just tell you, I'm not alone in the view that we feel that we're completely disenfranchised from the process. I know that maybe non-ag uses are a small part of this equation, but I would hope that those kinds of questions are perhaps going to receive a little bit more attention in the future.
MR. EHRMANN: Any comment just on the first -- on the HHS issue in terms of at least the nature of the consultations that have taken place to date and that kind of thing?
MS. ROSSI: Well, I can answer his question two, which is when and if what types of uses have they been asked about. Any public health uses they're asked to comment on. And I think --
MR. ROSENBERG: Lois, what's a public health use? Has anyone said?
MS. ROSSI: Well, we send the uses that you ticked off. I mean, the mosquito uses. We sent roach control. That kind of stuff. And we do have the list of public health pests being developed by the public health coordinator. Arlene's effort there. So that's the guidance we've been going on. We have plans -- and, Marcia, you might want to talk about that a little bit, too.
MR. EHRMANN: Marcia?
MS. MULKEY: Do you mean plans about engaging HHS more?
MS. ROSSI: Yeah. Yeah.
MS. MULKEY: We have a public health leader within our organization. We have a public health team within our organization. And they have opened a lot of different pathways to HHS. We have identified contacts within HHS. I'm thinking I'm going to try to spend some time in Atlanta spending time with those folks.
My understanding is that they feel that their capacity to participate has been limited by budgetary restraints. But I don't think that they have been uninvolved.
While I have the microphone, the second point you made about highlighting in our documents the interplay between the risk assessment and science policy issues, and also any particulars about the residential, actually at the refined risk assessment level, and at the time when we have been putting -- holding technical briefings, we have highlighted precisely those things. And you'll see that in each and everyone of these documents.
You'll see a discussion of how, you know, several of the key -- it varies from document to document, depending on what's relevant. And you will also see discussions about the degree of refinement and the nature of the databases for the risk assessments.
So you need to -- if you haven't focussed on that, it would be helpful if you did so. I'm not sure what more we could do. I think we're doing as much in that area as we are in the dietary risk driver area in terms of highlighting and pulling out and making more user friendlier that kind of baseline information.
MR. EHRMANN: Okay. Mark?
MR. WHALON: I would like to just share some observations as a land grant representative involved in the process of Azinphos Methyl and Methyl Parathion review. And one of the first observations that I would say is that the timing of when those particular reviews came was pretty unfortunate, right in the middle of the summer. And the already over committed personnel -- the land grants -- to turn their attention to that kind of task was a challenge.
I appreciate the issue that the agency was addressing, but timing is a real challenge. And you can never get around that and there is no guarantee that February for some people is any better than July. But timing is an issue.
The density of the information has been addressed, and I agree with a lot of the comments that have been made there. I appreciate the challenge of the interdisciplinary of what a risk assessment evaluation requires from the standpoint of a toxicology risk assessment policy view. That's pretty challenging. I'm glad that Dan is up to the task.
MR. WHALON: Even though I have some toxicology background, it's pretty challenging. And sorry, Therese and Al, for where we -- out in the field, you know, didn't come up to the mark really. It is daunting in a way.
And that leads to a suggestion that I have. And that is that I think there is a real opportunity here for USDA, and perhaps EPA maybe through the pest program and OPMP, to share in an effort -- an educational effort -- through the extension or something like that to bring people up to speed on the process as quickly as possible so that as we move through -- and I guess there are only four OPs that are early in the process. We're pretty much through a lot of this process for the rest of the OPs. But for the Carbamates and the B2's and the Pyrethroids and other things that follow, the sooner we're up to speed, the better I think the process will be. And so maybe we can fund an educational process out there to get that out.
Secondly, I would like to address some of the state, regional and national network challenges that this kind of policy puts or lays at the feet of the land grant. And the point has been made that there are represented commodities and areas and unrepresented or under represented commodities. And with Azinphos Methyl you found out, I guess after the fact, that forestry and ornamentals were pretty significantly affected. And I think that's going to happen more frequently as we move through these things faster. So that's a challenge. I don't know necessarily how to get around that, except to say that time is critical to that.
Thirdly, I would like to talk about risk assessment and risk management a little bit. I agree that they ought to be separated, because at least from a land grant perspective, maybe we have a greater role in risk management than we do in risk assessment in the reality of it. And so understanding the risk drivers, or whatever language you want to use there, is key. And I point to the cherry example as an opportunity where data could be brought to bear and things could change fairly radically and quickly. And that's good. That's really good. That's an indication that the process is working well.
But the last part of that is the area that I really like to address in substance, and that is the area of bridging data. We talked a lot about bridging data at various parts, particularly in subgroup two, and at TRAC 2, 4 and 5. And the truth about bridging data is that it's very difficult to anticipate the kind of data that the agency needs on a particular chemical, short of risk drivers, and short of the risk assessment. So whether you could actually get bridging data in a timely way to have any effect is challenging.
And we tried that in the State of Michigan. It's an organizational -- a very significant organizational challenge to accomplish that, and the cost to do that is very excessive. And the organizational challenge time frame that goes with that is pretty significant.
And finally on this FOIA issue, maybe some of that FOIA stuff that used to come at EPA has been transferred to the land grants, as we move into the bridging data thing, and requires a degree of sophistication that we haven't had in the past.
For example, in the center that I run at Michigan State University, we're actually having a workshop. We're trying to organize a workshop on how to deal with FOIAs.
MALE SPEAKER: Who are FOIA-ing you?
MR. WHALON: What?
MALE SPEAKER: With all due respect to your wonderful facility at Clarksburg, what's there that anyone wants?
MR. WHALON: Well, part of it is the issue of -- if you go out and get bridging data, you've got to be really careful about how you take that data to protect the contributors of that data.
MALE SPEAKER: Fair enough.
MR. WHALON: So that's a -- so you've got to be fairly sophisticated, really, in how you take the data and what you do with that.
The other point I would make is that I think we started a process -- at least for this bridging data area, facilitated by Pat Cimino and others in the agency, Ed Zager and Marcia, as a follow up on a meeting that we had -- to effect the kind of data that the agency could use. And I submit to you that if you really want bridging data, that has to go out in a better way to a broader network of people, so that they can properly anticipate and properly develop that data, so that it can have an impact on risk assessment and risk management.
Fortunately, the data that we did in Michigan had multiple uses. Our primary goal for that data was not necessarily to provide something for a risk assessment, but to help our growers understand what they were contributing in terms of their residue on a particular crop, as opposed to looking at PDP data and looking at a particular residue picture that is national in perspective or has some relevance to Michigan in specific.
So I think in that whole area there is a lot of slippage and there is a lot of improvement that we could make. And we've come a long way in that, and I actually applaud both agencies' efforts to try to bring us in the states up to speed.
The last point I would make is that when you move into this bridging data area, or in this risk management area, partnerships beyond land grants and commodities are key. State agencies -- state agencies, processors and others get involved in a significant way, and so that the web of communication that Dan was addressing really increases. It's a fold increase in communication that is necessary.
And that is my comments.
(END OF TAPE TWO, SIDE ONE.)
MS. MULKEY: -- mean when you say bridging data. This issue of studying the impact of changing the rate, or changing the period to harvest and so forth. And what we did in both Azinphos Methyl and this Carzol situation, was we made those changes as risk management judgments, and then put in place the data requirement to confirm whether they had the impact we hoped they would have. And that allowed us to make an educated, professional judgment that it would be useful, but to then have a window of time to develop the data and some consequences if they turned out good or bad that played out over time.
So I think we may have made some progress since you last sort of focussed on how to think about that that basically allowed us to make the risk management judgment conditioned or contingent on learning the results of bridging data rather than necessarily having it in hand.
MR. WHALON: Do you anticipate that that's going to happen before the risk assessment is released or after?
MS. MULKEY: Oh, no. This was long after the risk assessment was released. This was at the risk management stage that the decision was made to in effect put faith in the fact that these kinds of measures would reduce the residues and allow us to calibrate the tolerances. And then allow the data development, which is about a six month period, to be managed by the registrant as part of the risk management implementation phase.
MR. EHRMANN: Okay. I want to -- I don't want to get into an extended back and forth on this.
MS. MULKEY: Right.
MR. WHALON: But I need to --
MR. EHRMANN: Go ahead.
MS. MULKEY: We can talk about it off line.
MR. WHALON: I just -- it just points out that the de facto result of publishing that risk assessment and identifying risk drivers is that that chemistry on that crop in that state, processed or fresh, may be dead anyway, because processors may not accept it, or a packer/shipper process may not, or a retail outlet may not, so that the bridging data may not be very useful anyway, in fact.
MR. EHRMANN: Okay.
MR. WHALON: Because it's already done.
MR. EHRMANN: Cindy and then Steve and Paul. I'll just go around.
CINDY: I'll try to go quick, John. Now I understand. It's hard when you get to the end of the -- when you're at the end of the comment, because you have points you want to make.
But I think the whole concept that you pointed out, Lois and Al, in those early phases about the smart meetings and getting USDA and the other agencies involved or engaged early, in addition to bringing in stakeholders, whether they be ag or non-ag, Bob, I think is a very critical part of improving this process. Having been through this whole process, I can tell you that we learned a lot about how valuable it is to have that involvement early. We learned a lot about the dead times, Al, that you referred to in there. And I would like to make just a couple of comments on those areas where I think that there might be some improvement.
I certainly think, like everybody has talked so far, that identifying the risk drivers or risk characterization or whatever nomenclature you want to give to this, it's a very critical process. And I think you have to link some sort of consequence to that driver. But I think what Mark was saying and what we've heard in some of the side discussions, how you characterize that consequence becomes very critical because of the impact to the grower, to the processor or to the registrant on where that is.
And so I think you're going to walk a fine line there in having to be able to identify that, look, there is a consequence for this, and so we have some incentive to get comments, but not something that causes such an outrageous scare that you get the reaction that you don't want.
I also think that the point that Therese brought up about the eco -- the EFED -- assessments and the worker assessments is really critical. What we found in going through the process was that that was an area where people really did not have an understanding of what the consequences of those risk assessments were, and more importantly where they needed to provide input. Maybe it was, this is how we do this method of application. This is how many agents we treat. Or, guess what, when we use this product, the birds aren't back from migrating yet, so don't worry about the birds.
Or whatever the situation may be, identifying in enough plain English or user friendly language so that people can provide you with some real comments about those two areas I think is a whole, because I think that's one that we haven't spent a lot of time focussing on.
I would say the Federal Register notice. I know that's the way that you have to notify these things, but it's really not a very effective way of getting the word out to people. We've put together an e-mail group code, that I would be happy to share with the agency, that quite literally now contains all the commodity groups, land grant universities, commodity groups, state agencies and people who have contacted us. And I think you get quick response on that. When I send that e-mail out, I get an instant response from somebody about different information. So if you can, add the ways that you notified people about that. I think that helps in the process.
And then I would just say that I think we need to be cautious about the time lines here. I think the amount of time that it takes for people to comment on risk assessment -- when these risk assessments come out more refined and with those drivers identified, I think that you will get very helpful comments that lead you towards risk management. I don't think -- well, I think these processes have to be separate because you're going to get things in the risk assessment comments that may change what you have to do in risk management.
It's not like you're not going to learn anything about risk management in these processes. I think you're going to hear people talk about some of those things that take place there. So I think those generally -- one other piece I think that happens in the dead time that I would want to comment on is that one of the reasons I think you have some dead time, at least from a registrant's perspective, is when we submit comments back on that risk assessment, we don't necessarily know how the agency is going to react to that. And so when you get to the risk management phase, if I don't know whether or not those factors were considered, I'm a lot less likely to propose some risk management until I hear back.
So it might be helpful from registrants, and I would think from stakeholders that provided information about how they used the product, to know whether or not the agency can accept that, or they need additional information, or it's not valid, or whatever, so that they could then go forward and provide you with something beyond that.
MR. EHRMANN: Good. Steve?
MR. PAVICH: I just wanted to add a little bit. It's a little bit off the subject, but that's the subject of alternatives. And I don't see this group, you know, looking as a focus, or a very small focus, in the area of the alternatives that could be used by growers. And as a farmer, I know that if you're going to take an OP away from me, I would like to have some kind of alternative that is a viable economical alternative that can keep me in business.
And when I look at some of the information that has been generated by the department and also EPA, I notice that it's not very sophisticated stuff. There are growers across the country that I see that are successfully using some alternatives. Even if they just cut back one OP, or two OPs, over a season could make a significant difference in the total cup and risk assessment.
So I would hope that the group here would at least look or focus a little bit more on the alternatives, so that growers can have things that can work. So I just wanted to point that out.
MR. EHRMANN: Okay. Paul?
MR. HELLIKER: Thanks. As someone who is newer to this process than even Gary is, it's interesting to see that there are some common themes, I think, that we have around this table to those who aren't even here about risk mitigation and risk assessments. So I think if we were to hear from the environmentalists that they would probably raise that issue in a similar way. I know we certainly get criticized about that all the time, about risk mitigation influencing risk assessment. So I think that's something that you can have an unanimous agreement on.
I would like to also comment you on your transparency. It's certainly one of the things that we're trying to promote at DPR. So I think the past three years have really seen a C-change in the way EPA operates. So keep up the good work.
Thinking about how you can provide incentives for organizations to participate, I think certainly making the risk assessments relative is critical. And Jim talked about some ways that we could do that. I think that that is something -- what we tried to do at DPR is to cover the exposure assessment and the environmental FATE characterization in a way that makes sense to people and that means something. It doesn't necessarily play -- demonstrate what you're going to be doing in terms of what the ultimate risk mitigation decision is, but it gives people an idea of where the biggest risks are and what the different uses are that are the biggest problem. So I heartily recommend that that be something that EPA include in the risk assessments.
And then in terms of how to make sure that grower groups are involved, I think that the USDA transition strategies are a real critical element of this. I would like to see those for all of the different crops that we're concerned about for OPs particularly, but then again all the category one compounds. It certainly fits in to something we're doing at the department in terms of providing support for -- as Steve talks about -- alternatives to the current pesticide uses in terms of both reduced risk as well as non-chemical alternatives.
And while our funding is a drop in the bucket, I think it certainly has helped to modify the debate in California. And I'm hoping that USDA can use their good offices to make sure that for all the research that happens that there be a significant increase in alternatives research, so that as we get down the road on these risk assessments and use modifications, that we do have alternatives that are economically viable and have been demonstrated on the farm, which is the focus of our program.
So I guess my last point is that I like Steve's concept of a business plan, and I would like to promote that and offer our staff to be able to do that. So if we can work with EPA and USDA to help promote those concepts, I think that's really going to help modify some of the concerns we've had that cause August 2nd's to happen.
MR. EHRMANN: Okay. I'll go to Bob, Wally and Jose. Bob?
MR. KEIFER: Okay, thank you. I do want to echo Bob's comments earlier regarding the need for the involvement of HHS in the process for public health pesticides and public health uses. To expand on his comments on residential uses, I cannot stress any more the importance of identifying the risk drivers and underlying assumptions in the risk assessment process.
It's important -- we had testified -- CSMA testified before the House Ag Committee back in August and proposed that the agency needed to establish a process to ensure that needed non-agricultural, non-dietary residential uses, if you will, which we call consumer protection and health benefit products, are preserved and aren't forced out of the risk cup by other uses or risk drivers.
So it's very important in the risk assessment process that these drivers be identified. Because as end use formulators, we are subject to the economic realities and consequences that are being faced by the chemical producers and manufacturers of the active ingredient. And it's a possibility that these non-ag uses can be forced out of the risk cup due to other drivers. So it's important that there be a process in there to try to preserve many of the public health uses that are important, you know, for our safety and so forth.
MR. EHRMANN: Okay. Wally?
MR. EWART: I would like to echo Dan's suggestion that we need to have more time and maybe a smaller group of people to work on this issue of what the details are. I think we've all heard a lot of new things today and a lot of new concepts. However, I think there is certainly more work that needs to be done. And if we had TRAC continuing, obviously this would be a great work group discussion. But we, I guess, need to look for another forum right now to do that.
As a part of that, as I was listening to a lot of things, I noticed that there were comments made that really did fit into the problems we saw as being a commodity that is in the cross hairs that actually is under a bright light through all of this. We came up to times when we heard about a commodity that was really minor that actually was a risk driver in the same AI that we were wanting to work on. And we just shook our head and thought this can't be. You know, that commodity has no awareness that they are a driver now, today, this day or that day. And so we would scramble around trying to get a hold of various people in that commodity to help our efforts out for our active ingredient.
And I think that's something that we need to -- you know, we need address, because a lot of times it's just the fact that nobody has asked anybody if there is data on that obscure commodity that you think couldn't really be the one that is causing the problem and yet on the active ingredient it has a big impact.
The other point I wanted to make is that when EPA comes out, if they do, with mitigation at some time, we are really concerned that that mitigation is reflective of the best input. And obviously we think USDA and the crop commodities themselves are really the primary source of that information, whether it comes to EPA and then comes out from EPA, or it comes in a different form.
And so I just want to point that out that there is a great concern by the grower community that we get a risk assessment and risk mitigation coming to us that has the formula for how to solve the problem that has no reality, or really everybody in the field will look at that and say, we don't understand how anybody who actually ever went into a growing area would come up with that conclusion. I want to save EPA from going through that experience, and I also want to save the process from the attitude that growers would get after reading that. So that's something I want you to be aware of, that really we do need to make sure that when something comes out, even though it is just a proposal, it isn't final, it really does make sense and it doesn't lead growers to look at it and view the whole process negatively.
MR. EHRMANN: Okay. I'm going to take Jose and Henry, and then we're going to move on to the next topic. Jose?
MR. AMADOR: One of the things that I've learned in being a part of a big group like this one is that if you keep quiet long enough, somebody is going to say whatever you had in mind that you were going to say.
MR. AMADOR: So I agree with just about everything that's being said. But this brings one point that I want to make. There seems to be a lot of consensus and there seems to be a lot of agreement on the things that are being said among this group, and I think it's obvious why that's the case.
But there seems to be a lack of observation from the public interest group that walked out of the process. And although some of the opinions may be real opposite to the one that most of the people here seems to have, I still think it would be a good thing to have that other part as being part of the process.
So I was wondering. I think in the previous TRAC, Jay made kind of the same remark, you know, that he regretted other people had left and wished they would come back. Has any effort been made to get some of the groups? Maybe not the very same people, but some of the people from the public interest groups to be, you know, part of the program?
And if there has been, if that's the case for the post-TRAC or whatever phase -- you know, whatever way the POST-TRAC runs -- is an effort going to be made to make sure that, you know, we have some of the observations and comments and opinions of a group that I think is pretty important?
MR. JOHNSON: Well, I mean, that will be something that will be critical to talk about in the remaining time that we have as we talk about what are the activities that follow onto this process, absolutely.
MR. AMADOR: So I assume that an effort is going to be made to make sure -- because a lot of those people are part of the PPDC, which is kind of an extension of what we do here at the TRAC committee.
MR. EHRMANN: And the other thing, Jose, too -- and you mentioned one of them. But any of these things that we do -- we do a workshop. We do public meetings. We just put out -- you know, there are lots of different mechanisms. Again, that's a nice segue to the next topic after we hear from Andy.
But obviously we have -- you know, it's a duty and a responsibility and it just makes sense to do what you just said. So we plan on that. We have to do it. We will do it.
MR. AMADOR: And one last observation, that I know you've all been hearing my name a lot lately. I just want to make clear that if you hear anything about Jose weakening, or Jose drifting, you know, it has nothing to do with me.
MR. EHRMANN: Andy?
MR. ANDERSON: And I know south of Florida. I wish I could be there.
MALE SPEAKER: I just have two observation issues. I think from the state public health perspective, getting more information out earlier is good, and we would certainly support that. I think our only concern would be not to push that into the kind of closed component, that I think it really has to be out to the public component as well, so that it doesn't get moved into early engagement that doesn't involve the general public as well.
The only phase that I would probably -- or that we would like to see added to this, or be at least mentioned in part four, and that's kind of an evaluation follow up component. There have been a lot of efforts gone into the pilot projects. This is probably the most sweeping impact on pesticide use in a long time. And I think it would be, you know, really a shame if we did not move forward with this with an evaluation component to actually document through the dietary surveys that in fact there is less of specific agents in the diet and that this has worked, again, on the HHS -- the person sitting next to me here from the laboratory.
I think there is -- and it was pointed to, not necessarily here, but in other comments relating to the Parathion issue of Ann Haines' bio-monitoring data. I really think we need to not just implement this and then move on, but in fact keep the public aware that in fact this went on, agreements were made and that in fact the food is safer.
Also, the thing that we want to be sure on the public health side is despite Jon Jessen saying that he has never had any pesticide poisonings, other than a few perhaps skin abnormalities, what we want to be sure is that there is a system in place to see that as we move to different agents that we're not trading one type of injury for another. So that we want to be sure that we're not getting more dermatology problems amongst workers, although we're not getting acute OP type poisoning.
So I really think it's important that the agencies keep in mind that you need a monitoring surveillance. The manufacturers, almost like pharmaceuticals, have a post marketing survey type activity. And I think it's important that we let the public know that in fact hopefully pesticide poisonings are going down as a consequence of this type of action, as well as other actions being taken, and that it's not just an enforcement issue of good product stewardship. We don't want these products necessarily in the food supply. Obviously we don't want to make people sick. But I think it's important to point out that efforts are being made and that they are being successful. I mean, we really want to show that this has had more than a theoretic impact from the regulatory standpoint.
MR. EHRMANN: Thanks. Okay. Let me -- I know from talking to the co-chairs at the break that they're going to make some comments in their closing remarks for the whole meeting about next steps on this topic we just talked about. So rather than do that now and then repeat it, we'll save that for their closing closing comments right before one o'clock.
Let's turn to the next topic on the agenda, which is, as it's labelled there, post-TRAC activities. And we've had a number of I think very helpful comments already throughout the day and a half about different folks' view on what might happen next and the need for certain things.
Let me kick this off by saying that I think it would be very helpful for folks to think about -- to express your thoughts relative to what are the kind of functions that you think would be useful to have going forward, as well as comments you might have about structure. I think what the agency and the department have asked us to do -- Meridian to do -- is listen carefully to this discussion, carry on some other discussions with you all and others following this session, and come back to them with some suggestions and some options about what might happen next.
So we're not going to make any decisions today about, yes, this is not -- you know, should TRAC continue or not. The charter for this particular group is up. It was extended one meeting for this meeting. There is going to be something -- if something else happens, it's going to need to be kind of reconstituted or re-initiated. Obviously it could look a lot like this or it could not look a lot like this.
But I don't think the department and the agency plan to make any decisions today. Obviously they want to get your input, and ours, to think about the process and come back to them with some options, and then they'll make some decisions about what will happen next. But there will be an explicit follow up. You're not just going to be left kind of hanging in terms of the next steps. You'll be, you know, part of that thinking.
So let's entertain that discussion, both in terms of what you think needs to happen and the kind of characteristics of things you think need to happen, and if you have thoughts about a particular structure, obviously, you know, we welcome those as well as part of this discussion.
Bill? It seems like you have to start every discussion with somebody named Bill.
MR. SPENCER: There are a few of us at the table. The organization I represent, American Farm Bureau Federation, is also part of a larger coalition called the Implementation Working Group. And that group -- American Farm Bureau and that group sat down and came up with sort of a laundry list of things that we felt were important for us to continue in some kind of forum, as this process obviously has come to an end, as John says, no matter how many people we have begged and asked and pleaded for this process to continue.
So a lot of you have this laundry list, or a lot of you have seen this laundry list. But for the benefit of those people that haven't seen the laundry list, I would sort of like to go over it, as I think it represents the views of a lot of people sitting around the table, and it also represents a view of a lot of people, you know, throughout this country as we go about, you know, figuring out how to get through the implementation of the Food Quality Protection Act.
Generally, you know, we believe a forum for ongoing exchange among FQPA stakeholders and federal agencies should continue in some form, including continued improvement in transparency of actions and processes as it relates to EPA, USDA and FDA. And this time around, we feel that HHS definitely would be included in this process.
We think we ought to continue the work that we started today in the standardization process for public involvement in individual pest risk assessment and risk management actions. I think we started a good process today, but I don't think anybody is going to leave this table thinking that, you know, we know exactly, you know, how that process is going to go on.
We think that we need to clarify the policy for assessing carcinogenic potentials of pesticides. We think we need to identify the uncertainties associated with the timing of tolerance revocations and application of the FQPA safe harbor provisions for treated food products in the channel of trade and recommend a policy to address those uncertainties. And we talked a little bit about that with Bob and, again, we're not going to leave the table knowing really how we're going to address this issue.
We need to determine the appropriate forum for resolving issues of worker protection from pesticide related risks. We need to determine critical needs for reliable data in risk assessment under FQPA to avoid use of default assumptions in invalidated models and set in motion the regulatory mechanisms for obtaining that data. And while we're part way there, we're still not all the way there. And I think, you know, a group like this could be of valuable assistance to the agencies mentioned earlier in getting this done.
We need to establish a process to assess and review on an ongoing basis risk management actions and their refinements after they're developed by EPA. And, again, I think it goes back to some of the comments made earlier about, well, hey, you know, we've assessed some of these products. We're assessing some of these products. We don't have all the science policies in place. In fact, we only have one of them in place. As these science policies fall into place, you know, what about those products that we've already assessed. You know, how are we going to go back and look at them, you know, when all of these policies finally get in place.
A complete development of the various FQPA science policies and an evaluation of the application of real world situations. I think that's, you know, an important consideration for this group.
The determination of how residential exposure assessments will be handled pending the submission of reliable exposure data.
By continuing a TRAC type process, USDA's role will continue to be enhanced in the decision making process in pesticide regulations and in handling input in the process from growers and other pesticide users. We don't want to see this kind of forum go away, where USDA is no longer considered an equal partner with EPA. We want, you know, some kind of forum that we can have these two groups sitting up here at this table as equal parties in this FQPA implementation. And we think that is terribly, terribly important to continue, and maybe one of the main reasons for wanting to continue some kind of forum, whether we call it son of TRAC or, you know, whatever it is.
MR. SPENCER: You know, that it go on. And as I mentioned earlier, we need to define the role of the Department of Health and Human Services in the regulation of public health pesticides. I think this is absolutely critical. This outbreak of encephalitis and this other thing that these mosquitoes are carrying, and all these birds are migrating south and they're going to come back.
You know, I mean, how far is this thing going to spread across the United States, and what kind of pesticide tools are we going to need to control this. I just don't think that we can have another forum without HHS sitting at this table. They have to be involved. They're no less or no more critical than any of the other agencies or any of the stakeholders that surround this table.
I think that we need to evaluate the economic impact of FQPA implementation on various affected industries. I know there is no cost benefit analysis involved in FQPA. But I want to know -- I'm sitting here still totally convinced as a clod kicking farmer, you know, that you are virtually going to force making the wrong decisions in the implementation of FQPA. You are going to force the production of fresh fruits and vegetables offshore, and we're going to be importing more and more and more of our fresh fruits and vegetables. It could end up being a hundred percent in a worse case scenario.
You know, what are the cost benefit analysis of us getting into a situation where we have to import all of our fresh fruits and vegetables. I think it's frightening, you know, based on the fact that we've still got third world countries that we import food from that still use night soil, you know, much less the e-coli and salmonella problems that we've had from Guatemala, and raspberries and Mexican strawberries and, you know, things like that.
I think this needs to absolutely be looked at. I don't think you can go about taking the safest food supply that we have in the entire country and make it safer by forcing the production of these fresh fruits and vegetables offshore to third world countries. I think you are just absolutely kidding yourself, you know, if you think that's going to make our food supply safer.
And lastly but not least, I think that we need to further define what are acceptable transition strategies. And I think that this group has done a good job in beginning to work on that, but I think there still is a lot of work to do. Again, you know, I can't think of a better kind of forum than what we've got right here with all the affected stakeholders sitting at the table, and all but one of the necessary government agencies sitting at the table, you know, for us to have a free exchange of ideas to help not only American agriculture but public safety.
So those are my reasons for this maybe being the seventh and final TRAC. But it's also my reasons for hoping that, you know, we get back together again three or four months from now as the first meeting of the son of TRAC or whatever we're going to call it.
MR. EHRMANN: Thanks, Bill. Let me -- Bill has provided I think a good list of a number of ideas, and I'll invoke the I agree or don't agree with Bill rule or request again.
MR. EHRMANN: Again, because we've got a lot of folks who want to make a comment, I want to make sure I get everybody in. And, Cindy, I'm going to go to you since you waited so patiently last time.
CINDY: Oh, aren't you nice. Thank you, John. I guess I have a little bit different perspective, but may come to some of the same conclusions. Gowan was fortunate or unfortunate to be on the first federal advisory committee looking at FQPA, which was the Food Safety Advisory Committee. And I certainly attended all the PPDC meetings and then TRAC.
And I would have to say that I think that you've gotten some very valuable and candid input from this committee. And with all the experience that you have here at the table, the level of knowledge that is here at the table, I think it would be a shame to have to throw all of that away, when I think there are still some very serious continuing issues that need to be discussed.
That being said, I can lead on Lois' face every time I come. Oh my God, not another TRAC. And I know that it is a huge drain on resources for both USDA and particularly EPA. And so I would hope that there is some compromise format that we could come to.
One idea that I thought was working very well with TRAC that I think we somehow got away from is this work group concept. We had a work group one that was looking at risk assessment type issues and transparency and those things, and work group two which was looking at risk mitigation. And I think that we kind of assumed that that process wasn't working, because they weren't seeming to move along in a way that was fast. But I think that was more a factor of where we all were in our understanding of what was going on with risk assessment, rather than that that wasn't necessarily a good process.
So I would throw out that possibly a way for this committee to continue would be to have the work groups meet more frequently, and have the full TRAC meet less often. And there might be a way that you could get some focused input on some of these issues like transition and cumulative risk assessment. I think these whole science policy issues, where we are with those. How those are evolving. You know, what the impacts of those are. And certainly this new process that we're talking about in how we work through that isn't working.
And getting information might be a way to allow the members who have put a lot of time and personal effort, I think, into this committee, and I don't feel like we've seen it to closure yet. And we would like the chance to see that.
MR. EHRMANN: Okay. And, again, let me ask folks as you reflect on kind of the functions you think you would like to see addressed, as both Bill and Cindy there, if you have comments about structure, work groups, number of people, frequency of meetings, as Cindy has suggested, you know, please comment on those kinds of -- those issues as well.
MR. VROOM: I agree with Cindy and Bill, and would add the thought that one of the keys to success has been the commitment of the senior political officials, Rich and --
MR. VROOM: -- all of you.
MR. EHRMANN: The entire line of succession at EPA.
MR. VROOM: To be named later or whatever.
MR. VROOM: And so to get HHS involved, I think would require a commitment from that agency and department at that level. And I would hope that we could make that point, and certainly those of us who can attempt to get political support for this from various corners would be committed to doing that. And I think it's very important to elevate it to that level.
And none of this, I don't believe, any of us are saying in any way to suggest that Bob Lake hasn't been a terrific asset to all of this process. He just needs more cover and help. So that's kind of where we're coming from.
More predictability in terms of schedule and timing. This is going to be more permanent, the next whatever it is called, than what we have had to date in two different advisory committees on FQPA. And I think clearly we are going beyond just FQPA. We now see that the re-registration eligibility document and all the related risk factors are coming into focus.
So I recommend that that be encompassed and that the work group concept be spliced into that more efficiently and predictably as well. And I have a suggestion for a name. It just occurred to me that TRAC is just cart spelled backwards. So the committee for advising on re-registration and transition -- and I think the T for transition would help convince some of those who left to maybe reconsider and come back. And I'm willing to commit the ACPA membership to supporting the word transition in the title.
MR. EHRMANN: I thought you were going with the cart before the horse.
MR. EHRMANN: And then having the horse lead.
MR. EHRMANN: Mark Greenwood?
MR. GREENWOOD: Yeah. I wanted to raise a question about whatever this new formulation is, about whether you want to use the notion of it being a formal advisory committee or not. I think that's the key question.
I think under the laws that apply, you could certainly set it up as a formal advisory committee. Certainly if there isn't a cross section at the meeting, if you've made a reasonable attempt to try to obtain that, you can do that. But I think if there isn't a reasonable cross section of interest at the table, it does reduce the value from a practical point of view as an advisory committee.
And I think -- I assume from what Jim Aidala was saying earlier, there is going to be some effort to try to bring in these other factions. It doesn't have to be the same individuals, but certainly the same interests to bring that into this group. If that's possible, then I think that would make sense perhaps as an advisory committee.
But let's just recognize that if that doesn't work, a plan B means you can set up essentially the same framework that you have here. It's purely a sustained stakeholder involvement process. And perhaps that becomes a better model if you can't get a broader cross section.
MR. EHRMANN: Okay. Bob Rosenberg? Did you have your card up?
MR. ROSENBERG: Yeah.
MR. ROSENBERG: I wasn't expecting to get called so early.
MR. EHRMANN: I'm trying to give you a little more respect here, Bob.
MR. ROSENBERG: Thank you.
MR. EHRMANN: You said you didn't feel valuable.
MR. ROSENBERG: Not something I'm accustomed to.
MR. ROSENBERG: You know, I think one of the things that has made TRAC valuable has been -- you all would say you appreciate the valuable input which we provided to you. I think the flip side of that is for many of us having you there talking to us and explaining to us what you're doing has done a lot, particularly on the ag side --
MR. ROSENBERG: -- to provide a comfort level and a sense that a great deal of progress has been made. And in fact I believe that it has been an especially valuable exercise for those of us on our side of the table to have heard and seen you say those things.
I think the frustration that I feel, and I probably expressed before and will continue to feel, is that that sense of comfort and progress which has been made in the areas of dietary exposure and science policies associated with food uses, things like a process for involving stakeholders, there has been enormous progress. We on the non-ag side don't feel as if it's moved anywhere near as fast or as far, and certainly HHS' involvement will be important.
But I would add that even for the folks I represent, there are nonpublic health pesticides that are affected, things like termiticides. Now I don't think anyone is going to argue that termites are going to pose a public health risk. But then there are all the folks like golf course superintendents and lawn care operators and tree care guys who also feel disenfranchised. For the reason of dealing with that unfinished business, I think it's valuable to go on.
I would just add one other suggestion on this sort of non-ag side. In addition to this process, perhaps it would be useful for you all to consider the convening of a workshop for your non-ag partners, where some of these issues could be talked about and talked through.
And I think that's about what I think.
MR. EHRMANN: Okay. Nancy?
MS. RACHMAN: I want to second Cindy's proposal for using the work group framework. I think we have made some real progress towards transparency in those work groups, and we also managed to queue up some issues for the larger group. So it was a very useful process.
I would like to propose that one such work group going forward might be the risk characterization work group, and that that group be charged with helping both agencies and stakeholders to achieve the transparency that we all need, so that people understand the framework in which risk mitigation or transition or whatever else will be undertaken.
MR. EHRMANN: Okay. Bill Lovelady?
MR. LOVELADY: I said yesterday that I thought that the lack of resolution of all of the science policy issues was the most compelling argument that I could think of for some sort of continued stakeholder mechanism. And I still think that.
Elin I think made a point earlier today that if in a year from now, if we have all of these science policy issues resolved, then a lot of us might feel more comfortable with things that come afterwards. And I think that that is really very basic. These science policy issues have been viewed from the very beginning as very important, and I think it's important for us to continue to watch the evolution of these science policy issues. So I think that's the reason.
I made a statement at the -- my very first statement at my very first TRAC meeting was that I would have thought that we would have been successful if everyone there had acknowledged the fact that we have the safest, the most affordable and the most abundant food and fiber supply in the world, and that nothing should be done to disrupt that fact.
I was very heartened to hear Therese say something yesterday about the importance of keeping food affordable, especially for the less advantaged people in this country. Everyone of us in this room can probably feed our children good food, nutritious fruits and vegetables even if they get very expensive, because most of us here are middle class people. If we do something to even minimally increase the cost of a nutritious diet -- and what we're talking about are things that have effects on food prices. If we do that, all we will do is push the lower third of our country further into a macaroni and cheese diet.
And I think it's important that we continue and that there is ample opportunity for everyone involved in the production of food and fiber to this country that we see that that does not happen.
(END OF TAPE TWO, SIDE TWO.)
MR. SPENCER: I remember when this process
first started, FQPA, to a lot of us meant farmers quit planting anything. I think we've come a long way. Bill listed a lot of the unsolved and unanswered questions. And I agree with Bill. We don't want to shift the playing field outside of this country. I think none of us should ever forget that this is the Food Quality Protection Act.
And I think we need to move forward with that, and that any slight change in production practices forced upon the growers, they'll just quit. They don't have any choice right now. And we want to keep that production here. I know that I'm much more comfortable when I can go to the store and know that that food has been grown here in the United States, because I know we're the most regulated and controlled growers anywhere in the world. And that gives me a great sense of comfort.
So we need to move forward. I don't know if you want to call it the son of TRAC or cart or traction or whatever you want to call it. But there needs to be something in a mechanism that keeps all of the people who have been involved and are concerned, so that we can maintain our chance to be involved in this process.
MR. EHRMANN: Okay. Jim?
MR. CZUB: Everybody has seemed to put this so eloquently, and I mirror all their sentiments. And from a corn grower's perspective, I feel that we're really only about half way through this process with the water and residential left basically undone.
With corn growers growing roughly 80 million acres of crops with just about all of those pesticides ground applied, our great fear is the water quality side. And we would fully support an extension in some form and the participation in that extension.
MR. EHRMANN: Okay. Paul, then Wally and Mark.
MR. HELLIKER: At DPR we're going through a similar process right now trying to figure out what we do with our advisory committees, so maybe some of the things that we've been discussing would be helpful.
I think the purpose of a committee like this is to guarantee a couple of things. One, that there is accountability for the agencies that these committees advise and that also that there is an effective way of exchanging information. I think when we think about what should follow TRAC, we need to really decide whether this is the most effective means to do both of those things.
Certainly one of the things that we're looking at for our advisory committees is how do we make sure that all the stakeholders participate. How do we make it something that is of interest to them. Typically when you develop a committee, you do it to assign tasks to that committee, and you want to make sure that the committee is the right size and has the right mission to be able to accomplish those tasks. Because otherwise, the third item, which is the participants need to feel like their time is well spent, may not necessarily happen.
So I think those are all things that you should keep in mind about what should be the function of any kind of organization like this. Because you could accomplish this in many different ways. You could have public forums. You could have dialogues over the Internet. And you really need to think about what it means to bring people together and to use their time like this to help make sure that the Food Quality Protection Act is implemented.
MR. EHRMANN: Good. Wally?
MR. EWART: I would like to echo all of the comments I think I've heard about the reasons for keeping TRAC going. And I guess my emphasis would be that work groups are an extremely effective way to move forward on many of these technical issues. And we have a lot of technical issues left. Cumulative. We have all the science policies to implement. And at least speaking as a commodity that's already been in some of the decisions, we have just scratched the surface for what needs to be done.
And so to -- at this point I think that the course was laid out and everybody is comfortable with knowing that it's a transparent, open process that follows good science. I think we have quite a ways to go, and I think that's the reason, at least as I see it, for continuing TRAC.
MR. EHRMANN: Mark?
MR. WHALON: A year and a half ago, Vice President Gore essentially sent us all invitations to a ball. We had six dress rehearsals and now we're canceling the main event, cumulative analysis. I feel a lack of closure. And I think that we've accomplished a lot. I've been actually amazed at the amount that has been accomplished and the kind of effort the agencies both put into this, especially EPA. It's commendable.
But the key public issue is still out there. And if you look at the language in FQPA, it says the Administrator must consider. What does that mean? How is that going to be done? Who is going to do it? There is lots of room for mischief around that, I suspect. And how that actually happens, I think agricultural and non-ag uses of pesticides are imminently going to be affected.
The last part I would like to say is really an information thing, in that OPMP and USDA have funded some events -- or some things that are just coming on-line that are going to help and provide some new resources in this process. And one of those is a resistance database that just went on-line yesterday, which outlines resistance and resistance development and ties it to EPA's -- some of EPA's published and available information on registrations.
And that database is going to grow, and that database involved the private sector and the public sector land grant communities, and specifically Oregon State, Cornell and Michigan State. And I would like to give you that web page as you develop resistant inputs into this process as we've heard several times yesterday and today. That web site is wwwcips.msu.edu/eid.
There are also a couple of other things on that database -- on that web site -- that may be germane to cumulative analysis as we've applied them in Michigan. One is an analysis of mass -- some mass ag statistics. The Gianessi OP database is up there in a database format, so you can load pieces of that. What is registered, part of EPA's PPIS is there. Links to Michigan Department of Agriculture's database are also there.
Addressing some of Steve's comments, there is an array of alternatives that are not the kind of alternatives that are listed in the document that we had presented yesterday also on there. And it links those to some of the replacements in the IR-4 database that are up through Bob Hollingworth's efforts, and the OPMP pipeline efforts that have gone on are linked there as well.
So as we head into this cumulative kind of analysis, one of the things we're trying to do at Michigan State University is get cumulative to a pest crop level so we can understand what will happen, or potentially happen, in our state.
And so those tools are now available. I encourage you to use them if you can.
MR. EHRMANN: Okay.
FEMALE SPEAKER: What was the web site again?
MR. WHALON: It's wwwcips.msu.edu/eid. That gets you into --
MR. EHRMANN: You can put it up on the flip chart.
MR. WHALON: wwwcips.msu.edu/eid.
MR. EHRMANN: Thanks, Mark.
MR. WHALON: And that's going to give you a page. A page will pop up and it'll have four different things on it: the resistance database, cumulative information, replacements or alternatives, which include IR-4, some what we're calling right now non-IR-4 alternatives, use analysis and a draft on the cumulative stuff.
MR. EHRMANN: George?
MR. WICHTERMAN: Thank you. I would like to endorse Bill Spencer's remarks, as well as Jay's and Bob Rosenberg's, in reference to our non-ag and public health issues. And I know as a member of the Lee County Mosquito Control District -- we're also a member of the American Mosquito Control Association. And this forum has established a nice dialogue between the EPA and the USDA, and that I would hope that whatever forum this takes place in the future, that public health issues will be at the table at whatever size you all deem necessary to be, and that we can be a participant in the process.
Additionally, it would be nice to see the Department of Health and Human Services be a co-chair, perhaps, along with USDA and EPA as well. And I would also like to be a part of the workshop for the non-ag and public health uses if that gets off the ground as well.
Additionally, in the public health section of the FQPA, there is a mention about benefits of public health pesticides, and I mentioned this to Lois Rossi last week at our stakeholders meeting in Orlando. And it would be nice to see if we could have a benefits assessment enumerated along with the risk assessment as it is posted on the web page as well. At least when people are reading this, the external sources see only the risks. They don't understand what the benefits of the pesticides are. And it would be nice to see BEAD come through with an assessment, if possible.
MR. EHRMANN: Okay. Margaret?
MR. WHALON: Could I also make a comment on that web site? I'm sorry to interrupt. But that's also -- you can also get that through USDA's web site. That's linked together.
MR. EHRMANN: Okay. Good. Margaret?
MS. WITTENBERG: Well, I'm going to echo the hope that we can continue this process. My role has been really different than most of the other members of the group, because even though I'm not there as a registrant or a grower or whatever, as a retailer the buck really stops in my area, because I have to justify every single thing you guys do to all our customers. And believe me, we get people talking to us all the time regarding every single thing that everyone does, including the government.
And I think what I've learned here is just a tremendous amount of information about all the challenges and all the excellent work, too, that's been going on. And I would really like to see this continue. And I think the last meeting is where we really started getting some momentum. We had a rocky start just kind of feeling who are we working with and do people really want to have this work and so forth. And I think last meeting was a real change, and I think we're on a momentum and I would hate to see that stop.
I do agree with Cindy that the work group situation does work. I think the early ones didn't work because we weren't at that place. We weren't ready to really talk with each other. But I think work groups on more transition -- detailed transition issues, especially in regards to the farmers.
I am concerned about the potential increase in imported products. I am very, very concerned about that, and I think a work group on that would be interesting, as well as information outreach for consumers on how we're going to get this information to the consumers. Because believe me, nobody has a clue what FQPA is out there, except for us right here.
And then having the whole TRAC come back on a periodic basis, not as frequently perhaps. Certainly the work groups can take care of that. But I think the input of everyone and hearing what the work group has to say is extremely important, because as we've seen in the last couple of meetings, I think we've come a long way in hearing all of the messages and moving forward.
MR. EHRMANN: Dan?
MR. BOTTS: Thank you. As one of the primary authors of the letter to Mr. Gore that was sent on behalf of IWG, I totally endorse all of the information that's in there.
MR. BOTTS: But to build upon that and just give you an appreciation of where some of the information in there came from, about a week before that the Minor Crop Farmer Alliance met as a technical committee to provide recommendations to our organization, which was instrumental in developing Title II of the Food Quality Protection Act, which hopefully we'll get around to talking about implementing at some point in the future rather than the reassessment process. And they identified six priority areas that we were going to work on over the next year and a half relative to implementation of FQPA.
I think it's important to put it in a context, because we adopted a statement several years ago where our group was focussed in this effort and what we wanted out of the process. And those four goals still remain the driving force behind MCFA's activity. And I would like to go over those one more time, just so everybody understands where the Minor Crop Farmer Alliance has come from -- or coming from in this aspect.
First and most importantly is that implementation of FQPA will result in a sound scientifically based regulatory program which is appropriately protective of public health. And that's the overriding consideration of everything we do. Secondly, implementation of FQPA will be done in a manner to minimize disruption of existing pest management systems. Implementation of FQPA will be accomplished in a manner to protect due process rights of all stakeholders. And number four, implementation of FQPA will provide appropriate transition periods for impacted pest management systems.
We looked at over 150 potential action items for next year and boiled it down to six priority areas that we decided to recommend to the Association to work on. Those were, and not in any necessary order: transition and mitigation strategies; tolerance revocation strategy, including the safe harbor provision; USDA pesticide program funding, staffing and direction; input and follow up on EPA science policies; continuation of a stakeholder TRAC like process and forum, and the last one, assure that regulation of pesticide residues are based risk assessments rather than just the presence of detectible residues, which is an issue that came up in some of the earlier discussions. All of which dovetail into the continuation of the stakeholder TRAC like process, because those are all the same things that we've been talking about for the past several days.
I also think it is important to identify what our goal statement was for this forum if it goes forward. We are going to advocate to obtain an ongoing formal multi stakeholder forum for input to the agencies on FQPA implementation, including tolerance reassessment and managing the consequences of FQPA actions, including those related to non-organophosphates.
Key features of the stakeholder forums include the opportunity for participation by all relevant industry and non-industry sectors, hopefully with a more manageable size -- that goes to the work group issue, I think -- a formal standing to assure appropriate attention from the agencies that we hope will still co-chair and be involved, and hopefully with the additional of FDA as a co-chairperson in the process. Either HHS or FDA and let them sort out how that works.
I just wanted to put that on the table. Scheduling of those issues need to be worked out. Being someone whose boss would like to see more in Orlando than in Washington, I would advocate a more condensed meeting schedule. But we are committed to the process, and if it takes six meetings, eight meetings or ten meetings, we'll be here.
MR. EHRMANN: Thanks, Dan. Rick?
MR. JARMAN: I think the obvious sense is that there is a desire to have something continue. One of the things that I'm curious about is -- and it's a question to the agencies involved.
Are there any restrictions on the form that you may have to consider for a continuation? I understand this is chartered under FACA. Are there some restrictions, either from a policy or an over arching thing that we have to think about in terms of expectations once we leave today? Are there some things that you can't consider as a continuation, or that you can?
That's one. The other is in terms of the cadre of people that are here and the education that went on. It would be unfortunate to lose that. But on the same token, understanding that to keep a sustained effort by a lot of busy people may be difficult. So you may need to think in terms of some fluid participation, some way of keeping that so you don't depend on the same people all the time. But also not to go through a re-education effort. Try to avoid that, too.
MR. EHRMANN: Okay. I think on your questions, some of that will be incorporated in the closing thoughts. Steve and then Henry and then we'll take a couple of public commentors and wrap things up.
MR. BALLING: Well, I think what's really shocking is that this has been successful, because I don't think it was ever intended to be.
MR. BALLING: It was born as a political cover, face it. And in fact it was designed not to be functional at 55 members originally. Thank God a few people left so we could actually make it manageable.
MR. BALLING: I think actually that this group has actually worked in spite of itself. Did Lois just leave?
MALE SPEAKER: You ran her out, Steve.
MR. BALLING: I can't believe it. No. I mean, really the reason this was successful is because of the hard work of EPA, and in particular Lois and her group. And it's because they actually gave it a good faith effort. Not because the original design of this was ever intended to do what we have actually accomplished.
And I think that's an important issue. And to that effect, I would actually be more interested in Lois' opinion about how this could be successful.
MR. BALLING: Other than stopping it, because I know she said that. But how we could continue to move this forward and continue to make it transparent from EPA's perspective.
MR. EHRMANN: Thank you. Henry?
MR. ANDERSON: That's a hard act to follow.
MR. ANDERSON: I've just been on a lot of committees, and I think there comes a time when something has been accomplished that you need to look as to what are the other options to move on as opposed to keeping the committee operating. And I know that both agencies have multiple committees of various flavors and types.
I think it's important to look at what at least I see is the key elements to this committee. And one is, very few committees have joint responsibility of multiple agencies or departments. And I think it's been key to have both perspectives represented here, and I want to commend you all for attending. And, therefore, I would hate to see this move to one agency or the other. I'm not sure participation would remain as high.
So I would say one thing to look at is, are there existing committees where this could be maintained. I know there is the PPDC. I think if you look at work groups, those could probably be subsumed by others that would help you, perhaps administratively. But I think to me the major issue is, is there a forum. You've got, too, I think, if you tried to extend that to have another agency or department involved, then you start to look for fault lines, because getting three high level groups together at the same time becomes very problematic. But I think to have participation would be key.
So I think that's the thing I think you really need to look at. I think what really made it work was the commitment of both partners here in organizing this, and I think, then, that kind of kept the group largely in line, because recognizing there was that major commitment to make it happen.
So I think there were good things. We've made great progress. I think it's started. I think you need to look at how you can either maintain this through another mechanism, rather than just self perpetuate here.
MR. EHRMANN: And as I mentioned at the outset of this agenda item, we will be -- we meaning Meridian will be talking to you all individually more about these ideas, following up and floating some options, and talking to folks who aren't here, keeping in mind the kind of characteristics and criteria, as well as potential structural options, that have all been suggested. And I'll allow -- the co-chairs will address this more in their closing comments. But just so you know what the next step is there.
What I would like to do is take the three public commentors and then have the co-chairs make their closing remarks. And I would ask each of these folks to keep your comments just to a minute or so: Gabriel Ludwig, Gail Arce, if I'm reading that right, and Vern Highly.
MS. LUDWIG: Dear members of the Tolerance Reassessment Advisory Committee, Mr. Rominger and Mr. Guzy. My name is Dr. Gabriel Ludwig, and I'm speaking on behalf of the Western States FQPA Coalition. The membership of the Western States FQPA Coalition consist of grower groups, pesticide applicators, processors and other pesticide users located in California and Arizona, just to give you a rough idea of how it covers around 50 percent professional fruit production in the country. I'm also speaking as someone who has attended all of the TRAC meetings and has been following the implementation of FQPA for growers.
Let me first say, as has just been more explicitly said, that my skepticism of establishing a TRAC has not been borne out. The intense participation by USDA and EPA and individual members of the TRAC committee has led to a substantially greater understanding of what is involved and necessary for the implementation of the Food Quality Protection act.
Progress in several issues has been made. The need to explain and comprehend the process of conducting dietary and occupational health risk assessments has increased the understanding of all the participants. Discussions and expressions of needs by all the participants has led to a substantial increase in the public's ability to be involved in the process.
The increased transparency has provided growers with the option of participating earlier in the process. The discussions are helpful to EPA and USDA to find the issues and allow them to focus on the areas where clarification and additional efforts were particularly necessary. Growers appreciate the interest that EPA has been giving to the TRAC process. And the few times that TRAC has gone outside of the beltway has been beneficial for increasing the awareness of growers across the country.
Because of the positive outcome for all involved in the TRAC activities to date, the Western States FQPA Coalition would encourage the continuation of some form of TRAC. There are still some issues of great concern to growers that have not been fully discussed, and you've already heard more than I just mentioned.
How will the EPA handle transition issues? USDA is working on them, but it is unclear what process the EPA will use to consider growers' interest in those decisions. Clarify how growers can be involved in any risk mitigation decisions. Verify the policy for assessing and responding to potential drinking water concerns. Further discussions of the occupational health exposures are necessary.
While the EPA has provided the opportunity for notice and comment on many critical science policy issues, most of those policies have not been finalized yet. And for growers to continue to look to TRAC for assurances that all interested parties have a forum to discuss these issues.
I thank you for the opportunity to make these comments.
MR. EHRMANN: Thank you. Gail? Is Gail here? Yes, there she is.
MS. ARCE: My name is Gail Arce. I'm a toxicologist with Griffin. And I have more of a request than a comment. I think we all know that risk is hazard times exposure. And the smart meetings in our experience have been wonderful. It's an opportunity to begin that dialogue, because the smart meetings are really focused on usage and exposure.
And what I would ask is, if it is possible to extend those smart meetings to begin to discuss the toxic endpoints. The decisions that are made by the higher committee. The 10X factor. To open that up to make it a little more transparent. The selection of study to match an endpoint, whether it's acute or chronic, isn't always a logical decision. It's certainly not an objective decision. There's a lot of subjectivity involved and a lot of decisions made in terms of what a NOEL is. My experience has been across the board that if I submit a study to California or Europe or EPA, I don't always have the same NOEL selected on the same study reviewed by very competent scientists. It depends on those agencies.
So there is a certain amount of subjectivity that revolves around these decisions. And I think it would be appropriate to open those up to a smart committee or a smart meeting type process to allow those issues to emerge and to be discussed and to be resolved.
MR. EHRMANN: Thank you very much. Vern?
MR. HIGHLY: Thank you. I'm Vern Highly. I am on the Executive Committee of the Minor Crop Farmer Alliance, and I'm also on the Steering Committee of the IWG. And I also work with the Crop Protection Coalition on Methyl Bromide.
On behalf of my clientele, which is pretty far ranging from cotton to asparagus and the Imperial County, in particular the National Watermelon Association, I just want to say things to all of you who have had a part in the dialogue here, particularly on agriculture and citing the values of the single most important business and industry in this country, which is food.
I think it was Mahatma Gandi who said that even God dare not approach a hungry man except in the form of food. Now that doesn't resonate here, because we're all fed so well, but it certainly resonates with two thirds of the world who go to bed at night with a prayer on their lips that they would like to eat more tomorrow. And we go to bed at night with a prayer on our lips that we're going to try to eat less tomorrow.
So I can't say it better than Bill Lovelady, who said that if we're not careful, we push that one third -- I think it may be a little bit more -- down to the macaroni diet. But the people on welfare in this country live better than two thirds of the people around the world. They eat better. We have to keep that in mind what the real blessings of this country are.
I want to thank the farmers who are here. They're not here on anybody's payroll but their own. FACA is paying them their airfare and their lodging. That's small recompense for what Steve and Bill and Brad and Bill and Jim are taking away. They believe in the old axiom that profit is not a four letter word.
And why they get up in the morning and deal with all the vagaries of nature, and the droughts and bugs and all of these things, is so they can make a profit. That's what it's all about. And the illustration cannot be better than what Bill Spencer has done out here with his demo on lemons. There should be a fifth box, however, that is empty, just like the 88 acre field of sugar beets that Brad told me were completely eaten up last week in Imperial County because they were not allowed to use a chemical to kill these worms. They had to stand by and watch this 88 acre field of sugar beets completely eaten up.
And right now there is a trillion of white flies consuming the crops in Imperial County. We're trying to deal with IPM and controlling them with parasites, but I tell you, it's tough. We need to drop a bomb on them every now and then.
I want to thank the agricultural allied interests that are here who have spoken so well and supported agriculture, in particularly, Rich Rominger and Keith and Allen and Therese and all of you that we rely on. You have not let us down. And I particularly appreciate Danelle Farmer over here with the House Ag committee, who is here, and her coworkers from Capitol Hill who are here, who have taken a very biting interest in this crucial subject.
And then I want to thank all of you at OPP, particularly Marcia and Steve and then Jim and Susan, and you, too, Gary.
MR. HIGHLY: I think you're a nice guy, Gary.
MR. HIGHLY: No, really. You have all been very receptive. You've not turned me down when I've knocked on your door. But I hope you all have a continuing forum of some kind, because I'm going to bring a lot of farmers to town to knock on your door if you don't.
MR. HIGHLY: Thank you very much.
MR. EHRMANN: Thank you, Vern.
MR. ROMINGER: Once again, I want to thank each of you for the time and effort and commitment that you have put into this process, because it has certainly made a difference. And I think we've had another good session here, yesterday and today. We've covered a number of subjects with the updates that we had on what has taken place since the last TRAC meeting, discussing what the status is of all the OPs and where we are on those, and then into the transition issues and some of the things that are coming down the pipe. And your comments on the Southeast Apple Foundation for transition strategies were helpful in improving that process.
We talked a little bit about the channels of trade. That's another issue that is an important one and I think needs more discussion between all of us and with FDA on how that gets resolved. And then to the public participation process and how we can improve on what we did in this pilot process. And I think we have had some good suggestions and that we will be able to improve that process and make it more open and get advice in sooner so that we'll have a better outcome and won't have people spinning their wheels on the initial assessments that we know are going to be changed.
So in that process, I know there have been questions about whether everybody has been involved. I just wanted to mention that we have included in some of the workshops people who have not been coming to the TRAC meetings. So I think we have been getting input from that wider group as well.
Then I guess we're down to what happens next. And from my point of view, and I think you've made a good point -- made a lot of good points on why there needs to be some kind of a process to continue this discussion so that we get the advantages of your advice and your knowledge on all of these issues, because there are tough issues and tough decisions that have to be made.
I think the idea of using the work groups, again, is a good one. We will certainly consider that as we go forward. The idea of workshops in different areas I think is a good suggestion that could be profitable for all of us. So I think there will be a continuing process. We haven't made a decision yet whether it will be a FACA committee or some other type of process. But I think we do need to make sure that there is this continuing dialogue and involvement. And I would be happy if there are four co-chairs instead of two as we go forward.
But thanks again for all of your participation.
MR. GUZY: In the world before TRAC, if people can actually imagine that, I do believe that it is fair to say that there was not broad understanding of the way in which EPA was going about making its decisions of what our approaches would be, that the primary source of information may have been rumor or innuendo rather than clear communications, and that there was concern about whether we were using unjustified or nonscientific approaches and default assumptions embedded in our work.
And also, quite frankly, from the public health and environmental community about whether there was a real commitment to carrying forward the new children health protection provisions of the Food Quality Protection Act. And now we're firmly convinced that there is a process that is in place that will lead to much more clarity about how we're making decisions, and that the scientific approaches that we are developing and employing are much clearer and have a process for public input as well. There is a sense that while on the one hand we're very serious about carrying out the results of public health protection and addressing children's health concerns, we're also committed to doing that and moving forward in a responsible and a reasonable way.
And in short, as a result of the work of this group, and our commitment to this group and our partnership with USDA, we believe we're making far better decisions than we would have been making and that we have far better processes in place for making future decisions. And we thank you for that.
Let me turn for a second to the structure of activities upon conclusion of this group. There have been a number of very valuable comments that have been made around the table today about the need for an ongoing process. And we certainly will be working with Meridian and talking to other stakeholders who are not at the table to get their ideas and considering your thoughts and comments.
And I would say that both USDA and EPA continue to believe that constructive, meaningful, sustained communications with stakeholders is not only important. It's vital to how we go about our work in implementing the Food Quality Protection Act. We also think that you all, that all stakeholders, benefit from hearing each other's views as well, and that informs the quality of the advice that we get, and I believe that's an important part as well.
But through whatever means we finally develop, we are committed to continued, effective consultation with all of our stakeholders. We also believe that strong, effective communications and partnership with USDA -- between USDA and EPA's senior leadership -- are critical to our ability to effectively implement the Food Quality Protection Act. We also obviously are concerned that any process we come up with be done in a workable way. We have a threshold question of whether or not we invoke the Federal Advisory Committee Act in how we structure something, and we will consider that.
When USDA and EPA first set up this committee, we thought that it made sense to focus on organophosphates as an example of the work that would be done. Perhaps the most challenging example under the Food Quality Protection Act, but I think what's important is to recognize it as only an example. So there is a significant amount of additional work that applies to consideration of other substances that we're required to look at under that Act as well.
So one of the issues for us will be expanding beyond the pilots and the examples that we have been able to talk about in a concentrated and focused way here to the additional issues that are posed for us. And we look forward to our work with Meridian to help clarify those options.
A key topic obviously for any kind of process will be transition. And I really appreciate Jay's comments before about the importance of that from everyone's perspective. We will continue to support and encourage USDA efforts to develop reasonable transition strategies. We are committed to approving newer and safer products in a timely way. We believe -- and again I stress the announcement that Administrator Browner made on August 2nd of a risk reduction challenge.
We believe there are significant opportunities for growers, for commodity groups, for food processors and for industry to come up with voluntary transition plans that can assure that there are smart commodity based approaches that aren't necessarily chemical by chemical actions, that balance the clear goals of grower needs, as we've heard so often today, and practical risk reduction measures that will help achieve the risk reduction goals of the Food Quality Protection Act.
Let me also say that regardless of whatever structure we develop for continuing to consult after TRAC, we are committed to following the TRAC design process of notice and comment in bringing the nine science policy issues to closure. That's not going to stop with this meeting. We also know that as we proceed with our tolerance reassessment work, new science policy issues may arise. And, again, as significant new science policy issues arise, we intend to follow a notice and comment process to help ensure transparency and sound science.
Again, we appreciate the many important comments and experiences that you were able to share on the organophosphates pilot process. We intend to talk to other stakeholders who weren't at the table today to hear their comments and experiences. Our desire is to be able to broaden this beyond a pilot and institutionalize it.
Based upon all of the input we have received and based upon our work with USDA, our intention now is to propose any enhancements or any modifications to this process in the next 30 to 60 days, and take some formal public comment on that kind of process. So, again, there should be more opportunity for your input on that proposal.
Let me just say that as we think about the form of that process, one thing that continues to be vital -- and vital not only to any one segment of us here, not only to EPA and not only to retailers. But I think to all of you is the public confidence in the review process that we have in place. And it's critical that we strike the right balance point, for example, between error correction on the one hand and the ability that the public can be assured that there is adequate documentation and adequate transparency about these kinds of processes as well.
I really want to, on behalf of EPA senior leadership, on behalf of Administrator Browner, on behalf of Susan, Jim, Steve and the Pesticides Office staff, commend all of you for sticking with what has at times been a very difficult process. And likewise, I think it's fair to say that whatever process we develop, it may not be easy. It will require a lot of all of us. It will require that we all continue this spirit of constructive, good faith engagement, that we not all assume the worst of each other.
And that's an important point on our part. We know that we need to listen better. We know that we need to reach out better. We know that we need to communicate better. And we know that we have to continually be vigilant to the four principles that were laid out in commencing TRAC: transparency, sound science, consultation with the public and developing reasonable transition approaches, and common sense transitional approaches. We hear clearly those things.
Others who aren't part of this process, we think, will need to demonstrate a commitment to constructive input and dialogue. And quite frankly, it's probably their loss in not having been a part of the discussions we've had. For example, the important discussions we've had today on the processes that we use.
And we ask that you, again, at times give us the benefit of the doubt. Don't assume that we're about eliminating all of the growing tools that are important in this country, that you believe that the spirit of cooperation of working together, that we've demonstrated through this process, continue to be important to us.
But we also ask that you agree and continue to demonstrate that you understand the importance of the work that we're pursuing, that Congress and the President in signing the Food Quality Protection Act directed us to assure that our food supply is the best and the safest in the world. And that we continue to make progress on that and that we continue to pay special attention to the needs of children. So that will be something that we will ask of you all.
One of the most important results of this process has been the partnership that we have forged with USDA. We very much want to thank Deputy Secretary Rominger for all of his work in this effort. Secretary Glickman has been tremendously supportive and committed to this effort. The staff of USDA.
This could not have been done as well without a tremendous amount of work by the staff at EPA to develop really the ability to have meaningful discussions on these issues. And I personally want to thank them for their tremendous efforts to ensure that these were productive sessions.
We're very grateful to John Ehrmann and the Meridian staff for helping to work through some of these issues and make sure that it's meaningful.
And lastly and probably most importantly, we would very much like to thank each and everyone of you for your patience, for your guidance, for your energy and your commitment to this process, and we look forward to continuing to work with you.
(END OF TAPE THREE, SIDE ONE.)
MR. ROMINGER: -- between USDA and EPA, and thank Gary and his predecessors, and everyone at EPA who has really made an effort to make this partnership work. And we want to continue to build on that and to involve even more FDA and HHS in the process.
And so I just want to reaffirm my commitment and that of Secretary Glickman and everyone at USDA to this process and to making it even better in the future.
MR. EHRMANN: All right. Thanks to everyone. Give yourself a round a applause. I think you deserve it.
MR. EHRMANN: Travel safely. We'll be in touch.
(Whereupon, the meeting was concluded.)
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CERTIFICATE OF TRANSCRIPTIONIST
I, Connie Leonatti, do hereby certify that the foregoing proceedings were transcribed by me via audiotape and reduced to typewriting under my supervision; that I am neither counsel for, related to, nor employed by any of the parties to the action in which these proceedings were transcribed; and further, that I am not a relative or employee of any attorney or counsel employed by the parties hereto, nor financially or otherwise interested in the outcome of the action.
CONNIE LEONATTI, Transcriptionist