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PESTICIDE PROGRAM DIALOGUE COMMITTEE
(PPDC)
MEETING SUMMARY
APRIL 16-17, 1998

OPENING REMARKS:

Jim Aidala-Associate Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances: Good morning to one and all. This is the Pesticide Program Dialogue Committee meeting. My name is Jim Aidala and I am from EPA, Good news for us all -- I have no prepared remarks. I would first like to welcome everybody, especially the twelve new members of the Pesticide Program Dialogue Committee, as both the Food Quality Protection Act and this Committee enter their second year. I would like first to introduce Marcia Mulkey, our new Office Director for the Office of Pesticide Programs from Region III.

Marcia E. Mulkey - Director, Office of Pesticide Programs:

Welcome to all of you. I am delighted to be at my first PPDC meeting and I think it is really neat that I am joining the committee, if you will, along with a very august list of new members. I was looking at them and thinking of my first meeting with Jay Vroom and with Eric Olson, both of which were important firsts for somebody in my job, among others of the new members that I have had the pleasure of getting to know, including Mr. Carrasquillo & Dr. Wagner and others. I know you will all bring some rich, important texture to our dialogue. This advisory committee is of vital importance to the pesticide program and we declare our ownership of this committee in its very name, the PPDC. It is the advisory committee with which we hope to go into the future over the long term. All of you know at least a little bit about another advisory committee that the agency is going to use. Dr. Goldman will be providing you with full information about the Vice President's memo, the Administrator's and the Secretary of Agriculture's memo, and the advisory committee that those memos discussed to some extent. You know what those memos discussed to some extent. It is important and I know you are eagerly looking forward to hearing about that, but I want to make it very clear that the work of this Committee remains of vital importance to us and we expect it to continue to do so. I toyed with several colorful metaphors about this committee as it relates to others and decided that prudence would not allow me to use such words as "long-term marriage" or the "marathon" and that we are all together for the long-term to work through the kinds of issues that the Pesticide Program will be dealing with. Not just between now and 1999, not just in connection with the organophosphates, but in connection with the whole breadth and depth of what we do and over quite a long period of time. Today's agenda reflects that. I want to review the agenda with you very briefly. After we introduce fellow members of this group, we will go directly into an update on 10X. 10X is one of those subjects around which there has been a lot of recent public process among which was the Science Advisory Panel (SAP) presentations and their deliberations. We have Dr. Gene McConnell to report to you about that. In addition, in response to a recent memo from the Administrator and Deputy Administrator, there has been an intra-agency interoffice task force which has been working on the agency-wide issues relating to 10X. Jim Kariya, who chairs that task force, is here to give us a report on that. After we complete that subject we will go into an update on FQPA Implementation talking about the nuts and bolts of the work we're doing. All of you know Steve Johnson and you will hear from him. He will be joined by Jim Jones, who directs the Registration Division, and by Lois Rossi, who directs the Special Review and Reregistration Division, so that you will get a feel for where we are in our daily work.

Public comment will take place at the end of the morning. We do try to build in as much time for public comment as we can. There have been significant expressions of interest in opportunities for public comment. In the afternoon, Dr. Lynn Goldman will report to us about all the recent developments relating to the organophosphates as well as efforts to increase our involvement in public deliberations and public input to our processes. And then we will have some reports from the folks in our Environmental Fate and Effects Division relating to reviews of registration and ecological issues. We will get a report from our Office of General Counsel's expert on advisory committees so we all know the rules of the game which we are playing today.

Tomorrow we will get an update on the Consumer Brochure, which has now been through the public comment process. We will then, as part of the notion of continuity from previous meetings, focus on the suggestions about possibilities of expediting approaches to Sections 18's. We will focus somewhat on FDA's and even a possible EPA approach to a threshold below which it might not be necessary to regulate at all. Later in the day, we will get a forward looking opportunity to hear about an upcoming workshop for health care providers and what topics we might tackle next as a group. That's a very robust agenda even with the notion that there may be other fora discussing important issues in the next period of time. I will now move to the introduction of the members:

Margie Fehrenbach is the Designated Federal Official. We will proceed with self-introduction: Dr. Sheldon Wagner, Bill DeMare, Beth Marshall, Dean Zuleger, Ralph Lightstone, Jay Vroom, Bill Tracey, Jose Amador, Jim Kariya, Gene McConnell, Lois Rossi, Steve Johnson, Polly Hoppin, Bob Lake, Dr. J. J. Steinberg, Nelson Carrasquillo, Richard Dupont ( EPA Region 4 substitute for Deputy Administrator Stan Meiberg, of Pesticide Programs), Steve Balling, Bob Rosenberg, Marion Moses, Phil Benedict, Larry Elworth, Eric Olson, Paula Paul, Bill McCormick, and Carolyn Brickey.

Safety Factor--Update of what the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel has been doing with regard to 10X. Is everyone here acquainted with FIFRA and how it's set up? The FIFRA Scientific Advisory Panel is a group that has been mandated by Congress to provide advice to the Agency's Pesticide Program. Over the years, it has done so through periodic meetings (usually two to four meetings a year) to discuss specific issues or specific pesticides. During the last year this group has been concerned most with particular issues that have arisen out of the Food Quality Protection Act (FQPA). The agency will come to this Scientific Advisory Panel, which is composed of a core group of five to seven scientists with various backgrounds in health sciences, in toxicology, epidemiology, clinical medicine, pediatrics, etc., with expertise in these various areas. They add to that ad hoc members to cover specific areas of concern. The FIFRA has presented to the agency a couple of unique issues that have not been considered before to any degree. To me as a lay person looking at this law, I am struck by three particular issues that come out of the law for the toxicologist and for the agency. One of those issues is the extra safety factor to protect the children. The second issue is aggregate exposure. With a pesticide you can be exposed not just in your food; the workers spraying it on the food would be exposed from inhalation; the people who ingest the food might get some from eating (the oral route); and there is the possibility of people getting it on their hands (the dermal route). With the new law, the Agency is charged with trying to figure out what the total exposure is when you put all of these exposures together. That is the second part of the Act, which for me as a toxicologist is going to be quite challenging to the Agency, and they're dealing with that. The third issue in that law, which I think is a new issue which has not really been tackled in any depth before by the Agency, is a common mode of action of a pesticide. (If you have 2 or 3 different pesticides that work with the same mode of action, the law says you will add those up to give the total exposure.) This is a new issue for the Agency to consider and one that is very challenging for the scientist. What is the definition of a "common mode of action?" Just because a particular pesticide causes central nervous system effects, for instance, and another one also causes them, is that the common mode of action? Or do you go to the molecular level and say that it has to have interfered with cholinesterase for instance before you can say that's the same mode of action? Those discussions are going on right now. That is another issue that the SAP will be dealing with. The third issue that I'll talk about now is the 10X safety factor being included in the risk assessment process under the FQPA.

It may be worth while to give a brief history of the safety factors and how they were developed originally. About 20-25 years ago when this issue was first discussed about using animal data to protect humans, or to predict what might happen in humans and how to protect humans with using this data, there wasn't a great deal known. We didn't have the data base or the scientific knowledge that we do now. However, we did know that if you go from a mouse to a rat to a hamster, etc., you can see a difference in sensitivity between species. Sometimes the mouse was more sensitive than the rat and vice versa. Because of this unknown in the difference in sensitivity between species, they take the most sensitive indicator of toxicity in the most sensitive species that has been studied. Then, whatever that number is, we multiply times 10 because humans, theoretically, could be in the extreme at least 10x more sensitive, maybe even more than that. This produced the first 10X. Then it was known that within animals, even though they are genetically very close to each other, there are differences within that species. In a heterogenous group such as humans, there is even more difference in susceptibility, as there are subgroups that may be more sensitive than others. So it was thought at that time to be prudent to say we'll put another 10X safety factor on to adjust for susceptible populations within the population. So now we have a hundred-X (100x) safety factor. In other words, you take the most sensitive indicator of toxicity in the animal, (because we normally don't have human data for most of the pesticides that are entering the market). So you take the most sensitive indicator of toxicity and you multiply it by100 (10 x 10). This gives you an indication (and historically a reasonably certain feeling) that the number would probably be safe for human exposure. The new law says yes, still use that 100X number. But in addition to that, you will now use another 10X to protect children. So now we are saying whatever the most sensitive indicator is you multiply that by 1000X to protect children and basically that is the law. Also in this law, additional 10X safety factor can be reduced if there are substantial data to say that the extra 10X is not necessary. In other words, if the agency can establish that there is reasonable certainty of no harm with the 100X. By this law we are not required to necessarily use the other 10X. This was addressed at the last SAP meeting on March 24-25, 1998. They asked us specific questions about the science that might underpin this issue. At the onset of this discussion, the panel took the position that we were dealing with the science and not the policy. We didn't feel that we had the expertise to consider the policy of the law and debate that policy, but rather we would deal with the science as we saw it. I can tell you the issues that we discussed, but I can't tell you today what we came up with. The reason for that is that in the working of the SAP we have to come up with a report within approximately one month. That report is still in the process because it is undergoing a fine tuning at this particular point. It is not final and by law I am not at liberty to tell you what is in that report, although I understand the final report should be released within the next 2 or 3 weeks. I can talk to you about some of the issues that the panel discussed without telling you what the panel's decisions or views were.

Remember, we are an advisory panel to the EPA, and the EPA does not have to use our advice. But, in most cases they do and they give us very serious consideration and the courtesy of telling us if they don't accept our advice. We all realize that there are reasons other than science why things are done. At this meeting, normally the Agency comes before the panel which is much as you see today. The audience was well over 200 people. This is a very highly charged issue on both sides and there are people who believe the 10X should be used on every case and there are people who believe it should never be used, and of course, there are people somewhere in between. As I said, the agency comes and presents its position, and asks us specific questions which the panel deals with. The panel has a dialogue with the agency and during that dialogue people from the public, like yourselves, present and give opposing or similar viewpoints, etc. Then the whole committee discusses the whole issue and gives its advice in written form to the Agency. In this meeting, we had people from environmental groups, consumer groups, academia and industry. All presentations were highly credible and instructive to the panel and other panel members agreed. Some of the issues talked about: The developing human including the neonate has a central nervous system (CNS) which is not completely developed at birth. The neonate could possibly be more vulnerable to a wider variety of toxicants than the adult. There were diverse opinions in that regard as to how susceptible the neonate is, as compared to the adult, as to the types of pesticides and the uniqueness of the particular situation. This was discussed at some depth and our views will be in the report. It was also pointed out that there is a lot of data on pesticides buried at EPA that might shed some light on just how sensitive the central nervous system of the developing fetus is, vis-a-vis the adult. We want to look at the data base which may shed some light on this.

Another issue that we talked about was when do you incorporate this extra 10X safety factor. Is it during the period when you are doing the risk characterization, or the hazard identification, or the end of the process, during the risk management process, etc? The Agency proposed that probably the most efficient way to do this, and the way that would be scientifically most credible, is to do the risk assessment process as they have in the past, coming up with their reference dose. You do that whole process and then look at the particular pesticide and the data you have on it. Then you decide if that particular pesticide is subject to this particular Act (are children uniquely exposed and are the young and the developing fetus at more risk on the dose basis). When would it be most advantageous time to incorporate the 10X safety factor. The next issue is the magnitude of the difference in sensitivity between children and adults, using a lot of information which came from the National Academy of Sciences: "Report on Children." If you read that report, there are some differences of opinion, as with any committee, because you can find whatever suits you that particular day and you might find justification for it in the report. I suggest that everyone obtain a copy of that report. The overall tone of that report was very clear: that children are worthy of protection, need extra consideration compared to adults, and that science should drive this extra protection. We had a lot of interest in this - what is an appropriate data set to decide that you're not going to use the extra 10X? It was suggested that the Agency's current testing guidelines need to be reviewed and see how adequate they are to determine whether the developing fetus, particularly with the CNS, are adequate to determine if there is extra risk there or whether they might have to develop more sophisticated guidelines and another more sophisticated test to determine whether there are unique effects to CNS or the immune system. Discussed in some depth using lead as a prototype, some people on the committee had a lot of experience with lead over the years and they had seen this toxicity become more and more pervasive. At the same time, they brought to the table the issue that there were effects of lead which we wouldn't have thought 23 years ago might have been a problem. We need to figure this out in terms of pesticides and we discussed whether the current guidelines are adequate and how adequate are the current data that come in with those tests -- just how complete are they and are they adequate for a person to feel the CNS is particularly affected by one of these compounds. There was a lot of discussion as to whether the types of tests being used today are adequate and if the types of data are adequate to alert the Agency that there might be a unique effect on the developing fetus or on the neonate.

The other thing that was discussed was that you may know scientists on the experimental side that are dealing with these issues that come up with specific types of tests that are better than other types, etc. One of the things that toxicologists are good at are developing test methods in animals that are hopefully predictive of what may happen in a human. It is also important that these tests be validated - the tests should be able to be duplicated in different labs and get the same numbers. Four scientists may get the same answer, but is that relevant to humans and what underpinnings should be in a test before the agency adopts a test. Also, are the current data that come with pesticides sufficient to make that determination or is there unique susceptibility to the young or do we need more sophisticated tests? Maybe we shouldn't be worried about the tests, but if a pesticide works via the nervous system of the insect, that it should be studied by the most sensitive neurotoxicity tests available in animals to predict what might occur in humans. The other side thought the current protocols are adequate to alert you that you need to go on to other sorts of tests.

I apologize for not being able to be more definitive. As stated at the outset, I am restricted in what I can say in that regard; however, I can attempt to answer questions if anyone on the panel or the audience would have any - Marcia I would be glad to attempt to do that.

We are going to try to make an opportunity for some discussion by the panel and questions. If we can take a few minutes to have Jim Kariya speak - his report is inevitably preliminary too for the obvious reason that the Agency's Task Force response has not yet gone to the Administrator and Deputy Administrator. Obviously, he will be limited as to what he can tell us about that process. At least he will provide some context about that process and that will set the stage for the discussion.

Jim Kariya- (OPPTS)

In response to a memo from the Administrator and Deputy Administrator in late February, Lynn Goldman asked that a task force be set up to include the three offices that were mentioned in the Browner and Hansen memo, specifically the Office of Pesticide Programs, the Office of Research and Development and the Office of Children's Health Protection. It was felt that it would be good to have representation from the other program offices because of the potential impact of the 10X issue on the rest of the agency. So we have representatives from Air, Water, and Solid Waste Offices. We also have representation from the Department of Agriculture -- so we are up to about 25 people at the moment. Additional people are helping us out in work groups. We see our charge as making a recommendation about what child specific data are needed in order to support reduction or removal of the FQPA factor. We also will be looking at OPP's experience with the10X issues since the adoption of FQPA, how they have actually been making those decisions and what decisions have been coming out; have those decisions been consistent; what can be learned from the experience; and are there any inconsistencies that may need to be corrected? We'll be developing detailed guidance on how 10X decisions could be made and we'll try to set up a system so in the future, the way the decisions are being made as well as the decisions themselves, are clear and transparent, consistent and reasonable. We understand that some of the decisions have been a little difficult to understand and we like to make sure the public has full access to the decisions and how they are made. The task force is split into three groups, one of which focuses on toxicology issues, one on exposure issues, and one on the integration of those two parts .

I want to talk about our plans for public involvement, because the public has a great stake in this. We have two approaches, one is direct comment on some fundamental issues that are in the process of being identified right now and a review of the task force report. We will be putting the list of issues on a web page that will be available on Monday. These issues are put out to the public to focus discussion, obtain ideas and opinions to consider on critical issues. We will not be responding to each of the submissions separately. We see this as kind of an idea gathering process. We hope to have a channel on the Web for you to submit your opinions and ideas. There will be other things on the Web not specific to the task force but which relate to the 10X issue. A Federal Register notice will also have the issues. We hope to have your comments by July 15^th because we are on a very tight time schedule.

Second: The task force report should be out by June 1st. We look to PPDC as the primary means of public comment, and we would like to form a PPDC workgroup with the primary stakeholders. This would be a workgroup underneath the PPDC. We believe manufactures, growers, and public interest groups are the main stakeholders. The states will also be asked to join because of their interest in emergency exemptions. We envision three representatives from each of these groups. We would like for the EPA to stay out of the nomination process so we would appreciate it if the PPDC would be responsible for nomination and provide a list of representatives for this group. We would ideally like the representatives to be a funnel for the comments from those constituencies. We can be overwhelmed by individual responses and it would be most efficient if comments could be funneled through this group. We would like to have work group meetings in mid-June to develop comments and recommendations on the task force reports. Comments on the issues we put out will be very welcome as will be comments on the task force's report. We will be inviting the public to speak on open microphones at that work group meeting and we will look for the comments to come back through the PPDC to make sure that all the important stakeholder groups that are not represented on the work groups still have an opportunity to influence what comes out of the PPDC as advice to our task force. We would like to have comments back by August 1st. We recognize that there are other avenues for public comments. The new National Advisory Council on Environmental Policy and Technology (NACEPT) is having an organophosphates committee which is being set up and the 10X issue will also be considered by that committee. There is also the Children's Health Advisory Committee that advises the Office of Children's Health Protection. We do look to PPDC as the primary advisory committee. Following this public review we will be looking for scientific review of issues that have not been taken to the SAP. We envision taking it to the Science Policy Council within the EPA for an independent review outside the EPA and we were thinking of a joining of the Science Advisory Board (SAB) and the Scientific Advisory Panel (SAP) for issues not already vetted through the SAP. We will be looking for an interagency review in the fall of 1998. We are trying to make sure that we can have a stable set of guidance as soon as possible because tolerance decisions are being made and if, indeed, children really do require this additional health protection, we want to make sure the extra safety factor that FQPA says is necessary for children be instituted as quickly as possible. There are many complex issues to deal with and we find the timetable very ambitious but with your help, I hope we will be able to resolve the issues and be sure that we have a consistent and clear process for making decisions.

Marcia Mulkey:

It might be helpful to clarify that these are proposals which the task group anticipates forwarding to the Administrator and Deputy Administrator. These are not decisions about how to proceed.

Larry Elworth:

Given the actual language of the FQPA law, PPDC has never reached any specific decisions, so asking them to make recommendations requires that we discuss how we might do that. How are SAP members reacting to increased public attention? How do you separate scientific and policy decisions with 200- 300 members?

With regard to separating science from policy, that is difficult. If we debate about the scientific soundness of the policy, we would probably be in trouble. It isn't fair of us to second guess Congress. It is cleaner and easier to say that 10X is there and that some caveats are debatable. But the agency doesn't have to do this every time. What kind of science would you want and level of science would you want to modify this 10X? So, it became easier when we focused on that rather than debating the wisdom of 10X. Let the professionals handle policy.

Larry Elworth:

Yes I think that is helpful to the extent that various scientific options lead to various scientific outcomes.

Thanks to Marcia for the flexible agenda. Previously the entire time would be filled up with presentation with only a couple minutes for discussion. Please provide more information sooner so we don't need as much time for presentations at the meetings. The second point I wanted to ask Gene McConnell is on the 10X safety factor. Do you start with the 10X factor and work your way down, or do you start with 10X and work your way up? Would there be a difference in the result?

The default that is in the law states that you start with 10X and work your way down. There would be a difference where you end up.

Sheldon Wagner:

I assume your WEB address will give us all the answers, but if not, do we have a means of feeding back to OPP what our questions are going to continue to be? Second, on page 31 of the handout is a remark that the 10X factor will apply to all pregnant women. I thought the 10X factor applied to the entire population.

Marcia Mulkey:

It refers to the subpopulation of pregnant women from 13 years of age on up.

As for the process surrounding our ongoing issues of 10X - I think we are contemplating a special advisory committee focus. We will try to have multiple routes with some frequency.

Paula Paul:

I have two comments. I am pleased that you see this need. It is complex to weave the requirements of the law to protect children and to arrive at a process that represents sound science and sound public policy. I am pleased you are still discussing the issue. As for the SAP, I found myself very frustrated at the lengthy discussion. I felt the panel members lacked familiarity with how a reference dose was set, what kind of data are submitted to support a pesticide registration beyond toxicology data, but also metabolism, pharmacokinetics, and bioconcentration data that all impact on how decisions are made. Maybe it would be helpful to give that background to the panel members.

Dr. McConnell:

Any toxicologist should know how 10X came about, but many of the people are not aware of that and should not be expected to know.

Jim has described a complex and ambitious process for reviewing 10X policy. It seems the policy and issue becomes more complex with each new advisory committee that's added. The process looks like optimistically we would achieve a resolution by the end of the year. Meanwhile the agency has hundreds of Section 18 requests and probably a greater number of Section 3 requests. Are we going to see a delay on these decisions until this is resolved?

In the paper we presented to the SAP, accompanied by a memorandum, which stated that the work to date informs our ongoing decisions. We make decisions every day and we try very hard to keep things going and make decisions, and to be open. We are evolving and there is potential for further thought and change but we are not stopping decision making.

Ray McAllister:

In the fall of 1996 an interim approach to decisions on 10X was approached with the understanding that it would be revisited. But it sometimes appears to the regulated community that its being revisited with every decision as opposed to "we gain experience, then we revisit it and then we change the policy."

Marcia Mulkey:

We are trying very hard to be as clear as possible, but each chemical does present a subtle new twist. So it isn't as simple as if we designed an architecture this week and we'll follow it rigidly. There is an evolution that derives from the particulars of the case.

I understand the law says you start with a 10X safety factor and then you can choose a different safety factor based on reliable data. It doesn't just mean you can reduce the safety factor to below 10. There have been several suggestions that it only goes down - I wanted to confirm that that's the understanding.

That's correct and, in fact, we have had a couple of decisions where we actually raised the safety factor to be more than 1,000-fold.

Eric Olson:

My second question is that the Vice President's memo refers to the ten-fold issue and I am wondering if what was just put up on the overhead and what has been discussed is intended to be the Agency's response to that memo, or is there more?

The work that you see predated that memo and is not, per se, a response to that memo. Dr. Goldman is going to give a pretty comprehensive report this afternoon about the Vice President's memo and the Agency's response. You might want to raise that in that context. I don't any of us think our work is inconsistent with the Vice President's memo. I don't think it would be accurate to say that it is intended to be directly responsive to it - it predated it for the most part.

So the answer is that there may be additional activities that the Agency is going to undertake on the 10X issue on top of what we just saw.

Marcia Mulkey:

There may be - not just because of the Vice President's memo. Many of you have said that you wanted more process and public participation in this topic. In part, what we're trying to do is be responsive to that. We are also doing what we think is appropriate in terms of involving others in our processes. But, to some extent, the extent of additional effort may be a responsive situation - may be dependent upon the feelings about whether we got it right. I don't mean the substantive answers, but the process answers.

Jim Aidala:

Specifically, Jim's exercise is in response to the Carol/Fred memo - the 45-day exercise which is wrapping up around now. The Vice President's memo is an altogether different exercise. Obviously, we would hope that these two efforts are not entirely inconsistent.

Break (end Tape 1)

Welcome to all of you. Thank you for your ability and willingness to serve as members of this Advisory Committee. It is extremely important to the pesticide program's success that we have this kind of stakeholder input. We need to, as much as possible, open up the processes that we use for making decisions, especially as we are implementing a new statute - that we are doing it in a manner that is as open and transparent as possible and encourages as much participation as possible. This committee has contributed a lot to that and will continue to do so. You had a presentation earlier today about the 10X safety factor, the margin of safety as required by FQPA. You heard about the review by SAP of the scientific basis we're using for that. The next session will cover an update on FQPA implementation, and after lunch I will discuss the Organophosphates assessment, the Vice President's memo, and the Agency's and USDA's response to that. We have a lot of strands we need to keep together in terms of being able to successfully implement the statute -- that we get good science advice and the long-range input from this committee. This is our committee that is responsible for advising us over the long-term about broad direction for the pesticide program. It is a very serious responsibility to make sure that the things we are doing today make sense in terms of building towards the ultimate vision for the pesticide program. As you will hear about later, we are also going to get shorter-term advice on some of the specific issues related to FQPA implementation. Welcome again and thank you for being here with us. I know you take this time away from very busy schedules. It is extremely important to us that you are able to be here to provide not only the input to us but also the dialogue between the different stakeholders, which I think is very important.

Stephen Johnson:

There's a lot of interest in what is happening in our registration activities in OPP, whether it is in our biopesticide program or in the registration division handling conventional chemical pesticides. We want to give you a brief overview of where we're at in our registration activities -- also what's been happening in our Section 18 program, last year and this year and the future. Lois Rossi will provide brief comments regarding the reregistration process. We will than have a question and answer session.

The three divisions in OPP that handle registration of pesticides are Antimicrobials Division (AD), Biopesticides and Pollution Prevention Division (BPPD), and the Registration Division (RD). This year, the highlight for AD is that it has not missed any of the FQPA-mandated time frames for registration actions mandated by FQPA. Also nine new uses of existing pesticides were registered: three anti-foulants, three industrial preservatives, two manufacturing uses, and one wood preservative.

BPPD contributes a significant part to OPP efforts to reduce risk of pesticides. This division is a multi-disciplinary division. In case you're not familiar with it, all of the work in BPPD for new chemical and new use decisions occur within that division - they're self-contained. They have registered four new active ingredients this year, covering multiple food uses. They have also added a new use to a previously registered active ingredient.

Registration Division activities: we spent a considerable amount of time this year working on tolerances that were set before FQPA passed, and had expiration dates of tolerances that fell in this fiscal year. RD worked quite hard to be able to make or not make the safety finding required under FQPA, and for each of these cases, we were able to make the safety finding. None of these tolerances expired; they covered 10 chemicals, 47 tolerances, and 75 uses. The amount of energy and effort that went into the review of these activities was extraordinary and significantly depleted from our efforts in the new chemical and the new use arena. Also please note the bulk of these chemicals are synthetic pyrethroids. These are the principle replacement or alternative chemicals to Organophosphates. It would have been, environmentally, not a particularly positive thing if any of these had expired; they all met the FQPA safety finding. We were able to deal successfully with the aggregate risk provisions, the children safety factor provision, as well as residential and drinking water aspect of the aggregate risk.

Next are the Section 18 statistics for this year, which is a little worrisome to us right now. As you can see, in the first two quarters of this year, we have already received nearly 400 Section 18 requests - which is extraordinarily high compared to an average year where we receive that many over the course of the entire year. Granted, the second quarter is always when we receive the most requests because the states are gearing up for the growing season. We will spend a little time taking a look at what is going on there. For example, States are getting their Section 18 requests to EPA well in advance when use is needed. This is a good thing. This is somewhat reflected by the number of crisis exemptions that have been declared. There is a provision in our regulations that allow states to issue crisis exemptions to themselves if the agency does not have enough time to act on their request. Last year we had exceedingly high numbers of crisis exemptions as we struggled with FQPA. This year we only had eleven crisis exemptions. There are some things that will help us to explain the high number of receipts but it is still somewhat worrisome and we will be taking a look at that. We have issued 71 individual exemptions. An exemption comes from a State for a crop and a pest. So it is somewhat difficult to talk about the numbers of Section 18's, because multiple states often request the same pesticide for the same crop. The potato late blight example is a good example of where we had upward of 30 states requesting Section 18's for three separate chemicals to control late blight. So that in itself has inflated the numbers. We have denied eleven requests during the first two quarters of the fiscal year, eleven have been withdrawn, and there are 272 pending requests -- which is not unusual as a ratio at this time of year. If I told you that at the end of the 3^rd quarter there were 272 pending requests, I'd have a new job in the 4^th quarter. We established 31 tolerances covering the 71 exemptions that have been issued. Twelve tolerances have been extended. They were in place last year and we were able to extend them for an additional year. As I mentioned earlier, there were11 crisis exemptions.

We've been tracking closely the issue of how much the section 18's emergency exemption program has been drawing on our science resources this year? We spent an inordinate amount of our science resources dealing with section 18's, because FQPA fundamentally changed what was required under Section 18. This year after the first two quarters, we have significantly reduced the science review necessary to be able to make the safety finding -- which means more resources will be available for new chemical review and for new uses of existing chemicals. We are very heartened by that. We predicted that that would happen and we have begun to see it come out that way. So that's good news. Thus, the two biggest priorities in RD that I have just reviewed - the expiring tolerances (which we thought were very critical to get on top of), and Section 18's which are always a top priority in the RD.

As mentioned earlier, when I spoke of the Biopesticides and Pollution Prevention Division, safer-reduced risk pesticides are a premium in OPP and how we are spending our time and resources - it's beginning to be and has been for some two years now reflected in our new chemical and new use decisions. So far, this year RD has made five new chemical decisions for previously unregistered pesticides. Four of them are for food use pesticides, one is an indoor non-food use pesticide, and one is a reduced risk pesticide. I can say pretty categorically that for Cloransolam-methyl, Imiprothrin and Cyprodinil - these will significantly reduce higher risk pesticides, even though Cyprodinil is the only one that achieved a reduced risk status. We are pleased with the kinds of chemicals we are getting into the marketplace. So we are talking about 5 new chemicals with 8 food use tolerances which cover 24 commodities. Missing sometimes in these statistics when we talk about new food uses, e.g., Cyprodinil which was registered for four uses - well stone fruits is a crop group that includes more than just one crop. Pome fruits, again, is a crop group that includes more than one thing. All told, there are 24 new uses associated with these five new chemicals. The other highlight on Cyprodinil is this was an example of our working jointly with Canada on a new chemical registration. There has been concern about whether we are giving up some of our sovereignty. My experience is "not at all"; we are maintaining our scientific integrity on these joint reviews with Canada and we came up scientifically with the same answers on the risk assessment. With Cyprodinil we accepted some risk mitigation on the ecological side that the Canadians suggested that we likely on our own would not have put forward.. By working with our Canadian counterparts, EPA further improved on environmental protection in this case.

New uses registered thus far this fiscal year: There were 11 chemicals for which we added a new use. They include 20 food use tolerances. Of those 20 food use tolerances, there were 74 commodities associated with those food use tolerances. This is independent of the new chemicals I was just discussing. We had two reduced risk candidates and a methyl bromide replacement -- fludioxonil, a fungicide registered for potatoes. Interestingly, we are seeing an increase in the number of reduced risk fungicides which is very heartening for us, as for many years we have struggled with fungicides which posed significant risks. We spent a lot of time taking regulatory action on some of them. We are beginning to see cyprodinil and fludioxonil for which we added a new use this year and a couple more in the queue and another one we added last year. That's certainly a move in the right direction. Diflubenzuron, a termite bait station, is a reduced risk pesticide we were particularly pleased with. The last chemical - spinosad, registered on a cornucopia of new crops -- virtually all minor uses. Two years ago, when the company that manufactured this and got their original registration, applied for reduced-risk status and got it. For these uses, they did not apply for reduced-risk status; however, had they applied for it, they would have gotten it. This is a chemical that we are very pleased with - it's an OP replacement.

The other chemical is rimsulfuron on tomatoes. This is an example for those of you who think we're not flexible. We have a basic work plan that describes what we plan to do each year and we try to stick to our schedule. Last year, I was approached at a PPDC meeting by a representative from California who expressed a serious need for rimsulfuron because it was a methyl bromide replacement. It was way down on our list, but we got together with California which did the risk assessment and residue data review. We peer reviewed and made a couple of changes, but basically were in agreement. We were able to pull this chemical up and register it a few weeks ago. All told, it is becoming clearer to me as the person who is responsible for managing new chemicals in the Registration Division that I can begin to see the light at the end of the tunnel. For my peer, Janet Andersen in BPPD - they have maintained their production through FQPA and we will continue to maintain work in that Division as well. I know that many of you are concerned about whether we are getting work out in RD. Last month was particularly productive, but it really was the nine months prior to last month where all the work was involved in tackling some of the complex FQPA issues. We're expecting to be able to make 12 new active ingredient registration decisions this year, and close to 90 new uses. With that, I will turn this over to Lois Rossi.

Lois Rossi:

This year the reregistration program has been working on assessments for approximately 48 chemical cases. Thirty of the candidates are OP's and 18 are not OP's. The Reregistration Eligibility Decision on Deet was signed last week and is requiring several label changes to clarify use instructions and is requesting further expert consultation on combined Deet and sun screen products. The assessments on the 48 chemical cases, which includes a complete comprehensive look at these chemicals -- which means its dietary risk assessments, including consideration of the FQPA factors that are being discussed today and at SAP meetings; the tolerance reassessment decisions for the food-use chemicals; worker exposure risk assessments; and the fate and ecological effects risk assessments -- the whole range of end points, population effects. The food use reregistration candidates which are the majority of the candidates we are working on this year are all in Priority Group I of the tolerance reassessment schedule which was published last August, as required by FQPA. We are clearly at the point in the reregistration process, as we predicted many years ago, where the easy ones have been done and we are dealing with decisions on chemicals which will be important in protecting public health and the environment, but they are also very widely used chemicals and play an important and critical role in agriculture - presenting many challenges in this program. We expect many decisions to be made in the remaining months of this fiscal year. We are also queuing up next year's candidates - see the listing on carbamates. We are considering food use first and following again the tolerance reassessment priority scheme. We have already begun work on some of the carbamates listed. In conjunction with the reregistration program and tied very closely to the tolerance reassessment program which we have presented to this committee last year, we are carrying out the tolerance reassessment. Many of our actions over the last few months in the tolerance reassessment program have been focused on issuing revocations of tolerances associated with canceled chemicals or canceled uses of chemicals that remained on the books. We are taking comment on the fairly large proposed revocation rule of a few months ago and we will have more soon. There are hundreds if not over a thousand involved in these actions.

Dan Botts:

Regarding the Section 18 document, the numbers to me are quite frightening. Of the eleven denials, how many of those were issued Section 18's last year that were denied this year because of the increased peer review? For comparison purposes, the 323 petitions that you got the second quarter of this year, how does that relate to second quarter last year?

Jim Jones:

It was a 30% increase.

Do we have any breakdown of the amount of staff time that goes into the section 18's within the Registration Division and the Health Effects Division? It would be interesting to look at the allocation of time for Section 18's vs. Section 3's -- if one could make at least the contention that the Section 18 program is taking up too much staff time, it would be good to know what too much time means -- or some sense of that? I'm glad to see all these new registrations and I think it is really good work. However, imagine an oversight hearing question on the new chemical decisions in FY 98: why are 20% of the new chemical decisions on imported products? How will we deal with that issue over time and what kind of message does that send.

Stephen Johnson:

The Office of Pesticide Programs has a very sophisticated time accounting system where each employee keeps track of the amount of time. It is probably fairly unique in the Federal government, except perhaps for the Superfund program. We keep track of and are able to account for how much time a scientist or a registration specialist spends on a Section 18 or other parts of the program. We can certainly provide that type of information.

The issue is not the numbers but whether we have the resources currently to grant Section18's and new registrations for new pests. That's really the question - is the Section 18 program taking up an inordinate amount of resources.

In terms of the increased number of requests this year, I believe that because people want to give EPA more lead time, we are getting requests very early in the process. A consequence of that is some of those will be withdrawn because the emergencies won't actually develop. For those of you who have been involved with the Section 18 process know that there is a time window when you think there might be an emergency, but then if the weather conditions or other conditions are right, you don't end up having the emergency. The possible problem with this is that we will end up putting effort into requests that will be withdrawn because the emergency does not develop. That's not something we like to see regarding the most efficient use of government resources. We will need to work with the states and with the growers to at least try to minimize the requests where people just want to be sure that we can resource them. We do have the resources for the 18's. We consider them to be a very high priority. There is a consequence though and last year, we had very clearly a dent that was made in our special new use registrations for existing pesticides. I think it is very clear from our statistics that there was a dent that resulted because of having to establish tolerances and the amount of effort that was required from our Health Effects Division. This year, it will be far less a dent for two reasons. First, there are a fair number of repeaters in the system, and second, during last year, we were able to hire significantly in our science divisions and these people are trained and incorporated into the workforce, whereas last Spring, we had not completed the hiring. I'm optimistic that we'll meet projections this year.

Stephen Johnson:

We have added over 100 new staff to throughout the program, the majority of which are in the Health Effects Division and the Environmental Fate and Effects Division. We're now close to 870 staff in OPP, up from 750 from over a year ago. Thus, we've added considerable resources and most of the new hires are scientists.

Responding to Larry's question earlier - according to our time and accounting data for the second quarter, the science support for Section 18's is 50% of what they were last year. It is going right into new chemicals and new uses. Still a little above what it was pre-FQPA, but it is well below what it was last year.

Larry Elworth:

The question is not to second guess whether you are spending 40 or 42 FTE's on something - but just a sense of whether you have sufficient resources and people, is the output both needed and expected.

Lynn Goldman:

I'm not saying that we could not speed up new registrations if we had more resources - we certainly could. But, we are not going to have the same situation we had last year. That's pretty clear.

Responding to Dan's question earlier, there are a handful of Section 18's this year that were denied but that were not denied last year because of further development of our analysis. I can give you a list of those.

Marion Moses :

I was curious about the large number of synthetic pyrethroids. Are synthetic pyrethroids considered to have common mechanism of action? Are they considered to be aggregate exposures?

Our policy has been for common mechanism, until we have enough information to be able to determine whether or not there is a common mechanism we are taking a default that there is not. For synthetic pyrethroids, we do not at this time, have the information to make the determination as to whether they share a common mechanism, so we assume that there isn't. So we did not do any cumulative assessment based on the assumption that they share a common mechanism. That will occur ultimately in the tolerance reassessment of those compounds in the schedule that SRRD has. We do, however, and we do this for every chemical where we establish a tolerance, an aggregate assessment. For each of the 9 or so synthetic pyrethroids on this list, we added the dietary exposure with the residential exposure along with the water exposure.

The synthetic pyrethroids are part of the tolerance reassessment schedule. So there will be a formal assessment about common mechanism.

I am very curious since home use is such a big use of synthetic pyrethroids and I would love to see some of the data and where you got it because my understanding is that there isn't very much.

Actually for the synthetic pyrethroids, we took what we thought would be a worst-case home-use exposure scenario and we assumed that all such scenarios would lead to this worst case outcome. So we think it is a pretty conservative assumption with respect to the home owner exposure. We would be more than happy to provide you with the data that was used.

The other thing I was curious about, when I saw diflubenzeron here as a reduced risk pesticide, I found that a bit startling. I assumed it was for that use and not for other formulations.

Exactly. It's because its in a bait station and there will be no human exposure.

On the new uses, I was wondering what the communication has been between EPA and other agencies, such as USDA and/or other parties about these chemicals that are substitutions for other chemicals. The Methyl Bromide replacement is particularly intriguing for obvious reasons. Do you hear from USDA about these chemicals as substitutes, is it ad hoc information or how do you know what's in the pipeline that you could move up?

It is an informal exchange of information, although it appears that USDA often hears what is in our pipeline from obvious sources. Growers hear from obvious sources, as do the states and we get information from USDA. They'll call to say something is important to work on. It's an informal network of outsiders giving us advice about things like OP replacements.

What is the outlook for your getting that kind of information on OP replacements that may be in the pipeline now?

Jim Jones:

In the near future, we will be going out with a PR notice to get it a little more a public process to say that that we will give some special treatment to OP replacements. Anyone can actually come and say that we're aware of an OP replacement. Our experience is that it will likely be growers and companies. But anyone can come in and make the case.

Tape 2, side one ends.

I don't know categorically, but one of the things we have been doing is for spinosid - there was one use of spinosid high on the list so they went and pulled all sorts of other stuff up, as it's cheap to do it that way. I assume we don't have any other result here on uses in our queue or we would have done that.

We have to be cautious here. When we talk about a methyl bromide replacement, we are talking about a replacement for an individual use, whereas in the agriculture community they are looking for one chemical that does everything that methyl bromide does. But as far as we know, there isn't one chemical that does everything that methyl bromide does.

Beth Marshall:

In reading the paper: "Incremental Risk Assessment an Option for Section 18 Tolerance Setting", this paper was presented at the October 22nd meeting. It seems to me that under your former method of evaluating Section 18 requests you considered environmental effects as well as dietary effects.

Section 18 evaluation looks at the full range of issues -- not only dietary issues, not only worker issues, not only ecological effects issues, but environmental fate, whether its ground water, surface water, drinking water - so it is a full assessment. Obviously, it's done in a short period of time based on the available information we have before us. But it does cover all of those. More often than not there is a fairly lengthy set of mitigation measures placed on Section 18's to help ensure, particularly for the environmental effects rule, we may have some information but limited and when we feel comfortable enough to make a decision, yes but just to give us added assurance we put some additional mitigation measures on.

Thanks to the agency for allowing us to comment upon the potential registration for "balance." From a state perspective if the replacement product is worse than the products being used, we seriously wonder about the benefit of registering those products, especially under FQPA. Does the agency have a clear policy about this? I think that it should as companies cancel products and bring in new products that they consider safer. In many ways state programs are the monitoring programs in the field. And as we go to brand new chemistries and brand new products and we don't have standards and we don't have methods of analysis for the environmental media we are going to get in trouble. So I think as we speed towards new registrations we're going to have to be sure those things are in place or we don't register them until they are. We really have to make sure we have our field plan in place to monitor what the Registration Division is doing or I think we're going to create problems. In my mind the analytical method in some ways is lagging behind the registration process and somehow we need to pull those together.

What Phil is referring to is that the Agency has a new chemical before it and the decision hasn't been made so it is inappropriate to enter it into the discussion but some of the issues which the chemical presents to us makes us want to avail ourselves of the opportunity to consult with our state partners. So we did sit down with Phil and some of our state partners to look at some of these issues and to seek their input and guidance. We will continue to do that. As we begin to face difficult or controversial decisions even for a new active ingredient, we are perhaps looking at other opportunities and a more public forum and we need the companies support for that on confidentiality - trade secret issues. But we are looking at ways to open up the process beyond the states as number 1, and number 2 is obviously, on those kinds of issues, is the potential impact to the state? As for the monitoring field we need to take that into consideration before we make any decisions.

I'm just wondering, even though we haven't made a decision but we also haven't completed the risk analysis for the chemical so I don't think it would be helpful to talk about the individual chemical, but I think that the broad issue you're raising is an important issue to us and I would be interested in whether this advisory committee would like to get into that at some time. Maybe we could have a small group work with Phil in finding a way to queue it up for a substantive discussion here. It is a major issue that has come up in a number of contacts and how do we bring people into the front end of these decisions, especially where there will be impacts on the states and others including grower groups. It should be something we desire to do to increase the participation in the process and this could be a good way to bring that issue forward if the committee is interested.

We did address the Method of Detection issue in the statute in FQPA.

That has always been a part of the statute and of our regulations. If there is a detection method, but there is also the issue of the applicability of that method in facilities like state laboratories and the practicality of actually being able to use the method. If this is going to substitute for things that are less risky, in this individual case I don't think that we actually know that.

I call on Ralph and Jay and Eric.

We are beginning to enter reduced risk pesticides and the question in my mind is how does the Agency get to reducing the use or eliminating the use of the old high risk pesticide that is already registered on a specific crop.

There are number of answers to that. One is through the tolerance reassessment and reregistration that for those chemicals that may fall in the benefit risk situation that still may be subject to benefit provision of FIFRA, clearly if there are registered alternatives that don't have those risks, then that's going to tip the balance. In other cases we are finding companies actually voluntarily moving to the safer reduced risk even within their own marketing strategy; abandoning the more risky compound to the safer reduced risk. To the extent as we go through the tolerance reassessment and reregistration if we find compounds that are posing risks, then we will have to take action to eliminate the uses or the whole chemical if that were the case.

There is a regulatory role, but a mix of market place and information are key players. We have this partnership program which is one of the tools we use to enhance the information aspects. We are trying to get better and smarter every year about playing a role in the information base. The USDA has become a potential player in the information base. People will make prudent choices if they have the information.

Ralph Lightstone:

There are other market forces at work here. There has been a history of some registrants or forumlators marketing some of those off-patent, more toxic pesticides even while some other innovative company may be marketing a reduced risk pesticide.

We should wait until tomorrow to discuss the Section 18 status while we talk about the new proposal. For clarification, you have 71 new Section 18's issued, if I add up tolerances established and extended that's 43 and there is a 28 difference. Does that mean 28 of these 71 section 18's didn't require a tolerance?

No, it's that a tolerance only has to be done once whereas you may have multiple requests from different states.

What I was trying to get at is how many of these 71 or total of 365 are repeats from last year and can we get more information tomorrow? If you are projecting accomplishing 12 new active ingredient and 90 new uses, you are farther along on the new actives than on the new uses relatively speaking, if you are half-way through the fiscal year. Any explanation for that? And could you speak on our concerns about the old and now revitalized priority system for registrants - could we overlay that on this data and explain how its working and we ought to talk about getting a subgroup or this group to look at these questions as well?

Part of the reason we are about half-way there on the new chemicals and a quarter of the way there on the new uses because of the order in which we scheduled this work. I am very confident that we're going to meet our goal for close to 90 new uses. I think you will see a fair number of new uses coming out in April - May and we're pretty comfortable that we're going to meet our target. So basically it's a scheduling issue on how you order your work.

Could you add another column to these tables to reflect if these were company priorities, what number priority were they and how is that helping to either make the process responsive and smoother or is there some better way we could together reinvent the priority process, I think this group understands that priority system has kind of fallen victim to FQPA and a lot of other things the last couple years, but its till there and it ought to be either reinvented or -

Jim Jones:

We would be happy to do that. We have to figure out how to order our work. Until a few years ago it was first in first out. The registration division began to rethink that and we are now in a process where we wed the manufacturer's priorities to societal (EPA, USDA, states, growers, environmental issues, etc.) priorities and we try to bring these together and that's the process that Jay was talking about. I would be happy to get broad input of how priorities ought to be basically ordered

I would plan tomorrow when we talk about upcoming issues to identify a handful of issues; what about the priority scheme, the whole range of issues from items that should be revised so we should keep that in mind as a work issue for this committee?

Just for your background, a year ago we conducted a survey of our member companies products that were in the queue currently and then a look ahead for the next four - five years. We just updated that and we now have two years of data that we might sit down maybe with a subgroup of the PPDC and share it with the entire group to expand this charge and put things in perspective to see how the overall process is working.

I think we agree with this that the topics time has come for a certain attention..

What is the rough percentage of these new Section 18's, the new applications that have been received that are repeats? What happens to these repeats? How does EPA handle the continuous repeats?

I don't think that historically it's changed very much. Over 60% of the Section 18's we get in any given year are repeats from a prior year. Progress toward registration is a regulatory requirement for consideration of the section 18's and three years for submission of an application for most pesticides is the standard. Five years for submission of application for an IR4. We look at the progress of registration. We have not been strict on denying something outright because it didn't appear to be making progress toward registration but the concept of "are we making progress" can sometimes be because delay can be on our part, if we have an application that came on the fourth year and then we've had it for three years are we going to say that they've not made progress? It's not a black and white as it may appear, but it has not been a particularly hard and fast criteria.

The concern we have is that as you streamline the Section l8 process, it appears to me that the hurdles may not be as high for the Section 18 process. If that's becoming a replacement for Section 3 then that becomes a real concern for us and the less strict you are in dealing with that problem the more you'll see Section 18's coming in and potential replacement strategy for what otherwise would be a requirement for registration.

That is my concern that the agency has. The history that is important for people to understand is that in the early 1980's we had a significant use of Section 18's as a replacement for Section 3 full registrations. That is when some of these policies about progress toward registration, about not allowing repeaters beyond a certain amount of time, were put in place as well as a more stringent evaluation, a more significant burden on the states and on the growers to say that it is truly an emergency as opposed to just a use that is desired. We are very faithfully adhering to those policies but its something we watch very carefully because we do not want to see the Section 18 program used as a way of circumventing the requirement to get a full registration. We have to remember what happened in the past and not let that happen again. It was very damaging to the integrity of the Pesticide Program. Its taken a lot of time to rebuild from that and we are not going to let that happen again.

Jay brought up the prioritization process and I think that ought to be looked at. One quick comment on the Antimicrobial Division statistics is that while they're meeting their FQPA deadlines, what we're starting to see is that they do a lot of 11^th hour rejections to meet their FQPA deadlines to say they've met it but reject the application in effect so that is of concern to us. The other thing we have seen is a dramatic increase of the time for amendments out of the Registration Division and I would hope that as the staff has been increased we will see some improvement in that.

One question on the Section 18's regarding the tolerance that other states 18's are covered.

Two questions- is there a mechanism for a tolerance to be issued on a regional basis that would allow for a regional pest problem to be addressed rather than taking up a whole risk cup that might not be able to be granted since having a Section 18 for the whole country would send it over the risk cup where a small portion wouldn't and then secondly what about the time a tolerance is issued does that cover uses outside the country by allowing commodities to be treated outside and if so is that taking into consideration the risk assessment and does that also take up part of the risk cup that then may potentially prevent states from being able to get a Section 18 and causing a tolerance not to be issued because the risk cup is to great.

We're not going to be doing regional tolerances as we operate under the principle that a tolerance is a tolerance is a tolerance. So that, yes imported foods are allowed into the United States if there is a Section 18 tolerance. We generally for Section 18's , for many reasons you allude to, assume 100% of the crop treated to allow additional states to come and for imports as well.

We would not be allowed, under the international trading system, to have one standard for food grown in the United States and a different standard for food imported. That would be viewed as a trade barrier and if another country did that we would take them to the World Trade Organization and vice versa. That is not an option.

Jim, when you were talking about the pyrethroid decisions, you mentioned when you were looking at the home uses that in all cases you used worst case scenarios. My question is that because there was not real world data available and if so is there any process under way now to ensure that data is available by the time you get to the tolerance reassessment phase?

It is partly because at the time and the time constraint we were operating under we didn't have immediate access to the data, but the more pressing issue was we had no time. We had no time to pull it all together. We would have made the time if we weren't able to make the finding, but they would have just expired and we would have had to figure it out after they expired. It was mostly a time issue. We do have a process in place to gather more sophisticated information on residential exposure.

I have two more questions. The first one has to do with the registration list and I would like to thank the Agency for taking three of our Section 18's off the table by issuing the registration first for spinosid, but to give you a little history of what that represents in some of the issues associated with this effort - we came to the agency in 1996 with the understanding that this product, because of its reduced risk status, was going to be registered within the next three months. The only reason you had Section 18's for this use for the past 3 years was because the registration process didn't follow through with the projected time lines that had been issued prior to FQPA and that's over half of the tolerances that are associated there. To the remsulfuron issue that's there, there are three other commodities that are pending for that registration at the same time peppers and potatoes and there is a methyl bromide replacement that's specifically targeted to a nutgrass problem which is not addressed to Florida as it is post-emergent use which doesn't do us any good in Florida until we do additional research to see if we can use it under plastic much. So I would be very careful as to how you project some of these things as replacements. The other issue concerns the priority setting process. It's my understanding that the original schedule to actually do the next set of industry priorities and requests that came in that were agency priorities that were not scheduled for setting review slots until some time late this summer. So you have the last year priority setting process that's still out there and we're still working on the two sets of priorities that we requested prior to the FQPA process. Is there any indication that process is moving forward faster now that you have some time under your belt so we can project something less than a three year turn around?

Last summer when we scheduled the work we are doing right now we have basically - give or take a month here or there, been able to meet those schedules.. So we are now operating in an environment where we're confident that we're meeting schedules. Now I know there are people out there that are going to say that we're two weeks late on this or a month late on that, but basically we are not blowing schedules by a quarter, two quarters, or a year unless there is a risk issue which slows things down. We think the scheduling now is becoming more predictable and we are able to meet commitments. Another thing we are seriously considering for next fiscal year is to tell people at the beginning of the year what we are going to do. There are always expectations that people have that we've never even put on ourselves. I'm routinely asked "when are you going to get this or that out" when I've never even had them on my list . We only have so many resources and we need to be more transparent about what things we are committing to do.

I would suggest that's critically important because a lot of things that we're asked to get involved in from a political standpoint aren't even on your list to be considered and there may be miscommunication or some other action taking place. One more quick question: we're still operating under the interim program on the REDs that are issued now and I assume that those tolerance decisions that will come out based on the REDs reregistration process at this point will be somewhat time limited or will have a time to come back to readdress the issues associated with cumulative exposure and some of the other things as we come down to the process to get everything worked out. Any thought of the time line of what the tolerance period might be on REDs they are issuing now.

That depends on which class and when that class is scheduled in the reassessment process - that is the best clue. Also look at the last August FR notice that laid out the schedule.

So that with the pyrethroids we can assume that when they come back for the cumulative exposure in the second group which is sometime around 2002 that would be the time frame the tolerances would be issued which are now scheduled for the REDs.

Remember, in aligning those we tried to schedule the highest risk chemical classes first, which is why the pyrethroids certainly lined up behind the OP's, carbamates, B2 carcinogens and other chemicals that are scheduled earlier.

Thank you for the very heartening discussions. We are going to take time now for public comments.

Public Comment Session:

Dr. Laura Plunket:

United Fresh Fruit & Vegetable Association--I am a neuropharmacolgist & board-certified toxicologist and I am here to address two issues: the adequacy of the core testing under FIFRA to protect children's health, secondly, the additional use of the 10x safety factor in the regulatory process. If you look at the core testing under FIFRA, you can see from that testing that children are tested in that paradigm. For example there is a multi-generational test, that tests mother's, their babies and their babies' babies. So we don't omit children's testing or young developing organism testing in the current core testing paradigm under FIFRA. Secondly it is my understanding from the comments that I heard today that it has been hypothesized that lead as a toxicant is part of the reason why we believe that pesticides and particularly organophosphate compounds should be tested differently in this core testing program and maybe that is also why we need to add a 10x safety factor. First if you look at the toxicants, OP's versus lead, they have different mechanisms of action in the body and different mechanisms to produce neurotoxicity. Those are important points to consider when you look at comparing lead and OP's. To me as a toxicologist, lead and OP's are apples and oranges and you must remember that. If you look at the large amount of literature/animal data that is available on lead you will see that if you were trying to develop lead or a lead compound today as a new pesticide you would see that you could actually identify safe exposure levels from the data that's out there and you could do that using the current regulatory methods that you have and you wouldn't need to apply the additional FQPA safety factor. If you do that you will see that the safe exposure levels you identify are below the current CDC action levels for lead that are used to regulate these compounds. The next point is that if you look at the lead data very specifically you can see that if you compare children and adults with the toxic effects you get with lead, its not a 10-fold increase in sensitivity, it is closer to a 2-fold difference. So if you consider using a 10-fold safety factor (if lead was the example) you wouldn't need to do so. The lead analogy for the cholinesterase inhibiting pesticides doesn't make sense, in fact it actually supports the adequacy of the current testing program and the fact that you wouldn't need an additional l0-fold factor to protect children's health. (Written comments will be submitted.)

Darryl Sumner :

Wake Forest University School of Medicine-- I teach recognition in management of pesticide poisoning to second year medical students and a little bit about natural product toxicology and teach natural product toxicology to graduate students. As you discussed providing extra safety factors from chemicals for children I get more and more concerned about what's going to happen to the safety factors concerning the toxic natural products that I deal with. I am concerned about the possibility of the loss of pesticides in that there may be unintentional public health consequences. My request is that the agency consider public health effects or possible health effects in the regulatory process, to do so officially, and to include it in all the regulatory activities, particularly cancellation. I'll try and give a few examples of effects with children. I'm sure you're all aware of cockroach asthma. NIH has shown that by controlling roaches one can reduce the number of incidences and the severity of those incidences. As a toxicologist whose a little bit familiar with the sensitization studies that are done with guinea pigs I have to add that it seems logical that if these infants were not treated to the substantial insult of the cockroach protein perhaps the sensitization wouldn't develop at all or would develop much later. Several things that can be illustrated from the cockroach asthma situation. First, the need for effective and affordable pest control process. The people in the inner cities are a little shy on funds. Keep in mind that all the regulatory costs that go into product development are passed on to the consumer. If those consumers cannot afford to control the roaches the kinds of diseases that we see in children are the logical consequence. In addition, people are resourceful; they find products that work. We all know about the use of methyl parathion to control roaches, and that also reflects the need for effective, affordable products. The CDC reported in 1997 that a two year old who ingested pesticide treated grain which had been brought into the U.S. for rat poison. Luckily the parents witnessed this and took the proper medical precaution and there was a complete recovery. But it again illustrates the need for affordable effective products and that people will use other things if they don't get them. We could go on and on about diseases, lyme disease, malaria, encephalitis, but there are some other examples in the natural product area; potatoes for instance. Potatoes produce a compound called solanin. Solanin is a natural insecticide and it increases when insects chew on the plants. The safety factor for solanin ranges from 3 to 4, maybe 6. Its less than any of the safety factors for synthetic materials and it is a cholinesterase inhibitor just like organic phosphates In addition it appears to have teratogenic potential. We need to realize that as we alter the system there isn't much room for error, and this should be included in the regulatory process. Another example is a microtoxin - zeralanone which is particularly interesting in this regard. Zeralanone has an estrogenic potency which is very high and depending on the test they use it is almost as high as estradyol itself. Zeralanone produces estro hypergenicity in nursing piglets and lambs from the diets of the nursing mothers which do not produce adverse effects in adults. 32 parts per billion produced adverse effects in piglets in a study in Italy. And in a study in Egypt they found 80 parts per billion in tomatoes because of nematode infections. With nematode control using OP's and carbamates they reduced those levels back down. These are definitely effects that could show up in children and again I request that it be considered in the regulatory process. Also, we've noticed some incidents of pyrethroid resistance in public health issues in eastern Europe, specifically with head lice in children and that illustrates then that the regulatory process should also consider resistance and possible development problems further in the future. (A written submission will be prepared.)

David Irish :

Dry bean grower in New York state. Chairman of the New York State Dry Bean Advisory Committee. The committee is made up of growers, receivers, shippers and processors. I represent the deep frustration, concern and anger over the effect the FQPA standards are having over the NY bean industry. Annually 35,000-40,000 acres of beans are grown in NY with a market value of $10-14 million. No one argues with the intent of the FQPA. Safety is a concern to all, especially to the farmers who use these chemicals, what we are taking issue with is the implementation of the FQPA objective. We do not feel the realistic usage or actual rates are being considered when evaluations are done. Unless some scientific common sense is applied to this testing mechanism I would question the validity and the ability to defend the results scientifically. An example of this is the FQPA's effect on NY State's Section 18 request for Reflex which was withdrawn rather than be denied. In its study the EPA used "worst-case data" as Mr. Jones referred to. A scenario which included the highest label rate coupled with excessive rainfall on sandy soils resulting in trace amounts of chemical found in the ground water. My argument is as follows: Soil conditions vary tremendously and mention was made about regionality of it. Each chemical label recognizes this fact. Label rates correspond to soil type-X amount for sandy soils, X amount for medium soils, X amount for clay soils. Its on every label. Sand is a rare thing in New York and to my knowledge no beans are grown on sandy soils at all.

The highest label rates are not used or recommended. The lowest rates are used and very effectively.. Cornell researches have planed to recommend rates even lower than those on the Reflex label. I speak from experience as I grow 200 acres of beans annually, that even the lowest rate has a highly effective spectrum of weed control. A blanket denial of this type of information is ridiculous. A ban or restriction of the use on sandy soils would have been a reasonable stance.

With the use of Reflex I used one pint per acre at a cost of $12.00. With the loss of Reflex I will use a group of chemicals totaling one gallon and one quart per acre at a cost of $66.00 per acre and the worst part of it is that the weed control I get with this is less than that which I get from one pint of Reflex. I use Integrated Pest Management practices. I use cover crop rye which has weed suppression capabilities when plowed down before planting and also when we cultivate so we aren't out there running around throwing chemicals on the ground. Overall the long range impact to the NY state bean industry is immediate as well as long term Yields will be reduced do to weed competition.

Actual harvest yields will be reduced as well. Excess materials (weeds) being run through the

combine will cause harvest inefficiency resulting in as much as 25% of the crop. Weed infestation will result in higher dockage when taken to the elevator. Also of concern is the staining of beans caused by the weeds. This is especially true of white beans. This also leads to reduction of profits. Nightshade berries are the single largest weed concern facing the New York bean industry. The berries are similar in size and shape of a bean and therefore almost impossible to separate from the crop. Since no consumer wants to find nightshade berries in their beans, there is a near zero tolerance. In fact a whole shipment of canned beans was rejected because nightshade was found in them. This type of loss effects the grower, shipper and canner as well. The loss examples are going to increase exponentially since Reflex was the best chemical we had available to control Nightshade. You must agree that the potential for loss we face in New York is huge. I have clearly illustrated the extremely negative result the current methods of implementing FQPA will have. I have done so using just one chemical on one crop in one state. A common sense approach to testing must be used when evaluating chemicals. An example: if we used this type of analysis on gasolene we would all be walking to work by now. There must be some accountability on behalf of the EPA. We must all work together to strike a balance which ensures food safety but which permits the use of chemicals which are effective and cost-efficient. Growers are deeply concerned with the safety. After all it is the growers and their families which live and work in closest proximity to the areas being treated. We all have a vested interest in a safe and economical food supply. We cannot let laws with a good intent be implement in such as way as to cripple the ability of those who produce our food. A written comment will be produced.

We are happy in situations like this to answer your questions directly about how we did our analysis. So if you want to get details about analysis of this substance we are happy to show you're the calculations.

Jim Jones: We need to communicate better on some of these situations is that the water exposure on some of the subpopulations is what we need to worry about. There are numerous places where beans are grown where there are sandy soils. We had firm data that showed that Reflex was found in the ground waters in some areas even if there was no exposure in your area.

Our data was based on actual conditions in North Carolina.

At one time we thought we would begin to talk with some specifics about our approach to organophosphates, but to some extent we have focused at first on the important public participation aspects of our thinking about the OP's. I am glad that Dr. Goldman is with us to comment on this.

Organophosphate reassessment is, as many of you are well aware, attracting a lot of interest and concern across the country. It's the first major deadline that is coming up for the statute. It is the first set of chemicals on which that we are going to do a formal tolerance reassessment up to this point, as you have heard. The tolerances that we have worked on have been in the context of expiring tolerances when we needed to address them because they had a time limit on them or in the context of section 18's. The OP's are the first group in which we are going to do a full FQPA assessment. So I think it is natural as that date is approaching that there is more concern, there is more scrutiny for what we are doing. A considerable amount of misunderstanding about what our process is going to be. The best example of that is a piece that appeared in the Wall Street Journal recently that stated on May 15th EPA plans to cancels all the OP's which is not a plan that we have. EPA has not developed any plans relating to this. This rumor was widely believed by many and when coupled with concerns about do we really have the data to do the reassessments, what are the procedure that we are using? The procedures seem to be changing over time since the enactment of the law, some felt that our process has not been transparent. There have been legitimate concerns when coupled with the rumor mill that have led to a really very high level in the government to get engaged and ensure that this process is carried out in a way that is fair, transparent, and will ensure that we are using the best available science and have a reasonable transition. In your packet there are two documents that are key. One, a memorandum to Administrator Browner and Secretary Glickman from Vice President Gore. The second is a response signed by Carol Browner and Dan Glickman. Memorandum to Secretary Glickman and Administrator Browner from Vice President Gore. The Vice Presidents' memo points out that the FQPA act is the landmark statue as environmental law. Very important in that it is ensuring more scrutiny for pesticide risks to children, also very important that it respect the needs of agriculture. The Vice President is asking for more cooperation between EPA & USDA in terms of making sure that USDA is a full partner in the issues related to transition. Keith Pitts will address how USDA is moving forward to be a stronger partner with us. The memo also points out that there are some very complex and regulatory issues that are embedded in FQPA. Several areas that the Vice President asked both agencies to address: The first is that we are using sound science and protecting the public's health and it is our number one priority at EPA to use the best available science in making our decisions and this is very much in accord with that along with the use of peer review and public review of our methods and approaches. I would consider the work that is the committee does in term of public review to be a part of that in general and that we are careful when it comes to the use of default assumptions and exposure scenarios, that we are careful about how we use them and that we fully explain them. The memo asks us to ensure that the use of 10x safety factor, the margin of safety to protect children, is done in a manner that is in accord with the intent of congress, the intent of the National Academy of Sciences report, and that uses scientific peer reviews where appropriate.

The second area involves transparency. We are being directed to clearly and fully communicate decisions in a way that facilitates informed review by all affected constituents, that we fully present alternative approaches when those alternative approaches exit and that we fully disclose when we make a decision whether or not to request additional data.. And that it is clear to people why we are or are not requesting additional data from the regulated community.

Third area is the area for reasonable transition for agriculture and this is an area where the partnership with USDA is very important. The Vice President acknowledges that we have not anticipated canceling all of the OP's during the growing season. There may be some individual OP uses that as we go through the reassessment process we see that there are problems with those uses. This is not to direct us to avoid taking actions where we see clear public health and environmental problems, but it does say that if we do see that, then we should work with USDA, consult with them in how we do those actions. It also says that we need to make sure that the effective pesticide users and other constituencies have time, assistance, and support in going through the transition process. That we facilitate transition to newer and safer pest management strategies and in particular that EPA look for ways to further our registration process for those and that USDA devote the appropriate resources for research and technical assistance. That we review our operating plans and budgets and look to see if there are any strategies that we can pursue to expedite the approval of new uses; that we identify & implements any measures that might streamline the process for emergency pest management challenges so EPA can respond promptly and that we explore common sense approaches to achieve transitions in the selection of uses to work on and also in any way that we can do our work in partnership with grower groups.

Last but not least is the issue of consultation with public & other agencies & we were directed to establish an effective means of consultation with user groups the manufactures, environmental public health organization and others who are concerned about implementation. EPA and USDA has been asked to set up a mechanism to get formal advice from a whole array of stake holders. We have also been asked to make sure we are touching base with the Office of Management and Budget and the Food and Drug Administration on many of these issues, and the Vice President would like to see an enhanced role by the Office of Secretary of Agriculture in coordinating USDA pest management policy. We were asked to give a written report within 14 days and a copy of that report is in your package. The most important thing in the report is that we are going to set up a new Federal Advisory Committee that will operate over a short period of time, but in a very intensive fashion. It will address the organophosphates reassessment. We are putting together a fairly high level group that will include representatives from all of the stakeholder groups. The group will be co-chaired by EPA's Deputy Administrator, Fred Hansen and USDA's Deputy Secretary, Richard Rominger. The first meeting will be in May. It will probably have a total of four meetings in fairly rapid succession.. We will address a number of specific questions about how to make appropriate tolerance decisions, how to ensure the appropriate public participation in transparency in those decisions; a proper policy framework for considering if there is adequate science information. We will not be asking the group to peer review the science, we're going to ask them about the policy framework for the science. Is it appropriate and is our process for insuring the best available science, is that appropriate. Is it appropriate, and is our process for peer review, the insuring the best available science is incorporated, is that appropriate? How to speed the pace of decisions, appropriate and common sense strategies for reducing the risks to acceptable levels while retaining the pesticides of highest public value all will be on the table. And considering organophosphates, what are the priorities? Should we first consider the diets of children? Another thing that will be on the table for discussion will be on the 10X child-specific safety margin. That is an issue we are taking to numerous fora for discussion about science and policy. I think the more people who get engaged in that discussion the better. In terms of how we plan to use this process in the context of this committee, we view this as an opportunity to get some very focused discussions on the tolerance reassessment process that we will be able to bring back to this advisory committee much as we use the SAP in that context. They review issues from the science perspective. We will bring those issues back. We are trying to set up the committee so there is a fair amount of overlap with the PPDC so there will be several members of this committee who are very familiar with the program and have had the benefit of the experience that you have had on being around this table in terms of understanding the broader way that the program operates. We are also going to have overlap with the SAP, SAB, with the Office of Children's Health Protection, Children's Advisory FACA and with the NACEPT committee that this will be housed under, so that as much as possible this new committee will be able to draw on expertise that has already been created through some other advisory processes and will also be able to draw on some of the discussions that have already occurred. USDA is a full partner in this and not only co-chairing but also in identification and selection of potential members, particularly of the growers community. I would now like to invite Keith Pitts to add to what I have said and also to give you an overview of what USDA is doing, in addition to the advisory process to address the Vice President's memorandum.

Keith Pitts:

Lynn covered most of the memo but a couple of USDA specific points - you don't see a larger contingency from USDA since people are working on reports required of us because of the memo as it relates to research and technical assistance in support of IPM strategies and in implementation of the law.

The approach we are taking is getting the Office Pest Management program fully staffed and the decision memorandum is being pulled together this week to capture the money we need to get that staff up and running. We will also be pulling together existing funds that are left over from this year to direct them toward FQPA implementation. There are some program funds that have not gone out yet and we intend to capture those and fold them into the purview of the Office of Pest Management Program so that will be managed and targeted towards whatever guidance we get from this process. On top of existing funds we can re-direct this year, we are developing options to put forward as a fund for a project that the Secretary could consider for his discretionary authority. We are keeping an eye on the yet-to-pop out of Congress Research Farm Bill and there are funds there which are identified for critical and emerging issues and I think there is no doubt that FQPA implementation as well as meeting 75% IPM goals by the year 2000 will be key policy arenas where we will direct some of this research money. We will respond to the Vice President's memo and put out what we gave to this faculty group to let us know if we are on base or not or if we need to refine it some more. We are going to work with EPA very closely to make sure that anything we do in relation to FQPA implementation is tied in to the regulatory needs that are being identified in the FQPA implementation process.

Does Bob have anything to say in terms of FDA's perspective on this?

Not really except to say that it seems that the process of coordination and thinking through further processes is pretty well advanced and it makes sense from our perspective, so we fully support it..

I didn't mention this, but in terms of the advisory process that we're putting together right now, we are going to be asking the FDA and CBC to participate as well as USDA partly from the standpoint of the direction we received from the Vice President, but also because there are some public health uses and we need to make sure that the public health agency is at the table to address that side as well - both the risk side and the public health benefit side. Here I could use input on any insights or if any of you have ideas about how we are going to que-up all those issues. How this committee can play a role. I think we should provide you with the same materials the other committee receives so at the end of it you can report back.

I have two questions. Keith the first one is for you. There is currently the new office of Pest Management Policy or some such name, which is staffed by one person and a detailee from EPA.

We've got a couple of more people that came on this week. We have a work group of 10 people set up now between USDA and EPA which will help us work through some issues and help define what we will give this faculty. We are using this office to better coordinate with other programs that are directly or tangentially involved with other pest management issues. In that group would be NASCEP, IR4, NARS, food consumption issues, etc. Our working relationship has not always been so constructive, but we are working on it.We have a small group of USDA and EPA employees working on scoping documents we will be supplying to this faculty.

This new FACA committee does not sound dissimilar from the Food Safety Advisory Committee. Which I though was to big to be effective. The CEO's and others didn't really care about the issues but they will now. But we need to make sure you have people on the committee who really have a fundamental understanding of the potential impacts.

I think you are right about the size issue. It will end up being a fairly large committee when we cover all the bases and the stakeholder groups. I can't reassure you about the level of the members. Also because we are no longer dealing with interim policies but with policies that are making longer range and definitive decisions about chemicals and products, I think there will be more focus by the members. I hope that the EPA and the USDA learn something from that process. I felt that our presentations to that committee got more effective over time. In the end we actually started laying out the decision logic, and we are going to try to learn from this, in terms of how to do a better job, and how we frame the issues and discussions.

This is a question relative to the OP committee. Having been at several meetings to look at specific components of this tolerance reassessment process, how is that work going to be rolled into the advisory committee so that we get the benefit of the scientific review, of how to do cumulative exposures and the aggregate risk stuff and probabilistic analysis and all the things we've worked on?

We need to bring all of that forward in a policy context. I could use some advice from you on this. Some of our initial thoughts are to try to put it together as a road map. This committee can help us by looking at this as a framework about how to make decisions. If you have ideas on how we can do it, in particular, how we can get people focused on the factual part of what's going on, as opposed to the stuff that's on the level of fears and concerns.

I'd like to respond to that with an example. The best analysis of probabilistic modes and how they work was part of an attachment to an SAP document that went forward at the last meeting. It was an appendix which was clear, concise, direct and to the point. I don't know how you decide what gets sent where but those kind of documents need to be part of the review. The quality of the data base as used in the analysis will drive part of the policy discussion which will impact on the industry. Somehow all of that needs to be folded into what this group discusses.

That input is very helpful. If any one knows of documents that have been produced which are particularly clear and would help a group like this, you might let us know.

Will this group make consensus recommendations to the agency about how to proceed with OP's and other issues under FQPA. If that's not the case it should be clear up front about how this is going to happen. The expectation is that high profile issues are going to vary so having a clear idea up front will help. What happens to the output of the committee? We don't know how the output was utilized following the Food Safety Advisory Committee.

I have two questions. I've looked at the Charter for PPDC and have looked at the letter and I'm not sure what the difference is between the two committees and why there is a need for another FACA committee? Will this new committee develop consensus recommendations?

The new committee will be focused solely on the tolerance reassessment process and will be of intense but brief duration. It will be more involved with a different range of stakeholder groups than this group because of the urgency to receive more public input and to provide more transparency and for review of the processes we use to make decisions so we can make those decisions in time for the statutory deadlines under FQPA. This committee is concerned with the full range of activities that are carried out by OPP, not just public health protection, but ecological protection and all the issues that are included. This new committee will demand a lot of time over a brief period to help point us in the right direction. When finished the new committee will write its report and go out of business. The PPDC is a permanent advisory committee. The new committee is not. We are interested in your views on whether we will ask it for a consensus. It would be challenging to reach a consensus on many issues on a brief period of time with the array of stakeholders. Should we cover a few concerns and get consensus or cover concerns on a broader array. We need your feedback.

I have been on many EPA committees where there was an effort to reach a consensus on a much narrower set of issues than this, which in some cases took over a year or two with dozens of meetings. I don't think you'll get consensus from this group in a 4-day period.

Larry's suggestion that the interim decision logic that was a product of the Food Safety Advisory Committee would be a place to start in terms of specific steps. It would be instructive to get that in front of this group and the new advisory committee. We will be amazed about how much has happened since 1996. Consideration should be given to subgroups to deal with specific issues to flush out the tough issues. What was the underlying reason that the new committee will be convened under a larger authority than the PPDC.

The NACEPT committee advises the Agency's Administrator. So by putting it under the NACEPT committee it makes more sense. Operationally, it won't have an impact. The pesticide office will staff the committee along with their counterparts at USDA.

It's a reasonable time for the academics to weigh in. It would be wonderful if we could reach a consensus which would help to empower the process. I think that if we can empower the process in a few areas for example our dietary data as it relates to the EPA, the FDA, and particularly how it relates to children, is an area that we make sure remains well funded and that we can get the data. I think everyone can walk away from the room and say that it would be a good area to support. Once we have all this data, we have to make sure that we empower you and EPA that data remain accessible. The GAO has said we need to get a better handle on that data so it is available to the community, the public at large and certainly with the academic community. The lynchpin of much of this is good sound science. We need to partner better in good sound science than we actually are. I m not entirely convinced that we have an outstanding community that understands developmental or teratalogical effects in the environment. If there is such a group in NIH I would like them to come forward and to present their issues. I'm not so convinced that some of my brilliant colleagues in the development of cancer, in the carcinogenesis area have a handle relating to pesticides and toxics. I would like to hear from them. NIH does not have a standing committee where a group of environmental scientists sit. And peer review grants within environmental science and think that's something that we need. There is concern about research. ORD has been a leader in trying to make this available through the EPA. They should be applauded. We want to get some uniformity between ORD, USDA, and I would love to see NIH participate and if we can get that type of scientific interaction maybe we can get the grants we need to help the scientific community and give people the information they need. We still need to educate a generation of young physicians and that still remains difficult. General education to the public is critical.

The Memorandum from the Vice President -- this era of good feeling between USDA and EPA, which is a good thing -- much of what has been said here today -- all has a tendency to reinforce the suspicion and fears of those of us in the non-agricultural user community that we've got the stuff that little is known about that pose very big risks that are going to eat up disproportionately large portions of the risk cups. We're not really in this mix and we're going to be the big losers. Those that I represent -- lawn care guys, golf care guys, vegetation management guys - I think would all be reassured if there were some kind of indication that their needs were being attended to as much as agriculture.

I want to focus on the reasonable transition for agriculture that was part of the Vice President's letter and how that can play into this Federal Advisory Committee Act (FACA) exercise. We've talked about risk assessment, public health issues and the non-agricultural issues. We have a list from Lois' staff about the OP's and where they are in reregistration. I would like either USDA or EPA to take a look at where these OP's are registered, where the critical needs are , where there are alternative or reduced risk products are in the pipeline or maybe in the labs yet with some of the registrants and how there might be an expedited review of those especially if they are reduced- risk and meet the FQPA guidelines, we have to do the FQPA analysis on everything now, we've got a good sense of what those products are, that farmers need to understand what they will have to transition to. I also think that within the FACA committee if you look at some reduced risk products as partners with some of the OP's that we have to use because of critical needs. The result of that partnership will be reducing the risk cup for some of those OP's. I've talked with Jim (Jones) and Steve (Johnson) about the agency having the ability to expedite in critical areas, these new reduced risk products. It's been frustrating for us to work with the registrants on new chemistry that will be critical replacements for some of the OP's that may not make it. Only to have the agency come back and say "we don't have the internal mechanisms in place to deal with bring that product on line. We've talked a lot about process, process, process. The education process for growers is great - to get them to adopt this new technology, let alone pay for the cost of the new technology. I would like the FACA committee to take a look at the economic and social constraints of the transition. The new chemicals cost a lot of money and to be honest with you it is going to basically come down to grower bottom line issues. Some new chemicals cost 6-7-8 times more money than the OP's cost. I also would like to challenge CSREES and ARS to try to put together a functional, practical plan on how extension is going to work on some of these issues. There is a shrinking extension faculty out there in the grower community. That's were the transitional work is going to take place. I don't want to lose the common sense, practical approach to how my members, Dan's members, Steve's customers and clients are going to have to apply these risk assessments. I've looked at ILSI and seen an SAP report. Let's build consensus with our growers how that will work out in the field. The grower community is now saying "thank God they are studying this stuff because we don't have time, energy or resources to know how to use it."We would like to see this FACA committee talk about practical agricultural needs so we can apply this new technology to our farms.

As part of this process, I think USDA has a responsibility to lay out funds and tools we have available and there should be an assessment that they are being used adequately. Certainly, using this process as well as others outside of the FACA process to help correct that. Right now we are stuck with the current budget but over the summer we will be working on the next fiscal year budget. We should improve the interaction between research bodies within the states and USDA and grower groups. In some cases, it is working well and in other cases not.

I think the weakest stakeholder is the most important stakeholder and that's the public. I don't think the science is there and that is why consensus scares me a little bit. When we don't have enough information yet, and your response to my question about the synthetic pyrethroids and Lynn's response is understandable -- we're not going to do that until 2003. But in the interim, everybody is going to be exposed believing it is O.K. Based on what? I don't that there is anything in the bowels of the EPA that is going to lead us to this so-called consensus. I get nervous listening to public concerns and I don't think they believe there is so much wisdom at this table that we would come up with the right answer. There may be things we can all agree on -- perhaps motherhood and apple pie. We have to make some very tough decisions about allowing exposure during the time we don't know what's going on. That's why I like the second part of Lynn's comments on consensus in which we're going to be very open. At least maybe we can reach a consensus on what we think are the important issues, but not necessarily the policy. I think the public tends to get left out with no coherent voice.

Headquarters has funded the process called Regional Agricultural Initiatives which fits in very well with what efforts are to be put underway. These initiatives are designed to assist regional implementation of FQPA such as working with the state task force of FLA. It is designed to bring local people in and identify state by state concerns. We regions are trying to bring in local coalitions who do not have resources to come to Washington to identify pest management concerns on the local level. What the types of problems caused by the loss of chemicals are and how to assist them in developing alternative pest management strategies and to develop transitional processes to get them away from chemicals that are going to be lost and to get them to suitable alternatives. I hope this effort is successful and that headquarters will continue supporting this effort and expand it to the regions where it's not already in place. And to recognize that there is an infrastructure in place that allows a better contact for such things as meetings at the local level for getting in touch with the growers and constituents and not just agriculture but structural pest control and the state lead agencies that are dealing with these problems on a face to face basis with their constituents and dealing with the entire community, not just agriculture. In relations to the CES infrastructure, there is an effort underway to reshape the education and outreach that's currently done under the certification program. I want to encourage USDA and Keith (Pitts) to have your regional USDA cooperate with the regional EPA offices. There are some good ideas coming about regional training centers that would promote Ag engineering and promote and increase regional expertise on such things as IPM, and it works well with structures already in place. There is no need to create new offices since there are already offices and structures to deal with these issues that haven't been dealt with under previous regulatory constraints.

My sense is that whatever consensus might be achieved by this new advisory committee and what impact it may have on the regulatory process of EPA, is not the last bite of the apple. I think most people who have something to do with the regulation of pesticides expect us to see the use of science and regulation as a process to evolve as long as we have pesticides. I am reminded that there is another committee in the Agency and that is the Children's Health Advisory Committee which has identified the OP's and carbamates for review. It bothers me that agency resources are being scattered and stretched and disseminated over so many places that we may be just going in different directions and not accomplishing anything but burning resources.

I am concerned about the relationship of the Federal agencies. But I don't hear a lot about the role that the state agencies can play, particularly the experiment stations. The states have a two components - the extension service and the experiment stations. Extension services are more closely tied to the Federal than to the State. But I don't hear much about reaching the experiment station people. They have a tremendous amount of resources. My experiment station talks with ultimate users. The stations are closely in contact with the end users. Most stations have two, three, four or five advisory committees We should look at the possibility of the experiment stations getting more involved in the process as they have resources we should tap.

I think that a consensus summary helps the group define their needs. This way we can work out the important issues. We need to get the overlapping interests of EPA, USDA, and NIH and see how we can come together to get the best science available to the agency both at the basic level and in translational research. That's clearly what we need to move the agenda forward.

From a practical point of view, I think you're right. Consensus forces a discussion among the group. But the other choice is that we have an opportunity to say our 5 minutes worth to repeat what every one knows we are going to say. The producers are most concerned that they can still stay in business while you are regulating these pesticides. The questions have to be clearly defined. We have to heed the advice of those who sit with us during these discussions.

A good closing to a really lively discussion. Process matters!

This next topic, Registration Review, is probably the dullest label for something important. This is the concept in the new law and in the near future that we will find a way to look at pesticides periodically (15 years) to assure ourselves that we pay attention to what we know about things now. We have a workgroup that has begun the process of thinking about this internally. Denise Keehner from EFED will be reporting to us.

Thank you. I would like to provide an overview of the development of the registration review program. We are very early in the process and we are genuinely interested in obtaining some input from the PPDC on some key topics and key issues. In addition to tolerance reassessment, requirements for aggregate exposure, cumulative risk assessment and margins of safety for children. FQPA establishes requirements for periodic review of registrations (15 years). The administrator has to develop regulations to establish a procedure for that review. The goal of those regulations has to be reviewing the pesticide registration every 15 years. Must use data call-in authority to bring data in and that any cancellation action has to follow Section 6 procedures, that is, the outcome of any registration review cannot be any kind of a cancellation action, but other procedures have to be followed. There are no statutory deadlines for when the rule making has to be completed nor when to implement the program. As to program goals, there are two major reasons why we are looking at implementing the registration review program is that science does change and policies change. We don't want to be 30 years behind in terms of the science or policies with certain registration. We never want to be in that position again. The second goal is to institute a more systematic process for reviewing and revising and applying new data requirements. In December, Dr. Goldman asked OPP to pull together a work group to develop the new program. We have representatives from all the divisions of OPP. This team is jointly chaired by the SRRD and EFED.

We formed this team and began to discuss some of the key issues. We have to learn from the experience of the reregistration program and we want to design a program that is reflective of all the lessons we learned in the implementation of the reregistration program. Our near term goals: This team is a sort of a 'scoping out' team. We are looking at key issues in terms of how to approach the rule making, the establishment of the program, the legal issues. We want to obtain some early stakeholder input. We have to develop initial budget materials to fund the program and to begin implementing the program by June l998. We are bringing to the PPDC 9 or 10 topics that we want to talk about. To develop a conceptual model there are certain issues on which we want input. The nature or focus of the review. Reregistration was about a comprehensive reevaluation of a particular pesticide. About the reregistration program - should we focus on the reevaluation of all aspects of the use, or a more focused review, assuming we will be looking at pesticides at least every 15 years? The second area of discussion is of incentives for registrant cooperation. Reregistration has been slower than hoped and program people say there aren't as many incentives to move quickly to closure as there are for registration inside the program. We are also open to new approaches to streamline review processes, more innovative process to share administrative burdens more with the regulated community. There have been some thoughts about the concept of the registrants having a role earlier in the process and for preparing the draft risk assessment for the particular compound. It would have been nice to have more flexibility built in at the beginning. One size or one process does not fit all. We need different tracks depending on the characteristics of a particular active ingredient, the status of its data base and when it was last looked at comprehensively. Do we need as thorough a review for a pesticide that was registered recently for a new use as for one where there hasn't been a lot of activity for a number of years?

The fifth topic is Scheduling. How should we go about the process for developing the schedule for registration review. What compounds first, what are the criteria? Recognizing that there are many programmatic and statutory priorities we must be cognizant of including the schedule for tolerance reassessment, the statutory requirement for five year review for tolerances that are based on anticipated residues.. The registration review program may come into play before we have actually completed all of reregistration . There would be an issue as to what to do with those remaining reregistration compounds.

The sixth topic is Public Participation. How do we get the maximum value from participation without unnecessarily delaying the decision making process. Those topics are within the context of developing a conceptual model for this program and how it might be structures.

There are three additional topics: The desirability of issuing advance notice of proposed rule-making in the context of the regulation development process. We do have to pursue regulation development and advance notice is not necessary. There are two sides to this issue. Some think there is merit in developing ANPRM because it provides a structured framework for getting input on different aspects of the program before getting to the actual proposed rule stage. Others wonder why make that extra step. But we are interested in hearing PPDC's views on whether you view it as desirable to develop advance notice for proposed rule making. And if we decide to go in that direction we are talking about a nine month to a year process.

The second topic is the desirability of proceeding to issue initial data call in letters prior to the promulgation of the final rule for this program. If we envision the registration review program coming into place when reregistration is ending which should be around 2002 - 2003, the first registration review compounds would be up for decision at that time which means we should start data call ins over the next 6 - 9 months in order to make decisions in that time frame.

The final point is the issue of the future role of PPDC in the development and implementation of this particular program; interested in status reports or interested in more substantive involvement over the long term. We're interested in understanding your level of interest in this and how best to approach developing regulations and developing the program

I think we must move forward with this fast enough that we don't end up in the same position that the agency was in at an earlier time with reregistration -- where delays in moving forward that the amount of work that needs to be done accumulates to the point where it becomes almost impossible to do it. If you want to look at this issue in more depth, I think it may be important for the program to bring back to you some sense of when the compounds on the market were either registered or are slated for re-registration so that when the 15 year period comes up for them so you would have a sense of that. I sense that the first batch is small because we have a big bump-up of reregistrations that we are doing right now like last year. From 1996 on we have had a large number of reregistration so you can add 15 years to 1996 which will be a big year. But we will eventually hit a point where there are a lot of them due all at once.

It is my understanding that everything that was registered prior to FQPA has to go through a tolerance reassessment by 2006. In that process along with the registration process overlaying that you have a whole universe of other information coming in that was based on everything registered prior to 1984. How will you put this process in place and what kind of information will you need that will require a data call in effort to drive this process. Is it different areas than what you're looking at in reregistration?

It may be. Only the reregistration chemicals are going through reregistration. We are not looking at ecological risk issues. We're not looking at worker risk issues. We might not necessarily be doing data call ins because we may have chemicals in tolerance reassessment that from the standpoint of that process - we haven't figured that out yet, but it may well be from the standpoint of that process that we don't need to call in data. But yet we've revised the testing guidelines, but in the past when we've got guideline revision to bring chemicals up to date we've required additional testing. So there will also be a certain amount of that housekeeping. But as for keeping the science up to date that can be very important.

I think the agency is facing a whole universe as large as what the reregistration process faced when it was first set up. Are we trying to make work that we don' t need to do until we get through the tolerance reassessment process?

One of the key issues is that we as a program have a tolerance reassessment program going on. The statute says the periodic review is a mandatory requirement. Do we need to move on now and begin that process? Do we need to get the program up so there is a mechanism in place to complete tolerance reassessment for those beyond 2003.

If this tolerance reassessment program is going to shut down - what about worker protection, environmental fate -- what about inert ingredients. I would like to know where this fits.

I think to the extent where registration review covers inert ingredients is one of the issues being discussed internally within OPP. I would like to hear your views.

There is other ongoing work on inert ingredients which we are actually now calling "other ingredients". The term 'inert' was never meaningful and I think Marcia will raise this topic to look at tomorrow.

I am very concerned about farm worker children. Where in the process, if you look at the aggregate exposure of farm children who may be in the workplace but not be working, what is the Agency's thinking. They may not actually be working but they are definitely getting exposure. Where is the Agency's thinking on this?

Our research program is looking into those type children. We have a couple of studies underway to measure pesticide exposure - excellent topic for this group when we have some of the data. It is a complex set of issues but some of those children are not legally in the work area and we would not be able match up illegal type children with a label on a pesticide. If the labor practice is illegal it is illegal and issuing more registration is not going to make it more illegal than it is. There are other issues - in terms of children who are legal and old enough to work and there is a farm labor exemption for farm family children, there are also issues relating to drift into nearby homes and issues related to take home exposures from parents and they all need to be addressed. The Office of Research and Development is looking into these issues now. All will present us with some difficult policy issues and we will need your advice on how to address it.

Marion Moses:

We need to do more that acknowledge this. I don't care if they are legal or not, they are children. If we are going to focus on children and if we are going to look at common mechanisms of exposure, and if we are going to look at aggregate exposures, I don't understand how we can not look at this problem.

This issue can be queued for further discussion. We are going to address the issue but the questions is HOW we are going to do it.

There is a whole host of issues dealing with children in rural areas, housing developments adjacent to farms and we want to get smarter on these issues that are around the interface between people and these exposures (drift).

Marion, are you suggested that this be part of the reregistration renewal process?

Absolutely. We are talking about children not about workers. They are probably the ones most at risk. If we want to learn about more about children, then we need to look at these children and even at their mothers and their fetuses.

I think another advantage which registration review provides is a reluctance to register pesticide uses for which we can't categorically say they are okay. Gives us the chance to say, based on what we know now, this is a good pesticide to use now. There are some things we don't know but gives us the opportunity to go back to the statute and review these things as more information and science becomes available. That should help get things registered that are helpful and if we find out there are problems later on we can go back through registration and review those problems. Two responses: The advantages of an ANPR is it allows you to get a fairly specific input on the possible regulation without the constraints of rule making. This means it can be a much more open discussion type process. The other thing that is important, there is real concern that registrants know soon enough what may be of concern to the Agency so they have time to do the studies, so the studies are done right and the Agency has time to review those studies so we don't get 15 years out and suddenly say - oh we're sorry, we're 15 months from finishing the review but we have to cancel your use anyway. Its fair to the registrants to provide that opportunity.

Two things that have been discussed: illegal use and the implications for registration. We've seen it in the parathion example and it has been raised in the farm worker kids issue. The Act does speak of pesticides when used in accordance with widespread and recognized practice which is not necessarily legal practice. How does the agency deal with that issue? We've seen examples where there is allegedly fairly widespread use of certain chemicals which may not be consistent with the label.

The Agency will never say or do anything that will either directly or indirectly imply an approval of an illegal process. Even if it is illegal practice under someone else's law. We don't enforce the child labor laws, but there is no way that we would give any smidgeon of approval for people violating those laws. The same goes for the misuse or misapplication of methyl parathion in homes. We dealt with that. We changed the registration by making it very difficult to use that chemical in the home. We put a stenching agent in the product, we repackaged it, we bar-coded it , tracked it, but we did not put on the label instructions that if you want to misuse it, here's how to do it.

The question is, if you have a chemical(s) where there is a substantial exposure to a substantial population, perhaps of children, can't that be a basis for the agency canceling a registration because there's no other way to prevent that exposure.

With methyl parathion what we did with the registrant is that if we weren't able to obtain the changes in how the product was packaged, distributed, tracked, we would have canceled it on the basis of the ease of misuse. Other things can be done.

In analyzing exposures, what scenarios do we contemplate? In the drinking water area for example, when we analyze the amount that is likely to show up in surface water, we make an assumption that there will be a certain amount of drift, which is not unfounded by data. We have tried to be realistic when trying to get a handle on how much exposure occurs in some of these environmental roots.

There are data for some chemicals where there is substantial exposure to children in the farming sector from legal or illegal use. How does the Agency intend to deal with that? Simply by making label changes which may or may not be complied with according to past experience or is it actually going to move?.

We don't try to deal with risk with label changes unless we believe that the label changes will be effective.

Something we can dialogue about later is that we have the option when we make those kinds of changes to require data that those changes were actually effective in reducing the risk. We've done that on a number of occasions where we've done reduction in application rates but then required market basket data to make sure that the residue levels in the food were actually going down and so there is an ability to put a check into the process so we're not simply making a change and then walking away from it. We can do a better job than we do in understanding what the actual exposures in the population are, monitoring those over time and understanding what we attribute those to.

I like that, is there a budget for that, is it something that could actually happen overtime?

We are working on that with Health and Human Services. They have data on levels of numerous pesticides in kids but they want to go further with that kind of monitoring. The difficult thing is the translation of the data - where the exposure is coming from - illegal uses, legal uses, drift, directly in the food. We aren't good at contributing those levels to actual uses

Just a quick comment on the children's risk. I would hope there is an option if there is overexposure from illegal work practices that we could enforce. It may be outside EPA's purview but there should be some mechanism to enforce corporate work practices.

I'm not talking about illegal use. I'm talking about the standard day by day stuff that goes on there every day.

Getting back to the reregistration and tolerance reevaluation. I am an optimist. I have the feeling that since we have the experience under our belt, the job shouldn't be so big as it was.

There may be some upgrading of the data base, some new issues that need to be addressed, but I think the job will be smaller.

Don't try to do it all yourself. Use the shared review process, the things you have going with California and Canada for joint reviews. Don't do the same job twice if you don't need to. Put some of the burden back on the registrants to prepare at least a draft on the risk assessments. The registrants are the experts in the data base and they can do at least a first cut in the presentation of the risk assessments. Offer some kind of registration credits for completing reregistration so that the registrants who complete the reregistration of their products could use those points for getting new products reviewed more quickly.

Does the panel think we should explore the experience of the Superfund and the corrective action programs where the responsible parties fund the risk assessments?

I think it's important to get a perspective on what we're discussing here. There are two things at work: 1: the political, 2: the practical or regulatory side. The political is everything from us in the regulated, environmental and congress who have the headline opportunity to stand up and say "The EPA missed this deadline" or some crisis. Denise talked about "Never again 30 years".

I think I know how this provision in the FQPA came about. As Paula said we need a more clear and future overlooking view of what is expected. We can't anticipate what science is going to require, so going back to one of Denise' first questions - do we want this to be a comprehensive or a continuous series of small snapshots?. We need more clarity and forward looking predictability we can design into the process the better. It is in the law and we have to deal with it. So, should PPDC be involved. I think it absolutely that as a standing permanent committee this group should be engaged and provide continuity of input.

Going back to the discussion about children a while ago. From my point of view I want to bring that issue back for further discussion. I think that given what we don't know about these issues, we have to do the 10X in all these agricultural settings. We are compelled to do so by the lack of exposure data in those settings. From legal agricultural use, given the residential farmer housing embedded in those fields and from the work practices, we know that we don't have an adequate measure of that exposure and that compels the 10X. In response to Marcia's comment I have the impression that California scientists are finding substantially inadequate studies coming in from contractors and registrants with the summary not adequately representing the findings found in the study. This would raise skepticism about delegating risk assessments.

It wouldn't obviate the EPA staff to actually review the studies and the risk assessment because there would still be the government function to make sure that those data proved the case. You cannot delegate this to a contractor regardless of who hires the contractor.

Considering the size of the future process. Will there be new ways of evaluating that are better than those first used when the product was registered. It is important to have an institutional process in evaluating the science to find out what's new in testing. It will be at least as important to look at the science as it is to look at the product.

You're right. A lot of this is about science, the issue of new requirements that have evolved since the product was registered is the starting point. The data-call-in you hear about is primarily aimed at requiring the studies that have been required of more recent pesticides but weren't required at the time the pesticide was registered.

If there aren't any changes in the way you have to evaluate it, the process might be simpler.

Some of the compounds going through reregistration were initially registered in the 1950's. So the gap between the 50's, 80's and 90's were quite significant including the mandate under FIFRA, which changed to be much more of an environmental statute than it was. What you're suggesting is correct, that there is less of a gap in this 15 year review than what we had to do with reregistration.

Ralph Lightstone:

Just as a point of information in how the FDA develops drugs, clearly they work hand in hand with the company's in drug development and the drug companies, of course, come forward as it relates to information related to drugs - if that is a useful model.

I can't help but comment about the illegal use of pesticides. I hope we will never be basing a risk assessment such as methyl parathion on an illegal use (that we would take into account in determining the risk assessment how it is to be correctly used and the uses that are legitimately on the label into factoring a registration decision and obviously enforcement decisions come into play in how a chemical should be registered) but to say we'll take a chemical that isn't registered for indoor use and conduct indoor residential exposure assessments when that's not even a legitimate use of a product -- I think that's tantamount to endorsing that by conducting that type of assessment and I hope we would take a different attitude in the way to approach that type of situation.

Secondly: The 10X safety factor for children working in fields. Does the FQPA 10X safety factor apply also to that kind of risk? I thought it was only for food safety, but I didn't realize it was applied to occupational risk assessment.

It wasn't from occupational exposure. The kids, the labor camps and the housing are in the field, working and living there and getting take-home exposure and dust exposure and so on.

It might be helpful to provide the PPDC with information on what pesticides were registered for a certain date and afterwards. We need a better idea of the time frame for completion of registration for certain commodities and maybe have a better matrix to feel what priorities we're looking at in terms of different activities. Lastly, there is a certain group of chemicals - the post '84 non-agricultural chemicals that we never did an occupational exposure - re-review of labels as we did for worker protection in imposing work protection requirements. We went through those chemicals and imposed safety restrictions to address occupations in agriculture. For the rest of the chemicals the occupational exposure was to be addressed during reregistration. That was when we asked - why is agriculture being exposed to occupational exposure issues and why aren't the other chemicals being held to the same standards. I think we should look at evening the playing field so that all the people that work with pesticides get the same kind of protection that the agricultural sector is getting in terms of protection from occupational exposures. I think that would be one of the priorities we look at when we look at future registration reviews.

I would hope that as we build this reregistration process that one of the things we'll look at is when we have environmental or health related effects with the appropriate use of pesticides, which we see occasionally in the field. It is easy to find products that are used inconsistent with their labeling and associate those uses with those effects. But sometimes the applicator will follow the label to the letter of the law and we still have impacts. It isn't always science we're dealing with here; sometimes its verbiage. Some labels are just better done than others as far as being able to use them and not have effects. You need some kind of tracking system to pick up these issues whether they are by AI or by company or use patent or whatever. To me that's a big issue and I think that it has fallen through the cracks.

This whole question of incident reporting is this surge with this new rule in place. It becomes effective in June and we are trying to enhance our capacity to track incidents - our data bases in that regard which is also a subject that may be worthy of our attention from this group, especially as we get experience.

The improvement of a label doesn't have to wait until there is a whole renewal process. If we are seeing a pattern of incidents related to unclear labels we can address that and most companies

would want to address it right away because of liability concerns and concerns about their customers being satisfied they run into those kind of problems their going to lose customer base. As Marcia said, with the new 6(a)(2) rule in place we should be seeing more information. But do we have a handle to detect those and sort those out from the other incidents.

You need to build that system that will allow you to build it into the registration and the reregistration process. I view the reregistration process as the last chance to catch those things.

I've had the misfortune of litigating Superfund cases and working on regular cases as well and I wouldn't hesitate when I hear that the Agency may delegate the basic risk assessment process to registrants, having lived through that with the Superfund and with Corrective Action, etc. the concern is that there are so many assumptions to be made in risk assessment at least in the Superfund you have a single site and a single exposure out there and a specific site and a specific mix of chemicals. Here we're talking about a nation wide decision where you have to make assumptions for all routes of exposure. You have a lot of underlying basic assumptions that have to be made and you don't have real clear guidance on exactly how those assumptions have to be made right now. Even if EPA were to approve the contractor that the registrant is paying for, I have concern that contractors basically need to pay for their existence and to be competing to make their clients happy. I am very concerned that you might be delegating what I view as a fundamental governmental decision-making process to contractors. The other issue that was raised which a lot of people might misinterpret, was saying that illegal exposure was going on as a result of non-legal practices or practices that may be based on misinterpretation of the label, that the Agency needs to consider the registration process to change the labels or cancel or do what is necessary to avoid that. If you have a lot of data that imports have illegal tolerances on them, then you should be considering that in your risk assessment process. I also want to agree with Ralph's suggestion about the need to enclose a 10X safety factor until we actually generate the data on the farmer-to-kid type exposure.

Two quick points. I echo the need for up front and timely information out to registrants so they can get started as early as possible to get started with the process. Secondly, contrary to Paula's point, I think with 10X and with EDSTAC developments and the need for more non-agricultural exposure assessments there will be a lot of data that needs to be generated taking considerable resources. Finally, one of the 'train-wrecks' that may be coming - industry is varied and the consideration of exposure from the AI's producers prospective which may be agricultural primarily and some end use registrants who have a variety of Ag and non-Ag exposures will all need to get in the room and talk about what the risk cup may look like. This could be a rather contentious process. If the committee can come up with a working model for that so when the registration reviews come up there is a process for registrants to get together to work out the exposure side of the ledger.

We will have an ecological issues briefing from Joe Merenda.

We will give you an update on two key issues associated with ecological effects. This is a bit of a change of gears after all the talk of FQPA and registration review but don't think about it as too big a difference because ecological issues are bound to come up in those activities and what we are trying to present here and to get your input on is how to make sure that the ecological component that goes into those decisions is carried out the best way possible and that the decisions are the right ones for the environment. There are two areas to cover and we will try to keep the presentations brief so there is time for your feedback and discussions. First we want to update you in our efforts to develop new ecological risk assessment tools. There was a briefing for the PPDC on that about a year ago - before we started the technical work groups which began in June. Anne Stavola will give you a few issues on that topic.

The initiative has been given the acronym of ECOFRAM - the Ecological Committee on FIFRA Risk Assessment Methodologies. The initiative has three major goals - identify development, validate tools for doing a probabilistic risk assessment, work within the context of FIFRA and to maintain an open dialogue with the regulated community, the scientific community and the public interest groups. We expect to get a written document from ECOFRAM, to detail the kind of tools we need on how to do this kind of assessment, what kind of data is needed to do this kind of assessment, to clarify what assumptions go into an assessment of this kind and to be sure the assessment can be validated in a short period of time and that the science behind it is quality science. The current methods used by the EPA and by other countries is called the deterministic approach which is also called the risk quotient method. This assessment method takes the exposure concentration, compares it to the concentration in which an effect occurs, which can be an acute or chronic, and that is compared with an established level of concern. We currently use 0.5 to indicate a high risk for acute effects and 1.0 to give a high risk for chronic effects. The relationship between the magnitude of the risk quotient and any expected field effects is not linear. A risk quotient of 20 for a chemical and another with a risk quotient of 10 it does not mean that one chemical is twice as risky as the other one. It does indicate that both have exceeded the level of concern and both present a high risk. Because this risk quotient is not understood by a lot of people there are a lot of assumptions that allow us a certainty that we're moving to a probabilistic method. This will give a risk manager a totally new way of looking at the data. On this chart we take the effects data and the exposure data and using different statistical programs use by programs such as Monte Carlo analysis and will compare the magnitude of the effect (how big is the acute risk to animals or the reproductive risk) and the probability of seeing that effect out in the field. So instead of getting a risk quotient we get statements such as "we are 40% certain that 20% of the fish will be killed if this pesticide is applied on this crop."

One reason we want to reduce the uncertainty that goes with risk assessment is to provide risk managers with better data and better tools to be able to make better risk management decisions.

The important points: To increase the confidence we have and to make the best use of the data we have. Also to be able to identify more clearly which areas we need to focus on to reduce risk. One of the components of ECOFRAM is outreach by coming to groups such as PPDC, presenting papers at a number of different scientific associations and societies as well as public workshops. We also now have a home page for ECOFRAM. We would like for people to access it and let us know how useful it is.

The two main discussion points today: One problem we have in ECOFRAM is how to get more scientists from public interest groups involved in ECOFRAM process. We need scientists with technical expertise in wildlife and aquatic toxicology, soil chemists, statisticians, modelers, population biologists all of whom work for different public interest groups and who have the time to be able to participate in a process that will take over a year. We need input from PPDC and other groups on how to gain better access to people with these kinds of capabilities who are involved in these public interest groups and in using other mechanisms to reach out Are there other mechanisms we maybe haven't used at this point to be able to reach out to public interest groups, to be able to get the scientists in the ECOFRAM project. We are having a workshop in December of this year and we want to have scientists in the fields I mentioned to take part and to do a very thorough, in-depth, scientific review of what ECOFRAM comes out with. We are having a hard time finding people like this and we would like your feedback to us at EFED to be able to move forward to find people like this and to get your input.

The Ecology Society of America remains one of the largest and strongest societies pulling together environmentalists, biologists, field biologists that exists and I would urge EPA to partner with them on this. They have an office in Washington and the former president, Jane Luchenko who became president of the American Association for the Advancement of Science. It is a pivotal organization and they have not had the background to really appreciate the significance of some environmental issues I have brought them. It would be good for both organizations to interact with each other and I would love to see those EPA booths at meetings of the ecology meetings.

While we are focusing right now on the scientific activities and the peer-review workshop coming up at the end of this year, once we have technical recommendations from the ECOFRAM work groups all of that has to be converted into an operating approach to be used in the day to day pesticide assessments. We expect there will be others who will also be interested and we encourage their involvement.

The next topic is a follow-up on work that was begun in PPDC less than a year ago. This is the ecological standards program workgroup of the PDPC which is co-chaired by Kathleen Knox, who is Associate Director of the Biopestiscides and Pollution Prevention Division, and Denise Keehner.

This paper is a background and summary recommendations of this work group which is a subgroup of the PPDC. We will start out with what we would like the full committee to think about whether you agree with these recommendations from the subgroup. We have four members of the PPDC Committee on the subgroup, Steve Balling, Larry Elworth, Beth Marshall and Ann Sorenson. In addition we have seven other non-EPA members and six public observers. Is there more work the workgroup should do, what should the next step be? We would like some time on the next full PPDC meeting to come back to that and get a bit more reaction. A more complete report will be sent to you soon. As for the background, we started meeting less than a year ago through teleconferences. We have done a lot of work during that time, and I would like to thank the workgroup and especially Laura Dye who is a staff member of EFED. We used a case study approach to help educate the workgroup members about how OPP does ecological risk assessment and how decisions were made. We decided to use the Case Study approach. We developed some criteria of what the cases should be in order get the maximum educational value out of it. We eventually decided that would do two case studies. We ultimately brought in some of the scientists from the Environmental Fate and Effects Division and also the group managers who had worked on this just to be able to answer questions. After that the charge to the group was basically how to be a better crew, what other questions you would review. We had many conference calls ranging from the differences between our stakeholders to a particular item. We had ideas that went from one extreme to another. Ultimately we really wanted to reach consensus. Which didn't mean that everyone loved the recommendations, but that everyone could live with them. We tried to find common ground and really express the views that the group could share. Dr. Paul Thompson, a member of the workgroup, will present the groups recommendations. He is a professor of philosophy at Purdue University and main area of work is in agricultural and environmental ethics. His most recent book is called "The Spirit of the Soil - Agriculture and Environmental Ethics."

I'm sure many of you never heard a philosopher speak at a meeting like this and thus I thought it might be useful to define what a philosopher is. A philosopher is one who, when choosing their career would like to be a preacher or a priest or somebody who can tell other people how they ought to live their lives but who can't bear the burden of being a moral example himself. The mission of the Ecological Standards Program Workgroup is to review, evaluate and advise the PPDC on ways to improve the EPA's ecological risk assessment management processes, models and tools. I should stress that these recommendations are written as if they were for the EPA or specifically to OPP, but it's not the workgroup mission to advise OPP or EPA, but the workgroup advises PPDC, which then can advise OPP. In framing the mission objectives, we worked between two parameters: risk assessment methodologies as they relate to ecological risk (risk to the environment, wildlife, and ecosystems habitat as distinct from many other risk issues that we've been talking about, whether that would be economic risk or risks to the public health.) On the other hand a statement that Denise Keener made expressing concerns as to whether EPA is up-to-date with how Americans value the nation's environmental resources and therefore whether EPA is truly aligned with societal values when making pesticide decisions that require weighting environmental risk versus benefits from pesticide use. Essentially we were working between a fairly nuts and bolts set of questions about what kind of risk assessments should be made, what kind of information comes out of that and more broadly, a philosophical sense of how do Americans weigh these kinds of kinds of ecological issues and contrasts to these kinds of concerns.

The recommendations that we are actually bringing forward I thank that the case studies really drove what we are recommending. These are not prioritized in any way.

(l) OPP's decision documents should contain sufficient information for the interested public to discern the rationale for the environmental risk management decision made. It would be beneficial for OPP to provide:

(a) more information about the analyses it performed and why and

(b) more information about the particular attributes of the pesticide as compared with available alternatives.

Really what happened here is in the course of not only looking at the two cases we looked at in depth but in reviewing a dozen other sets of documents on particular decisions we found that although there was reporting of the data and a summary of the data and then a discussion of the decision the subcommittee finally made, it was really difficult for someone who was not fairly intimately involved in the decision making process either being part of the agency or being one of the regulated parties, to really get much sense of how ecological effects particularly in comparison to environmental, economic benefits or human health risks. We are not thinking about something that is a large task here, but in the process of preparing these documents it might be good to give more care in actually articulating the rationale used in making the decision. I think we were quite satisfied with the rationale that was proffered when we had the opportunity to ask risk managers about the decision making. We felt that some of that could have actually been incorporated into the memos themselves.

(2) An informed public is an important prerequisite to engaging society in a meaningful dialogue about the challenge of balancing ecological risks and pesticide benefits. Thus OPP should make pesticide decision documents and supporting analyses more understandable to the general public and more readily available/accessible. Doing this would create an open channel for feedback on public beliefs and attitudes about the ecological production goals of pesticide policy. In many respects these recommendations are organically put together. If you're going to go to the trouble to explain the rationale to outsiders you ought to make that information available to outsiders in some sense and give the process of making that information available as a way to get some feed back on the question that Denise Keehner posed - that is how to Americans tend to weigh these various dimensions of pesticide policy. So we're not thinking about some large program here but putting some summaries of these decisions about, working perhaps with groups of science teachers both at college and through grade 12 level, to have discussions about this kind of decision making even becoming more of a science education, working through extension services, etc.

(3) OPP needs to do more to better understand whether pesticide use is having ecosystem level impacts. OPP needs to obtain better insights about how pesticide use may effect plant and animal diversity, predator-prey relations and the stability of ecosystems in the face of other stresses. In order to gain a better understanding of these potential impacts OPP needs to do more to determine how to best monitor pesticide use and eco-system health and initiate efforts to obtain monitoring data and improve exposure assessments. One of the things that came up several times in our discussion of cases is that there is a tendency for kill-rates. You just count the number of dead fish or birds or whatever to kind of substitute for ecological effects and I think there was some discussion in committee that the workgroup is only concerned about a few dead or something that really disrupts an ecosystem. Sometimes you can have fairly short term effects in the numbers of animals that might be killed, but there is no really important long-term ecosystem damage, and sometimes long-term damage can accumulate and not be noticed if the indicator species are not telling you what you think they're telling you. So generally speaking the impetus here is try to get a better handle on ecosystem functions and try to better frame the risk assessment process more clearly and more transparently in terms of ecosystem function, recognizing that this is a very difficult challenge to meet. Our program mission I think follows on this is recognizing that the ECOFRAM committee which we just discussed is developing new and improved pesticide ecological risk assessment tools, methods and models. The workgroup believes that ECOFRAM initiatives should help us to better understand the potential magnitude and severity of ecological risks posed by pesticide use and is therefore an important and valuable initiative. However the workgroup also believes that OPP should consider other mechanisms such as task forces and partnerships to address some of the newly identified research needs such as developing approaches for better understanding of potential ecosystem impacts resulting from pesticide use. I think main idea behind this recommendation is that indeed many useful strategies and techniques will come out of ECOFRAM but there is nothing inherent in going from deterministic to probabilistic models that's going to address the ecosystem question that was raised in recommendation No. 3. So we are encouraging OPP not to rely exclusively on the ECOFRAM process as a way of addressing the broader ecological risk issues.

Finally, OPP needs to have greater consideration of potential adverse impacts to other commercial industries and beneficial non-target species such as negative impacts on fisheries or beneficial insects used in the pollination of agricultural crops and should factor these impacts into pesticide environmental risk management decisions. The most obvious kind of benefit consideration which was not taken into consideration had to do with wildlife recreational use values of animals that are non-target species, to used the technical term, that there are benefits to both sides of the equation - economic benefits and that it would be a completion of the national risk assessment process to be a little bit more inclusive of some of the benefits other than certainly for agricultural production. There are other members of our workgroup here and I should give them an opportunity to either add to or qualify something I have said or to amplify the recommendations.

Steve Balling:

We did have quite a diverse group and one of our difficulties was that we met so often and they provided us with so much information that it was difficult to try to keep up with it. In some ways the recommendations reflect the difficulty of trying hold such a diverse group together to try to achieve consensus. But this is a very difficult issue because the science is still so immature. We really don't have good knowledge on how to try to really measure ecological systems and impacts on such systems and how you separate it from the normal background noises that are bound to be in such systems. So it is a very difficult program and maybe great kudos should go to Denise and Kathleen's group for being able to run a program like this, because its not simple.

This workgroup demonstrates the best and worst the way PPDC runs workgroups. It's amazing how much information we went through -- difficult to get the whole workgroup together and to agree. One observation in the recommendations -- we fret over parts per million and residues and there is the whole rest of the world out there. Making ecological assessments if very difficult.

Compliments to our leaders on the amount of work they put into it. I'm not sure we're asking the right questions as far as the environment is concerned. No consensus on the committee on how to capture the effects on the environment. It seems to me that scientists had better be cautious about saying it can't be done. If science cannot be the servant of this process we need to take another approach and say "first - do no harm" which is an even more conservative standard. It behooves all of us to take a look at the process so it can be the servant and not the master.

This issue is one I have focused on the least. The first time I worked on it was the disastrous attempt to have FIFRA comply with ESA. The second time was when Linda Fisher talked to various individuals who worked on the policy and said that the tiering process that was used to require more tests really wasn't working and the program didn't think the product was worth requiring. So it was dropped. We had one or maybe two briefings on this in the past and we talked about ecological values, which I found interesting but squishy in the regulatory context. We talked about setting up this workgroup but I don't know what the mission is. Maybe it would be more helpful to hear about what these assessment tools and methods and models are.

I thought there was a great deal of missing information, but it occurs to me (l) who's going to do all this work and (2) who's going to pay for all this work? Is it the responsibility of EPA, academics, industry or whom? We need to know because otherwise we're just spinning our wheels talking about an issue about which we have no answer

There should be a wide variety of participation in these efforts. We might want to go in the direction of partnerships. Our Office of Research and Development might need to get involved and develop partnerships with other parties, certainly such as USDA. I think it was determined to make the first step and come up with the recommendations. The regulations are bland but there is a lot of substance. Now we should narrow it down and focus on just a few things and figure out how we're going to get these things paid for. We talked about it but came to no agreement.

I noticed in the background documents - one is the wingspread conference document of this year. Congratulations to whoever brought it into discussion because that concept is completely left out of our discussion in FQPA although the 10X gets us to a precautionary approach. As Steve said, you will never know because the calculations for determining ecological risk is so much broader than the food risk where we have as direct route and tons of data - adequate data - to do risk assessments now. We will never know what these effects are especially the low level effects. There is a study in California a couple weeks ago about chlorpyriphos and diazinon levels in streams at very low levels having significant impacts on insect populations and therefore impacts on fish populations. That science will come out over time, but doing probabilistic assessments that translate into risk mitigation strategies for this is a fruitless exercise in many ways. An alternative is to do alternatives assessment and a quasi NEPA (National Environmental Policy Act) process in a way - if you have a chemical that doesn't cause harm to the bugs in a stream what's the benefit of using that over the one that does cause harm, but you don't know what level of harm. But first, do no harm.

Two quick comments: The first relates to an informed public. Anyone who looks up CFR documents or other documents would beg that there would be a small summary in English that explains this to the general population. I know when I applied for grants, particularly to foundations, I know if I cannot explain it to the lay public as brilliant as it may be I will never see a farthing from my applications. So I think the ability to use plain English to explain what goes on in a CFR would be a high duty and I would like to see that.

The second thing, relating to ecosystems- we're living in a wonderful time where all of a sudden across the country we have large groups involved in biodiversity. If you talk to professionals such as Novicheck and Grippo, Francesca Grippo was a key person in AID for use and went to the American Museum of Natural History and is now heading one of the best biodiversity groups on the planet and is now getting lots of funding from NASA. So I think they would be very helpful in a number of these strategies. Obviously the Smithsonian and others would come to the fore and be very helpful. The biodiversity movement has been very helpful. A number of years ago the National Biological Survey who's job it was to conduct a survey of what the richness of America's ecosystem actually was. Unfortunately they were dismembered which saddened us all.

We have a number of public attendees wanting to make comments who have been waiting patiently so we want to work through that part of the agenda.

I will be very brief in my comments. I have prepared for the committee a memorandum that says everything important that I'm going to say. I want to talk about the procedural requirements you'll have to live with as you do the work of the Committee. I want to focus my comments to those 11 members who are new on the committee. The reasons we are doing things this way is the Federal Advisory Committee Act. FACA as we affectionately call the act has been around since 1972 and is one of the open government laws, like the Freedom of Information Act, the Privacy Act and the Government Sunshine Act. It is rather broad in nature. Whenever a federal agency establishes a committee or a panel or a task force or a commission to give it advice and recommendations, it is required to follow the procedural requirements of FACA. There are basically three requirements -- the first of which is the Open Meeting Requirement. FACA requires that advisory committees be open to the public which means that we are required to do a Federal Register Notice 15 days in advance of the meetings. Also there is a public participation process for committees. Anyone can file a written comment with an advisory committee whenever they want. Generally to the extent that there is time we will make available an oral presentation period as well. That is the process that FACA articulates for public participation beyond just the committee members. Also FACA requires that the committee be balanced in membership and we try to give a diversity of views and some say that we get such a diversity of views that consensus becomes a difficult process. But the point is that we want to hear from all the interested constituencies with developing views the agency can rely on. We want to make sure that there is someone at the table who can articulate positions for folks who are not at the table. As I mentioned, there are three requirements of FACA besides open meetings and a balanced membership. The third requirement is the Charter requirement which we've already gone through. I would urge you to take a few minutes to read the charter of the committee for yourself. Several in the agency spend long hours in working through the charter. It is a difficult process that involves going outside the EPA. We have to go the Office of Management and Budget and the General Services Administration to get their approval before we can establish a FACA. So it is worth it to know what the real reason was when the committee was formed. Sometimes it tends to evolve from that into something else, but it's worth it to go back and see what the agency had in mind when it first established that committee and you might be the person on the committee to keep them focused on what their original goals were.

I want to talk about making things available to the public within that open meeting requirement. Not only do we operate generally in a fishbowl, but your reports -- draft reports, working papers, other documents prepared for the advisory committee -- those also generally have to be made available to the public upon request. That's only for advisory committee records. Not every piece of advisory committee work that you do will necessarily be an advisory committee record. If you work on it at home, for instance, and have not yet shared it with the entire advisory committee, then it is not an advisory committee record yet for the purposes of FACA. But once it is shared with the advisory committee members, then any interested member of the public will be able to look at that document if they want to. You may want to keep that in mind when sharing your thoughts, especially when you think they may only be preliminary, you may want to keep in mind that they may be shared with the public upon request. We also get questions from members about how can we meet. Do we always have to meet in a fishbowl or can we have private meetings. The general rule is that when you meet as an entire committee, you are going to meet in a public meeting that has been noticed in the Federal Register 15 days in advance. But the law does exempt certain working group meetings from the FACA requirements. These are meetings where you are not giving advice to EPA during that meeting but you are doing preliminary work on draft position papers, working on information gathering/collection, preliminary to giving a report to EPA. You can have workgroup sessions -- although we encourage openness whenever possible, it may not always be possible.

Another question is "how do we get to the meetings" - "who pays for the airfare"? There is authority in the law that says the money is available for EPA to pay for invitational travel and per diem expenses to advisory committee members to the extent needed. We can only pay invitational travel for those participating in the meeting and providing direct face-to-face benefit to an EPA official. We can't pay for someone to sit in the audience.

The good news is that you are not here for life. Even if you have been given a term and serve for several years, you do serve at the discretion of the person who appointed you (the Deputy Administrator of the EPA). You can be summarily dismissed -- there's no formal process like that. We have not used that too often obviously. It's like a double-edged sword - you can be dismissed and you also can leave if you want.

There are anti-lobbying restrictions on EPA officials that you should be aware of. The Anti-Lobbying Act -- those of you who are friends of the EPA know that this has been an issue for the Agency and something that we're concerned about. We basically can't foster grass-roots lobbying and can't encourage you to go and lobby Congress on our behalf. We can't pay you to lobby on our behalf. But you are free to lobby Congress on your behalf without our assistance but not as a member of the advisory committee. You are only authorized by the charter to advise the EPA -- not to advise Congress. If there is testimony on the hill and they want you to participate, that will be through the Office of Pesticide Programs who can coordinate that sort of thing.

There are some conflict-of-interest issues. The good news is that you're not EPA employees. You are not subject to the conflict-of-interest rules. EPA employees are subject to those rules, but the rest of you are not subject to those rules. Forgive the analogy, but you are basically wolves in wolves clothing in a sense. We know you have interests but it is a balanced group so various interests can come together to give good advice and recommendations. So you're not subject to conflicts of interest - either from your own stock or bonds that you may own or because of who your employer may be. This only goes to policy advice you're giving to EPA - policy advice or advice on rules that you may be giving. If you were to get into individual registration packages or items that named parties to that and if your employer were named on that policy matter, then you should probably recuse yourself from just that matter. Now for questions. That's basically FACA in a nutshell.

MARCIA MULKEY:

Thank you -- very coherent! We promised a couple documents this morning. One is from the Administrator and Deputy Administrator of the EPA setting up the internal cross-office task force on 10X. You can see that memo. Another is a copy of the 10X section of the statute. We have several members of the public who wish to speak so let's move on.

I am an area extension vegetable specialist with Cornell. I am part of that shrinking extension system that was mentioned. I work in a 6 county area in western New York representing over 70,000 acres of vegetables. New York produces a wide variety of fresh, market and processing vegetables on over 200,000 acres. The total crop value is approximately $250,000,000 annually. In the past year I have been very involved in helping the New York State vegetable industry and the relative Cornell staff understand and respond appropriately to FQPA. It is in this role that I want to share the problems and concerns we have about the implications of FQPA for our industry and about the FQPA process. The first is on the request for use and usage information on OPs. We're currently collecting this use and usage information on selected OP's in some of the major vegetable commodities in New York in response to EPA's request. But we have been frustrated by the lack of a general agreement about a format, the specific content and even a time line. It's still not clear to us who should receive the information, how it will be used and when its not going to used and what are the appropriate sources of the information. So to cover our bets we a re using several formats and sending information to at least 3 different offices. Our great concern is about our capacity to adequately respond to further requests for such information. We can just manage this relatively limited task that we're working on right now, but collecting this use and usage information - detailed information for carbamates, the b1 and b2 carcinogens and on and on, will quickly go beyond our capacities and we will be left behind.

The second issue is the communication problem with EPA. Communication with EPA is not always easy. It is difficult to keep track of which office is doing what or to be sure that you're speaking to the right person. It doesn't always seem that one office doesn't know what's happening in other offices. This is especially challenging for New York, given our diverse vegetable industry and our rather modest political means compared to some other states. While USDA is increasing involvement in the FQPA process is very welcome, we hope that this will help clarify communications rather than make them more complicated.

The third issue is the impact of FQPA on the Section 18 process and I think that was covered pretty well this morning. I want to report the specter of losing critical pesticides when no viable registered alternatives exist. Regardless of whether critical labels are lost to New York growers because registration has been canceled or because registrants drop minor crop labels when they are no longer economically viable, there is a very great concern that growers will loose pest controls which they need and that this will have some economic impacts on an industry that is already facing some other very challenging issues. We need more time to develop real workable alternatives for some of the pesticides that are now under consideration in the review and a year or two years is just not enough time for a transition. We have a special problem in New York with our state pesticide regulatory agency which has already demonstrated that even the reduced risk pesticide alternatives that are being fast-tracked for federal approval, they still may not be labeled in New York, especially on Long Island because of higher water quality standards. An example recently is Quadros or Azoxystrobin which was recently denied labeling in Long Island, but the rest of the state can use it. A grower with whom I was talking last week said "How can we make them (and he meant you) understand what will happen if we suddenly lose some of these important pesticides. Tell them it would be as if someone erased your word processing program on your computer. If you had to do all you work with just the other programs left while waiting for someone to develop a new word processing program from scratch." I do greatly appreciate the wonderful cooperation I have received from Lois Rossi and others in support of a regulatory tour this summer.

My final comment is that our industry generally is not opposed to the ideas behind the Act for safe food to protect infants and children. In fact, the industry has a lot to gain if these issues can be put into the public mind. But, serious damage to the industry's viability could well be the result of an FQPA that is too hasty and rigid. A written comment will be submitted.

Member of the Structural Pest Control Division, North Carolina Department of Agriculture and Consumer Services. I'm also current President of the Association of Structural Pest Control Regulatory Officials which is analogous to APCO that deals with structural pest control regulatory programs in the states. The purpose today is to bring to your attention issues that are of concern both in my program and to members of the Association. Specifically as is evidenced by the discussion today, agriculture is what is on the forefront of everyone's mind. Loss of chemicals and loss of pesticides to the structural pest control industry will have dire consequences. We spend most of our time in our division on termite control issues. What I'd like to do is to give a few examples of what could happen if products are lost and impress upon this group in the Agency to make sure that we're dealing with sound science here and that we won't lose the valued tools. I'm sure everyone in the room has a home and most of those homes have been treated for termites. If there's recent construction they were probably treated when they were built. If they were treated within the last eight years they will probably have to be retreated every five to seven years. The reason for that is that the chemicals we use today that the industry that we regulate has in their tool box no longer last as what they had prior to that time. The cost of these chemicals is becoming of concern. We published some figures recently to reflect the cost of doing termite treatment using the tools available today. Those costs based on a 1500 square foot house with a one-car garaged ranged from a low of $230.00 to a high of $900.00. That's just the chemical, it does not include the labor. It is also based on a pre-construction treatment which is cheaper, not only for the amount of chemicals you have to apply, but for the time you spend doing it. You may be familiar with the articles recently published relating to termiticides. We in the regulatory community have for some years been trying to mandate that termiticides be applied at no less than the label recommended rate. The Agency did that in a PR Notice -- require label changes recently. The National Association of Homebuilders thinks - if you think that this cost issue is not really significant -- in response to that PR Notice and concerns that the cost of termite treatment is actually going to price people out of the home-buyer market, the National Association of Homebuilders recently passed a resolution to go to the Agency and, if necessary, to the Congress to reverse that PR Notice. Those amounts of termiticides are necessary if those products are going to work. There is no evidence that they will work at lower rates unless they are applied every six months. There has been some talk that perhaps termite baits could replace liquid termiticides, but again I want to bring up the issue of costs for these treatments. I already mentioned that a 1500 sq.ft. home could be treated for as little as $230.00 for chemical plus labor of probably about 4 hours. A treatment using termiticide baits would cost in excess of $1500.00. The cost of maintaining protection year to year would be from $200.00 to $400.00 per year as termiticide baits are labor intensive. So these things can be considered under options, but be careful, there are costs and there are real people out there. I had a discussion with a woman just last week who complained that EPA had approved termiticide products that had only lasted 5 years. And she was now faced with the company telling that they have to completely retreat it or they will not continue her coverage. These are real people that we are affecting and whom we serve. We also have concern about people using general or household pest control which is somewhat of a misnomer because household pest control could be performed at a processing plant, hospital, day care center, nursing home, etc. We still refer to it as household pest control. We've all heard resistance management issues on the ag. side. The same issues occur on the structural pest control side -- cockroaches, fleas, etc. -- public health pest control which is being performed by pest control companies. If they lose options and their costs go up, then the cost to consumers will go up. Those are very real concerns. If we protect children in a school from a theoretical risk posed by a very small risk from a pesticide and yet expose them to pest infestations to fleas, cockroaches, etc., that pest control can't control, have we really served the public?

I grow 8 commodities on 5,000 acres in western New York. We grow field crops of corn, wheat and soybeans. We grow 5 vegetable crops pre-processing which are snap beans, sweet corns and peas. We grow onions and cabbages. Five of those 8 crops are minor use crops and that's my concern which I want to express today.

The members of the New York State Vegetable Growers Association I don't think have a problem with FQPA legislation. We're very concerned about how the implementation will effect many of these crops. The story on the loss of dry beans this morning and the issue of growing beans on sand in North Carolina is ironic while Reflex has been lost to bean production it is still labeled for soybean production and soybeans are grown on sand over the whole country. So while we've lost a product which has been withdrawn for edible beans its still available for soybeans which are grown on l00's and 1000's of acres across the country. What this shows is the process bends, but how do we evaluate process? To evaluate process we might look at results or output and I'm sure that the process that you're putting together to remove pesticides is an important process and the steps are important but if we look at the results of what's happened we look at a product like Reflex which has very few substitutes and will be not loved. And yet on a crop of soybeans which are millions of acres across the country it is fully labeled. So if the problem is one of quality, why are we still using Reflex on soybeans. It would seem that soybeans which has many products labeled for it would make more sense to pull the Reflex label for soybeans and allow it on edible beans where there are fewer substances. I know there is a process for reviewing and I know that you believe in the process. We in the vegetable industry look at the results of your process and question how you came up with this. I think that we need time to evaluate and everybody I've met and heard from this morning by questioning the results of your process. I worry about the impact on minor use crops in New York.

I'm an Associate Cooperative Extension Food Toxicologist in the Dept. of Food Science and Technology at the University of California - Davis. I also direct the University's food safety program. In ten years of work at the Univ. of California, my research and outreach programs have focused primarily on pesticide residue issues, natural food toxin issues and risk assessment. Over that period I have received no financial support from the agricultural, chemical or food industries. I also represent the Institute of Food Technologists, which is a scientific society of 29,000 members representing academia, industry and government. I serve the Institute as a dedicated food science communicator and I'm also the chair-elect to the Toxicology and Safety Evaluation Division. I have provided copies of an article I wrote last year -- an Institute scientific status summary on assessing, managing and communicating chemical food risks. That document gets to the heart of what I've heard discussed today about reference doses, uncertainty factors, etc.

Today I have two issues: One is the low risks posed by pesticide residues in food and secondly, my concerns over what I think are overly conservative risk assessment methods prescribed by FQPA which may lead to scientifically unjustified decisions which may significantly impact agricultural practices in California and across the nation.

Obviously, FQPA presents an incredible challenge for EPA. The amount of science that has to be developed and the amount of policy that has to go with that is a very difficult challenge and I certainly feel for EPA in terms of what it has to do to implement FQPA. While I agree in principle with the provisions of FQPA, I do feel that the conservative nature of many assumptions used to calculate risks may ultimately result in the development of phantom risks that may lead to unsound regulatory decisions. Obviously, there are a lot of assumptions in the EPA risk assessment process. I heard a lot of discussion about the 10X safety factor for infants and children. Already in the process is the 100-fold uncertainty factor presumably there to guide extrapolation from animals to humans as well as to protect sensitive members of the population. But these are not the only conservative assumptions that go with the risk assessment process. I will talk about some of the other ones as well. We talked about exposure estimations -- we need to consider pesticide use, pesticide residue levels and food consumption estimates and typically the trend is to make very conservative assumptions that may exaggerate these levels. We talked about aggregate exposure to domestic exposure, water exposure to pesticides -- there is also the potential to use dramatically exaggerated estimates of exposure. It is critical to realize that the no-observed-effect level which is used to apply the uncertainty factors to generate the reference dose is in itself, in many cases, a fairly conservative estimation. As an example, we have chronic toxicology studies which demonstrate that you have no observed effect level with 10 milligrams per kilogram per day for a particular chemical and a lowest observed effect level of 200 milligrams per kilogram per day. The REAL no-observed-effect level is going to be in the range of from 10 to 200. It doesn't mean its going to be a 10 so just choosing 10 is also a fairly conservative estimate in many cases. It's hard to prove unless you want to spend money to develop a lot of extra data points. Such exaggerations of risk become even greater when we consider the cumulative exposure to pesticides which may possess a common mechanism of toxicological action such as OPs. In practice, this results in a stacking of the various conservatism that's already built into the assessment of the risks of individual chemicals. On top of that, we're talking about the possibility of throwing in an additional 10X uncertainty factor. In my opinion, the compounding of various conservative assumptions leads to the generation of phantom risks that exist on paper and may not exist in reality. What this means is that we may take this notion of a risk cup and could be translated more into a "risk medicine dropper." While we all focus on the treatment of uncertainty inherent in the risk assessment process, it is convenient to overlook what is known about pesticides and the possible risk in food. Results from hundreds of thousands of laboratory analyses from state and local agencies, federal agencies, the food industry, consistently demonstrate that the levels of pesticide residues in foods are extremely low and in fact are can hardly be detected. The list of residues are perhaps best reflected by the results of the FDA's total diet study which is a comprehensive market basket survey which is performed on an annual basis. As an example, consider this scenario. If we take our best estimates of pesticide exposure generated from the total study, we now feed laboratory animals 10,000 times this level of exposure typical for humans and it is 10,000 times our typical exposure on a daily basis throughout their lifetimes, what happens to the animal? In general, nothing. For any effects to occur animals must be exposed to amounts greater than 10,000 times what we're typically exposed to in a lifetime. Does this prove that pesticides are safe? No, certainly not, there are a lot of uncertainties, but it does explain why there's strong skepticism from members of the health communities over whether pesticide residue controls need to be tightened. So to summarize, the paths the EPA may take in the risk assessment process may create phantom theoretical risks that exist only on paper. Basing regulatory actions on such exaggerated estimates of that goes beyond events may be consequences. By unnecessarily restricting the use of many pest control products there may be trade offs and substitution of less effective chemicals which could increase lack of safety and environmental resistance management concerns. Food protection quality may also be affected leading to lower quality and higher consumer cost. Effects can be very dramatic in states like California which is the nation's largest agricultural producer. Almost all of California's agriculture centers on the 250+ minor crops they produce may be affected by regulations such as this. It's hard to argue against the safety of infants and children. As a father of 4 and 6 year old boys, I'm very concerned about their health. But if I'm really concerned about what they eat, what I want to do is to encourage them to consume more healthy fruit and vegetable products. In fact, what we may be doing is going in the opposite direction through possibly unnecessary regulation, through possibly restricting our access to these products by lessening availability and higher prices. It's critical to base our regulations on the best estimates of risk, not the worst.

Both the House and Senate voted unanimously for the FQPA. Whenever I see a unanimous vote in Congress on something other than a resolution I picture the robot in Lost In Space with his arms flailing WARNING, WARNING, WARNING, because usually a unanimous vote means that there was little or no debate and a lot of people cast their votes for something that they don't really understand. Among the problems of this act is that it doesn't consider risks against benefits. Headline from yesterday's Washington Post correctly prescribed drugs taken at home. The study found that over 100,000 Americans each year die from correct doses of over-the-counter and prescribed drugs. And yet doctor after doctor said that we mustn't have a stampede to action. Why? Because these very same drugs are clearly saving more lives than they take. In other words these doctors are comparing risks to benefits. Yet at least one, apparently influential environmental group is demanding a ban on some insecticides that while among the most frequently applied, have never caused a single accidental death. The FQPA does allow that group's position to be enforced by the EPA. And the EPA may do so if it chooses. But before it chooses I would urge it to first of all consider that there are already layers of redundancy built into setting reference doses in food tolerances. Indeed children are already accounted for in many ways including that some of the testing involved infant and fetal animals and that current standards also allow for super-sensitive persons which would include children in some cases. It must insure that if decisions are based on combined or concurrent exposures that the assessment should consider real data - not hypothetical situations - and have realistic considerations of what combined exposures would occur in the real world. It must consider the down side of any ban, any restriction, any tolerance decrease or tolerance removal. Now farmers are savvy businessmen. If there are better alternatives to the pesticides that farmers are currently using, they would be using them. Any one pesticide that they are prevented from using inherently forces them to switch over to an inferior one or none whatsoever. What are the possible consequences of a bad decision? (1) We could be replacing a well studied insecticide with one about which we know much less. This could then lead to that insecticide or that whole class being restricted or banned and forcing farmers to switch to an even more inferior replacement. We could start knocking out class after class of pesticides. (2) Some crops may no longer be price competitive. This means we will be bringing in foods from other countries where regulations on pesticides and on food handling are much less stringent than they are here. (3) If the EPA kicks OP's out the door then produce prices will rise in the store. If 2 Big Macs can be purchased for $1.99 and the price of apples and broccoli go up what is going to happen then? What will happen is that people will buy even less produce and children will eat even less of them than they do now. Finally, addressing household use, you may have heard that asthma deaths have gone up 6 times, 6 times, in recent years. What you may not know is that most all of this increase has taken place among inner city blacks. What is the main cause of this increase? Cockroaches - or as the EPA's Office of Air Quality might put it - Cockroach tailpipe emissions. You don't need to see a bigot behind every bush to accept the fact that middle class whites and their problems do get a lot more attention from the media and the government - that is the reality. For whatever reason the growing asthma problem isn't getting the attention it deserves. I don't think that the replacing the best household insecticides with inferior ones is going to help the situation. Perhaps you've heard the term "environmental racism" - this may very well qualify.

Finally the FQPA gave the EPA awesome powers. With these come awesome responsibilities. Please remember it's not the food we're protecting - its human beings. Please look at all aspects of this protection rather merely than the kind of simplistic formulas that some groups would urge upon you and would urge upon us.

Last but not least, Geraldine Graham is here from the Pest Management Regulatory Agency of Health Canada. Your Minister visited us last week to emphasize his commitment to harmonization.

I am happy to be here and to hear these discussions. Among the various issues you're grappling with as you implement the FQPA I think many of you may know that there is a technical working group on Pesticides under NAFTA. and that group is working toward harmonization of the regulatory process amongst Canada, the United States and Mexico in order to be able to share the work of registration and reregistration, to avoid trade barriers and to create a level playing field for the growers in all three countries. I was really happy to hear Jim Jones mention this morning the joint Canada-U.S. review of cyprodinil and to mention the benefits that he saw for the United States. We in Canada also appreciate those harmonization efforts and say that we hope as FQPA is implemented there will continue to be opportunities for Canada to be involved as you refine your risk management policies and methods and set your schedules and priorities for reassessment, etc. We hope that through the implementation process the harmonization will be enhanced and not jeopardized in any way.

That ends today's session and we'll see you all tomorrow.

Marcia Mulkey, Office Director, Office of Pesticide Programs:

We have a very rich agenda for the whole morning. My impression from yesterday is that the dialogue, or at least the serial commentary, was very rich and beneficial to all of us and so we want to make that a hallmark of this entire meeting. To do that we have to get the presentations over with and get the talking started. I will ask Anne Lindsay who directs our Division with the most different things to do, the Field and External Affairs Division, which does everything from deal with our letters from our friendly Congressmen, which some days come quite frequently and intensely, to our Worker Protection Program with a lot of things in between, not least of which is our external relations including the public and hence the Consumer Brochure responsibility.

Thank you, I think Marcia is actually stalling for time so I can collect my wits. Marcia and I together have had a hair-raising series of events but we are here. I actually am going to start the discussion and turn it over to Charles Franklin. My main message at this point was really just an expression of thanks to all the members of the PPDC and all of the auxiliary members of the PPDC that were added to the Right-To-Know workgroup. I think we started working together about a year ago. I have to admit, at the beginning I was probably very naive about how hard it could be to write a simple tri-fold brochure; there are probably only 250 words in it. There are a few pictures, maybe not a piece of cake but not too hard. I've learned that I am not good at estimating how much labor goes into these small products and that there is really quite a bit, but I think we've benefitted from the range of comments we've gotten both informally as well as from the formal comment period. So thank you a lot. We are not quite done but I think we are in the home stretch. I hope a number of you will sign on to help us or continue to help us with some of our web site development that we think should go along with the brochure. With that, let me turn it over to Charles.

Thanks Anne - As Anne said, we are about a year out from when we first met with you all. Oh actually, by the way in the interest of having more time for discussion, there is a handout that we pulled together just with basic slides that we might have gone through if we really wanted to just talk to you the whole time. But in the interest of actually having more time for discussion I am going to be really short and just skip over most of these, but just take these as something you may want to refer to. Just going over our progress to date, we've actually gotten quite a bit done especially in the public consultation ...obtaining public input. We developed a PPDC workgroup with PPDC members and external stakeholders who were really crucial to this general area and in helping us get the documents out to the stores. We conducted consumer research, talking to real consumers trying to get a sense of what are the kinds of things that they are looking for and what they already know. Working with the workgroup we actually developed several early drafts trying to start to pull together the issues of tone, content, style, and how to communicate this information appropriately. Then we actually conducted additional focus tests with consumers while we were holding a public comment period so we could get actual feedback from our stakeholders and as a result of that we've gotten a really good, large body of feedback from both the general public, the lay person who is going to be in the stores picking this up, and then also from those of you from all of your different positions coming to us with your own expertise, your own sense of how this document impacts you, your constituents and the public. So it's been really effective.

We've received a lot of comments on the draft. One of things we handed out earlier was a general overview table that goes through a lot of the key comments that we've gotten. These are just some of the type of areas: tone and length, graphics, layout and design; how to address risks and benefits; how to tackle the issue of organics; how to bring up the issue of IPM; how much and how to present the government's role in what we're doing; and how we should be looking at FQPA. Rather than go through those, again I encourage you to just take a look at the comments in the general summary. It's not exhaustive, but we got comments on every possible issue, but you see some interesting trends as you look through it. I'd like to just give you 3 observations that we've made just from looking at the comments and especially comparing them to the consumer research that we've seen so far.

One is the range of views that we got from comments reflects the range of views on almost every issue PPDC discusses. Some felt that it was too alarmist and some felt is was too optimistic in its presentation of how the government does its job. In case after case, there is a wide range of views as to how effectively our early drafts had done their job. Two, consumer research tends to reflect that people have different perspectives; however, one thing that we were really happy about was that consumers generally saw the brochure as balanced. In general, folks felt like they were getting good information, that it was informative even in its early stages so even as we refine something to a more final document we feel like we are hearing from consumers that it is on track. Finally, at this point we've done focus groups, interviews, and stakeholder meetings, and the public comment that we've received has given us really valuable information but there is no clear consensus path. Ultimately we are going to be making tough choices and deciding how to really address the comments that we've gotten and I think that's really one of the steps that we're at now -- just trying to look through and decide how to address these different areas. I am going to turn it over to Anne, just briefly to talk about our next steps at this point.

Anne Lindsay:

Okay. Basically, we have some consumer research to finish up, which will take place during the month of May. This will be very similar to the research that we've been doing through the public comment period, but in a couple of other parts of the country. That will be completed by the end of May. In the meantime, we are actually beginning what I will call the internal deliberative process, looking at the range of comments we've gotten from the public comment period, as well as the consumer research that we have currently. That internal deliberation will also include fairly extensive consultation with both the Department of Agriculture and the Food and Drug Administration. It's both one of the things this statute asks us to do as well as one of the things that we think we need to do to make the final brochure be the best it can be.

Our expectation at this point is it that the Agency would have a final brochure by about mid-June which would be ready to go to the printer and then for final distribution by early August, the statutory deadline. That is the track we're on. Its fairly fast but doable and the area that we've now been turning our attention to, besides finishing the brochure itself, is the development of a web site and perhaps beyond that other background information that would contribute to the consumers right to know, that would help a consumer be better informed about the quality of their food as it regards pesticides, if they so choose. Some of us when we go to the grocery store may not care at all, we may be more interested in the National Enquirer in the check out line, but other folks are interested and so what we want to do is make sure that we've got good quality information available to them above and beyond the Brochure.

Actually one of our goals is to use PPDC to have a discussion. We have a couple of different options. One of the things that we wanted to do was share where we are going with the distribution and with the web site and hope that we could use the time here in particular to discuss that rather than just a general perspective on the brochure.

In thinking about distribution, let me come back to the law for a second. One of the things that it directs us to do is to develop it for distribution in grocery stores, in large retail grocery stores, information to the general public, for the lay audience. One of the things it says is "in a manner to be determined by the grocer." So one of things that we've tried to do in thinking about format, layout, size, is make sure that it does fit with the type of material that grocers are able and are already putting up and hence the one size you see is the basic 4"x9" version. We want to share with you some of the basic elements of our distribution strategy, which I think are pretty straight forward. One, we want to make sure we've given notice to the grocers up front so they are expecting it, so that they are not just getting something in the mail that maybe doesn't make it past their trash can. Let them know that this is happening, let them know that we are looking to work with them to put it into stores. Number two, work with trade associations that work with the stores and try to get their support, help us get the word out, get support for the Brochure and distribute it. Ultimately, however, we see the Agency as an active distribution channel. So once we get into July and once we have the printed version, we will distribute copies directly to stores. Recognizing that in some cases stores may prefer to make additional copies themselves, we will be looking to distribute a camera ready copy as well. At the same time, one of the comments that we've heard is that a lot of stores will be looking to the Agency to provide copies. We will also be providing order forms to fill additional requests when stores want copies. We will send out an original quantity, but this is something that happens over time and we want to make sure that there is a mechanism in place for continuing to supply them and refurbish their stocks.

Lets go to the general layout. There are some issues we need to work through. For example, when talking with the key trade organizations, one of the things they are saying is that they want to see the final version, and that is one of the things that is going to help them decide whether they are going to be willing to work with us to get information out. So there is still a lot more discussion on consultation and deciding on exactly how we can most effectively do that pre-planning before we send copies out. Before we got into our conversation, turn for a moment to the Web Site. Another one of the things in the package we handed out was a very general list of the types of information that we saw as appropriate to augment what is in the brochure. From the beginning, I talked about the fact that there was rarely consensus between stakeholders, between all the different parties. One area where we did seem to get a lot of agreement was that there is more information that people need to know and want to know than we can fit into this brochure, no matter what those things are. There is really a need to give people alternatives if they want more information. We see the web as an excellent way to do that. Our general thinking right now is that people will be able to go onto the web, and using the brochure as a guide, dig deeper and find more information on the topics that are listed in the brochure.

In the handout that I gave out today, and also what was in the packets, it gives you some of the types of examples that we've been thinking about already -- just additional information on what are the risks, information on pesticides and children. Ultimately, as we develop the 10X policy, for example, one of the things we are willing to do is to make sure that we have some basic information in a fact-sheet length type of document that helps communicate exactly what it means to the lay reader. In terms of tolerances, there is already information we can make more easily available, information on exactly what the tolerances are that are already set for different foods, providing links to the Pesticides Data Program information where we have residue data that people can look at and can look at the summary -- the market basket study. There is a whole range of information that is already up so it is not necessary to develop new information, but it is necessary to provide people with a way they can get to the kind of information they are looking for. Again, a combination of simple fact sheets, one pager elaborations, and in some cases really giving them access to more specific bundles of data that they can use and look at. We see this as the key underpinnings of the broader Right-to Know opportunity that we have with the Brochure. That is just a general overview of these two areas. Again we are really getting feedback on these two areas in particular because we really haven't had a chance to discuss these in the past. At this point I would like to open it up for questions or comments.

You said you had a lot of comments on this. How many private comments did you have? I realize that from the industry, my industry and everybody else's industry you have hired guns who give the comments, but how many private citizens? I see 16 here.

Charles Franklin:

That sounds about right.

Jay Vroom:

What's our population -- 250 million?

Anne Lindsay:

That's one of the reasons we also, independent of the public comment period, have been doing consumer research because it has been my observation that the Federal Register is not a real good mechanism for getting direct comment from the ordinary person. It is a pretty good mechanism for getting comment from those of us who are sort of regular devotees of Washington or something. I'm not really sure how to describe it.

The other question is, was there consultation with USDA on putting the verbiage together on the Brochure?

Charles Franklin:

Yes. They were actually part of the workgroup. As we get into the next round we will make sure that we are working more closely with them in developing a new draft. But both USDA and FDA have been members of the workgroup that includes both PPDC members and external stakeholders, as well.

A couple of questions and this really relates more to what you provided in the packages as opposed to what you just explained now. One is, back to the soap issue and washing your fruit with soap. I am curious. One of the things we are looking at in terms of pesticide exposure to humans is exposure on hands and other various kinds of ways pesticides may reach people. What about the issue of soap. Has work been done on long-term ingestion of soap in people's diets? There's got to be a hundred chemicals in a bar of soap. Has anyone looked at what those are and what the long term ingestion problems might be?... And I think that needs to be seriously considered because you are going to end up with soap film residues on your food that are certainly at the same level as pesticide residue, probably higher.

I know, so far in this version we actually haven't included the recommendation ...are you talking about during the washing process for fruits and vegetables? In our current version, we haven't recommended using soap during the washing process. I think that is an issue and we did get comment on that... on both sides as to whether soap is an appropriate thing to recommend.

Part two is the IPM reference that was made. I thought it was very interesting that when IPM is explained that the public responds well and to be honest DelMonte has seen the same thing in Focus groups that we've done. We've never really done the marketing, never followed up on it, but certainly we do see very positive response on the part of consumers, particularly when it is real IPM and not superficial IPM. I think there would be great value in including some IPM statements in there. It is a real opportunity for us to begin to teach the American public about what that offers and what it does is begin to put some pressure on those of us who grow the crops to look at those kinds of options. Thanks.

Can you tell me how much money has been spent on this effort and how many FTE's in the last year and if you can't could we get that information? [Charles - Sure] And another question would be, what do we project? This is the first time that I've heard that EPA is going to be the primary source of distribution of this. Could we get information on what you project it would cost to do that? This is separate from the fact that Dan offered to do this personally as Bill just mentioned. (Laughter) It would be real interesting... Dean Zuleger is the only one I know at the table that has done this. But I have this idea that you are going to give stuff directly to stores. I used to give retailers money to do what I wanted them to do and they still wouldn't do it. I don't know who you are talking to about this, but talk to some people who try to make a living as merchandisers at the store level. For one thing, the chain stores resent more than you imagine your dealing directly with their stores. I really think you need to look at the cost of producing and distributing this stuff, even an initial shot at this, and secondly even if you had money it wouldn't necessarily work. That's just my experience. Maybe that's a testimony to my feeble abilities as a marketer. Also, I just have to feel honor bound to say a couple of things. This idea of doing a web page is certainly in the spirit of "Right-to-Know" in this Administration and EPA and it's commendable. In my view, it should not be considered as part of what's statutorily required here and I hope you make a distinction between the resources spent to deal with the statutory requirement and what you are doing for the web site. I know you can't separate the communications efforts, but they are two separate issues and I don't think that we should believe that the statute requires us to do that. Secondly, I just have to say that once and for all and since Richard Wiles isn't here I'll just say it for him too, I don't think the statute requires us to do this and I really would much prefer the Agency to spend its time and effort on something else.

I want to echo Larry in terms of the statute putting this in a Right-to-Know context and really requiring it when and if benefits-based tolerances are issued, which they haven't been. But given the decision to go forward, which has obviously been made, I've got some concerns about content and process at this point. There has been really a gallant effort made by EPA to include multiple view points and to conglomerate what are inherently a variety of conflicting messages from different interest groups. There has been as Larry suggested an enormous expenditure of resources and I too would like to know what that amount is. We are not overflowing with them (resources) in the Pesticides Program. I think what we have now in terms of content is a bunch of mixed and conflicting messages and it is really time for EPA to decide what it wants its single, coherent message to be. That message needs to be a consistent one One possibility is that it's the consumer's Right to Know that their food is safe. Another possibility is that there are benefits to pesticides. There may be risks from pesticides. The government is continuing to improve its capacity to address those risks but it is not there yet and there are things consumers can do to reduce their risks. I would suggest that the latter message is a more accurate and compelling message than the first one. Once you define what your message is, you need to associate some learning objectives with that message that you articulate up front and then determine, through consumer research once the brochure is written, whether those learning objectives associated with that message have actually been achieved and whether consumers not just think it's balanced, but actually retain whatever information it is that you wanted them to retain and really are educated, if that is the primary message of the brochure. So do they learn it, do they retain it, and then do they change their behavior in order to reduce risks as a result of it, if that is a component of the effort? So I just think it is time. I think the multi-stakeholder effort has been important to do from a process point of view, but it is time for EPA to take the reigns and decide what it wants the message to be and make sure that message is actually learned and retained by the people that read this. And just one other final content point related to the issue of the government on its way to protecting people from risks but not being quite there yet from a public health standpoint. I think the brochure implies that the tough new safety standard of FQPA is in place now. It is not yet and it should describe the time frame for implementation of FQPA partly because if benefits-based tolerances were to be issued, the brochure would need to be revised and you then would have thousands of copies of the brochure out there that stayed on the shelf and in a lot peoples hands and the first brochure needs to be consistent with whatever updates come about if benefit based tolerances are issued. Just make sure that it is accurate and projects those kinds of changes so that people aren't confused if a second brochure comes out.

Thank you for your rich set of comments. Carolyn.

Boy do I completely agree with Polly. I think that she hit it right on the head. And you should record whatever she said and do that because we have all talked about this thing enough and in fact people probably don't want to talk about it this morning. I also assumed that you have talked to the grocery stores and you know what their thinking is and, of course, they want to see the final version. But I'm going to give you the benefit of the doubt on that one and assume you know what their interest in distribution is. So tell us what is it?

They are pretty concerned. Based on the comments that FMI presented -- they were one of the key representatives -- I don't want to speak for them, but one of the things their comments reveal is that this is something they would have a hard time getting their stores to actually stock. From their perspective, the law does not really require them to make the kind of efforts that we would like to see to actually market and put this on the shelves.

So what is the fall back?

I think one fall back is that the Agency can make the brochure available. I think our experience with just putting things on the Web Site indicates that is actually one rather simple mechanism for making information available. This seems to get wide distribution. I also thought one of the consumer comments on this topic was interesting - what they would think if their grocery store did not carry the brochure. And they seemed to indicate that they would feel that the grocery store was withholding information from them. So I think there could be considerable consumer pressure to have this kind of brochure available.

This is a large part of what I do every day -- work with produce managers, produce buyers and then produce merchandisers. You can take the comments from FMI. You can take the comments from PMA, and those gentleman are wonderful people -- they understand their organizations, but for us it's: What's the produce merchandiser or produce managers in those individual stores going to do? If you take a look at "Produce Merchandising" and "Supermarket News" and some of these magazines that detail where the successful stores are putting their efforts with respect to information and merchandising, the stores are going to a very streamlined, kind of contemporary look, same kind of color, same kind of signage, and there has been a general movement away from a lot of recipes and point of purchase materials or brochures. We have gone to the point, as some of the other commodities groups have, of even sending them the Plexiglas container that they can either hang or velcro to the eye level shelf in the store and they still don't use it. And the reason is time. A produce manager or merchandiser has got to get a watermelon bin unloaded, has got to do the turns on potatoes, has got to stock all of its exotics, and all of its critically perishable fruits. A guy is going to leave those brochures sit somewhere on a shelf. So I would agree with Polly and Larry. Larry on the resource issue, Polly on lets kind of figure what we are doing before we do it, from a practical standpoint. I read the comments and I thought to myself is this what we really need to do? What the Agency really needs to do is to go out and talk with that 18 year old who's doing the merchandising at night after everybody leaves and say "would you put this up?" Because he's not going to do it, because the produce manager is going to worry about getting the fresh product rotated, out of the corner, back into the back room. We send them handling charts, the best way to handle potatoes and rotate, and they don't even put those up, and those are a direct benefit to the way they can reduce the shrink. So I think while I appreciate the Agency's effort, and I appreciate the comments on the public right to know. In practicality, even when you provide them with every tool available, and you make it as easy as you can for them to put something out in the store, they are not going to do it. And with the way that they are going to a corporate standard signage policy, they're not going to clutter up there corporate image with a lot of different brochures and a lot of different colors and schemes and cardboard. They just have decided to move away from that.

I agree that this is a fairly limp effort to communicate with the public, for all the reasons we have talked about as far as distribution. I see this as a first step and I see the process as very useful for EPA and those of us who are a part of it to focus our thoughts on what should be communicated and how it should be communicated. I think the web site is a very promising approach. I believe that governments have a responsibility to communicate with their constituents and that it is a valid and justified expenditure. You still have the responsibility to communicate not just with those who are regulated but with the consumer. I think expenditures in this effort are completely justified.

Secondly, there is a grocery store chain out there that is doing something on their own to promote reduced pesticide produced foods. Wakemens grocery store has a line of canned vegetables that is labeled IPM and they produce an excellent brochure explaining IPM which they distribute in their store. I picked it up, Larry, at the Pennsylvania farm show. I don't think it's a complete total loss out there as far as grocery stores.

Where is Wakeman's.

They are in Pennsylvania, New York and New England, I believe. As far as the content of the message. I definitely believe organic should be mentioned specifically and that IPM should be mentioned specifically. I believe that a message that says " I'm the government. I know what's best for you. A small amount of pesticides on your foods is safe -- trust me" is not a message that will sell. That is the point of giving people choices, including ways they can reduce risk, real or perceived. People feel comfortable if they can control risk. People don't feel comfortable that something is safe without offering proof.

Bill Demare:

I have a question regarding the tips for reducing pesticides and the number of comments that look for evidence that recommends measures of washing and peeling and cooking that actually reduce pesticide residues and is that true and what was the data to support it?

That is one of the areas we will address as we go into looking at the comments and how to effectively respond. We are pulling together our information to address all those.

I would say though that I know that as we have gotten data over the years on individual pesticides, we do get data on the effects of washing, peeling and cooking. If you are talking about a pesticide that is not systemic but one that will be in contact with the outside, washing and peeling can make a difference and cooking can at times make a difference - although sometimes cooking can have the opposite effect. I do remember from my Alar days that cooking can concentrate residues.

I think these are very good comments. One of my frustrations is to try and put this into a time continuum perspective. Clearly, current drafts do exceed legislative mandates, which is okay. Beth's point is correct that this Agency and the government in general has an obligation to communicate to the public. The web site expansion is a good thing which to me doesn't need to necessarily be tied to the FQPA brochure anyway. One of the challenges of the web is that it's probably more difficult to control because it is so instantaneous and effective in some ways. So there is a degree of caution and care that is required when you go on the web that all of us need to learn more about it. My frustration is similar to Larry's. How much have we spent, how much more will it cost and who's expending additional resources? We still don't know the answers to this. As I look around this table, I am one of the few people who actually get paid to do this on a full-time basis. Most of the rest of you have other work to do. It's really frustrating to me that the same questions were asked in October and we still don't have the answers. Most everyone is taking time from other work to be here. The brochure is a small thing to me. The resources are not all that significant in the context of a $7 billion EPA budget or a $100 million OPP budget. I just think that it's just so simple. Why not just do that. That frustrates me. Some people who I represent are concerned that there is a another agenda behind the FQPA brochure. Frankly, a little more transparency and openness would help us put some of that in the background so we don't have more political backfires trying to be set by people I represent and others in production agriculture who are inherently distrustful of government and EPA. I am frustrated by the wheel spinning that has come from the visible part of this brochure when there is more important stuff to be focused on with regard to the important work of OPP and EPA on the regulation of pesticides. Lastly, I would like to ask specifically who has participated from USDA because the staff time that I have invested from ACPA and being involved in the subgroup, the representatives there did not have any recollection of any specific individuals employed by USDA being in attendance at those meetings? So, I would sure like to know who those people were.

Our key contacts at USDA were Al Jennings and also John Impson.

Thanks, Polly, for nicely summing up the issue because we have been through this forty times it feels. To reiterate, you'll never do a brochure that will satisfy us, and Jay and GMA food processors, food marketers and all the rest. To echo Dean's comments, most mainstream stores have no interest in having any information on pesticides anywhere in the store, except for maybe the pesticide aisle. Given that and given the fact that Dean is right - most of them don't want it displayed because it might mess up the decor and have some weird EPA brochure with some funny cartoon on it sitting in the middle of the produce aisle, I would like to see a more public discussion of the distribution strategy. In my latest issue of the AgriChemical Insider has comments from GMA that I never saw in the docket that basically they still hate this thing and say that grocery stores have no obligation to distribute it. Let me repeat that grocery stores have no obligation to distribute it - not that they would ever advise grocery stores not to put this out, but I would just hate to see 40,000 boxes of your beautiful brochures end up in 40,000 landfills. I ended on that "snarky? note.

Did you have something specifically in mind about a public discussion of the distribution?

We haven't talked about it. All of the public conversations have been about content and not about how this thing is going to be distributed.

I feel different about this whole thing. There is a role for the government to provide education and information. I'm not sure if this is the best way to do that - through a brochure. I'm not sure that the law actually required a brochure. But,I do think the government has a responsibility to put information out. I felt from the beginning that this thing wouldn't please everybody - I now wonder if it will please anybody. I still think that it needs to be done and the Agency needs to move ahead. I agree with Polly -- decide on its message and move ahead. I would hope that this would not be the last thing that the program does. One of the biggest problems we have with the regulatory program today for pesticides is the lack of knowledge by the general public. I think that as long as that lasts, it does not matter what the Agency does and it does not matter what State programs do - if the general public does not understand what is going on, there is never going to be a sense that things are being managed. So, I would encourage the Agency to move on with the brochure and that about other educational efforts that would help deal with those kinds of issues. I fully support using computers and the web but many constituent groups don't have access to that. So, you need to look at other ways. I would suggest using PSA's. Lots of other groups use PSA's very effectively and I don't see why EPA can't.

I understand that 34% of homes have access to the web. I don't know whether you think that is a lot or not but I thought that was somewhat low.

Most of my comments have been said. My comment is about the Web. I understand what Larry was saying and I understand that perfectly. But, the web is the wave of the future and we need to make sure that we do all we can to use this avenue of information because more and more people are using it all the time. It reaches directly to the people who can influence the other people. So, I don't want to take away from what Larry said, but don't consider this to be the main source of information. Please do not sell it short. In relation to that, what effort are we making to make sure people know what is on the Web. One thing is to put it on the web and the other is to have a very proactive way of letting people know that if you wanted the information, you can find it on the web and how to get to it. The other question is what effort is being made to communicate this to the media besides the Washington Post and the New York Times? There are a lot of newspapers out there besides these two. People need to read about it and then go to the grocery store and ask about it if they don't see it. What effort is being made?

Charles Franklin:

All of these issues are still very much in development. These comments will be helpful. We have this basic mandate to get it out to the stores. Ultimately, we will have a very broad and multifaceted strategy for getting it out. We will also need to go beyond the media to let the general public know and we will be looking for different ways to do that. Just to note, this is only one piece of the pesticide communications program - one of the things I am most excited about with the web is not so much that it gives people access to the web if they have a computer, but the process of our developing these materials and thinking through the logic of having full and complete set of materials actually gives us additional products and materials for non-web communications as well. So, we do just think of this as one piece of a broader strategy.

I think it is a very good idea to talk about distribution. You are mandated to send these to grocery stores. Don't stop there. Surely you can locate lists of citizen and consumer groups. Send them out there and let them get more if they want them. I'm sure there are others who have suggestions about where else you should distribute these.

Targeted mailings - (Yes).

Sheldon Wagner:

Regarding use of the Web, if you listened to Good Morning America yesterday, there is a discrepancy between a web in a white household versus African American household. In the white household, 24% have access to the web and for African Americans, it's less than 5%.

Thanks. That's a good reminder.

Conclusion -- in terms about what we have spent so far, it's about 1.5 person years over the last year and about $150,000 - the bulk of which was spent on consumer research. The other much smaller portion has gone to the contractor who has worked on formatting and producing the graphics (which have been so popular so far -- laughter). We have actually given them more money to come up with some alternate graphics for either the food or the cartoons. I was actually hoping one of you would explain why Fresno, in particular, seemed to like the cartoons. The citizens of Fresno stood out in the consumer research on that particular point. (Laughter)

Regarding distribution, if you have not explored using the Food and Nutrition (Fnet?) Program, they were very good with the 5-a-day campaign and it reached a lot of people through nontraditional mechanisms, especially the disadvantaged program network. In the regional office, we have experienced a lot of favorable dealings with that program and you may want to consider that with distribution of the brochure.

Next subject will be opened by Lynn.

The issue is about Section 18's and how we are going to address the issue paper presented to us was a very difficult one for us. What we are going to hear today is a summary of the proposal that was presented and we're going to hear from the Agency's legal counsel about their opinion about the proposal and we will hear from the FDA about how they approach similar issues, which is a slightly different avenue to try to get to the same place. I hope we can hear a lot of discussion about how we can proceed. This is an open issue at this point. No decisions have been made by the Agency. We would like to see a way of being able to produce the effort that's required for processing 18's where that effort is unlikely to provide anything in the way of public health or environmental protection. If there are things that don't benefit public health or the environment then we can use that effort somewhere else. We have a general interest in finding a way through that would establish this resolution.

Marcia Mulkey:

We want start with enough of a summary of the presentation so that everybody can understand it.

It is a pleasure to be here and I send apologies from Dan Botts. This product as you know was a product of the Minor Uses/Section18 workgroup. It was a subgroup of that. The group worked very hard -- with conference calls -- since a lot of us are on the West Coast and in the Northwest. We really worked through 1997 to put this document together in October and obviously hoped that there might be some movement of the document at that time. We are somewhat dismayed that we're almost May before we can look at this again. But I did want to note that we feel that what we put together is certainly in line with what Vice President Gore has said -- on his reasonable transitions for agriculture -- point 5 -- he directed EPA and USDA to identify and implement any appropriate measures that will further streamline the process for responding to emergency pest management challenges to ensure that EPA is able to respond promptly and to preserve the FQPA's policies in emergency situations. The incremental risk assessment option for Section 18 tolerance settings -- I'm going to review the executive summary and add a couple of minor comments. As we all know, the passage of the law has had a major impact on Section 18's. It requires that tolerances must be set for Section 18's of FIFRA and EPA has implemented this requirement by conducting an aggregate risk assessment for pesticide residues for all foods for which there are established tolerances and for each active ingredient approved for the use under the Section 18 exemption. The Section 18 risk assessment process is similar to that use under the full registration--Section 3. This has resulted in the Section 18 approval process requiring much more time than pre-FQPA and has diverted scarce resources from other activities. Congress recognized that EPA's approach to issuing a tolerance for a Section 18 exemption could differ from that applicable to Section 3. The statute does not require that such approaches have to be the same. Thus, we believe the Agency has the flexibility to adopt a different approach to establishment of a Section 18 tolerance under the FQPA. In order to address the diversion of resources from other EPA high priority activities caused by the Section 18 tolerance setting process, a tiered risk assessment approach and expedited process for Section 18 tolerance setting is proposed. The tiered approach focuses initially on the incremental risk associated with the Section 18 use itself. If the incremental risk associated with the appropriate toxicological endpoints are less than 1% of the acceptable risk associated with the endpoint, then the tolerance would be approved without conducting an aggregate risk assessment for all the uses. The EPA would, of course, would always maintain the ability under special circumstances or at their discretion of doing the full risk assessment even if the 1% trigger was not seen. Using this tiered approach allows EPA to perform a level of risk assessment that is commensurate with the potential risk associated with the Section 18 use. This process would in turn expedite the review and approval of a significant number of Section 18's at a minimal exposure and limited potential risk. I think that all the minor use and major commodities see a Section 18 as one of the major routes to controlling pests through the initial phases of FQPA and because of this it is extremely important in terms of making transitions in agriculture. Yesterday, we heard numbers on the new active ingredients and new uses and in looking at that and looking ahead to the impact of FQPA, where there are reductions in the materials we will have available through possible cancellation actions, we believe that Section 18's have to been seen as the major tool for providing crop management. I think that if there is a way to go through this process and to get the resources that are currently going to Section 18's tolerance settings for those cases that fit these conditions and we will be able to look ahead and see the potential for having new active ingredients for products.

Marcia Mulkey:

To go from that proposal... we are going to do something a bit unusual and wave our attorney client privilege and let you hear what we have been hearing from our attorneys about their analysis of the legal defensibility of the proposal.

I've been asked to discuss the legal viability of the incremental risk assessment approach that was presented at the last PPDC meeting. A lot of serious thought and consideration has gone into reviewing this paper. This has led to the conclusion that this option would not be consistent with the law. The statute is very clear on the standard EPA must apply in establishing a tolerance for a Section 18 food use. The statute says, "...shall be consistent with ..." Shall is a mandatory term and does not provide EPA discretion in determining what standard to apply. The standard to apply is B2 and C2. The safety standard requires an aggregate risk assessment. Safety means, " There is a reasonable certainty that no harm will result from aggregate exposure to the pesticide..." Later in the standard it also requires us to take into account cumulative effects of substances with a common mechanism of toxicity and to also take specific account of children's and infant's risk. The incremental risk approach, which has been outlined here, conflicts with the plain language of the statute because it would allow EPA to establish tolerances for Section 18 food uses without looking at the aggregate risk of the pesticide chemical and without looking at other chemicals which may pose a common mechanism of toxicity. The reason that this is important to say is that it conflicts with the plain language of the statute which has to do with Agency actions which are reviewed in the courts. A tolerance is a regulation. When a court reviews a regulation it looks first to the plain language of the statute to determine if the Agency's action is consistent with Congress' intent. The legal basis that has been set out in the incremental risk assessment paper on pages 7-8 relies almost exclusively on a statement in the legislative history regarding EPA's processing of emergency exemptions and tolerances "expeditiously." Courts look first at the plain language of the statutes, if the language is clear they will not look at the legislative history for an indication at what was Congress' intent. We believe the language is very clear, it says shall, it says aggregate exposure, all exposures. This is very clear. Even if a court were to look beyond the plain language of the statute the plain language which has been cited in the paper we do not believe the court would find support for the notion that EPA should apply a different standard. This if my final point, the paper discusses an approach and process and changing EPA's process for reviewing exemptions to reserve resources, which could be applied to the review of applications for new active ingredients, however what the paper is really asking EPA to do is t apply a different standard, a negligible or reasonable risk standard. There does not appear to be any support in the statute for this approach, therefore we believe this option is inconsistent with the law and if EPA were to take action based upon it and that action was brought to court it would likely be overturned in court.

Thank you. I know that there is some interest in exploring some of this thinking. I would like to shift gears, but I would like to explore an idea (which I understand the FDA calls "the threshold of regulation.") as to whether there is some category of action which simply does not require, doesn't trigger, the regulatory provisions of a the statute.

I've been asked to help EPA say to PPDC that the negative response you've just heard does not mean the thinking has just stopped or that other avenues can't be explored. They asked me to talk about a couple of FDA approaches that have been used in dealing with similar problems. I'll briefly convey a few concepts that might be of some value as we look at this problem. First, I'll refer to what we call the sestivity of methods policy relates to animal drugs and the Delaney Clause that exists for animal drugs. The animal drug provisions of the Delaney clause has an interesting twist to it. It basically says FDA can't approve a carcinogen for use as an animal drug unless there is no residue in edible tissue, meaning meat or milk as determined by methods that are approved by the Secretary. If the Secretary determines that this is true it would be appropriate in that circumstance for the FDA to approve the use of the animal drug. The immediate question - what is the right method or how does one determine what the right method is? Beginning in the late 70's and continuing in the '80's the FDA came to use quantitative risk assessment as the method for ascertaining whether a particle method was sufficiently sensitive to protect the public health while still enabling the FDA to use the discretion that Congress had built into the law. The FDA came out with the idea that if you did a risk assessment and determined that the risk was less that 10 to the minus 6 that's the sensitivity that you needed and if you couldn't find it at that level you could treat it as not being there. This was the first time that the 10 to the minus 6 was put forward as the appropriate dividing line. Let me stop and shift to our regulations of food additives. One of the things that's in the Food Additives Amendment is language that's says food additives are not just those things you add to food but things that can indirectly find their way into food. The indirect language has been interpreted to include migrants from food packaging materials that get into food. We have many pages of CFR devoted to regulations of components of food packaging materials. We came to realize in the late '80 and early 90's that we were spending an enormous amount of resources and forcing companies to spend an enormous amount of resources generating data to approve very low levels of migration from food packaging into food with the result that there was not a safety concern. The reason being that the level of migration is very small. We began to wonder if there is a line - what came to be known as the "threshold of regulation" where we could say below a certain point, instead of writing a regulation we would do an expedited review and issue a letter. We, as part of this, looked at literature of toxicity, potencies of carcinogens and concluded that relatively potent carcinogens actually would pose a risk of less than 10 to the minus 6 if the level of migration was sufficiently small. With this in mind, we issued a final regulation in '95 that said that we would go to this new policy of not requiring the same data, do an expedited review and then issue a letter instead of a food additive regulation, under certain circumstances. One, we did not want this to be a vehicle for avoiding the Delaney Clause, so we said the policy would not apply to anything that was a carcinogen or suspect carcinogen. Two, if there were any known health effects in humans or significant environmental effects the policy would not apply. In any situation where the policy would not apply the full petition process would still be required. We also concluded that situations where the total dietary exposure on a day to day basis from a particular migrant was going to be less than one half a part per billion that we would not issue a regulation. That is the daily amount. For instance, if you are looking at migrants from plastic soft drink bottles (PDT), you are looking at the daily exposure. If that amount per day is less than one half a part per billion then in that situation we would issue a letter not a regulation. I will stop at that.

Before we go to comments and discussion, I think its important to look closely at what the Vice President's memo exactly said, " EPA and USDA should identify and implement any appropriate measure that would further streamline the process for responding to emergency pest management challenges to insure that EPA is able to respond promptly and to preserve the FQPA's policies in emergency situations." Now I think to put what we heard from the attorneys in context, and as Marcia said we don't usually present our legal advice to the public, but this is a risk assessment that says that if we are challenged we have a pretty dismal chance of surviving that kind of challenge in court. On the other hand, part of that risk assessment and that is not for the lawyers to do but for Marcia and me and Carol and Fred to think about is what is the likelihood that anyone would challenge us. We need to look at the legal risk and whether we would ever end in the situation in the first place. I don't think a negative risk assessment from the attorney's knocks the option out, but it does cause us to think creatively and looked at what FDA has done over time. I've asked OPP to take a look at the threshold of regulation and sensitivity of method and give it some thought and if it might be applicable and might help us meet what the Vice President has asked us to do. Another avenue to get to that place - Marcia, Steve, Anne and the attorneys have only given this initial thought. We have not moved this forward. We are at a very early phase in thinking. We want to hear from you whether this is a road we should take at all - after you've heard all of it. If so, do you have any sense of how we should approach it. Should we pursue the mode of the Section 18 paper or something closer to what FDA does or a hybrid in between? I see with what FDA does fairly clear safeguards to make sure the public health is protected.

We have put together a few overheads that should not take too long to go through and then we will open the floor to discussion. As you have heard, FDA does have a threshold of regulation policy. It means too me that there is some level or threshold that beneath which exposure and risk are so low as to be inconsequential and not needing regulation. If we moved ahead, there would be at least 4 performance characteristics I would expect it to meet. First, expedited approval of uses that qualified under the policy. Those that presented inconsequential risk, because no risk is in the food itself. 2) Save resources. 3) Legally defensible. 4). Assist us in the tolerance reassessment process, to be one of the streamlining measures that the Vice President's memo mentioned. This type of policy would exempt qualified uses from Section 408 of the FQPA and there would have to be no detectable residues and the risk would have to be inconsequential. It would be broadly comparable to FDA's threshold of regulation policy but not identical. Basically, you set a level that you treat as zero, calculate dietary risk from that zero residue level, and you might use a criteria of 0.1% of acceptable risk, to determine if is was an inconsequential risk or not. This is an exemplary number.

We do have a current policy that has been in place for some time. When doing risk assessment for a given pesticide and we come across a "non-detect" we will assume that there are actually residues present at one half the limit of detection and use that number for risk assessment purposes. When we do that if we can conclude that there is a reasonable expectation of no finite residues we won't require a tolerance. This has been applied, I think exclusively, in the areas of secondary residues in meet and milk and not direct application of a pesticide to a raw agricultural commodity. If we were to expand the current practice and develop a threshold of regulation policy, the way to expand it is what you see on the overhead.. If residues are not detectable, we would need a method detection that was appropriately sensitive and that's an area for discussion. How do you know that the risk at half the level of detection is inconsequential. If those two elements are satisfactorily meet - then you might be able to conclude that no tolerance was needed. To sum up The pros - more efficient use of Agency resources, stakeholder resources, more emphasis on high risk. There is an FDA and EPA precedent. Consequently, if all calculations aren't correct then the food is adulterated and could be subject to enforcement action. Second, still have to do a supporting analysis for each use of each active ingredient so it's not a no-cost option. Finally, given what you've heard do you think there is something worth pursuing?

We may have more comments then we have time. This is not the only opportunity for you to weigh in on the issue.

The provision in this act is clear on this point. Is there a way to expedite Section 18 without violating the statute. I don't think I've heard anything that complies with those two mandates. The concern I have -- with the approaches presented by FDA -- it seems to me we are clear about the legal standards. The Agency should be able to make some presumptions about aggregate risk and expedite that way, but to announce that it is not going to do an aggregate risk assessment or to approve the additional use of something for which the risk cup may already run over - I think is problematic. I would like to hear of other approaches where EPA may be able to expedite the aggregate risk assessment in a way that is consistent with the statute. Also not just in dealing with Section 18's.

The threshold regulation concept could contemplate context other than the Section 18's.

The reason this was in the statute was because of international trade.