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 Although the information provided here was accurate and current when first created, it is now outdated.

USDA-EPA TOLERANCE REASSESSMENT ADVISORY COMMITTEE
Meeting Summary
International Trade Center
Washington, D.C.
June 22-23, 1998

Opening Remarks

John Ehrmann, Meridian Institute, opened the meeting by welcoming participants to the second meeting of the U.S. Department of Agriculture (USDA) - U.S. Environmental Protection Agency (EPA) Tolerance Reassessment Advisory Committee (TRAC) which is constituted as a subcommittee to National Advisory Council on Environmental Policy and Technology (NACEPT) of EPA. A list of the TRAC members is presented in Docket # OPP00537.

Dr. Ehrmann recognized a new member of the Committee, Ralph Engel, Chemical Specialties Manufacturers Association, and noted an effort underway to add another pediatrician to the TRAC. In addition, Dr. Ehrmann recognized the individuals who were serving as alternates for several of the members. He took the opportunity to remind TRAC members of the ground rule that all members should plan to attend each meeting; however substitutes may participate if absolutely necessary and after conferring with EPA and USDA. Dr. Ehrmann then initiated a round of introductions and turned to the TRAC Co-Chairs for opening remarks.

Richard Rominger, Co-Chair of the TRAC and Deputy Secretary, USDA, welcomed members and observers and commented that he appreciated the continued participation of members and others. He reflected on the improvements made on the process based on comments from TRAC members at the first meeting, and thanked Work Group members for their hard work between the meetings to help move the process along. Mr. Rominger stated that he looked forward to hearing updates on the progress of the Work Groups over the next two days, particularly Work Group #1's suggestions for the next steps of the TRAC. He commented that his goals for the meeting were to develop a better understanding of the risk assessment and refinement process, the science policy questions that shape the risk assessment, and the ways and means that government can provide adequate public consultation on the process. Mr. Rominger commented that he would look for ways that USDA can continue to be a constructive participant in the implementation process. He observed that, through his conversations with many growers, there is much concern about the risk assessment process. He emphasized that current risk assessments are preliminary and may change as new information becomes available. He closed by stating that USDA looks forward to working with TRAC members on the implementation of FQPA.

Fred Hansen, Co-Chair of the TRAC and Deputy Administrator of EPA, joined Mr. Rominger in welcoming participants to the meeting. He observed that a lot of work had been done since the last meeting: Work Group # 1 met during the week of June 15 to discuss risk assessment; and Work Group # 2 met for several hours during the morning before the TRAC meeting to begin its discussion on risk management. Mr. Hansen commended Work Group members for beginning to work towards convergence on key issues and laying the groundwork to move the TRAC discussions along. As an example, he observed that Work Group # 1 made progress on developing a transparent process to address major science policy issues. He noted that the agenda for the current TRAC meeting would focus on Work Group # 1's ideas on different approaches to transparency in the risk assessment process, and discussions from Work Group # 2 would provide similar direction for future TRAC meetings. He explained that Work Group members would frame the issues discussed in their Groups for consideration by the full TRAC memberships. As an example, he noted that members of Work Group # 1 would present the discussion on EPA's preliminary assessment of organophosphate pesticides. In preparation for their presentation, Mr. Hansen clarified that, while the information on organophosphates is EPA's preliminary analysis based on the best information available, there will be more opportunities to refine the analyses. He expressed the hope that the preliminary information on organophosphates would provide TRAC members with a better sense of EPA's current assessment process and help frame a discussion on a transparent approach for refining the assessments. In addition, Mr. Hansen suggested that the discussion on organophosphates would help form the basis for future TRAC meetings on risk management and transition strategies. He closed his remarks by recognizing the efforts of the Work Group, EPA and USDA in preparation for the meeting.

Following the Co-Chair's opening remarks, Dr. Ehrmann provided the group with some additional details on the progress of the Work Groups and future Work Group meetings. He noted that the agenda was formed with the direct involvement of the Work Groups. Dr. Ehrmann commented that the Work Groups are interim groups and it is up to the TRAC to help develop their agendas, modify their structure and membership, or decide whether additional Work Groups should be formed. He proposed that, for now, the Work Groups as currently structured continue to meet to help prepare for future meetings and provide input on agendas for the meetings. He thanked TRAC members for their sensitivity about the small size of each Work Group, and invited them to continue to provide input on how Work Groups are used in the process. Dr. Ehrmann then reviewed the ground rules for the meeting, and asked TRAC members for their understanding on the short timeframe available to circulate meeting materials prior to meetings. Following his review of the ground rules, he introduced Barbara Stinson, Meridian Institute, to provide the group with an overview of the meeting agenda and materials.

Ms. Stinson began by explaining that the Work Groups are serving at the will of the TRAC. She indicated that the Work Groups are structuring their discussions around the issues identified by the TRAC at the last meeting. Ms. Stinson referenced the membership list for each Work Group for information (presented in Docket # OPP00537), and noted that there were many observers at each Work Group meeting. She noted that EPA, in consultation with TRAC members and other members of the TRAC, developed working documents as 'straw proposals' for each group to stimulate discussion on the issues. Ms. Stinson explained that EPA used input from Work Group members to revise the 'straw proposals' for TRAC members to consider at this meeting. She then summarized the discussion of each Work Group as the basis of the following TRAC meeting agenda:

Discussion of Staff Paper on Description of the Risk Assessment Process (Staff Paper # 7)

Discussion of Framework Refining FQPA Science Policies (Staff Papers # 8.1, 8.2)

Discussion of Graphical Information on Preliminary Assessment of Organophosphate Pesticides (Staff Paper 9)

Designing an Approach for Refining Dietary Risk Assessments of Organophosphate Tolerance Reassessment (Staff Papers 10.1, 10.2)

Designing a Decision-Making Process for Organophosphate Tolerance Reassessment (Staff Paper 11).

Ms. Stinson asked TRAC members to comment on the staff papers and provide each Work Group with guidance on where to focus their attention to help move the process along. She noted that each Work Group planned to meet again for a full or half-day meeting. Ms. Stinson also indicated that the agenda allowed time for public comments and to plan Work Group assignments and next steps for the TRAC. She noted that Work Group # 2 planned to hold a full day meeting in Washington, D.C. on July 1, 1998. Ms. Stinson invited comments and questions on the Work Groups and the agenda for the meeting.
 
 

Following Ms. Stinson's agenda review, Dr. Ehrmann introduced Anne Lindsay, Director, Field & External Affairs Division, Office of Pesticides Program (OPP), for an overview of Staff Paper # 7 on the Description of the Risk Assessment Process (presented in Docket # OPP00537). Ms. Lindsay explained that, based upon concerns raised by TRAC members at the May meeting about making the risk assessment process understandable to the non-risk assessor, EPA drafted the paper on the risk assessment process in language tailored to a broader audience. She asked TRAC members to consider the summary of comments from Work Group # 1 members, and introduced Work Group members Carla West, sitting in for William Lovelady, Chairman, National Cotton Council, and Ken Cook, President, Environmental Working Group, for an overview of the Work Group discussion on the staff paper.

Ms. West commented that EPA's summary of Work Group comments on the staff paper was generally good. She felt that there was a lot of agreement on the issues identified, and there was general agreement on the need for the audience to know more about the assumptions used for the risk assessment process and on the need to clarify how EPA makes decisions. Ms. West stated that Staff Paper # 7 represented a good start to address these concerns. She suggested that the explanation for the q₁ (the upper 95^th percentile estimate of dose response) be expanded. Ms. West added that transparency of the process is of key concern to members of the National Cotton Council. She closed her comments by stating that, once the process is clear and the public knows how decisions are made, it will be easier to focus on more detailed issues.

Following Ms. West's comments, Mr. Cook added that the list of items tabulated on the final page of the document accurately reflected the key points of the discussion. He observed that, with the exception of their discussion on transparency, the Work Group discussed the science of risk assessment throughout the meeting. Mr. Cook noted that Work Group participants had different interpretations of the word 'transparency', and there was a need to agree on a common interpretation of the term. He suggested that the term be interpreted to encompass more than what was represented in the flow chart in the staff paper, including public involvement earlier on in the process.

After the presentations, TRAC members asked questions of clarification and commented on the material presented. Many TRAC members felt the paper represented a good beginning for a 'plain English' version of the risk assessment process. TRAC members made the following suggestions to improve the paper:

Clarify the difference between the public process and the public's Right-to-Know. The Registrant should have the chance to review data and data interpretation before the information becomes available to the public to avoid the distribution of information that may not be accurate.

Include information on what data is used, how it is used, and what assumptions are made in the risk assessment process. Particularly, distinguish between the assumptions made for children versus those made for adults. In addition, the paper should include information on what an uncertainty analysis is and how it is used.

Provide EPA with the tools to make reasonable decisions on risk that are based on facts and common sense to prevent taking products off the market prematurely or not taking products off the market that pose risks.

EPA should post a schedule of what information it needs by when in order to make timely decisions.

Develop another more general explanation of the risk assessment process that would be clearer for farmers to use. The document could reference more detailed information for risk assessors or other interested parties. In addition, the document should include a list of definitions and reference to the web site for additional information.

Transparency of the process should apply to everyone, not just the Registrant. Transparency should include not only the process but also the data and assumptions used in determining children's and adult exposures.

Provide an example of how the risk assessment was applied to a real product.

Clarify the data gaps and include information on how pesticides are used in the field.

Include the public throughout the risk assessment process.

Dr. Ehrmann closed the discussion on the risk assessment process with a summary of what he heard to be the main points of the discussion. He then introduced Stephen Johnson, Deputy Director, OPP/EPA, to present a summary of Staff Papers # 8.1 and 8.2 on the Framework for Refining FQPA Science Policies.
 

Framework for Refining FQPA Science Policies

Mr. Johnson provided the group with an overview of Papers # 8.1, Framework for Refining FQPA Science Policies and 8.2 Framework for Risk Assessment Policy Making (presented in Docket # OPP00537) and explained that the papers were developed to address concerns raised by TRAC members at the May meeting on the broad science policy issues of FQPA and how they fit together. He noted that the Work Group identified eight major science policy issues which are presented in Paper 8.1, including information on the current approach in risk assessment, timing, and suggestions for improving transparency. He also referenced the timeline for publication and comment on each issue presented in Paper 8.2. Mr. Johnson then asked Work Group members Jay Vroom, President, American Crop Protection Association (ACPA), and Daniel Botts, Director, Environmental and Pest Management, Florida Fruit and Vegetable Association, to present summaries of Work Group comments on the papers.

Mr. Vroom commented that he viewed these papers as works in progress that would benefit from comments and additions. As a starting point, he referred TRAC members to the summary of Work Group member's comments attached to Paper 8.1. Mr. Vroom recognized the need to address the quality of data and how it impacts the public and suggested adding reliable data as the ninth issue. He then invited Mr. Botts to share his comments on Work Group discussions.

Mr. Botts felt the matrix represented a good starting point and a work in progress. He suggested that it would be helpful to include additional background information on policy options and a summary of what other guidance groups like the International Life Sciences Institute (ILSI) have recommended in the past. Mr. Botts expressed concern that the TRAC maintain the overall focus on how the process will work.

Following the opening comments, TRAC members asked questions of clarification and commented on the Papers. Their suggestions on how to improve the document are summarized below:

Add a column to Paper 8.1 indicating what about the issue involves something new as the result of FQPA to help identify where there may be more questions.

Add a column to Paper 8.1 that indicates what is not new and clarifies the basis of EPA's decisions (e.g., how many decisions were based on theory/models).

Clarify the policy on comment periods. Mr. Johnson indicated that EPA hopes to have a consistent approach to comment periods for all of the issues. He explained that most issues have a 30-day comment period with the exception of those issues which are expected to be more controversial.

Clarify what happens with the papers after TRAC comments are provided. It was suggested that the product from this group would include a modified matrix that would contain a description of issues reflecting the diversity of opinions from the TRAC and an understanding of the timeline for decisions including comment periods.

Include more qualified scientists for the discussion on reliable data. Focus in this Group on defining the line between science and science policy.

The exposure assessment issue in Paper 8.1 should include discussion on using the 98 instead of the 99.9 percentile for Monte-Carol analyses.

Dietary assessment in Paper 8.1 should include information on the percent of crops treated, frequency of crop treatment, and risk reduction resulting from washing and cooking. In addition, clarify when actual data is used as a basis to determine usage. Use actual data more frequently.

Base product cancellation from the market on real versus theoretical data. Decisions based on theory are often more conservative than actual conditions and may overestimate the amount of the risk cup taken up by the pesticide.

Several members were concerned about EPA's use of 'less than reliable' or limited data. They were concerned about the potential for making bad decisions, such as the decision made on Pyrethroids. It was clarified that EPA makes decisions that are scientifically sound based on the weight of evidence.

. A similar concern was raised about the use of non-validated models. EPA explained that, where a model is not validated, EPA works with the Office of Research and Development to address the circumstance. They focus on scientifically sound information to make the decisions.

. Allow EPA to evaluate theoretical risk where data are lacking.

. The Monte-Carlo analysis is appropriately used to evaluate full risk across all ages.

. Address the broader issue of release of pesticides to the environment, including an evaluation of their relative persistence in the environment.

. Consider the trend of increasingly stringent detection limits and the impact on crop protection plans.

. Clarify EPA's approach when models to address exposures from the residence, ground-water and in the aggregate are not fully tested. It was clarified that the Agency balances its continued need to make decisions on registrations with the best available data and models. Registrations are not necessarily cancelled where modeling capabilities are lacking. The Agency is able to model residential exposure and has the scientific capability of modeling aggregate exposure.

. Include information on the quality of data used in the risk assessment and how exterior factors such as State ground-water management plans were considered in the risk assessment.

. For issue # 3 under the explanation for the current approach in Paper 8.1, clarify what is meant by "technical reasons" and "expanding circumstances" in relation to "no residues detected."

Dr. Ehrmann invited TRAC members to submit additional comments on Papers 8.1 and 8.2 by June 30, 1998 to Margie Fehrenbach, Designated Federal Officer, Executive Assistant to the Director, OPP/EPA, via facsimile at 703-308-4776, by telephone at 703-308-4775, or by e-mail at Fehrenbach.margie@epamail.epa.gov. He noted that Work Group # 1 will meet again on June 30, 1998. Dr. Ehrmann then introduced Lois Rossi Director, Special Review and Registration Division, OPP/EPA, for an overview of EPA's Preliminary Assessment of Organophosphate Pesticides.

Preliminary Assessment of Organophosphate Pesticides

Lois Rossi began by referring TRAC members to Staff Paper # 9, Graphical Information on Preliminary Assessment of Organophosphate Pesticides (presented in Docket # OPP00537). She explained that the graphs were intended to provide TRAC members with an idea of EPA's progress on the risk assessment of 40 organophosphates with active registrations. Ms. Rossi stressed that the graphs represent in many cases 'a work in progress', and that some of the data are more refined than others. In particular, Ms. Rossi noted that the dietary information needs to be expanded and refined. She also stated that the graphs do not include ecological information, which is currently being developed. Ms. Rossi explained that there are a number of steps in the assessment process before it is complete and that the assessment is revised when additional information becomes available. She noted that it was critical to understand the assumptions in the assessment process to determine the next steps.

Ms. Rossi summarized the status of organophosphates. She noted that 35 of 40 organophosphates are subject to reregistration and 7 additional organophosphates are cancelled but could still have import tolerances. In addition, she explained that these organophosphates were for food, non-food, residential, and public health uses. Additional details about the status of these organophosphates is presented at the end of Staff Paper # 9.

After summarizing the status of organophosphates, Ms. Rossi described the four graphs. She noted that each pesticide was assigned a number from 1 to 40 and the number assigned to each pesticide differed on each graph. In addition, Ms. Rossi commented that, where data is lacking, the assessment is still in progress. Following her description, TRAC members asked questions of clarification.

Graph # 1 Preliminary Assessment: Acute vs. Chronic - No Observed Effects Level (NOEL)

One member asked if there were variances reflecting the time the registration was sought? Ms. Rossi responded that there may be, particularly where information submitted for reregistration reflected differences in the animal studies.

Another member wanted to know how much of the data reflected cases where young animals were exposed. Ms. Rossi explained that some of the data reflected the young, but, based on the way the data were presented, she could not provide information regarding specific cases.

An individual requested clarification on the type of chronic effect studied. Ms. Rossi stated that they looked at neurotoxicity. She added that EPA evaluated the weight of evidence based on the entire database including cholinesterase for both acute and chronic studies.

One member asked if the data included the lowest observed effect level (LOEL) in addition to the NOEL. Ms. Rossi responded affirmatively and clarified that some of the data have an additional uncertainty factor.

Several members were concerned about EPA's decision to represent the data by number without identifying the individual organophosphates. One member suggested that the information could be obtained through the Freedom of Information Act. Mr. Johnson explained that there was not consensus on how the data should be presented. He noted that some of the data were preliminary and indicated potential problems with individual pesticides. In addition, Mr. Johnson indicated that there would be additional time for discussion on this concern later in the meeting, and suggested deferring additional comments until then.

Graph # 2 Preliminary Acute Dietary Risk Assessment: DRES versus Monte-Carlo

To begin the discussion on Graph # 2, Ms. Rossi explained that the acute dietary risk estimated represent first-level assessments using tolerance level residues and assuming treatment of 100 percent of the crop. She observed that the data reflected high-end estimates. In addition, where the first tier assessment showed unacceptable risk, she explained that the Monte-Carlo method was used. She also noted that the percent of the reference dose reflected the most highly exposed subgroup.

Several members wanted to know what safety factors were applied in the graph. Ms. Rossi commented that the application of safety factors varied. One participant was specifically concerned about whether the 10-fold safety factor for infants and children was applied. Ms. Rossi responded that EPA has information on the 10-fold safety factor, but not in this graph. She stated that EPA would provide this information.

Another member requested clarification on the data used in the Monte-Carlo analysis. They suggested that the analysis should reflect exposure to refined age groups of children (e.g., ages 1 - 2 years). Dr. Lynn Goldman, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances (OPPTS)/EPA, explained that EPA does not have that level of data yet. The individual suggested that EPA could obtain the refined data based on the ages of the individuals in the database. Dr. Goldman noted that USDA is proposing to perform a survey to obtain this type of data.

One member requested clarification on the assumptions made for different levels of consumption for commodities, like juices made from raw foods, which are consumed in greater volumes by children. David Miller, EPA, explained that, for blended commodities, EPA uses average residues. He noted that, if there is processing information on the transfer of residues, they use it; otherwise default values are used. He added that exposures across food sources for the day are assumed for acute effects.

A member asked for an explanation of results for organophosphate # 18. Ms. Rossi explained that the bar graph indicates 40 times the reference dose for one highly exposed subgroup (e.g., children from 1 - 6 years, 1 - 12 years, non-nursing infants, or women of childbearing age) based on the DRES run, and 17 times the reference dose using the Monte-Carlo run.

Another individual requested clarification on whether the same model was used to perform the Monte-Carlo analysis and whether the model was proprietary. Mr. Miller explained that the same model was used in all cases and that the model is available on the open market. He clarified that only the data sets changed.

Graph # 3 Preliminary Assessment: Chronic Dietary Assessment Refinements to Date

Ms. Rossi began the discussion on Graph # 3 by explaining that, similar to Graph # 2, EPA assumed residues at the tolerance level and 100 percent of the crop was treated. In addition, she noted that the assessment was stopped if the reference dose was low or not exceeded (e.g., organophosphate # 4 where only 10 percent of the reference dose is used) otherwise the data was refined using anticipated residues (AR). She explained that AR data are derived from data that measure residue values closer to the point of consumption. Use of AR and percent of the crop treated (%CT) rather than using the tolerance values make the chronic risk assessments more realistic. She observed that only theoretical maximum residue contributions (TMRC) are available for many of the pesticides because the refinement studies are incomplete.

One member observed that there was no consistent correlation between the TMRC and AR/%CT values. He asked for clarification on the relationship between these values. Ms. Rossi explained that the relationship between the values varies based on the type of use, consumption patterns, and the actual percent of the crop treated.

Another member requested clarification on the conversion from information on the percent of the crop treated to a reduced percent of the population exposed (e.g., is the lesser value based on field data or a modeling assumption). Mr. Miller explained that EPA uses data from USDA and other organizations. In addition, the data is confirmed by the EPA Biological and Economic Analysis Division (BEAD). As an example, if one assumes 100 percent of the crop treated and 100 percent of the population is exposed using TMRC, and 15 percent of the crop is treated and 15 percent of the population is exposed using AR/%CT, is it assumed that the remaining 85 percent of the population is not exposed? Mr. Miller responded that EPA assumes a uniform distribution of the population is exposed.

A third individual requested an explanation on how the value for the percent of the crop treated was validated. Ms. Rossi commented that BEAD provides them with profiles of the use of chemicals from proprietary sources. In addition, EPA checks with Extension Services, USDA, and other data sources to validate the proprietary information. Mr. Miller explained that the data is averaged over time.

Graph # 4 Preliminary Assessment: Most Refined Dietary Estimates to Date

As a starting point for the discussion, Ms. Rossi explained that Graph # 4 pulls together information from the other graphs to provide the most refined dietary estimates to date and compare acute versus chronic values. To clarify, where available, Monte-Carlo analyses are presented for the acute values, and AR/%CT values are presented for chronic values. She observed that DRES values are used for most acute values, and TMRC values are used for chronic values.

One individual asked EPA to comment on why this or the other graphs generate concern about organophosphates. For example, for organophosphate # 4, the acute assessment is less than 100 percent of the reference dose and the chronic assessment is 750 percent (7.5 times) the reference dose. She noted that, as one evaluates the assessments, exceedances of the reference dose are observed. In addition, it is apparent that refinements in data make a difference in the assessment.

Another member asked for clarification on the goal of the assessments. She wanted to know if the goal was for each chemical to register less than 100 percent of the reference dose and to attain less than 100 percent in aggregate. Ms. Rossi responded affirmatively. In addition, she wanted to know whether the 10-fold children's safety factor was applied in some or all of the chemicals. Ms. Rossi explained that, if it was EPA's decision to apply the safety factor, then it was incorporated in the assessment.

Following the questions of clarification, Dr. Ehrmann invited members of the public to comment on the day's discussion.
 

Public Comment

Allen Scriber - a representative of the asparagus industry in the Northwest, was concerned about the impact of canceling the use of organophosphates in the asparagus industry for the control of aphids. He indicated that the amount of use in the industry is small but critical to the effective control of aphids. If the organophosphate used in the industry is canceled, it will result in a major decline in U.S. production of asparagus, job loss, and an increase in foreign production of asparagus which is not subject to the same pesticide use restrictions.

Chuck Benbrook, Benbrook Consulting Services - commented that there was more progress in refining databases than was reflected in the TRAC discussions. He noted that there was a considerable degree of agreement on critical issues like the margin of risk. He observed that we have known about foods with excessive risk and high-risk chemicals for years. In addition, Mr. Benbrook was supportive of transparency and increasing public input and commented that it was necessary to win and earn the trust of the public. He felt that chemical by chemical assessments were not the way to go.

Warren Stickle, Consultant, Legislative and Regulatory Affairs - was concerned about the impact of canceling the use of selected organophosphates on vector control, particularly mosquito control. He noted that there are 5 organophosphates that are key to mosquito control, and cancellation of these organophosphates could cause a unique public health problem that will affect our quality of life. He requested that the 5 organophosphates be exempt from the tolerance reassessment.

Mark Keating, Henry A. Wallace Institute for Alternative Agriculture - commented that FQPA cannot resolve all controversy and uncertainties. He was concerned that an unintended consequence of FQPA would be an increase in alternative controls including synthetic pesticides, some of which have unintended impacts on human health. He supported the reduced application of hazardous chemicals and stressed that it is time to move agriculture to safer and ecologically balanced uses.

Paul Guillebeau, Pest Coordinator for UGA - observed that the elimination of organophosphates and carbamates will have a major impact on the peanut industry and on human health. He commented that the peanut industry is substantial and is a major source of revenue and jobs in the U.S. He explained that organophosphates are not applied to the edible part of the peanut, and the loss of organophosphates will increase the chance of aphlotoxic contamination.

Stan Abramson - King & Spalding - commented on the risk assessment process and the link between FQPA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). He noted that pesticide residue poses a safety hazard and unreasonable risk under FIFRA. He observed that, before a public risk analysis is performed, it is necessary to perform a valid test raising prudent risk concerns. For this purpose, it is necessary to provide the Registrant a reasonable opportunity to address the concern about risk before involving the public to prevent premature indictment of pesticide products. In addition, Mr. Abramson supported the use of sound science when evaluating human exposure.

Steven Jellinek, Jellinek, Schwartz & Connoly, Inc. - commented on acute dietary exposure in the Risk Assessment Process. He explained that, while there was a perception that there was a lot of interaction between the Agency and the Registrant, there actually was limited interaction. He also observed that the process of registration and reregistration before FQPA was predictable, whereas EPA's current decision-making process is not. He supported EPA's commitment to the public process and looked forward to learning more about how decisions are made. In addition, he observed the need for improving the database necessary to evaluate the risk posed by drinking water.

J. R. Tomerlin, Novigen Sciences - observed that there were inadequacies in the Tier I model for evaluating dietary exposure. He explained that the Tier I analysis relies on unrealistic assumptions and would be more aptly used as a screening tool. He stated that only the Tier III model should be used for definitive purposes.

Dr. Ehrmann welcomed TRAC members and observers to the second day of the meeting. He reviewed the agenda for the day, and invited the Co-Chairs to provide opening comments for the meeting.

Mr. Rominger also welcomed members and observers to the meeting. He then turned to his Co-Chair, Mr. Hansen who reminded TRAC members that the focus of their discussion is on policy versus the science underlying the policy. He invited members to seek opportunities to have more detailed and technical discussions off-line.

Following the opening remarks, Dr. Ehrmann opened the discussion on the preliminary assessment of organophosphates. He suggested that the discussion begin with some comments from several of the Work Group # 1 members.

Preliminary Assessment of Organophosphate Pesticides (continued)

Routt Reigart, Pediatrician, Children's Hospital, Division of Emergency Medicine, Harvard Medical School, shared some of his impressions from the previous day's presentations on the Preliminary Assessment of Organophosphate Pesticides. He commented that the Work Group spent time discussing the technical details about how the graphs were generated in order to assess them. Dr. Reigart added that the group discussed some of the assumptions and the analyses in order to understand the driving forces that form the graphs. He noted that Work Group members had mixed opinions about whether or not to 'blind' or number the chemicals. Dr. Reigart also commented on the issue raised during the previous day's discussion on whether the Agency should lower the reference dose for each chemical individually or address the reference dose of organophosphates as a group. In closing, Dr. Reigart stated that the Work Group saw an opportunity for the TRAC and the Work Group to help EPA develop a strategic plan to have a major impact on FQPA implementation.

Next, Nancy Rachman, Director, Global Regulatory Affairs, American Cyanamid, commented on the Work Group presentations. She began by observing the need to clarify the distinction between what was meant by the most sensitive and most highly exposed populations. Ms. Rachman also suggested that EPA could help increase the understanding of the huge body of information portrayed in the graphs by providing a 'sensitivity uncertainty analysis' on each assessment. This analysis would include more information about the assumptions used and the dominant factors influencing the reference dose exceedance on the graph (e.g., is it the assumptions made on: the default values used for meat, milk and eggs; the treatment of non-detections; or the application of the 10-fold factor?) Ms. Rachman observed that the Tier I risk assessment generates the worst case scenario. She suggested that, with more information about the assumptions and the analyses, EPA can obtain a better understanding of real risk before making regulatory decisions.
 
Lora Lee Schroeder, Chair, AAPCO FQPA Minor Use Committee and Director, Pesticide Division, Georgia Department of Agriculture, added her comments on the Work Group discussions. She recalled that the Work Group evaluated ways to clarify and simplify the graphs. Some of their suggestions included: defining the target audience for the graphs; providing attachments to the graphs explaining the assumptions; correlating the numbered organophosphates with particular crop uses to help the reader evaluate which uses are most vulnerable; and clarifying the Monte-Carlo method and its application.

Following the Work Group member's opening comments, other Work Group and TRAC members shared their ideas about the assessment of organophosphates. A summary of their comments is presented below.

Many TRAC members agreed that additional information about the assumptions driving the risk for each chemical was necessary to fully evaluate the graphs. Several individuals agreed that the assumptions used in the Monte-Carlo analysis, in addition to details on the model, should be provided to the public. One individual was particularly concerned about the data used for dietary exposure. He observed that the Pesticide Data Program (PDP) data were comprehensive and recent and wanted to know if these data were used in the Monte-Carlo analyses. Mr. Miller explained that PDP data were used for blended or mixed situations but not for single serving data due to concern about diluting chemical concentrations. Keith Pitts, Special Assistant to the Deputy Secretary, USDA, added that USDA was working with EPA to gather additional data on children's exposure to food for acute and single servings.
 
Other members felt that interpreting the information on the graphs was of limited value without additional information on chemical use and the names of individual chemicals. One member suggested that providing the chemical name along with a case study would represent a good starting point because knowledgeable individuals could then evaluate the existing information and more readily provide missing information to ensure the overall chemical evaluation was based on the best available data. As an alternative, a member suggested that EPA select an organophosphate for which they have already taken action or use a composite of chemicals to provide real information on chemicals. Another individual felt that all parties should have access to the same assumptions and information on which decisions are based in order to make their own informed decisions.
 
One member felt that it was not necessary to provide the name of the chemical as long as information about non- detection, market basket surveys, and other details are provided to evaluate whether the numbers are representative and whether the analysis will reflect 'real world' conditions. Another member agreed and stated that, if there is confidence in the information used to generate the graphs, there might be less reluctance to provide the names of individual chemicals. Several other members felt it is not appropriate to provide detailed information about individual chemicals until the information is determined to be accurate. One member was concerned about the potential consequences of publicizing misleading data, including causing unnecessary concern to the public. As an example, he referenced the possible consequences of publicizing data prematurely on termiticides that are used in many homes in the U.S. He suggested that the TRAC could help to ensure there is a process to provide adequate information to make an evaluation. The process could include how EPA addresses erroneous data and data refinements. One member suggested that the group acknowledge the hesitancy of the industry to provide information prematurely and consider how they might obtain and use 'real world' information that will not compromise industry's concerns, but will move the TRAC towards developing agreement on a process.
 
From this discussion, Mr. Rominger noted that all parties were trying to identify a process on how to effectively evaluate the data. He observed that there was a question regarding how much information was necessary to develop a process to apply to all chemicals.
 
One member noted that, while there appeared to be differences in opinion about whether to provide specific information about the chemical name, it was really a matter of differences of opinion on when the information should be made public. He suggested that, in lieu of information on the chemical, it would be helpful to indicate on the graphs the chemical uses and a description of where EPA is in the process of risk assessment.

Another individual observed that there was general agreement that the preliminary risk numbers are not accurate enough to use for regulation. Based on that assumption, she suggested that the TRAC focus on developing criteria to determine when there is enough confidence in the risk numbers to disclose to the public and share where the uncertainties are, what the Agency needs, and what the possible outcomes may be. In addition, she suggested that the TRAC develop a set of criteria that would enable them to rank individual chemicals by risk. Mr. Hansen suggested the Work Group # 1 could help to identify the timing and opportunities for more disclosure.
 
Several TRAC members commented on the policy question regarding "no residues detected" (non-detections). They suggested that, in addition to clarifying how non-detections are established, EPA provide additional information on what they plan to do with non-detections in the risk assessment process. One individual wanted to know what percentage of the tolerances is based on non-detections. Mr. Johnson explained that roughly 25 percent of the 9,700 tolerances were based on non-detections.

Some members felt that EPA should clarify its assumptions on what drives the risk process. Mr. Miller commented that meat, eggs and milk are sometimes the drivers. Mr. Pitts added that EPA and USDA are currently working on obtaining better data and that they are considering a combination of factors including drinking water.
 
One individual observed that there will always be a question on whether there is enough data for risk characterization. And, whether or not there is sufficient data, EPA needs to continue to manage risk. For this reason, he suggested that EPA be clear on the data and assumptions it is using. In addition, he suggested that EPA be strategic about risk management by identifing key risks and managing to acceptable levels.

Mr. Hansen summarized what he heard from the discussion. He stated that he heard some similar concerns about transparency and that the timing of when information became available was part of the discussion on transparency. He observed that the group saw a role for Work Group # 1 to explore the whole process and identify when information should be provided, including how accurate the information should be prior to releasing it. Mr. Hansen noted that EPA needs to provide more information on the distinction between science and policy and how the Agency makes decisions (e.g., based on non-detections, etc.) In addition, with the help of Work Group # 1, there needs to be more clarity on what the policy elements are.
 
 
 

Before the discussion on Refining Dietary Risk Assessments for Organophosphate Tolerance Reassessment began, Jay Vroom, ACPA, stated that ACPA was offering to work with EPA and Ken Cook, President, Environmental Working Group (EWG), to prepare a presentation of a full risk assessment walk-through on one or more organophosphates. Mr. Cook indicated that he would have to confer with his colleagues before committing to taking part in the offer. Mr. Hansen thanked both individuals and suggested that, before making a decision whether to accept the offer, the TRAC complete its discussions for the day and determine whether the presentation would further the goals of the group. Several participants were concerned about the origin of the presentation because they were interested in learning how EPA addresses the risk assessment process. They preferred that such a presentation come from EPA. The group agreed to defer further discussion on the offer until later in the meeting.

Following these comments, Lois Rossi provided the group with an overview of Staff Papers 10.1, Framework for Tolerance Reassessment and Transitions, and 10.2, Refining Chemical Risk Assessments (in Docket # OPP00537).

She explained that Staff Paper 10.1 represented the current framework for tolerance reassessment and transition. Ms. Rossi noted that, while the focus was on dietary exposure, work on worker and other exposures were performed concurrently. She noted that Work Group # 1 is addressing the first 3 boxes in the diagram, and Work Group # 2 will evaluate the remaining boxes in the diagram. Ms. Rossi then described the 3 options on refining chemical risk assessments and asked for additional comments from two of the Work Group members.
 
Pat Donnelly, Dow AgroSciences, commented that EPA did a good job summarizing the discussion on Staff Paper 10.2 looking at the arguments for and against the various options. He observed that the discussion today on the timing of disclosure of risk assessments is very similar to the discussions held at the Work Group meeting last week. He felt it was important for the TRAC to understand that the Rule for notification of the Registrant was meant to notify the Registrant of the Agency's concerns and allow the Registrant the opportunity to clarify the information. He explained that FQPA does not change this aspect of the notification process but instead, makes a linkage between the tolerance reassessment process to the regregistration process. In addition, he expressed concern about how EPA can meet its statutory obligation of public disclosure of risk assessments when there is a question about whether the assessment models are validated. Mr. Donnelly commented that the transparency issue was the driver for many of the debates in the Work Group discussion. He outlined an approach to transparency for the group to consider: as long as EPA captures the interaction and revisions of a risk assessment performed during the private consultation with the Registrant then the process is transparent.
 
Dr. Reigart then shared his impressions of the Work Group discussion on this issue. He began by explaining the context of the 3 options. Both of the first two options moved public involvement further 'up stream' from where it is in the current process in option # 3. He noted that the distinction between options # 1 and 2 was eliminating the first private interaction between the Registrant and the Agency. In addition, he observed that in option # 2 there was a variation allowing semi-private discussion between the Registrant and other stakeholders. Dr. Reigart raised as a concern the question of trust. He commented that trust is bi-directional and cannot exist if one or the other side does not trust the other. Dr. Reigart suggested that, in regard to when the public becomes involved, if Registrants do not trust the communities exterior to their own and EPA accepts this distrust, it is hard for those in the exterior communities to trust the Registrant or EPA. He observed that the communities need to move toward trusting each other. He then invited others to comment.

Many members of the TRAC recognized trust as a major issue for the TRAC to address. Some members felt that limited access to preliminary work was a deterrent to developing trust. An alternative response to concern about risk would be to provide more information to help reduce potential anxiety about risk. One individual suggested that clarity on the groundrules for making science policy decisions would not only engender trust but address the need for transparency. Another individual commented that a first step towards building trust and refining the process would be to open up the discussion on assumptions underlying the process.

Several TRAC members noted that public confidence in the risk assessment process and the results of the process were critical to motivate the public to accept tolerance reassessments and the implementation of FQPA. One member noted that, to have confidence, the public needs to believe good science was used and the process was transparent. He felt that public confidence would be fostered by providing preliminary information early in the process with an explanation about the status of the information. Another member added that transparency on the regulatory decision-making process would help to instill confidence in the process.

Other members commented on the issue of transparency and the timing of disclosure to the public. One individual reiterated their concern about premature disclosure of information to the public because of the potential for distortion and overreaction from the public. He felt it was important to take the time to ensure the information was accurate before disclosing it to the public. In addition, he supported using a rational approach to prioritizing the products that cause the greatest concern and disclosing information about them in a rational timeframe to minimize the potential for overreaction to preliminary risk assessments. He was also supportive of maintaining the process in option # 3 of interaction between EPA and the Registrant prior to public disclosure. He felt, if EPA improves the amount of time they take for their review, public disclosure will be more timely. Another individual commented that the concern about public response to potential risks was exaggerated and could be alleviated by using plain language in the reporting process. She added that the consumer is more likely to use preliminary notification to make informed decisions.
 
As an alternative or refined option, one individual suggested incorporating a 30-day comment period after completion of the draft preliminary risk assessment during which Registrants could provide comments on errors that may have been made by EPA. She explained that EPA would then have a specified time period to revise the risk assessments or otherwise respond to the comments. Both the Registrant comments and EPA's response would be published along with the risk assessment for public comment.
 
One individual observed what he felt was a difference in interpretation of the term transparent. As an example, they noted the on-going discussions between Registrants about a potential process to evaluate cumulative risks. He felt that the discussions should be open. Others commented that it was a technical working group focusing on toxicity factors across chemicals in preparation to assist the Agency and the public for the open debate on the policy on common mechanism of toxicity.
 
To help the group evaluate the options on refining chemical risk assessments, one individual suggested that EPA provide information on the resources required for each option. He felt that a resource evaluation would help to identify areas in each process that were not sufficient and could be improved. Of particular concern was the consultative process in the current option # 3, which they felt was too extensive and could be better focused. He was supportive of option # 2. Another individual agreed that the impact of changing the 'bright line' of when to involve the public needs to be evaluated. The cost of earlier versus later involvement should be weighed. In addition, he was interested in the impact of the 'bright line' movement question on the public release of preliminary data as contrasted with the 1978 Grassley-Allen amendments passed by Congress and the NRDC FACA law suit settled in 1985. Mr. Hansen indicated that EPA would respond to this legal question in writing later.
 
As part of the process, several individuals were concerned about mitigation after the risk is determined and where mitigation fits into the options. One individual felt it was essential to focus on mitigation in the field and prioritizing the risks that need to be mitigated. Another member was particularly concerned about how the mitigation process discussed in this group will be integrated with how other States like California are mitigating risks identified in risk assessments and whether the measures are fair and implementable in the field. She explained that how California decides to mitigate one of the pesticides in the group of 40 organophosphates may have an impact in the risk evaluations of the full group of 40. She wanted to know if there will be a separate document on mitigation available for comment. Ms. Rossi explained that mitigation was not shown in options # 1 and 2 because it takes place beyond the steps represented on the chart. In option # 3, mitigation takes place between the publication of the Reregistration Eligibility Decision (RED) and the final RED. Mr. Hansen suggested that this issue be addressed in more detail in the Work Group setting. Another individual stressed that others, including State regulating agencies, should be involved in evaluating the mitigation measures. Mr. Rominger agreed that all parties need to be involved when evaluating and implementing mitigation measures.
 
One individual recognized that TRAC members interpret the term 'preliminary assessment' differently. She observed that much of the information on organophosphates has been available for years; consequently she was confused about the concern about releasing the information. She suggested that the group try to agree on the definition, commit to getting information out early in the process and get on with the process. Another individual agreed and suggested, if after 10 years, the community is still considering the data they have as preliminary, it may be time to consider the system that motivates the submission of refined data.
 
A member was concerned about the potential for the tolerance reassessments for all of the 40 organophosphates being processed at the same time. He observed that it might not be reasonable to assume EPA can process that volume of material at once. He also suggested that an additional earlier step be included with the option selected which would summarize the preliminary discussions of this group to prepare the public for the formal release of the risk assessment.
 
Several individuals were supportive of option # 1. One member added that it was important to involve USDA early on in the process because they have critical information on use and usage, percent crop treated, alternatives, and unintended consequences. Another member felt that option # 1 addressed their concern about consumer response to premature release of information.

A TRAC member commented that, in order to proceed with tolerance reassessment in a timely fashion, it was necessary to decouple the tolerance reassessment process from the RED process.
 

Decision-Making Process for Organophosphate Tolerance Reassessment

 Keith Pitts summarized the following topics discussed by Work Group # 2 at their first meeting:

 Overlap with Work Group # 1's coverage of the risk assessment process and how to tie the work of the two groups together.

Chemical by chemical or cumulative approach in dealing with the regulatory process. While there was no resolution on this issue, Mr. Pitts understood that it would be easier to use a chemical by chemical approach for mitigation management. The concern with this approach was that there was a potential for losing secondary products that you may have used as a result of the cumulative assessment process.

Integrating the ability to reevaluate the cumulative analysis and reconsider selected chemicals for critical use.

Mitigation process and providing for adequate public input, data, and acceptable format and point of entry for the data.

Setting up criteria to make decisions on how to proceed on critical uses (e.g., targeting highest risk, process to define and preserve important uses, etc.)

Process to maintain a high priority use.
 
He referred to Staff Paper # 11, Designing a Decision-Making Process for Organophosphate Tolerance Reassessment, for additional detail on the Work Group discussion (refer to Docket # OPP00537). Mr. Aidala added that the Work Group felt it would be helpful to have examples to make the discussions more concrete. He noted that EPA would provide the group with some examples in addition to providing more background on the criteria listed. He then turned to Work Group members to share their impressions of the meeting.
 
Carolyn Brickey, Executive Director, National Campaign for Pesticide Policy Reform, added that the group grappled with the distinction between risk assessment and management. She noted that risk mitigation and management are performed in a short time frame and are dependent on information: type; how reliable; and source. Ms. Brickey commented that the kind of data that will be necessary will include a combination of chemical, crop, and pest. She felt that the role of USDA would be critical in the process because their resources would be needed for the transition to be successful. Ms. Brickey also commented on the list of criteria. She noted that the group added criterion for societal concerns and the impact of foods consumed by children. In addition, Ms. Brickey felt this process could be used strategically by EPA to address the risks of selected organophosphates and involve growers in a process to develop a good cumulative risk assessment.
 
Elin Miller, Director, Government Affairs, Dow AgroSciences, commented that others had well summarized most of the discussions at the Work Group meeting. She noted 3 additions to the list of decision-making criteria: Registrant support of the chemical use; opportunities for risk reduction and mitigation; and prescription use. Ms. Miller also noted that the group recognized the need to provide a mechanism to address the potential impact of other external decisions such as decisions regarding worker safety.
 
Following her comments, Dr. Ehrmann invited others to comment on the Work Group presentation. A summary of their comments is presented below.

One member noted that the process of reevaluating pesticides registered in the State of California might have an impact on the efforts of this Group. She explained that many of the active ingredients that will undergo risk assessments are included in the chemicals addressed by the TRAC. In addition, as they move through the mitigation process in California, they may make changes required in California that will impact on a Registrants decision to retain the use. She wanted to know how mitigation driven by regulatory decisions in other States on issues like worker exposure, fit into the Risk Evaluation Process and the overarching risk cup. In response to this question, Jim Aidala, Associate Assistant Administrator, OPPT/EPA, commented that EPA is making efforts to coordinate such circumstances. Another member desired clarification on whether EPA took advantage of supporting data on mitigation from PDP and other sources. Mr. Aidala responded affirmatively. Mr. Pitts added that USDA would provide EPA with refined data as it becomes available on a continuous basis. A third individual added that there will be a number of issues that State Pesticide Control Offices will be involved with in the risk mitigation process including: label changes and restrictions on labels; resources; State laws and regulation; and data. She encouraged EPA to obtain as much information as possible from the State of California and coordinate with other State agencies to take advantage of their resources and coordinate the mitigation and implementation process.
 
Another member commented on how data-intensive this process is. He stressed the importance of collecting the data from all sources before the mitigation process to develop a good baseline for decision-making. As an additional motivation, he observed that much of the same data are useful for the preliminary risk assessments. He also noted that the data should be similarly formatted to enable fleshing-out the potential tradeoffs (e.g., the decision-making criteria that will and will not be able to be met).

One individual felt that some elements of risk management are beyond the scope of what FQPA enables EPA to do. As an example, he commented that suggesting the Agency has a responsibility to determine benefits in the context of exceeding risk is beyond the scope of FQPA. He also stated that it should be made clear the Agency will evaluate non-chemical alternatives when addressing disruption to the food supply.

TRAC members suggested other additions to the decision-making criteria. One individual proposed adding unintended consequences to the list. Another individual commented that, in the context of unintended consequences, resistance management, the impact of alternatives (e.g., biological controls, synthetic substitutes, etc.), and instances where there are no alternatives should also be considered. Others felt the list should include a mechanism to address circumstances where the data are inadequate to make a decision (e.g., poor quality, etc.) Specifically, they asked if EPA should make decisions within the established timeframe or delay the decision until the data are adequate? Several members did not want the decision-making process to be compromised as a result of short timeframes.
 
Another member observed that the Work Group did not identify criteria to rescue pesticide uses. He also noted that, while FIFRA does not require that the growers be involved in the reregistration process, it is important for EPA and the Registrant to continue to involve growers in the decision-making process because of the growers knowledgeable perspective on potential trade-offs if uses are canceled.
 
An individual added that, since reregistrations began to be required, very few chemicals have REDs associated with them. He commented that the public is concerned about the potential hazards of chemical use and it was essential for the process of tolerance reassessment to move more quickly. He suggested streamlining the process and avoiding the addition of more opportunities for consultation that would expand the process.

A member suggested that it would be helpful for Work Group # 1 to obtain information on how the Food and Drug Administration (FDA) handles relevant timing and transparency issues with regard to public disclosure of data about registered food additives. Bob Lake, FDA, commented that he was happy to assist the Work Group, but noted that the FDA procedure for food additives differs because there is no equivalent to a reregistration process. The TRAC member also suggested that EPA provide the Work Group with the operating policy on preliminary risk assessments and whether there is a 'bright line' on the timing of public involvement. Mr. Hansen agreed to provide the information. In addition, the member suggested that EPA openly coordinate with the Outdoor and Indoor Exposure Task Forces to exchange information. He suggested that EPA publish the schedule of their work plan.
 
Several TRAC members commented on the role of alternatives in the TRAC process. One member was specifically interested in how EPA viewed the use of Integrated Pest Management (IPM). There are IPM users who see no alternatives to the reduced amount of organophosphates they currently apply for pest control. Mr. Pitts explained that USDA has an active IPM program, representatives of which will be attending the Work Group # 2 meetings. Another member commented that it is possible to successfully adapt to using lower risk pesticide alternatives, but it takes time and resources. He felt the TRAC could identify the higher risk pesticides and assign a Work Group to develop mitigation strategies. A third member stressed that the number of alternatives is limited and that alternatives are often more costly than the pesticide they are replacing. He stated that growers need more time (e.g., 1 or 2 years) to shift to the use of alternatives successfully. One member commended EPA for its funding of IPM research and suggested that there be more recognition for the research. Others commented that one reason alternatives like IPM are not applied as much as they could be is because of a lack of education and available information.
 
Other TRAC members agreed that limited funding was an issue, particularly for developing pesticide alternatives. Mr. Rominger recognized this concern and noted that USDA is evaluating how to best use its limited funds and is seeking opportunities for additional funding. Another member observed that there is a need for more advocacy to generate funds. She suggested that there be a reevaluation of priorities when approaching Congress for support.
 

Work Group Assignments and Next Steps

 Work Group Assignments

Ms. Stinson provided the group with an overview of potential work products and activities as presented below.
 

Discuss and Refine Framework for Addressing the Broad Science Policies

Identify what of this framework is new.

Discuss "sensitivity analysis" around each issue; what are the drivers that are typically used?

As part of the framework, develop descriptions of elements of decision-making while framework is being completed.

Detail current assumptions.

Present 2 - 3 Examples of Organophosphates Preliminary Assessment Results With a Variety of Drivers

Work Group input first.

Appropriate scientific level of detail that people understand.

Identify specific policy issues/choices, particularly generic/broad scientific policy issues.

Further Discussion/Update of "Refining Chemical-Specific Risk Assessment"

Other options in addition to 3 options such as a hybrid (e.g., distinguish between errors of refinement and data issues).

Information to be provided: FOIA, 1978 Grassley-Allen, 1985 NRDC FACA Lawsuit.

Update Staff Paper on Risk Assessment Process Based on Comments Received

Preliminary Organophosphate Assessment

Identify drivers in risk assessment/exceeders.

Can we disclose stage of refinement for each organophosphate on the chart without giving away chemical names?
 

Identify Means to Make Mitigation Negotiations Transparent
 
How Do We Allow for Growers and Other Stakeholders to Be Involved in Mitigation Decisions?
 
TRAC members asked some clarifying questions and made the following suggestions about the Work Group assignments and activities:
 
Add to Section III, Subsection C. Food and Drug Administration, and D. Policy on Defining Bright Lines.

The issues outlined are good but clarify what work products are expected of the Work Groups and what would be useful to USDA and EPA. It was suggested that there might be an outline of the process and a timeline for science policy issues for discussion in the 4^th TRAC meeting. Additional work products might include a refinement of the chemical-specific risk assessment options presented at this meeting and a description of the risk assessment process and mitigation.

The TRAC should focus on 'real world' concerns.

The TRAC cannot accomplish addressing V. B. (above) - Preliminary Organophosphate Assessment without knowing chemical names. Without this information, the capacity of the TRAC to inform EPA and USDA will be limited.

Add Work Group # 2 involvement in the discussion of mitigation decisions. One aspect of the discussion might include how to better involve stakeholders in the process.
 
Other Next Steps

Work Group # 1 will hold its next meeting at the Crystal Mall # 2 in the Fish Bowl on June 30, 1998 in Washington, D.C.

Work Group # 2 will hold its next meeting at the same location on July 1, 1998.

TRAC members will submit any additional comments they have on the Staff Papers discussed at the meeting to Margie Fehrenbach by June 30, 1998 or early July, via facsimile at 703-308-4776, by telephone at 703-308-4775, or by e-mail at Fehrenbach.margie@epamail.epa.gov.

The next TRAC meeting will take place on July 13 - 14, 1998 in the Hotel Washington in Washington, D.C. The meeting will start at 1:00 p.m.

The 4^th TRAC meeting will take place on July 27 - 28, 1998 in the Omni Hotel.
 
 

Stan Abramson, King & Spalding - commented on the FQPA standard of "reasonable certainty of no harm." He stated that the standard defines safety under FQPA, and, among other things, it determines the appropriate margin of safety for infants and children. Mr. Abramson explained that the standard was not new and has been used as a standard by FDA since 1958. In addition, he noted that the standard is also not new to EPA because from 1970 to 1996 they applied it every time they approved a food additive regulation for a pesticide under Section 409 of the Food and Drug Act. Mr. Abramson acknowledged that the concepts of aggregate exposure and cumulative effects are new and it will take some time for the science and the data to catch up. He compared FDA's examination of a food additive that has been on the market to the reregistration process. He observed that the FDA process is data intensive and involves a great deal of scientific evaluation and judgement. Please see EPA Docket # OPP00537for a copy of Mr. Abramson's written comments.
 
Mark Keating, Henry A. Wallace Institute for Alternate Agriculture - expanded on his comments from the Monday TRAC meeting. He observed the need for government to support research to develop safe and cost-effective alternatives to organophosphates and synthetic pesticides. The resources could be used to support sustainable agriculture education and the study of IPM. As an example, he cited the USDA grant to field-test IPM which have the benefit of reducing the use of high-risk pesticides.

Connie Eash - commented on children exposed to organophosphates in school. She stated that her son's exposure to pesticides in the school cafeteria cause brain damage and permanently influenced his ability to process information. Since his exposure she has performed research and discovered information through EPA on Dursban poisoning. She supported increasing the availability of information on children's exposure to pesticides to prevent similar incidences from happening in the future. She suggested that data on children's exposure to pesticides in school be added to the database.

Elin Miller expressed sorrow for the situation, but stated that she did not believe there was a connection between the health effects described and the use of the product Dursban.

Warren Stickle, Consultant, Legislative and Regulatory Affairs - stressed the importance of organophosphates in mosquito control and the prevention of disease. He stated that mosquitoes have developed a resistance to the current alternative, Pyrethroids. He emphasized the importance of developing effective alternatives and stated that the small quantity of public health uses cannot afford to carry reassessment.

Marcia Van Gemerte, Van Gemerte & Howswirth - spoke about the 10-fold infant and children's safety factor. She observed that the NAS pesticide study on children did not indicate that children are always more susceptible than adults. She noted that some studies show the opposite. Dr. Van Gemerte clarified that the uncertainty factor is applied to address prenatal circumstances. She clarified that the NAS committee intended that the 10-fold safety factor be applied only when there was evidence indicating concern.

Chris Chaisson, TAS Environmental - commented on the use of the Monte-Carlo method of data interpretation in the risk assessment Process. She clarified that the Monte-Carlo method yields less risky results because it uses better residue data, more accurate information on food intake, and the use information is effectively applied with probability distributions. These improvements in the underlying data result in answers that better reflect actual conditions. She observed that the Monte-Carlo method is a tool and, if algorithms are correct, it allows the user to identify risk more accurately.
 

Mr. Rominger thanked TRAC members for their participation. He recognized the sacrifice participants made to take the time to take part in the TRAC process, particularly those who participated in the Work Groups. Mr. Rominger observed that Work Group members will be challenged to accomplish all of the work intended between now and the next TRAC meeting. He invited other interested TRAC members to take part in Work Group meetings via conference calls. Mr. Rominger welcomed TRAC members to continue to provide USDA with guidance on how it can improve its role in the process, and noted that USDA plans to continue to be actively involved in the future.

Mr. Hansen also thanked TRAC members for their hard work. He observed that there had been progress on addressing the issue of transparency, and asked the group to continue to provide input on transparency in the risk assessment process. Mr. Hansen recognized mitigation and the concern about the impact on organophosphates was one of the next major issues, as well as the potential influence of recent decisions on pesticides in California. He hoped that, through the efforts of the TRAC, there will be a richer sense of how those issues can be addressed in a productive and timely manner.

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