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Meeting Summary
International Trade Center
Washington, D.C.
July 13-14, 1998

MONDAY, July 13, 1998

Opening Remarks

John Ehrmann, Meridian Institute, opened the meeting by welcoming participants to the third 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 the National Advisory Council on Environmental Policy and Technology (NACEPT) of EPA. A list of the TRAC members is presented in Docket # OPP00537. He initiated a round of introductions and turned to Co-Chairs of the TRAC, Richard Rominger, Deputy Secretary, USDA, and Fred Hansen, Deputy Administrator of the EPA, for opening remarks.

Mr. Rominger welcomed members to the third TRAC meeting. He thanked the group for all of the time and effort that went into the first two meetings of the TRAC, especially the efforts of the Work Groups. Mr. Rominger acknowledged that the group was addressing a number of tough issues and stated that the group had made progress as a result of those efforts. He observed that, as a result of the group's efforts, important lines of communication were opened, thus increasing the understanding of the issues and improving the chances for the group to move toward convergence on the issues and the process.

Mr. Rominger expressed concern that TRAC members had not yet discussed the specifics of the risk assessment process, but he noted that the group had engaged in the discussion of science policy issues. Mr. Rominger observed that it was clear that TRAC members want to discuss real world issues in order to understand more about the elements of the risk assessment process. He stated that it is important for the group to be able to articulate the risk assessment process at a level of detail that explains data requirements, how data are used, and to begin risk mitigation discussions. Mr. Rominger commented that, until the group addresses the risk assessment process, it will be difficult to provide the public with details on the sequence or the schedule of events for tolerance reassessment of organophosphates. He observed that much of the data required for these purposes must be gathered from field trials performed during at least one full growing season. Mr. Rominger stated that during tomorrow's discussion, the USDA will provide an overview of what they are doing for data collection and possibly research. He acknowledged the need for accurate data and observed that USDA relies on agricultural producers and grower organizations to help ensure the availability and use of the best data. Mr. Rominger also noted that USDA is asking the Land Grant University system to take a lead role in data collection and analysis. In addition, he stated the USDA has asked them to work with growers in their respective States to help them in their efforts. Mr. Rominger also noted that USDA will talk about their efforts to align their research priorities with FQPA requirements. He commented that USDA has made good progress, but there is need for additional work.

Mr. Hansen also welcomed members to the third TRAC meeting. He reiterated Mr. Rominger's comments on the progress being made, and observed that the TRAC had reached the half way point of the process. He stressed that the TRAC had developed a strong foundation including: a framework for decision-making; a process for refining the underlying science policy issues; the risk assessment process; and preliminary risk assessments. In addition, he noted that the TRAC had made progress on the issue of notice and comment and some of the other issues of transparency. He observed that risk management is one of the key areas for additional work.

Mr. Hansen acknowledged the importance of the Work Group efforts to the progress of the TRAC. Mr. Hansen noted that Work Group members have indicated that more time for their deliberations might be very helpful, particularly for Work Group # 2, and that there is not enough time between the meetings to make progress. To accommodate the Work Group needs, Mr. Hansen noted that USDA and EPA are planning to modify the schedule as follows:

The July 27 -28, 1998 TRAC meeting will be condensed to one full day on July 28, thus allowing for additional time for Work Groups to meet on July 27.

A fifth, one or two day TRAC meeting will be added in mid-September. The likely dates for the meeting are September 15 - 16.

Mr. Hansen closed his comments by thanking TRAC members for their hard work and commitment to the process. He stated that he looked forward to a productive meeting.

Review of Recent Activities and Agenda
Following the introductory remarks, Dr. Ehrmann reviewed the agenda for the meeting and provided some additional remarks on the status of the TRAC. He explained that the agenda for the first day of the meeting consisted largely of Work Group # 1 risk assessment topics, plans for a case study presentation on organophosphates, and public comments. The agenda for the second day consisted of Work Group # 2 risk management topics, an update on USDA crop information and a brief presentation on research priorities, and public comments.

Dr. Ehrmann then commented on the progress of the TRAC using the July 10, 1998 memorandum from the Meridian Institute to highlight some of the work and progress on the key objectives of the TRAC meetings. The objectives are summarized as follows:

Methodologies and Framework for Risk Assessment (Work Group # 1)

Risk Assessment Science Policies

"Plain English" Guide

Decision Process for Risk Assessment, Risk Management and Transition (Work Group # 2)

Preliminary Risk Assessments

Risk Management Principles and General Approach

Tolerance Reassessment Principles and General Approach

Transition Strategies

Dr. Ehrmann invited TRAC members, on behalf of EPA and USDA, to provide input on the elements of each of the objectives. He commented that, unless TRAC members suggested other wise, the remaining efforts of the TRAC would be organized around the framework of objectives presented above. He noted that TRAC members will receive an additional document proposing a series of TRAC activities and a potential schedule to meet the objectives listed above for the months of July through September later in the meeting. Dr. Ehrmann then invited members to comment.

One member also acknowledged the amount of work that had been done by the TRAC, but recognized that there were a number of issues that required additional discussion. He was uncertain about the intended products from the TRAC and how they would be used. He felt it was important to start building a record or document showing the status of issues addressed by the group. In addition, he wanted to know how the Agencies were viewing the input from the TRAC.

Mr. Hansen explained that the Agency was planning to take the TRAC guidance on science policy and risk assessment elements and solicit public comment through the formal Notice and Comment process. He stated that, as long as there is general agreement amongst TRAC members about a direction that meets statutory requirements, EPA will plan to follow that direction. Mr. Hansen noted that, where the group is not in agreement, EPA will make its judgements on the issue, having been informed by the TRAC discussions.

Mr. Rominger added that USDA was in the process of responding to FQPA with, for example, the Office of Pest Management. He noted that USDA was seeking input from the TRAC on issues like data collection and methods to ensure the resources for data collection. Mr. Rominger also noted that USDA was looking for guidance on research priorities.

Dr. Ehrmann responded to the concern about the focus of the TRAC and use of potential end products by referring TRAC members to a document on the activities and proposed schedule for the TRAC through the month of September (above referenced attachment to the July 10 Meridian Institute memorandum). He explained that the schedule was developed to integrate the group's input on the objectives listed above. Dr. Ehrmann shared his understanding that EPA and USDA had not contemplated a single document, but rather, a series of work products addressing selected issues including: the "plain English" guide; the details of the formal Notice and Comment on the science policies; and a schedule to address the issues regarding the tolerance reassessment process.

Several TRAC members suggested that it would be helpful to include an overall document that would explain the individual work products of the TRAC, clarifying the integration between the risk assessment and management processes.

Science Policy Framework
Steve Johnson, Deputy Director, Office of Pesticides Program (OPP)/EPA, initiated the discussion on the Science Policy Framework by referring TRAC members to Staff Paper # 12, Framework for Refining FQPA Science Policies (Docket # OPP00537). He explained that the Staff Paper included the Framework for Refining FQPA Science Policies - detailed considerations, a matrix summarizing the key elements of each policy, and a preliminary schedule for release of guidance of science policy issues. Mr. Johnson described each of the three documents, the process Work Group # 1 went through to get to this point, and future plans of the Work Group.

He noted that the Work Group had been focusing their efforts on the eight science policy issues. To respond to the TRAC's interest in understanding the issues in each policy area, EPA's current approach and their future plans for the policy area, the Work Group worked with EPA to generate the detailed Framework for Refining FQPA Science Policies and the summary matrix for quick reference. Mr. Johnson also commented that the Work Group developed the Preliminary Schedule for Release of Guidance on Science Policy Issues to put the plans for the science policies in the broader context of the statutory requirements under FQPA.

As an example of how the detailed document might be used, Mr. Johnson described the components of the science policy area of applying the FQPA 10-Fold Safety Factor as follows:

Definition of the Issue

The Science Policy Issue

Approach in Risk Assessment

Issues Related to Current Approach

What EPA is Doing to Address the Issue

What EPA Will be Doing in the Interim

Summary of Current Assumptions


He then described how the Matrix would be used and outlined the Preliminary Schedule for Release of Guidance on the 10-Fold Safety Factor as an example. The schedule for the 10-Fold Safety Factor includes: the Scientific Advisory Panel (SAP) presentation in July; posting the Framework Documents as a draft for public comment in October; and a public Workshop on the 10-Fold safety Factor in November. The final Guidance on the 10-Fold Safety Factor would be issued in December of 1998.

Mr. Johnson explained what the Work Group envisioned as a final product for the science policy guidance document. They suggested packaging the three draft documents presented in the Federal Register as the approach or framework to address the eight broad science policy issues. The documents would include attachments detailing the Agency's current approaches in the interim to address each science policy issue. He noted that EPA hoped to have these attachments available by the next TRAC meeting. Mr. Johnson stated that this information, combined with the public comment period and selected workshops, would comprise an open and transparent public process. He closed his presentation by explaining that the Work Group intended to focus next on science policy issues # 3 through 8.

TRAC members were then invited to comment on the process, timing and products related to the science policy issues.

One member commented on science policy area # 6, Assessing Residential Exposure. He felt the current Standard Operating Procedures (SOPs) were overly conservative and did not make adequate use of available data. In addition, he was concerned about viewing the approach to addressing the science policy on Residential Exposure as complete when the process for integrating current and future input from the SAP and the Indoor Residential Exposure Joint Venture Task Force was unclear. He stated the necessity for reliable data and progress on the ability to determine cumulative risk for effective representation of residential risk. He suggested that the current evaluation of Residential Exposure be viewed as a screening tool rather than a definitive determination of risk. Mr. Johnson explained that EPA and USDA intend to comment on the type of input on the SOPs received to date. He added that EPA and USDA also feel that this is an iterative process that will provide a mechanism to integrate new information as it becomes available to reflect the state of knowledge at the time decisions are made.

Another TRAC member requested clarification on when information on the safety factors being used would be made available, particularly for organophosphates. Mr. Johnson indicated that the FQPA Safety Committee has met and gone through the 40 organophosphates and made preliminary determinations on whether to retain, modify or remove the safety factor. He explained that the results of their decisions will be summarized and available in about two weeks.

Several members were concerned about the interim nature of decisions and the process of revising interim decisions. One member wanted to know how the results of the preliminary risk assessments would be addressed if, after applying the safety factor, the results indicate the "risk cup" is exceeded. Mr. Johnson explained that the refinement process will be clarified once the overall risk assessment process is determined. He noted that, once the risk assessment is refined, the risk will be mitigated using input on the mitigation process from Work Group # 2. The member was concerned about the potential for additional exposure as a result of delayed decisions on pesticides. Mr. Johnson noted that, while this is possible, EPA has, in the past, taken measures including emergency suspension and phasing-out or down, when such concerns were identified. He added that EPA is seeking counsel to help to address this concern. Mr. Hansen acknowledged the concern that the Agency move quickly once an exceedance of the "risk cup" is observed, and commented that Work Group # 2 is working on how to make this a transparent process.

In a similar vein, a member was particularly concerned about the refinement process of interim decisions which are based on less developed components of the risk assessment process like cumulative risk, risk from drinking water, and residential risk. Mr. Johnson note that, in addition to the registration renewal process requiring refinement every 15 years, interim decisions are often addressed as Section 18s or under time-limited tolerances and registrations to address the need for updates. He explained that, in the interim circumstances, EPA is forced to revisit the decisions. In general, he noted that EPA revisits decisions on older chemicals when new information is received. Another member wanted to know if EPA would modify decisions on the 10-Fold Safety Factor based on new data. Mr. Johnson referred the member to the science policy detail on the 10-Fold Safety Factor for additional information.

Another member observed that there might be disagreement with an interim decision, especially if the member was aware of new data that would support modification of the decision. Mr. Johnson commented that, in addition to the required timeframes for reevaluating decisions, EPA generally revisits any decision when asked. He noted that there will always be a desire for additional information, and the threshold question is "what to do in the interim?" Mr. Johnson indicated that, while EPA uses the same criteria across chemicals to maintain consistency, decisions are made on each chemical separately.

A member suggested that a ninth science policy issue be added to clarify the concept of reliable data. Mr. Johnson commented that the definition of reliable data is a key concern, both within EPA and in the Work Group setting. He explained that the Work Group felt the discussion on reliable data would be more effective when addressing a specific issue. They decided to add a discussion on reliable data as it related to each science policy issue.

End point selection was also suggested as a ninth science policy issue, particularly for cholinesterase inhibition. It was observed that there are still some unanswered scientific questions on end point selection such as when to use cholinesterase inhibition and when to move away from it as an end point.

Another TRAC member was concerned about the use of data from the "open literature." She suggested that there be additional discussion if the policy for its use is changing.

One member felt that there should be additional information on the definition of "non-detection." Mr. Johnson commented that Work Group # 1 intends to address the issue of "non-detection" in greater detail at their next meeting.

At the close of the discussion, Dr. Ehrmann summarized some of the key elements of the discussion as follows:

TRAC members should submit any additional comments on Staff Paper # 12 to Margie Fehrenbach, Designated Federal Officer, by July 22, 1998 (later changed to July 20), or prior to the next Work Group meeting on July 27.

Background documents detailing EPA's current science policy approaches will be available before the next TRAC meeting.

There were suggestions to add some discussion on additional science policy issues such as end point selection and definition of reliable data.

Address how to affect the timing of interim decisions and the links to risk management.

Clarify the policy for revisiting decisions.

Keith Pitts, Special Assistant to the Deputy Secretary, USDA, also noted two corrections to the Framework for Refining FQPA Science Policies - Detailed Considerations document in Staff Paper # 12 as described below:

Page 9-10, regarding USDA's collection efforts on food consumption by infants and children. The survey data will be complete by next spring.

Page 13, USDA is also communicating with AMA regarding drinking water exposure.

Options for Refining Chemical Risk Assessments
Lois Rossi, Director, Special Review and Registration, OPP/EPA, provided the TRAC with an overview of the options for refining chemical risk assessments. She referred members to the three parts of Staff Paper # 13, Refining Chemical Risk Assessments; Four Options for Refining Risk Assessments; and Elements of OPP's Preliminary Risk Assessments (Docket # OPP00537) for additional details. Ms. Rossi then reviewed the four options as summarized below:

OPTION # 1 - the preliminary risk assessment is completed and sent to the Registrant. The Registrant provides the Agency with comments and the Agency refines the assessment and initiates the public review and comment period by posting a notice of availability of the preliminary risk assessment along with an analysis of the Registrant's comments in the Federal Register. The Agency then reviews the comments, modifies, and finalizes the assessment.

OPTION # 2 - The Agency posts a notice of availability of the preliminary risk assessment and provides the opportunity for both the public and the Registrant to comment on the assessment concurrently. The Agency then reviews the comments, modifies, and finalizes the assessment.

OPTION # 3 - is the current refinement process used by the Agency. The preliminary risk assessment is shared with the Registrant for comment. The Agency revises the assessment and provides an opportunity for the Registrant to review the revised assessment. The Agency then revises and finalizes the Assessment.

OPTION # 4 - the Preliminary Risk Assessment is completed and sent to the Registrant. The Registrant provides the Agency with error corrections only and the Agency corrects the errors in the assessment and initiates the public review and comment period by posting a notice of availability of the preliminary risk assessment and background information on the errors in the Federal Register. The Agency then reviews the comments, modifies, and finalizes the assessment.

After Ms. Rossi's presentation, Dr. Ehrmann invited TRAC members to comment.

Several TRAC members were concerned about how each option would influence the timing of when the preliminary risk assessment would become available to the public. Members observed that only option # 2 allowed all parties to have access to the preliminary risk assessment at the same time. They felt that option # 2 was the only option that addressed the need for transparency. For the other options, the Freedom of Information Act (FOIA) was recognized as the alternative means for all stakeholders to obtain information on the preliminary risk assessment at the same time as the Registrant. In addition, one member observed that the public would have to be alert to access the same information as the Registrant concurrently using FOIA.

Mr. Johnson clarified that, with the exception of Confidential Business Information (CBI) such as trade secrets and market information, all information on file is subject to FOIA. He explained that the Agency performs the FOIA clearance, and the clearance can take a short or longer period of time (months) depending on the scope of the request. For comparison, Mr. Johnson noted that it can take up to one year for the public to have access to the preliminary risk assessment in option # 3, and 60 days with option # 4.

One member expressed concern that the timelines for the options were short and unrealistic. She noted that it was important to reflect accurately the time required for public input and the logistics of the process in the timelines for each option. She suggested that EPA perform a resource assessment to determine whether they have the ability to address tolerance reassessments for 40 organophosphates within the required timeframe. Based on experience, she observed that a time span of 30 to 90 days could easily become 30 days to two years. Ms. Rossi also clarified that the timelines for the options also did not account for obtaining additional data (e.g., field and market basket studies).

It was recognized that the timelines would be more realistic if they were enforceable. The group discussed ways to enforce the timelines. Mr. Johnson suggested one possible, less preferable method to establish firm timeframes was to use the rule-making process. Another individual proposed that EPA address adherence to a fixed timeframe by advising the Registrant that, if EPA does not receive a response from them within the set timeframe, EPA will proceed with public notification.

Several members felt that option # 4 provided a middle ground; addressing the concerns of some that the preliminary risk assessment be made available to all parties early in the process, and the concerns of others that the information presented be as accurate as possible. Some agreed that option # 4 would be a happy medium if the 30-day review for errors could be enforced. Another individual commented that it was more important to avert a public scare because of misinformation than it was to adhere to a strict 30-day timeframe. A third member commented that the notion that there would be a public scare as a result of inaccurate information was not well founded. They suggested that the public would be supportive of obtaining better information. Several members expressed concern about selecting option # 4 without further refinement of the science policy issues. One member commented that it is important to know what the rules are and to be familiar with them before the timelines are tightened up. In addition, he stated that adequate time must be provided to generate data to comply with the rules. For some perspective, one member noted that option # 4 was similar to the processes used by other Agencies in their interaction with industry. Another individual commented that the distinction between options 1 and 4 will be blurry in practice because it will be difficult to distinguish between errors and comments. They felt the option # 2 was the only viable alternative.

Some members requested clarification of what is meant by "error correction" in option # 4. Ms. Rossi explained that the term referred to incorrect numbers (mathematical) and assumptions. Another individual asked if EPA's omission of data would be considered an error. Ms. Rossi responded affirmatively.

One individual commented that the preliminary discussions between EPA and the Registrant were not well understood. She explained that the preliminary discussions are highly technical and may not be easily understood or useful to the public. Another member noted that the Agency review always results in major changes. For this reason, he supported the use of option 1 or 4. A third individual commented that the risk assessment process involves complex science and it is appropriate for EPA and the Registrant to take the time to make sure the science is right before presenting it to the public. He was supportive of options 1 and 4.

Another member wanted to know where refined data would be introduced in the options. Ms. Rossi commented that refined data would be integrated at any time in the process, but particularly at the start of the process and included in the review. The member noted that the Registrant would be inclined to provide better information at the start of the process.

Planning for Organophosphate Case Study
Mr. Johnson introduced Jay Vroom, President, American Crop Protection Association (ACPA), for an update on the progress of the case study on organophosphates. Additional information about the case study process is presented in Staff Paper # 14, Presentation of Risk Assessment for Specific Organophosphate (Docket # OPP00537). Mr. Vroom explained that he contacted some of the members of ACPA to see if they would be interested in making a presentation of a risk assessment for a specific organophosphate. He indicated that one company expressed interest and they would be prepared to present the case study at the July 28, 1998 TRAC meeting. Mr. Vroom explained that it would be a joint presentation shared by EPA and the Registrant or a representative of ACPA. Mr. Johnson added that, based on discussion at the previous TRAC meeting and at the Work Group meeting, the presentation should include input from an individual representing the public interest community. It was also suggested that the presentation include information on the sources of data, major drivers, scenarios of zero detection and half of the detection limit, and a discussion on mitigation or changes to the label. If possible, an overview of the case study would be presented at the Work Group # 1 meeting on July 27.

Following the update on the case study, members asked questions and commented. While several members were supportive of hearing the type of detail in a case study, they were concerned about how one case study (versus providing information on all of the preliminary risk assessments) answered the requirement of a transparent process. Mr. Hansen clarified that the example was not seen by the Agency or USDA as satisfying the need for a transparent process. The case study was viewed as a means to describe how a chemical is evaluated. One member stated that the Agency should at least be clear about its plans to release details on organophosphates and other chemicals. Another member proposed that the case study illustrate one or more of the science policies. Others suggested that the case study include the rationale for each decision and provide information on "what-ifs" such as what would happen if the 10-fold safety factor was applied.

Some members continued to express concern that one case study was not sufficient to represent the diversity of chemicals subject to tolerance reassessment. One member proposed that EPA present basic information on all of the organophosphates including: RFD; usage; status of the preliminary risk assessment; model used; and key variables and drivers. Another member noted that information on preliminary risk assessments for a number of the organophosphates has been available for years and should be made available to the public. A third member observed that the group was seeking two things: a case study and information about all of the organophosphates. She suggested that the two efforts progress independently in preparation for the next meeting.

Dr. Ehrmann closed the discussion by reaffirming that the organophosphate case study was on the agenda for the next meeting. He noted that EPA and USDA will continue to evaluate how to proceed with the preliminary risk assessments as a separate development from the case study.

Upcoming Scientific Advisory Panel Meeting
Stephanie Irene, Associate Director, Health Effects Division (HED)/EPA, provided TRAC members with an overview of the upcoming Scientific Advisory Panel (SAP) meeting to be held on July 29 - 30, 1998. She referred TRAC members to website and the public Docket at 703-305-5805 for additional information about the meeting. She also invited members to contact the Designated Federal Officials of the SAP, Larry Dorsey at 703-305-5369 and Paul Lewis at 703-305-7398, for additional questions. Dr. Irene then provided the group with a detailed overview of the agenda for the SAP meeting as summarized below:

Proposed Methods for Basin-Scale Estimation of Pesticide Concentrations in Flowing Water and Reservoirs for Tolerance Reassessment;

Linear Low Dose Extrapolation for Cancer Risk Decisions: Sources of Uncertainty and How They Affect the Precision of Risk Estimates;

Dichlorvos Risk Issues;

Chlorothalonil: Mechanism for the Formation of Renal and Forestomach Tumors; and

FQPA 10X Safety Factor: Status Report.

Public Comment
Nancy Alderman, Environment and Human Health, Inc. - Requested that environmental effects be added into the exposures considered to determine risk. She was particularly concerned about the omission of the exposure data from pesticide spraying in schools, lawn and tree care and well water. Ms. Alderman noted that a survey of schools in Connecticut showed that the schools spray for pest control on a monthly basis without notifying teachers or students in advance. She also noted that no certification or training is required for individuals applying the pesticides. Ms. Alderman felt that the exposure to pesticides resulting from this practice is substantial to students, teachers and those applying the pesticide. Ms. Alderman was also concerned about the amount of exposure to pesticides resulting from lawn and tree care. She noted that, because there is no coordination between homeowners who contract for pest control services, there is the potential for multiple exposures resulting from individual applications performed at different times by different contractors. Ms. Alderman also noted that many homeowners are not aware of the possibility that their well water may be contaminated by the pesticides applied for lawn and tree care and are thus unable to make informed decisions to protect their health.

Barbara Baughman, Knob Hill Pecan Orchard, South Carolina - Commented on the importance of the organophosphate she uses with the integrated pest management program for pecan farming in South Carolina. She noted that their ability to continue producing pecans and remain competitive with foreign markets will be compromised if the organophosphate is cancelled because there is no alternative on the market. Ms. Baughman stated that she is concerned about safety, but has also observed no ill effect from the pesticide use after years of application. She closed her comments by stating that the US currently provides a safe and varied food supply and the fate of organophosphates could reduce the US supply and increase foreign production.

Mark Keating, Henry A. Wallace Institute for Alternate Agriculture - Was supportive of the progress on science policy issues and the framework. He requested clarification on how occupational exposure, particularly exposure to farm workers, is addressed when determining aggregate exposure. Steve Johnson explained that farm workers are part of overall assessment. He added that EPA continues to sort out how to focus more directly on the exposure to farm families and children.

Steven Jellinek, Jellinek, Schwartz & Connoly, Inc. - Commented that the presentations and discussions were thorough and informative. He expressed concern about the interim approach to FQPA implementation. He referenced, as an example, the suggestions on an improved interim approach proposed by the FQPA Implementation Working Group. Mr. Jellinek also suggested that the TRAC focus on the science policy assumptions (e.g., for residential and drinking water exposure) rather than the science underlying the policy, noting that the science will be updated and policy can be changed at any time. In addition, Mr. Jellinek requested clarification on how the proposed science policy # 9 on end point selection would be presented to the public. Mr. Johnson explained that the new policy would be presented in a similar format to the other science policies and put out for public notice and comment.

TUESDAY, July 14, 1998

Dr. Ehrmann opened the discussions for the second day of the TRAC with an overview of the agenda for the day. Following his agenda review, several members reflected on the discussions from the preceding day. One member was concerned that some of the discussion on the case study suggested a misunderstanding of the offer. He explained that the offer to present a case study represented an effort on the part of industry to begin a new way of doing business. He was supportive of the offer and confirmed his commitment to the TRAC process. A second member expressed frustration that the previous day's discussion focused heavily on Right-to-Know issues. In view of the tight timeframe to cover all of the TRAC issues, he hoped that the future TRAC meetings on July 28 and in September would be productive and focus on issues like a transparent process and a road map for implementing FQPA.

Mr. Hansen provided some additional opening comments. He explained that he and Mr. Rominger supported a fifth TRAC meeting and devoting July 27 to Work Group meetings to be responsive to the Work Group's need for additional time to progress on their issues. Mr. Hansen acknowledged that scheduling would be a challenge but hoped that more members would be available if the additional meeting was scheduled two months in advance. He stated that he and Mr. Rominger would double-check their schedules to see if there were alternative dates for the meeting in September. In addition, he felt it was important to acknowledge the level of commitment exhibited by members of the TRAC. He stated that this type of commitment is what makes FACA's successful. Mr. Hansen noted that, while some may have been frustrated by some of the discussions at yesterday's meeting, he felt the group was progressing towards achieving the TRAC goals.

Mr. Rominger supported Mr. Hansen's comments, particularly the need for additional time for Work Groups in the process. He also appreciated the scheduling challenges, but hoped that most of the TRAC members would be able to attend the upcoming meetings. Mr. Rominger felt confident that the TRAC would continue to progress, particularly with the assistance of the Work Groups.

Before proceeding with the agenda item on Risk Management Decision-Making Criteria, Dr. Ehrmann reminded members that the fifth TRAC meeting was scheduled for September 15 - 16, 1998. He noted that the Co-Chairs will check their schedules for alternative dates soon in order to advise the group accordingly. He then introduced Lois Rossi for an overview of Work Group # 2's progress on Risk Management Decision-Making Criteria.

Risk Management Decision-Making Criteria

Ms. Rossi began her presentation by referring members to Staff Paper # 15, Decision Criteria and Straw Risk Management Decision Process (Docket # OPP00537). First, she described the purpose of decision-making criteria. She explained that Work Group # 2 members reviewed the purpose and provided comments to the Agency. In response to their suggestions, the Agency modified the purpose statements. Ms. Rossi explained that the purpose of the decision-making criteria is that it can be used any time the Agency is trying to make choices between uses where "a reasonable certainty of no harm" finding cannot be made based on the presently registered uses. She noted that the decision-making criteria could be applied to choose among uses for a single chemical, to make choices within a single commodity, and across commodities and chemicals. Ms. Rossi stated that the Agency laid out draft principles and criteria and the Work Group provided suggestions on grouping the criteria under the following six basic categories:


Dietary Exposure

Importance to Agriculture

Public Health

Non-Dietary Exposures

Other Considerations

Ms. Rossi noted that the Work Group spent most of their time discussing the Straw Risk Management process (Docket # OPP00537). She described the process by referring TRAC members to the diagram of the process. Ms. Rossi explained the diagram leads the reader through a decision process that could be used to make choices between uses. From left to right: the first boxes (a - c), which were initially part of the first box in the decision process, are generic to establishing criteria and would only take place once; box 'd' on data used to apply the criteria, would actually start the decision-making process; box # 1 - EPA applies the criteria and develops a proposal to show how a different chemical crop combination ranks against the criteria; box # 2 - EPA consults with stakeholders on how the criteria were applied and the results of the application; box # 3 - Registrant proposes risk mitigation options; box # 4 - EPA refines the risk assessment and develops a proposal which goes into a regulatory action plan; box # 5 - public comment; box # 6 - FFDCA/FQPA FIFRA legal process for tolerance revocation or amendment; and box # 7 - transition. After her overview, Ms. Rossi turned to several representative Work Group members to provide comments before others commented on the presentation.

Bob Rosenberg, Director of Government Affairs, National Pest Control Association, felt that Ms. Rossi did a good job explaining the discussion and the process. He noted that there were additional issues on which the Work Group would like input from the TRAC. The issues follow:

Are there any other decision-making criteria that should be added to the list and are the criteria grouped appropriately? In addition, how do you measure items like toxicity and importance in agriculture? How do you measure individual chemicals and how do you weight them based on the criteria?

If there is agreement on the decision-making criteria, how should they be integrated in a coherent model addressing stakeholder concerns? As an example, he suggested that in Michigan they use a pesticide priority index.

In boxes # 2 and 3 on the flow chart, who are the stakeholders? In addition, what is the process for stakeholder involvement, what mechanisms come into play, and how do we translate factors other than risk that should factor into regulatory process?

Allie Devine, Secretary, Kansas Department of Agriculture, felt that Mr. Rosenberg's report was fair and impartial. She added that TRAC members should pay close attention to the decision criteria because they have not been fully debated. For instance, she noted that the Work Group has not yet discussed trade and regional implications. She noted that both of these issues need to be discussed along with their health implications.

John Cady, President, National Food Processors Association (NFPA), noted that the NFPA submitted comments on the decision-making criteria as summarized below:

Apply the decision-making criteria at the end of the risk assessment process;

Apply criteria to individual pesticides and groups of pesticides in a way that combines the principles of toxicity and exposure to establish risk reduction objectives; and,

Simplify the criteria so people can understand it.

Mr. Cady then deferred to his Technical Director, Richard Jarman, for additional comments. Mr. Jarman confirmed Mr. Cady's summary of the NFPA concerns, some of which he noted were reflected in the current version of the Staff Paper. He stressed the need to consider how the criteria fit together, but suggested avoiding getting hung up on weighting the criteria numerically.

Jeannine Kenney, Policy Analyst for Pesticides Consumers Union, also noted that the Consumers Union submitted comments on the Staff Paper. She noted that there was some similarity between the Consumers Union and the NFPA comments on the grouping of the criteria. Ms. Kenney stated that the first and most important category should be risk reduction, capturing both concerns of exposure and toxicity and target risk mitigation efforts accordingly. In addition, she explained that the Consumers Union suggested that the second most important category of non-dietary exposure be renamed as "the potential for harm to environment and human health". She closed her comments by suggesting that the category of "agriculture" be more appropriately named "risk mitigation options".

Following the opening remarks, Dr. Ehrmann invited other Work Group and TRAC members to comment. Several members felt the overview and layout of the decision-making process helped to clarify the process. Some of their specific suggestions are listed below:


Clarify what is meant by "non-dietary", including water, residential, high-end exposures like confined spaces. Address children specifically "non-dietary" concerns.

Keep the methodology for ranking criteria simple. Quantifying and trading-off criteria will be challenging. Possibly use cost-benefit analyses to achieve.

Under Dietary Exposure: Ground-water and/or Surface Water Detections - add drinking water. Add discussion on non-detections and whether the chemical is regulated under the Safe Drinking Water Act.

Add a criterion for analytical methodology to address the trend towards lower tolerance limits and help improve the control of residual pesticides on international products.

Add a criterion to address consumer impact and impact on the food supply.

Add a criterion for impact on trade.

Health criteria are critical and economic criteria (importance to agriculture) are of less importance. To rank risk, identify the greatest health risks and determine the risk drivers. Break out and clarify non-dietary exposures, identifying those who are closest to the risk, such as farmworkers and farm children, as priority risks.

Make criteria on risk to children explicit.

Under Other Considerations, "Does the Registrant Support This Chemical/Use Combination" - was recognized as the "trump card" of the criteria.

Add more detail on what has gone into the development of the decision-making process. Make a clear statement that the Agency will meet health-base criteria.

Clarify the overarching principle of the decision-making criteria to include reference to meet the statutory requirement of assessing aggregate and cumulative risk for everyone, including children.

One member commented that it is necessary to have a system to monitor the environment to determine whether exposure has occurred. He explained that, without monitoring, it is difficult to set and maintain health and safety standards for environmental exposure.

Several members were confused about how the diagram on the Straw Risk Management Decision Process fit with the charts on Chemical Risk Assessment. One individual felt that the two diagrams presented two separate opportunities to reduce risk: first on a chemical-by-chemical basis during the Chemical Risk Assessment; and second on a group of chemicals during the Risk Management Decision Process. She observed that the public involvement process and preliminary ideas for risk mitigation actually begin in the risk assessment process. She wanted to know how the results of the risk assessment process on individual chemicals were integrated in the risk management process which addresses a group of chemicals. Ms. Rossi noted that this point of confusion would be addressed in the following discussion on the approach to tolerance reassessment.

One of the pediatricians on the TRAC expressed concern about the lack of discussion on the special protection of infants and children and the 10-Fold Safety Factor. He noted that there was no direct reference to these special concerns in Staff Paper # 15 and questioned the need for pediatricians to be part of the TRAC. Mr. Hansen emphasized the importance of these issues to the Agency and stressed the importance of the perspectives of pediatricians in the dialogue.

Another member clarified that the focus of Work Group # 2 is criteria for risk management, not criteria for the risk assessment. He explained that the risk assessment process, where the 10-Fold Safety Factor for children and other factors are addressed before the Risk Management process. In addition, he suggested that the Decision Process diagram be modified to indicate that data collection (box d) occurs first.

Some TRAC members commented on the duration and timing of the process. One individual was concerned that, with the addition of TRAC meetings extending the process, it will be more difficult for EPA to meet the FQPA deadline for tolerance reassessments of August 1999. Mr. Hansen stated that EPA would meet this deadline. Another individual shared the concern that it may not be possible for EPA to meet the statutory deadline for organophosphates. He noted that it is the completion of the Rulemaking identified in box # 6 in the Decision Process diagram that constitutes compliance with the deadline. Based upon the amount of work to be done and the process being developed, he commented that this may not be a realistic timeframe. He expressed the view that, as transparency and science-based decisions help to build a credible process, so does a process of reasonable length.

Another individual stressed the importance of focusing on the process more than the individual criteria. He observed that, while the list of criteria may change, the notion of a fair process will give credibility to the decisions made. The individual also suggested that EPA apply to the TRAC process some of the experience with TSCA Consent Agreements and the public involvement process. He explained that the TSCA process was developed in a similar environment where trust was lacking. In addition, in box # 3 of the Straw Risk Management Decision Process, industry will be in a position to decide which uses to cancel and maintain. As this process may trigger anti-trust concerns, the individual suggested that EPA may want to consult with FTC and the Department of Justice to avoid such circumstances.

One representative commented on the group of criteria for Public Health. He acknowledged Public Health is an important category of criteria, but was concerned about the potential for loss of important minor uses of organophosphates for public health in the decision-making process. To avoid such losses, the individual reinforced the need for EPA to consult with other departments such as the Department of Health and Human Services (DHHS) in the decision-making process.

Dr. Ehrmann reminded members to submit additional comments on Staff Paper # 15 to Margie Fehrenbach by July 22, 1998 (later changed to July 20).

Tolerance Reassessment Principles, Approach and Transition

Lois Rossi began the discussion by referring members to Staff Paper # 16 Phased Cumulative Reassessment Approach and Cumulative Reassessment Approach (Docket # OPP00537). She explained that the Staff Paper diagramed two potential approaches to a tolerance reassessment process combined with text describing each approach. Ms. Rossi also explained that, at their July 1 meeting, Work Group # 2 members agreed that it would he helpful to have a set of principles on which to base a reassessment process. She summarized the following principles proposed by EPA for the Work Group to consider as a basis for the process:

Take action on chemical/use combinations posing the highest risks on an expedited schedule if needed.

Make decisions within a reasonable timeframe.

Provide opportunities for stakeholder input.

1. Make decisions based on sound science.

2. Make Agency decision-making transparent.

3. Provide adequate transition periods for agricultural production.

Ms. Rossi then described the two sample conceptual approaches to tolerance reassessment presented in the Staff Paper. She explained that one of the examples, the Phased Cumulative Reassessment Approach, considered aggregate and cumulative non-occupational risk from all routes of exposure posed by an individual chemical (e.g., food, water, and residential sources). The other, Cumulative Reassessment Approach, addressed the cumulative risk posed by chemicals thought to have a common mechanism of toxicity. Ms. Rossi emphasized that some of the components of each example approach could be modified and/or interchanged to develop other approaches.

Ms. Rossi described the common elements of each approach as follows:

Guides by the set of 6 principles.

Considers goals to achieve risk reduction.

Accomplishes tolerance reassessment.

Works with the grower community.

Begins with individual chemical risk assessment.

Focuses on assessing risks to sub-populations (e.g., children, women of childbearing age).

Assumes the science policy processes discussed in Work Group # 1 and peer review.

Assumes the methodology to do cumulative risk assessment will be developed.

Includes steps that alternate between risk assessment and management.

The differences between the examples were summarized by Ms. Rossi as presented below:

Summary of Differences Between Approaches
Point Phased Cumulative Cumulative Approach
1 Initially considers tolerances associated with individual chemicals based on food only first, incorporating residential and drinking water risk later. Requires risk be brought to acceptable levels for all endpoints and allows interim measures for mitigation. Initially considers all tolerances together.
2 Focuses on food risks for individual chemicals and manages the risks and reduces residential and water risks. Focuses on chemical/use combinations identified as high risk considering food, water and residential exposure.
3 Addresses worker and ecological risk in individual chemical decisions by managing to acceptable levels under FIFRA. Uses worker and ecological risk as criteria for identifying high risk/high priority chemical use combinations.
4 Allocates a percentage of risk level (food) on a commodity by commodity basis. Does not allocate risk in this way.
Ms. Rossi closed her presentation with a request for the TRAC to help direct Work Group # 2 on the issues and questions which should be addressed in designing the tolerance reassessment approach.

Before the Work Group members commented, Mr. Hansen asked if each of the two approaches had the same end point. Ms. Rossi explained that each approach ended with making final FQPA tolerance reassessments. It was clarified that, in the Cumulative Approach, the tolerance decisions would be determined under FQPA and the remaining uses for chemicals subject to reregistration would be completed.

Ms. Rossi then asked several Work Group members to provide an overview of Work Group discussions.

Elin Miller, Director, Government Affairs, Dow AgroSciences, stressed that the Work Group discussions were in the formative stages. She suggested that it would be helpful to distinguish between the two approaches and present the pros and cons of each approach (e.g., cumulative first or not, how does each approach integrate into the final reregistration process, resources, timeline, etc.)

Carolyn Brickey, Executive Director, National Campaign for Policy Reform, agreed with Ms. Miller's comments and added that it was complex to design an efficient and productive process for tolerance reassessment. She noted that one of the key differences between the approaches was that one applied a phased FIFRA process (Phased Cumulative Approach) and the other (Cumulative) did not. Ms. Brickey felt that some of what is required under FIFRA (e.g., worker and other types of acute risk) should be incorporated in both approaches. She commented that it is more important to design the best, most timely tolerance assessment approach than to spend more time on refining the criteria.

Several members were concerned about the potential ramifications of determining the allocation or uses of specific commodities. One member wanted to know who was responsible for allocating uses and whether there were legal concerns. She commented that there were a lot of unknowns that need to be clarified. Another member noted that this concern was equally important to those discussing the risk assessment process. She felt it was important to discuss this concern fully in the Work Group and full TRAC settings. She proposed that it may be appropriate to develop a sub-group comprised of members from each Work Group to flesh-out this discussion and address aspects of the interface between the risk assessment and management processes.

One member reiterated that the tolerance reassessment process will be complex and there will be challenges with its application. He observed that EPA would need to have the flexibility to make judgements when these complexities arise. Ms. Rossi commented that the process will evolve to address uncertainties and integrate developments in policy. Several members noted that it was important for EPA to be clear on how it plans to manage a flexible, evolving and iterative process.

Many members were concerned about the timing required for each approach. One member noted that the unknowns about the cumulative risk assessment process were of major concern. She noted that without knowing what the cumulative risk assessment process is, it is difficult to determine aggregate and cumulative exposure to pesticides that have a common mechanism. She suggested that, to develop an approach to tolerance reassessment which is based on individual pesticide risk assessment and an unknown cumulative risk assessment process is not only unfair to those producing commodities but also to the consumer. Another member commented that, regardless of the state of the cumulative risk assessment process, EPA is responsible for evaluating cumulative risk, based on the best available data and methodology.

It was recognized that there is an important role for well documented "default assumptions" for application in circumstances where there is insufficient information. One member cautioned against the use of "default assumptions" because they have been disruptive in other circumstances and are not intended for use by the FQPA. Another individual recognized the need for "default assumptions" but stated that EPA must be clear about when they are used and their plans to replace "default assumptions" with actual data. A third member stated that it would also be helpful for EPA to provide explanations for why they are using "default assumptions". He was concerned that, in some instances, the reason for using 'default assumptions' is that the Registrant has not provided the data.

Several individuals commented on the principles for organophosphate tolerance reassessment. One member stated that public health should be clearly stated as a principle. Mr. Hansen acknowledged the concern and explained that all of the draft documents were meant to reflect the requirements of the FQPA and that the omission of public health was unintended. A second individual suggested that a principle be added to address how the Agency will advise the public about interim information about chemicals. As an example, they were interested in how the Agency planned to advise the public about indications of risk posed by pesticides on a heavily consumed food.

Ms. Rossi acknowledged the concerns about timing. She added that there were other factors, including the amount of stakeholder involvement, that influence the timing of both approaches. Ms. Rossi suggested that the group would develop a clearer understanding of the amount of time required for each approach as they look more closely at what is involved with each step of the approach.

A member echoed the concern about the complexity of each approach. However, she observed that both approaches may put too many burdens on EPA and not enough on the Registrant for the information required to address risk. She suggested that it may be appropriate to develop an approach with more phases or a series of different approaches to consider. As examples, she proposed the following alternative approaches:

The manufacturers for organophosphates, working with consumer and growers groups, be responsible for coming in under the risk line for their own family of organophosphates and then move to aggregating risk.

On a per chemical basis across companies, reduce the risk of that chemical to below the risk line, and then address aggregate risk.

On a per crop basis, get under the risk line and then aggregate risk across crops.

Target the top 10 foods used by children and evaluate individual and aggregate risk for each.

She stressed the importance of starting the process of tolerance reassessment someplace and not delaying a decision for an extended period of time.

One individual was uncomfortable with the phased approach because of the implication that key aspects of the FQPA, specifically, the 10-Fold Safety Factor; evaluation of all sources of exposure; and cumulative risk assessment when there is a common mechanism; would be put off until later. In addition, he expressed concern that, by focusing on the individual chemical risk assessments, EPA would further delay addressing the cumulative risk assessment process. He was also concerned about the assumptions used for residential and drinking water exposure. To help Work Group # 2 address these concerns, he requested access to residential data and US Geologic Survey data on ground-water. Another individual expressed the concern that, by focusing on the individual chemical risk assessments, EPA would delay addressing the cumulative risk assessment process and prolong the tolerance reassessment process.

Presentation on Organophosphate Use in Michigan

Dr. Mark Whalon, Pesticide Research Center, Michigan State University, provided the group with an overview of organophosphate use in Michigan. A copy of his presentation slides and a reference list are in Docket # OPP0037. Dr. Whalon's discussed: (1) residue mitigation as an untapped solution to many minor crop FQPA challenges; (2) four production system "snap shots" (apples, cherries, peaches, potatoes); (3) organophosphate reduction pattern (1973-1998); and (4) how many minor and some major crops are trapped by legal quality standards and pesticide regulation.

For apples in Michigan, he concluded that: there are currently no organophosphate alternatives for Plum Curculio and the Apple Maggot; residue mitigation is possible; biointensive IPM is dynamic and expensive; resistance can destroy the utility of IPM and/or alternatives; and organic production uses much more pesticide in Michigan's humid conditions. The conclusions for cherries were: the economic reality of $0.18 per pound drives the system; zero tolerance for Plum Curculio and Cherry Fruit Fly; there are currently no organophosphate alternatives for Plum Curculio or the Cherry Fruit Fly; and there are no organophosphate residues on tart cherries. For peaches in Michigan, he concluded that: without organophosphates some pests are uncontrolled; organophosphate alternatives are more than twice as expensive than the pesticides themselves; and the information necessary for alternatives is five to ten times greater than calendar spraying. Dr. Whalon concluded for potatoes that: when "plug-in and spray" alternatives are available, growers use them; CPB and late blight resistance drive potato production; multi-tactic IPM was used when there were no other choices; and single-tactic "biorational" alternatives are very vulnerable to resistance.

Following his presentation on the production systems, Dr. Whalon summarized the overall conclusions from the study:

All pesticides kill or mitigate pests.

Organophosphate residues can be reduced dramatically in many crops.

There are no alternatives currently available for organophosphates in some crop/pest situations.

IPM systems are expensive, complex and often difficult to sustain.

Resistance often drives change in minor crops.

Quality standards dictate pesticide use whether for conventional, biointensive or organic.

Public support of pesticide alternative research and IPM implementation has been inadequate.

FQPA implementation could have many unintentional effects on US agriculture.

Dr. Whalon closed his presentation by stating that the intention of the presentation was to illustrate transitional issues and how they have been addressed in Michigan. He then asked TRAC members for questions and comments.

Several members commented on the relative costs of different pest control approaches. Based upon the Michigan study, organic farming and IPM were shown to be costly. Both approaches were considered by many to be underfunded. In some States, it was noted that IPM is partially funded by the public. Some members commented that, while the initial costs of total biological control methods may be greater than conventional methods of pest control, the cost of organic production decreases over time. One individual noted that, based on his experience, the cost of pest control with organic systems relative to conventional pest control methods is not as much as suggested in the Michigan study (three or four times greater). Dr. Whalon commented that the expense comes in as a result of trying to control the key pests in the system.

Some members were interested in clarification of assumptions used in the Michigan study. One member asked whether the oils used in the different types of pest management systems were pesticides. Dr. Whalon explained that oil was considered as a pesticide, generally bearing 60 -90 percent active ingredients. Another individual commented that values used for sulfur in organic farming may be misinterpreted because it is used for pest control and as a nutrient.

One member observed that there was an example of a successful shift from the use of hard chemicals (organophosphates) on peach production in Michigan to less harmful pest control methods. It was clarified that, while successful, the shift in pest control methods took a number of years. Another individual suggested that it would be helpful to the TRAC if EPA scheduled a presentation on a similar shift in pest control methods to increase understanding and highlight some of the challenges encountered with the shift.

Another member asked if, even though there was no residue on a product like Michigan tart cherries, the risk of worker and farm children exposure would be addressed in the aggregate risk assessment. Dr. Lynn Goldman, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances (OPPTS)/EPA, indicated that it was possible that worker and children's risk would be addressed in those circumstances. A second member added that there are regional differences in the way crops are handled (e.g., tart cherries are mechanically harvested which results in lower risk to the farmworker) which should be taken into account. A third member stressed the importance of non-dietary exposures and noted that these types of exposures may drive the decision-making process. They suggested that EPA add a presentation on non-worker risk, including poisonings, to a future TRAC meeting agenda.

A member requested clarification of Dr. Whalon's observation of the tension between the quality of food and pesticide use. Dr. Whalon explained that, in addition to consumer standards, Michigan State and USDA statutes require a certain level of food quality. He noted that the statutes on food quality drive the producer to use pest control measures to meet the food quality standards.


Decisions on Preliminary Risk Assessments

Following the presentation on organophosphate use in Michigan, Mr. Rominger and Mr. Hansen provided some comments before the discussion on Crop Information. Mr. Rominger began by referring to yesterday's discussion on refining the options on chemical risk. He noted that, while the group did not come to agreement on the options, he and Mr. Hansen felt it was time to make some decisions regarding the preliminary risk assessments and continue with the discussions on the options. He then turned to Mr. Hansen to outline the timetable for the release of the information discussed by the group on the first day of the meeting.

Mr. Hansen outlined the approach agreed on by EPA and USDA as follows:

The three FOIA requests related to the TRAC process will continue through the normal FOIA response process.

For the nine organophosphates for which the preliminary risk assessments are complete and have been shared and discussed with the Registrant, EPA will immediately (no more than seven days) notify each of the Registrants that any additional questions on errors must be provided to EPA immediately. By no later than August 10, 1998, the preliminary risk assessments and documentation on the discussions between the Agency and the Registrant will be placed in the Federal Docket for public comment. He clarified that no CBI information will be included in the release. If, from the standpoint of the Agency's workload, they are unable to post all of the information by August 10, the remaining information will be posted soon thereafter (no more than nine days later).

The seven organophosphates for which preliminary risk assessments are complete but have not yet been shared with the Registrant, will be shared with the Registrant, and the Registrant put on notice no later than July 21, 1998. The Registrant needs to comment on errors in the preliminary risk assessments by no later than August 20, 1998. EPA will plan to correct the easily corrected errors within that timeframe. The Agency will also post in the Docket the issues raised and the documentation of discussions between the Agency and the Registrant on the errors. The Agency will plan to place the preliminary risk assessments for the seven organophosphates in the Docket by September 9, 1998.

The 24 remaining organophosphates will also be subject to the 30-day timeframe for comments on errors, similar to the approach outlined in option # 4. He explained that some of the remaining organophosphates will not have full preliminary risk assessments because they were reassessed prior to the earlier requirements, and others will have an updated assessment or an FQPA assessment.

Mr. Hansen expressed concern about delaying action while waiting to come to agreement on an option over the next two TRAC meetings. He stressed that it was his and Mr. Rominger's goal to have the information on organophosphates available in the Federal Docket as soon as possible. Mr. Hansen proposed that the group consider the outlined approach as a pilot to see how the process works to identify and correct errors.

Mr. Hansen then proposed the following clarification on what he meant by the term "error" to be used only as an operating procedure for this set of organophosphates:

Error correction shall cover all factual errors which do not pertain to matters of policy or interpretation or applicability of data. In this context, error means mathematical, computational, typographical or other similar types of error. All others would be considered differences of opinion, including new data availability, disagreement about judgements regarding the applicability of 10X, SOPs for residential or drinking water screening criteria, etc. Any changes to the preliminary risk assessment shall be noted, explained and entered into the Docket. For all comments for which the Agency determines do not fit the definition of error shall be noted, described in the Docket and addressed in the post-Docket publication period.

After Mr. Hansen's presentation, TRAC members were invited to ask questions of clarification. A summary of their comments is presented below:

Many members were supportive of the pilot proposal. They felt it represented a good example of a transparent process and would increase the public's confidence in the process.

Some members were concerned about implementing the pilot and adopting option # 4 before the group reached resolution on the science policy issues.

One individual wanted to know when the organophosphates will be identified? Mr. Hansen responded that the organophosphates will be identified and categorized as described above.

Another member inquired about the level of the risk assessment (e.g., Tier I or other)? Mr. Johnson commented that risk assessments will be at different levels of maturity for each preliminary risk assessment. He explained that some will be refined using the Monte-Carlo analysis and others will be less refined. He commented that the reader will be able to tell the difference. Mr. Hansen added that EPA will include an explanation about the status of each assessment in the Docket.

Several members were concerned about the potential for misinterpretation of preliminary information and cautioned the Agency to be aware and prepared for this. Mr. Hansen acknowledged the concern and noted that the Agency will be clear about the preliminary nature of the material in the Docket. One member suggested that EPA not release any Tier I risk assessments.

One member inquired whether the preliminary risk assessments are based on more than dietary analyses? Mr. Hansen explained that the Agency will present all of the types of analyses used for the assessment, including occupational exposure and other.

An individual wanted clarification on the schedule for the remaining 24 preliminary risk assessments. Mr. Hansen noted that he expected several to be completed in the next two weeks and the others to be completed after that. He indicated that the schedule for their completion will be provided later.

A member suggested that the Agency include the uncertainty analysis in the draft chapter.


USDA and EPA Presentations of Crop Information

Following these comments, Steve Johnson and Allen Jennings, Office of Pest Management, USDA, provided some opening remarks before initiating the discussion on USDA and EPA presentations on crop information. For additional information, he referred members to Staff Papers # 17, Organophosphate Tolerance Reassessment Use/Usage Matrix, Staff Paper # 17.1, USDA Office of Pest Management Policy (OPMP) Crop Profiles, and Staff Paper # 17.2, USDA Office of Pest Management Policy (OPMP) List of Crop Profiles (Docket # OPP00537). Mr. Johnson commented that use and usage information has always played an integral role in EPA's risk assessment process and mitigation in the Risk Management Process. He noted that, as the Agency moved into FQPA implementation, the importance of the accuracy of use and usage information in the risk assessment process was emphasized, as was the need to have that information early on in the implementation process. He explained that the use/usage matrix was developed in response to the request for clarity on what information EPA needs from the field for the risk assessment process. Mr. Johnson then asked Mr. Jennings for some additional remarks.

Mr. Jennings noted that USDA, through its National Agricultural Statistical Service (NASS), has been collecting use and usage data for many years. He added that there are many other sources of use and usage information (e.g., subscription data sources). Mr. Jennings explained that the advantages to the NASS data are that they are statistically defined at the State level, and they are publicly available. He noted that there are challenges to using all sets of data. He added that, more recently, USDA and the new Office of Pesticide Management began two projects to better utilize the use and usage information: Crop Profiles and Transition Strategies. Mr. Jennings also noted that, with the increasing need to coordinate with EPA, a senior level Working Group was formed to talk about USDA and EPA's mutual interests; how to share information, avoid overlaps, etc. He then introduced Sherry Sterling, Acting Director, Biological and Economic Analysis Division, OPP, EPA, for an overview of the Organophosphate Tolerance Reassessment Use/Usage Matrix, (Staff Paper # 17).

EPA Crop Matrices

Ms. Sterling began her presentation by defining the terms 'use' and 'usage' as follows:

Use - what is on the label.

Usage - how much of the product is used across the country.

She then described the highlights of the matrices and how to use them. She described the first matrix, Organophosphate Tolerance Reassessment Use/Usage Matrix - Crop Summary for apples, as a national picture of the five major apple-producing regions across the country. Ms. Sterling explained that the subsequent matrices in Staff Paper # 17 provide summaries of pesticide use in the New England region. She stated that the first matrix was developed to compile the information that a risk assessor could use for risk assessment. Ms. Sterling noted that the matrices do not contain all of the information about use and usage, thus they are best used in combination with the information from USDA on crop profiles. Ms. Sterling then observed the following elements of the Crop Summary matrix:

Listing of data sources.

QUA - quantitative use analysis.

LUIS - label use information system.

Information on the table is what goes into a refined risk assessment.

NS - not specified.

Next, Ms. Sterling described the matrices of regional information on apples: Organophosphate Tolerance Reassessment Use/Usage Matrix - Pest Summary. She noted the following elements of the matrix:

Listing of data sources.

Timing of application (e.g., pre-bloom, post-bloom).

Constraints of alternatives - identification of problems such as resistance.

Additional information not captured in the matrix.

She noted that they have completed the matrices for four crops, and will need to complete a total of 75 matrices to address all of the organophosphate uses. Ms. Sterling also noted that they are working on similar efforts on public health and residential information on exposure.

Several Work Group members provided additional comments on the presentation.

Dr. Robin Spitko, Plant Pathologist, New England Fruit Consultants, made comments on the Crop Matrices presented by Ms. Sterling. She noted that developing the matrices is complicated because they are dealing with dynamic biological systems that change constantly. For instance, she observed that the pests change from major to minor over the course of one year. Dr. Spitko commented that, with the exception of a few minor discrepancies, the matrices on New England are accurate. In addition, she felt that the matrices for the country are basically accurate. Dr. Spitko closed her comments by offering that the group of Certified Independent Consultants is also a good source of crop information.

Jean-Mari Peltier, Chief Deputy Director, Department of Pesticide Regulation, California Environmental Protection Agency, added that there is confusion on the part of the grower and data collection communities about the interaction between the crop profiles and the data being developed by USDA and EPA. It would help the user community gathering this data for USDA and EPA to clarify data needs. Ms. Peltier agreed with Dr. Spitko's suggestion to tap into other sources of data, including groups like independent consultants and States. She observed that growers are not certain whether "now is the time" to answer the call for data, based upon the history of false starts for similar efforts (e.g., QAP, QAP2, and DPR's generation of data). She agreed that, in addition to information on the percent of crop treated, residue data were also important. She suggested that potential untapped sources for this type of information include food processors and shippers. Ms. Peltier also referenced Work Group # 2's idea to evaluate the role of a deterministic model of "what-if" scenarios for Risk Mitigation. As a potential resource for information on deterministic modeling, she referenced on-going work at the University of Berkeley in California. She closed her comments by noting that updating the matrices was critical.

Larry Elworth, Executive Director, Program for Strategic Pest Management, added that the key issue is not just having good data, but also to have the data used. He noted that it was important to clearly articulate the process binding all of this information together (e.g., data collection, data sources for crop profiles and matrices, and how they are used together). Mr. Elworth also noted that the accuracy and utility of the data is important.

TRAC members were then invited to comment on the presentation. Some of their comments and questions are presented below:

When will the information on public health be available? Ms. Sterling responded that they are currently working on the public health information.

How is EPA soliciting comments on information in the matrices? Ms. Sterling indicated that, through USDA, they are asking for input from members of the grower community. Mr. Jennings added that they are also planning to solicit input from the Land Grant University system starting later this summer. One member commented that there was a need to formalize and clarify the process of soliciting grower input.

What is the source of funding for this effort? One member was concerned about using valuable USDA funding on this effort. They wanted to make sure there was a formal agreement in place between EPA and USDA to protect USDA funding. Mr. Jennings commented that this effort was funded separately. Mr. Hansen acknowledged the concern and also noted that EPA was trying not to duplicate efforts. Keith Pitts, Special Assistant to the Deputy Secretary, USDA, added that Work Group # 2 was also looking at a process to define who does what, when.

Provide more detail on how field data is used in the risk assessment process by HED and clarify the process to acquire more data when necessary. Mr. Johnson commented that EPA will provide more information on how the data are used in the risk assessment process. He noted that EPA is currently trying to link and better utilize all of the data from growers and registrants to add to the information they have. They are also developing guidance on data gathering and use in addition to the use of Monte-Carlo as a refining tool.

There is a need for a database to compile data from EPA and USDA and help prevent duplication of data collection efforts. Mr. Johnson agreed and commented that USDA and EPA are working on developing a database.

There is a need to make the linkage between the crop use/usage information more directly with information on crop profiles.

Ms. Sterling invited TRAC members to provide additional comments to her or to Neil Anderson at 703-308-8091.

USDA Crop Profiles and List of Crop Profiles

Mr. Jennings provided the group with an overview of USDA Crop Profiles. He suggested that the group think of the Crop Profiles as the process to get the Land Grant University partners fully engaged in FQPA implementation. Mr. Jennings explained that they are responsible for assembling the data for crop protection and pest management in their States. As an example of a commodity and pest management profile on peaches, he referred members to Staff Paper # 17.1. Mr. Jennings views the profiles as abstracts of crop production methods and pest management. He explained that USDA is trying to address all pests and are looking beyond organophosphates and carbamates (e.g., fungicides and herbicides). He noted that the Land Grant Universities have been instructed to work closely with agricultural producers in their State to put these profiles together and review the results. He commented that the profiles are to be well documented and will be available on the web. In addition, USDA plans to link the profiles with other crop information and create a mechanism for routine updates. Mr. Jennings commented that there are some questions on crop segregation and how far USDA needs to go to capture differences (e.g., fresh versus process), and seed production versus crop production. Mr. Jennings closed his overview by commenting that they view the crop profile as the beginning, not the end, of the process to be used to begin a discussion on what it means if a chemical is taken off the market.

After his opening remarks, members were invited to comment on the presentation. A summary of their comments is presented below:

Do the information sources used reflect reality? How are NASS and Pesticide Data Program (PDP) data incorporated?

How are NASS and PDP coordinated once EPA receives their data? Are their data being used in the preliminary risk assessments?

Crop profiles are important but they should be prioritized based upon the needs of FQPA. What guidance is being offered to States on how to prioritize which profiles? Mr. Jennings explained that they sought input on priorities from the Land Grant Universities. He commented that, as the information on the sixteen organophosphates becomes available, they may readjust the priorities. Another individual commented that, in addition to consulting with the Land Grant University system, EPA should tap into the sustainable and organic agricultural communities for input.

It is important that there is a mechanism to integrate new chemistry and alternatives into the process.

Include post-harvest concerns in the profile.

Does the Agency have information on the chemical effect of a single tank mix of different organophosphates? Mr. Johnson commented that the Agency has scarce information on the toxic synergistic effects to humans of combining organophosphates. They do not have information on the synergistic effects on the pests.

Focus on discovery when looking for alternatives to organophosphates, not just research.

Are the values for the percent of crop treated in the crop profiles consistent with the percentages used to determine risk? Mr. Jennings responded affirmatively but also indicated that EPA may need to aggregate and weigh according to the amount of product coming from each State.

What is the source of information use for individual States? Mr. Jennings responded that NASS data would be the source of preference. He indicated that, in some cases, State survey data is used.

How is the data on the percent of the crop treated verified (e.g., how do we confirm that there is no under or over reporting)? Mr. Jennings indicated that there is typically not a second set of data for verification. Mr. Johnson explained that EPA uses a variety of sources including the USDA, private services for larger crops, State data, and the production data from each company. He also stated that, when EPA uses percent crop treated data, they are required to reassess the tolerance every five years. Mr. Robert Epstine, PDP, added that they are looking at NASS data and residue data that follows.

Make the data available on a GIS system. These data are important for developing water exposure assessments and for looking for compounds in wells.

USDA Transition Strategies

Mr. Jennings provided an overview on USDA Transition Strategies. He referred members to Staff Paper # 17.3, USDA Office of Pest Management Policy (OPMP) Transition Strategies, for more details. He suggested that TRAC members view the Staff Paper as a discussion guide that would lead to developing and transition strategy. Mr. Jennings noted that much of the information in the tables will come from the crop profiles. He explained that, using asparagus as an example, the Staff Paper included:

Production information on where the crop is grown, how it is used, etc.

Pest information - The Asparagus Beetle - summary of pest management practices to control the pest by type.

Pipeline Information - what pest control alternatives are developed and could be used in the future.

Pest information - Asparagus Aphid - summary of pest control practices to control the aphid. There are very few chemical options and some other potential control methods.

Pipeline Information - for the Aphid there are currently no alternatives for aphid control in the pipeline.

He summarized by stating that information in the Staff Paper is useful for engaging in discussions when a pest control method may be cancelled to help determine what the options are and what may be in the pipeline. Following his presentation, TRAC members were invited to comment.

One individual commented that it is important for USDA and EPA to seek out information on non-chemical alternatives to help make a change.

Another member asked, when EPA makes the percent crop determination, if the data for that determination include information on where the food goes (e.g., food sheds)? Ms. Sterling explained that EPA does not have a specific database for food sheds. However, she commented that EPA thinks of the crops as food. As such, EPA discusses and evaluates food sheds qualitatively. In their consideration of food sheds, they use crop specific, pest-level proprietary data in addition to State data. Another technical specialist from EPA stated that the use of State level data is challenging because there is so much of it. However, he noted that EPA is able to determine high use data from States. Also, he explained that the information for large crops is more accurate than data for minor crops. Mr. Hansen added that EPA needs to clarify how they will proceed to gather information on food sheds to provide quantitative assessments of the qualitative evaluations. Another TRAC member suggested that EPA consider the design on the PDP sampling program.


USDA Research Priorities


Keith Pitts, Special Assistant to the Deputy Secretary, USDA, presented an overview on USDA research priorities. For additional detail, he referred TRAC members to Staff Paper # 18, USDA Research Priorities (Docket # OPP00537). He explained that the Work Group had decided to wait to discuss research priorities until it had completed its discussion on decision criteria, the tolerance reassessment principles, and crop profiles and matrices, because those discussions will help to determine needed research priorities (e.g., at risk commodities or the top 10 children's foods). Mr. Pitts stated that the Work Group will be identifying the drivers between now and the last TRAC meeting. He noted that some members planned to meet later in July to get a better understanding of existing USDA projects to see if it is possible to leverage existing programs while also evaluating new programs. He commented that the Work Group agreed to look at short-term programming (e.g., IR4) and long-term programming on implementation (e.g., an area wide program to look at commodities and broad spectrum of issues). Mr. Pitts encouraged people to look towards new programs and then evaluate the need for resources for both organophosphates and other pesticides. Following his presentation, TRAC members provided the following comments:

It is important for EPA and USDA to develop a Memorandum of Understanding (MOU) to clearly define the financial resources for work related to the FQPA and to protect committed resources for other USDA responsibilities.

Clarify whether research on the percent of crop treated will be used for acute dietary risk assessment or for chronic dietary risk assessment. A representative of EPA responded that, until recently, EPA used the maximum percent of crop treated over a 10-year period for assessing acute dietary risk. More recently they have used a distribution and a Monte-Carlo analysis of the percent of crop treated to perform acute risk assessments (e.g., like a weighted average). One individual expressed concern because they recalled that the language in the statute says, in establishing, modifying or relieving an effect of a tolerance for pesticide chemical residue, the Administrator may, when assessing chronic dietary risk, consider the percent of crop treated.

Try not to inadvertently narrow the options available to growers by prescriptive agriculture.

Clarify whether it is use associated with growing crop or use associated with actual production.

Public Comment


Kevin Magro, Clarke Mosquito Control Products, Inc. - Reinforced the need to secure organophosphates for public health and mosquito control. He commented that organophosphates represent a critical part of IPM across the country. In addition, Mr. Magro observed that, over time, the number of pest control products has decreased and research has not yielded many alternatives. He commented that there is a small group of pesticide applicators whose application technique is well defined. He noted that these professionals are exposed to low risk and that risk management practices are successful.

Mark Keating, Henry A. Wallace Institute for Alternate Agriculture - Stated that he appreciated that some of the TRAC work was being put into effect and observed that the TRAC process was working towards the overall goal of achieving FQPA implementation. He was concerned about using exposure to food residues as the primary driving process in Staff Paper # 15. Mr. Keating stressed the importance of including worker and other exposures, and addressing selected more vulnerable populations. He was supportive of a more systemic approach to determining cumulative effects.


Summary and Next Steps


TRAC members will submit any additional comments on the Science Policy documents, Decision-Making Criteria, and Risk Management Approaches to Margie Fehrenbach by July 20, 1998.

The next Work Group # 1 and # 2 meetings will take place on July 27, 1998 at the Omni Shoreham Hotel in Washington, D.C.

The next TRAC meeting will be held at the Omni Shoreham Hotel on July 28, 1998.

Work Group # 1 will hold its next meeting on August 12, 1998 in Washington, D.C. at the EPA Crystal Mall # 2 in Arlington, VA.

Work Group # 2 will hold its next meeting on August 13 - 14, 1998 in Washington, D.C. at the EPA Crystal Mall # 2 in Arlington, VA.

There will be a fifth TRAC meeting in mid-September. The likely dates for the meeting will be September 15 -16, 1998. The Schedules for the Co-Chairs will be checked to evaluate the potential for alternate dates.

EPA plans to provide the preliminary risk assessments along with documented errors for the organophosphates in Docket # OPP00537. CBI will be deleted prior to posting. The schedule for posting this information follows:

9 of the organophosphates (completed Preliminary Risk Assessments and interaction with Registrants) by August 10, 1998;

7 of the organophosphates (completed Preliminary Risk Assessments and no interaction with Registrant) by September 9, 1998;

The preliminary risk assessments for the remaining 24 organophosphates will use the 30-day error correction process, but no firm schedule for them was laid out.


Closing Comments

Mr. Rominger observed that the TRAC made good progress in their discussions on the decision-making criteria and tolerance reassessment approaches, and began to address the importance of crop profiles and transition strategies. Mr. Rominger stated that he looked forward to the group's discussion on research priorities to help USDA continue to refine the focus on its research efforts. He thanked TRAC members for their commitment to the process.

Mr. Hansen also thanked TRAC members for their hard work. He stated that he looked forward to seeing TRAC members at the next meeting later in July.


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updated January 7, 1999