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USDA-EPA TOLERANCE REASSESSMENT ADVISORY COMMITTEE -- Final Summary

Information provided for informational purposes only

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 Although the information provided here was accurate and current when first created, it is now outdated.

August 2000

I. Background and Overview of the TRAC Process

The Food Quality Protection Action (FQPA) of 1996 amended the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) to improve the registration of pesticides. FQPA mandates a single health-based standard for pesticides in all food; provides special protection for infants and children; expedites approval of safer pesticides; provides minor crop protection; and requires periodic reevaluation of pesticide registrations and tolerances.

In April 1998, the Vice President directed EPA and USDA to work together to ensure that implementation of FQPA followed four guiding principles: apply sound science; provide reasonable transition for agriculture; develop transparent regulatory process; and consult with diverse stakeholders. The Tolerance Reassessment Advisory Committee (TRAC) was established under the Federal Advisory Committee Act to carry out the Vice President's directive. Co-Chaired by EPA's Deputy Administrator and USDA's Deputy Secretary, a large group (52 members) was formed consisting of senior-level representatives of a wide variety of stakeholders: environmental/public interest groups, farm worker representatives, pesticide industry and trade associations, farmer and grower organizations, food processors and distributors, State and Federal agencies, pediatricians and public health groups. Moreover, international observers from Canada and Mexico serve on the Committee, and a high number of congressional staff are included as meeting participants. The EPA Administrator considers this Committee to be an essential part of EPA's implementation of FQPA.

Between May and September 1998, the group met five times. An additional ten work group meetings were held during this time period. While originally envisioned that the Committee would complete its mission by September 1998, EPA's Deputy Administrator and USDA's Deputy Secretary agreed to continue the Committee for two more full meetings. Moreover, two "update" meetings - one for East Coast and the other for West Coast TRAC members - were held in February and March of 1999 to provide members with a current understanding of the many science policy and OP risk assessment issues. A sixth TRAC meeting was held in April 1999, at which several concerns were raised by both TRAC members and public attendees about the desire to continue the stakeholder process as the Agency begins to make important risk management decisions affecting the OP pesticides. Also, with several key science policy issues, e.g., the cumulative risk policy, the FQPA child safety factor (or "10-X" policy), etc., being drafted and ready for public consultation, many of the TRAC members were interested in additional stakeholder meetings to have an effective forum to raise concerns to both EPA and USDA as these important decisions are unfolding. A seventh and final TRAC meeting took place on October 20 - 21, 1999, in Arlington, Virginia.

In April 1999, the environmental/public interest group and farm worker members resigned from the Committee based on their concerns about the pace of Agency decision-making regarding tolerance reassessment and their view that children and other sensitive populations are not being adequately protected. Extensive media coverage included the Washington Post, New York Times, several trade press and many other newspapers around the country through the Associated Press. While this group resigned from the formal Committee, they committed to continue working with the Agency in addressing regulatory actions with the OPs. Despite continued efforts to regain the participation of the environmental/public interest groups and farm worker representatives, the groups decided not to rejoin the TRAC for the remaining two meetings.

Following is an overview of the TRAC meetings and the supporting work group efforts. TRAC meetings were open to the public and members of the public were provided opportunities to comment at each meeting.

II. May 28 - 29, 1998 TRAC Meeting

The agenda for the May 28 - 29, 1998 meeting was as follows:

Highlights from the meeting are as follows:

A.  The agenda for the meeting was designed to address the key issues outlined in the Vice President's memorandum of April 8, 1998 including sound science, transparency, reasonable transition for agriculture, and consultation with stakeholders.

B. EPA and USDA proposed an outline for the TRAC process which initially involved a series of four meetings, the second of which would address EPA progress and elements of evaluation on OPs, the third would focus on details of the approaches for OP reassessment, and the fourth would address transition approaches for agriculture.

C. The group heard about the FQPA framework and the evolution of FQPA implementation. They learned that the core of FQPA is evaluating risk in aggregate fashion, cumulative risk amongst chemicals that act in a common way, and providing protection where special sensitivities exist, particularly for infants and children. They also learned about a series of consultation opportunities provided by the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP), International Life Sciences Institute (ILSI), and other groups. Each of the core aspects of FQPA was compared with current policy using an interim decision logic. EPA agreed to provide the group with additional information on the SAP and ILSI. EPA assured the TRAC that there would be additional discussion on the transparency between the TRAC, other scientific committees, and the development of policy. They agreed to provide the group with copies of the decision-making logic that was developed following the passage of FQPA.

D. TRAC members heard a presentation on the 10-X Safety factor. They were asked to consider questions on the definition of "completeness" affected by emerging science and new data requirements, the potential need for additional testing, and potential regulatory action if the estimated risks exceed this newly revised "risk cup." Some of their concerns included: the ability to integrate risk mitigation in the decision-making process; how and when the safety factor will be applied; and the use of data call-ins.

E. The group received an overview of dietary exposure and Monte-Carlo techniques for undetected residues. They were asked to comment on the percentile to regulate to with the Monte-Carlo analysis, the possibility of regulating to different percentiles for different toxicological effects, whether Monte-Carlo runs should routinely be done for different types of crops. Members expressed concern that the Monte-Carlo method has not been used long enough to have confidence in its use to evaluate risk to children. It was recognized that the method would yield better results if based on a better database. There was concern that the Monte-Carlo technique was so complex it was perceived as a "black box" approach so it would be hard for many to judge the adequacy of the method. The potential for unnecessary loss of products was noted as a concern as well as the potential for FQPA implementation to disrupt the food supply.

F. To respond to the group's interest to know more about how EPA views the overall flow of the policy framework, two Work Groups were formed and comprised of smaller groups of TRAC members to think through how the larger policy framework on risk assessment will work, and to discuss what happens once the framework is established. The Work Groups were identified as Work Group #1 (WG1) - Risk Assessment Framework, and Work Group #2 (WG2) - Risk Management - What Happens Once the Framework is in Place/Transparency.

G. The group also heard about how the Agency planned to make the regulatory process and decision-making more open, accessible, and transparent. It was proposed that there be more opportunities for involvement in the registration process, Section 18s, and the reregistration process, with tolerance reassessment a critical part of registration and reregistration.

III. June 22, 1998 WG2 Risk Management/Transparency Meeting

WG2 met on June 22, 1998 to define the role and subject matter for WG2, describe the key issues and tasks, and develop an approach for discussing these issues.

A. The group addressed the issue of whether to conduct cumulative risk assessment analysis first, or analyze individual chemical's risks and then conduct the cumulative analysis for all OPs.

B. The group also briefly discussed mitigation measures and potential decision-making criteria to be used in making risk management decisions.

C. The group agreed to meet again and agreed to address the issues discussed in additional detail.

D. EPA agreed to consider, as a starting point to the discussions, the Staff Framework of Reassessment and Transition, the decision process flow chart and the listing of potential decision-making criteria.

IV.  June 22 - 23, 1998 TRAC Meeting

The agenda for the June 22 - 23, 1998 TRAC meeting was as follows:

Highlights of the meeting follow:

A. Based on the concerns raised by TRAC members at the May meeting about making the risk assessment process understandable to the non-risk assessor, EPA drafted the paper on the risk assessment process in language tailored to a broader audience. TRAC members provided suggestions to improve the document including: clarifying the difference between the public process and the public's Right-to-Know; information on what data is used, how it is used, and what assumptions are made in the risk assessment process; tools to make reasonable decisions on risk that are based on facts and common sense; posting a schedule of what information it needs by when in order to make timely decisions; developing a more general explanation of the risk assessment process that would be clearer for farmers to use, transparency on the process and data and assumptions used in determining children's and adult exposures; an example of how the risk assessment was applied to a real product; and including the public throughout the risk assessment process.

B. The group heard a presentation on a Framework for Refining FQPA Science Policies and for Risk Assessment Policy Making which were developed by EPA to address concerns raised by TRAC members at the May meeting on the broad science policy issues of FQPA and how they fit together. The presentation addressed the eight science polices identified by the Work Group, information on the current approach in risk assessment, timing, suggestions for improving transparency, and the timeline for publication and comment on each issue. TRAC members provided suggestions to improve the document including: adding reliable data as the ninth issue; adding background information on policy options and information from other related guidance groups; clarifying the comment periods and what happens with the papers after TRAC comments are provided; involving more qualified scientists for the discussion on reliable data; using a range of percentiles for Monte-Carol analyses; providing more information on the percent of crops treated, frequency of crop treatment; and risk reduction, using actual data more frequently and base product cancellation from the market on real data.

C. EPA presented information on the preliminary assessment of the OP pesticides with active registrations including information on acute vs. chronic risk and no observed effects level (NOEL), the Dietary Risk Evaluation System (DRES), chronic dietary assessment refinements to date, and the most refined dietary estimates to date. TRAC members provided comments on the presentation. Comments included: the need to clarify the distinction between what was meant by the most sensitive and most highly exposed populations; providing a "sensitivity uncertainty analysis" on each assessment, defining the target audience for the graphs; providing attachments to the graphs explaining the assumptions; correlating the organophosphates with particular crop uses to help the reader evaluate which uses are most vulnerable; the need to provide additional information about the assumptions driving the risk for each chemical; the need to provide additional information on chemical use and the names of the chemicals for adequate interpretation of the information; the preliminary risk numbers are not accurate enough to use for regulation; the need to clarify how non-detections are established and how non-detections in the risk assessment process; and clarification on the assumptions on what drives the risk process.

D. EPA presented an overview of refining dietary risk assessments for OP tolerance reassessment. Representatives of American Crop Protection Association (ACPA) offered to work with EPA and the Environmental Working Group (EWG) to prepare a presentation of a full risk assessment walk-through on one or more OPs. The group heard presentations on the framework for tolerance reassessment and transitions, and refining chemical risk assessments. TRAC member's comments on the presentation included: the need for the Rule for notification of the Registrant to allow the opportunity for the Registrant to provide clarification of their information; the lack of trust and the need to build trust into the process; the need to develop public confidence in the process and the importance of taking the time to ensure accurate information before public disclosure.

E. USDA provided a presentation on designing a decision making process for OP tolerance reassessment. TRAC members commented on: the importance of USDA involvement for successful transition; the impact of foods consumed by children; strategic use of this process by EPA to address the risks of selected organophosphates; the involvement of growers in a process to develop a good cumulative risk assessment; additional criteria for decision making including Registrant support of the chemical use; opportunities for risk reduction and mitigation; prescription use; unintended consequences; and methods to rescue affected pesticide users; considering examples of how different states currently approach the same issue; learning from FDA practices; and the importance of available alternatives.

F. Next steps for WG1 were as follows: discuss and refine framework for addressing the broad science policies; present 2 or 3 examples of OP assessment results with a variety of drivers; further discuss/update refining chemical-specific risk assessment; update Staff Paper on risk assessment process based on comments received; and present a preliminary OP assessment. The next steps for WG2 were: identify means to make mitigation negotiations transparent; and address a way to allow for growers and other stakeholders to be involved in mitigation decisions.

V. June 30, 1998 WG1 Risk Assessment Meeting

On June 30, 1998, WG1 met to discuss the following topics:

A. The group reviewed the Science Policies on 10-X and Monte Carlo in detail and agreed to discuss the last six Science Policies at the next Work Group meeting. Science Policies would be updated according to comments received, and notice and public comment periods would be provided for each of the Science Policies and associated documents. EPA would conduct workshops for further discussion on the most important topics in fall of 1998.

B. The group discussed two ideas for the example OP risk assessment presentation: 1) Discuss specific OP's as offered by Jay Vroom of ACPA; and 2) Discuss the full Risk Assessment process, highlighting key Science Policy decisions using examples from different OP assessments in preparation for the next TRAC meeting.

C. The group reviewed three options for refining chemical-specific risk assessments and discussed a refined approach. The refined approach, which was NOT agreed upon by the group, included a strict 30-day comment period by registrants upon completion of a draft preliminary risk assessment indicating errors and mistakes made by EPA. Within another 30 days, EPA would revise the risk assessments, documenting the comments on errors received, as well as details on any alterations made to the risk assessments, and publish (or otherwise make fully available) the preliminary risk assessments along with the documented comments and alterations. At that point, a full 90-day public review and comment period would proceed, in accordance with the timeline of Option 1.

D. The revised 'Plain English' Guide to Risk Assessment document was reviewed by all TRAC members.

E. The Work Group agreed that it would be helpful for the TRAC to discuss Mark Whalon's work at Michigan State University briefly at the next TRAC meeting.

VI. July 1, 1998 WG2 Risk Management/Transparency Meeting

On July 1, 1998, WG2 met to discuss the following issues:

A. The Work Group reviewed a draft listing of decision-making criteria used by EPA and discussed in previous meetings. They revised the criteria and grouped them according to six major principles. The next draft of Criteria would be presented for discussion at the next TRAC meeting.

B. The Work Group reviewed a number of flow charts outlining potential elements to the risk management decision process. Some of the flow charts attempted to represent the relationships between risk assessment and management activities as well as approaches for conducting the cumulative risk assessments. Work Group members indicated that these charts may be directionally correct in making a transparent and effective decision-making process, but members indicated that they required additional refinements and consolidation. The charts would be refined for discussion at the next TRAC meeting.

C. The Work Group received presentations on current USDA and EPA data gathering and research efforts. Presentations for the next TRAC meeting concerning use and usage information as well as on the USDA Crop Profiles and Transition Strategy would be developed.

VII. July 13 - 14, 1998 TRAC Meeting

The agenda for the July 13- 14, 1998 TRAC meeting was as follows:

Highlights of the meeting follow:

A. The group heard an overview of progress on the science policy framework for refining the science policies including a summary matrix for quick reference, and 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. TRAC members were concerned about a variety of issues, including: the way in which residential exposure was addressed and the need to include updated information in the process; interim nature of decisions and the process of revising interim decisions, particularly those that are based on less developed components of the risk assessment process like cumulative risk, risk from drinking water, and residential risk; and the possibility of additional science policy issues including one to clarify the concept of reliable data and another to address end point selection.

B. EPA provided an overview of the four options for refining chemical risk assessments, including: OPTION # 1 - The preliminary risk assessment is completed and sent to the Registrant; 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; OPTION # 3 - The current refinement process used by the Agency; and OPTION # 4 - The Preliminary Risk Assessment is completed and sent to the Registrant. Some of the members concerns are summarized as follows: it was unclear how each option would influence the timing of when the preliminary risk assessment would become available to the public; different options allowed for more transparency than others; timelines were short and unrealistic; OPTION # 4 appeared to provide a middle ground addressing concerns about timing and transparency; and it was unclear when refined data would be integrated in the process.

C. The group heard a presentation on planning for the OP case study. A member of American Crop Protection Association (ACPA) expressed interest in presenting a case study of an OP at the July 28, 1998 TRAC meeting. The presentation would be shared by EPA and the Registrant or a representative of ACPA. The presentation would include input from an individual representing the public interest community and 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.

D. TRAC members were provided with an overview of the upcoming SAP meeting to be held on July 29 - 30, 1998 which would include updates on methods of estimating risk from drinking water, cancer risk decisions, sources of uncertainty, and other related issues.

E. EPA provided the group with an overview of the decision criteria and straw risk management decision process developed by WG2 designed to help make choices between uses where "a reasonable certainty of no harm" finding cannot be made based on the presently registered uses. TRAC members commented on the list of decision-making criteria, criteria grouping, criteria measurement, and the measurement and weighting of individual chemicals based on the criteria; integration of the criteria to address stakeholder concerns, and the process for stakeholder involvement. TRAC member's commented on the following: 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; simplify the criteria; focus on risk reduction; clarify some of the language including what is meant by "non-dietary" concerns; add drinking water and a discussion on non-detections and whether the chemical is regulated under the Safe Drinking Water Act; add a criterion for analytical methodology; add a criterion to address consumer impact and impact on the food supply; add a criterion for impact on trade; make criteria on risk to children explicit; and avoid the loss of important minor uses of organophosphates for public health in the decision-making process.

F. The group heard a presentation on tolerance reassessment principles, approach and transition. Two approaches were summarized: the Phased Cumulative Reassessment Approach, which considered aggregate and cumulative non-occupational risk from all routes of exposure posed by an individual chemical; and the Cumulative Reassessment Approach, which addressed the cumulative risk posed by chemicals thought to have a common mechanism of toxicity. The group discussed the pros and cons of each approach. Some of their comments are as follows: some of what is required under FIFRA (e.g., worker and other types of acute risk) should be incorporated in both approaches; focus on designing the best, most timely tolerance assessment approach, not refining the criteria; clarify the potential ramifications of determining the allocation or uses of specific commodities; the timing required for each approach might be an issue, particularly with regard to the unknowns about the cumulative risk assessment process; and the role of "default assumptions" where there is insufficient information was of concern.

G. TRAC members heard a presentation on organophosphate use in Michigan, including residue mitigation as an untapped solution to many minor crop FQPA challenges, production systems, organophosphate reduction patterns, and how many minor and some major crops are trapped by legal quality standards and pesticide regulation.

H. EPA and USDA presented a pilot approach for identifying and correcting errors in the preliminary risk assessments, including a timetable for the release of the information. The approach addressed the three Freedom of Information Act (FOIA) requests related to the TRAC; the nine organophosphates for which the preliminary risk assessments are complete and have been shared and discussed with the Registrant; the seven organophosphates for which preliminary risk assessments are complete but have not yet been shared with the Registrant; and the 24 remaining organophosphates. TRAC members commented on the proposed pilot. Some of their comments are summarized as follows: some members were supportive of the pilot proposal; some members were concerned about implementing the pilot and adopting option # 4 before the group reached resolution on the science policy issues; and several members were concerned about the potential for misinterpretation of preliminary information.

I. EPA and USDA proposed a clarification on what was meant by the term "error" to be used only as an operating procedure for this set of organophosphates.

J. USDA and EPA presented a summary of crop information, including EPA Crop Matrices, USDA Crop Profiles and List of Crop Profiles, and USDA Transition Strategies. TRAC members asked questions of clarification and provided some suggestions on the presentations.

K. USDA presented an overview on USDA research priorities, including risk drivers, short-term programming, and long-term programming on implementation. Some of the TRAC member comments included: a suggestion to develop a Memorandum of Understanding (MOU) to define the financial resources for work related to the FQPA and to protect committed resources for other USDA responsibilities; and a caution to avoid narrowing the options available to growers by prescriptive agriculture.

VIII. July 28, 1998 TRAC Meeting

The agenda for the July 28, 1998 TRAC meeting was as follows:

Highlights of the meeting are as follows:

A. EPA presented an overview of the case study on the Methidathion Risk Assessment. The assessment focused on dietary risk. There were no residential, public health or non-occupational uses, and the risk assessment on drinking water was in progress. The objectives of the case study were to illustrate the dietary risk assessment process and its complexity, the tiered risk assessment process, and the drivers of the risk assessment (opportunities for refinement and mitigation). Some of the concerns raised by TRAC members included: the 10-X safety factor combined with the "reasonable certainty of no harm" issue and the lack of a developmental neurotoxicant study; EPA's decision to use the percent of crop treated in the determination of acute risk; the impact of unintended consequences; the handling of the 10-X safety factor; making better use of more sophisticated risk assessment techniques.

B. The WWF presented an overview of a collaborative effort between the WWF and Wisconsin Potato and Vegetable Growers Association (WPVGA) to look at problems and solutions to toxic loadings that were threatening the health of people and ecosystems in the Great Lakes Basin.

C. An organic farmer from the Pavich Family Farms presented an overview of insect and disease management in organic grape production.

D. EPA presented an overview of WG1 discussions including: follow-up items with FDA; framework for addressing the nine science policy issues, Staff Paper # 20; science policy issues # 3 - 9; other issues; status of the release of the organophosphates; and Plain English version of the Risk Assessment Process. Some of the TRAC members comments were as follows: add a distinction between what is meant by "error" versus "refinement"; address how EPA will address comments such as the Implementation Working Group's (IWG) "Road Map" Report on a science-based framework for implementing FQPA; and explain how the issue of testing pesticides on humans will be addressed within the TRAC process.

E. EPA presented an overview of WG2 discussions including: clarification of the process modeled in the flow-chart designed to portray the need to perform individual risk assessments to establish the basic science on the individual chemicals, while at the same time conveying the reality that it will take time to work out some of the essential science policies, such as how to perform cumulative risk assessments; and issues and decision points for the organophosphate tolerance reassessment process, such as mitigation of individual organophosphate risk endpoints and the fundamental question of whether to complete individual assessments before performing the cumulative risk assessments, or whether to proceed by doing things in parallel. WG2 also discussed the principles for transition, transition timetables, and the research and information to support transition. Some of the comments and concerns raised by TRAC members included: the need to define what is meant by the "detection level"; the importance of providing alternatives that are economical; the potential for the phased cumulative approach to change the goal post in the risk process; and the possibility for some tolerances to be determined at an early stage.

IX. August 14, 1998 WG1 Meeting

Following is a summary of key elements of the discussion, major agreements, and next steps of the WG1 meeting:

A. WG1 will participate in an agenda planning conference call for the fifth TRAC meeting on August 31, 1998. Potential agenda items proposed by Work Group members include: the Plain English Risk Assessment Paper and the Federal Register Notice for the nine Science Policy Issues; and Documentation on EPA's current practices on the science policy issues.

B. Work Group members discussed FDA's approach to food additive regulation, as it may be applicable to FQPA implementation. Work Group members discussed FDA's approach to food additive regulation, as it may be applicable to FQPA implementation. Work Group members were interested in the potential applicability of FDA's experience with the use of guidance documents.

C. The group discussed aspects of USDA's Food Consumption Survey, including the use of limited data (e.g., those sample sizes that do not meet reporting guidelines), the validity of basing risk decisions on limited data, how to address data variability and the impact of removing extreme values from the data base.

D. Work Group members discussed the use of data from the Pesticide Data Program (PDP) in FQPA implementation, including the protocol for the uses of PDP and other data in risk assessments; use of PDP data in acute dietary risk assessments (single serving versus blended); protocol for, and integration of, proprietary data; and the use of the limit of detection versus zero detection.

E. The group discussed the use of percent of crop treated in acute dietary risk assessments. They commented on the limitations of using a national average for percent crop treated, EPA's Biological and Economic Analysis Division (BEAD) practice of including information for regions or states with unusually high pesticide usages in the Risk Assessment, and bridging studies.

F. Work Group members discussed additional modifications to the revised Plain English Risk Assessment Paper, including making reference the applicable science policy issues, and the process for finalizing the document.

G. The group commented on the Draft Federal Register Notice and agreed to OPTION 1, Immediate issue of Federal Register notice on the nine Science Policy Issues and later publication of the remaining components of the tolerance reassessment process, including a summary of the materials published previously on science policy and risk assessment refinement.

X. August 13 - 14, 1998 WG2 Meeting

Following is a summary of key elements of the discussion, major agreements, and next steps of the WG2 meeting:

A. WG2 will participate in an agenda planning conference call for the fifth TRAC meeting on August 31, 1998. Potential agenda items proposed by Work Group members include: Early Assessment; Regulatory Tools; USDA "consensus" statement; criteria for reasonable alternatives; and Public Participation in the Risk Management process.

B. WG2 discussed criteria for determining a "reasonable" alternative to a pesticide. It was suggested that these criteria be included with the decision criteria. Some of the major factors for consideration of a "reasonable" alternative are the time, help, equipment and cost of using the alternative.

C. The group commented on EPA's draft description of the possible criteria for identifying OP uses with very low risk contribution and/or high public value that potentially could be subject to an early assessment.

D. WG2 members developed a "consensus statement" regarding how EPA should use and interpret the RA'/RM Cumulative flow chart presented as the OP Tolerance Reassessment Process.

E. The group commented on EPA's draft description of the regulatory mechanisms available for achieving pesticide risk mitigation.

F. WG2 members discussed USDA's plans for FQPA Implementation and developed a consensus statement regarding USDA's role in Transition.

G. The group discussed the level of public participation appropriate for the risk management process and agreed that in the risk assessment process, the TRAC had identified a fairly clear and definitive role for public participation that would be both transparent and rational. For Risk Management, the opportunities for public input outlined in the flow chart on Straw Risk Management Decision Process might be burdensome and duplicative for all.

XI. August 31, 1998 WG1 & 2 Conference Call

Work Group members discussed the following topics on the conference call:

A. The Status of TRAC Work Products including providing sufficient time for TRAC members to review the documents prior to the September 15 - 16, 1998 TRAC meeting and the amount of time allocated to discuss the materials at the meeting.

B.  Follow-up on TRAC issues, including insuring a mechanism for continued involvement in finalizing the science policies, particularly, the 10-X safety factor and cumulative risk.

C. Ways to help focus TRAC discussions at the final meeting, such as providing TRAC members with a brief written summary of the Co-Chairs comments on the TRAC.

D. Post-TRAC Activities including the need for some forum to continue the discussion and development of TRAC issues (e.g., the progress of TRAC decisions and issues overall, discussion on the risk management process, involvement at critical decision-making points, include all or a representative subset of TRAC members in the post-TRAC activities, ensure USDA continues a primary involvement, and effective reporting on the progress of TRAC issues.)

E. Alternatives to the TRAC (e.g., utilizing existing groups and resources including one or some combination of the Pesticide Program Dialogue Committee (PPDC), SAP, and Science Advisory Board (SAB), reconfiguring the PPDC to involve USDA as an integral part of the membership and a representative subset of TRAC members, using the model of USDA Pesticide Issues Discussion Group, and ensuring an effective report-back mechanism to TRAC members on the progress of TRAC issues)

F. The draft Agenda for the next TRAC meeting including: sufficient time to discuss Work Group topics; feedback from EPA and USDA on what they learned from the TRAC; progress made; intensions to address the issues identified in the TRAC; unintended consequences of the TRAC process; the integration paper; closing comments from TRAC members; and suggestions for time allocation for agenda topics.

XII. September 9, 1998 WG1 Conference Call

In preparation for the TRAC meeting on September 15 - 16, 1998, WG1 members participated in a conference call to discuss comments on the WG1 materials for the next TRAC meeting, the draft Federal Register Notice, the final agenda for the next TRAC meeting, and the 'integration' paper on integrating the risk assessment and risk management processes. The results of their discussions were reflected in the agenda and meeting materials for the September TRAC meeting.

XIII. September 9, 1998 WG2 Conference Call

Also in preparation for the September 15 - 16, 1998 TRAC meeting, WG2 continued its discussion of public participation in the risk management process, comments on the other WG2 documents, USDA's role in the transition process, and the 'integration' paper on integrating the risk assessment and risk management processes. The results of their discussions were reflected in the agenda and meeting materials for the September TRAC meeting.

XIV. September 15 - 16, 1998 TRAC Meeting

The agenda for the September 15 - 16, 1998 TRAC meeting was as follows:

Highlights of the meeting are as follows:

A. EPA provided the group with an overview of WG1's discussions on risk assessment including the risk assessment process and the framework for addressing the key science policy issues, and the pilot for public participation in refining risk assessments on OPs.

B. Some of the comments on the risk assessment process were: describe more explicitly the role of USDA in risk assessment and cross-reference the Staff Papers on USDA's Role in Risk Assessment, Risk Management, and Transition Strategies; clarify that "safe" means "reasonable certainty of no harm," as defined by FQPA; because children's levels of exposure differ from those of adults, explicitly reference exposure to children; clarify where the tolerance will be set; clarify the intended audience for the document; and explain the use of different percentiles with different modeling approaches.

C. Some of the comments on the framework for addressing key science policy issues included: clarify what regulating to a certain percentile using the Monte Carlo analysis means; clarify how comments such as those presented in the IWG "road map" referenced on page 20 will be addressed in the process; explain how USDA's other efforts will be integrated regarding refining consumption data statistical methods for composite to single servings and addressing issues of accuracy of reported high-end consumption; the indication that organophosphates and carbamates have a common mechanism of toxicity that is based on cholinesterase inhibition is a misrepresentation; specify that the language in FQPA allows for an increase in the 10-X safety factor in addition to reduction, removal or retaining the safety factor; discuss issues of a lack of reliable data to evaluate residential exposure; clarify when and why it is necessary to apply single-serving-size exposure data.

D. Comments on public participation in risk assessment included: questioning how the process will be evaluated and with what criteria; clarifying USDA involvement in the process; concern with EPA posting errors when they may have had the time to make corrections before posting the preliminary risk assessments and the potential for causing problems among agricultural users and consumers as a result of releasing preliminary risk assessments; and the clarification on the time period for the pilot.

E. EPA and USDA provided an overview of WG2's risk management discussion, including decision-making criteria, early assessment for OP uses with very low risk contribution and/or high public value, risk assessment and risk management process, regulatory mechanisms for achieving pesticide risk mitigation, and public participation in the risk management process.

F. Comments on the decision-making criteria included: clarification on some of the timeframes; the need to clarify what is meant by limits of detection; clarify that benefits are not used to decide how much risk to tolerate; emphasize the intent of the statute to make food safe for children; encourage the use of less toxic pesticides; develop criteria to channel resources to address high exposure scenarios; clarify how these criteria would be used to make a regulatory decision; clarify that the process will be for organophosphates and other pesticides; and clarify that the criteria address cumulative risk.

G. TRAC members provided the following comments on early assessments: there is a need for criteria on how EPA would weigh public health use in the decision making process; clarify that EPA plans to address the chemicals that present the greatest risk first; and substitute the concept of giving some uses a "bye" rather than guaranteeing a spot for them in the risk cup.

H. Comments on the risk assessment and risk management process were as follows: clarify that EPA will address the "worst first" and clarify how and when in the process critical uses of organophosphates and the pesticides with older chemistries were addressed.

I. TRAC members provided the following comments on regulatory mechanisms for achieving pesticide risk mitigation: regional or geographic differences should be addressed; add suspension to the list of outcomes for an acute significant risk as determined with a refined risk assessment; limited uses should be reflected in the summary table; uncertainty about the effectiveness of label changes as a regulatory mechanism; the difficulty of advising the Agency and USDA on how to go about the risk management process until the nine science policies are in place.

J. Comments on public participation in the risk management process were as follows: it is necessary to have a clear structure for the process to succeed; the timeframes proposed for the public involvement process may or may not be appropriate depending upon how much information is available at the start of the process; and providing a schedule of release for EPA's work plan for making decisions on organophosphates and cumulative risk would be helpful.

K. The group discussed the need for post-TRAC activities. EPA would be supportive of extending the TRAC if it were structured in a way that lessens the burden on EPA staff with meetings that are focused on tightly defined activities, spaced sensibly, and limited in number. USDA agreed that additional TRAC activities should be less rigorous. TRAC members shared the following comments and concerns about extending the process: extending the TRAC process should not be done at the cost of diverting the staff at EPA from the work necessary to proceed with FQPA implementation; other mechanisms for public input should be explored; wait to reconvene the TRAC process until the defined process was tested and after EPA receives public comments on the preliminary risk assessments and resolves its guidance on the risk assessment process; more time is necessary to strive for closure on outstanding issues such as how the Agency applied the decision criteria to a complex mixture question, risk management after the science policy issues are resolved, residential and drinking water exposure data are refined, aggregate and cumulative analyses are refined; insure that the process does not discourage healthy competition amongst Registrants; and evaluate the impacts on international trade.

L. USDA provided an overview of its priorities including their role in risk assessment, risk management, and transition strategies. Some of the comments USDA received were as follows: insure USDA data is utilized and the agricultural community is preserved; insure short term availability of alternatives; update the agricultural community on crop profiles; address the lack of data to determine exposure from drinking water; expand beyond the Land Grant University system for data and alternative controls; look for alternatives that reduce reliance on chemicals; develop the crop profiles for the highest risk crops first; act as an honest broker by bringing information from growers into the process and communicating "real" risk; recognize the consequence of increasing regulation and the consequent increase in imported foods; there is not a level playing field between domestic and foreign producers; there is a need to link National Agricultural Statistical Service (NASS) and PDP data for commodities; there is a need for accurate field data on use and usage; the risk posed by some of the processed foods that are heavily consumed should be viewed more closely; and biocontrol needs more funding; clarify that USDA's role in FQPA is essential and an active role is critical, particularly in providing data on pesticide use and consumption.

M. EPA provided the group with an update on the human testing issue. There were many different and strong views about the issue. EPA agreed to craft a memorandum directing Office of Prevention, Pesticides, and Toxic Substances (OPPTS) to develop this policy to be finalized by February 1999 and hold the joint SAP/SAB meeting augmented by ethicists and other experts. The process to address the issue of human testing would include new research performed by others and would involve a lot of discussion with a number of experts and would take time.

N. EPA presented an overview of the integration paper on risk assessment and risk management. Some of the comments from the TRAC included the following: good first step towards describing how the pieces fit together which also highlights the amount of remaining work; need to define whether and if early assessments would tax EPA resources; consider whether EPA can identify the low risk pesticides without spending time and resources; and clarify how EPA plans to make the parallel process work; distinguish between negligible risk and zero risk.

XV. February 25, 1999 East Coast and March 2, 1999 West Coast "Update" Meetings

To provide TRAC participants with information on the progress of USDA and EPA since the September 15 - 16, 1998 meeting, two TRAC 'update' meetings were held, one on the East Cost on February 25, 1999, and a second on the West Coast on March 2, 1999. TRAC members were provided with updates on the following:

XVI. April 8 - 9, 1999 WG2 Meeting

The agenda for the April 8 - 9, 1999 WG2 meeting was as follows:

Highlights of the meeting are summarized below:

A. EPA provided the group with an update on the pilot process proposed by the TRAC for the development of risk assessments and stakeholder involvement including a status of: the OPs in the process; the EPA and USDA intergovernmental review process to develop revised risk assessments; and public meetings (to be called technical briefings). Some of the comments and concerns of WG2 members follow: the potential for a complex chemical to increase the timeframe; determine to what level risk must be refined; clarify who at EPA and USDA was involved in different parts of the review process; define when the pilot will become formal; "risk contributors" were key issues; application of lessons learned from EPA and USDA coordination thus far in the process; clarify USDA's involvement in the review process; and cumulative risk remains a key issue in the process.

B. EPA presented an updated dietary risk assessment for Azinphos-Methyl (AZM) including possible additional data and refinements that could modify the results of the risk assessment. Some of the comments and concerns noted by TRAC members are as follows: there is a need to represent what the percentiles of risk mean in plain English; there is a need to evaluate the importance of finding acute hazard data as a benchmark to the assessment of safety factors; concern was expressed that the risk refinements resulted in lowering the level of risk; it was acknowledged that this evaluation could change with the addition of cumulative risk, the use of additional OPs, and factoring in ecological and worker risks; and public reaction to refined risk assessments that may be modified based on additional data, and the combined effects of updated information on additional organophosphates and cumulative risk was of concern.

C. EPA and USDA described the concept of "technical briefings" for the purpose of presenting the results of the risk assessments and to obtain recommendations on risk management proposals prior to placing the revised risk assessment into the public docket. TRAC members were generally supportive of the concept. A summary of some of their additional comments is as follows: present the information in tabular form; make the information available on the Internet; highlight worker exposure and include incident data; provide an overview and summary of the material promptly to compare with the risk assessment; correct assumption errors; and clarify the approach to addressing additional data needs and defining when there are enough data for decision-making on chemicals.

D. The group received a presentation on the Gerber Agricultural Program including how Gerber evaluates risk.

E. USDA provided the group with an overview of the core elements of a transition strategy. Some of the comments and concerns raised by TRAC members follow: in the absence of the results of a cumulative risk assessment, transitional strategies should address chemicals by class; add "economical" to the criteria for alternative tools; reconsider the idea of requesting help from the grower community on risk management strategies because it could foster competition between grower groups; clarify how public health considerations fit into the risk assessment process; recognize that there are different elements of transition, including regulatory transition, economics, the environment, farmers and agriculture; provide more information on Integrated Pest Management (IPM) to help foster its use; consider how chemicals fit into a broader resistance management strategy; and recognize and address the need for resources to address transition issues.

F. TRAC members then heard a presentation on an FQPA-Targeted Pesticide Residue Study performed by Michigan State University (MSU) and the Michigan Department of Agriculture for Region 5.

G. The group heard an overview of the elements of a transition strategy. Some of their concerns follow: economical considerations in pest control alternatives; unintended consequences; need for grower outreach; consideration of different production regions; include input from registrants and state lead agencies; clarify USDA's priorities; address the issues and concerns regarding imported foods; the use of crop profiles; the importance of new products; and the use of input from land grant universities. USDA acknowledged the importance of their role in transition and mitigation, including building partnerships and address import issues to protect the consumers and the agriculture of the country.

H. The group discussed the timing for the final TRAC meeting, agenda items, and other issues relevant to how the TRAC should operate in the future. September 1999 was suggested as the time for the final meeting. Many TRAC members felt ending the TRAC process in September was premature because there were many unresolved issues. Some ideas for the agenda included: use the list generated in the WG2 meeting as a basis; cumulative risk; worker risk; data needs and a review of data collection activities; risk benefit; and non-dietary residential risk process. Other comments included the following: welcome those who left the process to rejoin the final meeting; make sure the products addressed earlier in the review process benefit from lessons learned from the pilot process before making decisions on the OPs; allow for more preparation on worker safety issues including consideration by the PPDC and case studies; access to privately maintained databases; consider setting national performance standards for worker safety.

I. The Agency and USDA committed to one additional TRAC meeting. They suggested that the agenda might include: progress on a "mini-cumulative analyses on several OPs; and additional developments on transition; institutionalizing the pilot process for OPs; and other classes of chemicals.

XVII. April 27 - 28, 1999 TRAC Meeting

The agenda for the April 27 - 28, 1999 meeting was as follows:

Highlights of the meeting are as follows:

A. The group heard a brief overview of the WG2 meeting which was held on April 8 - 9, 1999.

B. TRAC members were provided with an update on the pilot process proposed by the TRAC for the development of risk assessments and stakeholder involvement. The presentation included an overview of the six stages of the pilot process and comments on the process. USDA involvement in the review process was also described. TRAC members requested clarification on the following: the handling of non-error comments in the "error only" review; adequacy of the period for USDA review of the risk assessment; adequacy of time for EPA review in Phases 4 and 6; conclusions to be drawn from the sensitivity analysis for risk drivers, including possible refinements on the scope of data collection; the value of the crop profiles in the risk assessment process; lessons learned from public comments from the different phases; the extent to which EPA evaluates different percentiles in the probabilistic risk assessment; OPs that pose public health risks; plans for use of state composite data; modifications in the preliminary risk assessments as a result of the pilot process; and future plans for making the risk mitigation process transparent.

C. TRAC members were provided with an overview of the prototype briefing on AZM. The presentation included the dietary portion of the risk assessment as well as information on the other components of the overall risk assessment to illustrate how the risk assessment has changed and evolved through the various phases of the TRAC pilot public participation process. The group then heard key perspectives regarding the organophosphates pilot process and AZM prototype briefing from the grower and Registrant communities.

D. TRAC members heard a general overview of how the Agency conducts a worker risk assessment, including the basic methodologies, a discussion of the issues gleaned from the OP assessments conducted thus far, and how to address them. Some of the concerns raised by the group were as follows: how reduction on worker exposure is addressed in the equation on risk; relying on the data in the Pesticide Handlers Exposure Database (PHED) and the use of default values; limitations with the assumptions used for hazard identification; assumptions used for dermal absorption; the potential consequence of pesticide cancellation as a result of worker protection concerns; and consideration of worker safety strategies used in other organizations like NIOSH and OSHA.

E. The group was provided a brief update on the nine science policies.

F. TRAC members then heard a presentation on an FQPA-Targeted Pesticide Residue Study performed by Michigan State University (MSU) and the Michigan Department of Agriculture for Region 5.

G. The group heard an overview of the elements of a transition strategy. Some of their concerns follow: economical considerations in pest control alternatives; unintended consequences; need for grower outreach; consideration of different production regions; include input from registrants and state lead agencies; clarify USDA's priorities; address the issues and concerns regarding imported foods; the use of crop profiles; the importance of new products; and the use of input from land grant universities. USDA acknowledged the importance of their role in transition and mitigation, including building partnerships and address import issues to protect the consumers and the agriculture of the country.

H. The group discussed the timing for the final TRAC meeting, agenda items, and other issues relevant to how the TRAC should operate in the future. September 1999 was suggested as the time for the final meeting. Many TRAC members felt ending the TRAC process in September was premature because there were many unresolved issues. Some ideas for the agenda included: use the list generated in the WG2 meeting as a basis; cumulative risk; worker risk; data needs and a review of data collection activities; risk benefit; and non-dietary residential risk process. Other comments included the following: welcome those who left the process to rejoin the final meeting; make sure the products addressed earlier in the review process benefit from lessons learned from the pilot process before making decisions on the OPs; allow for more preparation on worker safety issues including consideration by the PPDC and case studies; access to privately maintained databases; consider setting national performance standards for worker safety.

I. The Agency and USDA committed to one additional TRAC meeting. They suggested that the agenda might include: progress on a "mini-cumulative analyses on several OPs; and additional developments on transition; institutionalizing the pilot process for OPs; and other classes of chemicals.

XVIII. October 20 - 21, 1999 TRAC Meeting

The agenda for the October 20 - 21, 1999 TRAC meeting was as follows:

Highlights of the TRAC meeting are as follows:

 

 

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