USDA-EPA TOLERANCE REASSESSMENT ADVISORY COMMITTEE
Meeting Summary
Arlington Hilton & Towers, Arlington, VA
October 20 - 21, 1999

WEDNESDAY, October 20, 1999

Welcome and Introductions

John Ehrmann, Meridian Institute, welcomed participants to the seventh 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. He then initiated a round of introductions for the benefit of the public. A list of the TRAC members and materials for the meeting are presented in Docket # OPP00537.

Following the introductions, Dr. Ehrmann turned to Co-Chairs of the TRAC, Richard Rominger, Deputy Secretary, USDA, and Gary Guzy, General Counsel, EPA, for opening remarks. Mr. Rominger welcomed everyone to the last TRAC meeting. He observed that a lot had been accomplished since the start of the TRAC in implementing the Food Quality Protection Act (FQPA). Mr. Rominger reviewed some of the milestones of the process including developing difficult science policies in an open process, applying the risk assessment and management processes to ensure stakeholder involvement in shaping regulatory decisions, and learning more about different perspectives on pesticide regulation in general and the FQPA in particular. He stated that EPA and USDA learned from the input of the TRAC and he thanked members for their participation because it is contributing to successful FQPA implementation. Mr. Rominger observed that, while EPA met the first deadline for tolerance reviews, there are additional agricultural concerns and the potential for FQPA to have major impacts on farmers and others and there is a lot of work still to be done. He recognized that the framework and processes developed in the TRAC have worked, and he hoped that EPA and USDA could establish a process for the future to address the remaining issues such as cumulative risk, with a similar momentum and spirit as established in the TRAC. Mr. Rominger stated that he looked forward to input from the TRAC on a future process that would capitalize on stakeholder expertise. Finally, Mr. Rominger recognized that there were different interpretations of what transition means ranging from a plan of action to alter current pest management practices toward a biologically based system to a shorter term plan to address chemical-specific issues. At the conclusion of his remarks, Mr. Rominger turned to Mr. Guzy for opening comments.

Mr. Guzy also welcomed TRAC members to the final TRAC meeting and thanked them for their commitment to the process. He stated that the Agency and the Department had benefited from the advice of the TRAC. Mr. Guzy stressed that, while there had been a number of changes in EPA senior leadership over the course of the TRAC, EPA remained strongly committed to TRAC, the processes it has developed, and to continuing a working relationship with all stakeholders who are concerned with FQPA implementation. On behalf of Administrator Browner, Mr. Guzy stated that EPA will continue to devote a significant amount of senior leadership attention to FQPA issues and they will continue to respond to the concerns raised by the TRAC and others during the FQPA implementation process. Mr. Guzy also took the opportunity to reflect on some of the benefits of the TRAC which included: an increase in the degree of transparency on tolerance reassessment and risk assessments; a timely process to assess the tolerances for OPs; and an improved public comment process on nine key science policies that are important in the tolerance reassessment process. In addition, Mr. Guzy acknowledged as a direct result of the TRAC process, the unprecedented cooperation between EPA and the USDA and the enhanced ability to work cooperatively with all stakeholders to make regulatory decisions.

Mr. Guzy reviewed the progress on the five objectives summarized in the memo from Secretary Glickman and Administrator Browner to the Vice President at the start of the TRAC process. He stated that, while adhering to the principles of sound science, transparency, stakeholder involvement and a reasonable transition for agriculture, EPA and USDA first sought advice from stakeholders in an open and transparent process for tolerance reassessment. The result was a pilot process for the review of Organophosphates (OPs) and risk assessments, review and comment on risk assessments, technical briefings, and opportunities for stakeholder involvement in risk reduction. Mr. Guzy stated that the second objective was a policy framework for deciding if there was adequate scientific information on which to base tolerance reassessment decisions. He commented that, through the TRAC process, nine science policy areas were identified and a public process was established to refine the science principles. The third objective noted by Mr. Guzy was to speed the pace of decision making to make newer and safer pesticides and new uses of existing pesticides that meet FQPA requirements available to growers. To address this need, he noted that EPA put in place a process where alternatives to older chemicals can be given higher priority for review, and in collaboration with USDA, information about alternatives can be disseminated to growers. Mr. Guzy stated that the fourth objective was to identify common sense strategies for risk reduction while retaining pesticides of high public value and implementing reasonable phase out schedules for those pesticides requiring action. In response to this need, USDA and EPA are working in partnership to determine reasonable time frames to implement changes in pesticide use that reduce risk. The fifth objective was to prioritize the OPs that present the greatest risk to children. He explained that in response, EPA adopted a rigorous schedule to complete tolerance reassessment and to review individual OPs. Mr. Guzy summarized by stating that, through the previous TRAC meetings and the work group meetings, EPA and USDA laid a solid foundation to move forward on completing the assessment of tolerances required by the FQPA.

Mr. Guzy stated that one of the primary goals of the final meeting of the TRAC was to hear input on options for the structure of future stakeholder activities to address pesticide issues. Regardless of the structure, he noted that EPA would remain committed to following the principles of sound science, transparency, public involvement, and reasonable transition for agriculture while progressing to ensure a safe environment for our children and us. Mr. Guzy then took the opportunity to describe some of the progress since the last TRAC meeting. He noted that EPA published six science policy papers in the Federal Register for public comment; held eight technical briefings on OP's; and shared 14 risk management options. In addition, Mr. Guzy referenced EPA's actions on Azinphos Methyl (AZM) and Methyl Parathion (MP) that were consistent with the principles outlined by the TRAC. He summarized by stating that, for EPA, the TRAC process has been critical, educational, and has enabled them to move forward responsively and responsibly to address concerns raised by stakeholders. In addition, he felt the TRAC helped the members to understand how EPA regulates and provided EPA with a better perspective on the needs and concerns of the stakeholders. Once again, Mr. Guzy thanked TRAC members for their commitment to the process.

Agenda Review and Comments

After the introductory remarks, Dr. Ehrmann reviewed the agenda for the day as follows:

Review of Recent Activities and Agenda;

EPA Updates on TRAC Issues, including cumulative risk, human studies, tolerance reassessment progress, and worker risk assessments;

Status Report on OPs;

Transition Issues;

Tolerance Revocations/Channels of Trade; and

Public comment.

He explained that the agenda for the second day of the meeting would include:

Public Participation Process: Next Steps including options for the final process, experiences from the pilot process, FY 99 reregistration eligibility decision documents (REDs), non-OP REDs and the development process;

Post-TRAC Activities; and

Public comments.

Following the agenda review, Dr. Ehrmann introduced William Jordan, Office of Pesticide Programs, EPA and Margaret Stasikowski, Director, Health Effects Division (HED), Office of Pesticides Program (OPP)/EPA for the presentation on cumulative risk and other science policies.

Mr. Jordan began with a presentation on a number of science policies to assist in setting the context for the discussion on the culmination of the risk assessment process when looking at a group of chemicals with a common mechanism: the cumulative risk assessment. He referenced Staff Paper # 41, TRAC Science Policy, for his presentation and indicated that he would also include information about some recent activities not contained in the paper. Details on his presentation and all of the Staff Papers are presented in Docket # OPP00537. A summary of the highlights from his presentation is presented below.

Mr. Jordan commented that the science policies are comprehensive and cover issues from the start of the risk assessment process to the risk management phase. He noted that EPA was able to make a lot of progress on the policies thanks to input from the TRAC on identifying key issues of concern to various stakeholders and the hard work of individuals in the science divisions, HED, and the Environmental Fate Effects Division (EFED), as well as other parts of OPP. Mr. Jordan described the paper and stated that it provides schedules on the release of the various science policy papers. Among the papers released, Mr. Jordan referenced the most recent paper on threshold regulation as an example of a document that had been reviewed by the public and reissued as a revised policy document. He noted that the document had not yet been announced in the Federal Register. Mr. Jordan also explained that the drinking water exposure assessment paper, also reviewed and revised based on public comment, was complete and would be announced in the Federal Register soon. Other papers in various stages of review included the guidance on aggregate exposure, cholinesterase inhibition, the 99.9 percentile policy, and the policy on cumulative risk assessment. He stated that, when the policy papers on drinking water and aggregate risk are released, 18 out of the total of 19 policy papers would have been addressed. He added that, when the papers on drinking water and threshold regulation are finalized, five out of the 19 papers would have been finalized. Mr. Jordan thanked TRAC members for their thorough and thoughtful comments on the papers. Following his presentation, Mr. Jordan invited TRAC members to comment on his presentation.

Several members were concerned about EPA continuing to make decisions on pesticides before the science policies are finalized. One member commented on the amount of progress made by EPA, but she cautioned that there were still some outstanding science policies that could have some substantial ramifications on the decision making process. As an example, she referenced the recent deliberations of the World Health Organization (WHO) on chlorpyrifos in which they applied a different science policy to determine risk using the same information that EPA has. This approach yielded substantially different results in their calculations for chronic and acute risk. Another individual observed that, while the 19 science policy papers might be finalized by the middle of 2000, there is not another statutory deadline until 2002. He questioned the need to rush to judgment on additional products when some of the science policies could change between now and when they are finalized. He advised EPA to suspend decisions such as AZM and MP until the science policies are finalized.

Mr. Guzy responded that EPA was aware they are working on refining science policies while at the same time making decisions on individual chemicals. He commented that their interpretation of the congressional intent when FQPA was enacted was for EPA to manage their schedule in a reasonable and rational way and not wait until the established deadlines to complete the reassessments required. He stated that, as part of responsible management, EPA was also responsible for addressing the most risky pesticides first. In this regard, he felt that EPA could not stop the process, but would proceed using the existing science policies and adapt when and if the policies change. Using the example of the recent decisions on AZM and MP, the participant did not agree with the EPA approach because the determination of the safety of chemicals at this time could change when the policies are finalized, thus causing confusion in the marketplace. He stated that, in a channel of trade situation, the registrant will not go back and reproduce the product nor will the farmer use a product that has been determined to be unsafe. He asked EPA not to rush to judgement on additional products and take the chance of scaring the public unnecessarily. Jim Aidala, Associate Assistant Administrator, OPPTS/EPA commented that no one wants to see EPA stop its work on pesticides. He observed that if they had, they would not have approved 100 new active ingredients since FQPA. Mr. Aidala reiterated that as EPA approaches each decision, they evaluate which science policy applies and how a potential change in the policy might impact the decision so they can plan appropriately. As an example, he explained that, for MP and AZM they considered whether a change from 99.9 to a lower percentile could substantively alter the decision. For MP they determined there would be no measurable impact, whereas for AZM the impact could be significant, so they looked at different mitigation measures as a result of that analysis.

A third individual commented that, while he did not feel comfortable with EPA continuing to make decisions in the absence of final science policies, he understood that they had to move forward. He expressed concern about the way the August decisions on AZM and MP were made, and commented that he and others lost confidence in the progress made over the past year. He viewed the fact that decisions continue to be made without finalized science policies as the most compelling argument for continuing organized stakeholder involvement in the process.

Other TRAC members commented on the drinking water policies. One individual felt there was a need for more transparency regarding the drinking water policy papers. She commented that review by the Scientific Advisory Panel (SAP) was not a substitute for public comment. The individual was particularly concerned about the fact that risk from drinking water was recognized as a concern in each of the technical briefings based on EPA modeling which in turn is based on science policies that have not yet received comments from the public. Mr. Jordan explained that when EPA issued Paper number eight, entitled Dietary Drinking Water Exposure Estimates, they identified two improvements to the model, index reservoirs and percent crop treated, which they felt would make the modeling results more realistic. He stated that the comments from the SAP and the public at that meeting supported these changes. Mr. Jordan commented that EPA decided to implement the changes based on these comments, and address the changes in next two papers on drinking water, at which point the public will have the opportunity to comment. He clarified that the papers are Paper number 25 on quantitative uses of concern for drinking water, and Paper number 26 on the kinds of information that reflects the impact of water treatment on pesticide residue levels consumed by humans in drinking water. In response to another question of clarification, Mr. Jordan explained that EPA was developing a tiered assessment scheme for drinking water that was similar to the dietary assessment.

The individual also felt that the approach EPA was using to assess drinking water was "backwards" and she wanted to know why. Keith Pitts, Special Assistant to the Deputy Secretary, USDA, responded that the Pesticide Data Program (PDP) residue monitoring program for water would also be used in the future. He noted that the PDP data and or industry data might be used for additional information when a chemical is identified through modeling as a persistent problem. He also noted that no regulatory decision has been made on drinking water and decisions are currently made by looking primarily at food uses. Mr. Guzy added that the Agency recognizes the evolving nature of the work on drinking water which is why decisions like the one made on August on AZM and MP were tailored to look primarily at dietary risk rather than relying on the areas of less certainty. As a final comment, the individual cautioned against EPA singling out one active ingredient in its study and that it is important to factor into consideration patterns of pesticide use, geography and environmental characteristics.

One individual asked for clarification on the stakeholder process that will be used to address future similar issues associated with new product registration and reregistration, such as occupational health and safety and the new cancer guidelines. As a specific example of how the FQPA model worked, he referenced the paper on common mechanism of toxicity in which there was a description of the Agency's thinking on the comments received and how the policies were changed as a result. The individual wanted to know if EPA was considering a similar approach to address future issues. Mr. Jordan responded affirmatively.

Another member raised the concern that EPA had not yet addressed the cancer policy through a transparent process. He felt the issue was not only what the general policy was, but also how to decide whether a product should be regulated with a threshold or non-threshold mechanism. He noted that the potential impact on the risk cup would not be linear when considering the regulating mechanism. The member felt that the same standard of transparency applied to other science policy issues should also be applied to the cancer and other policies, before making too many additional decisions on products. Mr. Aidala responded that tomorrow's discussion on post-TRAC activities would begin to address the concern about how stakeholders would be involved in decisions on future policies. In response to the question on threshold and non-threshold cancer assessment, Mr. Aidala explained that the Science Advisory Board (SAB) which is also a public forum is currently considering this issue. As to how the process on the cancer policy applies to pesticide decisions, Mr. Aidala recognized that would be a follow-up issue to TRAC. In addition, he acknowledged that the application of the different regulatory mechanisms of threshold and non-threshold can make a substantial difference in the risk assessment and that is one of the reasons EPA is also anxious to hear the results of the SAB evaluation of the cancer policy. The member elaborated on what he saw as a potential connection with FQPA. In FQPA, when addressing cumulative risk when there is a common mechanism, it is necessary to consider all of the mechanisms. He encouraged EPA to address this connection soon. Mr. Aidala commented that EPA is well aware of the complexity of this issue and explained that the statute was written with the nomenclature of threshold and non-threshold with this complexity in mind. He suggested that the discussion on cumulative risk might illuminate this discussion. As an example of how this concern might influence the common mechanism, another member referenced the mid-Atlantic Apple review in which the to-do lists under the chemical scenarios is dependent on getting chemicals through the pipeline that are either new uses of an existing active ingredient or a new active ingredient. He commented that judgements regarding many of those chemicals could be influenced by the cancer policy. In response to this concern, Mr. Guzy observed the importance of these points and agreed that it was difficult to wait for clarification on the cancer policy. However, at the same time, he stated that it was also important for EPA to ensure that the right scientific and public processes are used and that process takes time.

Following these comments, Dr. Ehrmann turned to Ms. Stasikowski for her presentation on cumulative risk. She began with an overview of EPA's progress on developing a cumulative risk assessment methodology since the passage of FQPA. Ms. Stasikowski explained that EPA solicited input from stakeholders, workshops, and other agencies to complete the first phase of work that was reviewed by the SAP. She explained that in their discussions with the SAP, they considered the selection of chemicals for cumulative risk assessment, selection of key toxicity points that would trigger cumulative risk assessment, risk estimation methods, and how to apply the uncertainty factor. After summarizing some of the key points of the methodology in an example, Ms. Stasikowski summarized that in a cumulative risk assessment, chemicals in a group are compared against the same endpoint. She stated that the uncertainty factors and safety factors would be applied to the entire group as appropriate. Ms. Stasikowski clarified that uncertainty and safety factors from individual chemical risk assessments will not be used in the cumulative risk assessment. She stated that the SAP review was supportive of these approaches and EPA expects to submit information on exposure assessment, risk characterization, and a case study to the SAP for their review in December 1999. She stated that the guidance would be available for public review in the spring of 2000.

After Ms. Stasikowski's presentation, Dr. Ehrmann invited members to comment and ask questions of clarification. One individual asked for an example of how the uncertainty and safety factors would be applied to a group of chemicals. Ms. Stasikowski explained by comparing individual versus a cumulative risk. She used the example of chemical A which causes eye lesions where they have applied an uncertainty factor for inter-species of 10 and an intra-species factor of 10, yielding a total factor of 100. She noted that the same inter- and intra-species factors apply for chemical B, however the red blood cell cholinesterase never reached a No Observed Effect Level (NOEL) and an additional uncertainty factor of three was applied. In the case of chemical B, she noted that the total uncertainty factor was 300. For the cumulative risk assessment, Ms. Stasikowski explained that it might not make sense to apply the additional uncertainty factor of three because the NOEL was not reached, consequently the uncertainty factor might be 100 with a sufficient database. The member stated that this policy issue should be addressed in more detail and he suggested that TRAC would not be complete until this significant science policy is addressed.

Another individual asked for comments on the development of the exposure side of the equation and whether there will be a different kind of demand for exposure data, other than the chemical by chemical and aggregate data, to complete the entire analysis. Ms. Stasikowski acknowledged that these are complex issues and explained that EPA will be presenting exposure assessment issues to the SAP in December and it was premature for her to discuss them in any detail. Mr. Aidala agreed that addressing this issue would be difficult and he reassured the member that the process would be open to peer review. The member added that, with more detailed residue data and exposure projections, it would be possible to show instances where simultaneous exposures were not occurring. In addition, he felt that the approach to collecting exposure data might have to change in order to address other factors such as the use of different chemicals on different coasts and the unlikely chance of commingling those kinds of food supplies to represent a potential common mechanism of exposure. He posed the question of whether EPA should be thinking about how to factor these kinds of issues into the current efforts.

One member requested additional clarification on feedback from the SAP on the common mechanism for OPs. He recalled that the International Life Sciences Institute (ILSI) determined that there was not sufficient evidence to say that they did not have a common mechanism, but that a clear affirmative statement was not made by ILSI. Ms. Stasikowski responded that the comments from the SAP were supportive of EPA's and ILSI's conclusion that OPs should be viewed as a common mechanism group. Mr. Guzy followed up by saying that EPA could pull the language from both ILSI and SAP to confirm this. He commented that it was important to note that the Agency concluded that based on the ILSI and SAP findings, the OPs share a common mechanism.

A participant observed that the September SAP report recommended grouping OPs together in addition to grouping the class of OPs with some pesticides in the carbamate class. Based on this, he asked if EPA expected that other classes of pesticides would be grouped together. Stephen Johnson, Acting Deputy Assistant Administrator, OPPTS, EPA, responded that, as EPA continues down the tolerance reassessment road, they recognize that there will be groups of chemicals, like the OPs and carbamates, for which they will be seeking public input and determining whether there is a common mechanism and if there is any crossover. He noted that EPA is aware of some of the related work being performed by industry on synthetic pyrethroids that indicates that a common mechanism is not shared among all synthetic pyrethroids. At the same time, he cautioned that this is early information that has not been reviewed by EPA. Another individual asked for clarification on what was meant by the term "crossover." Mr. Johnson explained that an example of what he meant by crossover was the similarities between the OPs and the carbamates. He stated that, based on his limited understanding of toxicology, he was not aware of other examples of crossover at this time.

Marcia Mulkey, Director, OPP/EPA, provided the group with a brief update on human studies. She stated that EPA has never required the use of human toxicity test subjects to evaluate the toxicity of pesticides. In addition, she recalled that last summer it became clear that a number of pesticide companies were conducting these kinds of studies. At that point, she noted that EPA announced an interim approach to its consideration of these studies to explore the way EPA would handle them while at the same time consulting with key experts in science ethics to inform a longer-term approach. Ms. Mulkey further clarified that the Agency announced last summer that it would not base any final regulatory action on these studies in the absence of a policy approach that would enable a full evaluation of the ethical acceptability of the study. At the same time, Ms. Mulkey indicated that the Agency convened a joint panel of the SAB and the FIFRA SAP, including regular members and invited members who were eminent science ethicists, for a two-day meeting in December to discuss these issues. She explained that, in its preparation of a report on the meeting, the group determined that they needed additional discussion to prepare a report on these difficult issues. Ms. Mulkey stated that EPA agreed to an additional meeting on November 30, 1999. In the meantime, Ms. Mulkey explained that EPA is proceeding with their interim approach and they are eagerly awaiting the final report on this issue from the SAB and SAP.

Following her presentation, a member asked Ms Mulkey to explain what she saw as an inconsistency in timing and approach to the use of human testing. She referenced guidelines on neurotoxicity testing that were finalized on May 14, 1998, section 3.1.1.4, Human Laboratory Exposure Studies, which read, "neurotoxicity assessment has an advantage not afforded to the evaluation of other toxic endpoints, such as cancer or reproductive toxicity, and that the effects of some chemicals are short in duration and reversible. This makes it ethically possible to perform human laboratory exposure studies and obtain data relevant to the risk assessment process." Alternatively, she noted that a month later, EPA made a statement suggesting that no human tests would be accepted because OPs are neurotoxins. To her, this was confusing and inconsistent. Ms. Mulkey cautioned that it was important to clarify whether the studies referenced in the guidelines were human exposure studies, which have not been the subject of such intense focus with regard to ethical issues. The member responded that the referenced guidelines were for toxic endpoints. Ms. Mulkey reiterated that there is concern that a number of these studies are occurring and it is time to look carefully at the ethics associated with the conduct of these studies. Mr. Aidala added that this was raised as a TRAC issue and it remains an unfinished science issue. While it would be preferable to have addressed the issue conclusively, EPA is now in the process of resolving it. The member remained confused about whether the guideline was voided or not. In response to her concern, Mr. Aidala explained his understanding that the key concern to OPPTS was oral dosing, however he could not represent what other programs in the Agency were concerned about in their evaluation of the issue.

In response to Ms. Mulkey's explanation of why EPA announced an interim approach to considering human testing, one member asked EPA to clarify the source of its concern about human studies. She observed that human testing performed prior to FQPA formed the basis for selecting endpoints and provided EPA with reliable and available data about how a chemical reacts in a human. She wanted to know if EPA now considered these tests to be unreliable or whether they considered the tests to be unethical. Ms. Mulkey explained that, until EPA has a policy to help it sort through whether to rely on the studies and how for ethics purposes, EPA thinks it is appropriate not to rely on the historic human studies for any final regulatory action. She added that they think it is appropriate, aside from ethics, to evaluate how valuable those studies might be to understanding other scientific principles. She also noted that, on closer evaluation of the studies, EPA determined that some of them are not suitable for continued use and some do not contain conclusive information. Ms. Mulkey closed her comments with the observation that EPA has also determined that some of the studies, on which they have based reference doses, are out of date and better scientific data are available. Based on Ms. Mulkey's comments, the participant inquired whether this meant that EPA would approach each circumstance separately. Ms. Mulkey responded that it would depend on the content of the final policy. The member asked if this discussion also pertained to studies for worker exposure. In response, Ms. Mulkey explained that although there are ethical issues regarding studies conducted to understand worker exposure, they do not present the same kind of challenging dilemmas that the science panels are struggling with. She stated that EPA continues to evaluate those and accept or reject them on a case-by-case basis.

Another member reminded EPA that the decisions it makes on science policies like 99.9 percent could put the U.S. grower at a competitive disadvantage, particularly with foreign growers who are not held to such strict standards. As an example, he referenced the earlier comments on the consequence of applying the guidelines of the WHO, not the federal government, on chlorpyrifos. The member also referenced the science policy on the level of detection as an additional disadvantage to the domestic grower because foreign growers are not held to the same standard. He stated that by the time the foreign fruit reaches the U.S., the U.S. Food and Drug Administration (FDA) is unable to detect residual pesticides and the fruit is marketable. He urged EPA to find a way to address the ethics problems regarding human testing in the same manner as done by the rest of the world.

One member was concerned about the use of the phrase "final determination" in the interim policy on human testing and asked if that meant based on the preponderance of the data? Ms. Mulkey explained this referred to taking a final action with a clear understanding of all of the issues.

A participant commented on the data call-in for neurotoxicity studies. She observed that there are some cases where OPs have been further along in the process at which point the Registrant has received documentation from EPA indicating that based on the preponderance of the data, there is no need for a developmental neurotoxicity study. She asked if this was a firm determination. Ms. Mulkey responded affirmatively.

Jack Housenger, Associate Director, Special Review & Reregistration Division, OPP, provided the TRAC with a summary of the tolerance reassessment process. A summary sheet of his presentation is contained in Docket # OPP00537. Mr. Housenger reminded TRAC members that the FQPA establishes time frames for EPA to complete reassessing all of the tolerances that were on the books as of August 3, 1996, one third of them every three years until August 3, 2006. He explained that EPA grouped the pesticides in accordance with FQPA and group one contains the largest number of tolerances, including those pesticides that are seen to pose the greatest risks. Mr. Housenger noted that, as of August 1999, EPA met their goal for completing the first round of reassessments. Out of the total number of tolerances, 9,721, EPA reassessed and released 3,290, greater than one third of the total. Mr. Housenger observed that most of the pesticides reassessed were from group one, and there are 3,369 pesticide tolerances remaining in group one to be reassessed. Mr. Housenger concluded his remarks by stating that EPA made additional progress in the reassessments since August and as of mid-October had completed over 35 percent of the reassessments.

Following Mr. Housenger's summary, Dr. Ehrmann invited comments from TRAC members. One individual took the opportunity to express his disappointment regarding EPA's decisions on AZM and MP in August 1999. He felt that, regardless of the progress made on reassessments, the decisions represented a step backward in the process because they appeared to be made for political reasons rather than being based on science. The member commented that those decisions hurt EPA's credibility and encouraged them to be more sensitive to the agricultural community by not repeating the same mistake in the future. Dr. Ehrmann explained that there would be additional discussion on this topic during the update on OPs.

Another member noted that FQPA's Section 408(Q), Publication of Schedule, required an initial Federal Register Notice in not less than 12 months. However, he observed that the schedule was changed more than once since the posting and inquired whether the schedule could be clearer in the future. Ms. Mulkey responded that while some of the pesticides reassessed in the first group were not on the first list, the posted list of priorities is still valid. She also stated that EPA would check this and make efforts not to post misleading information.

One individual asked for information on what was done with the tolerances that were completed. Mr. Housenger responded that 1,498 were revoked and the tolerances that have been reassessed with REDs are as follows: 143 need to be raised, 133 need to be lowered, 584 remain the same, 93 need to be revoked, and 46 need to be determined. The individual also asked for clarification on the label validation process because inappropriately labeled material creates problems in the market place. Mr. Housenger explained that after labels are modified to the technical registration, they ask the Registrant to communicate the change to the customers. EPA then follows up and asks for voluntary cancellations if appropriate. The member commented that this process needs to be clarified because, based on his experience, the communication is not always happening effectively. He stated that it is unclear whose responsibility this is. In response to this concern, Mr. Johnson commented that there are two aspects to think about: one is to make sure the Federal licensing process is followed and makes its way through the channels of trade, and the second is label enforcement to make sure the labels are in full compliance with the action. As a point of clarification, one individual commented that it falls to the responsibility of the regulating state to make sure that the labels are changed. At the same time, he observed that states are generally not included in the decision making process and are left to react to the decisions. He noted that label changes take time to implement, as evidenced by products like Paris Green remaining on the shelves in some locations, and create a lot of work at the state level where multi-year registrations may be in place. To address a label change in this circumstance, the state makes the company reregister the product and this requires time and creates paper work.

In light of the limitations of the studies on neurotoxicity and developmental effects, one member asked how many reassessments involved applying the 10-X children's uncertainty factor. Ms. Mulkey responded that EPA will provide those data but she did not have the details to present at the meeting. In addition, she noted that there was a major science paper on how EPA applies the FQPA safety factor analysis that was released in July 1999. Ms. Mulkey also stated that there were multiple presentations to the SAP on this subject and a description of how EPA applied the safety factor in the risk assessments for each of the OPs. As an addendum, another member referenced a recent comprehensive study by organizations representing the international community to evaluate whether the current methods for setting maximum residue limits are adequate for the protection of developing organisms. She stated that the conclusion of the study was that there is currently no basis for changing the current approach to addressing the susceptibility of developing mammals as compared to that of adult organisms in the toxicological evaluation of pesticides.

Dr. Stasikowski initiated the presentation on the expanded public participation process in occupational risk assessment. She referenced Staff Paper # 43, Occupational Risk Assessment, for the presentation and explained that the purpose of this presentation was to try and respond to a request from the TRAC at the last meeting for additional information on occupational risk assessments and more public participation earlier in the process. She summarized some of the related activities that took place over the summer, including Land Grant University (LGU) review of the risk assessments and an EPA briefing on the methodology at the July Pesticide Program Dialogue Committee (PPDC) meeting. Therese Murtagh, Office of Pest Management, USDA, added that, in the course of their review of OP risk assessments and occupational risk assessments, the LGUs concluded that they would better serve EPA as contributors to the assessments. They also requested additional information on the data required in a risk assessment and the Pesticide Handlers Exposure Database (PHED) and on a process that could facilitate their earlier involvement. To respond to these requests, Ms. Murtagh explained that EPA initiated a series of meetings with different representatives from the LGU system, the most recent of which took place in Louisiana in September 1999. Through the meetings, Dr. Stasikowski noted EPA was able to clarify the risk assessment process and answer a number of questions posed by the LGUs. Ms. Murtagh commented that EPA was well on their way to addressing the LGU's request for more information on the occupational risk assessment process, but they need to set up a working process for the involvement of the LGUs as contributors to the process. She noted that, later in the meeting during the discussion on a revised public participation process, USDA hoped to add an earlier opportunity for involvement by LGUs. In addition, Ms. Murtagh stated that there are a number of upcoming meetings in the spring during which occupational risk assessments will be discussed, including a multi-day workshop for LGUs coordinated by Larry Olsen, Michigan State University, as an expansion of the Louisiana meeting. Dr. Stasikowski summarized the presentation by emphasizing that the Louisiana meeting was open to the public, as will be future meetings in the spring. She also stated that USDA has joined industry and the EPA task force for further development of the PHED.

A member asked for clarification on the regions represented by the LGUs and whether different, less traditional agricultural practices were represented. Ms. Murtagh responded that, at the Louisiana meeting, representatives from all USDA regions were represented.

Another member supported EPA in its efforts to expand the worker risk scenarios because they are complex. As an example of the potential benefits of this effort, she referenced what she thought were telling comments from the LGU on Bensulide and its agricultural uses. She also requested clarification from EPA on whether it is evaluating probabilistic risk assessments for worker exposure scenarios and whether EPA is accepting this type of risk assessment from industry. Dr. Stasikowski responded that, as EPA collects more information from the industry task force they hope to move toward probabilistic risk assessments. She also stated that EPA is accepting probabilistic risk assessments from industry and that they hope to see more of them.

One individual clarified that worker risk protection was addressed in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), not FQPA, and that FIFRA also requires a risk benefit analysis. He asked EPA to clarify how it plans to address risk benefit analysis in this context. Ms. Mulkey responded that in the situation where there are risks posed to workers, it is necessary to consider whether the risks are unreasonable adverse effects when the benefits are taken into account. For example, she noted that risk benefit was taken into account when evaluating whether to take risk management measures. She stated that the same is true when evaluating ecological adverse effects. Mr. Aidala also clarified that FQPA was a set of amendments to FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA) and the amendments to FIFRA did not change the benefit considerations for worker risk.

Another member asked if in the case where a product is regulated for a non-threshold effect from the dietary standpoint, was there a bright line for handling the safety assessment for workers on the same product? Ms. Mulkey explained that there was not a bright line for handling the general public safety; however, she commented that there is a point at which the benefits analysis comes into play.

One individual took the opportunity to provide some perspective on working conditions in the field. Based on his experience, working conditions in pesticide production are safe and there have been no toxicity incidents in his operations for the past three or four years. In addition, he observed that there have been no incidents resulting from the application of pesticides since 1984. He stated that as long as people follow the rules of safety there is no problem. He cautioned against developing too many regulations because of the potential unnecessary burden on the industry and agriculture. Mr. Aidala explained the logic of connecting worker safety and food quality. He noted that, while addressing aspects of FQPA, the discussions would also logically incorporate the related FIFRA concerns of reregistration requirements. Mr. Aidala added that it was important to have a method to make the connection between what is observed in the field and what is understood in other arenas.

Status Report on Organophosphate (OP) Pesticides

Lois Rossi, Director, Special Review & Reregistration Division, OPP/EPA presented an overview of the Agency's review of OPs. Ms Rossi stated that the status report reflects a great deal of work by the Agency, the Department, and stakeholders present and those not at the meeting. She acknowledged that there was a lot of work to be done, but she hoped TRAC members would also reflect on the accomplishments to date. Ms. Rossi explained that she planned to present an update on the schedule for review of the individual OPs, technical briefings and stakeholder meetings, and highlights of decisions regarding several Ops, including MP and AZM.

For this part of her presentation, Ms. Rossi referenced the handout entitled, Status of OPs in the Pilot Public Participation Process. She noted that the Agency has released a large number of preliminary risk assessments that are now in the Docket, including 35 OPs with four OPs to go. She reviewed the timing of release and the number of preliminary risk assessments released since the process started in August of 1998. Ms. Rossi also summarized the number of OPs that are in each phase of the review process. In addition, Ms. Rossi explained the current activities on the OPs and how EPA is refining the risk assessments. She noted that EPA has worked closely with USDA over the past year to ensure that appropriate refinements were made to the risk assessments that also play a role in risk management. First, she stated that composite PDP data are used to estimate single servings in probabilistic risk assessments and the best data are used in the assessments. She explained that they are determining risk contributors or drivers and the underlying assumptions for the drivers. Ms. Rossi commented that for occupational risks they have received and used a lot of data from the Agricultural Reentry Call-in Task Force and they have been working to refine the risk assessments using the best data and assessment tools available.

Ms. Rossi briefly summarized the status of the 39 OPs, four of which are in Phase 1, four are in Phase 2, and three are in Phase 3. She stated that 12 chemicals are in Phase 4 and are next in line to have refined risk assessments released for public comment. Ms. Rossi noted technical briefings would take place over the next few months for Acephate, Amidophos, Dimethoate, Methidathion, and Oxydemothon. She noted that there are eight chemicals in Phase 5 and eight in Phase 6. To date, Ms. Rossi explained that EPA has released 16 revised, refined risk assessments for chemicals that are in Phase 5 and 6. She clarified that the same day they release the revised risk assessments to the public Docket and the Internet, EPA opened Phase 5 which is a 60 day public participation period. Ms. Rossi clarified that the 60-day period is the opportunity to submit risk management ideas and to meet with the Agency to discuss assessment data, methodology and mitigation proposals.

Ms. Rossi commented that EPA has learned a lot from the technical briefing and the stakeholder meetings. Staff Paper # 45, Status of OP Technical Briefings, provides additional details on the presentation. She recalled that the pilot process was modified to include a technical briefing to provide an additional opportunity for stakeholders to hear a brief presentation on what went into the risk assessment and to meet with and ask questions of the Agency. She explained that EPA conducted the technical briefings with input from USDA and they are scheduled at the end of Phase 4 after the revised risk assessment is completed. Ms. Rossi stated that eight technical briefings have occurred and those in attendance included representatives from industry, commodity associations and growers, and other non-governmental organizations. She commented that in preparation for each of the technical briefings the review teams worked closely together and with management to produce a better quality risk assessment which was presented to the public in understandable terms. Ms. Rossi stated that the technical briefings have been a successful internal process for OPP review teams and the management team and have been beneficial to the public and the Agency in other ways. She noted that the collective wisdom produced as a result of the interactions has helped to ensure sound decisions. In addition, Ms. Rossi indicated that the Agency is committed to the public participation process and will continue to encourage it by providing notice of the technical briefings and maintaining good communications with the stakeholder community. As part of what they have learned from the process so far, Ms. Rossi explained that EPA is planning to hold the next technical briefing outside of Washington, D.C. in California where two of the chemicals that will be discussed are mostly used. She reviewed the upcoming schedule for technical briefings and explained that the Agency decided against formal technical briefings for several chemicals because of their limited use patterns. As an alternative for these chemicals, Ms. Rossi indicated that EPA staff is available to meet separately to discuss questions and concerns.

Ms. Rossi provided the group with some highlights on decisions on OPs that are close to closure, Bensulide, Profenofos, and Cadusafos. She noted that for all of these chemicals, EPA has been working closely with the registrant and the user communities and all of these pesticides are in reregistration so the work has involved REDs and a discussion of risk management strategies on the non-dietary concerns. Ms. Rossi stated that for Bensulide and Profenofos the issues have largely been non-dietary. For Bensulide, EPA has worked with the Golf Course Superintendent Association to address turf use issues, and for Profenofos, which is used on cotton, they have worked closely with the cotton growers on mitigation measures. For Bensulide and Profenofos, EPA is producing REDs that will stipulate that the tolerances will not be reassessed until a cumulative risk assessment is done on the OPs. She indicated that for Cadusafos the primary concern is an import tolerance on bananas.

Ms. Rossi also referenced an additional OP used in greenhouses for ornaments, Sulfotep, which has been undergoing reregistration for years. She stated that the outcome of the reregistration process was to declare it ineligible. However, she noted that because of its importance to the industry, EPA has agreed to a five-year phase out plan. Finally, she commented on the three OPs used for public health concerns, Fenthion, Naled, and Temephos. She indicated that there was a successful preliminary stakeholder meeting on these chemicals and EPA plans to discuss risk mitigation and management plans soon.

Following her summary of OP highlights, Ms. Rossi provided a status of the implementation agreements for MP and AZM. As background, Ms. Rossi stated that both of the chemicals have food uses and tolerances that are required to be released under FQPA and they are OPs in the pilot process and in the reregistration program. She noted that the review of AZM began prior to the passage of FQPA and a preliminary risk assessment was released in August 1998, as one of the first nine released for public comment in the pilot process. AZM went through Phases 1, 2, and 3, and in the preliminary risk assessment dietary concerns were raised. Between October 1998 and May 1999, the Agency, in consultation with USDA, revised the human health risk assessment and PDP data were integrated into the process. Ms. Rossi stated that the refined human health assessment indicated that the chemical would not meet the FQPA safety standard. She noted that a technical briefing on AZM was held on May 19, 1999 and Phase 5 was initiated involving public participation with an additional focus on risk management strategy. Ms. Rossi commented that Phase 5 was completed on July 19, 1999, at which time the fate and ecological effects risk assessment was still lagging behind. Then Phase 4 began and discussions with USDA and stakeholders on risk mitigation commenced, drawing from prior discussions in Phase 5. Ms. Rossi summarized that based on all that was learned in Phases 1 - 5, it was determined that a modified use pattern with supporting data would probably be the appropriate risk management decision for AZM. Based on this conclusion, EPA initiated discussions with the registrants. Through these discussions, she explained that the registrant agreed to reduce application rates to pome fruits, cancel some uses on cotton, sugar cane and ornamentals. Ms. Rossi stated that EPA believes the use modifications and cancellations resulted in reduced risk to workers as well as to the ecology, but they are also following up with the registrants to better assess the risk. She summarized that the actions they have taken include approving revised labels for the next growing season, and impending announcements for the cancellations of sugar cane, eastern cotton use, shade trees, Christmas trees and a number of ornamentals. Ms. Rossi stated that as an important part of the agreement, EPA continues to meet on data to confirm that the modified use patterns will result in reduced residues.

Ms. Rossi then summarized the status of MP. She explained that MP was not as far along in the process as AZM and that the preliminary risk assessment was submitted to the Registrant for error correction in October 1998. Following the error correction, the preliminary risk assessment was released in December 1998, showing levels of concern. She explained that between February and early August of 1999, the Agency refined the risk assessment using the benefits of what was learned in the AZM process. She stated that the results of the refined risk assessment showed that dietary risks were orders of magnitude above the levels of concern, no further refinement was possible using current data, and it was unlikely that the FQPA safety standard would be met. Ms. Rossi indicated that EPA began to try and identify potential drivers and mitigation measures in May 1999 with the help of USDA, registrants and growers. She stated that a technical briefing was held in August 1999 announcing the results of the risk assessment and incorporating the mitigation measures agree to with the registrant. She noted that the cancelled uses accounted for approximately 90 percent of the acute dietary risk to children, roughly 10 percent of the total use of MP. Ms. Rossi commented that EPA believes that these measures qualitatively have an impact on reducing worker and ecological risks. She summarized that the status of the agreement on MP is that old use patterns were cancelled on August 25, 1999 and the new products with the revised use pattern were approved on October 8, 1999. In addition, she stated that the agreement calls for additional data to be submitted, particularly addressing worker risks.

Ms. Rossi summarized the next steps for AZM and MP. She stated that there is a lot of follow-up activity for both chemicals. For AZM, the Agency will convene a group to develop a production cap which was an additional mitigation measure discussed along with the other suggestions for mitigation. She noted that EPA will continue to follow-up on the specifics of voluntary cancellations, and they will begin to construct the REDs for AZM. Ms. Rossi indicated that for MP, EPA is still taking comments on the refined risk assessment. Ms. Rossi closed her comments with the statement that there has been a tremendous amount of effort by everyone to get the 35 OPs to their current state. She noted that the pilot process for the OPs has been used to carry out the reregistration process for many of the chemicals, with the exception of four chemicals that were registered after 1984. Ms. Rossi stated that many of the steps in the process are characteristic of the standard reregistration decisions; however, the process has been opened up for stakeholder involvement and the transparency of decisions has been significantly increased.

After her remarks, Ms. Rossi invited TRAC members for comments and questions. One participant commented on the importance of the technical briefings and asked if there had been a briefing on Terbufos, an important pesticide for cotton. Ms. Rossi responded that they did not have a technical briefing on that pesticide because of the limited use pattern, but she invited the participant to request a stakeholder meeting on Terbufos as an alternative.

Another participant applauded Lois Rossi and Margaret Rice and their staff for their performance at the stakeholder briefing in Orlando, Florida the previous week. He felt the only drawback was the absence of the Department of Health and Human Services (DHHS) and their apparent lack of focus on these issues. He inquired about the timing for the technical briefings on the public health pesticides. Ms. Rossi explained that the stakeholder meeting last week would substitute for the technical briefings on those pesticides. The member commented that there was insufficient time in advance of that meeting for comment on the risk assessment for Fenthion. Ms. Rossi added that the risk assessment is released at the time of the stakeholder meeting; consequently, the review occurs after the meeting. Ms. Mulkey clarified that the stakeholder meeting used the same process as is used at the technical briefings. Mr. Guzy added that the Agency appreciated the constructive comments on the stakeholder meeting.

One member complimented Ms. Rossi and her staff and the registrant on the cooperation shown during the discussions on AZM. As a result of his experience with AZM, he proposed two improvements in the process. First, he stated that the time frame for obtaining grower comments was too short for meaningful comments. He suggested that EPA establish a schedule and stick to it. Second, he felt it was necessary to clarify the way in which growers should submit their information for consideration, particularly for minor crops which may not be a top risk driver. As a follow-on to this comment, Mr. Aidala took the opportunity to prepare TRAC members for some of the next morning's discussion. He explained that they hoped during tomorrow morning's discussion on the pilot process to hear more comments like these on what did and did not work well in the pilot process to assist in improving the process. Ms. Rossi added as an example, that EPA learned the importance of early involvement through their experience with the pilot process.

An individual suggested that it would be helpful to bring the stakeholders, registrants and the Agency together to evaluate the AZM and MP experience and have them reconstruct the process on the basis of the four principles embodied in the TRAC process to highlight the lessons learned. He also asked whether the FIFRA 6(F) Voluntary Cancellation Provision, which requires 180 days before the cancellation takes effect, was waived in the case of AZM and MP agreements and whether the waiver was published in the Federal Register. Ms. Rossi explained that the agreement included a waiver of the comment period and a waiver is not typically published.

In response to some of these points, Mr. Guzy explained that there were a number of factors that influenced the Agencys decisions, one of which is their belief that there had been a lengthy public process involving substantial public review of the risk assessments of these substances. He stated in the case of AZM, they adhered to the time frames clearly spelled out in the process developed by the TRAC. In the case of MP, Mr. Guzy was certain that EPA adhered to the time frames for developing the refined risk assessment. In addition, he felt that EPA was consistent with what they have articulated about significant exceedances of the risk cup, where the Agency reserves the right to move forward on risk management, when appropriate. He stated that EPA respected the science process and the meaningfulness of the public participation in forming the risk assessment for these chemicals.

Regarding the concern that EPA did not meet their requirements on the deadline of August 3, 1999 and that they did not address the key priority chemicals specified in the notice, Mr. Guzy commented that EPA does not agree with this position. However, he also recognized that there are some who believe that the requirements are not being respected and that EPA is moving too slowly. As a further clarification, Mr. Guzy stated that EPA felt that it made sense to take early action to provide growers with information as quickly as possible, and to avoid confusion. He asked TRAC members to judge EPA's actions by the character of those actions. Mr. Guzy commented that EPA, along with USDA, decided to work closely with the registrants to achieve agreements, and with growers to understand the critical uses and viable alternatives to achieve risk reduction. He noted that EPA's approach was not an "across the board" kind of approach. Mr. Guzy felt that their agreements would withstand the test of time because they were carefully made and were based on science, and in the same spirit and in accordance with the principles developed by the TRAC process.

Another participant asked the USDA if, in developing the AZM and MP agreement, they considered economic alternatives for the lost uses and what the transition strategy is for the lost uses. Allen Jennings, Office of Pest Management, USDA, explained that USDA suggested some modifications to address the southern peaches and cotton needs east and west of the Mississippi, but they generally felt there were available alternatives. He explained that they discussed the issues with a number of rural organizations and their state affiliates to refine their ideas about alternatives. Mr. Jennings added that USDA did not think there would be major transition concerns. Mr. Aidala added that these were the specific questions EPA and USDA got as they developed the agreement and they evaluated each question.

One member commented on Mr. Guzy's characterization of the AZM experience. She stated that she hoped that the process used to reach an agreement on AZM is not the intended process because the 48-hour period to reach a settlement agreement is not reasonable and is not consistent with the process laid out by the TRAC. Mr. Johnson responded that one of the issues EPA faces is whether there are other examples similar to AZM where the pesticide is well studied and has been in the queue for years. He suggested that, while in a sense 48-hours seems a short period, when you consider that the pesticide has been in the queue for years, 48-hours may not seem so unreasonable. In regard to MP, Mr. Johnson commented that EPA exercised its right to take action outside of the six phases if they felt there was sufficient risk. In the case of MP, he stated that EPA felt it was necessary to take action. Also, Mr. Johnson commented that EPA felt they used a constructive and deliberative process and that addressing 90 percent of the risks with 10 percent of the uses is not invoking a food scare. In balance, Mr. Johnson observed that most of the OPs have gone through the pilot process and only two were identified with dietary risk, AZM and MP. He asked the participants for some feedback on how EPA was doing with Bensulide, as another example. The participant responded that the dialogue on Bensulide has been very good, in particular because of stakeholder involvement. She felt that when there is an opportunity for stakeholder input in the decision making process, a better decision results. Another participant echoed the concern about the short time frame for response, however, he also recognized that there were other time constraints and pressures contributing to the circumstance. He suggested that it was important to acknowledge that the process was working more smoothly now and focus on that. Ms. Mulkey commented on the concern about the short time frame for the AZM agreement. She clarified that the dialogue with the registrant was initiated in June 1999 and there was more like a two-week window of active discussion before the decision was made.

Another individual requested clarification on how and whether the grower groups were involved in the decision making process for AZM and MP. Ms. Rossi stated that the growers were involved. For example, in the case of AZM, the process was initiated through the first meeting with the registrant and the major commodity group. Following that meeting, Ms. Rossi noted that USDA took the lead in keeping in contact with the commodity groups. She stated that EPA has also used its Minor Use Team to talk with the smaller commodities, particularly with MP. Mr. Jennings added that the USDA also spoke with and through a number of their LGUs to smaller commodity groups. At the same time, he acknowledged that the process was somewhat ad hoc, which he identified as an issue that will be part of tomorrow's discussion on ways to improve the process.

A participant asked for clarification on when in the process the growers come to the table and have a voice. Ms. Rossi commented that that was a good question and one that has been discussed with a number of commodity groups because it was not clearly mapped out as part of the TRAC process. She explained that there was no specific place identified in the six phases of the pilot program for this and that to date their involvement has been ad hoc. Ms. Rossi suggested that this would be an issue to address in tomorrow's discussion on ways to improve the process. Mr. Jennings agreed that it is necessary to do a better job of integrating grower input. Mr. Pitts added that another part of the process that has not worked well is that the refined risk assessments are not clearly linked with mitigation. Consequently, when the LGU's review the risk assessments, they are not able to correlate them with real world action. He stated that that is an issue that the USDA would like to raise in tomorrow's discussion. Mr. Aidala also clarified that the word "public" refers not only to growers but to all stakeholders, all of whom have had access to the same material over a period of years and who may not have provided input on some of these issues in a timely way. As a baseline for comparison, Mr. Aidala asked Ms. Rossi to compare the current process to the RED chapters, which EPA has been producing since 1988. He observed that few people asked for information on the risk assessments until recently. Ms. Rossi commented that the traditional practice was to share the chapters with the registrant and discuss the risk management and mitigation proposals with the registrant. Following these discussions, the RED was announced.

One member was encouraged that EPA was learning from these experiences, but she cautioned against assuming that EPA represents the growers in the country and stated that the growers need to be at the table if EPA wants their buy-in. She stated that the decision making process concerns her greatly because the consequences affect her livelihood. Another member responded to Mr. Aidala's comments on the REDs, by stating that the stakes were different under the RED process because FQPA covers more and the timing is different. The participant also observed that it is too soon to know the full impact of the AZM and MP decisions because they are late season decisions and there were still OP alternatives available. He also stated that it is hard to evaluate the short and longer term impacts of these decisions because it depends on what EPA does with new registrations and whether they fit in with existing Integrated Pest Management (IPM) systems. Further, he stated that the transition strategy for row crops is very different for perennials and ornamentals. In this regard, IPM strategies are very site specific and require a lot of information. He wanted to know where the information is coming from to help growers make a transition with a system that is already challenged by the processes we have put in place.

An individual observed that comments on the preliminary risk assessments are not always placed in the Docket in a timely way. He stated that if he knows his comments will not be used or placed on the Docket, he will not spend the time commenting and would rather reserve his comments for something that will be used like a refined risk assessment.

A member asked for clarification on the following: 1) Regarding the RED process and AZM, will the label changes be based on dietary risk? 2) Has occupational exposure been evaluated and how does that fit into the RED process? Ms. Rossi explained that most of the label changes correspond to the rates that were related to dietary risk and the reentry intervals will change for worker protection. In addition, she clarified that the RED process involves a comprehensive review of the entire chemical. Everything is evaluated including dietary, worker, and ecological risk. In response to a question on occupational exposure, Ms. Rossi added that because the ecological and fate assessment lagged behind the health effects assessment, she was uncertain whether the occupational exposure would be revised.

One individual expressed concern that the discussions at the meeting did not sufficiently address protection of children. He stated that children's health should still be the guiding principle for the process. The individual recalled the description of how children's safety factor was addressed with regard to AZM and felt that there was not enough detail on why the safety factor was not applied. He questioned the source of information on risk, whether it came from the SAP or some other sources, and how the subsequent results would impact growers, registrants, and public health. The individual stressed the need for the process to address the public health aspects consistently. Mr. Johnson thanked the participant for his comments and stated that both EPA and USDA are concerned and need to reach out to different constituents for comments and concerns. He also commented that the principle behind FQPA is public health and environmental protection - public health in particular, given the FQPA's particular attention to children. Mr. Johnson stated this principle guides the actions EPA has taken. As an example, he referenced the AZM agreement where the risk driver was the sub-population of children from one to six. Another participant supported the concern about children and shared his appreciation for the diversity of perspectives remaining at the table.

Transition Issues

Mr. Jennings provided the group with an overview of the progress on transition issues. He referenced the USDA document entitled, The Foundation for a Transition Strategy for Lessening Dependency on Organophosphate Insecticides in the Mid-Atlantic/Appalachian/Southeastern Apple Production Region, as an example of the technical basis for the discussion. Mr. Jennings stated that transition is interpreted differently by certain individuals to some, it means a specific response to a risk assessment, and to others a planning document with a long range view looking at changes in fundamental pest management practices such as moving towards environmentally friendly, more biologically-based pest management systems. He noted that a common thread through all of the potential definitions of transition is the need for a firm technical basis. Mr. Jennings commented that the information platform or technical basis for pest management alternatives should be common for a commodity for a specific region. In this regard, Mr. Jennings observed that pest management issues are local, consequently the key to a good transition strategy is knowing the commodity and the region in which it is produced. Mr. Jennings referenced two similar studies on peaches, one in California and the other in the southeastern region. He noted that the California study is complete and they hope it can be expanded and applied to other stone fruits and many common pests because of common growing conditions. The peach study in the southeastern region should be available in a few weeks.

Mr. Jennings also explained that USDA had been meeting with their LGU cooperators to discuss continuing the effort to work with their state and local organizations on high priority commodities. They envision involving crop production experts from the LGU system, the grower community, and from the Agricultural Research Service (ARS). He described the output from the studies as varied, including a collection of information about pest management alternatives and a "to do" list to ensure that actions are taken. Mr. Jennings clarified that actions may include inspiring the ARS to change the fundamental direction of research or emphasize particular research. He summarized his comments with news that USDA is likely to be funded for two new programs: Crops at Risk; and the Risk Avoidance Mitigation Program, both of which could further transition implementation. He then invited participants to comment on the apple study and on the "to do" list.

Several members complimented USDA on the overview. They felt the example was helpful as was the "to do" list, and the series of questions that were posed in the document were instructive. One individual commented that the questions presented in the document suggest the need for new products and new uses. She stated that it would be helpful to know more about the status of some of these alternatives. In addition, she felt the information about the status of pesticide alternatives for different pests could be used to help prioritize the next steps in the pest management plan. For future similar studies, she suggested adding the perspectives of growers and food processors to the work group. She recognized the potential for transition strategies to be complex and for this reason she felt that finding a way to prioritize the key issues in each region would be key to the success of a transition plan. Another participant also recognized that much of the work done in this region could be applicable to other regions. However, she also noted that it takes time to confirm the success of larger scale applications of alternatives that were successfully used on test plots. In addition, she noted that some successful alternatives are labor intensive and may not be practical for that reason.

An individual requested clarification on what was meant by a "systems" approach and wondered whether it was appropriate to consider a systems review as part of a transition strategy. He also stated that, based on a preliminary review of the alternatives presented in the document, several of them would not be viable. He suggested that USDA consider providing some prioritization of the available alternatives as an additional tool for planning transition. His final question was whether USDA referred to and utilized the Work Group II discussion on using a set of criteria as a way to define alternatives. In response, Mr. Jennings recognized that developing transition plans is and will involve a dynamic process of testing and shifting pest control measures. He indicated that the approach used in selecting alternatives would meet the definition of alternatives considered by Work Group II. Mr. Jennings turned to Wilfred Burr, Office of Pest Management Policy, the primary author of the paper, to respond to the question on a systems approach. Mr. Burr explained that it took approximately a month and a half to produce the apple strategy for transition. On the systems approach, Mr. Burr commented that the necessary step of applying small scale orchard research on alternatives to broad scale application would require a systems approach that would look at the big picture, including insecticides and herbicides. He also commented that the work group that developed the paper screened alternatives in part based on their economic viability. In addition, Mr. Burr noted that the work group identified a need for education for the growers on the alternatives and how to use them.

For an additional perspective on a systems approach, a member commented that systems research found its origin in electrical engineering as a way to identify the universe of control. He observed that many of the elements in the agricultural system are dynamic and require monitoring. In the agricultural system, the individual described starting from the current practices, identifying the future goals for the system (e.g., reduced use of OPs, etc.), followed by designing a system to get from the current state to the future state. He noted that this process would take a lot of on-site research. The individual also observed that transitioning from a relatively simple system of spray control to more complex alternatives will require more information to manage the system. He questioned whether there was a source for this information and whether there was a system to disseminate the information.

Another member stressed the need to educate the public on some of the success stories on transition. She felt that some of this public education could help people to understand what the farmer is dealing with in the field. She wanted to know if there were any specific plans for advising the public in this way.

Another individual commented on the implication in the paper that 60 to 70 percent of the apples are for processing, when in reality a higher percentage of the apples are fresh. The individual also observed that transition plans need to look more broadly at alternatives, not just as potentially controversial OPs and carbamates. At the same time, he commented that the goal of a transition plan might not be to phase out OPs, but rather to have OPs regulated based on their risk and to have those risks mitigated. The participant commented that for apples at this time there are very few proven alternatives. In the regard, he cautioned that there might be fewer applicable alternatives in the pipeline than we think. Mr. Burr agreed that there are regional differences in the percentage of apples processed and fresh and that regional differences need to be taken into account in a transition plan. He also acknowledged that OPs were not enough as a pool of alternatives and that a longer term perspective on OPs that might be phased out would be appropriate. He explained that this is why the study was characterized as the "foundation" for a transition strategy designed to point out what needs to be done if the OPs are phased out or if the uses are modified over the next few years.

A member highlighted the fact that OPs are currently critical to the control of pests at different times in the growth cycle of apples. For this reason, he stressed the importance of proceeding with caution when considering an OP phase out, particularly when there are limited or no alternatives. He felt that this study accentuated some of the pitfalls agriculture faces and the present and critical need for research on alternatives.

Another individual expressed concern that organic farming was not identified as an alternative. He provided examples of successful organic farming and stated that it should be considered as a viable alternative. Mr. Burr explained that the work group on the paper considered organic farming, but felt it was not applicable to the size of orchard considered in the study. The member noted that organic farming has been used successfully on substantial orchards. One individual agreed that we should not lose sight of organic farming as an alternative, and that we should take a closer look at the circumstances under which it is a viable alternative and consider it as an alternative in those circumstances.

One member felt that the paper pointed out that the role of USDA in risk assessments and risk mitigation should be expanded. He felt this expansion would increase the credibility of the process and that funding should be made available for the expanded role.

An individual supported the inclusion of resistance management in the study because it is a critical and real concern. He also asked for clarification on the audience for the document. Mr. Jennings responded that the audience for this and similar documents would be the agricultural research community and those interested in transition. Ms. Murtagh also stated that they were still trying to answer what resistance management means to EPA, USDA and the LGUs. The member suggested that the commodity groups should also be the intended audience. He proposed as a next step that a commodity group take a study like this and based on it, develop a business plan for the next five years. Mr. Burr was supportive of this idea.

A member commented that he hoped that some of the additional research on transition would also go to studying endpoints because they are a critical part of the big picture and refining appropriate alternatives. Mr. Burr responded that some of the items on the "to do" list point in the direction of endpoint studies.

At the close of the discussion, Mr. Guzy reflected on the work that was done on the study and some of the comments in this session. He recalled the comment on the importance of including growers in risk mitigation decisions and Mr. Johnson's comment about thinking in a rational, comprehensive way about the future given the likely scenario on the use of OPs. He also noted that EPA has established a time frame for action to which they are committed. He stated that, as with AZM, EPA can make certain assumptions in cooperation with USDA, registrants and growers about targeted approaches and reasonable phase-outs and transitions. However, he also saw this as an opportunity and a challenge, as indicated in the August 2, 1999 announcement by Administrator Browner, for pesticide manufacturers and growers to propose additional voluntary measures to reduce risks from other OPs and to shape future actions on OPs and other pesticides. Mr. Guzy noted that some preliminary ideas about the criteria for voluntary programs were presented in the August 2 announcement. They included a focus on the most significant risks associated with children's foods, eliminating uses or achieving no detectable pesticide residues in high consumption children's foods, moving toward safer use, use of safer reduced risk alternative pesticides, and defining an acceptable timeframe for achieving goals. Mr. Guzy recognized that this should not be done alone by a voluntary group, but with the support of the government. For this purpose, he stated that EPA and USDA have discussed an approach to targeting resources for critical research and extension. In addition, he commented that EPA is committed to expediting registration of reduced risk pesticides and promising new chemicals and chemical uses. He noted that this kind of program was somewhat overlooked in the August 2 announcement and the Agency is open to others finding common sense transitional mechanisms, building on the base of knowledge provided in the report that was just presented.

Mr. Rominger appreciated the positive and helpful comments on the report and stated that USDA will use the comments to improve future transition strategies. He added that these comments help USDA to clarify where they need research and where they need to place more effort. Mr. Rominger also noted that when additional resources are secured, with the help of industry and growers, USDA could make a difference in the process. He thanked USDA staff for their work and commented that they developed a model that can be built on in the future.

Tolerance Revocations/Channels of Trade

Mr. Housenger described the channel of trade issue and the provision in FQPA that addresses it. He explained that, after a crop is treated with a pesticide, detectable residues of the pesticide might result. Mr. Housenger noted that following harvest, the product goes through points of distribution, or channels of trade, on its way to sale and consumption. In the case of fresh food the produce moves through commerce quickly, where as in other cases, such as with processed food, commodities with detectable residues could remain in the channels of trade for up to four years. Mr. Housenger stated that the channels of trade might become an issue when, through reregistration the use is cancelled, or it is voluntarily cancelled and tolerance revocations might occur as a result of FQPA. He noted that where tolerance reassessment results in termination of the tolerance, a revocation is the means by which the reassessment is completed.

As background, Mr. Housenger described the provision in FQPA that is designed to solve the issue with channels of trade in Section 408(5), otherwise known as the "safe harbor provision." He explained that the law states that any food that was treated lawfully under FIFRA prior to the revocation shall not be deemed unsafe as long as the residue does not exceed the level of tolerance that was in place at the time of treatment. As a caveat, Mr. Housenger noted that EPA could override this provision should it determine that the food poses an unreasonable dietary risk. He added that the Agency is committed to assuring the implementation of these provisions in a way that addresses the channel of trade issues. He commented that EPA is working with FDA and USDA on the implementation of the safe harbor provision, determining what kinds of information the Agency needs to provide for implementation and ascertaining what special circumstances may need to be addressed as a result of its implementation. He explained that EPA has already begun to provide information to FDA on expected residue levels for commodities for MP, in addition to information on the length of time fresh and processed commodities remain in the channels of trade. Mr. Housenger commented that he hoped this kind of information would assist FDA in developing its strategy for implementing the safe harbor provision. He then turned to Robert Lake, Director of the Office of Policy, Planning and Strategic Initiatives, Center for Food Safety and Applied Nutrition, FDA, for an explanation of how FDA is addressing these implementation issues.

Mr. Lake recognized this issue as important and difficult. He noted that one of the difficulties is meeting the desire to assure that lawfully treated food is allowed to go through the channels of trade to be sold to consumers and consumed, while at the same time addressing a use that has been canceled and the tolerance revoked. Mr. Lake described the channels of trade as a pipeline that is always full, that goes from the farmer's field to the fork of a consumer. He explained that when a decision on a pesticide and a commodity is made, it affects some products that are in the pipeline. Mr. Lake interpreted the congressional intent of the provision to allow the material in the pipeline to continue to move, unless there is a finding that was contrary to public health. He stated that this issue is not new, as tolerances were revoked prior to FQPA, and now as in the past, FDA recognizes the challenge of discerning between residues remaining after a period of time in the pipeline that result from lawful treatment from those that are not. He observed that this point of discernment could vary depending upon the pesticide and the commodity. In addition, Mr. Lake noted that there is a tension between wanting the channels of trade to clear, while at the same time not allowing the continued use of a pesticide after it is no longer allowed. An additional tension is between allowing the channels of trade to clear while at the same time not allowing foreign growers to unfairly take advantage of the situation. In regard to the challenge with foreign markets, Mr. Lake explained that while a registration can be canceled in the U.S., it may still be allowed in other countries. However, he noted that when produce from foreign markets enters the U.S., it is monitored by FDA and is subject to meeting the allowable pesticide residues in the U.S. Mr. Lake commented that this circumstance creates an additional tension between the domestic grower who can no longer use the pesticide and the foreign producer who continues to use the pesticide and take advantage of the U.S. market.

To address some of these challenges, Mr. Lake summarized an approach for FDA which is based on past practices. He stated that the desire is to have a policy to effectuate the channels of trade while assuring that fresh produce goes through the channels of trade before FDA acts on an enforcement program to look at the residues. In addition, he noted that the policy should also address the fact that there will be some processed food that will have a longer shelf life and be in the channels of trade longer. Mr. Lake clarified that these foods are likely to have detectable residues below the tolerance longer than fresh foods, but at some point, the level drops to below detection. In the case of MP, Mr. Lake indicated that information provided by EPA suggests that the levels of MP in fresh fruits will decrease to non-detection within a year and FDA feels it is unlikely that they will detect MP in fresh produce by the next fiscal year. However, some levels of MP may remain in processed foods for up to two years. He invited suggestions on how FDA should address the longer term residue issue for MP. One idea that they have considered is requiring processors to track the date they process their food. In closing, Mr. Lake stated that FDA is in the process of developing guidance on this issue and the draft will be published in the Federal Register for public comment. He invited TRAC members to comment on his presentation and the future draft guidance.

Following Mr. Lake's comments, Mr. Jennings added that the Food Safety Inspection Service (FSIS) provides the enforcement mentioned by Mr. Lake on poultry, meat and eggs. He envisioned that FSIS would develop a parallel system to the system ultimately developed by EPA. In addition, he noted that there might be export issues other than enforcement that might be key to U.S. tolerances, such as in the Taiwanese Trade Agreement.

One member asked for clarification on how much imported fresh produce FDA is able to inspect. Mr. Lake stated that they are able to check less than one percent of the total because the volume has grown substantially in recent years. In a similar vein, the participant inquired about the percent of processed imported food that is checked. Mr. Lake stated that the amount of all imported foods, fresh and processed, might be between one and two percent. He added that the level of FDA sampling for imported and domestic foods is at an all time low and is half of what it was at the beginning of the decade, following a declining trend over the past two decades. Mr. Lake commented that there has been a long term trend towards declining resources for monitoring and enforcing pesticide tolerances in food.

Mr. Aidala inquired whether PDP data includes both domestic and imported foods. Mr. Jennings responded affirmatively that it is both and indicated that they report violations to FDA. Mr. Lake commented that this is useful intelligence, however, by the time the information gets to FDA, the food is long gone and their ability to track the source of the information is limited. He noted that the PDP information informs FDA on the commodity and provides some idea about the source of the food.

An individual found it ironic that in FQPA one of FDA's goals was to move away from action guidelines in the Section 18 process because those numbers were not defensible, and the current circumstance is similar because we are moving away from actual tolerances and essentially "looking in the other direction." Mr. Lake clarified that, in this case, the old tolerance number applies as long as the food remains in the channels of trade. He reiterated that the challenge is determining at what point it is possible to say that the value seen was or was not in the channels of trade when the action was taken. In the case of MP, Mr. Lake explained that FDA would monitor as they always do and if they find a residue within the old tolerance for MP within the first year, they assume that the food is legitimately in the channels of trade and was lawfully treated. However, if the values were above the old tolerance level, FDA would take action. Similarly, if FDA observed a value below tolerance for food that had been in the channels of trade for more than a year, they would assume the value was not lawful. The member asked if states would adopt a similar strategy. One representative from state government indicated that their policy would probably be similar. The member also asked if the example of MP was a worst case scenario that might apply to the dissipation of many pesticides. Mr. Lake responded that it was not a worst case scenario and that he understood each case would be addressed individually. Mr. Aidala clarified that it is not only the dissipation of the pesticide, but also the dissipation of the food form through the channels of trade. Mr. Housenger added that residue levels calculated over three, six, and nine months assumed that the commodity was treated at the label rate closest to harvest, consequently PDP data indicate the levels seen in commerce are lower than that.

An individual inquired about the practice for products that are stored for a longer period of time, such as grains, that may also be mixed in storage. Mr. Lake commented that this is one of the most difficult challenges in an implementation plan and asked for suggestions on how to address this. The individual felt that this circumstance was an example of a fundamental problem for food processors; that they are guilty until proven innocent. He felt their only recourse was to refuse to purchase crops treated with MP. Mr. Lake suggested one way to address this concern would be to say that for processed food anything that the processor buys and processes within a certain time frame is presumed to be okay. He stated that FDA would like input on this approach and how to deal with foods that have been in the channels of trade for longer periods of time.

Another member felt that this discussion suggested that the policy was shifting back to practices prior to FQPA. He understood that one of the initial reasons for FQPA was to appease the World Trade Organization (WTO) under the Section 18 process that we did not have a tolerance established, in which case they could not import commodities from other countries. Now, he observed, there is a time limited tolerance and we are in a circumstance similar to the one that existed prior to FQPA and are placing foreign countries at a disadvantage because we are essentially doing away with tolerances. He commented that the WTO would not be pleased. As a second concern, the individual questioned EPA's ability to harmonize with neighbors like Mexico and Canada in view of the recent decisions on AZM and MP. He felt that it was unreasonable to assume that they will alter their use of these pesticides. In addition, from the processor's point of view, many domestic juices are blended with fruit from other countries. He did not see how revoking someone's tolerance in the U.S. would not have an impact on growers in the U.S.

One participant commented that the situation is not black and white. He noted that one pivotal point is that the application of the tolerance revocation and what triggers the revocation. He noted that there may be some discretion in its application and this may address some of the concerns expressed. The participant observed that with MP, there was a safety finding that foods that have been treated during this growing season and into the future are safe because of the continued use of MP after the cancellation decision. He felt this poses a different situation than when a decision is made that those foods are not safe, there is a residue problem, and immediate action is required. Regarding the concern about a "level playing field," the individual noted that the domestic industry is impacted when the domestic grower cannot sell his crop, the processor cannot accept the crop, or the customer will not buy a product because of pesticides. He commented that this circumstance needs to be evaluated more carefully by a broader audience to determine if addressing the channels of trade in this way will cause minimal disruption while at the same time maintaining the safety standard that has been discussed all along.

Another member commented on foreign trade and the channels of trade. He stated that he works with two foreign trade partners for fresh and processed materials that are dependant on U.S. tolerances, and these partners defer to the U.S. tolerances where there is no Codex MRL or other applicable tolerance. In this regard, the individual was concerned about the MP decision because, if cancelled, it will jeopardize the crops that have been treated with MP and will impact a number of growers and packers in the U.S. A second concern to this participant was how the decision on MP would impact those in the frozen concentrate industry. He explained that, in some cases, the juice concentrate is frozen for a period of four years, thus creating another channels of trade issue. Mr. Aidala clarified that the contract for the law of trading partner can be modified to say that it meets U.S. standards or some other benchmark as opposed to a tolerance.

One individual provided another example of the complexity of the channels of trade issue in the citrus market and how growers and the people who buy the product expect to be at the point of compliance. As an example, he described the process for fresh citrus juice production at a plant in Florida. He noted that the packinghouse runs up to 130 truckloads of fruit per day through the processing facility. Each load of fruit is segregated prior to USDA certification for juice processing. The individual noted that the juice is then commingled with the other truckloads for the day and contained in tanks for up to two years. The individual wanted to know how to advise people in his industry on how they can meet the standard that will allow them to meet the safe harbor provision within these common timeframes. Mr. Lake stated that FDA plans to develop guidance for public comment later in the fall of 1999; so now is the time for input on implementation.

Based on the preceding discussion, it was unclear to one participant whether EPA was suggesting that OPs be taken off the market and he wanted to make sure that there was discussion on the issue before any such decision was finalized. Mr. Pitts clarified that that is not the case, and the confusion may have been the discussion on the apple study where one scenario which was to assume that OPs will be phased out of use. The individual was also uncertain whether EPA was suggesting that they discontinue the tolerance system. Mr. Aidala stated that the goal is to meet the standard which may or may not result in the elimination of products. Secondarily, he stated that there would still be a tolerance, or an enforcement level at the detectable level. Mr. Pitts added that USDA is trying to engage growers to discuss transition over the next five years and one of the goals in the risk avoidance and mitigation program is to solicit proposals from the commodity groups on how to achieve a no detect or lower residues. The individual cautioned against EPA and USDA pushing the limits of the agricultural system by eliminating OPs and requiring no detectable levels, because the agricultural community and the American public will suffer the consequences.

Adam Sharp, American Farm Bureau Federation - commented on the importance of preserving the opportunity for public comments on the drinking water science policy papers numbers 18 and 19. He stated the SAP meeting does not provide sufficient opportunity for comments because there are also elements of policy in each of those papers.

THURSDAY, October 21, 1999

Dr. Ehrmann opened the second day of the TRAC meeting with a review of the agenda for the day. The agenda included two topics suggested on the first day, data call-in and the PR notice on worker protection. Additional scheduled topics included the public participation process and post-TRAC activities, and time for public comment. Dr. Ehrmann then introduced Lois Rossi for preliminary comments on the data call-in and the PR notice.

Ms. Rossi commented that both the data call-in for neurotoxicity information and the PR notice on worker protection were announced on August 2, 1999. Regarding data call-in, Ms. Rossi stated that EPA is requiring Registrants of pesticides thought to have neurotoxic effects to conduct acute, sub-chronic and developmental neurotoxicity studies. She stated that the program to call-in data will apply to approximately 140 pesticides and will be completed in phases over the next several months. Ms. Rossi noted that on September 10, 1999 EPA issued the first phase of the data call-in notices which are referenced in the handout entitled, New Data Will Help Ensure Protection of Children. She stated that EPA issued the data call-in notices to all the registrants that had registrations for OPs, including formulators and base manufacturers, and they are required to respond within 90 days indicating how they plan to respond to the data requirements. After her remarks, Ms. Rossi invited questions and comments from TRAC members.

One participant inquired how many laboratories are equipped to test the required 140 compounds. Ms. Mulkey responded that EPA looked into the laboratory capacity issue and that is one reason EPA is approaching this in phases. She stated that to the extent that laboratory capacity is a limiting factor, registrants could work it out with EPA. The individual also asked for clarification on the issue of inter-laboratory variability and protocols for some of the newer behavioral measurements. Ms. Stasikowski explained that EPA has a work group that is preparing a consultation process for registrants to come and discuss protocols and other related issues for these measurements. The participant explained that a particular concern of hers was the lack of historical control experience for some of these studies, against which to compare the new data. Ms. Stasikowski indicated that the work group would also address issues like that.

Ms. Rossi referenced the handout entitled, Fact Sheet on PR Notice Worker Risk Mitigation for Organophosphate Pesticides, for details on this presentation. She noted that this PR notice is also out for public comment. Ms. Rossi explained that the notice presents an approach EPA has been considering for years to level the playing field with across the board measures on classes of compounds like OPs. She noted that this approach would encourage, during the risk assessment process, closed systems and enclosed cabs. Ms. Rossi noted that EPA would ask voluntarily that registrants do this by the end of the year 2000 to the extent required by the risk assessment. She stated that the fact sheet presents a description of the approach for reviewing each OP and making decisions to manage the worker risks.

There were no comments or questions on this presentation. Dr. Ehrmann then asked Ms. Rossi to provide an overview of the public participation process.

Public Participation Process: Next Steps

Ms. Rossi provided the TRAC with a presentation on the public participation process for tolerance reassessment and the reregistration of OPs. She noted that EPA and USDA have been using this process since it was developed by the TRAC last summer. She explained that the results and statistics on the process were described during the meeting yesterday and today her presentation would focus on the process. Ms. Rossi stated that the goal of the process was to increase transparency of EPA's regulatory processes and to enhance consultation with stakeholders by expanding public access to EPA's risk assessment and risk management processes. Through their consideration of the process, Ms. Rossi hoped that the TRAC members could help take the "pilot" out of the process. In addition, she noted that EPA and USDA would also like input on whether the process should be applied beyond tolerance reassessment for OPs and applied to other pesticides subject to reregistration and tolerance reassessment. She also stated that she would provide an update on activity at the end of this fiscal year on pesticides other than OPs. First, Ms. Rossi planned to share how EPA and USDA believe the process is working and then, based on that experience, discuss modifications to enhance the effectiveness and efficiency of the process and produce better products and make better use of everyone's time.

Ms. Rossi summarized that there are six phases in the process, which are presented in Staff Paper # 42, Public Participation Process Options for the Final Process. The phases are: Phase 1, Registrant "Error Only" Review; Phase 2, EPA Considers Registrant's Comments; Phase 3, Public Comment on Preliminary Risk Assessment; Phase 4, EPA Revises Risk Assessments; Phase 5, EPA Solicits Risk Management Ideas; and Phase 6, EPA Develops Risk Management Strategies. In her overview, she noted that Phase 4 was modified as discussed at the April TRAC meeting to include USDA's review of the revised risk assessment. At that time, she noted, they also added the technical briefings to share the revised risk assessment with the public to increase the transparency and to assure public understanding of the risk assessment.

After describing the phases of the process, Ms. Rossi reviewed some of their experiences with the process on what was received and what was not:

Phases 1&2 - 31 OPs completed the "Registrant Only" error review period; most comments were not error-related and did not impact the release of the preliminary risk assessment; 5 preliminary risk assessments were modified; 11 OPs received mostly error corrections from registrants, half of which identified mathematical errors and others included spelling and grammatical corrections; 20 OPs received non-error comments including objections to the risk assessments and commitments to submit new studies; and some of the older preliminary risk assessment received no comments.

Phase 3 - 27 OPs have completed the public comment period on the preliminary risk assessment; from non registrants comments generally supporting or opposing aspects of the assessment were received for 18 OPS, and 9 OPs received submissions of usage information, studies or other technical information; registrants submitted mostly general comments, five of which were new studies and studies to confirm or upgrade existing submitted studies. Ms. Rossi commented that receiving use and usage data and new studies resulted in rework, consequently it would be helpful to receive this information earlier in the process.

Phase 5 - comments and ideas on risk management were usually received by EPA via meetings and conference calls rather than written submissions.

Ms. Rossi then summarized some of the lessons learned in the process and some of the guiding principles for modifying the process. She stated that the first lesson was that the earlier the involvement and receipt of information, the more useful the information was in improving the accuracy of the risk assessment. Similarly, EPA learned that it is helpful to have earlier involvement in developing risk management strategies. The second lesson she noted was that many of the tools that are developed and needed to refine the risk assessments are now developed and there appears to be little added value to producing an unrefined risk assessment based on assumptions of 100 percent crop treated and tolerance residue levels. Ms. Rossi stated that EPA proposed beginning the public review process with the refined risk assessment. She observed that there were very few comments on the preliminary risk assessments and EPA has heard many stakeholders agree with this revised approach. She stated the third lesson was that there is a need to have a process that is understood so stakeholders can plan effectively and know what information is useful to the agency. She stated that stakeholders need some degree of predictability in the process and the schedule of chemicals being reviewed. Ms. Rossi noted that the fourth lesson learned was that a common understanding of the risk assessment was needed before stakeholders were willing to participate in risk management. In response to this need, she explained that EPA worked hard on making the risk assessments transparent and developed charts and summary documents with USDA. In addition, Ms. Rossi noted that EPA and USDA have also learned that broad stakeholder involvement has resulted in sounder risk management decisions, more creative decisions aimed at risk reductions, and more credible and workable decisions.

Based on the lessons learned, Ms. Rossi proposed a modified public participation process. She explained that the modified process integrates many of the same elements of the pilot process and enhances public participation at important stages. Ms. Rossi noted that the revised process is detailed in Staff Paper 42, and described the Phases as follows:

Pre-Phase 1 - Public Engagement - Inter-agency cooperative effort that involves the engagement of stakeholders early in the process to ensure that the risk assessments reflect actual use and usage, available data, current labeling, and other information on use practices that stakeholders can provide. Ms. Rossi stated that as part of pre-phase 1, EPA plans to work with USDA and other agencies like DHHS and FDA prior to Phase 1 to organize SMART meetings (from the idea of "working smarter") where the registrant meets with the Agency to explain how the chemical was used and what data is under development for the risk assessment. She explained that the SMART meeting is to take place four to six weeks before the risk assessment begins. In addition, Ms. Rossi noted that EPA and USDA learned that stakeholders need to have more current information about the schedules for pesticides in this process. In response to this need, she noted that EPA would announce for each pesticide the dates for submission of data and information. Registrants and other stakeholders also need to help EPA become aware of other ongoing studies.

Phase 1 - Risk Assessment Registrant Error-Only Review, Chemical Profile, and Inter-Agency Engagement (30 days) - Phase 1 would be the same as the previous Phase 1. However, Ms. Rossi noted that there would be two additional activities with regard to the chemical profile and interagency engagement. In addition, EPA will publish a Federal Register notice to advise the public about the pesticide that has started the public participation process including the release of the basic chemical information.

Phase 2 - Agency Considers Registrant Error Comments (up to 45 days) - This is similar to the original Phase 2 process with some additions. Ms. Rossi stated that EPA plans to jump-start the stakeholder involvement two weeks before the end of Phase 2 at which point EPA will have provided USDA with a revised risk assessment overview and USDA will schedule communication, such as a conference call, with stakeholders to review and discuss the overview. She noted that EPA would work with USDA to address the suggestions from the stakeholders and comments from DHHS, FDA, and USDA before the revised assessment is released.

Phase 3 - Public Participation Period: Technical Briefing, Public Comment on Risk Assessment, and Risk Management Options (90 days) - Elements of Phase 3 are similar to the original Phase 3, however there are some modifications. The changes include the release of risk management options for the same 90-day period and holding a technical briefing for chemicals with lots of uses, at this time. She explained for pesticides with limited uses, EPA would offer the option of stakeholder meetings. Ms. Rossi noted that the same FR notice used to announce the release of the risk assessment would also be used to announce the availability of options for risk management and the technical briefing or the stakeholders meeting. She stated that the technical briefing or stakeholders meeting would be held at the beginning of Phase 3 to share the revised risk assessments and the range of possible ideas for risk management options. As part of this discussion, she indicated that EPA would identify the risk drivers to help identify potential risk management alternatives. At the same time, Ms. Rossi indicated that an interagency effort would begin to engage stakeholders in a dialogue on risk assessment and management options through means like conference calls to solicit their ideas on these issues.

Phase 4 - Develop Final Risk Assessments and Risk Management (30-90 days) - Phase 4 would be designed to develop a final risk assessment and risk management decisions. In this phase, EPA would review and consider the comments, data and risk management ideas, and proposals received during Phase 3's public comment period, from stakeholder dialogue, conference calls, meetings and interactions. She emphasized that the dialogue with stakeholders would continue through this phase, as well as being initiated in Phase 3. Ms. Rossi stated that EPA would develop the revised risk assessment, and with input from USDA, FDA, and DHHS, develop risk management documents. In addition, at this time, EPA will also coordinate an interagen