Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.
John Ehrmann, Meridian Institute, opened the meeting by welcoming participants to the first meeting of the U.S. Department of Agriculture (USDA) - U.S. Environmental Protection Agency (EPA) Tolerance Reassessment Advisory Committee (TRAC) meeting which is constituted as a subcommittee to the National Advisory Council on Environmental Policy and Technology (NACEPT) of EPA. A list of the TRAC members is presented in Docket Number OPP00537. Dr. Ehrmann then initiated a round of introductions and turned to the TRAC Co-Chairs for opening remarks.
Fred Hansen, Deputy Administrator, EPA, Co-Chair of the TRAC, formally welcomed participants to the meeting. Mr. Hansen commented on how rewarding it was to see both familiar and new faces, and acknowledged those individuals who participated in the 1996 Food Quality Protection Act (FQPA) dialogue. He recognized the importance of the work to be performed by the TRAC and thanked members for committing their time and expertise to help EPA and the U.S. Department of Agriculture (USDA) with their implementation of the FQPA.
Mr. Hansen stated that the FQPA was a very important milestone in the work of this Administration and commented that it will assure that Americans will continue to have the safest food supply in the world, especially for infants and children. Mr. Hansen noted that he viewed implementation of the FQPA as a means of providing protection of human health and environment alike assuring an adequate amount of protection to ensure economic growth. He urged TRAC members to take the opportunity to influence this decision-making process of EPA and USDA, and to seek areas of convergence in their deliberations. Mr. Hansen referenced the April 8, 1998 Memorandum from Vice President Gore on Food Quality Protection in which the Vice President outlined four guiding principles to ensure effective implementation of the FQPA (presented in Docket Number OPP00537):
· Sound science in protecting public health;
· Reasonable transition for Agriculture; and
· Consultation with the public and other Agencies.
Mr. Hansen explained that the work of the TRAC will help establish the overall priorities and direction for FQPA implementation. He clarified that the purpose of the TRAC was to provide input on policy options and an implementation strategy, not to provide technical scientific guidance. To establish the overall framework, EPA and USDA are asking TRAC members to focus their efforts on organophosphates, which are a widely used group of pesticides for agriculture and other public health uses. He explained that preliminary analyses, done by EPA and others, show that some organophosphates appear to exceed the FQPA safety standard. Mr. Hansen noted that EPA and USDA plan to share preliminary information on organophosphates with the TRAC at the next meeting. He also commented on the FQPA requirement of adding risks when pesticides have a common mechanism of toxicity. Based upon available information, Mr. Hansen explained that the International Life Sciences Institute (ILSI) has stated that there does not appear to be a scientific reason not to conclude that organophosphates should be treated as having a common mechanism of toxicity for conducting risk assessments. He noted that the FIFRA Scientific Advisory Panel (SAP) and ILSI will be further advising EPA on how the organophosphates should be evaluated in total.
Mr. Hansen stated, in view of the preliminary information on organophosphates and to meet the public health and the special children's protection of FQPA, some changes are expected to take place. He observed that, because of the current reliance on organophosphates, careful planning for transitions is necessary to meet the requirement of public health protections of FQPA while maintaining an abundant food supply. He called upon TRAC members to work with EPA, USDA, and each other in meeting the challenge. He then turned to his Co-Chair, Richard Romancer, Deputy Secretary, USDA, for additional comments.
Mr. Rominger stated that he was pleased to join Mr. Hansen in his welcome to the group. He thanked TRAC members for agreeing to help EPA and USDA address the critical work necessary to move forward on FQPA implementation and stated that there were a number of sensitive issues to address. Mr. Rominger noted that the committee brings together a broad range of interests and Congressional staff as observers. He recognized all participants as critical to achieving the broad-based support necessary for the implementation of FQPA. Mr. Rominger commented that USDA and EPA are fully committed to the process and expect to do a lot of listening. He urged TRAC members to take the opportunity to step aside from the current public debate and look for areas of convergence on how to establish a balanced policy framework for FQPA implementation. Mr. Rominger stated that he and Mr. Hansen support the high standards set by FQPA, and believe they are beneficial to both farmers and consumers. He observed that a fully implemented FQPA will enable the federal government to state that the pest management tools in place have been determined to be very safe.
In addition, Mr. Rominger recognized the need to work together to outline a common sense approach to FQPA implementation. He stressed the importance of ensuring environmental protection while maintaining economic growth, and commented on how the four guiding principals outlined by Vice President Gore would help the group achieve this balance. Mr. Rominger asked TRAC members to help develop the policy framework for FQPA implementation, and reiterated the need to focus on organophosphates. Mr. Rominger noted there were a number of USDA programs contributing to the implementation of FQPA, including the Food Consumption Surveys, Pesticide Use Surveys, the Inter-regional Research Project No. 4 (IR4), the Pest Management Alternatives Program, and the Pesticide Data Program. He commented that several of these programs were modified in support of FQPA implementation and that USDA would continue to evaluate ways to improve USDA's efforts.
Mr. Rominger commented that organophosphates have hundreds of important uses. He noted that, in some cases, integrated pest management (IPM) systems, public health, and resistance management programs depend on them and we need to consider the many health, environmental m and agricultural consequences of FQPA implementation strategies. Mr. Rominger also observed that the preliminary analyses of some organophosphates indicate they are not meeting the public health standards of FQPA and some uses may change or will need to be eliminated. He commented that USDA is committed to supporting agriculture with potential transitions. Mr. Rominger noted that much work was underway at USDA and elsewhere and a lot more was necessary to identify pesticide alternatives. He reiterated that the purpose of this group was to explore policy options to address transitional issues and to help define the appropriate role for the USDA in supporting farmers in the process. Mr. Rominger referenced the recent development of the Office of Pest Management Policy (OPMP) to assist in the integration and coordination of pest management and pesticide data programs to support the needs of FQPA implementation. Mr. Rominger commented that they were working closely with growers on vulnerable crops and that they look forward to the group's recommendations on how the USDA can improve its role in the process.
See Docket Number 00537 for the full statements by Fred Hansen and Richard Rominger.
Dr. Ehrmann then introduced Hale Hawbecker, EPA Office of General Counsel (OGC), for an explanation of the Federal Advisory Committee Act (FACA) requirements. The highlights of his presentation are summarized below.
Federal Advisory Committee Act Procedures
Mr. Hawbecker provided an overview of the FACA process. He explained that it was one of the open government laws. He noted the following three FACA requirements for the TRAC process:
1. The TRAC is chartered as a subcommittee to NACEPT with the approval of the Office of Management and Budget (OMB) and the General Services Administration (GSA);
2. The TRAC must have a balanced membership to address all of the interested concerns; and
3. All of the TRAC meetings are open to the public.
In addition, Mr. Hawbecker noted that, with the exception of draft documents which have not been reviewed by TRAC members, all draft reports generated by or for the group are available to the public upon request. He also explained that Work Groups created for the purpose of the TRAC do not advise EPA directly and are not subject to the full FACA process. He recognized the Congressional staff observing the TRAC and noted that they were subject to the Anti-lobby Act. In addition, Mr. Hawbecker noted that EPA cannot organize grass roots' involvement to reach more of the public; however, TRAC members are not restricted from this kind of outreach. He closed his presentation by inviting TRAC members and observers to contact him with additional questions about FACA.
See Docket Number 00537 for the memorandum of March 24, 1998 from Hale Hawbecker regarding the legal requirements of FACA.
After Mr. Hawbecker's description of the FACA procedures, Dr. Ehrmann summarized the draft groundrules for the TRAC. A copy of the groundrules is presented in Docket Number OPP00537. Some of the key elements of the groundrules include:
1. Adhere to FACA rules;
2. Represent the concerns and interests of your organization and attend each meeting;
3. Agree to promote a constructive problem-solving atmosphere;
4. Respect different opinions;
5. Seek to understand the merits of other perspectives;
6. Work to create mutually acceptable solutions;
7. Strive to reach convergence; and
8. Refrain from making statements characterizing the views or comments from other TRAC members.
Dr. Ehrmann added that the key elements of the discussion at each meeting will be captured in a summary and distributed to TRAC members for review before the summary is submitted to the Docket. One member suggested that members be encouraged to talk with each other in addition to presenting ideas to EPA and USDA. Another member requested that meeting materials be distributed at least a week before each meeting, or with sufficient time for review prior to the meeting. Recognizing these additions, the group agreed to the groundrules as proposed.
Group Discussion of Key Issues for TRAC Agendas
Dr. Ehrmann then provided the group with an overview of the agenda for the meeting and suggested agenda topics for future TRAC meetings. He noted that the agenda topics for this meeting were designed to address the key issues outlined in the Vice President's memorandum of April 8, 1998:Meeting #2: EPA Progress and Elements of Evaluation
· Sound science;
· Transparency; and
· The registration processes.
He explained that the purpose of the presentations on each of the key topics was to provide members with updates on EPA's and USDA's current thinking. In addition, as a starting point, Dr. Ehrmann referred TRAC members to the questions that were posed to structure the discussion on each of the issues. He requested that members orient their discussion around the policy elements of FQPA implementation. Dr. Ehrmann reminded members that there were other forums in which the science issues will be addressed. He then asked TRAC members for comments on the proposed agenda. Their comments are summarized below.
One member requested that there be clarity on the purpose of each session. They also observed that the resolution of the risk issues determine the intended goals of the meeting. In addition, they commented that it would be helpful if there was clarity on how the discussions from each meeting would be utilized in subsequent meetings.
Another member felt it was essential to have an understanding of the scientific foundation required to make decisions in order to hold informed discussions on policy. In particular, they felt it was important to understand what about the science is controversial. Mr. Hansen commented that he expects the group will address some of the controversial issues. As an example, he suggested that, for a general type of data call-in or a type of information request associated with a particular pesticide, the group could discuss how to address the uncertainty relative to the 10-fold FQPA safety factor. The discussion might include considering whether the 10-fold safety factor should be applied based on: a level of uncertainty at which point the 10-fold safety factor is automatically applied; a weight of evidence; or on a pesticide-by-pesticide basis. Mr. Hansen agreed that there is a fine line between these issues and suggested that the group focus on how to use sound science to make judgements on policy. Mr. Rominger reminded members that there were other groups addressing the scientific basis for policy decisions. It was suggested that it would be useful for the group to have time allocated to discuss the process by which the science will be reviewed to help address some of the concerns regarding sound science.
A member was concerned about the status of EPA's and USDA's thinking on organophosphates. They felt they were led to believe that the decision-making process was well developed and that decisions were already made about the fate of selected organophosphates. Mr. Rominger reiterated that there were preliminary analyses which indicated that some organophosphates did not meet the FQPA health standards. He stated that the analyses to date are preliminary and that no decisions had been made on organophosphates. Dr. Ehrmann added that EPA and USDA intended to provide the group with additional detail on the progress of their thinking on organophosphates at the second TRAC meeting.
With this input on the agenda, Dr. Ehrmann proceeded to provide the group with the following overview of the proposed meeting topics for future meetings:
· Work-to-Date/Work-in-Progress on Organophosphate AnalysesMeeting #3: Details of Approaches
· Identification of Elements of Approaches for Organophosphates
· Consultation/Public Participation
· Data Acquisition
· Evaluation Criteria
· Priority Setting
· Regulatory Tools
· Transition Options
· Designing Approach(es) for Organophosphate Tolerance ReassessmentMeeting #4: Transition Approaches
· Examining and Detailing Each Element of Evaluation
· Designing and Developing Reasonable Approaches to Transition for Agricultural and Other Products
Following his summary of proposed agenda topics for future TRAC meetings, Dr. Ehrmann asked for comments. The group's comments are presented below.
One member commented that Meeting #3 suggested that EPA was planning a systematic elimination of organophosphates as a group. Other members agreed and stated that they were also anxious about the lack of information on the scientific basis for decisions on the fate of organophosphates. In addition, they were concerned about the potential impact on growers of reduced use of organophosphates.
A Congressional staff person expressed a similar concern that sound science be a part of all TRAC meetings to help the group make informed decisions about elements like: the 10-fold safety factor for infants and children; reliable data; common mode mechanism; weight of evidence; and risk assessment. He felt the lack of discussion on sound science was not consistent with the guiding principle of transparency. Another member added that the discussion on sound science should draw on the substantial body of knowledge and experience on topics like the reasonable uncertainty standard, aggregate exposure, and other similar issues. Mr. Hansen explained that no decisions had been made on the disposition of organophosphates, but that preliminary research indicated that some of the organophosphates exceeded FQPA health standards. He suggested that the group focus instead on addressing transitional issues. The member then asked for clarification on whether transition included mitigation. Mr. Hansen elaborated that managing safety and children's health could include mitigation steps.
Several members commented on the need for transparency. One member felt that the definition of transparency should be clarified. To some there was a need for more information on data and science; to others it was appropriate to limit the discussion on science; and others felt there was a need for transparency in the decision-making process.
One member commented that data is the basis of decision-making and is very important to the process. Another member felt there was a need to resolve some of the science issues before they could comment on policy issues. They suggested that the group try to look at some real world examples in a way that does not compromise the proprietary needs of the registrants and growers. A member stated that it would be helpful to the group if EPA and USDA provided them with some understanding of the assumptions used for the risk assessment in Meeting #2. Mr. Rominger recognized the need to look at the assumptions made for the preliminary analysis of organophosphates.
In a similar vein, a member stressed the importance of maintaining transparency throughout the process. They observed that, while the process was transparent at the beginning following the passage of FQPA, it had not been transparent over the past 18 months. A second individual agreed, and stated that FQPA implementation actions have not been consistent or predictable. Based on this observation, they expressed concern about the ability of this group to come to convergence on a process to resolve some of the key science policy issues. Some members wanted clarification on why this process was handled differently from other rulemaking processes. Several supported greater use of the Administrative Procedures Act (APA) where the Agency is required to explain each of its decisions. Another member noted that there is a decision-making process underway and there are no forgone conclusions. He hoped that part of the mission of this group is to establish a scientific process and suggested that the Agency shift from the focus on organophosphates to generic transitional issues. In the process, he proposed that the Agency clarify the boundaries of transition. He expressed concern about the perception that decisions were final and supported the Agency's efforts to advise the group of its preliminary decisions. He saw no reason for the Agency to revisit all of the decisions made during the 1996 dialogue on FQPA. Mr. Hansen commented that he and Mr. Rominger agreed on the need for more transparency and that was one of the reasons for the TRAC. He suggested that the TRAC was a more robust way to involve stakeholder input than was provided for in the APA alone. Mr. Hansen commented that clarification on the decision-making logic developed during the 1996 FACA on FQPA could help to dispel concerns about the transparency of the process.
A member proposed that a smaller subset of the Committee be established to help refine the agendas for future TRAC meetings. He felt that a smaller and diverse group could better reflect group issues in the agendas. Dr. Ehrmann suggested that the group discuss this idea in greater detail later in the meeting.
Another member wanted to know if the TRAC membership would change over time. He felt that there were not enough pediatricians representing expertise on children's health on the Committee. Mr. Hansen responded by reiterating the importance of the pediatrician's perspective on public health and the special provisions for children and infants. He commented that, while they felt the participation of four pediatricians was sufficient, the concern about the balance of Committee representation could be revisited.
Pending additional input on the agendas, the group agreed at this time to proceed with the agendas proposed for future TRAC meetings, but also agreed to review the content of future agendas based on the results of the initial meeting. Dr. Ehrmann then introduced Anne Lindsay, Director, Field & External Affairs Division, Office of Pesticide Programs (OPP), EPA, for a presentation on FQPA implementation.
FQPA Framework - Evolution of FQPA Implementation
Anne Lindsay provided the group with an overview of the FQPA framework and described the evolution of FQPA implementation. She referred TRAC members to Staff Paper #1 (see Docket Number OPP00537) for additional details on the presentation. She also described a series of consultation opportunities provided by the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP), ILSI, and other groups. Ms. Lindsay explained that the core of FQPA is evaluating risk in aggregate fashion, cumulative risk amongst chemicals that act in a common way, and providing protection where special sensitivities exist, particularly for infants and children. She compared how each of the core aspects of FQPA was addressed in the interim decision logic with current policy as follows:
· Aggregate Risk - the basic approach to determining aggregate risk exposure is still the same as mandated by FQPA and the data and analytic tools are improving;
· Risk Cup - the Agency has evolved screening systems to sort out from the Risk Cup those pesticides where non-dietary exposures are not the driving concern, and to focus further data gathering and analysis where more realistic exposure estimates are needed;
· Common Mechanism - tolerance decisions were initially determined to be conditional on a future revisiting of the issue as reliable methods became available, with organophosphates the current exception based on the existence of a common mechanism based on work with the external science community;
· Children's Safety Factor (10X) - a weight-of-evidence approach and professional judgement was used with a more formal approach under development;
· Monte-Carlo - analyses are being accepted and used and the Agency is looking to expand use in drinking water and residential exposure as sufficient reliable data are available.
Ms. Lindsay added that EPA hoped to outline a more formal approach to determining children' risk later in the meeting.
Following her presentation, Ms. Lindsay invited comments from TRAC members. Their comments are summarized below.
One member was concerned about the balance of representation on other advisory groups like the SAP and ILSI. Ms. Lindsay explained that the statutory (FIFRA) nomination process required by the National Science Foundation and the National Institute of Health to nominate candidates was rigorous and that nominations are considered carefully.
Another member suggested that it would be helpful for EPA to provide the group with copies of the interim decision logic and summaries of the SAP and ILSI recommendations so that all members would have a common understanding of the basic background information. Other members agreed that more information on the SAP and ILSI work products would be helpful, and asked for clarification on their relationship with the TRAC. Some of their specific interests were:
· How does EPA select the questions SAP and ILSI address? One member felt that the discussions of SAP and ILSI were being constrained by specific questions, thus limiting potentially creative solutions.
· What are the results of the SAP and ILSI discussions?
· How is input from SAP and ILSI on recommendations from the TRAC addressed?
· How is input from SAP, ILSI and the TRAC used in FQPA implementation?
Some members wanted clarification on how data gaps would be filled to address time-limited tolerances and other circumstances where data is lacking. They wanted to know if data call-ins would be used to address data needs. Others were particularly concerned about whether there was a sufficient database to conclude that organophosphates had a common mechanism of toxicity. They noted that the charge to the ILSI Working Group was narrow, consequently, aspects of the common mechanism of toxicity were not considered in detail. They felt data were lacking and, to insure that decisions on organophosphates are based on reliable information, additional data should be collected before final decisions are made. One member suggested that the decision logic be modified to include a process for acquiring missing data (e.g., data call-ins, etc.) Another member proposed the addition of a mechanism to modify regulatory decisions based upon updated or new information. A member reminded the group that, in addition to the three core aspects of the FQPA, EPA was also instructed to: make decisions based on available data and request data when necessary; protect public health while managing pesticides in the context of risk; and maintain the economic viability of agriculture.
Another member was concerned that there was no set-aside in the risk cup for drinking water. They felt this raised the issue of maximum contaminant levels (MCL) and exposure from drinking water. In addition, they felt the change in emphasis would have ramifications on other regulatory programs that should be taken into consideration. Dr. Lynn Goldman, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances (OPPT), EPA, recognized the concern and explained that OPP and the Office of Drinking Water were working together to explore the ramifications of FQPA and the Safe Drinking Water Act (SWDA) amendments in order to improve and enhance coordination of activities, information, and priorities pertaining to the protection of human health from risks posed by pesticides in drinking water. One member suggested that the TRAC advise the Agency on how to match interim decisions with interim science and data. They observed that science and data will evolve and here must be some way to match the stringency of the regulatory decisions to the evolving scientific basis for regulatory decisions. In addition, it would be helpful for industry to know about regulatory changes in a manageable timeframe so they can focus their resources appropriately.
At the close of the discussion, Dr. Ehrmann summarized what he heard as next steps to address some of the group's concerns:
· EPA will provide the group with information on the membership of SAP and ILSI and with copies of the documents generated from their discussions.
· There will be additional discussion on the transparency between the TRAC, other scientific committees, and the development of policy.
· EPA will provide the group with copies of the decision-making logic that was developed following the passage of FQPA.
FQPA Safety Factor (10X)
Bill Burnam, Chief of the Science Branch, OPP, EPA, presented an overview of the FQPA Safety Factor (10X). Additional information about his presentation is contained in Staff Paper #2 in Docket Number OPP000537. He stated that the FQPA provided a new level of protection for consumers. Specifically, he explained that FQPA required the application of "an uncertainty factor of up to 10-fold" to ensure an adequate margin of safety infants and children. Mr. Burnam stated that EPA's approach to implementing the safety factor had evolved since the enactment of FQPA in 1996 based upon experience and a better understanding of toxicity. He explained that, as practiced before FQPA, the safety factor was determined by reviewing available data for risk assessment. However, in addition to scientific judgement based upon the weight of evidence approach, there is more emphasis on the completeness of the toxicity data base, the type and severity of the effect observed (developmental data), and the quality of the data. Mr. Burnam stated that the revised approach was recently formalized and submitted to the SAP for review.
To start the group discussion on the safety factor, Mr. Burnam posed a series of questions that the TRAC might address:
· How is the definition of "completeness" affected by emerging science and new data requirements? As new data requirements are identified, should the Agency re-evaluate previous decisions to retain, reduce or remove the safety factor?
· In situations where as a result of the Agency's review, a need arises for additional testing, should the Agency automatically retain all or a portion of the FQPA safety factor even where the registrant has satisfied all of the requirements of Part 158, or should this decision be made by a case-by-case application of the weight of evidence approach?
· If the Agency retains the FQPA safety factor based upon the need to acquire and review these newly-identified studies, what regulatory action should the Agency take if the estimated risks exceed this newly revised "risk cup"? Should the Agency do a data call-in? Should the Agency consider delaying regulatory action until it has had the chance to gather and evaluate data generated to support these new information needs? Would the answer be the same for new pesticides as for existing pesticides?
Mr. Burnam then invited the group to comment on the safety factor. A summary of their comments are presented below.
The group asked some clarifying questions:
· Will the same group of individuals be involved with each determination? Mr. Burnam responded that it had been the same group of individuals since March of 1998.
· Will information on the adequacy of data be integrated in future evaluations? Mr. Burnam responded affirmatively.
· Is the basis for determining the safety factor similar to that used to evaluate aggregate exposure? Mr. Burnam commented that most of the data are from animal studies.
· Are both chronic and acute risks considered? Mr. Burnam responded affirmatively, with the exception of carcinogens.
· What happens after the evaluation is complete? Mr. Burnam explained that the group evaluates each chemical separately, identifies different endpoints for each circumstance, and evaluates the completeness of the data.
One member felt that, in the final risk determination, it is important to allow the grower the opportunity to integrate mitigation activities like changing the use and reducing the frequency of application. They wanted to know how EPA planned to integrate mitigation under different circumstances. Mr. Rominger noted that that this was a valuable point and asked the group to consider a mechanism to factor mitigation in to the decision-making process.
Another member felt that the difference between the current and initial approach to applying the safety factor was unclear, as both approaches were based on weight of evidence. Mr. Burnam clarified that the current approach looks more specifically at what the data say in terms of the sensitivity to children in addition to the completeness and quality of data and the level of exposure.
Several members wanted clarification on the interpretation of the term "notwithstanding" in the phrase "notwithstanding such requirement for an additional margin of safety". Mr. Burnam explained that the safety factor can be retained, reduced or removed and a factor of 1 to 10 established based upon the overall picture presented and the weight of evidence. Where data may be lacking, EPA may issue a time-limited tolerance until sufficient data is collected to determine otherwise.
The group continued to discuss how the decision is made to apply the 10-fold safety factor. Several members felt the 10-fold safety factor for children should be applied automatically, particularly when the data set is incomplete on pre- and postnatal toxicity. As an example, one participant felt the lack of data on behavioral neurotoxicity for organophosphates was sufficient cause to apply the additional 10-fold safety factor. Others supported an approach that would enable EPA to consider all factors including the completeness and quality of data and indications of susceptibility and sensitivity when evaluating how to apply the children's safety factor.
Some members were confused about whether the 10-fold safety factor was applied before or after the dose-response assessment and whether it is applied in addition to the traditional margin of safety (100-fold). One member stated that the margin of safety, which is applied to account for inter- and intra-species differences in sensitivity, is a separate issue from the 10-fold safety factor applied for children. They cautioned against mixing issues and suggested focusing on the safety factor for infants and children. Mr. Burnam clarified that the 10-fold children's safety factor is applied after other uncertainty factors are applied.
Data completeness was raised as an issue throughout the discussion of the 10-fold children's safety factor. One individual felt there was a need to define the term "completeness". Another member expressed the concern that there were not enough members, particularly pediatricians, with sufficient scientific backgrounds to discuss the completeness of data relative to the application of a safety factor. A third individual commented on the scarcity of non-dietary exposure data. They felt that additional data was necessary to adequately evaluate the risk from non-dietary sources, and requested clarification on how EPA addresses this data gap. Mr. Burnam explained that, where data is lacking, EPA uses models to provide what they consider to be a conservative estimate of non-dietary exposure. Other members felt it was important to recognize that science was evolutionary and that new data on many chemicals would become available on a regular basis. They suggested that one policy consideration should be how to integrate new data in the process of risk determination.
Data call-ins were noted by some as a valuable mechanism to address data gaps, and they wanted clarification on their use. Dr. Goldman explained that data call-ins were used in a number of ways. She noted that data call-ins were valuable but are also resource intensive. Dr. Goldman suggested that one policy consideration might be whether to apply the additional safety factor when data are missing, or delay the application of the safety factor until the data are available.
One member inquired whether the existence of a common mechanism of toxicity was used as a source of information on similar chemicals when determining a safety factor for a chemical with limited data. Mr. Burnam explained that he was only aware that EPA considered one chemical at a time. Dr. Goldman added that EPA has not yet considered using data from similar chemicals to address data gaps.
Another member commented that the "notwithstanding" clause in FQPA was added, in part, to address the evolution of science and the acquisition of new data. They explained that the clause was designed to give EPA the flexibility to look at the available data and require registrants to fill in data gaps, while continuing to consider the registration. The 10-fold safety factor was viewed as building in an uncertainty factor. One member was concerned with this interpretation because it placed the burden of uncertainty on farm workers, children, and others. They interpreted the FQPA to mean that the burden was to be shifted to the registrant to provide additional data when there is uncertainty about the toxicity of a chemical. Others supported this comment and added that the emphasis should be placed on developing better testing methods to adequately characterize toxicity.
Several members felt that, in addition to the 10-fold safety factor, there was insufficient enforcement on the proper use and storage of pesticides. One member commented that risk would be reduced with proper enforcement, and enforcement would be more effective with additional resources. Another observed that farm workers were among the first to be exposed to pesticides and are particularly vulnerable to the uncertainty of risk and the consequences of poor enforcement.
At the close of the discussion, Mr. Hansen summarized what he heard as key concerns. To address some of them, he committed to providing the group with additional information on the 10-fold safety factor including how its application has evolved and discussions from the internal Agency work on 10-fold. He also stated that the group will return to the issue of 10-fold when discussing the broader policy framework. Mr. Hansen called upon TRAC members to provide more input on when to use the additional 10-fold safety factor in future discussions.
Dietary Exposure Assessment
Randy Perfetti, Associate Director, Health Effects Division, OPP, EPA, provided the TRAC with an overview of dietary exposure and Monte-Carlo techniques for undetected residues. Mr. Perfetti referred TRAC members to Staff Papers 3.1 and 3.2 for additional information on the presentation (see Docket Number OPP00537). Mr. Perfetti began his presentation with a description of the Dietary Risk Evaluation System (DRES), and the Monte-Carlo technique to determine a probabilistic or statistical assessment of dietary risk. He explained that, until recently, the DRES model was used for all acute risk assessments. In addition, he noted that the assumptions made for DRES calculations are that all crops are treated and all crops contain pesticide residue at the tolerance level. The resulting risk estimates are "high-end" and not necessarily characteristic of the overall distribution of risk exposures. Mr. Perfetti stated that EPA currently regulates at the DRES 95th percentile.
In contrast, Mr. Perfetti commented that the Monte-Carlo assessment is based on actual distribution of pesticide residue level results from experimental field trials and on the percentage of the crop treated. The resulting information on the range and probability of exposure and the associated risk value more accurately reflects actual conditions. He explained that EPA is currently considering regulating using Monte-Carlo for chronic conditions at the 99.9th percentile.
After his presentation, Mr. Perfetti asked TRAC members to consider the following questions as a starting point for their discussions:
· Regarding the Monte-Carlo analysis, at what percentile is it appropriate for the Agency to regulate? 99.9%, 99%, 95%, 99.9999%?
· Instead of regulation at one percentile for all toxicological effects (regardless of severity), should the Agency regulate at a variety of percentiles, depending upon the toxic effect observed? For example, a lower threshold of regulation (perhaps 98th percentile) might be warranted for fully-reversible effects (such as mild anemia) while a more stringent threshold (perhaps 99.9th percentile or higher) might be justified for severe, non-reversible effects (e.g., birth defects).
· Given that a Monte-Carlo analysis is not a 'sum of the parts' and therefore risks posed by each crop cannot be broken out, should Monte-Carlo runs routinely be done for different permutations of crops?
Dr. Goldman added that the Monte-Carlo method was controversial in part because there is a lack of understanding about the differences between the DRES and Monte-Carlo models and because there are differences of opinion on whether the 99.9th percentile is more or less protective than the 95th percentile. She commented that the Agency raised the question on the range of percentiles to address the differences of opinion on the level of protection. Dr. Goldman observed that, to some, moving from regulation at the 95th percentile with DRES to the 99.9th percentile with Monte-Carlo is seen as more protective and to others it is perceived as a less conservative approach. She noted that some feel the Monte-Carlo method is sufficiently protective.
One member asked for clarification on whether Monte-Carlo has been used on acute or chronic risk. It was explained that, to date, Monte-Carlo has been used to determine acute risk. When the Monte-Carlo technique is more fully evaluated and understood, it may be used to determine chronic risk in the future. A member added that the use of Monte-Carlo to determine chronic risk is limited due to the lack of data on one individual over time. Another member suggested that, until sufficient data is obtained, Monte-Carlo could be used as a screening tool.
Another member commented that some experts feel that the Monte-Carlo method has not been used long enough to have confidence in its use to evaluate risk to children. Dr. Goldman recognized this information and indicated that the SAP was asked to consider this issue as it evaluates the Monte-Carlo method.
Many TRAC members were confused about what it meant to regulate to the 95th percentile (e.g., 950 times out of 1,000 a good thing happens) using the DRES method and the 99.9th percentile using the Monte-Carlo method. After some discussion, the following points were made to help clarify the concepts:
· The differences between the risk numbers generated by the two techniques can be measured.
· Risk numbers generated using the Monte-Carlo technique are generally lower (less conservative) than those generated using DRES, but the Monte-Carlo values are considered to more accurately reflect actual conditions.
· An exceedance of either regulatory threshold does not mean there is a health effect. The regulatory threshold is a least two orders of magnitude (100 times) below a dose at which no effect occurred in animal studies.
· If the 99.9th percentile is utilized, it is possible that some of that fraction of the population (some fraction of 23,000 people) could be exposed to levels that exceed the regulatory threshold.
· The database for the Monte-Carlo distribution differs from the database for DRES, as described above.
Many TRAC members were concerned about the number of people that could be exposed to values exceeding the regulatory threshold when regulating to the 99.9th percentile using the Monte-Carlo method. Dr. Goldman clarified that the figure was determined by assuming worst case values. She noted that the actual number will vary. David Miller, OPP/EPA, commented that there is a 50/50 chance that up to 23,000 people would be exposed to values exceeding the tolerance level. One member commented that, in contrast with the DRES method, which provided some measure of additional protection by assuming residual pesticide values at the tolerance level, the Monte-Carlo method did not have a similar margin of safety. They requested that EPA allow for this additional measure of safety. Mr. Hansen commented that, as the Agency works with more accurate data, it recognizes the necessity to develop a better policy framework to evaluate exposure in that context. Another member commented that the Agency should regulate to the highest percentile in which there is confidence in the data. To do this, they suggested that the Agency look at each set of data.
Several members observed that the Monte-Carlo technique would provide a more realistic representation of risk if there were a more complete and sophisticated database on residue and exposure. They wanted to know how the Agency planned to approach improving the database. One participant noted that additional resources would be required to expand the database effectively, and another suggested that the Agency develop guidelines on data collection. David Miller, EPA, explained that the Agency was working on a number of steps to meet the data needs including: maximum treatment rates; cooking studies; storage and transportation; residue decline after application; and market basket surveys. He commented that the Monte-Carlo method can account for some of these refinements. Keith Pitts, USDA, added that the USDA had also made some refinements in its data collection efforts including: bolstering the national food consumption survey to increase information on children; addressing "hot" commodities; obtaining more real world information on application rates; and developing the ability to differentiate between different commodities using the Monte-Carlo technique. It was recognized that obtaining data from the consumer was paramount and would be resource intensive.
One member commented that the Monte-Carlo technique was so complex it was perceived as a "black box" approach. As such, they felt it was hard for many to judge the adequacy of the method. They suggested it would be helpful to apply the Monte-Carlo technique to different data sets including ground-water data to perform sensitivity analyses. The analyses could include determining the sensitivity to non-detections. In addition, they commented that people would be more confident with the results if they were familiar with the database.
Dr. Ehrmann closed the discussion for the day with the proposal that the group continue its discussion the following day. He then invited members of the public to comment.
Barbara Peterson, Novigen Scientists - Ms. Peterson was concerned with evaluating risk at the 99.9th percentile with the Monte-Carlo method. She suggested that EPA develop a method to address outliers in the data set before framing the policy for FQPA. Ms. Peterson felt that, unless outliers in the data set are addressed, EPA could risk developing policy based on a data set that does not reflect actual conditions. She provided the group with some examples of data which was poorly interpreted a result of outliers in the data set.
Daniel Byrd, CTRAPS - Mr. Byrd expressed concern about farm worker safety. He commented that data show a record of farm worker poisoning by organophosphates, particularly migrant farm workers. He suggested that the poisonings have occurred because of poor enforcement and application mistakes. Mr. Byrd stated that no incidences of poisoning are acceptable among farm workers. Possible solutions to this problem include requiring the Department of Labor and the Food and Drug Administration to enforce worker safety, and improve worker training on application.
Tom Van Arsdall, National Council of Farmer Cooperatives - Mr. Van Arsdall was uncertain why EPA and USDA had chosen to seek public input in the FACA setting. He felt that a more appropriate approach would have been to seek public input using the conventional rule-making process.
Dietary Exposure Assessment (continued)
Work Group Concept
After some brief opening remarks, Dr. Ehrmann and Mr. Hansen invited to speak those TRAC members who had not spoken on the prior day. A summary of their comments is presented below.
Several representatives from the grower community commented on yesterday's discussion. One member was concerned about the implication that growers were responsible for contributing to the potential exposure of infants and farm workers to pesticides. He commented that it was difficult to find laborers and it would not be in the interest of growers to risk exposure of farm workers. He called upon TRAC members to work together to help guarantee a continued supply of safe, affordable food.
A second member of the grower community observed that growers were responsible for years of providing a successful, safe food supply. He explained that the grower community approached pest control responsibly, integrating progressive technology and practices according to circumstance. He cautioned against taking essential pest control products off the market without planning because such changes could severely influence the grower's ability to meet the demand of a safe food supply. In addition, he requested that EPA and USDA ensure that food entering the country meets similar safety requirements. He felt the real concern is the way analysis is done and how the data on risks are interpreted.
Another member of the growers community was discouraged with the previous day's discussion on risk and the overflowing risk cup. He stressed the need to focus on developing a process to evaluate risk that would integrate the ability of the grower to mitigate to reduce risk. He asked the group to acknowledge that "the sky is not falling" and to work together to maintain a safe food supply.
A representative of the food processing industry expressed a desire for the group to work together and make the process work. He suggested that the group spend less time on the technicalities of the science and focus more on policy issues. He commented that it would be helpful to the group to hear more from EPA on their interpretation of the data. He felt there were several issues the Agency would benefit by soliciting comment from a broader public notice and comment.
Several other members commented on the process selected to address FQPA implementation and tolerance reassessment. They were concerned about the size of the group and its ability to reach decisions, and felt a rulemaking process would ensure broader and more balanced public input.
One TRAC member commented that they would prefer to have more opportunity to share their comments during the meeting. They suggested future agenda items include: unintended consequences; risk trading; FQPA and international trade; and what the grower can and cannot use on crops. They asked that EPA be explicit about how they intend to fill data gaps, and clarify the rules of the game on how the FQPA will be implemented.
Dr. Ehrmann commented that he hoped future discussions would be more satisfying and proposed revisiting the agenda to address some of the concerns raised. He also suggested that the group may divide into smaller groups in the future to focus more specifically on what the TRAC will accomplish. Mr. Rominger thanked TRAC members for their comments and stated that he appreciated members sharing their frustrations because it will help the group focus again on the issues of importance. He commented that he also wants this to be a constructive process that will not cause the unnecessary loss of crop protection products.
A member of the pest control community shared some of the preceding frustrations. He was concerned about the potential for unnecessary loss of products and the use of unreliable data as a basis for decisions. He felt a rulemaking process would ensure a more fair, balanced process and expressed concern about the ability of this group to reach agreement on the issues.
Another representative of the growers community expressed concern about taking selected organophosphate off the market without evaluating the unintended impacts, such as on integrated pest management systems. They stated that organophosphates are critical and are used in complex environments. Mr. Rominger agreed that integrated pest management systems need to be considered in a broader context and as part of the process of determining uses.
One of the local government representatives expressed the importance of sharing the ideas of the group. They committed to working with the group, EPA and USDA towards a successful conclusion of the process and reminded members to communicate with the communities external to the process.
A representative from the distributors community commented that many people are concerned about exposure. They stressed the need to work together and invest in research to solve the problems facing the industry.
One member of the academic community commented on the importance of considering unintended consequences in the process. He noted that growers have refined pesticide use to a fine point and further reduction in selected uses could compromise the quality and safety of the food supply. In addition, he commented that the risk process and the underlying assumptions should be made clear to the group so that participants can provide informed advice.
Several members were concerned about the potential for FQPA implementation to disrupt the food supply. They were supportive of the process and stressed the importance of maintaining a diversity of grower's tools, a predictable process, and transparency.
A representative of the non-agricultural user community expressed concern about the potential loss of pesticides that are used for disease prevention. He commented that if the agricultural uses of pesticides currently used for disease control are discontinued, he will lose his ability to protect public health.
A member of the congressional staff reminded TRAC members that the potential problems with organophosphates were suspected for a long time. They stated that there are systems in place through EPA and USDA to perform necessary research and there is a process to address FQPA implementation. They encouraged the group to work together to address short-term decisions on cancellations and to plan for longer-term challenges. Mr. Rominger agreed and commented that USDA will look at how they can improve their programs to address some of the research needs.
Mr. Hansen provided clarification on some of the issues identified by the group. He stated that it was EPA's goal to have a more robust process than that required by APA alone. In addition, Mr. Hansen commented that the full rulemaking process will continue for tolerance decisions. He noted that the issue is that these certain steps were done informally in the past and that this process will be more transparent in the future.
Dr. Ehrmann observed that the group wanted to know more about how EPA views the overall flow of the policy framework. He commented that, if the goal is transparency, then the agenda for the next meeting should include a bigger picture look at what all of the pieces of the process are. It should also include an explanation of the current thinking of the Agency on organophosphates.
To respond to the group's interests, Dr. Ehrmann suggested forming two smaller interim Work Groups to think through how the larger policy framework on risk assessment will work, and to discuss what happens once the framework is established.
WORK GROUP #1 - Risk Assessment Framework
WORK GROUP #2 - Risk Management - What Happens Once the Framework is in Place/Transparency
Dr. Ehrmann suggested that both Work Groups have input on future agendas. He explained that the TRAC would still have plenary meetings as scheduled, but the meetings would include input from the Work Groups. He proposed that the agenda for the next meeting include the material that was not covered at this meeting, in addition to input from the Work Groups.
Lois Rossi opened the discussion on transparency with the statement that the Agency heard clearly that there is a need to make the regulatory process and decision-making more open, accessible, and transparent. She proposed that, to do so in OPP, they plan to have greater opportunities for involvement in the registration process, Section 18s, and the reregistration process, with tolerance reassessment a critical part of registration and reregistration. Ms. Rossi explained that FIFRA and FFDCA require giving notice to the public for various activities. As an example, she explained, in registration, public notice must be given when the Agency receives an application for the registration of a new active ingredient or to change the use pattern of an active ingredient. Ms. Rossi also noted that the Agency is required to put notice out and take comment when it receives information about a deletion of uses for manufacturers or a request to voluntarily cancel a particular use of a produce registration, before the deletions become final. She noted that, with regard to FFDCA, the Agency is also required to give notice of filing and take comment on the receipt of a pesticide tolerance petition as well as a proposed rule. Following the notice and comment period, a final rule is issued to establish a tolerance, an exemption from tolerance or change a tolerance.
Ms. Rossi continued by explaining that, in the Section 18 program, there are also regulations requiring the solicitation of public comment when certain criteria are met (as outlined in the background paper). In addition, she observed that, while there are no requirements or regulations for public participation in the reregistration process, the Agency adopted several procedures that allow for public comment and participation since the programs' inception in 1989. The Agency publishes the list of chemicals that will be considered in the registration program at the beginning of each fiscal year. Reviews and assessments that are completed and signed off by the science divisions are then sent to Registrants, a Docket announcing the availability of the Reregistration Decision Document is opened; and the document is issued for comment. This information is also accessible on the Internet. Ms. Rossi added that a number of additional options were identified that provide greater transparency in the regulatory process while allowing the Agency to meet its' goals. She commented that EPA is aware that various constituencies have concerns regarding the transparency of the pesticide regulatory decision making process and is interested in a higher degree of participation throughout the process.
A representative of the environmental community explained that the public interest community has been interested in transparency for a long time. He observed that, while many in the group were interested in real world data, they were reluctant to speak openly about the data. He asked the group to reflect on what kind of information they would consider public. He also asked the group to consider the kind of data they felt would fall in the category of confidential business information. He closed his comments with the statement that it will be difficult for this group to talk about real data without knowing the specifics on the Agency's current thinking on organophosphates.
One of the representatives from the growers' community commented on the meaning of transparency to a farmer. He explained that a farmer needs to know enough about EPA's thinking on the pesticides at risk (e.g., carbamates and organophosphates) to provide EPA with missing data, information on real risk (versus theoretical risk), pesticide use, and to plan for alternatives. In addition, a farmer needs to know EPA's overall plan on FQPA implementation to plan for the future and protect his business. He would like to understand the assumptions and the scientific basis for EPA's human risk assessment and would like those assumptions to reflect a more realistic model than the risk cup. A farmer would also like to know about the alternative products that are currently under review and when they will be available for use. He felt the basis of a relationship between a farmer and EPA should be shared knowledge and trust.
A registrant began his comments on transparency with the suggestion that members of the group agree not to be involved in the spread of information outside the TRAC that might be inflammatory. Dr. Ehrmann suggested that while members cannot control everything that goes on outside the process, members should take this concern into consideration and be aware of the potential for misrepresentation as they communicate with different parties outside the dialogue. The member stated that transparency is all about due process. It is also about openness, consistency and predictability. He added that transparency is an assurance of information flow between the public and the Agencies about issues like the range of options, priorities in the registration system, and the science on which decisions are based. In particular, there should be clarity on who poses questions to the SAP, the 10-fold safety factor, and what transparency is all about. He stated that there should be more openness and engagement with the public through rulemaking.
One member cautioned that, while open access to information and reporting was desirable, it is appropriate to be concerned about how the information will be used and whether there is a possibility of misrepresentation. She felt it was particularly important to be more open with information on pest management analyses.
Another member stated that registrants are reluctant to share product-specific information in the TRAC discussions because of a lack of information on the Agency's preliminary position on specific products. They noted that there are only 14 companies holding registrations for organophosphate active ingredients, and suggested that coordinated communication would facilitate the sharing of information.
A member commented that they were committed to providing EPA with information on use and usage but noted that this takes time. They cautioned that the information about use in the field is different from the information provided for registration.
Another member commented that, in the spirit of transparency, it is important to clarify critical organophosphate uses to determine the viability of alternatives. In addition, while the Agency is doing a better job clarifying the process, they are still not providing enough opportunities for public involvement within a meaningful timeframe.
Several members felt that a rulemaking process was necessary to ensure that there is an understanding of the underlying premise on the implementation of FQPA and for predictability. In contrast, another member expressed concern that a rulemaking process would take too long. They supported the current process and suggested the following improvements in transparency: require disclosure of information like health effects and residue data and avoid private meetings with registrants; make Section 18s a more open process and reveal applicable information to the consumer; do a better job collecting information on farm worker poisonings and disclose the information; and provide information on advisory boards, including their membership and funding sources.
A member expressed concern about different information on the timing for decisions on organophosphates. He commented that, in the interest of transparency, contradictory information like this should be avoided. He requested clarity on when decisions will be made on organophosphates in order to plan for alternatives. Dr. Ehrmann shared his understanding that no decisions will be made that will influence the 1998 growing season.
Another member observed that the term transparency was interpreted differently. One meaning is that you know how the decision is made and what the outcome will be. A second interpretation is that there is more information on EPA's process and how they are making decisions. They felt there was a need for EPA to provide more information on the deficiencies in the information on which they base their decisions.
One member stressed the need for transparency on alternatives to organophosphates. They recognized the need for additional research on alternatives to organophosphates and called for additional funding for research.
Other members were concerned that valuable information on issues like cancellations was not provided to the public in time to plan for alternatives. They suggested that parties who could facilitate transitions or who may be influenced by decisions be involved earlier in the decision-making process.
· EPA will provide the group with information on the membership of SAP and ILSI and with copies of the documents generated from their discussions.
· EPA will provide the group with additional information on the 10-fold safety factor including how its application has evolved and discussions from the diverse technical group working on 10-fold.
· Representatives of the Meridian Institute will work with TRAC members to organize two Work Groups; one on the overall risk assessment framework, and the other focusing on the decision making process that should take place once the framework is established. They will circulate ideas for Work Group agendas and ask you for preferences for participation. It was agreed that Work Group membership be reserved for TRAC members. Work Groups will convene prior to the next TRAC meeting in June.
· TRAC members will provide suggestions for topics on the next agenda to the Agency before the next meeting.
Egan Murphy, Press Secretary for Republican Ed Towns (N.Y.) - Egan Murphy expressed concern that the implementation of FQPA would negatively impact the ability to control the cockroach population. It was explained that cockroach dust is responsible for many cases of asthma in urban children and organophosphates combat the cause of asthma. In recognition of Allergy Month, Egan Murphy urged EPA and USDA to ensure that products that are used to eradicate cockroaches remain on market.
Ralph Engel, Chemical Specialties Manufacturers Association - Mr. Engel explained that his organization represents the non-agricultural pesticide industry; home lawn and garden pesticide use. He stated that his organization acknowledges the work of the TRAC and offered the services of two work groups created by his organization: the Indoor Residential Pesticide Working Group and its counterpart for anti-microbial pesticides. They will continue to develop data relating to indoor exposure and look forward to working with EPA and others in this arena.
Fran Smith, Consumer Alert - Urged the TRAC, EPA, and USDA not to look at risk in a vacuum. She cautioned all participants that when the government looks at risk, it must also look at unintended consequences. She explained that some of the unintended consequences can be severe and include health problems in inner city residences, poorer quality food, and reduction in the quantity of healthy and affordable foods like fruits and vegetables which are effective in preventing cancer and other disease. Ms. Smith noted that the poor and children will suffer most.
Mr. Rominger thanked TRAC members for their time. He felt that the day's discussions were productive and that the group was off to a good start with the plans for Work Group involvement. Mr. Rominger commented that the group will have a better feel for how the process will work by the next meeting, and felt that would benefit everyone involved in the process.
Mr. Hansen also thanked members for their time. He observed the dialogue between TRAC members during the day's discussion and urged members to continue to talk with each other. While he acknowledged that it would be a challenge for such a large group, Mr. Hansen commented that he heard some indication of potential areas of agreement during the meeting. He was optimistic that the group could help EPA and USDA shape and make the policy of the future.
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updated January 7, 1999