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Meeting Summary
Ramada Hotel & Exhibition Center
New Carrollton, MD
September 15 - 16, 1998
TUESDAY, September 15, 1998
Opening Remarks
John Ehrmann, Meridian Institute, welcomed participants to the fifth 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. Dr. Ehrmann then initiated a round of introductions for the benefit of the public. A list of the TRAC members is presented in Docket # OPP00537.
Following the introductions, Dr. Ehrmann turned to Co-Chairs of the TRAC, Richard Rominger, Deputy Secretary, USDA, and Fred Hansen, Deputy Administrator of EPA, for opening remarks.
Mr. Rominger welcomed members to the fifth session of the TRAC. He thanked TRAC members for their commitment, insight, ideas, and willingness to step forward to bring the discussions of the TRAC to their constituents. Mr. Rominger observed that the TRAC had spent a significant amount of time framing and clarifying the issues, and had provided USDA and EPA with extremely valuable guidance on a process to guide the implementation of the Food Quality Protection Act (FQPA). He noted that some members expressed the desire to continue the TRAC, while others felt the TRAC process had served its purpose. Mr. Rominger viewed the desire to work through and seek solutions to the issues identified in the TRAC as a measure of the success of the process to date.
In addition, Mr. Rominger took the opportunity to report on several developments in the USDA arena. First, he commented on the Relevancy Panel that was developed for the purpose of increasing stakeholder involvement in USDA programs. Mr. Rominger explained that the Relevancy Panel, formed to evaluate and score proposals for near-term pest management alternatives for at-risk crops based on their relevancy to the problem, the panel consists of grower organizations, public interest groups, academia, EPA, and USDA. He stated that USDA plans to use this approach for other USDA research programs. The second development was that the crop profile for walnuts was placed on the web earlier in September. He noted that it is the first of approximately 400 crop profiles being developed in a cooperative effort between the Land Grant University partners and agricultural producers that will be placed on the web for public access in the next couple of months. Mr. Rominger commented that the crop profiles will become an important resource for agriculture and other stakeholders. The third development noted by Mr. Rominger was that the EPA/USDA Senior Working Group established a joint technical committee to take a detailed look at the USDA data and its use in the risk assessment, mitigation, and management process. He noted that their initial focus will be on use surveys, residue data, and food consumption surveys. Mr. Rominger explained that the Senior Working Group will also be tasked with reviewing risk assessments and presenting issues and recommendations to Senior policy makers, and reviewing public comments on the nine science policy issues to be published for notice and comment. A fourth USDA development was that USDA will work with EPA to help fund the development of a revised and publicly available Monte Carlo risk assessment model.
Mr. Rominger concluded his comments by recognizing that Mr. Hansen would be leaving soon for his new position with the Regional Transportation Authority for the Portland Metropolitan Area in his home State of Oregon. He stated that Mr. Hansen had done a great job leading the TRAC process, and thanked him for all of his efforts. Mr. Rominger commented that Mr. Hansen will be missed. In addition, he stated that USDA looked forward to working with Peter Robertson and maintaining the cooperative relationship that has been established between EPA and USDA.
Mr. Hansen thanked Mr. Rominger for his kind comments and welcomed TRAC members to the meeting. He observed that, while great progress has been made in a number of areas, there was a lot of work yet to do. Mr. Hansen stated that he planned to take several steps before his departure to insure that the progress made as a result of the TRAC is institutionalized within EPA. He reiterated that the Agency is continuing the process outlined in the Vice President's memorandum: integrating sound science, transparency, consultation with stakeholders, and preparing for a reasonable transition. Mr. Hansen observed that there was progress on the first three of these issues, and transition would be discussed more extensively at this meeting.
To provide context for the discussions at the meeting, Mr. Hansen recalled the general perception at the beginning of the TRAC process that people were confused about EPA's plans for the FQPA implementation process, there was a lack of transparency, and there was a general distrust about the process. He observed that, while the TRAC had not come to closure on all of these issues, significant efforts were made to describe the risk assessment and risk management processes and to increase public participation in the steps. Mr. Hansen noted the specific steps taken in the risk assessment process, including: making the preliminary risk assessments on 16 of the 40 organophosphates available to the public; identifying the key science policy issues and establishing a notice and comment process to solicit additional input on the issues; and EPA and USDA are devoting substantial time from Senior staff to follow-through on the steps outlined. He noted that the process has required a lot of effort and hard work on the part of EPA and USDA staff. Mr. Hansen expressed concern that some of the staff involved in the process were also committed to revising risk assessments, evaluating new science, and to insuring that the policies of the FQPA are implemented.
Mr. Hansen noted that the risk management process presents an equal set of challenges and that there is need to clarify how EPA is both proceeding with the risk management process and providing the opportunity for greater public involvement in the risk management decisions. He expressed hope that the TRAC can reach agreement on a process for public participation in the area of risk management, but he assured the TRAC that he and Mr. Rominger are prepared to make decisions necessary to progress with a process for public participation. Also, he observed that Work Group # 2 (WG2) expended a significant effort in the development of the criteria to be used in making decisions on the reassessment of the organophosphate tolerances. Mr. Hansen stated that he looked forward to hearing about and discussing the decision making criteria, and to discussing possible options for the early assessment of organophosphate uses that may present very little risk. At the same time, he noted that preliminary data indicate that the risk cup on a number of organophosphates exceeds what is necessary for the proper protection of public health and the environment. Mr. Hansen observed that there will be some difficult decisions to make in the future and it is important to have a process that will allow the successful implementation of the FQPA and assure that the food supply in this country is even safer than it has been.
In addition, Mr. Hansen acknowledged that many TRAC members raised the issue of whether there should be additional TRAC meetings. He commented that he looked forward to discussion on this issue later in the meeting. Mr. Hansen thanked TRAC members for all of the time they had devoted to the TRAC effort.
Review of Recent Activities and Agenda
After the introductory remarks, Dr. Ehrmann provided the TRAC with an outline of the agenda and a summary of activities since the last TRAC meeting at the end of July. He explained that the agenda is based on updates from Work Group # 1(WG1) and WG2, both of who met several times since the last meeting; WG1 met on August 14 and September 9, and WG2 met on August 13 - 14 and September 9. In addition, Dr. Ehrmann noted that a subset of each Work Group took part in an agenda planning call on August 31 in preparation for this TRAC meeting. He commented that the resulting agenda is structured to provide time for WG1 updates on Tuesday morning and similar updates from WG2 on Tuesday afternoon. Dr. Ehrmann stated that the agenda for the second day of the TRAC meeting will include time for discussion on: an integration paper designed to show how the issues discussed by each Work Group fit together to provide a sense of the overall flow of the decision making processes and issues considered by the TRAC; an update on the human testing issue; information on USDA's priorities and activities; and closing comments from TRAC members and the Co-Chairs. He noted that there will be an opportunity for public comments on both days of the meeting.
Dr. Ehrmann reiterated that the TRAC process was convened in an effort to discuss a number of issues related to the implementation of the FQPA. He commented that, while the TRAC sought convergence on the issues, the Department and the Agency would continue to make decisions as required, with the advice and perspectives of the TRAC. Dr. Ehrmann observed that while there has been open dialogue on important issues, decisions to modify the process have been made and implemented during the process. In addition, he noted that the goal of the meeting is for the Department and the Agency to be clear about the: current status of the issues on the agenda; how they are viewing the options under consideration; and what their sense is of where they are, what decisions are pending, and potential next steps on the issues.
Work Group # 1 Risk Assessment Discussion
Steve Johnson, Deputy Director, Office of Pesticides Program (OPP)/EPA provided the TRAC with an overview of the products generated as a result of WG1 activities. For this purpose, he referenced the following Staff Papers: Staff Paper # 25, EPA's Risk Assessment Process for Tolerance Reassessment; Staff Paper # 26, Framework for Addressing Key Science Policy Issues; Detailed Considerations and Summary Matrix; and Staff Paper # 27, Public Participation in Risk Assessment (presented in Docket # OPP00537). He then highlighted some of the key issues, proposals for how to address some of the issues, and suggested next steps that are planned for each of the documents.
Mr. Johnson began with an overview of Staff Paper # 25. He explained that, after circulating the draft document to Work Group and TRAC members and the public, EPA received a number of comments. In addition, he noted that at the last WG1 meeting, some additional refinements were suggested. Mr. Johnson commented that many people contributed, but he extended particular thanks to Work Group members who also circulated the draft document for comment amongst the grower community. He stated that many of the suggestions were addressed and explained that EPA plans to publish this version of the document to describe EPA's current risk assessment process for tolerance reassessment in the coming weeks. Mr. Johnson noted that EPA will update the document as necessary based upon the evolution of the nine science policies.
Following his description of Staff Paper # 25, Mr. Johnson provided an overview of Staff Paper # 26. He explained that this paper may form the basis of a Federal Register notice and is composed of the following parts: a document which would become the Federal Register notice; an updated framework for refining the FQPA science policies; an updated matrix summarizing the nine science policy issues; and an updated timeline for releasing the guidance on the science policy issues. Mr. Johnson also commented that notebooks describing EPA's current interim practices on the nine science policy issues were distributed to all members. He then noted the following key aspects of the draft Federal Register: (1) a section on page 19 describing EPA's interim approach while assessing the nine science policies; and (2) beginning on page 19 there is a description of how the Agency is going to address the variety of comments they have received through the TRAC process and in parallel with the process (e.g., formal petitions, formal reports including the IWG and EWG reports). Mr. Johnson also noted that the dates on the timeline were modified to include realistic timeframes and, in most cases, allow for a public comment period of 60 days. He explained that the Agency plans to publish a document similar to this one, referencing the attachments, to describe the process for notice and comment on the nine science policy issues within the next few weeks.
A member asked for clarification on the content and timing of the workshop on drinking water and residential issues. In response, Mr. Johnson clarified that the workshop was intended to bring experts and interested parties together for input on all aspects of performing a drinking water assessment for agriculture and residential risks, including monitoring and modeling. He noted that the workshop is currently scheduled in two parts, one in October and the second in January 1999.
Mr. Johnson then described Staff Paper # 27. He explained that the purpose of the paper was to describe the pilot for public participation in refining risk assessments on organophosphates (option # 4). Mr. Johnson called particular attention to the last section of the document titled, "Distribution of Documents on the Internet," where EPA describes the process the Agency is using and will use for the remainder of the pilot to post documents on the Internet. He explained that EPA planned to issue this document as the current interim practice, and the process will be revised based on experience at the close of the pilot process.
Following Mr. Johnson's overview of the documents, Dr. Ehrmann invited members from WG1 to provide additional comments on the documents prior to taking comments from the full TRAC. He asked members to comment on the papers in the order of reference and reminded members to submit any written comments to Margie Fehrenbach. Members' questions and comments are summarized below by paper.
Staff Paper # 25, EPA's Risk Assessment Process for Tolerance Reassessment
Will input from the EPA/USDA Senior Working Group on the nine science policy issues and the risk assessment process be integrated into the document? Mr. Johnson indicated that their input will have an impact but they feel they have highlighted the significant issues, including the use of the food consumption survey, Pesticide Data Program (PDP) data, and drinking water, in the current draft. He reiterated that the Agency plans to work closely with the Senior Working Group on the science policy issues. Mr. Hansen clarified that this document will not have to be revised to account for their comments, but their input will be taken into account when each science policy issue is addressed individually. Allen Jennings, Office of Pest Management/USDA, added that this level of detail addressed by the Senior Working Group will not affect these papers.
Cross-reference Staff Papers # 25 and # 27 with Staff Paper # 28, USDA's Role in Risk Assessment, Risk Management, and Transition Strategies, and describe more explicitly the role of USDA in Staff Papers # 25 and # 27.
In the Federal Register notices, will the Agency indicate when it will respond to the various petitions? Mr. Johnson responded affirmatively and stated that there is a timeline established for each of the science policy issues. He also noted that the key issues identified in the petitions will be highlighted as questions before they start the notice and comment period.
In both Staff Papers # 25 (page 3) and # 26 (page 1 of the Attachment), clarify that "safe" means "reasonable certainty of no harm," as defined by FQPA.
On page 6, explain how a compound is determined to be present when it is "below the level of detection."
Children's patterns and levels of exposure differ from those of adults. In particular, because the FQPA requires the application of the 10-fold safety factor for the protection of infants and children, this document should explicitly reference exposure to children. Some examples of where this could be clarified are: (1) in the blocked text on page 1, when referencing the special sensitivity of children, add a reference to exposure to pesticides; and (2) make explicit reference to how the exposures to children are assessed in the chapter on Exposure Assessment.
On page 5, add specific reference to the use of PDP data when discussing residues and exposures.
Add reference to the reregistration process where appropriate (e.g., data needs, data call provisions, and the process of regulatory adjustments.) Jay Vroom, President, American Crop Protection Association, volunteered to provide editorial suggestions to address this omission.
Clarify where the tolerance will be set: at a safe level or at a level below which exposure is safe. Marcia Mulkey, Director, OPP/EPA, explained that the Agency wants to be sure it estimates risk correctly, and in the risk management phase, reevaluate the necessity to change the tolerance. Dr. Lynn Goldman, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances (OPPTS)/EPA, added that the Agency will strive for legal food that is safe food, and safe food that is legal. She noted that the Agency wants to avoid the circumstance where the tolerance, which is measured by the Food and Drug Administration (FDA) at the farm gate, is set at a point where food that is safe would not be legal. Dr. Goldman observed that there could be instances where the tolerance number is higher than the number in the risk assessment because of known factors that result in residues below the tolerance level at the point of consumption. She commented that, as a result of FQPA, the risk assessments that may result in this circumstance will be more transparent and people will be able to understand why the risk assessment level may differ from the tolerance level. Some members expressed concern that this means that the tolerance level was set in a way that could result in overexposure to children.
Clarify the intended audience for the document. The document may not be simple enough for the broader stakeholder community. Graphics could be used to clarify the information presented in the document, particularly to convey the concept of aggregate exposure. Mr. Johnson clarified that, based upon feed back from WG1, as a middle ground, the target audience for this document was educated laypersons.
Add some discussion on how confident the Agency is in their risk assessment and what the uncertainties are as part of the risk characterization.
Explain the use of different percentiles with different modeling approaches (e.g., 95th percentile with Dietary Risk Evaluation System (DRES) and 99.9th percentile with Monte Carlo). Clarify the number of people and children exposed for each percentile.
Staff Paper # 26, Framework for Addressing Key Science Policy Issues; Detailed Considerations and Summary Matrix
Delete the statement in the Attachment on the bottom of page 4 that, "..in practice risk assessments done at the 99.9th percentile using more refined data frequently result in lower estimated risk than risk assessments done at the 95th percentile" because it is misleading and is not always true. Mr. Johnson stated that the Agency's experience is that when they shift from using DRES to the Monte Carlo method using more refined data, they find that frequently the risk becomes acceptable.
On pages 1 and 2 in the Attachment, the term "fundamental information" is ambiguous and should be replaced with language which is consistent with the law: "reliable data."
On page 4, clarify what regulating to a certain percentile using the Monte Carlo analysis means and provide some comparison between regulating to different percentiles. A member suggested that the explanation should include an estimate of the number of people and children that would be exposed at each percentile.
Clarify how comments such as those presented in the IWG "road map" referenced on page 20 will be addressed in the process. Mr. Johnson explained that EPA will do the following: identify any comments they have already received in the Federal Register; ask questions based on issues raised in those comments; and as the Agency goes through the notice and comment process, it will consider petitions and documents such as the IWG Report as part of the public comments received and explain how they have addressed the issues raised.
On page 7, change "level of detection" to "limit of detection (LOD)."
Will documents referenced in the Federal Register notice hold the same weight as attachments? Yes.
Will the combined EPA and USDA initiative to revise the Monte Carlo risk assessment model include some of USDA's other efforts on refining consumption data statistical methods for composite to single servings and addressing issues of accuracy of reported high-end consumption? Mr. Jennings clarified that USDA has committed to help fund a module on pesticide use data in a publicly available Monte Carlo model that is being developed through a cooperative agreement between EPA and a research organization. Keith Pitts, Special Assistant to the Deputy Secretary, USDA, added that USDA will continue to make sure that USDA's data collection is consistent with EPA risk assessment needs and that the data are in a format that is compatible with the software. Mr. Jennings noted that the model will be more accessible and how assumptions and data drive the endpoints will be more transparent. He also explained that USDA's work on the accuracy of high-end consumption values is a separate effort that they hope to complete in two months. During that time, technical groups from EPA and USDA will meet to identify areas of concern to raise as policy issues. He observed that use of the input data was fundamental to the risk assessment model.
On page 3, item (1), change "dietary risk" to "aggregate risk" to be consistent with FQPA.
On page 5, item (2), the range of data used for Monte Carlo analyses is broader than the "entire range of data from controlled field residue studies."
Clarify which of the interim approaches to the nine science policy issues have been modified since the start of the TRAC and whether others may be modified prior to publication for notice and comment. Mr. Johnson noted that three of the policies were modified as follows: (1) drinking water exposure - now uses the concept of the drinking water reservoir versus the farm pond model; (2) dietary exposure estimates - now uses the Dietary Exposure Evaluation Model (DEEM) instead of the DRES software; and (3) the application of the FQPA10-fold safety factor was updated. He explained that other policies might be modified based upon input from the TRAC, reports from groups like EWG and IWG, and petitions, to varying degrees before they are published for comment.
On page 2 in the last paragraph of the draft Federal Register notice, make sure the language reflects the fact that science issues were taken off the table at the first TRAC meeting and it is a misrepresentation to say that the TRAC advised EPA with respect to sound science and the implementation of the FQPA. Nancy Rachman, Director of Regulatory Affairs, Agricultural Products Research Division, American Cyanamid, offered to submit written comments to clarify this issue.
The last paragraph on page 17 of the draft Federal Register notice indicates that organophosphates and carbamates have a common mechanism of toxicity that is based on cholinesterase inhibition. Some members felt that this is a misrepresentation of the current status of that issue. They suggested that the language be modified to provide a more balanced reflection of whether there is a common mechanism of toxicity, including more detailed interpretations and the scope of their evaluation. One way the Agency could portray a more balanced reflection would be to modify the text to state that, "based upon the data we have in hand today, we might make the conclusion that.."
On page 7 under section (3), the policy for non-treated commodities (e.g., meat, milk, and eggs) should be specified.
There was a concern in Staff Papers # 25 and # 26 about the apparent shift from using the no-observed-effect-level (NOEL) as a starting point to the less protective no-observed-adverse-effect-level (NOAEL). Dr. Goldman stated that, in the context of the SAP, because the Pesticide Program was using a NOEL like an NOAEL, they felt they should call it a NOAEL. She explained that the Agency did not think this would result in much of a change because of the way they have used the NOEL. However, based on these comments, Dr. Goldman suggested that the Agency might need to reevaluate this and determine whether to propose the NOAEL or propose two different alternatives before making a final decision.
Science policy # 9 is a science issue that the Agency brought to the SAP several times and resolved. It should not be a science policy issue before the TRAC.
In both Staff Papers # 25 and # 26, it should be clarified that the language in FQPA allows for an increase in the 10-fold safety factor in addition to reduction, removal or retaining the safety factor.
There was concern about the lack of reliable data to evaluate residential exposure. It was felt that residential exposure is currently over-estimated and there is a potential for losing a number of quality products. Before residential exposure is included in an aggregate assessment, reasonable scenarios and reliable data are necessary. The status of the SAP review of the standard operating procedures (SOPs) was requested. Mr. Johnson explained that the review of the SOPs will be complete in December 1998 and a draft of the SOPs will be published for notice and comment soon after that.
It is important to define the term "reliable data" and to use reliable data for the determination of the 10-fold safety factor in addition to other scientific elements of the FQPA.
On page 6 of the draft Federal Register, clarify when and why it is necessary to apply single-serving-size exposure data. Will this detail be included in this notice, particularly in view of the fact that it is possible to extrapolate from PDP data on blended commodities to single-serving data? Mr. Johnson commented that, because acute dietary risk analyses are driven by single-serving food analysis, it is necessary to have single-serving data. He noted that, in some cases single-serving data are available and in other cases single-serving data are extrapolated from PDP data using statistical methodologies. It was suggested that it would be helpful if EPA clarified where single-serving data is needed.
On the bottom of page 17 of the draft Federal Register notice; modify the text to address more than organophosphates and carbamates. The inclusion of the word "organophosphates" is unnecessary in the heading of this section.
In the Schedule for Release of Guidance on the Science Policy Issues, consider staggering the timing of when the science policy papers will be open to public comment because a number of them are scheduled for comment over the holidays.
On page 16 of the Attachment to Staff Paper # 26 under assessing residential exposure, the reference that drinking water residential models may significantly over estimate exposure is not consistent with the language on page 14 of the draft Federal Register which indicates that these models may also under estimate exposure.
The Agency should articulate the public policy in the draft Federal Register notice on why they may lean on the side of safety and over estimate exposure to address public health protection.
There are data indicating that, for the mean consumption of apples, the reference dose (RfD) is exceeded for a number of organophosphates at the tolerance level. It was suggested that, if the food supply were to be considered safe, it would be necessary for the Agency to move tolerances to a safe level.
Staff Paper # 27, Public Participation in Risk Assessment
How will the process be evaluated and with what criteria? Mr. Johnson commented that EPA does not currently have a formal evaluation process, but they plan to put more thought into the kind of evaluation process that they intend to use. He noted that EPA is hearing from many how they can improve the process. Mr. Hansen added that he will look at the suggestions to improve the process, particularly on how to make it a more transparent process. Mr. Pitts commented that as the technical teams look at the commentary and gain more experience, USDA and EPA will clarify a system to address the comments and will try to address the suggestions earlier in the process. It was suggested that the process should include an evaluation of whether option # 4: furthers the early submission of good information and review; creates additional burdens on the staff; furthers responsible analysis and review of the data; enhances the orderly production of crops; and whether it shortens the process.
Has USDA commented formally to EPA on the preliminary risk assessments? Mr. Pitts explained that USDA looked at the preliminary assessments generally prior to their release but they have not yet formally commented on them. He noted that USDA had formed teams to evaluate the assessments.
On page 1 in the second bullet, specify the time period for EPA review of comments (e.g., 30 days or less.)
On page 1 in the second bullet, several members were uncomfortable with EPA knowingly posting errors when they may have had the time to make corrections before posting the preliminary risk assessment. It was suggested that the language from an earlier draft which indicated that the Agency would review the comments on errors and "make" appropriate corrections (versus "or acknowledge that an error exists if it would be too time consuming to make the correction") would be more appropriate. Mr. Johnson explained that, since EPA would have released the preliminary assessment and the opportunity for error correction was underway, if a substantial error is recognized at the close of the 30-day period, for transparency it would be appropriate for EPA to make that information available. It was suggested that the information about the error be presented in bold letters. Mr. Hansen added that EPA intended the term "error" to include mathematical miscalculation rather than the presence of additional data which, if attributed, would result in a different risk value. He suggested striking the phrase beginning with "...and appropriate or acknowledge ...before public release."
Releasing the information on the preliminary risk assessments is important to all parties, and parties and the Agency need to work together to deal with issues that arise.
There is the potential for causing problems among agricultural users and consumers as a result of releasing preliminary risk assessments. To date, there was one concern in the user community but there has been no other evidence of consumer concern.
Some members prefer option # 2 rather than option # 4.
On page 1 in the first bullet, has EPA observed any confidential business information (CBI) that should be excluded from public release in a preliminary risk assessment? Mr. Johnson commented that he is not aware of any EPA preliminary risk assessment containing CBI. Mr. Hansen clarified that some of the information placed in the Docket as attachments to the assessment is supplied by the Registrant and could include CBI. He stated that the language in the bullet should be clarified.
Make USDA's comments on the preliminary risk assessment available to the public. Mr. Pitts explained that there are on-going discussions on USDA data and its compatibility with the EPA risk assessments, including the size of a single serving and the extent of sampling. He noted that they are willing to think about whether and how to make these routine discussions available to the public. Mr. Pitts added that USDA is committed to setting up at least an annual meeting with stakeholders for education and feedback on various programming efforts including: research; PDP; National Food Consumption Survey; and NASS use data.
On page 1, modify the language in the first bullet to indicate that, in addition to error corrections and comments on CBI, Registrants can submit additional comments. Dr. Ehrmann clarified that the additional comments would be addressed in the public notice and comment following the 30-day comment period.
How long will the pilot be in place? Mr. Hansen commented that the pilot will be modified before the release of additional organophosphates (beyond the preliminary 16) in October. He noted that the pilot will probably continue to be used with modifications on a more permanent basis. Modifications that have been made to data include refining the Internet posting process and addressing the Multi-National Declaration issue.
Following the comment period, Mr. Johnson asked members to submit any additional suggestions to Margie Fehrenbach within the next week because EPA hopes to finalize the document in the next month.
Comments from USDA and EPA on Progress, Results, and Next Steps
Before summarizing some of the key points from the WG1 discussion, Mr. Hansen introduced Peter Robertson who will be taking over as Acting Deputy Administrator of EPA on October 1, 1998. Mr. Hansen recognized Mr. Robertson as a common sense Administrator who knows the Agency well and who will do an excellent job in the position. He explained that Mr. Robertson understands that the TRAC will be an area of high importance for his personal attention. Mr. Hansen then turned to Mr. Robertson for comments.
Mr. Robertson commented that he was looking forward to working with the members of the TRAC and to hearing their thoughts and recommendations on his role as the TRAC evolves. He acknowledged the importance of the work with which members have helped to the Agency. Mr. Robertson commented that he was particularly grateful for TRAC member's efforts, time, and expertise. He closed by stating that he looked forward to working with TRAC members as the implementation of the FQPA progresses.
Mr. Hansen summarized the progress and next steps for the discussion. He observed that there will be clarifications and modifications to the documents to make them clearer and more precise. Mr. Hansen viewed the improved clarity and transparency that this reflects as critical to the process. In addition, Mr. Hansen noted that a reasonably clear, accessible plain English description of the risk assessment process will be widely distributed. He stressed the need for members to provide suggestions for actual wording changes or diagrams to Margie Fehrenbach within the next week. In terms of the substance of the discussions, Mr. Hansen observed that the TRAC recommended a major new process for consultation, public participation and accountability which has been put in place. He noted that the process includes notice and comment on the major science policy issues. Mr. Hansen also explained that, in the interim, during the notice and comment period, EPA will use the science policies as outlined. For example, he noted that the 99.9th percentile will be used with more refined data as provided for in the Monte Carlo analyses. In addition, the 10-fold safety factor will be reduced, retained or removed based on the underlying science. He commented that when EPA is concerned about a health endpoint, such as neurotoxicity, they will look at both the toxicity and the exposure. As EPA makes the determination about whether to retain, reduce or remove the 10-fold safety factor, they will start with the assumption that the safety factor will be retained unless the science supports otherwise. Mr. Hansen also recognized that there is a new openness in public participation in the risk assessment process. He viewed the pilot (option # 4) as a success. He commented that it will continue to alter the dynamic for interaction between the Agency and the Registrants and has opened the process to all of the parties. Mr. Hansen observed that it is necessary to find ways to achieve the same openness in the risk management process. He felt that, over time, the flow of information and how EPA processes it in preparation for the preliminary risk assessments will become more efficient. He stressed that the TRAC process is something to which EPA is committed and in which it believes very strongly. Mr. Hansen turned to Dr. Goldman and to Mr. Johnson to comment on this issue.
Dr. Goldman added that EPA recognizes that these developments represent fundamental changes in the way EPA does business when it comes to pesticides. She noted that this is the first time in 52 years of federal pesticide registration, where the government is going to be able to: explain to people how the risk assessments are done; provide notice and comment for science policies; and enable interested parties to participate in the risk assessment process for each pesticide. Dr. Goldman commented that these are enormous changes to which EPA is committed. She noted that the Agency thinks that this is the right direction for the Pesticide Program to take and there is no way to turn back the clock on this kind of change. Dr. Goldman stated that it is very important for everyone to make use of these opportunities. She noted that the success of this process will be measured by the extent to which there is participation and involvement by everyone.
Mr. Johnson commented that, from the perspective of the Pesticide Program, the issues identified by the TRAC are the issues the Program has been grappling with. He noted that the TRAC and Work Group process has helped them to focus on the major issues including the nine science policy issues, and the process used to address the issues. Equally as important, Mr. Johnson observed that the TRAC highlighted a number of the sub-issues, some of which may have been overlooked. He stated that, as the Program moves forward to address the science policy issues and refine the risk assessment process, the Program will benefit in many ways. Some of those benefits include better data earlier on in the process, which will help them to make more refined assessments and deal with real risk issues earlier in the process. Mr. Johnson expressed their commitment to all of the activities discussed by Mr. Hansen and Dr. Goldman, and he closed by stating that the Co-Chairs of WG1 appreciate the cooperation and the hard work of the members of WG1.
Work Group # 2 Risk Management Discussion
Jim Aidala, Associate Assistant Administrator, OPPTS/EPA, provided the TRAC with an overview of the papers developed as a result of WG2 discussions. He identified the work products of WG2 as: Staff Paper # 29, Decision-Making Criteria; Staff Paper # 30, Early Assessment for Organophosphate Uses with Very Low Risk Contribution and/or High Public Value; Staff Paper # 31, Risk Assessment and Risk Management Process; Staff Paper # 32, Regulatory Mechanisms for Achieving Pesticide Risk Mitigation; and Staff Paper # 34, Public Participation in the Risk Management Process (presented in Docket # OPP00537). Overall, Mr. Aidala characterized the WG2 discussions as robust and indicated that the issues addressed by WG2 were less developed and more conceptual than the WG1 issues. He noted that WG2 had spent a great amount of time discussing Staff Papers # 29 and # 30. He explained that both papers will be expanded and made available for public notice and comment. Because more detailed papers will be available in the future, Mr. Aidala asked TRAC members to focus on whether the issues are framed properly and on the associated background information.
Mr. Aidala explained that Staff Papers # 31 and # 32 are provided as background information for people who want to understand how the Agency will approach assessing organophosphates. He described Staff Paper # 31 as presenting a parallel approach regarding how the Agency will proceed with individual risk assessments and addressing urgent risks, while at the same time, proceeding with the cumulative risk approach as it is developed. He called particular attention to the statement representing the convergence of the workgroup in the document. Mr. Aidala described Staff Paper # 32 as a background piece to provide a common understanding of the nomenclature of regulatory mechanisms for achieving pesticide risk mitigation and some of the steps entailed in the process.
Mr. Aidala introduced Staff Paper # 34 as a subject that has not been discussed by the full TRAC before. He noted that the Agency views public participation in the risk management process as very important and the paper presents some ideas about how to encourage and increase public participation in risk management decisions. Mr. Aidala explained that, once the risk assessment is finalized, the Agency will have to make decisions about the risk management approaches they plan to put forward. He noted that, while traditionally the Agency has discussed risk management alternatives with the Registrant, many stakeholders recognize the strength of expanding the discussion. Mr. Aidala indicated that the paper includes some ideas on the boundaries and timeframes for public involvement, in addition to laying out a process.
Following Mr. Aidala's overview, Mr. Pitts added his comments on the Staff Papers. He noted that for Staff Paper # 29, USDA felt it was good to get some broad principles in place to deal with public health and the importance to agriculture. Mr. Pitts stated that USDA plans to use the paper as a guideline when they develop their crop profiles and transition strategies. He referenced a concern raised in an earlier TRAC meeting about the ability to quantify these aspects of a pesticide or pesticide use. Mr. Pitts commented that USDA will try to work with a less quantitative approach, but will try to be as specific as they can as they develop the crop profiles and transition strategies. He stated that USDA continues to think that Staff Paper # 30 represents an important principle for regulatory management and for helping USDA to focus its limited resources on the research of key risk drivers and identifying commodities of low risk and/or high use. Mr. Pitts observed that, in Staff Paper # 31, USDA recognized the importance tying the risk assessment and management processes together. He commented that USDA will be involved in both parts of the process and will be looking for ways to incorporate growers as decisions are made in both arenas. For Staff Paper # 34, Mr. Pitts explained that USDA was supportive of the pilot for the risk assessment process and would like to see a similar public participation process implemented for the risk management process.
Marcia Mulkey, Director, OPP/EPA, provided the TRAC with additional details on Staff Papers # 32 and # 34. She began with Staff Paper # 32 and explained that the paper was designed to describe the legal tools that are available once the risk management phase begins and a change in the registration or the tolerance is determined to be necessary. Ms. Mulkey then referred to the chart that presents the universe of possible regulatory outcomes (in the left-hand column), and, reading across the chart, how they would be accomplished if all the relevant Registrants consented, and how it would be accomplished if there was resistance to that change. Ms. Mulkey then walked the group through the continuum of examples presented in the table, including: changes in the use reflected in label changes; change to conditions of registration; elimination of uses; elimination of active ingredients; and phase-out: delayed elimination of use(s) or active ingredients. She commented that the examples were not exhaustive, but they may stimulate ideas for other alternatives. She summarized by stating that the table provides a sense of the kinds of ways to address risk as well as the legal tools and how they differ whether there is consent or not.
Ms. Mulkey then described Staff Paper # 34. She began by referring TRAC members to the chart on Public Participation in the Risk Management Process and to Staff Paper # 27 and the chart on Refining Chemical Risk Assessments (options # 1 - 4), in particular, option # 4 (the pilot). Ms. Mulkey called attention to the dark line on both charts labeled, "end of public comment period on risk assessment," and noted that the last 90-day period on the chart in Staff Paper # 27, Refining Chemical Risk Assessments, overlaps with the first 90-day period on the chart in Staff Paper # 34. She commented that, in the 90-day period, people might begin to provide the Agency with their preliminary ideas for risk management. Once, in that 90-day period, the risk assessment is finalized, the Agency will initiate a 60-day comment period to solicit active public involvement and comments on risk management. Ms. Mulkey explained that, during the 60-day period, the Agency might propose: a specific risk management proposal; a set of options; or refer to proposals submitted by Registrants and others. In addition, Registrants would submit proposals for risk mitigation and there would be meetings with the Registrants and other interested parties that would be documented and published in the Docket. She explained that, following the 60-day comment period, the Agency would consider the proposals and public input and develop a risk management approach and the formal process for public participation would begin (as described in Staff Paper # 32). Ms. Mulkey also noted that, as indicated on the chart on Public Participation in the Risk Management Process, USDA would be involved throughout the process, as appropriate. In addition, while this chart is designed around the individual chemical, a similar process would be used for cumulative risk management, once cumulative risk assessments are performed.
Following Ms. Mulkey's description, Dr. Ehrmann invited comments and discussion on the Staff Papers, in the order of reference.
Staff Paper # 29, Decision-Making Criteria
At what point will there be a notice and comment on this Staff Paper? Mr. Aidala responded that the Agency had not yet developed a timeline, but he expected that the paper would be out for comment in three or four months so the criteria can be used for decision making in the next 12 months.
On page 2 of the attachment (Staff Paper # 15) under section II in the second item, "detectable residues at harvest and/or consumption should not be detectable," may be too constraining because it leaves open at what limit residues might be detected. Mr. Aidala commented that the Agency agreed with this comment.
As stated on the first page of Staff Paper # 15 in the third bullet, make it clear in Staff Paper # 29 that "the Agency would not be using benefits to decide how much risk to tolerate, but rather to choose among competing uses." As currently written, Staff Paper # 29 could be interpreted to mean, "benefits are back in FFDCA."
The language in the Overarching Principle in Staff Paper # 15 should be refined. It should include reference to language in the statute on, "making food safe for children." In addition, the concept of "strategic risk reduction while maintaining benefits wherever possible," should be captured. Mr. Aidala noted that there was no disagreement with the intent of the statute. Mr. Pitts reiterated that meeting the standard was essential. Another member suggested that the reference to children's safety should be done in a manner that will not lead to increased cost of production to the point where the parents of poorer children will not be able to afford nutritious food for their children.
The safety of children should be explicitly referenced in other sections of the discussion in Staff Paper # 15, particularly in the discussions on dietary and non-dietary risk.
In Staff Paper # 15, sections I and II, it was urged that the Agency change the language to encourage the use of less toxic pesticides. Mr. Pitts acknowledged this comment and noted that the use of alternatives was addressed in section III.
In Staff Paper # 15, section I, clarify that the reference is to mammalian toxicity versus invertebrate aquatics.
In Staff Paper # 15, section V, insure that the phrase "non-dietary exposure" refers not only to occupational exposure, but also to children in schools and other "non-dietary" scenarios.
The meaning of the term criteria should be made consistent in Staff Paper # 15.
There is no recognition of the limited ability of the Agency to monitor and control exposure. While some environments are monitored well, others, such as indoor environments, are not well monitored. Where there is no monitoring, some members were skeptical of the Agency's ability to determine and contain exposure so there is reasonable certainty of no harm. It was suggested that the Agency develop criteria to channel resources to address high exposure scenarios, and consider canceling uses for unmonitored environments.
It is not clear how the Agency would actually use these criteria in making a regulatory decision. As an example, if a Registrant is in the position of making a decision about pesticide use on two commodities, is the Agency in a position to advise them to choose one or the other? Mr. Aidala commented that the decision making takes place in a broader context. He clarified that this paper identifies considerations that will be relevant if the Agency proceeds with decision making criteria, which will lead into a first cut at a risk management regulatory approach. Dr. Ehrmann added that others were also concerned about how to strike a balance between quantifiable criteria versus a set of descriptors of the factors that need to be weighed in the decision making process.
There is insufficient time to resolve all of the policy issues in the TRAC, and some of the issues cannot be resolved without the Agency gaining more experience over time. As an example, if, based on the decision criteria outlined in Staff Paper # 29, EPA determines that mitigation should be implemented for a registration or a tolerance to proceed, how will EPA implement use and usage or residue mitigation if the data are not available? Mr. Aidala commented that this circumstance would suggest that there is information indicating the need for mitigation. He noted that additional data might be necessary to refine the mitigation strategy. Ms. Mulkey added that it might be helpful to think about this issue in terms of the applicable regulatory tools. She noted that some of the tools, like suspended animation and a phase-out, involve time, while others offer more immediate solutions. Ms. Mulkey commented that the factors considered when selecting the regulatory tool include whether more data are required and what is known to cause the level of concern at the outset. Dr. Goldman also commented that, to some extent, common sense and judgement will be applied to determine the tools to use and the timeframes in which to address a wide range of issues. She noted that there will be a need to address the more serious risks quickly.
It should be clarified that Staff Paper # 15 is setting up a process for not only organophosphates but also other pesticides.
Clarify that the criteria address cumulative risk.
The definition of "reasonable alternatives" should be realistic and address the fact that the cost of alternatives will differ and modifications in use training may be required.
Staff Paper # 30, Early Assessment for Organophosphate Uses with Very Low Risk Contribution and/or High Public Value
To begin the discussion on Staff Paper # 30, Dr. Ehrmann referred members to the copy of the written comments from TRAC members (Docket # OPP00537) and noted that some of the comments were addressed in the revised draft of the paper that members received at the meeting. Mr. Aidala also noted that EPA will provide the TRAC with information on the schedule for notice and comment on this paper. The comments on the paper from TRAC members are summarized below:
How would EPA preserve the use of one organophosphate without destroying another in the following circumstance: one organophosphate is good for protecting public health, and the other organophosphate that has another use, has a high risk or a high use? It was noted that pesticide use for public health protection is limited and varies regionally. The lack of knowledge about when potential use cancellations may occur is problematic. Mr. Aidala rephrased the concern as the need for criteria on how EPA would weigh public health use in the decision making process. He acknowledged that it is helpful for EPA to be reminded that, as in the statute, public health use is viewed in a somewhat different category from agricultural uses. Mr. Aidala noted that, answering the question on how EPA will weigh public health uses is as difficult to answer as how they will weigh soy beans and brussels sprouts. Mr. Hansen added that it is important to recognize that the Registrant and the Agency, since the beginning of the pesticide program, have faced these types of issues. He noted that the difference in this discussion of the issue is that it is part of a broader and more transparent decision making process involving input from many other parties. Mr. Rominger also commented that, when evaluating all uses, it is important to look at the existing and developing alternatives for pesticide control.
It should be explicit that EPA plans to address and commit its limited resources to the chemicals that present the greatest risk first. There is concern that the Agency will commit their limited resources in preliminary risk assessments of the "lower" risk (versus "negligible" risk) chemicals. Mr. Aidala responded by referring TRAC members to Staff Paper # 31 for additional detail on the Agency's commitment to addressing known risks and the worst first. In addition, he noted that, with regard to early assessment, the Agency agrees that it is important to conserve resources and use them more efficiently. Mr. Aidala reiterated that the comments like these will be addressed in detail during the notice and comment period. Mr. Hansen agreed that the Agency can be more explicit about its commitment to prioritizing the worst first.
Substitute the concept of giving some uses a "bye" rather than guaranteeing a spot for them in the risk cup. This would enable EPA to: prioritize chemicals; put those that do not present risk aside, rather than guaranteeing them a spot in the risk cup, and reserving the right to address them based on additional information; and focus resources on the priorities. Mr. Pitts explained that this issue was discussed but was not resolved by WG2. He commented that the Work Group viewed this as a tool to address chemicals that do not present public health risk and critical minor use chemicals that may represent marginal or unresolved risk. Mr. Pitts noted that WG2 did not resolve under which circumstances a place in the risk cup would be reserved. He added that WG2 considered another option where EPA might decide a particular use was of high value and allow the tolerance to remain on the books for another Registrant to assume responsibility. A member noted that there are other related issues, such as the LOD or half of the LOD, that impact the risk cup. Mr. Pitts acknowledged this concern and commented that this type of issue will be addressed in the notice and comment period.
Staff Paper # 31, Risk Assessment and Risk Management Process
The comments on the concept of "worst first" apply to both Staff Papers # 30 and # 31. A concern was raised that EPA will not be able to manage the risk assessment and management process. There is a lot to be done in a short period of time.
There are both advantages and disadvantages to addressing the "worst first." Most organophosphates are used for many crops or uses. The biggest uses determine whether the product is sold, and if the bigger uses are lost because they do not meet the new standard, some of the smaller uses that do meet the standard will be lost.
Risk assessments are currently proceeding on the basis of active ingredients and are completed prior to product registration. At what point were critical uses of organophosphates and the pesticides with older chemistries (which are based on 24C's residing with the follow-on Registrant) identified, and who is responsible for notifying the product Registrant that the 24C is at risk? Ms. Mulkey responded that the Agency hopes that all constituents, including the Registrant, EPA, and the user community, are involved in the process as early as possible by focusing on the developing risk assessment. She explained that the clear chance for involvement is in the public comment period on risk mitigation. Ms. Mulkey commented that it is important that the public participation process frames the mitigation issues in a way that highlights the issues and provides ample notice to affected entities. Mr. Pitts added that USDA is trying to capture all of the 24C's for the particular commodities in the crop profiles. He indicated that, since USDA is responsible for gathering the data on the 24C's, they will feel responsible for making sure the growers groups are aware of the information. Mr. Hansen pointed out that Registrants will be part of the process and will have the ability to provide information about how potential decisions may impact the pesticide market, as will representatives of the grower community who will be able to comment on their concerns about the 24Cs. He added that, with experience, the process might be adjusted.
Staff Paper # 32, Regulatory Mechanisms for Achieving Pesticide Risk Mitigation
Regional or geographic differences should be added to the chart of regulatory alternatives. Ms. Mulkey suggested that geographic restrictions could be added to the list under outcome # 1, Changes in Use Reflected in Label Changes.
For an acute significant risk as determined with a refined risk assessment, add suspension to the list of outcomes. Ms. Mulkey stated that both suspension and emergency suspension are available outcomes. It was noted that the list will be modified accordingly.
If there is a full registration, is it possible to go back and apply conditions to the registration? Ms. Mulkey responded that, if upon consent, the Registrant could request an amendment to their registration to impose the conditions. She explained that, in the absence of consent, the "notice of intent to cancel (NOIC) unless," applies and the Agency issues a notice of intent to cancel unless the label changes are made.
Information in the text, such as limiting some or all uses of a pesticide unless certain specific triggers occur, should be reflected in the summary table. For example, it should be clear where labels that portray limited uses appear to the regulating state. Ms. Mulkey explained that, if the Agency were to maintain a registration for a use but the use must not be marketed for a period, the label would be modified to exclude that use for that period. She noted that the label could also be modified to state the limitations in use. A member commented that label changes are a clumsy way to address a transitional status because they require not only changing the label but also controlling the products with old labels and reeducating the public on the use. Ms. Mulkey noted that, while the Agency often chooses to allow existing label products to stay in the channels of commerce, they also have the authority to recall product or sticker-over labels at any point in the channels of commerce. Mr. Johnson provided examples where the Agency required stickered-over labels, including: modifying products for worker protection; modifying the use date under the Section 18 program; and, through the distributor level, restickered product to add requirements. He noted that fenthion is an example of a pesticide for which the Agency required sticker modifications.
There was some skepticism about the effectiveness of label changes as a regulatory mechanism. The question of whether grower compliance with changing labels is monitored was raised. Ms. Mulkey explained that in the early stages of a change in registration there is some heightened enforcement. She noted that, while the states do most of the enforcement under FIFRA, there is some enforcement in EPA regions and at Headquarters. A member noted that there are no assurances that everyone will comply with label changes. However, he observed that there are many people monitoring what growers are doing. He noted that the key is to recognize and take advantage of the mechanisms that are available to make smart risk reductions efficiently. In addition, he commented that voluntary programs work if they are taken seriously. Labeling was recognized by many state representatives as an important way to control product flow. One state representative recognized that 48 out of 50 states have primacy over field enforcement that includes looking at labels and observing how farmers used pesticides in accordance with the labels in their fields. In addition, she explained that some states manage another independent, unscheduled check of pesticide residues through residue monitoring programs. Mr. Pitts added that the USDA uses PDP data to help with risk assessments and, if they become aware of a residue problem, they notify the state and EPA. Robert Lake, Director of the Office of Policy, Planning and Strategic Initiatives, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA), added that, if, in its monitoring, FDA identifies unauthorized pesticide residues, they will take action.
How would EPA respond in a circumstance where a product was canceled and six months later a problem arises and the state applies for a Section 18? Will EPA adhere to the cancellation if insufficient data are available, or will they use default assumptions? Mr. Hansen responded that EPA will address each circumstance individually, considering all of the available information. He stated that the statute is clear that the Agency must test to determine where there is reasonable certainty of no harm.
The actions taken by the Agency to modify a label or suspend a use will reflect the Agency's judgement on the level of concern.
It will be difficult to advise the Agency and USDA on how to go about the risk management process until the nine science policies are in place.
It is encouraging and important that everyone will be at the table when risk mitigation decisions are made. A member commented that, while this may be encouraging, the reality is that decisions are ultimately made by the Agency with the Registrant. She noted that Registrants will have to make decisions based on the economic circumstances and minor use farmers will make decisions accordingly. She stressed that, because USDA is in a knowledgeable position to participate, it is critically important for USDA to be actively involved with EPA in regulatory decision making processes. In addition, she hoped that the Agency and the Registrants recognize how important the USDA research budget can be in conducting research that is necessary for producer groups to learn from the USDA what the alternatives are and how transitions can be made.
Staff Paper # 34, Public Participation in the Risk Management Process
For the public participation process to succeed, a lot of work will be required at the outset to provide a clear structure for the process. It also will be necessary to educate the grower groups and the others involved on how to take part in the process. In addition, it will be helpful to integrate a mechanism for feedback to learn from and improve the process. Ms. Mulkey commented that a member previously suggested selecting one pesticide as an example to show how the process works. She noted that there was merit to this idea but observed that no one chemical is the test of a successful process. A member agreed and suggested that the example include issues like drinking water and residential exposure. Ms. Mulkey also commented that, while a 60-day comment period is not equivalent to a meaningful collaborative effort, it provides a framework for stakeholders to make as meaningful input as they can. A member added that it may be useful to look at other mitigation efforts, such as those designed to address worker safety, if the mitigation also impacts FQPA risk concerns.
The timeframes proposed for the public involvement process may or may not be appropriate depending upon how much information is available at the start of the process. For Registrants, early discussions with stakeholders to obtain realistic information and knowledge from USDA about alternatives, is critical. Mr. Rominger agreed that USDA data is important and stated that stakeholder involvement throughout the process is essential to insuring that USDA is getting the right data for the process.
A schedule of release for EPA's work plan for making decisions on organophosphates and cumulative risk would be helpful. Ms. Mulkey referred TRAC members to the timelines outlined for the risk assessment and risk management phases. She explained that the 16 preliminary risk assessments for organophosphates that were released are in the 60-day comment period of the proposed timeline. Following the comment period, those organophosphates will enter the 90-day period where the Agency will review the comments and complete the risk assessments. She commented that, at the close of the 90-day period, the 60-day period during which the Agency will solicit comments on risk management alternatives will begin. Ms. Mulkey noted that the Agency expects the remainder of the organophosphates will enter the preliminary risk assessment comment process in October 1998, or soon after. She stated that the Agency expects to be able to present the approach for cumulative risk assessment in March 1999. Once the method for cumulative risk assessment is established, the same timeline would apply for cumulative risk assessments. The risk management process would then begin following the timeline proposed on the chart.
Comments from USDA and EPA on Progress, Results, and Next Steps for Work Group # 2 and TRAC Discussions
Following the discussion on the WG2 documents and issues, Dr. Ehrmann turned to Messrs. Rominger and Hansen for summary comments on the highlights of risk management issues. Mr. Rominger began by outlining where USDA is in this process and what they plan to do. He noted that USDA will do the following: continue to provide significant resources to support FQPA implementation, particularly for data development and research on alternatives and the implementation of alternative practices; gather information from growers on their needs; improve stakeholder input into USDA programming; improve the relevancy of USDA programs; solicit stakeholder input into pest management programs; provide a key role for EPA in the USDA programming work on data and research; play an important role in the risk assessment and mitigation process; and insure that growers are well represented by USDA.
Mr. Hansen added his perspective on EPA's position, results, and next steps. He recognized that, as complex as the risk assessment process is, the addition of the risk management processes increases the complexity. Mr. Hansen observed that the TRAC has helped the Agency and USDA to articulate a number of issues including how to integrate individual chemical management with cumulative risk. He referred to the WG2 statement that clarifies the necessity to proceed with individual risk management decisions while allowing the continued development of the cumulative risk assessment. Mr. Hansen noted that balancing these necessities as they are applied will be a challenge. He reiterated that EPA and USDA need to collaborate in a new way, and recognized the importance of USDA's cooperation and guidance, on behalf of the growers, on where and how to make risk management decisions within the risk cup. Mr. Hansen summarized the results as follows: the notice and comments on the two important concepts, the criteria for evaluating among uses, and early assessment; and the understanding about the need to move forward with cumulative risk assessment. He noted that, implicit in all of the discussion, is that EPA needs to make progress with decision making to reduce risk. Mr. Hansen expressed interest in exploring ways to pilot the concepts presented in Staff Paper # 34 to create a framework for how to integrate these issues and test some of the ideas.
Post-TRAC Activities Discussion
Dr. Ehrmann invited the Co-Chairs to comment on their preliminary thoughts for post-TRAC activities. He noted that the TRAC would have additional time to discuss their ideas on post-TRAC activities on the second day of the meeting.
Mr. Hansen observed that prospect of post-TRAC activities has been raised as an issue in both Work Groups. He stated that, for him to consider additional meetings, the time commitment must be bounded in terms of the number of meetings, and the amount of work between meetings must not demand such heavy involvement of EPA staff because they need to be able to proceed with their other work. Mr. Hansen observed that the TRAC has done remarkably well and it would be unfortunate to lose the opportunity to work together and reap the benefit of TRAC member's advice to the Agency and the Department. He summarized that an extension of the TRAC would have to be structured in a way that lessens the burden on EPA staff with meetings that are: focused on tightly defined activities; spaced sensibly; and limited in number.
Mr. Rominger commented that this group has made progress in a way that has been helpful to USDA and EPA. He stated that USDA wants to take advantage of the TRAC while the process progresses. In addition, Mr. Rominger observed that the process has been time consuming, and he agreed that additional TRAC activities should be less rigorous. He felt that it would be beneficial to USDA and EPA to have a check on the progress of the process by reconvening the TRAC in the future. Mr. Rominger commented that it was appropriate to continue the dialogue in order to answer to stakeholders, other organizations, and congressional committees on what EPA and USDA are doing, how they are doing, and what progress is being made on FQPA and the deadlines established in the law. He agreed that there was a future role for the TRAC but not at the same pace.
Following the Co-Chair's remarks, Dr. Ehrmann invited TRAC members to comment. Many TRAC members began their comments by commending EPA and USDA for all of their hard work on the process. A number of them felt that the TRAC had accomplished a lot in a short period of time, particularly as an arena for public input and transparency. Several TRAC members questioned the need for additional TRAC meetings and asked for clarification on the purpose and timing of additional meetings. Mr. Rominger stated that there was no specific time suggested for the meetings, but he suggested that the next meeting would be after the first of the year to check the progress of the process.
Some TRAC members stated that their primary concern with extending the TRAC process was diverting the staff at EPA from the work necessary to proceed with FQPA implementation. They did not see a reason to extend the TRAC and were concerned about the potential for spending valuable time rehashing the same issues. They felt that there were other mechanisms for public input and supported testing the public process outlined by the TRAC as a means for additional public input, and modifying the process based on experience. A member observed that the additional meetings would also divert energy and resources from the critical public comment periods. Several members felt that the TRAC had identified the key issues and that additional discussion would not be worthwhile until some decisions were made and the process was tested. One member agreed and suggested that, before committing to an expanded process, the Agency should proceed with some decisions to test the process and that those members who are interested in additional TRAC meetings carefully define the purpose, boundaries, and agenda for the future meetings. Another member commented that the TRAC should not reconvene until after EPA receives public comments on the preliminary risk assessments and resolves its guidance on the risk assessment process. As a compromise, a member suggested using a "filter" to identify future TRAC issues that add value to the process while accomplishing EPA and USDA goals. She felt that there was potential for the TRAC to come to closure on some of the outstanding issues and expressed concern that discontinuing the TRAC dialogue at this point would create anxiety and a level of frustration similar to that experienced at the outset of the TRAC process.
Members discussed the purpose of additional TRAC meetings. One member asked whether the additional meetings would be to provide oversight or to reach convergence on the outstanding issues? She commented that she did not think the TRAC would reach convergence on a number of the issues. Mr. Hansen responded that EPA and USDA wanted to hear what TRAC members see as the purpose of additional TRAC meetings to help them in their evaluation about whether and how to extend the process. Several members felt that, while the TRAC has made progress on many of the issues, discussion on some of the issues has been limited and more time is necessary to strive for closure. They supported extending the TRAC process. Another member supported an additional TRAC meeting based on a carefully structured and focused agenda reporting on some of the central issues including how the Agency applied the decision criteria to a complex mixture question. Some of the other issues that TRAC members saw as part of future agendas include: WG2 issues including risk management after the science policy issues are resolved; unresolved issues discussed by the TRAC at this meeting; residential exposure data; drinking water exposure; aggregate and cumulative analyses; Monte Carlo analysis; data; policy questions that arise as the process progresses; insuring that the process does not discourage healthy competition amongst Registrants; and impacts on international trade.
In the interest of time, Dr. Ehrmann closed the discussion and asked the Co-Chairs for comments. He reminded TRAC members that there would be additional time to continue the discussion on the following day. Mr. Hansen stated that the discussion was helpful and he looked forward to additional comments tomorrow. He observed that there were divergent opinions, but heard that, if there are additional meetings they must be limited and focused on useful topics. Mr. Rominger chose not to summarize until he heard the remainder of the discussion tomorrow. He commented that, after hearing from TRAC members tomorrow, he and Mr. Hansen will decide how to proceed.
Dr. Ehrmann then invited the public to comment.
Public Comment
Judith DeCarli, concerned citizen - explained that she sustained chemical injury by routine spraying of pesticides. As a result, she developed hypersensitivity to chemicals, lost her job, and was forced to relocate. After relocating to a mini-farm, she was exposed to agricultural pesticides used on nearby farms. Since her initial exposure, she has been unable to avoid additional exposure to chemicals and has experienced a series of health problems, which have compromised her ability to function normally. She stated that pesticide use should be looked at closely because the costs of pesticide use to society, insurance companies, individuals, and government are high. She feels that the pesticide industry should be subject to that same scrutiny as the tobacco industry and less pesticides should be used.
Michelle Gaby, concerned citizen - stated that she was overexposed to pesticides used to control fleas in her apartment. As a result, she became ill and she developed health problems. Ms. Gaby explained that, since these exposures, she was diagnosed with multiple chemical sensitivity and her lifestyle has had to change significantly. She became physically disabled, lost her job, and has had to relocate her home several times. Ms. Gaby noted that it took three years for doctors to diagnose her illness, but she has found a resource for her illness through MCS Referral and Resources in Baltimore, Maryland.
Connie Eash, concerned citizen - spoke about her son's organophosphate poisoning in 1993 when he was exposed to chronic low levels of pesticides at school. She commented that he now suffers from chemical sensitivity. Based on her experience in the pharmaceutical industry, she commented on the limitations of using the results of animal testing on humans. She noted that if there was an indication that a drug was more toxic or worked differently on humans, the drug was dropped. Ms. Eash observed that there is substantial documentation of adverse human response to pesticides. She referenced a survey she recently completed on a number of schools in Pennsylvania where integrated pest management (IPM) is used effectively. Ms. Eash closed her comments by requesting that EPA prioritize their work on residential exposure and used case studies as a resource, and that EPA consult with a physician prior to negotiating with pesticide manufacturers.
Mark Keating, Henry Wallace Institute for Alternative Agriculture - indicated that the Institute has been supportive of the TRAC efforts and feels that it has increased awareness and attention to pesticide regulation. He noted that they feel EPA has made great strides in developing a workable framework for implementing FQPA. Mr. Keating stated that Institute is aware that Mr. Rominger is committed to positioning the USDA to facilitate the transition process, but they are concerned about the impact of budgetary constrains within USDA to make this possible. He noted that many of the concerns about FQPA existed before the passage of the law. Mr. Keating stated that the Institute is supportive of the regulatory reform represented by FQPA, and commented that they would like to see FQPA be part of a broader transition of American agriculture.
Sheila Massey, Women Involved in Farm Economics - commented that she and her family own and operate a small farm in New Mexico and Arizona. She explained that they use various crop management tools and some organophosphates. Ms. Massey noted that the organophosphates they use are used sparingly because they are expensive and they are applied to the soil at planting. She stated that organophosphates are an essential part of their crop management strategy and there are no substitutes for them. Ms. Massey requested that EPA support the responsible use of organophosphates and base their decisions on sound science.
Cynthia Kelley Smith, Golf Course Superintendents Association of America - commented on the lack of discussion in the TRAC of non-agricultural pesticide uses and noted that these uses are also important. She encouraged the TRAC and the Agencies to do the best job possible in implementing the FQPA by getting the data so the decisions are based on facts about exposure and risk. Ms. Kelly Smith commented on the importance of preserving the non-agricultural pest management options. She noted that using default assumptions and models causes the loss of products that have value. Ms. Kelly Smith stated that the data are collectable and available, and urged EPA to take advantage of data resources and to understand the reality of pesticide use in the non-agricultural community.
Jim Miller, cherry grower in Michigan - commented on potential effects the FQPA may have on apple growers. He noted that he uses organophosphates for pest management, and without them, his IPM program would be compromised and his apples would not look appetizing to consumers. Mr. Miller explained that he has tried to use alternatives to organophosphates, but they are costly and are not effective. He noted that FQPA might result in destroying his competitive advantage, thus shifting his share of the market to foreign producers.
Rodney Baker, Arkansas, Farm Bureau - stated that it is difficult for him to know how to advise his farmer members about the impact of FQPA. He commented on the general lack of information on FQPA available to growers, and stressed the importance of making this information available so that he can better advise his growers and they can plan alternative pest management. Mr. Baker noted that it would be helpful for them to know the following: what products are in the registration queue; whether there are replacement products and whether the replacement will require multiple pesticide usage; the cost of replacement; how USDA is coordinating with EPA on identifying alternatives; the status of research on alternatives; and how EPA will conduct cumulative exposure assessments. He noted that the lack of information creates a lack of trust in the process. He encouraged EPA to educate the growers on the law and how it will influence them.
Steve Apple, President of the Washington State Farm Bureau - commented that farmers in Washington are concerned about the impact of FQPA implementation for the following reasons: the decisions are based on unrealistic usage data; the decision making process is unclear; the policies are not written in understandable language and should be subject to public comment; and the potential impact of FQPA on the essential use of pesticides in IPM.
Dean Kleckner, President of the American Farm Bureau Federation - stated that he and his community were initially supportive of FQPA; however, with greater understanding of the details of the Act, they feel FQPA substantially changes agriculture. He noted that farmers are struggling with high prices that will increase if alternatives are more expensive and they are forced to use them. He used an example of an apple producer to show how a farmer might be forced out of the market as a result of FQPA and other factors, thus losing their market share to foreign producers. Mr. Kleckner commented that, as pest control shifts to an organic base, it will become more difficult to meet the existing and growing demand for food.
Luke Olson, concerned citizen - stated that he represented the children of America in his comments on pesticides. He noted that too many pesticides are bad for a number of reasons. He noted that children consume grapes and carrots in great quantities. If there is too much pesticide on them, the children consuming them could become ill. He felt that all food should be pesticide-safe.
Bob Holm, Associate Executive Director of IR-4 - provided the TRAC with details on the IR-4 program, USDA's minor use pesticide registration program. He described the amount of data the IR-4 program has developed in support of food and ornamental use labels and biopesticide registrations. Mr. Holm commented that they have recently updated their strategic plan to meet the challenge of pesticide management on minor crops to focus on safer, reduced risk products. He observed that many of the minor crops have no alternative for organophosphate pesticides and they are at risk as a result of the FQPA tolerance reassessment process. Mr. Holm stated that, to protect the minor crop growers, it is critical that EPA provide adequate time for the crop protection industry and IR-4 to develop and register the newer, reduced risk products. To do this, he suggested that EPA expedite the establishment of tolerances or exemptions for those products on minor crops.
WEDNESDAY, September 16, 1998
Welcome and Agenda Review
Dr. Ehrmann began the discussion by reviewing the agenda for the day. The proposed agenda for the day is presented below:
USDA Priorities and Activities
Human Testing Issue Update
Integration Paper and Remaining Issues on Risk Assessment and Management
Post-TRAC Activities
Closing Comments for Committee Members
Public Comments
Closing Comments.
USDA Priorities and Activities
Role in Risk Assessment
Allen Jennings summarized Staff Paper # 28, USDA's Role in Risk Assessment, Risk Management, and Transition Strategies (Docket # OPP00537). He explained that the staff paper is an effort to describe how each of the issues discussed by the TRAC fit into the risk assessment and management processes. Mr. Jennings noted that the FQPA, in addition to requiring USDA to establish a minor use program, also specified that they address data and the generation of data for EPA to use in risk assessments. Some of the specific sources of data for which USDA is responsible include pesticide use surveys, food consumption surveys and the PDP program.
Mr. Jennings described USDA's role in the risk assessment process. He noted that they have actively engaged in the Land Grant system to create crop profiles and other information on pesticide use and usage. Mr. Jennings observed that the major change in their approach is the transition from providing data to assuming the ongoing stewardship of what data is available, how it is collected, the characteristics of the data, and how it is used. He stated that the first step for USDA is to work through their Senior Working Group with EPA on USDA data and making sure the users at EPA understand the extent of the data available.
Mr. Jennings also described the elements of the pesticide use and IPM practices surveys. He commented that USDA is initiating a pilot program with the state of Michigan to improve their data by increasing the information on pesticide use, specifically the timing of application as well as the timing of harvest and the target pest. Mr. Jennings noted that, if the pilot provides better information, they plan to expand the program for fruits and vegetables and the field crop survey. In addition, he commented that IPM and other pest management techniques continue to evolve. He explained that USDA is working with EPA on addressing the likely errors in the food consumption surveys and how to best utilize the available data in the risk assessment process. He stated that USDA is currently collecting supplemental consumption data for approximately 5,000 children and the data will be available in the spring of 1999.
In addition, Mr. Jennings described the PDP program. He explained that, because of concerns about acute toxicity and the acute endpoint the EPA is using for organophosphates, USDA is evaluating gathering more single-serving size residue information. USDA is currently collecting data on pears and plans to expand the sampling to apples. Mr. Jennings also commented that USDA is talking with Registrants about working together to perform additional single-serving size sampling. He noted that USDA will publish the data on pears next month and will soon publish the results of the most recent (1996 or 1997) sampling, including single potato residues for aldicarb. Mr. Jennings commented that some of the early information will provide a model that will allow USDA to translate other combined commodities to the single serving values. Mr. Jennings also stated that, pending information on the 1999 budget, USDA is considering collecting drinking water samples for analysis, as well as taking a closer look at meat, poultry and eggs.
Role in Risk Management
Mr. Jennings viewed risk management in two parts: risk mitigation and management. He described the role of USDA as data gathering for crop profiles to build the database of crop production practices and fundamental crop and pest management. Mr. Jennings noted that the crop profiles will form the basis of discussion with grower groups and other interested parties to evaluate ways to effectively manage the pest and the risk simultaneously in a way that ultimately reduces risk. He observed that the role of chemicals in IPM and resistance management is critically important. Mr. Jennings commented that grower involvement was key and that growers will be involved in the development of crop profiles. He also recognized that the accuracy of information is an issue and USDA is instructing the Land Grant programs and grower organizations to rely on the National Agricultural Statistical Service (NASS) survey data for pesticide use information or equivalent data quality. Mr. Jennings stated that the USDA currently has 350 - 400 crop profiles under development and the California walnuts are the first profile to be completed and made available on the Internet.
Role in Transition Strategies
Mr. Jennings noted that crop profiles play a central role because they provide basic information for transitions to alternatives. He described the pipeline database as key to transitions and as the USDA's effort to identify effective pest management alternatives that are not yet registered but are potentially available in the short-term. Mr. Jennings stated that this information will also soon be available on the web within a few months. He commented that, once the information is available on the web, there is a mechanism for individuals to comment on the data. As examples of the type of data available in the pipeline database, he referenced the IR-4 program, Section 18 emergency exemptions, experimental use permit data, and other information about short-term alternatives. Mr. Jennings explained that the intent was to be able to provide the opportunity to transition from the use of one type of chemical to another within two years. He stated that the crop profiles allow the EPA to identify the problems and priorities that will develop, and the pipeline provides the alternatives. Mr. Jennings explained that the final piece of the transition is the Pest Management Alternatives Program (PMAP), which is intended to identify short-term alternatives for high-risk crops. He explained that USDA experimented last year with a relevancy panel for PMAP, which was developed to help USDA evaluate the proposals to make sure the proposals were relevant to applying short-term alternatives to some of the at risk crop chemical combinations. Mr. Jennings indicated that USDA will continue to fund PMAP. He noted that they will also invest in longer-term research of IPM programs over a five to ten year period.
Mr. Jennings summarized that USDA is intending to integrate greater EPA and stakeholder involvement in their programs, the development of proposals for research, and in setting priorities. He referenced the flow chart in Staff Paper # 28 as a graphic representation of his presentation. He noted that the information presented in bold represents points of USDA input into the decision process. He described it as WG2's description of USDA's role in the process.
Mr. Pitts added that he would like feedback from the TRAC on whether USDA should expand its current efforts to solicit input on it's data collection programs beyond NASS, food consumption surveys, and PDP, to include crop profiles. He reiterated that USDA wanted to hear comments from the TRAC on all of their programs. Mr. Pitts noted that USDA considered these documents to be "living documents" that would be modified as necessary. He commented that he felt confident that the budget planning for the year 2000 was adequate for USDA to address what WG2 members outlined for USDA to do in the attachment to Staff Paper # 28.
Ms. Mulkey also stated that EPA is continuing to work on the front end of the process, the registration pipeline, which she felt was consistent with the TRAC's support of progress on alternatives.
Following this overview, Dr. Ehrmann invited TRAC members to comment on Staff Paper # 28. Their comments are summarized below:
For FQPA to be successful, USDA must insure that their data is utilized and that the agricultural community is preserved. There is a need for a formal memorandum of understanding (MOU) between EPA and USDA to insure that EPA uses USDA information appropriately and that funds are allocated appropriately.
Some pesticide alternatives must be available sooner than the proposed short-term of "within two years" because that is the equivalent of five crop cycles and is too long a period. Mr. Jennings responded that he would like to commit to a shorter timeframe, but explained that to deliver a viable alternative takes some time. He commented that one of EPA and USDA roles is to help the user through the transition period.
What is USDA's plan if the NASS prototype survey in Wisconsin is not successful? Mr. Jennings responded that, if the prototype is not successful, USDA will not continue with collecting detailed data, but they will continue with the surveys. He explained that the prototype was designed to help evaluate whether collecting that level of detailed data is worthwhile. Mr. Pitts added that some of the concern is whether those surveyed will have the patience to fill out a detailed survey.
It is important for the agricultural community to know the status of USDA's progress on the crop profiles.
Does USDA have a framework for data collection that the private sector or another agency could use to help with the data collection efforts? Mr. Jennings responded affirmatively.
Does the data collection performed by municipalities for the purposes of the Safe Drinking Water Act (SDWA) conform to USDA data requirements for determining water exposure? Mr. Pitts referred to EPA for more details on this and added that USDA is working through PDP to develop a methodology with EPA to address data collection at the point of consumption to determine drinking water exposure. Mr. Jennings stated that the SDWA requires testing for very few pesticides. Ms. Mulkey commented that they are working with the EPA Drinking Water Program on this issue. She confirmed that, at this time, there is a relatively small number of pesticides for which there is testing. However, she noted that there are some important changes in the SDWA that will increase the amount of reporting of those data. Ms. Mulkey stated that EPA is also working with the American Water Works Association (AWWA) to work out some issues of common interest. A member suggested that states might be able to fill in some of the data gaps. She suggested that EPA and USDA coordinate with them to help insure that their data collection efforts conform to EPA and USDA needs as much as possible. Ms. Mulkey noted that EPA is aware that there is an enormous amount of information that is not reported consistently in a single database. She explained that EPA is struggling with how to access this information in a cost-effective way.
Go beyond the Land Grant University system because they are not experts in alternative controls. Change the reference to the Land Grant University system to, "agriculture research and information community," to emphasize that USDA will utilize other resources of information like the independent crop consultants, and sustainable agriculture organizations.
Clarify that, in addition to seeking changes in chemical efficiency, part of the USDA strategy will be to look for alternatives that reduce reliance on chemicals. While Mr. Pitts noted that alternatives are referenced in the flow chart as new registrations, it could be clarified that bringing a new product "on board" for an existing use is important. Mr. Rominger added that it could also be clarified that USDA is going to other sources than the Land Grant University system for information on a broader spectrum of alternatives. One member noted that farmers would use alternatives to chemical pest control if cheaper alternatives were available.
Develop the crop profiles for the highest risk crops first. Mr. Pitts noted that, for crop profiles, USDA has asked states to focus their efforts on the highest risk chemicals and alternatives are addressed. He commented that USDA has been working with organizations other than the Land Grant University system such as independent crop consultants who have committed to reviewing USDA data that is within their expertise. In addition, he explained that USDA is in the process of working with NASS to include IPM tactic questions on the NASS survey.
Act as an honest broker by not only brining information from growers into the process but also communicating "real" risk and helping to minimize misinformation.
It is important to recognize that, because the data collected today will shape what we decide to worry about over the next decade, the structure for monitoring where pesticides go in the environment is critical. Drinking water is consumed in great amounts and should be monitored fully for residues. Rural wells should be included in the monitoring program. A state representative commented that states have independently developed ground water monitoring programs. They have also pursued independent monitoring of municipal and private wells and there is a good understanding about the kinds of pesticides that pose difficulty in ground water.
Pay attention to the consequence of increasing regulation and the consequent increase in imported foods. Better control is necessary, particularly at the border. Mr. Jennings commented that USDA tries to correlate the number of import samples with the consumption patterns. Robert Lake, Director of the Office of Policy, Planning and Strategic Initiatives, Food & Drug Administration (FDA), commented that the food supply, including fresh produce and manufactured foods, is increasingly a global food supply (e.g., 2.5 million separate entries each year). He explained that entries range from small truckloads to huge shiploads. Mr. Lake added that the increase in the volume of imported foods has put a strain on FDA's and Custom's ability to monitor imported foods. As a result, he noted that a small percentage of imported foods are monitored. One member recalled the FDA monitors a figure of approximately one percent of all of the produce entering the country. Mr. Lake stated that the Administration has a broad Food Safety Initiative, a component of which is designed to insure domestic and foreign agricultural practices that insure fresh produce is free of pathogens. Pesticides may be addressed in the future. He commented that, in the pesticide arena, the level of resources to monitor for pesticides has decreased. Mr. Lake observed that, despite the limited resources, the FDA performs a lot of monitoring and they find that the majority of foods are within EPA tolerances. He noted that, of the imported foods that are monitored, FDA observes a two to three percent rate of violation for international foods and a one to two percent violation rate for domestic foods. He closed his comments with the statement that, from a resource standpoint, FDA is struggling to keep up with the monitoring of the increased volume of imported foods. A state representative commented that California has a pesticide residue monitoring program for produce, which parallels FDA in volume. Mr. Pitts acknowledged that the amount of monitoring is of concern to everyone. He explained that, to try and address this concern, the Administration proposed as part the Food Safety Initiative, legislation that would provide FDA authority to evaluate other countries' food safety system and deny entry accordingly. Mr. Lake observed that there will never be sufficient resources to monitor the border to the level the public will find acceptable. He explained that this is why there will be emphasis on increasing the understanding of other countries' food systems as a basis for decisions.
The limitations in the monitoring of imported foods do not create a level playing field between domestic and foreign producers. Not only is the fact that such a small volume of foreign produce is monitored not a deterrent, but also the fact the many organophosphates are not detectable when foreign produce reaches the boarder. As a consequence, while the use of organophosphates by domestic farmers is in jeopardy, foreign producers can continue to use organophosphates. A member commented that a higher percentage of imported foods are monitored for residue than the percentage of domestic food. He also noted that it is easier to monitor imported foods because the points of entry are defined. He observed that U.S. companies own and import much of the foreign produce. In addition, he stated that many of the foreign crops are not in competition with domestic crops. Also, the results of a comparative study showed imported produce to have similar pesticide residue values.
Does FDA have plans to increase its monitoring of organophosphates in the future? Mr. Lake responded that FDA has had some technical discussions on this issue. He indicated that there will be additional discussion on what the objective would be and what is possible. In response to a question, Mr. Lake commented that FDA has not yet discussed budgetary needs for expanding their program to include monitoring organophosphates. A member observed that the most likely source of funding will be from USDA. Mr. Pitts explained that USDA will be reevaluating their budget and will consider redirecting funds to address management issues. They will also be looking at grants as a resource.
USDA funds are a fraction of Land Grant University systems. For example, USDA funding of the University of Michigan Land Grant programs varies, but often represents a fraction of the funding received from other sources. Other sources include foundations, formula funding, the Michigan Department of Agriculture, the Department of Defense (DOD), the Department of Energy (DOE), and industry. Funding of IPM in general and especially for minor crops is insufficient. Regional and formula funding is inadequate to address transitional issues. Mr. Rominger commented that USDA is seeking additional funds for Land Grant Universities and for matching competitive grants programs. He observed that funding for Land Grant Universities and formula funding have been flat. A member observed that, in order for Congress to increase funding for agricultural needs, manufacturers and grower groups must ask for the funding and make the funding a priority.
What is USDA's long-term strategy for responding to the need for alternatives and to addressing EPA's data needs?
The linkage between NASS and PDP data is missing for most commodities. There is a need for some studies to allow that linkage to occur. A member commented that previously NASS data lacked robustness because it has not been checked against the records for accuracy.
There is a need for accurate field data on use and usage. The grower community has developed databases. Obtaining the database and putting it in a useful form is the challenge. To obtain this type of data, what is the likelihood of a mandatory national pesticide data reporting process? Mr. Rominger commented that this will depend on whether the grower groups feel there is a need for a national database. He observed that a national database would help them do a better job. Another member felt that it was time for mandatory use requirements on all pesticides use. She also commented that USDA should take advantage of other sources on usage information, including data from food processors.
The risk posed by some of the processed foods that are heavily consumed should be viewed more closely. Mr. Jennings explained that, within budgetary constraints, the PDP program has expanded its coverage of processed foods to include some canned and frozen commodities. Some of the produce they have begun to monitor includes green beans, grains, and corn syrup.
Put all of the intake and residue data on the web. Mr. Jennings indicated that data, including food consumption data, are on the web in the agricultural marketing service site. Mr. Pitts added that NASS data are also available on the web. As an alternative, it was suggested that USDA could be contacted directly for more up-to-date information.
If the IR-4 program is successful, why has EPA gone from 98 to 100 approvals annually to one? Ms. Mulkey stated that EPA is committed to the IR-4 program. She acknowledged that, in the first year of FQPA, EPA struggled with the pace of all kinds of new uses. Ms. Mulkey commented that EPA hopes to regain and improve the pace. Mr. Pitts added that USDA is identifying someone within USDA who will follow-up with EPA on the status of IR-4 petitions to help move the process along.
Did USDA participate as an equal partner with EPA in the risk assessments of the nine organophosphates and will their review be part of a Federal Register notice? Mr. Jennings explained that USDA reviewed the risk assessments prior to publication to insure the communications process looked good, but they did not review the technical details. He noted that USDA was developing a team to provide comments on risk assessments. In addition, Mr. Jennings stated that some of the Land Grant Universities are looking at the risk assessments. He noted that, in the future, USDA plans to become involved in the review process earlier. In addition, he expects USDA comments will be placed in the Docket. Mr. Hansen clarified that, while they welcome USDA's input, it is EPA's responsibility to make the final decisions on the risk assessments.
Focus on the problem pest/crop situations.
Recognize that farmworkers are part of the agricultural community and should be at the table.
What is meant by retooling the ARS and the CSREES to respond to the FQPA? Mr. Jennings explained that USDA intends first to clarify their understanding of the ARS and CSREES research programs, and second to evaluate how the research meshes with USDA's and other stakeholders' priorities. Mr. Pitts added that USDA will want to work with stakeholders to review the catalogues USDA is developing. In addition, he explained that USDA needs to coordinate the relevancy panels to help USDA work on determining their research programming. A member reminded USDA not to forget about other pesticides when retooling.
Biocontrol needs more funding. Use European experience as a resource on this and look for long-term solutions. Quality control has been an issue in the past. Biocontrol needs federal support. Mr. Pitts commented that USDA is trying to get the biocontrol program back in shape. He noted that they have formed a Biocontrol Coordinating Council and one of their first tasks is to revitalize the regulatory reforms. In addition, he noted that USDA is reconsidering the budget for biocontrol. He also referenced the Administration's initiative on Non-native Invasive Species, one aspect of which is biocontrol.
Share USDA expertise to help EPA with better dietary exposure data earlier in the risk assessment process and assist them with more effective risk management proposals earlier in the process.
How does the USDA Office of Risk Assessment fit into FQPA and can some of their resources and expertise be used to assist EPA? Mr. Jennings commented that this office is part of the team USDA has formed, along with human health experts, AFIS, ARS, and CSREES to address these issues.
It is challenging to identify successful alternative pest control methods because natural systems are complex.
Clarify that USDA's role in FQPA is essential and an active role is critical, particularly in providing data on pesticide use and consumption. USDA can play a key role in facilitating the validation of field data from grower groups and the Land Grant systems, and can insure that the data is used in the regulatory process. In addition, USDA can show growers and the Land Grant systems how the data is used as a means of improving data in the future.
In addition to having raised expectations for what the Agency can provide, and for what USDA can achieve in the field, we have also raised the expectation that farmers can make the changes necessary for FQPA in real time. At the same time, Congress has not committed to help make these changes and the programs necessary to be responsive to farmer's needs are not in place.
Does biointensive pest management include bioengineered crops and biotechnology?
How are pesticides for which there are no tolerances in the U.S., that are exported and licensed for use in other countries, and may later be imported on produce, addressed? Mr. Rominger commented that imports must meet U.S. tolerance requirements. Mr. Lake clarified that typical violations are most usually pesticides that have tolerances and are currently approved for use in the U.S. on an alternative commodity. He explained that the values are often below the tolerance level for another commodity. He noted that this circumstance represents a violation and the commodity is detained. Mr. Pitts added the PDP testing targets multiple pesticides.
Are meats, eggs and poultry tested for persistent pesticides that no longer have tolerances because they were cancelled (e.g., chlorinated hydrocarbons)? Mr. Pitts noted that they have completed their dairy monitoring and it is available in the PDP data. With the exception of an occasional indication of DDT, he observed that most of the samples are clean. Mr. Pitts added that USDA has authority over meat and poultry through FSIS and they are working with EPA to set up a system to continue their monitoring efforts on meat and poultry. It was clarified that FDA is responsible for monitoring fish. He explained that meats will be monitored on an ongoing rotational basis. Mr. Jennings clarified that EPA sets tolerances for meat and for poultry, eggs and fish USDA enforces the tolerance. The PDP program involves more sensitive methods and thorough sampling to determine actual residue levels.
Is USDA addressing drift and other non-agricultural spraying (e.g., roadside and right-of-way spraying) as part of aggregate exposure? Mr. Pitts explained that USDA focuses their monitoring only on commodities. He commented that USDA will work with EPA to hold a workshop with state regulators to discuss other sources of data on issues like roadside spraying to integrate in this process. Mr. Johnson also noted that there is a Spray Drift Task Force that has existed for approximately five years. He noted that EPA has received results from the Task Force, which they are using to make regulatory decisions. Mr. Johnson added the Task Force addressed technology advances and data. He invited TRAC members to inquire with EPA for additional details.
On page 3 under, "USDA's Role in Transition Strategy," add something about USDA's participation in the development, introduction and regulation of biotechnology alternatives, in particular, maintaining production agriculture's voice represented in the context of EPA policy on resistance management, decision making, and regulatory trend lines.
To move forward with the ideas expressed in Staff Paper # 28, USDA will have a challenge coordinating the different departments.
Emphasize that USDA's role is to protect both agricultural interests as well as consumer interests.
Will the process for generating crop profiles be Land Grant University coordination of grower groups who will develop the crop profile? If so, what are USDA's plans for outreach to independent crop consultants, IPM experts, and farmers who know a lot about sustainable or biointensive agriculture? Mr. Jennings clarified that the Land Grants will coordinate these efforts and they will go to growers for details including non-chemical control for each pest. He invited TRAC members to observe the crop profiles as they are posted on the web and provide comments to USDA. He noted that the crop profiles are living documents and may be modified based on comments. Mr. Rominger added that the process for outreach is not clear. He commented that it is essential for USDA to follow-up. A member suggested that the strategy for outreach be included in Staff Paper # 28.
It would be helpful if USDA would develop a panel of people to help put additional details on the ideas of what kind of transition program USDA would desire and recommend within the next couple of months.
Human Testing Issue Update
Dr. Goldman provided the group with an update on what EPA has done and what they are going to do to address the human testing issue. She began by stating that EPA is very concerned about this issue. Dr. Goldman explained that EPA wants to make sure that, for the studies, the informed consent process is appropriate, there is full and voluntary consent, and there has been appropriate consideration of the risks and benefits of the research to the individual person who is the subject. She noted that the specific category of studies that were of concern involved the intentional dosing of human subjects with pesticides to look at observed adverse effect levels. Dr. Goldman commented that, as EPA evaluated this issue more carefully, they identified other categories of studies employed by EPA that they plan to include as they evaluate the issue more broadly. In addition, she stated that EPA has also recognized that the Pesticide Office is not the only part of EPA that is concerned about the issue of conducting or utilizing of human studies. Dr. Goldman explained that Mr. Hansen and Carol Browner have felt that the issue should be addressed at the Agency level. To achieve this, she noted that the Agency is planning a joint meeting of the Science Advisory Board (SAB) and the FIFRA Scientific Advisory Panel (SAP) by the end of the year. Dr. Goldman commented that the Agency plans to augment the panels with experts in the science but also complex ethical issues. She stated that the Agency is preparing an Agency-wide EPA Order that will fully implement a regulation called the Common Rule that was developed as a government-wide regulation for protection of human subjects. Dr. Goldman explained that the Agency Order will develop specific procedures for EPA, including the full participation of OPPTS and OPP.
Dr. Goldman recognized that there is an urgency to this issue for the Pesticide Program and she and Mr. Hansen are working to make sure that they address these issues in a timely fashion. First, she commented that there is a need for OPP to develop a policy to help assure that the protections that are intended in the Common Rule occur for testing performed by outside parties and are submitted to EPA for their decisions. Dr. Goldman explained that the Agency is currently collecting and evaluating the standards and procedures used by other Agencies with similar missions, particularly FDA processes, but also CDC and some of the other federal Agencies. She stated that they are identifying individuals to involve both in and outside the government, particularly those who are familiar with clinical studies. Dr. Goldman commented that their goal is to have the SAB and SAP review a policy for the OPP by the end of the year and to finalize the policy by February of 1999. She explained that there are a number of different kinds of studies that the Agency employs, and part of what they will supply for the review is a full description of the human data that might be used. Dr. Goldman stated that they need to make sure that the studies used meet the highest ethical standards and have appropriately considered the protection of human subjects.
Following Dr. Goldman's remarks, two TRAC members commented on the issue. Jay Vroom, President of the American Crop Protection Association (ACPA), began by stating it is important to recognize that voluntary clinical testing has been a key component of pharmaceutical development testing and market approval. He noted that there is a history of government and business experience with managing the critical issues identified by Dr. Goldman, including the ethical, moral and scientific matters surrounding the issue. While historically, Mr. Vroom indicated that there has been very little voluntary clinical testing for agrichemical testing and regulatory decision making, it is an important tool that contributes to the regulatory decision making about safety and the reduction of uncertainty associated with pesticide use, marketing approval and existing product review. Mr. Vroom explained that there is a growing international component to the question of volunteer testing with organizations including: the World Medical Association; the Declaration of Helsinki; the European Community's Good Clinical Practices Guidelines; and the World Health Organization Guidelines for Drug Evaluation. He noted that in the U.S. clinical voluntary studies for pesticides are governed by Section 12 of FIFRA. Mr. Vroom stated that ACPA welcomes the Agency's and OPP's additional commitment to bringing forward more guidance and clarity on how to use this important tool.
Carolyn Brickey, Executive Director of the National Campaign for Pesticide Policy Reform (NCPPR), explained that she was substituting for Ken Cook in her comments. She commented that this is a very important, serious and difficult issue. Ms. Brickey stated that she was pleased to hear the level of Agency commitment to the issue. She noted that there are a number of issues that the Agency and TRAC need to be concerned about, particularly the purpose of the studies in question. Ms. Brickey commented that the purpose of pharmaceutical studies is to make people well, and some of the tests for pesticides may not serve this purpose. A second issue recognized by Ms. Brickey was the design of the test and whether there was complete consent. A third question she noted involved the possible risks involved with the tests. Ms. Brickey explained that environmental organizations are concerned about the use of the tests may result in a decision not to impose the 10-fold safety factor. She summarized by commenting that this is a very important issue in terms of government responsibility and the TRAC. Ms. Brickey stated that they are hopeful that the guidelines will be comprehensive, that they participate and assist in the process, and there will be a quick resolution to how these tests will be conducted, and which tests will be conducted.
After Ms. Brickey's comments, Dr. Ehrmann invited additional comments from TRAC members on the human testing issues. Their comments are summarized below:
There is great concern about human testing with products like organophosphates. There is a lot of information indicating immediate and long-term negative effects resulting from exposure to these chemicals. The Agency should carefully evaluate how this testing could be a regulatory disadvantage because it is hard to envision the regulatory advantage of this type of testing.
There is a fundamental ethical issue because no one will volunteer for this type of testing if they are fully informed as to the risk.
The motivation for the testing is to potentially reduce the 10-fold safety factor for intra-species differences and children. Because the testing is likely to take place on male adults, using this information to base decisions regarding the 10-fold safety factor for women of childbearing age and children may have serious consequences.
Human testing would be performed to help insure that people do not get sick and to make sure that farmworkers are protected.
A member observed that one company has agreed not to continue testing human beings. They asked Mr. Vroom if he was aware of any other companies in ACPA who have committed to do the same? Mr. Vroom stated that he is not aware of any Registrants who have committed to abandoning this testing approach.
There is confusion and misperception about how this testing is used. It has nothing to do with the 10-fold safety factor or establishing the range of sensitivity in the human population.
There is a wide variation on what kind of human testing is acceptable. It is important that EPA have some oversight of the research to insure that people performing the testing are not utilizing review boards that are not equipped for the task. There needs to be more oversight of the process than whether there was informed consent.
It is a misrepresentation to refer to these tests as "toxicity" experiments. The tests are designed to establish the minimum level of exposure necessary to cause any kind of enzyme response.
EPA's approach is appropriate. The questions on human testing are best answered by an informed audience like the SAP, SAB, and other experts. There is a lot of history on human subject research regulation on which to draw.
Insure an even-handed treatment of this issue and a clear understanding of the basis for decision making.
Try to look at human testing as another scientific tool.
People are given the opportunity to decide when they use drugs and perfumes. Exposure to pesticides is usually involuntary.
Involve the Office for Protection from Research Risks at NIH because of their experience with human testing.
Mr. Hansen observed that, based on this discussion, there are many different and strong views about human testing. He emphasized that this issue has an emotional element because of the nature of the ethics involved. Mr. Hansen commented that he will craft a memorandum that directs OPPTS to develop this policy to be finalized by February of 1999 and hold the joint SAP/SAB meeting augmented by ethicists and other experts by the end of this year. Mr. Hansen stated that this is an important issue that EPA has historically dealt with in terms of research that they have funded or in which they have been directly involved. He noted that the process outlined by Dr. Goldman will, appropriately, include new research performed by others. Mr. Hansen observed that this issue will require a lot of discussion with a number of experts. He indicated that the discussion will involve more than pesticides, and while it is hoped that the issue will be addressed quickly for the purposes of the TRAC, coordination with the other Agencies involved may take time.
Integration Paper on Risk Assessment and Risk Management Process
Ms. Mulkey provided the TRAC with an overview of Staff Paper # 33, Integration - Documents of Tolerance Reassessment and Reregistration (Docket # OPP00537.) She observed that the interaction of all of the concepts identified by the TRAC is complex and developing Staff Paper # 33 was challenging. Ms. Mulkey explained that, in the paper, they have tried to provide a simple narrative format that strings together all of the elements the TRAC has discussed in a way that allows the reader to focus on the intersections between the elements. She noted that she began to describe the relationship between integration documents # 2 and # 3 yesterday (Staff Papers # 27 and # 34) and the linear approach to risk assessment, risk assessment refinement and risk management, including the process for public participation. Ms. Mulkey noted that integration documents # 4, # 5 and # 6 are elements that would occur in that process. She referred first to the Early Assessments (integration document # 4) idea of identifying and preserving a group use pesticide combinations that pose only negligible risk. Ms. Mulkey explained that this would combine a risk assessment result and an early stage risk management decision. She noted that the decision-making criteria (integration document # 5) are related to risk management choices among uses and circumstances where the level of risk associated with all existing uses is too great. At the end of the design phase and after the input and the choices are made, the formal regulatory tools are used to implement the choices (integration document # 6). Ms. Mulkey commented that transition (integration document # 7) is considered when designing the risk management approach and in selecting the appropriate regulatory tools. She explained that this occurs during the implementation phase. She noted that the details that may have been left out in this draft summary are important, may currently be addressed elsewhere in the TRAC documentation, and are not meant to be minimized by the omission (e.g., where the data are integrated, the role of USDA, etc.) Ms. Mulkey noted that integration document # 1 is an effort to refine the science policies to have them influenced by more public processes and is designed to occur as soon as possible to enable their application in the risk assessment and management processes.
Following Ms. Mulkey's overview, TRAC members were asked to comment on the paper. Their comments are summarized below:
The paper is a good first step towards describing how the pieces fit together but it points out that some of the work of the TRAC is "in progress" and needs to continue during this period of transition while the science policies are implemented. It would be beneficial, as the implementation of the science policies progresses, to continue the TRAC dialogue. At the same time, it is essential for EPA to proceed with reregistrations. The suggestion was made to develop a master calendar, including the science policies and other issues, to assist people to planning.
How does EPA plan to address the concern that the early assessments would divert energy from handling the worst pesticides first? Ms. Mulkey acknowledged that the issue of early assessments is complex. She explained that the concept was put forth for comment to address this and other concerns. Ms. Mulkey observed that many in WG2 were supportive of early assessments because if, based on very low contribution to risk, some of the commodity uses can be set aside, they felt the transaction costs for everyone involved would decrease significantly.
Can EPA identify the low risk pesticides now rather than spending the time and resources necessary to identify them? Ms. Mulkey suggested that it might be possible to select the "cut" point for identifying low risk pesticides that are known and would not require many resources to identify. She stated that EPA is soliciting comments on what the selection process should be. A representative from the Registrant community added that the early assessment process might also inspire the Registrant community to provide additional information to help facilitate this process.
How does EPA plan to make the parallel process (outlined in Staff Paper # 31) work? Ms. Mulkey commented that they think about this daily. She explained that, in the short-term, the focus will be on the individual chemicals in preparation for the cumulative risk assessment process. At the same time, Ms. Mulkey noted that EPA is increasing its efforts to determine how to perform cumulative risk assessments and how to manage their resources.
It is important to use something like Staff Paper # 33, in addition to the individual work products, to pull the process together, summarize what has been done, and establish a basis for future related efforts. It may also provide a means to identify other tasks like a product that lays out the interaction between the BEAD matrix, the crop profiles and the transition process.
Taking the low risk pesticides out of the risk cup and posting a list of those chemicals would be consistent with a transparent process, free-up a lot of EPA's time, save resources, and help farmers plan for the future.
It is essential for the Agency to distinguish between negligible risk and zero risk. A negligible risk is not "no" risk, and negligible risks are cumulative.
Mr. Hansen commented on the importance of this discussion. He explained that, in his last weeks at the Agency, he plans to focus on the areas where the Agency can set aside those pesticides of lower priority for the required tolerance determination, and focus on the pesticides of highest risk. Mr. Hansen viewed this process as a means to phase the risk assessment approach. He noted that this approach will provide growers with some confidence about the pesticides they can rely on in the short-term, and the pesticides for which they need to start planning for the use of alternatives. Mr. Hansen commented that, in response to the concern about how the Agency will organize itself internally to meet the demands imposed by FQPA, the Agency is already beginning to reorganize and will share some of that framework over the next couple of weeks.
Public Comments
Jack Sullivan, American Water Works Association (AWWA) - represented the drinking water community in his comments. He noted that, AWWA is interested and concerned about pesticides in drinking water from a public health perspective. Mr. Sullivan commented that there is a strong need to coordinate what is taking place in the pest field with the drinking water community. He stated that the pertinent policies in water associated with public health and pesticide policies must be consistent. Mr. Sullivan noted the AWWA appreciates the open process and EPA's willingness to listen to their concerns.
Vern Highley, Highley Associates - explained that he has watched agriculture change over many years and observed that the number of farmers producing most of the food has declined. He observed that people in the U.S. can feed themselves well and intelligently. Mr. Highley commented that FQPA will change farming practices, and for this country to continue to produce food and increase its safety, everyone will have to work together to achieve mutual goals. He hoped that farmers and environmentalists would go together to Capitol Hill to obtain a critical mass of funding for USDA to focus in the Land Grant Universities and other research areas so more can be done with IPM and parabiological control.
Mark Jensen, Jensen Agricultural Consultants - explained that he was an agriculture consultant with a lot of experience in pesticide studies. He observed that the industry is experiencing cutbacks that are compromising work quality and causing studies to be cancelled. In addition, he noted that there are delays in field testing and bench level studies. Mr. Jensen noted that there is a need for continuous reevaluation of pest management strategies and felt continuing the TRAC process was important.
Connie Kille, private citizen - stated that she became ill as a result of pest control spraying of her home. She explained that she is now hypersensitive to chemicals and cannot live comfortably in her home. Ms. Kille noted that she had to relocate to a rental property and can eat only organic foods. She stated that industry should use more caution when selecting and applying pesticides and take the responsibility for caring for people they have hurt. Ms. Kille closed her comments by requesting that the government and industry assume appropriate responsibility.
Robert Kille, private citizen - Ms. Kille's husband, described how his wife's illness had influenced his and their lives. He described the severity and progression of her illness and noted that his wife became temporarily paralyzed as a result of additional exposure to pesticides after the first incident. Mr. Kille stated that they have incurred additional expenses, including renting a house in which his wife can live some distance from their original home. As a result, he explained that he is only able to visit his wife on the weekends. Mr. Kille stated that their lives have been totally changed as result of her exposure to pesticides.
Following the public comments, Dr. Ehrmann invited TRAC members to provide additional comments on post-TRAC activities and other closing thoughts. Their comments are summarized below.
Additional Comments on Post-TRAC Activities and Other Closing Comments
The TRAC has not yet addressed all of the requests and guiding principles in the April 8, 1998 Memorandum from Vice President Gore on FQPA implementation. The relationship between the Agency and USDA has been strengthened as a result of the TRAC process and continuing the TRAC process will enhance that relationship.
Continuing the TRAC process would facilitate additional public input and meeting the deadline for tolerance reassessment established by the Vice President in his memorandum.
The TRAC could provide EPA and USDA policy guidance and help establish priorities.
It is important to maintain membership continuity and to take advantage of the fact that the TRAC is working more effectively as a group. It is possible to balance the amount of work required by utilizing Work Groups as sounding boards on the issues. The TRAC or its Work Groups could be used effectively to screen feedback from groups like the Senior Working Group on the science policy issues. In addition, the TRAC could serve as a sounding board and help insure that issues including unintended consequences, international trade, and fairness, are dealt with in an informed manner.
Use the TRAC to resolve how to address: drinking water exposure; residential exposure; processed and fresh foods; funding; problem pest situations; usage data and how it will be used; reporting policy; and what FDA actually does on their treatment of certainty of no harm.
The cooperation between USDA, EPA and the members is a real plus and will help benefit everyone.
The TRAC process has paid off and is paying off and is worth it. It should continue on a focused way to address issues including transition and risk mitigation, and unforeseen issues resulting from the implementation process.
If the TRAC proves to help EPA and USDA implement the FQPA effectively without causing delays and taxing staff and financial resources, the process should continue.
The TRAC is a work in progress and should be continued to address the outstanding issues at key decision points including: after the notice and comment period on the nine science policies before the Agency makes decisions; cumulative risk; and the risk management process after the nine science policies are finalized.
Continue the process with clear goals and limitations on the process.
One member suggested that TRAC members reflect and evaluate whether this process benefits the health and welfare of children as required by FQPA. He suggested that the fact that only one of four pediatricians on the TRAC had attended the TRAC meetings is an indication that they feel the process has not effectively addressed this aspect of FQPA. He commented that he would decide whether continuing the TRAC process was worthwhile depending on how the health and welfare of children was addressed in the future.
Several members expressed concern about the large amount of EPA resources that were committed to this process. One member commented that, if this kind of resource commitment continues, it will interfere with EPA's ability to make timely decisions on important issues. He suggested that there are other venues for this kind of discussion including the PPDC. Another member commented that there was value in continuing the process of public input, but felt that the notice and comment process was the appropriate mechanism to solicit the input. Some of the environmental representatives felt that, until EPA makes some of the difficult decisions and progresses with tolerance reassessment, it will be difficult for them to continue with the TRAC process. One member disagreed with the idea of reducing the TRAC to the size of a subcommittee like the PPDC because it will not represent the diversity of the TRAC and does not include grower representation or the USDA.
A member expressed concern that, after all of the TRAC discussions, some members of the public are still concerned about transparency, much of which has been addressed by the TRAC. She also noted that there appears to be a misperception on the part of some individuals that a policy is not resolved unless they agree with it. She commented that the TRAC is not the forum to resolve disagreements on policy. In addition, she observed that there are some issues that will never be resolved by the TRAC. Another member agreed with this statement and commented that some of the issues are technical and it would be inappropriate for the current TRAC membership to address them.
A member felt that, to help intern EPA's regulatory decisions with the legitimate needs of the agricultural community, it is essential to integrate early and continued involvement of USDA throughout this process. She expressed concern that USDA has the perception that its role is only at the end of the regulatory process.
Summary Comments
Mr. Hansen observed that the TRAC had made a lot of progress and he characterized where he thought the group was in the process as "at mile 22 in a marathon." He observed that concrete things had been accomplished including:
A greater understanding of the complexities of the issues and communication of the issues to other parties. Mr. Hansen stated that it is the responsibility of the trade organizations to educate their membership on what the TRAC accomplished. He noted that, through the Agency and the Department, he and Mr. Rominger will also be communicating this information.
The identification of the nine key science policy issues that will undergo a public comment process.
The process of transparency including the release of the first sixteen preliminary risk assessments for organophosphates, and the later release of the preliminary risk assessments for the remaining organophosphates.
The development of risk management approaches addressing public participation in risk management.
Increased cooperation between EPA and USDA. The TRAC process has allowed the Department and the Agency to begin to institutionalize some structured settings for the senior policy people to address TRAC and other issues.
Mr. Hansen reflected on the issues that had been addressed and on the Vice President's memorandum. He commented that the EPA and USDA have taken some substantial steps in moving ahead on sound science, transparency, reasonable transition, and consultation with stakeholders. He acknowledged that, while there is and will always be some work required to involve stakeholders as they move forward to implement the fundamental new law, the TRAC has set down the main principles of the process. Mr. Hansen stated that EPA is committed to make sure that the processes established by the TRAC continue as a part of how they do business. He also commented that EPA has taken other steps that are important in terms of being able to hear issues including the issue of a level playing field for imported produce. Mr. Hansen explained that, within the next year, EPA plans to devote additional funds to introduce efficient, cost-effective, and easier monitoring methods that can lower detection by an order of magnitude. He commented that USDA and FDA will assist in this process. Mr. Hansen observed that this is important in a number of ways, including addressing the level playing field relative to imports and defining the limit of detection in the risk assessment process. He explained that as the limit of detection drops by an order of magnitude, the issue about using half of the limit of detection become less significant.
Mr. Hansen then discussed the issue of additional TRAC meetings. He explained that, if EPA were to support additional meetings, the scope of the meetings would have to be tightly bound. Mr. Hansen commented that he and Mr. Rominger concluded that two additional meetings are appropriate to address specific issues. To address the issues, he stated that he and Mr. Rominger will support:
Two additional TRAC meetings. The first meeting would be in approximately February of 1999, and the second would be in the April to May period of next year.
No more than two supporting Work Group meetings; one per TRAC meeting, if necessary.
Mr. Hansen explained that the goals for the first meeting would be to provide an opportunity for USDA and EPA to give a status report and to seek consultation from the TRAC on the nine science policy issues. He clarified that EPA intends to keep to the schedule to adopt the science policy issues and that the public needs to take advantage of the notice and comment and other processes to provide input. Mr. Hansen stressed that comments should not be delayed until the TRAC meetings. He stated that they will also be able to provide an update on refining the organophophate risk assessment pilot, the public participation in the organophosphate risk management issues, and USDA's participation throughout the process. In addition, Mr. Hansen stressed that, in the interim, EPA will be making decisions. He explained that they will be seeking lots of input from the USDA, and they will utilize the draft science policies as a guideline to make decisions. Mr. Hansen also stated that the risk management process will proceed before the science policies are finalized in order to achieve effective transition. The goals for the second meeting would be to discuss cumulative risk assessment, and a pilot of public participation in the risk management process.
Mr. Hansen recognized that the environmental and public interest groups in the TRAC expressed the greatest concern about whether there should be additional TRAC meetings. He commented that it is fair for these representatives to defer their continued commitment to the TRAC until they see what happens when "the rubber hits the road," and they see some results. Mr. Hansen stated that he is confident that the Agency will have made the decisions that will allow them to be comfortable in participating in the next two TRAC meetings.
In addition, Mr. Hansen stated that the most important aspect of FQPA is reducing risk in a significant way. He acknowledged that, while there is debate about how great the risk is, there will probably be organophosphates that represent problems individually and in the aggregate. He stated that EPA has to be able to address the worst first, as well as identifying those chemicals that represent lesser risk to enable focus on the highest risk. Mr. Hansen committed, on behalf of the Agency, that the deadlines established in the FQPA will be met. He also commented that input from TRAC members, including the "Road Map" submitted by the Registrant community and the recently released report by the Consumers Union on "Worst First," were constructive contributions. He invited TRAC members to continue to be constructive because it is key to helping decision makers do better work. Mr. Hansen thanked EPA staff who have helped to document and make the TRAC process work. In addition, he thanked TRAC members for their time and commitment to the process. Mr. Hansen closed his remarks by stating the TRAC had made a lot of progress.
Mr. Rominger stated that Mr. Hansen provided an adequate summary of what has happened at the TRAC, and he commented that he was sorry Mr. Hansen would not be at the finish of "the marathon." He commented that he appreciated TRAC member's input into the process, and thanked EPA staff for their work to help make the process a success. Mr. Rominger observed that the FQPA has placed some new responsibilities on USDA and has created some challenges and new expectations. He stated that they intend to be involved early and often and not just at the end of the regulatory process. Mr. Rominger commented that the TRAC has helped them to focus on what they need to do. He stated that the day's discussions were particularly important because it was the first opportunity for USDA to hear directly from TRAC members about their own policies and programs and how their resources should be applied to implement the FQPA. Mr. Rominger noted that they expect to follow-up on the suggestion to ask representatives of the TRAC to help them flesh-out the work plan at USDA.
Mr. Rominger stated that he understood the concern about whether the Department will have sufficient resources to be fully effective in the implementation process. However, he committed to the TRAC that he and Secretary Glickman will be doing what they can to adequately serve the needs of the grower community, the consumers, researchers, and EPA's needs in this process. He commented the FY '99 and FY 2000 budget process will provide important and concrete opportunities for new funding for FQPA relevant programming. In addition, Mr. Rominger felt that these budget cycles will be used to improve USDA's overall programming, particularly additional stakeholder input into their efforts.
Mr. Rominger agreed with Mr. Hansen's outline of the future TRAC process to continue stakeholder involvement. He added that USDA is also committed to additional informal channels of communication to help meet the goals and responsibilities that TRAC has defined for USDA. He closed by stating how much the Department appreciates and values the relationship that has developed with EPA and how it has helped them develop. Mr. Rominger also observed how the TRAC has helped both agencies communicate and coordinate at all levels. He then thanked Mr. Hansen for his relationship with USDA on the TRAC and other issues.
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updated April 11, 1999