CARAT June 2000 Meeting Summary
Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.
National Rural Electric Cooperative Association Conference Center, Arlington, VA
June 22 - 23, 2000
Richard Rominger, Deputy Secretary, US Department of Agriculture (USDA), began the meeting by reading a statement by Vice President Gore, released from the White House, Office of the Vice President on June 22, 2000, to the members of the Committee to Advise on Reassessment and Transition (CARAT). (1) In the statement, Vice President Gore was appreciative of the group's commitment to assisting with the implementation of the Food Quality Protection Act (FQPA) of 1996, with the goal of providing safe and economical food in an environmentally sound way. He referred to the FQPA as a landmark statute and an example of partnership among government, growers, pesticide manufacturers, and the public health and environmental community. Vice President Gore recognized the progress made on improving the safety of food and sound agriculture, but also observed the continued need to provide smooth transition for agriculture in a manner that is guided by four key principles: sound science in protecting public health; transparency; reasonable transition for agriculture; and consultation with the public and other agencies.
Mr. Rominger thanked CARAT members for their commitment to address the challenges of FQPA implementation. He noted that at this meeting USDA planned to focus on pest management strategic planning and EPA would describe its transition activities and approaches to facilitating public participation in the risk assessment process. Mr. Rominger observed that the schedule established in the FQPA for tolerance reassessment is rigorous and there are some major issues to be addressed, including cumulative risk and endocrine disrupters. In addition, he recognized the valuable experience USDA and EPA have gained from working together on FQPA implementation, and looked forward to continuing to work with EPA and CARAT members to address the challenges ahead. He hoped to hear substantial input from CARAT members on what they want to see the advisory process through CARAT accomplish.
Michael McCabe, Deputy Administrator, EPA, also thanked CARAT members for their commitment. He noted there is important and challenging work ahead for the Committee. Also, observing the four principles reiterated in the Vice President's statement, Mr. McCabe summarized the challenges faced by the Agency, the Department and the CARAT:
1. Completing the review of the OPs by the end of this year;
2. Pressing forward on the remaining science policies including assessing cumulative risk;
3. Allocating resources to the scientific and regulatory work necessary to reassess Group 1 pesticides; and
4. Strengthening the relationship with stakeholders and other federal agencies to ensure that decisions are based on the best available information, while at the same time protecting public health.
Mr. McCabe reviewed the accomplishments of the Tolerance Reassessment Advisory Committee (TRAC), including issues relating to transparency and sound science, as context for the work ahead of the CARAT. Based on the foundation of TRAC accomplishments, Mr. McCabe outlined the goals for CARAT:
1. Focus on transition from the most hazardous pesticides while ensuring that farmers have adequate and economically viable alternative pest control techniques and growers needs are met;
2. Giving high priority to assessing pesticides to which children are exposed;
3. Increasing the availability of safer pesticides including expediting registration decisions and identifying non-chemical alternatives;
4. Fostering broad public participation in the preparation of cumulative risk assessments while at the same time assuring the timely completion of risk assessments; and
5. Thinking creatively about and planning for cumulative risk assessments.
Mr. McCabe looked forward to hearing from CARAT members on what they thought about the proposed goals and agenda for the CARAT.
As a basis for establishing the groundrules for the CARAT process, Dr. John Ehrmann, facilitator, Meridian Institute, noted that the EPA-USDA CARAT was established as a subcommittee under the auspices of EPA's National Advisory Council for Environmental Policy and Technology (NACEPT). In that context, the CARAT is operating under the ground rules of the Federal Advisory Committee Act, through the NACEPT main charter. CARAT meetings are therefore public and will include a period for public comment. There will also be a transcript of each meeting, as well as a short summary of key points and major discussion items. In addition, building on the experiences of the TRAC, Dr. Ehrmann reminded CARAT members that their primary charge is to provide advice to EPA and USDA. He advised them not to provide comments that might be directed at others who are not taking part in the discussions at the table. Following the overview of the ground rules, Dr. Ehrmann described the agenda for the day.
Priority Issues Related to Reassessment and Transition
Dr. Ehrmann invited CARAT members to comment on what they felt were priority issues related to tolerance reassessment and transition. Highlights of their comments are summarized below:
- Work through and resolve the remaining science policy issues, particularly cumulative risk.
- Refine default assumptions.
- Continue to improve the risk assessment process to look at real versus theoretical risk. Address concerns about residential and other non-agricultural risk, worker exposure and risk as part of the reassessment process.
- Focus on transition. Utilize bodies like the Pesticide Program Dialogue Committee (PPDC) and the Scientific Advisory Panel (SAP) effectively to avoid diverting EPA resources unnecessarily and insure that EPA is able to "get its job done." Address the real issues like identifying the difficult crop/pest/pest management situations and implementing safer alternative pest management practices as model transition strategies. Develop pest management strategies with stakeholder involvement. Evaluate the economic impacts of transition to help insure that transition takes place in a reasonable timeframe in a way that does not transfer unreasonable costs to the farmer. Take advantage of related work by others such as information on the impact of transition from states like California and similar efforts in the international arena.
- Continue the emphasis on sound science in the decision making process as it will have direct bearing on the success of FQPA implementation. Insure that the decision making process is not influenced by other factors like politics.
- Reassess and continue to improve the public involvement process.
- Address the issues with tolerance revocation and "channels of trade."
- Evaluate unintended consequences of FQPA on agriculture across the US, including impacts on trade, pest resistance, invasive species, staffing needs at USDA, and other economic and resource consequences.
- Clarify the standards on which recent decisions were based. Clarity on scientific standards is also essential as a basis for the many challenging and pressing decisions necessary for transition.
- Consider forming a CARAT work group to evaluate the recent decisions on azinphos methyl, methyl parathion and chlorpyrifos, as a way to analyze and improve the decision making process. Develop a matrix to highlight the inconsistencies and consistencies of each decision, including the application of the FQPA safety factor, the implementation of the public participation process, and end point selection.
Mr. McCabe acknowledged and appreciated the comments from CARAT members and observed that the group identified a number of critical issues. Based on concerns he heard during a break in the meeting about limiting the discussion of CARAT to transition issues, Mr. McCabe stated that EPA and USDA hoped to incorporate time for discussion on a wide range of issues, including aspects of the reassessment process. Because the developing agenda for CARAT was full, he suggested that the group try to focus on specific issues rather than broad concerns with reassessment and the overall purposes of FQPA. Mr. Rominger was also thankful for what he felt were good suggestions on issues to be addressed by the CARAT. He acknowledged that, while there was some interest in hearing a status of the science policy issues, many in the group wanted the focus of the CARAT to be on reasonable and economical transition and the development of pest management strategic plans. In this regard, Mr. Rominger requested that CARAT members think about ways in which to accomplish this most effectively.
USDA Transition Activities/Pest Management Strategic Planning
USDA Crop Profiles
Stephen Toth, North Carolina State University Cooperative Extension Service, provided the group with an overview of the progress on USDA crop profiles as a foundation for Pest Management Strategic Plans (PMSPs). He described the origin of crop profiles, what they are, and how EPA, USDA, and producers use them. He noted that he expects 300 crop profiles out of 523 to be complete by the end of July 2000. A copy of his slides are available on the EPA web site http://www.epa.gov/pesticides/carat/. Additional information about Dr. Toth's program is also available at http://ipmwww.ncsu.gov/opmppiap/.
After the presentation, the group expressed interest in how EPA used information from the crop profiles. It was explained that some information from the crop profiles was used in the risk assessment process to supplement national information on measures like the percent crop treated, and as a "reality check" on some of the assumptions used in risk assessments. In addition, crop profiles are used in the risk management process to help understand regional differences.
CARAT members also discussed how USDA updated the crop profiles. One member suggested that USDA consider taking advantage of options including updates from industry and getting help from USDA National Agricultural Pesticide Impact Assessment Program (NAPIAP). It was noted that the development and maintenance of crop profiles is approached somewhat differently in each state. Often the grower communities or commodity groups, in cooperation with Land Grant Universities, produce crop profiles. This collaborative process was seen as a beneficial opportunity for those involved to discuss some of their issues. In general, it was noted that USDA fosters diverse input, including input from growers using alternative pest control methods and crop consultants.
To a large degree, the ability to update the profiles is dependent on funding. Allen Jennings, Office of Pest Management, USDA, was hopeful that NAPIAP funding would be available for crop profile updates. However, he noted that as a result of changes in budget classification, the process for NAPIAP funding was now slower than it used to be. Keith Pitts, Special Assistant to the Deputy Secretary, USDA, added that the Pest Management Alternatives Program (PMAP) received a slight increase in funding for 2001, but additional funds are necessary. In a similar vein, one participant questioned whether there were sufficient funds for research implementation. Dr. Toth noted that, while there was significant new funding for crops at risk, the Regional Integrated Pest Management Program (RIPM), and PMAP, funding requirements for PMSP are still unknown.
The group commented on additions to the crop profiles that could make them more useful. Comparative information on the economic aspects of the pest control measures was suggested as one addition because economics are key to successful transition. It was explained that economics are considered as part of the overall PMSP. Other additions included information on worker and other activity in application areas, reentry intervals, preharvest considerations, and historic or annual information necessary for effective mitigation strategies.
Access to annual information was regarded as beneficial for several reasons, including the ability to track pest pressures over time to plan for transition and to understand and address unintended consequences of FQPA. It was explained that, while most states do not have annual data, some are beginning to review crop profiles on an annual basis. In addition, the National Agricultural Statistics Service (NASS) provides annual chemical usage statistics at the state level for major field crops, alternating between fruits and vegetables every other year. Information about key knowledgeable contacts is also listed on the crop profiles for additional information.
Building on the discussion of NASS survey and the use of crop profiles in risk assessments, one individual inquired whether USDA has considered expanding the crop profiles to capture a larger percent of crop production to reflect national conditions more effectively. Future Regional Pest Management Centers were identified as potential means to expand the base of information regionally. It was also noted that information from NASS could factor into risk assessments because the data are collected on a state-by-state basis and are comparable. In addition, it was suggested that EPA consider whether and how it could use additional information from states in the risk assessment process and to clarify what that information would be.
The group also discussed crop profiles in a broader context, including the interface with other state and federal environmental regulations. It was suggested that the US consider what its trading partners are doing in regard to the reassessment of MRLs to help assess its national and international vulnerabilities in trade. Crop and pest management were viewed by some as part of the same system; consequently they should be considered together to insure US food and fiber are produced with safer alternatives for pest control.
Examples of Pest Management Strategic Plans
Following Dr. Toth's presentation, Wilfred Burr, Office of Pest Management Policy, described two examples of PMSP, one for Michigan carrots and the second for California almonds. Using the Michigan carrots as the initial example, Mr. Burr described the process of developing a PMSP. The results of the Michigan effort are presented in Pest Management in the Future - A Strategic Plan for the Michigan Carrot Industry, March 1 - 2, 2000. A copy of this document is available on EPA's web page at http://www.epa.gov/pesticides/carat/. It was explained that some of the additional PMSPs on which USDA is working, include almonds, apples, carrots, citrus, peaches, pears, potatoes, tart cherries, grapes, cranberries, and asparagus. Half of the PMSPs will be complete and posted on the web by October 2000, and the more complex PMSP will take longer to complete. CARAT members had no comments on the presentation.
Template for the Process for
Pest Management Strategic Plans
Following Dr. Toth's presentation, Larry Elworth, Center for Agricultural Partnerships (CAP), described the work that CAP was doing on developing a process for PMSPs. Mr. Elworth explained that CAP focused their work on large area crops of tree fruits. They facilitate the involvement of large area crop growers and other stakeholders in their development of the PMSPs, document the process, and provide USDA with suggestions for improvements to the process.
One individual commented that efforts like the PMSP and crop profiles help to develop grower confidence in the regulatory agencies, as compared to the kinds of concerns raised by the recent decision on Dursban. He noted that growers felt the decision on Dursban did not adequately weigh the benefits of the pesticide against the risks on which the decision was based, and proposed that the reassessment process be based instead on the type of integrity shown by efforts like the PMSP process.
USDA was asked to clarify the goals of the PMSP and describe whether the plans address issues like worker risk, individual chemicals and pests, or the system as a whole. It was noted that the PMSP are developed on a pest-by-pest basis and are not driven by risk endpoints. The PMSP would be utilized by USDA to help direct future funding and by registrants to identify alternative markets. EPA could utilize the PMSP to help identify priorities as well as future research needs.
The group discussed stakeholder involvement in the PMSP development process, particularly in regard to outreach efforts and participation by individuals from non-governmental organizations (NGO) and organic farmers. It was explained that participation in the process was open and state organizers were responsible for determining who participated, with suggestions from USDA. In some cases, individuals from the NGO community, farmer organizations and organic farmers were specifically invited, and in other cases they were not. Members also recognized that, in some situations, representatives from the environmental community and organic farmers chose not to become involved in the process. Still other interests might not be aware of the value they could add to the process and need to be educated of this value and encouraged to participate.
PMSP were also discussed in the broader context of progress towards integrated pest management (IPM). It was explained that, following the receipt of the NASS surveys, USDA expects IPM to be applied to greater than 50 percent of the acreage in the US. While members acknowledged the evolution of IPM over the 1990s, one individual felt that, in comparison to activities in the European Union where IPM is perceived as a baseline from which they are developing a more comprehensive environmental approach to agriculture, registrants in the US are not as committed to IPM overall. The individual suggested that the US could further enlist the support of registrants towards the goal of IPM by adding a measure to NASS on how industry and registrants are accomplishing more IPM. It was observed that, while establishing goals for IPM in agriculture was important, it was also important for USDA to measure changes in field practices in both research extension and other programs. In addition, it was felt that early planning through efforts like CARAT would allow a more comprehensive approach to agriculture in the US. The group recognized the need for both the Department and the Agency to remain aware of how efforts like PMSP in the US influence or are influenced by international agricultural laws and practices.
The group discussed the schedule for completing the PMSPs and how the process would be coordinated with other overlapping efforts such as progress on herbicide management. As an example, one CARAT member questioned whether other work by the SAP on herbicides used on corn would also be considered in completing the PMSP for corn. Mr. Elworth was not aware of a specific schedule for corn. He noted that while FQPA has been a key issue for some of the major crops, issues like biotechnology, trade and water quality were paramount for other major crops. It was also observed that, while the focus of FQPA has been on minor crops, because of the IPM targets, there was also progress on other issues like herbicide management.
EPA Transition Activities
Kathleen Knox, Associate Director, Pesticides and Pollution Prevention Division, EPA, initiated the presentation on EPA transition activities. She provided the group with an overview of a variety of EPA's programs and partnership efforts contributing to FQPA implementation. Her overview included descriptions of Regional FQPA Agricultural Initiatives, partnership with American Farmland Trust on IPM, pollution prevention research grants and other cooperative grant programs on IPM in urban settings, Pesticide Environmental Stewardship Programs, and the EPA partnership with USDA Cooperative State Research, Education, and Extension Service (CSREES) and matching funds for Sustainable Agricultural Research and Education (SARE) program.
One individual emphasized the need to continue integrating regional EPA efforts in transition activities. Where funding is not available for EPA positions in regional offices, she supported EPA authorizing state agencies to manage the funds that are available through their existing IPM programs.
Expediting the Review of
Alternatives to OPs
Following the presentation by Ms. Knox, James Jones, Director, Registration Division, EPA, gave a presentation on expediting the review of alternatives to OPs. In his presentation, Mr. Jones described how EPA prioritizes its registration and designates an application as an OP alternative. He also summarized EPA's progress in registering OP alternatives. In addition, Mr. Jones commented on an EPA proposal to address the user community and registrant community's frustration with the lack of experimental use permits (EUP) that will preserve EPA's ability to maximize the number of new chemicals and new uses which meet the FQPA safety standards.
Many members complimented EPA's work on EUPs and were appreciative of the overall progress on the review of alternatives to OPs. The group also raised several concerns about the review process. There was a concern that, with the short-term focus on identifying OP alternatives, the long-term consequences - pesticides that are alternatives today may not be alternatives tomorrow - might be overlooked. In a similar vein, it was observed that there are few direct replacements for the OPs and the range of pests controlled by the alternatives is limited. In addition to OPs, the group suggested prioritizing the identification of alternatives to B-2 carcinogens, which will be of concern in the context of post-harvest control.
CARAT members considered the value of having more information on how the priority of OP replacement was established, including consideration of reduced risk, minor use, and trade registrant priorities. One individual felt this information would help stakeholders understand the progress being made and provide the means to evaluate whether the priorities make sense. It was noted by EPA that information on reduced risk was presented on the list of alternatives and 80 percent of the use chemical combinations in the IR-4 program are reduced risk.
The group discussed minor use pesticides and the factors influencing how they fit into the scheme of prioritization for transition. One individual was interested in the extent to which the FQPA incentive for registrants to add minor use labels played a role in the prioritization process. While EPA did not have specific figures on this factor, a registrant commented that this was an incentive to registrants.
The challenge of meshing the more rapid domestic registration process with the slower process of obtaining CODEX tolerances was discussed. The lack of coordination between the international and domestic processes was seen as a barrier to international markets because, if a pesticide is not registered in Europe under CODEX, the US could not use the unregistered product on US produce. It was noted that EPA is aware of this challenge and is in the process of addressing it. One possible approach would be to utilize an interim MRL.
In response to some of the concerns about new products, Robert Holmes, Executive Director, IR-4 Program, USDA, was asked to describe the role of IR-4 in accelerating the registration of newer chemistries in the pipeline. Mr. Holmes described the partnership program between USDA, Land Grant University systems and registrants to develop minor crop strategies. As a result of these efforts, the use of reduced risk chemicals has gone from 13 to 80 percent over the past five years. Mr. Holmes also referenced USDA's ongoing coordination with the EPA IR-4 Technical Working Group to more effectively and efficiently register crop protection tools on minor crops.
Public Participation Process for OP's
Lois Rossi, Director, Special Review & Reregistration Division, OPP/EPA, presented an update on the public participation process for OPs. Ms. Rossi began her presentation with an overview of the pilot process developed by the TRAC, including modifications to the process that was made during the TRAC to shorten the process and enhance stakeholder participation. She provided the group with a summary of the progress made on risk assessments, technical briefings, stakeholder meetings, and decisions made in regard to the OPs as a result of the pilot public participation process. Ms. Rossi also described a proposal to revise and expand the OP public participation process, as presented in Federal Register: March 15, 2000, Volume 65, Number 51. The process refinements included increasing the communication with stakeholders prior to initiating the process, more up-front work to assure that risk assessments were done based on the best available data, enhanced involvement by other federal agencies, and that the process be applicable to all pesticides. Also included in the proposal was an interim public participation process that would be applied to non-OPs scheduled for reassessment and reregistration development work immediately.
CARAT members expressed some reservations about the public participation process and modifications to the process. There was a concern that the modifications would result in truncating the opportunity for public input and that risk mitigation measures would be implemented without involving the state that is responsible for subsequent enforcement actions. It was noted that EPA was conscious of this concern and recognized the need to identify ways to keep states in the loop in regard to these issues. In a similar vein, a member felt the grower community would have more confidence in the review process if EPA would retain comments on assumptions like the default value used in one risk assessment and apply them, where applicable, to the assumptions made in subsequent risk assessments. Some members felt the public participation process was inconsistent, as exemplified by the recent decisions on azinphos methyl, methyl parathion and chlorpyrifos. In addition, it was noted telescoping the data review and decision-making process creates a strain on all parties involved. As an alternative, EPA could consider calling in data earlier in the process. One individual also observed that the review process for occupational risk was not yet smooth or consistent and suggested that the CARAT be used to help standardize the occupational risk assessment process.
CARAT members also commented on what they saw as limitations of the interim public participation process. One individual felt EPA should consider requiring a full public participation process for all of the major use pesticides. Another member stated that the interim process did not allow sufficient time for public comment and supported using the pilot process until a final pubic participation process was agreed on.
The group also reflected on how the public participation process was working. They wanted to know about the quality of comments received and how the comments were distributed within the agency to other divisions like EPA's Health Effects Division (HED). It was explained that the quality of comments ranged from unrefined to refined data. When the data is received, it is directed to a chemical review manager within the Special Review and Reregistration Division who catalogs the data and advises EPA management of the type of data received, at which point the data are reviewed by a management team.
Next Steps and Future for CARAT
Mr. McCabe opened the discussion on the future activities and focus of CARAT. On behalf of EPA and USDA, he suggested that the next CARAT meeting would take place in the first part of October 2000. The format for the meeting might be similar to that of this meeting, with a one-day work session on reassessment and transition issues identified during this meeting, followed by a one day CARAT meeting for discussion on key issues. The agenda for the meeting would be developed based on input from CARAT members at the June 22 and 23, 2000 meetings.
In addition, to address critical reassessment issues and key science policy issues, Mr. McCabe proposed a technical briefing on the draft cumulative risk assessment guidance in July 2000. (Following the June 23 meeting, EPA selected a date of July 20 for the briefing). He viewed the briefing as an opportunity for EPA to explain the guidance and assure robust participation by CARAT members in refining what he viewed as an important science policy issue.
Mr. McCabe also commented that there were other existing and potential opportunities for CARAT members to participate in the ongoing related efforts of EPA and USDA, and urged members to take advantage of these additional venues to discuss issues of concern. He commented that EPA and USDA would welcome additional input and information at any point in the CARAT process and would continue to seek out the advice from members as the process evolves.
Following his remarks, Mr. McCabe invited additional comments and suggestions. Mr. Jennings reiterated USDA's interest in receiving input on the crop profiles and the PMSP. Mr. Pitts suggested that this input would be most helpful following the grant-making cycle in July 2000. In addition, a representative from the Food and Drug Administration's (FDA) invited comments on their channels of trade guidance and how the provisions of FQPA should be addressed in that context. He requested that comments be directed to the FDA docket.
The group's comments and suggestions are summarized below:
- The format for additional input and discussion on key issues should be defined based on the agenda for the next CARAT meeting. The format might be similar to the one used for this meeting with a one day informative meeting followed by a one day interactive meeting. For the more controversial issues, EPA and USDA might consider work groups.
- Hold workshops or technical briefings on issues like cumulative risk, dietary exposure, drinking water, worker exposure and worker risk, and non-agricultural uses. Cumulative risk was identified by many as a critical issue central to the implementation of FQPA.
- Evaluate the recent decisions on azinphos methyl, methyl parathion and chlorpyrifos, as a way to analyze and improve the decision making process.
- Provide a detailed agenda for the meeting in the Federal Register prior to the meeting and set the date for the meeting in time for members to plan to attend. In addition, provide a similar briefing book in preparation for the next CARAT meeting.
Mr. Rominger felt the presentations and the questions on crop profiles and PMSP were good and added value to the process. He shared what he saw as some of the benefits developing crop profiles and PMSP collaboratively. He observed that through such efforts, the stakeholders involved - growers, researchers, and the agencies - are coming to view agriculture in the US as a whole system. In addition, much of the information generated for the crop profiles and the PMSP is necessary for making better risk management decisions and transitions. Mr. Rominger acknowledged that there were a number of additional concerns identified by CARAT members that need more attention, and invited input from the group on how USDA and EPA should proceed to address those concerns.
Mr. McCabe closed the meeting by thanking CARAT members for their contributions to what he viewed as a very important process. He commented that EPA and USDA looked forward to working with CARAT members in the future.
One individual from the public provided comments. He was supportive of continuing to apply the four principles outlined by Vice President Gore, while focusing on non-agricultural uses as well as agricultural applications of pesticides, minor uses, and addressing cancer guidelines in the process. Additional details on his comments are presented in the transcript of the meeting, which is available on the EPA web site at www.epa.gov/pesticides/carat/.
1. A copy of the statement is available on the US Environmental Protection Agency (EPA) web page at http://www.epa.gov/pesticides/carat. Also available on the web page is a list of Committee Members, meeting materials, and a transcript for the meeting.