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 Although the information provided here was accurate and current when first created, it is now outdated.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
April 27 - 28 1999
TUESDAY, April 27, 1999
John Ehrmann, Meridian Institute, welcomed participants to the sixth Tolerance Reassessment Advisory Committee (TRAC) meeting of the U.S. Department of Agriculture (USDA) - U.S. Environmental Protection Agency (EPA.) He reminded TRAC members that the TRAC was a subcommittee of the National Advisory Council on Environmental Policy and Technology (NACEPT) at EPA. Dr. Ehrmann then initiated a round of introductions. A list of the TRAC members and/or their attending alternates is presented in Docket # OPP00537. Following the introductions, Dr. Ehrmann turned to Richard Rominger, Deputy Secretary, USDA, for some opening comments.
Mr. Rominger began by thanking TRAC members for coming to the sixth TRAC meeting and commented that he looked forward to updating TRAC members on the Administration's on-going efforts to implement the Food Quality Protection Act (FQPA.) He also stated that he looked forward to hearing from TRAC members on the progress made to date, as well as their guidance on future actions being considered by USDA and EPA as they shift into the risk management phase for some of the organophosphate (OP) chemicals currently in the final stages of interagency review. In addition, Mr. Rominger welcomed Peter Robertson, Acting Deputy Administrator, EPA, as the Co-chair of the TRAC. He emphasized how much he valued the working relationship with Mr. Robertson. For him, that sense of value and respect also extended to each TRAC member. He noted that each individual had an important perspective to offer to the TRAC and ultimately to the larger effort to insure that the FQPA is fully and appropriately implemented. In this regard, Mr. Rominger commented that the implementation suffers in the absence of any one segment of interest or individual. He stated that the decision of the environmental and public health community members to resign from the TRAC was very disappointing to himself, Mr. Robertson, and to the Agency and the Department. Mr. Rominger stressed that USDA and EPA are fully committed to getting the most out of this process to better inform and shape implementation of the FQPA. He also clarified that their responsibilities in implementing the law extend beyond the TRAC, and that USDA and EPA will make an effort to solicit a broad range of input to fully inform their decisions. Similarly, he observed that the contribution of TRAC members was not limited to the TRAC process and that he and Mr. Robertson look forward to working with TRAC members and others under other circumstances.
Mr. Rominger referred to a recent gathering of the Pesticide Coordinators of the Land Grant Universities (LGU) at which they discussed the work that they are doing to help USDA on crop profiles and risk assessments, and the increasing involvement they will have as mitigation and risk management strategies are developed. He explained that USDA presented some examples of what they had accomplished and how they expect to be partnering as they continue to implement the FQPA. Mr. Rominger stated that their LGU partners are fully engaged and will be of tremendous value as they proceed with FQPA implementation.
In addition, Mr. Rominger shared some of his observations on the status of the TRAC in the OP review process. First, he noted that, of the 10 OP risk assessments EPA has formally delivered to USDA, USDA has completed its review of four and will complete its review of two additional risk assessments within the next few days. Mr. Rominger commented that the agencies also recently met to discuss a seventh chemical, Azinphos-Methyl (AZM), and agreed to work intensively over the next few weeks to bring that inter-agency review to closure.
Mr. Rominger reviewed some of the lessons he had learned from the experience with this subset of the OP class of chemicals. First, he observed that the risk assessments are complex. In this regard, Mr. Rominger stated that USDA had developed a greater appreciation for the difficult work that EPA undertakes in the risk assessment process. Second, he noted that EPA and USDA are jointly making every effort to insure that risk assessments are conducted utilizing the best available data. He stated that USDA is confident that EPA is using the data that USDA is collecting and that USDA data are collected in a manner and format that is useful to EPA. Thirdly, Mr. Rominger observed that the refined data have had a significant impact on the preliminary risk assessments (PRA) for dietary exposure on individual chemicals. Fourth, he noted that many agricultural uses appear to contribute little or nothing to the individual risk cups, in contrast to the major contributions to the risk cup from some chemicals through a few commodities. Fifth, recognizing that the results of the cumulative risk assessment will have an impact on some commodities, Mr. Rominger stated that USDA and EPA want to engage selected commodities on mitigation and transition strategies now to avoid the risk of future market disruption. Lastly, he noted that worker risks are a consistent issue across the class of OPs and will challenge all of the impacted parties.
Based on the knowledge and insight USDA has gained from its new working relationship with EPA, Mr. Rominger felt that USDA is in a better position to understand and anticipate the needs of EPA and the grower community. He noted that USDA is accepting its new role in this process and is making long-term budgetary and immediate resource allocation decisions to support the implementation of FQPA, particularly as risk mitigation needs arise from the regulatory process. Mr. Rominger closed his comments with the statement that he looked forward to hearing the thoughts of TRAC members on how the Department can continue to be an effective partner in this evolving process. He then turned to Peter Robertson for his comments.
Mr. Robertson began by stating that he was very grateful to TRAC members for their continued willingness to commit to this process. He turned to Mr. Rominger and expressed gratitude for his warm welcome and for his willingness to work with him, and counsel and tutor him over the last several months. He stated that he appreciated Mr. Rominger's personal help and the help of others in USDA as he has come up to speed on the TRAC process. Mr. Robertson observed that this is a critical time for EPA, USDA and for the agricultural community as they move forward with the implementation of the FQPA. He noted that there was a full agenda ahead and commented that all of the parties had reached the current stage in the process because of the commitment of every one involved in the TRAC. However, Mr. Robertson stated that the continued full support of all involved would be necessary to move ahead in this process.
Mr. Robertson recognized the enactment and implementation of FQPA as one of the most significant accomplishments of the Clinton Administration. He noted that EPA and USDA are working together to insure that the statute is fully implemented in a timely manner to achieve greater food safety for US consumers, particularly infants and children. Mr. Robertson added that he enjoyed his working relationship with Mr. Rominger and the USDA and that EPA and USDA have a closer relationship than has ever existed before.
The recent resignations of some of the members from the TRAC was also of concern to Mr. Robertson. He explained that the resignations resulted from differences of opinion on an acceptable timeframe for regulatory or transitional issues. Mr. Robertson stated that he regretted the resignations because he felt that they do not help the shared goal of protecting the health of the American people. Further, he noted that TRAC is charged with insuring that EPA's implementation of FQPA is transparent, inclusive, based on sound science and that it provides a reasonable transition for agriculture. While he recognized that these charges are easy to enumerate, they are not easy to carry out. Mr. Robertson stated that the Clinton Administration is committed to implementing FQPA's important protections on schedule, as the law requires. He noted that insuring that EPA's risk reduction actions are based on sound science is integral to guaranteeing that FQPA's promise of protection for children and the American public is fulfilled.
Mr. Robertson then clarified some of the issues that led to the recent resignations. He focused on issues about which he felt there were no differences of opinion. He stated that there was no disagreement about the fact that OP's pose health risks. In addition, there was no disagreement that significant reductions in use will be required. He also stated that EPA wishes that this process could move faster. At the same time, he stated that EPA is on schedule for assessing risk and for taking risk reduction actions starting in August, as the law prescribes. In the interim, Mr. Robertson commented that EPA is asking OP manufacturers to work with them on reducing OP risks in a sensible manner. He noted that EPA would also continue to work with the farm community to insure that it can continue to provide the public with an abundant, affordable, healthy and safe food supply.
Mr. Robertson recognized the outstanding accomplishments of TRAC thus far as one of the reasons he was discouraged by the recent resignations. He observed that EPA has made a fundamental change in the way they approach pesticide regulation. Mr. Robertson commented that the goals of transparency and inclusiveness have never been better enunciated or accomplished than in this process. He noted that EPA has also changed the way pesticide decisions are made, particularly in the review of OPs. Based on input from TRAC, Mr. Robertson expressed the hope that the review process would be applied to other groups of pesticides. Mr. Robertson also expanded on the goal of insuring the use of sound science. He explained that EPA forged a strong partnership with USDA to help EPA ensure the use of the best available agricultural data. He observed that the cooperative efforts with the LGUs increased the quality of the information used, as has working with all of the stakeholders in the TRAC process.
Mr. Robertson stated that there are great challenges yet to come and stressed the need for continued help from the TRAC to meet those challenges. He commented on the need to build on the progress made on the OPs and work to insure continued protection for public health and stability for US agriculture. Mr. Robertson observed the need to continue to improve transparency, particularly in the area of worker protection. He stated that EPA will continue to work hard to support stakeholder involvement and to insure a reasonable transition for agriculture through the tolerance reassessment and risk mitigation efforts. In addition, Mr. Robertson committed to working with USDA and stakeholders to reduce the risks that the American public faces, and minimize disruptions for growers while providing appropriate levels of protection. He expressed the hope that during the final TRAC meetings the group will focus on formulating ways to gain input from every one on practical, feasible and affordable risk mitigation measures. Mr. Robertson thanked every one for their continued willingness to help EPA do their job of protecting public health and the environment while providing a strong agricultural community for the country.
After the introductory remarks, Dr. Ehrmann reviewed the agenda for the day as follows:
Brief report back on the Work Group II Meeting;
Review of Organophosphate pilot process;
Prototype briefing for AZM;
Key perspectives regarding the OP pilot process and AZM briefing from representative TRAC members;
OP worker risk issues; and
He explained that the agenda for the second day of the meeting would include:
Brief update on the nine science policies;
Presentation by Mark Whalon regarding transition activities in Michigan;
Transition issues with USDA;
Planning for the final TRAC meeting; and
Report Back on Work Group II Meeting
Dr. Ehrmann provided the group with a brief overview of the TRAC Work Group 2 (WG2) meeting which was held on April 8 - 9, 1999. He observed that a number of TRAC members attended the meeting, which he recognized as a helpful opportunity to prepare for the discussion on a number of the issues on the agenda for this meeting. For efficiency, Dr. Ehrmann commented that he would not describe the WG2 meeting in detail because much of the information from the meeting would be covered in the agenda for this meeting. To provide those who did not attend the meeting with some sense of the discussion at the WG2 meeting, he noted that a status of the OP pilot process was presented, as was a description of the dietary risk assessment of AZM. Dr. Ehrmann commented that WG2 members felt the presentation on AZM was the clearest presentation of the risk assessment process that the TRAC had experienced and gave a sense of the kind of refinements and inter-agency coordination that are taking place as the risk assessments move forward. In addition, he explained there was a "dry-run" technical briefing on bensulide, which provided the group some idea about how the technical briefings will be structured. Following the dry-run, Dr. Ehrmann stated that the group heard presentations from Gerber and the World Wildlife Fund on work that they have been doing on transition, after which WG2 learned about the status of the nine science policies. Dr. Ehrmann explained that the group then began a discussion on the OP pilot process and developed ideas for the agenda for this TRAC meeting.
Dr. Ehrmann then introduced Lois Rossi, Director, Special Review and Registration Division, Office of Pesticide Programs (OPP)/EPA, and Allen Jennings, Director, Office of Pest Management, USDA, to begin the presentation on the organophosphate pilot process.
Organophosphate Pilot Process
Lois Rossi provided the group with an update on the pilot process proposed by the TRAC for the development of risk assessments and stakeholder involvement. Her presentation included an overview of the six stages of the pilot process and some comments that she felt might provide a basis for discussion later in the day. Ms Rossi summarized the phases of the pilot process using Staff Paper #35-a, Organophosphate Pilot Process Discussion, Phases 4 and 5 of the OP Pilot Public Participation Process (presented in Docket # OPP00537) as a reference. A second reference included in the Docket is Staff Paper #35-b, Status of Review of Organophosphates in the Pilot Process. In her overview she highlighted some key points for each phase. She also explained that EPA has started to characterize the phases as EPA, Registrant, or inter-governmental activities. For phase 1, she noted that the Agency received the comment that 30 days is too short a time to review some of the lengthy risk assessments. In this regard, Ms. Rossi noted that there are other comment periods during which individuals can provide comments. Also in phase 1, she observed that the Agency has received additional data and analysis in addition to error comments. She noted that the Agency has been able to address the error corrections and indicate the changes in the revised risk assessment in the public Docket.
For phase 2, which she described as primarily an EPA activity, EPA has received a lot of additional data within a rapid timeframe. Ms. Rossi characterized phase 3 as the first public comment period and explained that the majority of comments received were from the Registrants. She noted that the comments from other stakeholders were often generic to all of the OPs while a few were chemical-specific. As Ms. Rossi described phase 4, she observed that 27 chemicals were currently in that phase of the pilot process. She commented that in drafting the revised risk assessments in this phase of the process the Agency and USDA discussed and implemented several revisions to the risk assessments. Highlights of these modifications included: developing a method to use composite Pesticide Data Program (PDP) data to estimate single servings in probabilistic risk assessments; using the best available data to get the most realistic exposure estimates; determining the risk contributors (e.g., drivers such as commodities, food forms within commodities, consumption data, residue levels, etc.) of the risk assessments (also referred to sensitivity analysis); running the dietary probabilistic assessment model to evaluate the impact of using zero instead of non-detection levels; and running the assessment models at different percentiles such as 99, 99.5, and 99.9. To address worker risk, Ms. Rossi explained that EPA is receiving data from the Agricultural Re-entry Task Force which was formed in response to a data call-in (DCI) issued by the Agency in 1995 to get better worker re-entry data. She noted that these data are being used in the risk assessments as they are received. To help clarify the data and assumptions used in the risk assessment process, Ms. Rossi explained that EPA developed standard risk assessment formats, overviews and an abbreviated summary cover sheet. She commented that EPA hopes that these efforts will help to make clearer what goes into the assessments and allow for increased understanding, more focused public comments, and aid in the risk management process.
After the revised risk assessment and overview are completed, Ms. Rossi explained that EPA sends the entire package to USDA for inter-governmental review. Based on their experience with the first few submissions, Ms. Rossi noted that EPA has added a meeting or briefing with USDA to highlight what EPA has learned about the risk assessment prior to USDA's detailed review. At this time, she noted that USDA has 10 revised risk assessments in review, and there are 17 revised risk assessments yet to deliver. Ms. Rossi explained that USDA would focus their review on the assessment's utilization of use and usage data, the assumptions used, as well as possible strategies and options for managing the risk. She noted that their review team would include their LGU affiliates. Ms. Rossi stated that EPA would also consult with the Department of Health and Human Services (DHHS) when an OP has public health uses, in a capacity that will be similar to that of the USDA. She commented that DHHS has reviewed and commented on one OP to date.
Ms. Rossi observed that while the 90-day comment period is generally adequate for review and modification of the risk assessment, the time necessary for inter-governmental review might in some cases take greater than 90 days. Examples where the 90-day time period has proven to be inadequate have been when comments on the risk assessment were extensive and have included submission of additional data. To address the potential need for additional time for inter-agency review EPA and USDA agreed that if EPA takes the full 90-day period for their review, they will consult with USDA on the additional time they will need to complete their review of the risk assessment. USDA may elect a 2 to 6 week additional review period depending on the complexity of the chemical (e.g., the number of uses for which it is registered,) which may result in extending the review period up to 180 days total.
At the close of the inter-governmental review, Ms. Rossi explained that USDA would send their comments to EPA and the Agency would discuss and incorporate the comments in the risk assessment. She noted that EPA would then announce and post a notice in the Federal Register regarding the date of a public "Technical Briefing." Ms. Rossi described the Technical Briefing as an opportunity to explain the risk assessment, the underlying assumptions, the key risk drivers, the base data, and how public comments have influenced the assessment. She added that USDA could bring to the meeting ideas on possible risk management strategies and options. Ms. Rossi commented that at the Technical Briefing stakeholders would have the opportunity to pose clarifying questions and that the discussion at the Technical Briefing would be documented and posted in a public Docket. She added that based on a suggestion from the WG2 meeting at the time of the announcement EPA would also post the two-page summary of the risk assessment to help stakeholders determine their level of interest in the Technical Briefing. In addition, she noted that WG2 members suggested that the Technical Briefings focus on the areas in the risk assessment that are most likely to require risk management.
Ms. Rossi stated that phase 5, public participation in risk management, would be initiated at the same time as the Technical Briefing, by opening a public docket and posting the revised risk assessment for public comment and proposals on risk management. During phase 5, EPA and USDA would also conduct docketed meetings with registrants, growers, and others to discuss strategies for risk management of the chemical. She noted that EPA has not yet had experienced phase 6 of the pilot process, but that it represents the first step in the formal regulatory decision process involving EPA and USDA. Ms. Rossi closed her presentation by expressing the hope that TRAC members would comment on the phases of the pilot process in an effort to formalize the pilot process for the review of chemicals in the tolerance reassessment program. She then turned to Allen Jennings for his comments on the pilot process.
Mr. Jennings began by referring TRAC members to Staff Paper # 36, Reassessment Pilot: USDA Role and Time Line, for an outline of the USDA risk assessment review process. He commented that USDA's experience with the pilot process thus far has been positive with a good exchange of thoughts and data on the first few risk assessments. He noted that the lessons learned from the first several reviews would improve the review process for forthcoming risk assessments. Mr. Jennings observed that the detailed briefing at the start of the USDA review of the risk assessment would be helpful and save a lot of time during the review process.
Mr. Jennings commented that the USDA review does not address toxicology, but focuses on risks from exposure looking at the data generated by USDA including PDP data, consumption survey information, as well as the National Agricultural Statistical Service (NASS) pesticide use information. He explained that in the USDA review, they want to insure that the risk assessment accurately captures USDA information, the analysis is supportable, and that data gaps and errors are identified. Mr. Jennings added that this review process has also caused them to reflect on how to improve their data collection programs to increase their value to users like EPA.
Once USDA receives the revised risk assessment, Mr. Jennings explained that USDA creates a broad-based team that is comprised of representatives from USDA Headquarters and LGU partners. Participants from within USDA Headquarters include the NASS, Office of Risk Assessment and Cost Benefit Analysis, the Agricultural Marketing Service, the Agricultural Research Service (ARS), and Animal Plan Health Inspection Service. Mr. Jennings stated that representation from the LGUs is determined based on the use pattern of the chemical and the risk drivers identified. He noted that while the representatives from the LGU are asked to review the revised risk assessment within a specified time frame, their review time is not within the control of USDA and may not jibe with the USDA schedule. Once the review is complete the comments are returned to Mr. Jennings office at USDA and Therese Murtagh assembles all of the comments for submission to EPA. To be proactive, USDA also informs EPA of issues as they are identified during their review process. He closed by commenting that the review team that USDA is developing will also provide the expertise and leadership for the risk mitigation and management phase, as well as the transition process. He then asked TRAC members for questions of clarification.
Before initiating the question and answer session, one member shared a comment on the TRAC from the Oversight Hearing that took place the week before the TRAC meeting. He stated that Congressmen Charles Stenholm was complimentary about the progress that had been made by the TRAC.
Following this remark, TRAC members posed the questions listed below:
How are the non-error comments that are received during the "Error Only" review handled by EPA? Ms. Rossi explained that those comments are placed in the Docket and handled with the comments from phase 2 as part of the revised risk assessment.
Is the time allocated for USDA review adequate and does the risk assessment documentation arrive in a usable format? Mr. Jennings commented that the time is generally adequate and UDSA can negotiate for additional time if they need it. He noted that USDA has been challenged by the worker risk component of the assessment because of their relatively limited experience with it. Mr. Jennings added that he and Ms. Rossi have talked about holding a workshop for USDA's LGU partners to improve their capabilities in this area.
Is there enough time in phase 4 and 6 (90 calendar/60 workdays) for EPA staff to perform their review and because it is a pilot process, can these time lines be revised? Similarly, is 60 calendar/40 workdays enough for USDA to perform their review? Ms. Rossi stated that 90-days is a good target to shoot for and most of the review is complete within 90 days. However, this time line is challenged when a lot of new data is submitted and as a result of interpreting what the risk assessment means when it is completed. She noted that with experience, this process is taking less time. In addition, the quality of the PRA is improving and will necessitate less time for review and revision in the future. Mr. Jennings responded that 90-days is enough, particularly if additional resources and experienced staff become available.
Can any general conclusions be made from the sensitivity analysis for risk drivers? She commented that EPA has seen different factors make a difference for each chemical they have studied including residue values and the end point. She noted that it is not always the same commodity and the driver also differs depending upon what sub-population and the food form considered.
Based on some of the experience with the sensitivity analyses, is it possible to refine the scope of data collection to better meet EPA and USDA's data needs? Edward Zager, EPA, commented that the USDA PDP has been focusing on the top consumption foods for children and the data is very useful, and additional targeted but not duplicative efforts in this area would be helpful.
Are the crop profiles valuable in the risk assessment process? Mr. Jennings responded that the crop profiles are not tools for risk assessment, but rather for risk mitigation, risk management and transition strategies. However, he added that these data are helpful in identifying which LGUs need to be involved in the process and to identify risk drivers.
Is there a difference in the volume, applicability, relevance and robustness of the public comment between phases 3, 4, and 5? Is there anything we can learn from the variation in the volume and characteristics of the comments across these three points of opportunity that could help sharpen this process from experience with this pilot and from other public comment processes prior to FQPA? Ms. Rossi clarified that they have only experienced public comment from phase 3. She suggested that EPA could consider producing a summary sheet for the PRAs in addition to the revised risk assessment. However she added that the quality of the PRAs in the future would be better, based on what is learned in the earlier submissions.
If the Agency is running the probabilistic risk assessment models at 99, 99.5 and 99.9 percentile, has it or will it also run the model at the 95 and 97.5 percentiles? Ms. Rossi explained that the model produces results for many different percentiles and the modeling results for different percentiles can be obtained by looking at the modeling printout.
As a follow-up question, it was asked whether EPA used the modeling results from different percentiles? Ms. Rossi noted that these results might be considered as part of a sensitivity analysis to see what is happening to the results between the 97 and 99.9 percentiles. Mr. Jennings added that it is a question of how you interpret the output of the model. He noted these sensitivity analyses and others, such as whether using zero or the limit of detection (LOD) makes a difference, help to narrow in on the real risk and risk management issues to focus on.
There was a request to provide additional information on the one OP that might pose a public health risk, which is currently in review at DHHS, and comment on how the process with DHHS is going. Ms. Rossi stated that there were actually two chemicals in review at DHHS, Temephos and Phenthion, both of which are used for mosquito control. She explained that DHHS has commented on both chemicals and their comments are in review. Following their review, EPA plans to schedule a meeting with DHHS, which is located in Atlanta, GA, and engage them in a dialogue similar to that which is being done with USDA.
Are there plans to use some of the state composite data along with PDP data in the National Residue Database (NRD) in the future? Ms. Rossi responded that EPA is able to use the composite data using the method of estimating single serving data discussed at the WG2 meeting. Mr. Zager commented on the role of state data, and stated that for acute analysis EPA will look at the number and the quality of the data received from various states and, based on that review, the state data will be incorporated into the NRD.
How many of the changes observed in the revised risk assessment results from new data versus changes in the process, the model and the way EPA looks at the risk assessment and the results? Ms. Rossi responded that the new data has mostly related to the toxicology side of the equation whereas utilizing the data on hand and looking at it differently and developing methods to use it the best way has mostly happened on the exposure side of the equation.
Will there be a more organized and focused PRA document as a result of some of these changes? Ms. Rossi commented that PRAs that would be forthcoming would be more focused as a result of prior experience.
What are the plans within USDA to make the process of developing risk mitigation transparent? Mr. Jennings responded that it is a joint effort with EPA and the Technical Briefings are the starting point. He commented that he envisions some follow-up with stakeholders including a listserve page where stakeholders can share ideas about risk mitigation and transition electronically rather than holding a series of meetings over an extended period of time.
Prototype Briefing for Azinphos-Methyl
Dr. Ehrmann introduced the prototype briefing on AZM. He explained that, while the WG2 presentation on AZM focused on the dietary portion of the risk assessment, this presentation would include additional information on the dietary assessment as well as information on the other components of the overall risk assessment. He then turned to Ms. Rossi to present the prototype briefing.
Ms. Rossi began the presentation by explaining that she and other EPA staff intended to describe and explain a complete risk assessment for AZM, and illustrate how the risk assessment has changed and evolved through the various phases of the TRAC pilot public participation process. Before describing the details of the risk assessment, Ms. Rossi introduced the members of the health risk assessment team for AZM and described their roles in the process as follows: Barry O'Keefe, Special Review and Reregistration Division (SRRD), Chemical Review Manager; Jess Rowland, Health Effects Division (HED), Toxicologist; Kathy Monk, SRRD, Branch Chief; Dave Jones, Environmental Fate and Effects Division, Agronomist and Risk Assessor for Water; Michael Metzger, HED, Branch Chemist; Felicia Fort, Residue Chemist; Jack Arthur, HED; Catherine Eiden, HED, Risk Assessment Coordinator; Richard Dumas, SRRD,Team Leader; Neil Anderson, Biological and Economical Analysis Division (BEAD), Biologist; and Tom Keily, BEAD, Economist.
Ms. Rossi explained that the presentation would expand on the acute dietary case study presented at the WG2 meeting and include a discussion of all of the risks considered in a comprehensive risk assessment performed in the reregistration review of every chemical. She commented that the risk assessment includes worker risk, ecological risk, as well as the dietary risk from food and drinking water. Ms. Rossi clarified that the AZM assessment would not involve an evaluation of residential risk because it does not have residential uses. She explained that AZM was selected as an example because it is far along in the pilot process and represents many of the complex methodological and policy issues related to the OPs that will be faced with other OPs. Ms. Rossi stated that the presentation was a prototype for the Technical Briefings that include phase 4 of the pilot process. She noted that the Technical Briefings would be public meetings jointly hosted by EPA and USDA or DHHS and would share the refined risk assessment and initiate the discussion of risk management options. Ms. Rossi commented that the goal of the presentation would be to show advances in the methodology and the revisions that have been incorporated in the assessment. As part of the presentation Ms. Rossi stated that EPA would clarify where assumptions are used, where actual data are used, the sources of the data and the uncertainties of the assessment. She stated that the discussion would focus on risks of concern, as they will be the focus of the risk management phase of the pilot process.
Ms. Rossi added that the AZM risk assessment considered human health effects and ecological effects. She explained that the potential effects on humans included dietary exposure from food and drinking water on both an acute and chronic basis. In addition, Ms. Rossi noted that the assessment considered risk to agricultural workers before, during and after pesticide applications. Ms. Rossi stated that because there is no method for evaluating exposure to bystanders from secondary exposure, such as drift, this exposure was not included in the risk assessment. She explained that in the ecological effects assessment the potential effects of pesticides on birds, mammals, fish, and other aquatic species as well as impacts on water resources are evaluated.
Ms. Rossi described the status of AZM within the pilot process. She referred TRAC members to Staff Paper # 38a, Azinphos-Methyl Technical Briefing (presented in Docket # OPP00537) for a copy of the slides for her presentation. She reviewed the timing for the completion of each phase of the pilot process for AZM. Among the details of the status report, Ms. Rossi observed that the preliminary health assessment that was placed in the Docket in August 1998 showed acute dietary risks of concern. She explained that that assessment was based on a non-probabilistic model referred to as the Dietary Risk Evaluation System (DRES), use of mostly tolerance level residues except for blended commodities where field trial data were used, 100 percent crop treated, and 1977-78 USDA consumption data. She added that the preliminary human health assessment also indicated a concern for workers based mostly on surrogate data and some chemical-specific data. Ms. Rossi noted that the preliminary ecological effects assessment indicated risk of concern for both aquatic species and terrestrial species. In phase 3, public comment period, Ms. Rossi explained that the Agency received approximately 15 comments addressing AZM and a similar number of comments addressing all of the OPs. She noted that the Registrants generally felt the Agency should incorporate data as it becomes available, and public interest groups were concerned about how the 10X factor was applied and requested that the Agency take action based in the results of the preliminary assessment. Growers commented on the importance of AZM in the Integrated Pest Management (IPM) programs and raised a series of concerns about the potential negative impact of the risk assessment on apples, cherries and almonds.
In addition to providing comments, Ms. Rossi noted that growers and Registrants provided additional data. Growers provided information on actual use practices, application rates, and other use parameters. Registrants provided a Monte Carlo analysis along with residue data files and dermal exposure studies for cotton and apples (dislodgeable foliar residue (DFR) data) submitted in response to the agricultural reentry DCI issued by the Agency in October 1995. She noted that EPA has taken these data into consideration in the revised risk assessment.
Based on these comments, Ms. Rossi described the phase 4 revisions to the assessment and explained that the most dramatic changes to the assessment resulted from refinements to the acute dietary risk assessment. She explained that this was possible because of the Monte Carlo submission with residue files that allowed EPA to do multiple modeling runs and sensitivity analyses projecting what-if scenarios. Ms. Rossi commented that the dermal exposure data submitted did not greatly change risk estimates for post-application exposure and no changes were made to the chronic dietary risk assessment. She summarized that there were key changes made to PRA that are reflected in the revised risk assessment for AZM and will be used in future risk assessments. Some of the specific changes included developing a method for using the monitoring data for acute dietary assessments, the in-house Monte Carlo capabilities, the ability to perform sensitivity analyses to see which factor most influences the risk assessment, and incorporating new data as it is received. Ms. Rossi explained that the work that remains to be done focuses on the ecological risk assessment, which is in phase 4.
Following this overview, Ms. Rossi initiated the detailed discussion on AZM. She began with a summary of the regulatory history of AZM and introduced Rich Dumas for a description of the use of AZM, followed by a presentation from Catherine Eiden on the dietary portion of the human health risk and overview of the worker risk assessment from Jack Arthur.
Mr. Dumas stated that AZM was first registered for food use in 1959 and it is currently registered for use on about 50 foods. He explained that the Agency gets its use information from the USDA/National Agricultural Statistics Service (NASS) and others, including Registrants and growers. In the case of AZM, Mr. Dumas indicated that most of the data were from the USDA. For additional information, he referred TRAC members to a paper recently completed by the Agency on pesticide use policy including the sources of use data, how estimates are developed, and how the Agency uses these estimates in risk assessments. Mr. Dumas then summarized some of the statistics on AZM, including the fact that an average amount of two million pounds of AZM are applied annually in different amounts on fruit trees, nut crops, and cotton. He added that some of the food crops for which a high percent (50 percent or more) of the crop is treated include apples, pears and cherries. Fruit crops for which less than 25 percent of the crop is treated include blueberries, almonds, pistachios, and cranberries. He noted that AZM is used throughout the US, but predominantly in California and the Pacific Northwest on tree crops and on the Delta and in Texas on trees and cotton. To illustrate the role of some of the use practices in the risk assessment process, Mr. Dumas referenced a table of the Agency's recent use information including application rates, method and reentry intervals for selected crops. For additional information on how the AZM assessment was performed, Mr. Dumas turned to Ms. Eiden for an overview of the dietary and aggregate risk assessment.
Ms. Eiden began her presentation by explaining that she would describe the dietary (food and drinking water) and aggregate risk components of the human health risk assessment. As a basis for the discussion, she reviewed the risk equation (risk = hazard X exposure, where exposure = consumption X residue.) Ms. Eiden then described the acute and chronic dietary risk assessments conducted for AZM. She noted that the chronic dietary risk assessment was completed early in the process and the risk estimates based on that assessment did not indicate risk concerns, so consequently the focus of the presentation would be on the acute dietary risk assessment. Ms. Eiden reviewed the acute and chronic toxic endpoints for AZM used in the assessment and explained that the toxic end points are the fundamental basis of the risk assessment. For the acute toxicity of AZM, EPA used a neurotoxicity study in rats and the endpoint of cholinesterase inhibition in red blood cells (RBC), plasma and brain tissue, resulting in the lowest adverse effect level (LOAEL) of 1.0 milligrams per kilogram of body weight per day (mg/kgBW/day.) The no observed adverse effect level (NOAEL) was not determined. For the chronic toxicity of AZM, EPA used a 1-year chronic feeding study in dogs and the endpoint of cholinesterase inhibition in RBC. The LOAEL was determined to be 0.70 mg/kgBW/day, and the LOAEL was 0.15 mg/kgBW/day. Ms. Eiden commented that, once the endpoints were selected, the uncertainty factors were selected as follows: 10X for inter-species variability; 10X for intra-species variability; and an additional 3X factor to the acute dietary risk assessment to account for the lack of a NOAEL. The resulting total uncertainty factor applied to the acute dietary risk assessment was 300X, and 100X for the chronic risk assessment. Using information on the endpoints and the uncertainty factors, Ms. Eiden described how the reference doses (RfD) for AZM were calculated and stated that the acute RfD was 0.003 mg/kgBW/day and the chronic RfD equaled 0.0015 mg/kgBW/day. She explained that the RfD is then used in a percentage form as a measure of risk (e.g., %RfD = exposure/RfD X 100.)
Ms. Eiden described the analysis of special sensitivity of infants and children for AZM. She explained that EPA reviewed the database for completeness and performed a search of the open literature and it was determined that there was no evidence of cholinesterase inhibition between adults and their offspring. On that basis and a series of other observations, the FQPA 10X safety factor was not applied. Ms. Eiden also noted that a developmental neurotoxicity (DNT) study was not required, however she noted that EPA is considering a broader requirement for a DNT study on a class of chemicals which would include AZM.
Next, Ms. Eiden described the exposure side of the risk equation. For consumption she stated that EPA used the Continuing Survey of Food Intake by Individuals (CSFII) 1989-91 data to determine exposure. However, she commented that the assessments would be updated with the 1994-96 CSFII data when they are validated and become available and with USDA's supplemental children's consumption data sometime after December 1999. For residues, Ms. Eiden described the different sources of information for Tier 1 - 3 risk assessments and commented that as EPA moves through the Tiers of assessment they are able to refine the risk estimates because the source of the residue data is closer to the point of consumption. Ms. Eiden summarized the results of the chronic dietary analysis. She noted that for four key sectors of the population the risk estimates were presented as a percentage of the chronic RfD. The most exposed subgroup, children ages 1 through 6 years of age, had 33 percent of the available exposure or chronic RfD of their diet taken up by residues of AZM.
For the acute dietary risk assessment Ms. Eiden explained that EPA began with a Tier 1 risk assessment using tolerance residues, a non-probabilistic model, and the assumption that all crops has a tolerance level residue. Following the Tier 1 assessment, she explained that EPA performed a Tier 3 assessment using probabilistic model, which incorporated monitoring data, and specific information on the specific percent of crop treated with AZM. Ms. Eiden commented that the monitoring data used was PDP data and Food and Drug Administration (FDA) Surveillance Monitoring Data when PDP data were not available. She also commented on some of the other types of data that might be used in the absence of PDP data including field trial data and processing data for blended or processed foods.
After describing the acute risk assessment process, Ms. Eiden summarized the results of the assessment, including a comparison between the Tier 1 and 3 assessments. The results of the Tier 1 assessment in the 95th percentile indicated the need to perform a Tier 3 risk assessment. The results of the Tier 3 risk assessment in the 99.9th percentile showed a marked difference in the risk estimates and indicated that the most exposed group is children from ages 1 - 6 years of age.
Ms. Eiden highlighted the differences between the preliminary risk assessment submitted to USDA and the refined risk assessment, including the use of new percent crop-treated data, new single-serving pear data, and the application of a canning or saucing factor for canned fruits. In addition, she noted that EPA evaluated the major contributors to the risk assessment, which included apples, peaches, pears, and cherries. Minor contributors were tomatoes, grapes, almonds, citrus, and beans. Ms. Eiden also noted that a sensitivity analysis on using non-detectable residues versus zero showed in insignificant impact on risk. She noted that the results of a sensitivity analysis on the impact of changes in percent crop-treated are forthcoming.
Next, Ms. Eiden described the drinking water risk assessment. She explained that the assessment was conducted because AZM is widely used and its environmental fate profile indicated that AZM could enter the surface water and ground water to some extent. Its presence in surface and ground water was confirmed by some monitoring data. She noted that EPA relied on modeling estimates for the drinking water assessment and the results of the modeling showed that there was no concern about chronic exposure to AZM in drinking water.
Ms. Eiden then summarized the results of the aggregate risk assessment, which includes exposures from food and drinking water. Residential and other non-occupational sources were not considered in the aggregate assessment because there are none. She explained that EPA did not perform an acute aggregate risk assessment because of the results of risk estimates for acute exposure to AZM on the dietary side. However, a chronic aggregate risk assessment was done and the results show that the combined effects of exposure to food and drinking water are not of concern. She then turned to Jack Arthur for a description of the occupational risk assessment.
Mr. Arthur began his presentation by explaining that the assessment covers two worker populations, handlers (e.g., farmers, applicators, growers) and post-application workers (e.g., workers in the field after application.) He noted that the risks for each group are assessed separately because the data and the assessment approaches differ. Mr. Arthur listed a number of factors forming the basis for handler risk assessment including formulation and application equipment, unit exposure, rate of application, areas treated per day, toxicity endpoint, and levels of protection. Integrating these factors, Mr. Arthur described that calculation of dose as (unit exposure X application rate X dermal absorption)/body weight for a milligram/kilogram/day exposure dose. He added that the margin of exposure (MOE) or the ratio between the NOAEL/dose is calculated for each exposure scenario and should be 100 or greater. To clarify what was meant by the term "exposure scenario," Mr. Arthur listed the 14 handler scenarios used in the analysis. He noted that out of the 14 scenarios the results for the short- and intermediate-term handler risks show only one has an MOE above 100.
Next, Mr. Arthur summarized the factors forming the basis for post-application worker risk, including DFR and transfer coefficient (TC.) He described how these factors are used to calculate the dose = (DFR X TC)/body weight. Mr. Arthur added that by looking at MOEs on various days post-application the reentry interval (REI) could be determined.
Mr. Arthur then presented the results of the occupational risk assessment. He noted that the risk estimates for reentry workers posed some concern for all uses of AZM based on current application rates and REI. Mr. Arthur also presented some Incidence Information from the California Pesticide Illness Surveillance Program (CPISP) and the American Association of Poison Control Centers (PCC.) He observed that that information showed some cases of illness such as skin, eye and respiratory systems, among mixers/loaders, applicators, reentry workers, and spray drift. Mr. Arthur stated that these results reinforce some of EPA's concerns about worker risk.
Following Mr. Arthur's remarks, Ms. Rossi added that worker risks are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as compared to the tolerance and dietary risks which are regulated under FQPA.
In wrapping up the presentation on the revised risk assessment, Ms. Rossi shared a few comments on the ecological risk assessment. She commented that the ecological risk assessment is preliminary, has not yet been revised, and it is in phase 4 of the pilot process. Ms. Rossi explained that the comment period closed in March 1998 and comments from Registrants and growers were received. The Registrants commented on fate and water issues, whereas the growers commented on the application methods. She noted that the aquatic risks seem to be of greatest concern as a result of runoff and drift. Ms. Rossi observed that these concerns are supported by incidents involving fish kills, many of which were associated with sugar cane uses. Since these incidents, she noted that EPA has worked with the states on sugar cane use. Ms. Rossi added that estimated risks to birds and small mammals appear to be high and incident reports support this concern. She completed her presentation on the ecological risks by stating that EPA is in the process of reviewing and addressing public comments on the preliminary assessment.
Ms. Rossi summarized the conclusions from the presentation on AZM including the acute dietary, worker, ecological risk assessments, and forthcoming additional data. She then highlighted some outstanding issues, many of which are in peer review and/or are being discussed actively by EPA and USDA. She noted that there are questions about some of the data inputs such as the use of the maximum percent of the crop-treated as opposed to using a weighted average, and the use of decomposited distribution. Ms. Rossi also stated that there are concerns about worker risks for both handlers and post-application workers regarding REIs and other exposures.
Following the presentation, Dr. Ehrmann invited clarifying questions from the group. Before TRAC members responded to this request, Mr. Rominger asked Mr. Jennings to introduce the USDA staff that has been involved in the AZM risk assessment. Mr. Jennings introduced the following USDA staff: Doug Kleweno, NASS; Norman Bennet, NASS; Jim Smith, NASS; Phil Kott, NASS; Linda Abbott, Office of Risk Assessment and Cost-Benfit Analysis; Bob Epstein, Secretary's Science Advisor (formerly PDP); Martha LaMont, PDP; Mark Whalon, Michigan State University Land Grant; Jay Brunner, Washington State University Land Grant; Catherine Daniels, Washington State University Land Grant; Bob Crieger, University of California - Riverside Land Grant; Wilfred Burr, Office of Pest Management Policy; Alanna Moshfegh, ARS; and Joe Goldman, ARS.
TRAC members then posed the following questions of clarification:
To the extent there is data sufficient to perform a higher tier risk assessment, what is the value of doing the lower Tier analyses? Ms. Rossi responded that the value in performing a lower Tier analyses is that they may save time because they take less time to do. If they show there is no risk concern, then no additional assessment is conducted.
Is there a risk inherent with stopping after a lower Tier risk assessment in view of potential changes resulting from the cumulative risk assessment? Ms. Rossi acknowledged that the cumulative risk assessments would necessitate refining some individual risk assessments in the future.
How often are tolerances exceeded on crops? Mr. Zager commented on the method EPA is currently using which generates values for single servings, which exceed the tolerance levels, and these numbers are being included in the risk assessments. He explained that EPA is consulting with statisticians and the Science Advisory Panel (SAP) to evaluate these results.
Is the approach to performing NDT studies adequate enough to protect children? How can EPA rationalize dropping the FQPA 10X safety factor in the absence of consumption data and DNT studies? Mr. Zager commented that, as indicated earlier in the meeting, EPA is considering the use of DNT studies on full classes of chemicals. However, in the case of AZM, the existing toxicity study did not indicate the need for an DNT study.
How did EPA arrive at a 3X uncertainty factor in the absence of an NOAEL? Mr. Zager responded that a factor of 3X has historically been applied in the absence of a NOAEL and studies have supported the use of the 3X factor. He added that the science policy paper on the FQPA 10X safety factor is also going to be reviewed by the SAP.
What was the factor difference on the chronic risk assessment study where the data on the NOAEL was available? It was clarified that the 3X factor was not applied because a NOAEL was available, but the relative factor difference was between 3 and 4 times.
How does EPA determine when to evaluate additional elements of a risk assessment (e.g., in the case of AZM when EPA decided that it was not necessary to proceed further with the drinking water assessment because the exposure from food used so much of the risk cup)? Ms. Rossi commented that drinking water was recognized as representing some risk and, at some point, room in the risk cup must be allocated to drinking water. In addition, she noted that the risk assessment is not yet final and elements of risk are still being evaluated.
Will there be alternatives to AZM, which is used in Michigan to control fruit flies and where cherries are largely harvested mechanically, if the concern over safe REI precludes its use? What will it cost to reeducate people on the proper use of pesticides or their alternatives? Ms. Rossi commented that this is a presentation on where EPA is in the risk assessment process. She suggested that some of the suggestions made in the context of the question, such as using mechanical harvesting, are more relevant to the discussion on risk management strategies. Mr. Jennings added that when stakeholders meet to discuss risk drivers they would address REIs and an assessment of what is going on in the field.
Might the use of the LOD make more of a difference in determining risk drivers in some circumstances? Ms. Rossi clarified that she was discussing the impact on the total risk cup when she commented that there was no difference between using LOD or zero, not the determination of risk drivers such as cherries. She added that it would be possible to perform an analysis like this to study the impact on an individual commodity.
Was percent crop treated used in this study? Ms. Rossi responded affirmatively.
When the single serving data become available in addition to market basket survey and PDP data, does EPA plan to average it in with prior years of data and do the decompositing, or will the new data set be used as a baseline of current, more accurate information? Mr. Zager stated that EPA would compare the single serving data to other sources of data and the compositing results to evaluate how accurate the data is. He commented that they would probably not average the composited information in.
Having identified cherries as a major risk contributor, has EPA evaluated the impact of removing cherries from the risk cup to see if their removal makes an observable difference in the total risk? Ms. Rossi clarified that there were three major risk contributors. The next one after the major contributors was cherries. Ms. Ford explained that EPA performed an analysis that excluded cherries from the analysis. She noted that the results did not change measurably for the children and infant groups, but there were some changes in the other age categories. Several TRAC members reiterated that growers are sensitive about a crop being identified as a risk driver based on a small database. They stressed the importance of EPA doing what they can do to check the significance of the crop as a driver.
In the occupational assessment, slide #43, fourth bullet on the areas treated per day, is it possible to provide detail on the method of application (e.g., ground or aerial application)? Mr. Arthur explained that their assessment is based on the amount of pesticide applied per acre. Mr. Aidala added that the specific measure is intended to address both the concerns about exposure resulting from both the method of application and the amount of area covered in the application.
In the occupational assessment, slide #45, handler scenario, is the description of personal protective equipment sufficient and consistent with the label description? Would additions to the level of personal protective equipment (PPE) such as glasses and boots change the results of the exposure scenario? Ms. Rossi explained that the guideline used was the information on the federal label and protection factors from the Pesticide Handlers Exposure Database (PHED.) She explained that they quantify what they can. However, if protective equipment were expanded as part of a risk management program, EPA would have to use some judgement on the contribution to the reduction of risk. Ongoing studies on the protective impact of different application systems are expected to provide additional information on this issue.
In the occupational assessment, slide #48, which of the handler scenarios resulted in an MOE of greater than 100? Mr. Arthur responded that it is #10, the flagger risk.
Does EPA perform a sensitivity analysis on the worker risk assessment? In this regard, it was suggested that it would be good to do a reality check with the label and to highlight the risk drivers.
Would the handout #38b be the prototype for the Technical Briefing? Would the handout include a complete listing of the residue inputs used in the analysis? Ms. Rossi responded that if TRAC members feel this type of document would be helpful, EPA would plan on using it at the Technical Briefing. The TRAC member stated that such a document would be very helpful and suggested adding key elements of the discussion at the Technical Briefing in the summary document of the risk assessment.
If state data that were submitted as part of the NRD are not currently being considered, is it necessary for the state to resubmit these data for AZM? Ms. Rossi stated that she would check and follow-up on this question off-line.
One member expressed concern about identifying cherries as a risk driver. He did not understand how they could be identified as a risk driver, given some of the information available in Michigan where the ratio of processed to fresh cherries is 4:1, residuals are very low on processed cherries, and less than 2 percent of the cherries are consumed by children between the ages of 1 - 6 years old. He felt the data used were insufficient and suggested that EPA consider adding a step in the risk refinement process for USDA to identify potential errors that might lead to interpretations like this. Ms. Rossi commented that, to address this concern, it is necessary to look at how much one assumes is processed, what factor is used for processing, and what is meant by fresh. She asked Ms. Ford to provide more detail on how these values were derived for cherries. Ms. Ford explained that for AZM, EPA did not have monitoring data but used field residue data that would cause the residue levels to be higher. She added that EPA used information on both sweet and tart cherries and food processing data to adjust the data to address the different types of food forms. She welcomed additional data. Mr. Aidala reiterated the comments of Ms. Ford and stated that in its evaluation of information on a chemical like AZM, EPA would consider the limitations of the data set. Keith Pitts, Special Assistant to the Deputy Secretary, USDA, added that USDA is providing this type of review at headquarters as well as through the LGU system.
Another TRAC member questioned the adequacy of children's consumption data. Mr. Jennings explained that the consumption data are based on a statistical sample and they are representative of the US and various subpopulations. To address some of the uncertainties in the data, he noted that USDA is performing a supplemental survey of an additional 5,000 children's data points to make the analysis more robust. Mr. Jennings also commented that these data are being validated and entered into a database and will be available to EPA early in December 1999. A TRAC member suggested that to address some concerns about children's health, EPA share the letter responding to a series of questions posed to Dr. Goldman by Dr. Reigart of the TRAC.
A TRAC member expressed concern about EPA making decisions prematurely at the expense of transparency and sound science in the attempt to adhere to established timelines, and not allocating sufficient time for growers and registrants to respond to some of the decisions. He referenced as examples a circumstance where EPA had changed an endpoint after the close of the public comment period and a situation where EPA did not remove an FQPA 10X safety factor as expected. He urged EPA to take the time that they need in the decision making process to avoid premature or untimely decisions. Mr. Robertson appreciated the comment and reiterated that Mr. Jennings and Ms. Rossi both had indicated that they felt the time allocated was appropriate to the tasks involved. He commented that he felt this was an appropriately deliberate process and stated that EPA will try to insure that there is sufficient time to make sure that sound science is applied in every case within reasonable timeframes.
Following this discussion, Dr. Ehrmann turned to Daniel Botts, Director of Environmental and Pest Management for the Florida Fruit and Vegetable Association, and Jay Vroom, President of the American Crop Protection Association (ACPA), to initiate the discussion on perspectives regarding the OP pilot process and the AZM Technical Briefing.
Key Perspectives Regarding Organophosphates Pilot Process and Azinphos-Methyl Prototype Briefing
Mr. Botts began by explaining that most of his comments would be influenced by the discussion at the WG2 meeting two weeks ago. He also noted that his comments would focus on the process, not on specific technical details except as examples for a few key issues. He observed that when the PRA for AZM was released people recognized that the numbers were preliminary. However, he commented that the industry was tremendously concerned about how to deal with the magnitude of the risk exposure numbers generated for different subpopulations. The reduction in risk exposure numbers resulting from the risk refinement process, which involved error correction and USDA review, illustrates a concern of the industry about publishing preliminary screening results when more accurate risk numbers, at least from the dietary exposure standpoint, indicate that industry is not creating problems for the public. He suggested using the term "risk contributor" rather than "risk driver," and cautioned against the Agency referring to single commodities, like cherries, prematurely as risk contributors because it implies something that may or may not be true about the commodity. In this regard, Mr. Botts commented on how to make the transition from the pilot process to a process to use in the long-term. He stated that the PRAs are incomprehensible for growers to deal with. In contrast, he noted that the refined risk assessment and the supporting and summary documents presented at the WG2 meeting represent the minimum documentation necessary to accompany a description of the refined risk analysis to help focus user input and response to any individual commodity being identified as a risk contributor.
Mr. Botts then stated his understanding that the refined risk analysis opened a comment period to allow discussion to further refine the risk analysis to more accurately reflect what would be real risk from use of those products in American agriculture. He then commented that based on the discussion earlier in the day the refined risk assessment is EPA's final determination on the risk. Following USDA's refinement, the next step is risk mitigation. As an alternative, he suggested that the refinement process at least include the opportunity for commodity groups to assist in further refining the use information. As an example, he noted that the percent crop treated used differs for celery depending on the planned use of the crop and commodity groups could provide this kind of information. In addition, in view of the range of risk estimates presented in slide #33 for the acute dietary risk analysis results, he suggested that EPA involve USDA earlier on in the risk assessment process before the assessment is finalized to minimize the necessity for multiple analysis of the same data to achieve the refined risk.
Mr. Botts also recognized that one of the biggest issues is where the process goes from here. He acknowledged that the pilot process has not been followed to completion on any individual compound. In this regard, he stated that the user community is concerned about what their role would be in the risk mitigation process and whether they will be involved in identifying options and how to test them to insure that they meet the goals of EPA and the user community. He expressed the hope that the risk mitigation process would be as open as the risk assessment process.
Mr. Botts closed his comments by expressing the concern that limited resources available to EPA and USDA not be devoted entirely to tolerance reassessment and the TRAC process and that they also be applied to new product registration and other essential actions.
Mr. Vroom opened his comments by referring to a copy of the overheads for his presentation on OP Pilot Process for Earlier Public Disclosure of Preliminary Risk Assessment Information (presented in Docket # OPP00537.) He reminded TRAC members that the AZM example was offered in the spirit of understanding the process and that there are additional stages of analysis and data yet to be completed that might either reduce or increase the risk estimates.
Mr. Vroom observed that since the pilot process began at the July 1998 TRAC meeting, ACPA members were canvassed and they generally acknowledge that the pilot process responds to the need for transparency regarding the process as well as the substantive information being presented. He noted that ACPA members recognize that the pilot attempts to allow EPA greater management control of information than would otherwise be accessible through the Freedom of Information Act (FOIA) and this is an important benefit of the pilot. Mr. Vroom also stated that ACPA members acknowledge that the pilot was developed "on the go" while a lot of other FQPA activities were underway and that the pilot has enabled many stakeholders to gain a practical understanding of the risk assessment process and how it is being applied on various chemicals, especially in the utilization of the new standards being brought forward and implemented through the science policies stemming from FQPA.
Mr. Vroom commented on how the various stakeholder groups have fared through the pilot process. He commended the registrants for cooperating with the pilot process and providing examples for the Agency and the TRAC to review and assess. In addition, he stated that EPA and USDA staff should be commended for working to adopt an approach to earlier public release and implementing it simultaneously with appropriate caveats. Mr. Vroom observed that lessons had been learned and it continues to be a work in progress. He noted that growers and the food companies should be commended for keeping the market place informed and calm as the pilot information has been released and disseminated. Mr. Vroom also commended environmental and consumer groups for avoiding distortion of information that has come from the pilot process.
Mr. Vroom then discussed the potential path forward for the pilot by posing a series of key questions. He stated that ACPA feels that one of the most fundamental questions is of a legal nature and addresses where the FOIA bright line has been drawn. Mr. Vroom stated that he assumes the Office of General Council at EPA has drawn that line and suggested the need to discuss the question of whether the line is drawn too early in the process, particularly in light of the significant change in the risk estimates illustrated by the risk refinement for AZM. Based on this example, Mr. Vroom questioned whether it was the public's right to be made aware of such a revision in risk estimates. In addition, he questioned whether the bright line for FOIA is being fairly and uniformly applied and requested more information on this issue. Mr. Vroom reiterated his concern over whether there is a benefit to the regulatory process to be gained from the volume, quality, and robustness of public comment and is the process currently in place enhancing that process. Lastly, Mr. Vroom commented that ACPA wonders about the ability to enlarge and/or clarify the definition of error correction in phase 1 of the pilot process.
Mr. Vroom closed his comments by committing ACPA to submitting written recommendations regarding these questions and others before the next TRAC meeting.
Dr. Ehrmann thanked Mr. Botts and Mr. Vroom for their presentations and invited other TRAC members to make any additional comments regarding the pilot process and the AZM Technical Briefing.
One member was interested in hearing more about the kind of public reaction EPA received in response to the results of the PRA of AZM. He commented that he expected the public would be concerned about the results of the PRA and questioned the rationale for making the conservative results of a preliminary assessment available to the public. Ms. Rossi explained that EPA received 31 comments on the preliminary AZM risk assessment, half of which addressed AZM and the other half were general comments on all OPs. She noted that most of the comments were from registrants and growers and two sets of comments were from the environmental groups. Ms. Rossi stated that registrants focused their comments on data that was being developed, growers commented on the importance of the role of the chemical in agriculture. Mr. Aidala commented on the concern about the transparency of the process. First, he explained that the results of the preliminary risk assessment represent EPA's understanding of the risk at that point in the evolution of the risk evaluation. He added that if EPA posts information about one preliminary risk assessment which might indicate that there is no exceedance of the risk cup, it must also post the results of other preliminary risk assessments which highlight areas of concern that require additional assessment and what areas do not. Mr. Aidala added that this is another reason for the identification of major contributors and what data are used for that determination (e.g., PDP data, consumption data, etc.) He acknowledged that PRAs must also be accompanied by appropriate caveats explaining the context and limitations of the assessment and requested feedback from the group on whether EPA addressed the context effectively and whether they did a good job of communicating the information.
In response to Mr. Vroom's comments on public documents and FOIA, Mr. Aidala questioned, if this is a public document because it is subject to FOIA, what would be the rationale for not putting the document out in a less formal context, such as in response to an individual request. He invited additional discussion on this issue. Using the PRA as an example, one member suggested that EPA consider posting the preliminary assessment to the Docket for informal comments, as precursor to the risk assessment document on which they plan to base decisions. At a later point, EPA could post the refined risk assessment on which they plan to base decisions for formal comments. Dr. Ehrmann added that the format of future PRAs would be more similar to the refined risk assessments, which will also facilitate the review process. In addition, another member stated that future PRAs would be more refined.
One member observed that as changes are made based on risk refinements the market shares and use of different pesticides will change in response. He questioned how EPA planned to keep up with these fluctuations. Ms. Rossi responded first with the comment that FQPA requires a regular reevaluation of percent crop treated. She then clarified her understanding of the question which was, how will EPA address making a decision on one of the chemicals without looking at what is happening to the other ones? She stated that in the risk management process this consideration and the question of market share would be part of the decision-making process. Mr. Jennings added that some of these issues were the reason EPA and USDA started looking at the crop that might be affected and working on transition management strategies that dealt with a category of chemicals. The TRAC member suggested that it would be helpful and simpler to go back to using the risk cup as an analogy.
Several TRAC members commented on the successes of the TRAC. One member felt that it was important to recognize some of these successes and noted that some important questions have been asked about how we can look at pesticides as a result of FQPA and the TRAC that may not have been asked without the TRAC process. Another individual stated that it is unclear how important FQPA is to EPA and where the decision-making process will go following the TRAC process. He added that it would be helpful for EPA to provide more information on some of the variables used in the risk assessment, such as in slide #33 where by changing the percent of crop-treated the risk to infants was reduced by a factor of 3X. He suggested that EPA provide some indication of how they plan to stabilize this figure so that is does not just reflect a single point in time (e.g., to address seasonal variability, etc.). Also, he stated that EPA needs to clarify what values will trigger some kind of action. The individual also cautioned that when EPA indicates that they are not concerned about the chronic risk they should clarify how this temporary determination may change when cumulative risk is addressed.
To address some of the concerns about changes in the percent crop-treated, another TRAC member referred to PDP as a tool that integrates all the sources of variability in the production of crops and the use of pesticides over time. She observed that this would answer the concern about year to year fluctuations in the percent crop treated. In addition, the individual suggested that USDA think about expanding the PDP database to make it more comprehensive and to use it as a means to have confidence that EPA's risk assessments provide a valid representation of risk. Mr. Pitts commented that this is an idea that is under discussion. He also stated that USDA is looking at long-term monitoring efforts as well as evaluating methods for determining whether USDA is meeting its targets. He noted that USDA is also looking at a way to integrate PDP and NASS data for a complete date profile.
Mr. Aidala closed the discussion by reflecting on some of the feedback EPA received on the WG2 meeting, including comments from the environmental and consumer groups, for the benefit of those who were not in attendance at the work group meeting. He noted that many applauded the improved transparency of the pilot process. At the same time Mr. Aidala recognized that some of the WG2 members were concerned about the potential for delay as a result of the various phases in the pilot process. He commented that while people acknowledged that additional data could always improve the quality of the results the ongoing submission of data could at some point translate to delay and be a deterrent to decision-making. In response to Mr. Aidala's use of the term "delay," one TRAC member commented that the TRAC needs to be deliberative because some of the tools that might be taken off the market as a result of input from the TRAC process could adversely impact the agricultural community.
Organophosphate Worker Risk Issues
Jack Housenger, Associate Director of Special Review and Reregistration, presented the group with a general overview of how the Agency conducts a worker risk assessment, including the basic methodologies, a discussion of the issues gleaned from the OP assessments conducted thus far, and how to address them. A copy of the slides for his presentation are presented in Docket # OPP00537. Mr. Housenger stated that EPA evaluates worker risk for all registration and reregistrations in the same manner for each pesticide. He observed that, unlike dietary risk assessments, which are governed by FQPA, worker risks are governed by FIFRA, which requires a consideration of the benefits of the use of the pesticide when taking regulatory action. Mr. Housenger explained that past actions were taken to address high rates of incidents observed in workers exposed to ethyl parathion in 1991. Also in 1991, he noted that EPA began a project called the Acute Worker Risk Strategy (AWRS) which looked at incidents across all pesticides to determine which pesticides post the greatest risk to all agricultural workers. As a result of the AWRS project, all uses of mevinphos were voluntarily cancelled. Mr. Housenger commented that for almost every registration decision made to date, some worker mitigation measures have been included to reduce exposures. He then turned to Mr. Zager to explain how a worker risk assessment is conducted.
Mr. Zager stated that he would describe how the Agency estimates the risk from the occupational exposures related to pesticides. He noted that some of his presentation was included in the discussion on AZM and introduced Jack Arthur and Jeff Dawson who helped to prepare the presentation and would be available for questions. Mr. Zager described a variety of settings in which pesticides could be used, including agricultural, industrial. commercial, and in public places. He noted that 1 billion pounds of pesticides was applied in 1995, of which 80 percent was used in agriculture. Mr. Zager stated that pesticides are also used for public health purposes such as mosquito control. To estimate exposure from pesticides, Mr. Zager explained that a number of factors must be considered including use patterns, types of exposure, hazard (toxicity) aspects, chemical properties, job function, and methods of application. He noted that each of these factors could significantly impact the exposure (or factor) and the associated risk. Mr. Zager also discussed the sources of variables that are used in the exposure calculations. For handlers or mixer/loader/applicator calculations there is chemical-specific exposure data or as a secondary source, the PHED. For post-application exposure EPA uses chemical-specific exposure data or standard factors from public and industry data. Mr. Zager explained that, for chemical-specific exposure data it is preferable to have chemical- and scenario-specific data. These data are limited, but the data they receive generally supports the values from the PHED.
Mr. Zager provided some background on the PHED. He explained that PHED is a product of a taskforce comprised of EPA, Health Canada, California Department of Pesticide Regulation, European countries and industry. He noted that approach has been extensively peer reviewed including the SAP. Mr. Zager noted that the premise of the database is that it is active ingredient (a.i.) independent and related to how the chemical is applied and how much is applied. It is a library of actual exposure monitoring data. Mr. Zager explained that the Agency and the industry sort the data by formulation type and application methods. In addition, the database also included protective clothing information. PHED allows the Agency to calculate the exposure by finding the best match of an application question to the existing database. Mr. Zager then described an example of using PHED to determine the unit exposure volume from application of a liquid via a ground boom. In the example, the unit exposure for an applicator that is wearing a shirt and pants is estimated. Other factors used in the exposure calculations include the number of acres treated, body weight, duration of work, and skin surface. He noted that the standard references and data sources include the Exposure Factors Handbook, survey data, and equipment manuals.
To calculate the exposure for handlers, Mr. Zager described the following equation:
Daily Exposure (mg a.i. /kg/day) = [Unit Exposure (mg/lb a.i.) X Acres/day X Rate (lbs a.i./acre)]/BW (kg).
He also defined the MOE = NOAEL (mg/kg/day)/Exposure (mg/kg/day). He noted that an MOE of 100 is adequate and explained that the value of 100 was derived from an inter- and intra-species extrapolation (10X and 10X.) If the MOE needs to be increased, Mr. Zager note that protective measures could be applied such as adding protective clothing, changes in application equipment and rates.
Mr. Zager then described the calculation of exposure for post-application activities. First he defined TC as the level of contact with treated foliage while performing an activity. He then stated that in 1995 and extensive DCI was issued. He noted that an industry Agricultural Reentry Taskforce is working closely with Canada, California, DPR and EPA. Mr. Zager commented that one of the results of the DCI would be an extensive TC library and product-specific data on dislogeable residues. He then described the equation for determining the exposure to post-application workers is as follows:
Daily Exposure (mg a.i/kg/day) = [DFR (ug/cm2) X (mg/1000ug) X TC (cm2/hr) X 8hr)]/BW (kg).
He described a second equation for the MOE, as calculated for the handler scenario. Again, if the MOE is unacceptable, Mr. Zager indicated that certain steps could be taken to reduce the risk, such as requiring a longer worker reentry interval. He then turned to Jack Housenger for additional details.
Mr. Housenger began by commenting that, of the 27 risk assessments performed on OPs to date, 26 of them included worker risk assessments. He noted that most of the risk assessments have indicated concerns for workers, either mixers/loaders/applicators or persons entering a treated field or both. For handlers, he observed that risks are solved easily in some cases by requiring an additional layer of clothes or wearing chemically resistant gloves. Others require the use of engineering controls such as closed mixing/loading systems or the use of enclosed cabs, while others still have inadequate MOEs regardless of the corrective measures. For post-application risks, the risks might be addressed by increasing the reentry interval or cancellation.
Mr. Housenger stated that the worker risk assessments are complex and not easily understood and there are some pending concerns. He noted that USDA has raised concerns about the difficulty of interpreting the EPA risk assessments, as have some of the other commenters. Because of this, EPA is planning to work on improving the transparency of the worker risk assessment process. . Mr. Housenger also referenced the 1995 DCI, and indicated that some of those data on individuals entering treated fields were used in the AZM refined risk assessment. While data from this DCI will be integrated into risk assessments as it is received, EPA does not expect all of the data to be available until 2001 and the most refined risk assessments for some of the OPs will not be available until that time. Mr. Housenger also noted that, since worker risks are regulated under FIFRA, a benefits assessment would be necessary when risk concerns indicate the need for regulatory action. The benefits assessments could require substantial resources, consequently Mr. Housenger suggested the importance of exploring alternative ways to meet the FIFRA requirement such as addressing up front the question of what level of benefits off-sets a low MOE and by more actively involving USDA in the risk/benefits assessment.
Mr. Housenger also discussed the role of incident data. He explained that when worker risk is evaluated it is useful to consider incident data to look at the effects from the exposure to pesticides in the field. When evaluating incidents, Mr. Housenger commented that it is important to consider how much of the pesticide is used, and to normalize the incident data so that it can be compared across pesticides. He noted that it is also essential to evaluate the severity of the incident because greater concern is given to a pesticide if the majority of the related incidents result in hospitalization versus the production of clinical effects. In addition, it is important to recognize that incidents are usually under-reported, the worst events being the most likely to be recorded.
Mr. Housenger commented that there are a number of sources available with varying levels of information on which to draw conclusions about whether the incident actually occurred from the pesticide in question, how the pesticide exposure occurred, if it was a misuse, etc. He stated that the best source of information available is from the California Department of Pesticide Regulation. Mr. Housenger observed that California has a mandatory reporting system by physicians of all illnesses suspected of being related to exposure to a pesticide. He noted that California collected data since 1992 and that there are other sources of information with either little information or data collection efforts have just recently been initiated. Mr. Housenger summarized some of the incidents reported from the PCC (1993-86) and the California Surveillance Program (1991-95). In the data from the PCC the OPs were the cause of the greatest percent of severe illnesses, and the majority of illnesses in California resulted from OP exposure.
Mr. Housenger closed his presentation with a discussion on issues for consideration. He observed that when EPA conducted the Acute Worker Risk Strategy it was evident from the incident data that for the more toxic pesticides such as the OPs and the carbamates, the protection generally provided for on the current labels was not sufficient. While the measures required to address risk concerns for some pesticides involved reducing further exposure, the risk concerns for OPs were endpoint driven where the toxicity endpoint or the NOAEL is so small that even small amounts of exposure exceed the MOE. To help address the OP risk concerns, Mr. Housenger suggested increasing the baseline protective measures for all OPs and requiring engineering controls for the most toxic OPs. To address risks for people entering treated fields; Mr. Housenger proposed increasing the REI until refined risk assessments are performed. He also suggested that other baseline protection could include additional worker education programs on the risks of exposure to OPs. He closed his presentation by describing two ways to accomplish some of the baseline generic measures for the OPs and/or the carbamates. One way is to have registrants voluntarily agree to amend their labels to achieve the quickest mitigation with the least resources. A second, more involved and time-consuming method would be through regulatory action. Mr. Housenger noted that voluntary measures are quicker and could be in place by the next growing season. There could also be a phased approach based on how easily the measure can be implemented. He welcomed the advice of TRAC members on how to approach the issues surrounding worker risk for the OPs.
One member asked for clarification on where the reduction in worker exposure, like increasing the use of PPE, is reflected in the equation to determine daily handler exposure on slide # 8? Mr. Zager explained that the reduction would be reflected in the unit exposure part of the equation (Unit Exposure (mg/lb a.i.)) base on information from the PHED database. Mr. Aidala added that there would be one value for the Unit Exposure if you did not have gloves on and another value if you had gloves on. Mr. Zager suggested that it would be helpful to look at individual calculations for specific scenarios to understand how the addition of PPE changes the level of exposure. As an additional means of clarification, Stephen Johnson, Acting Deputy Assistant Administrator, EPA, referred TRAC members to the lower chart in slide #16 describing part of the Pesticide Database. He noted that there were a total of 160 cells representing the method of application and the PPE that may be used with that. Mr. Johnson explained that EPA is able to correlate the information from a label, which describes the method of application and the PPE, with a cell in the PHED and the resulting Unit of Exposure value. Marcia Mulkey, Director, OPP/EPA, stated that the data in the PHED cells is measured data with the various application approaches and PPE. The member suggested that providing an example like this on how to use the chart would be helpful. Mr. Housenger also explained the approach EPA uses to calculate the worker exposure for each PRA begins by evaluating worker risk on the basis of PHED followed by matching the results to the label requirements. They calculate the worker risk starting with a baseline of a long sleeve shirt and long pants. For comparison in the differences of exposure, EPA then calculates the exposure after adding an extra layer of clothing, followed by the addition of engineering controls.
Another TRAC member was concerned about relying on the data in PHED and questioned whether it might be appropriate to consider reviewing the PHED database and updating old data and providing data to replace default values. Mr. Dawson responded that EPA would prefer scenario- and chemical-specific data to work with and that they might correlate information on exposure from one scenario to similar scenarios (e.g. same formulation and equipment types, etc.) He noted that there are exceptions, such as some of the new granular materials that break up into smaller components of dust and that these are not well represented in PHED. The member asked whether air-blast data were covered by PHED. Mr. Dawson commented that the air-blast database is one of the richer data sets with good quality control and assurance associated with it. The member then asked if there was any extrapolation of data in the PHED database? Mr. Dawson indicated that while every cell in the PHED is based on some data they might have to extrapolate in some cases with standard protection factors for the presence of gloves or a respirator.
A member questioned some of the assumptions used for hazard identification, particularly for OPs. She recalled that the dietary hazard for OPs is endpoint-driven, and expressed confusion on how EPA could treat two different endpoint effects (e.g., plasma cholinesterase depression in one study and in another study a compound where a lesion occurred) for two different chemicals the same way with the same assumptions. She questioned the validity of this assumption when looking at hazard identification.
Another member requested clarification on where dermal absorption factors fits into the TC and, in the absence of chemical-specific data, what the default assumption is used for the amount of the chemical that is absorbed from the surface of the skin. Mr. Zager responded that the assumption is 100 percent (assuming the same absorption dermally as is seen orally) in the absence of data. Ms. Rossi explained that EPA assumes 100 percent dermal absorption lacking data when using an oral study. If EPA uses a 21-day dermal study as the endpoint, then no different factor is considered. The member suggested that EPA provide additional details on the assumptions used for these safety factors. The member also asked how this assumption compares to the chemical-specific data. Ms. Rossi commented that the chemical-specific values range.
One individual commented on slide #7 on the use and usage data. He asked if the results of the voluntary survey performed by the American Mosquito Control Association were included in the revised risk assessment, and, if that is the case, he wanted to know how EPA planned to integrate these results in the risk assessments of the public health chemicals, Fenthion, Naled, and Temephos, currently in phase 4 of the pilot process? Mr. Zager responded that he was not sure about this and that he would follow-up with the member on the answer to his questions. The individual also asked if EPA had developed a process to assess the benefits versus the risks issue as it relates to public health pesticide issues? Ms. Rossi responded that EPA has not worked out a process and they plan to work on this.
A member asked if EPA knows the specific causes of the incidences summarized on slide #26 for the PCC and California survey data? Mr. Housenger commented that that information is probably available for California, but not for the PCC data. They questioned the robustness of the conclusions on worker exposure generally and specifically for AZM? Mr. Housenger clarified that the MOEs are calculated based on cholinesterase inhibition, not on clinical signs. He stated that there would be a different endpoint and MOE developed based on clinical signs. Mr. Dawson added that when an MOE is near 1 it means that you are at the level at which no effects are observed.
Another member expressed concern that some of the suggestions, such as increasing the REI for protecting worker safety could result in the cancellation of valuable pesticides. He commented that additional time is necessary to develop the data that is needed to demonstrate worker safety and suggested that while some incidences may be under-reported others may be over-reported. He cautioned against considering classes of pesticides when addressing worker risk issues because not all pesticides merit a change in use. In this regard, he urged EPA to consider protective measures carefully because the potential for an exaggerated worker safety protocol could put the US agricultural market at a disadvantage. In contrast, one individual commented that agricultural workers have the highest fatality and injury rates of all occupational groups in the US, and pesticide surveillance is minimal due to lack of resources. He recommended that the Agency consider strategies with the other occupational enforcement agencies such as NIOSH and OSHA to see what their experience has been. He suggested that the Agency investigate to see if the guidelines are being followed and rely on enforcement actions before changing the guidelines. One potential tool for this purpose would be bio-monitoring supported by educational programs on worker safety.
Mr. Johnson clarified for the group key points of reference regarding worker risk assessment. He commented that the US has been performing worker risk assessments for a number of years and, with the development of the PHED, there was a quantum leap forward providing a foundation of data on which to base worker risk decisions. Since then, Mr. Johnson observed that EPA has made hundreds of risk decisions. In addition, as EPA has begun to address the OPs, they are seeing elevated risk numbers across the entire class of pesticides, which give them cause for concern. With this information as a basis he explained that EPA is asking for input from the stakeholder community on where to go from here. He noted that while EPA has the regulatory authority to address chemical by chemical and company by company, does it make sense to address OPs as a class? Are there some things that can be done across the class to help protect workers without putting a grower out of business? In addition, Mr. Johnson commented that, as EPA moves toward a regulatory approach, it triggers FIFRA, which is a risk/benefit statute. However, he observed that their experience is that it is possible to work with key players to make progress faster while dealing with a number of these issues. He noted that, addressing some of the issues as a class of pesticides is one way of leveling the playing field. Mr. Johnson called on TRAC members for ideas and suggestions on innovative approaches for dealing with worker risk issues, rather than the traditional chemical by chemical approach.
One member suggested that EPA consider developing a cost-share or incentive program for growers who are trying to implement risk mitigation measures to reduce worker exposure.
Several TRAC members commented on additional sources of information. A member stated that there is a lot of data available from the state lead agencies on enforcement issues and incidents. Other individuals indicated that some states bio-monitor agricultural workers for exposure to pesticides. It was clarified that California has required bio monitoring in the area of pesticide use for approximately 5 years, while other states may implement surveys to obtain similar data.
A member asked if it was possible to achieve zero exposure through the use of PPE? Mr. Dawson responded that very low levels, which are close to the levels of detection, are observed; however, the monitoring is limited by the detection limits of the chemical analysis.
Mark Keating, Henry A. Wallace Institute for Alternative Agriculture (HAWIAA) - observed that EPA has made a lot of progress over the past six months on FQPA implementation methodology. He stated that it is evident that the EPA and USDA are "talking the same language" regarding the single chemical risk assessment and are beginning to do so for risk mitigation policies behind FQPA. Mr. Keating felt that bringing USDA into the process represents a very important part of that success. To him it is clear that while the statutory responsibility lies with EPA USDA has established a very significant role in bringing the progress forward. He stated that HAWIAA is supportive of the FQPA, and it is necessary to view the next step in the process as transition. Mr. Keating also observed the importance of recognizing the agricultural crisis in the US while transitioning to the next stage of using reduced risk and new pesticides. They recognize that there are still some major hurdles including cumulative risk assessment and remaining issues with worker risk. The HAWIAA will continue to support the TRAC process.
Ed Gray, Jellinek, Schwartz & Connoly, Inc. - stated that it would be easy to generalize the chart in Staff Paper #38a to cover all OPs and the crops they are registered for and post it on the Internet. While the end product would include information that had been massaged, he felt that getting the information out as soon as possible would be helpful to registrants, growers and others, to help them be better prepared when it comes time for EPA to make decisions about chemicals in the future.
Jan Kunstman, BAYER - stated that BAYER was the primary Registrant for AZM. While Mr. Kunstman was not excited to see AZM presented for the Technical Briefing because of the increased scrutiny of the chemical, he was pleased to see that when more accurate data were used in the refined risk assessment, a more reasonable assessment of risk resulted. Mr. Kunstman expressed concern about proceeding with the risk management phase of work prematurely when additional data were still being submitted and alternatives are not well developed for the effected uses. He suggested that the Agency consider an incentive system to promote voluntary mitigation by Registrants.
WEDNESDAY, April 28, 1999
Dr. Ehrmann opened the second day of the TRAC meeting with a review of the agenda for the day. The agenda topics included an updated on the nine science policies, a presentation from Dr. Mark Whalon, Pesticide Research Center, Michigan State University, USDA transition issues, planning for the final TRAC meeting, and time for public comment. Dr. Ehrmann then introduced William Jordan, EPA, for the update on the nine science policies.
Brief Update on Nine Science Policies
Mr. Jordan referred the group to two background documents for the presentation, Staff Paper 37a, Data for Refining Anticipated Residue Estimates Used in Dietary Risk Assessments for Organophosphate Pesticides (the "bridging" paper,) and Staff Paper 37b, Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern. He noted that, while he did not intend to go through the papers in detail, the papers contain a lot of information about the status, content, and schedules of the science policies. All of the documents are presented in Docket # OPP00537.
Mr. Jordan explained the broad context of the TRAC science policies including where the EPA started from, what they have accomplished, and what remains to be done. He explained that seven months ago there was a sense of confusion about some aspects of what EPA was doing in the science policy arena and whether they were approaching the development of these policies in the appropriate manner. Mr. Jordan observed that there was also a sense that if EPA listened better they would understand more about how to address the science policies. He commented that those motivations led to the recommendations from the TRAC that EPA engage in a process involving public comment on nine broad science policy issues. EPA and USDA felt this suggestion had a lot of merit and agreed to proceed with the process. Since that time, Mr. Jordan observed that a lot of progress was made on the science policies beginning with the paper issued in October 1998 in which EPA laid out the nine science policy issue areas. Nineteen specific papers are now in the process of being made available for public comment. In addition, he noted that EPA identified other related efforts, such as reviews by the SAP that would help to inform and shape science policy decisions. Mr. Jordan stated that since October 1998, EPA issued 11 of the 19 papers for comment, of which one or more of the papers address 7 of the 9 science policy issues. He referred to Staff Paper 37b for a status of the review processed for each of the papers. Mr. Jordan stated that EPA is generally on schedule addressing the nine science policies. He stated that EPA feels that the policy papers have helped to clarify what EPA is doing on the nine science policies, focused the discussions on the policies, and served to get helpful information into the Agency which will help change the policies in ways that will make them clearer and scientifically defensible. Mr. Jordan recognized the parts of EPA that have worked on the science policy papers, including several divisions within OPP; Health Effects Division, Environmental Fate and Effects Division, Field and External Affairs Division, BEAD, as well as the Registration Division and the Special Review and Reregistration Division. Those organizations that have contributed from outside of OPP include USDA, FDA, EPA Office of Research and Development, EPA Office of Water, EPA Office of Children's Health Protection, OPPTS, and the Office of General Counsel.
Based on the success of the effort to develop the science policy papers, Mr. Jordan noted that other EPA staff have identified additional science policy papers on which they would like to receive public comments. He then provided the group with more detail on the status of specific science policy papers, including issue dates for the drafts for public comment and revision after public comment, as summarized in Staff Paper # 37b. He closed his comments by stating the process has been valuable for EPA and they have appreciated the public efforts to work through organizations to submit a series of comments in one collective submission. He stated that the comments that EPA has received have been high quality. Mr. Jordan then invited questions and comments from TRAC members. Their comments are summarized below.
One member asked for the status of the Series 875 Group B Post-Application Exposure Monitoring Test Guidelines. He also wanted to know about the revisions to 40CFR Part 158 that will lay out the requirements for registrants to follow? Mr. Jordan did not have information on the 875 Guidelines, but he commented that the Residential Standard Operating Procedures (SOPs) that are related to those Guidelines are scheduled for revision over the spring and summer 1999. Mr. Jordan noted that EPA received a number of comments on this and there is a lot of work to do. He commented that these two papers should be looked at together and asked Mr. Zager to provide additional comments. Mr. Zager stated that the Residential SOPs are going to the SAP in July 1999. He commented that he would have to get back to the individual who commented later with additional information on 875.
Another individual stated that bio-monitoring data could provide a very useful tool in determining whether there are individuals who are contacting pesticides through occupational pursuits and what the probable risk is. He added that bio-monitoring requires some human pharmacokinetic data. In this regard, he asked if there was any progress on the human testing policy since the WG2 meeting? Ms. Mulkey explained that the primary focus of the Science Advisory Board (SAB)/SAP meeting and EPA's policy regarding human testing has not been on this kind of testing, but rather on testing to establish toxic endpoints. She added that SAP/SAB met and had a significant dialogue in December 1998 and their report is expected in two weeks. Ms. Mulkey stated that EPA intends to move as expeditiously as possible regarding a policy on the ethical acceptability of human testing, particularly toxicity testing.
Presentation by Mark Whalon Regarding Transition Activities in Michigan
Dr. Whalon provided the group with an overview of an FQPA-Targeted Pesticide Residue Study performed by Michigan State University (MSU) and the Michigan Department of Agriculture for Region 5. He explained that there were four key points that he would emphasize throughout the study: 1) the accomplishments in Michigan relate to building partnerships at all levels; 2) the systems integration approach; 3) overall integration; and 4) service as a primary focus of a LGU in applied science and extension. Dr. Whalon then summarized Michigan's production systems and described the results of a study on a systems view of pesticide issues in Michigan. As a result of the study a series of short-term (<5 years) and long-term (>5 years) goals were established. The short-term goals included: understanding and monitoring the forces driving change; developing information for decisions (e.g., pesticides and commodities at risk, etc.); triage, or assigning resources where they are most appropriate; and developing a Plant Initiative Project called Generating Research and Extension to Meet Economic and Environmental Needs (GREEEN.) The Long-term goals involved are: proactive planning, or the Agricultural Systems Management Program; developing incentives for producers to adopt integrated pest management, sustainable agriculture and biologically intense management; and pioneering appropriate alternatives.
As described by Dr. Whalon, the Michigan Agricultural Systems Management Approach to managing pesticide use in the state integrates a number of stakeholders, including producers. It has three database features addressing pesticides at risk, pesticide alternatives, and commodities at risk. It also has two different delivery mechanisms, one involving the evaluation trials at the Agricultural Experiment Stations and the other involving on-farm trials. In addition, Dr. Whalon explained that the approach has a large value-added component that is focused on developing new products from Michigan Agricultural Systems. To address the problems that agriculture faces in society which cut across many different disciplines in the University system, Dr. Whalon described the formation of the MSU Center for Integrated Plant Systems (CIPS.) He noted that CIPS is unique because it is integrated around the concepts of agro-ecology and is based on the biophysical processes that take place in the soil and soil health. Dr. Whalon stated that CIPS is focused on best practices and could embrace different agricultural practices. He noted that CIPS recognizes two principle systems including the social system and policy integration and productivity. The following delivery mechanisms come from the agro-ecology focus of CIPS: IPM; plant stress management; phytosanitation; import/export and the legal ramifications of growing and marketing crops; and soil and fertility and management.
Dr. Whalon identified some of the key staff representing each discipline and described the inclusive structure of CIPS. He then described the pesticides at risk (PAR) database and how it works in preparation for FQPA impacts. He listed the goals and objectives of the PAR as: identifying risk and impact factors; establishing the logic to combine those factors; applying a pesticide-use ranking calculation; and verifying the database output through peer review. Through the PAR process, Dr. Whalon explained that pesticides are ranked and based on the ranking system a PAR committee awards grants through the Agricultural Experiment Station Extension Service to deal with selected agricultural problems. This information is then released to decision-makers that set policy that impacts the agricultural systems in the state. As an example of how the PAR works, Dr. Whalon presented the 1998 results of the PAR.
Dr. Whalon then described the impact of the implementation of FQPA in 1996. He noted that CIPS took a systems approach to understanding the pesticide loss factors associated with FQPA. In his description, Dr. Whalon referenced the Michigan Pest Management Team (MIP-MAT) which was formed following the implementation of FQPA and continues to meet to discuss FQPA-related issues. In addition, he noted that funding was allocated from a variety of agricultural organizations in Michigan to support the project called GREEEN. Among the issues encompassed by GREEEN were pesticide alternatives. Dr. Whalon explained that, to address pesticide alternatives, GREEEN set about developing a database on biologically-based technologies that fit into the agricultural system and integrated information on future industry needs (e.g., pipeline database) and biological and parabiocontrols. This information was then factored into the alternatives research and delivery (ARD) system. Dr. Whalon referenced the handout on Integrated Crop Management in Apple Production by the Clarksville Horticultural Research Station & MSU as an example of a production ARD systems view. He noted that it was necessary to have on-farm research and a mechanism of evaluation to assess the progress and effectiveness of these systems as they approached grower implementation.
To help in the evaluation process, Dr. Whalon explained that it was helpful to divide the natural control area into a biological control group and a parabiological control group (e.g., genetic engineered plants, host plant resistance, etc.) Then to evaluate the alternatives he described the application of a series of feasibility criteria (e.g., economic, biological, cultural, environmental, etc.) As examples of the evaluation systems, Dr. Whalon presented summaries of the ecological and operational evaluation systems for insect biopesticides. To show another perspective in the alternatives system, Dr. Whalon summarized a comparison of conventional controls versus mating disruption in peach farming based on the 1996 data to develop an indicator for potential savings from alternative controls. He stated that the results of the study showed that it was not economical to use biological controls on peaches in this circumstance. Using the results of both the Clarksville apple production and the study on peaches as a basis, Dr. Whalon summarized that applying a systems approach is informational intensive, complex, and costly, particularly to the public. He noted that the systems approach has shown that a diverse agricultural system alone is not a panacea and the correct diverse agricultural system is required. Dr. Whalon also provided an example of how a lack of understanding of the diversity of systems in a "systems view of an agricultural production system" can result in crop loss. In addition, he observed that in the evolution from conventional to biological methodologies, the complexity index of pesticide alternatives is increasing over time.
Dr. Whalon described the MSU IPM/ICM program. Dr. Whalon noted that the integrator positions are supported through the combined resources of GREEEN funds and the commodity supplier requesting the integrator position. He explained how the integrator is trained and administered and commented that they are key to integrating the complexity of the system into the field. Dr. Whalon explained that there is a continuum of change in IPM/ICM, which integrates a closed system, economic returns, environmental sensitivity, ecological diversity, biologic intensity, usability, and best practices. In addition, he observed that the IPM/ICM program has done a good job integrating non-governmental organizations (NGOs) and has increased the number of partnerships. Dr. Whalon also commented that education is key to the success of the IPM/ICM program.
Next, Dr. Whalon provided the group with an overview of Michigan's approach to use and usage data and EPA/FQPA requests for data. He noted that the intent in Michigan was to set up a system to collect and aggregate data and put the data into public information databases that were available on the Web. Dr. Whalon explained that the goals were to assure the data reflected accurately pesticide use in Michigan, assess and address the data gaps, and prioritize the data collection efforts. He described the system for their data collection efforts, which borrows heavily from sources including the federal government, states and Universities, professional associations, and private consultants. The system he described focuses on their Area of Expertise Teams in Extension that, with the help of MIP-MAT, would be responsible for collecting data from their area of expertise. As an example of some of their data collection efforts, Dr. Whalon described their cooperative effort with NASS to complete a vegetable-chemical survey data on application rates, preharvest intervals, and target pests.
Dr. Whalon also discussed crop profiles in Michigan. He noted that two crop profiles were completed, eight were near completion and many additional profiles were underway. He hoped that work on all of the crop profiles would be complete by the end of this fiscal year.
The last topic addressed by Dr. Whalon was bridging data and residue mitigation efforts for various crops. As an example, he reported on Michigan's progress on OP mitigation in the Northeast apple producing area. He noted that currently there are no pesticide alternatives for two apple pests, the plum curculio and the apple maggot. Using half the prescribed dose of application in the field and in processing, Dr. Whalon explained that they have succeeded in reducing the residue. He noted that their bridging data cooperative project involving EPA Region 5, Michigan Farm Bureau, Michigan Department of Agriculture, commodity representatives, and other stakeholders began with the goal of obtaining real-world bridging data using data collection methodology - the comprehensive residue management program - that would be useful to other states. Dr. Whalon noted that they had developed Standard Operating Procedures (SOPs) for the methodology including handling the chain of custody in a manner that preserves the privacy of the data origin. To show how the sampling system to develop bridging data would work, he used an example of grape production in Michigan.
Dr. Whalon closed his presentation by posing a series of critical outstanding issues and questions related to the implementation of FQPA:
Worker risk issues.
What are the endocrine disruptor effects?
What are the consequences of interactions between OPs?
What are the true use and usage patterns in agriculture, non-agricultural, residential, etc.?
What are the real alternatives out there?
Following Dr. Whalon's presentation, Dr. Ehrmann asked for comments and questions from TRAC members. A summary of their comments is presented below:
As stated in the presentation, it was critical to implement an integrated approach involving field application and the grower's education and thoughtfulness about what they are doing along with expert disciplines from across the state. Is this approach similar to that used by USDA over the last year and are other states using similar approaches? Dr. Whalon commented that many of the other states have similar IPM programs, many of which are more robust. He commented that Michigan is unique in their overall systems management approach, particularly in view of enhanced partnerships and service. He observed that FQPA succeeded in focusing the agricultural community, and Michigan's efforts were able to take advantage of this consequence of FQPA. He commented that FQPA presented a great opportunity to get a lot of things done.
How were concerns about worker protection addressed in the context of Michigan's efforts? Dr. Whalon acknowledged that he did not cover worker protection in his comments because it was not the focus of his presentation. He commented that Michigan has done a lot of work on worker protection because agricultural labor is unionized. Dr. Whalon added that they have performed a lot of cholinesterase testing in the past for all of their pest management field assistants.
How is Michigan handling crop loss damage liability when using less than label rates of application and who is assuming the liability if and when there is crop loss? Mr. Whalon explained that MSU's legal staff has addressed this issue often. While MSU does not openly recommend using reduced application rates, he noted that growers are experimenting with reduced rates of application all the time and they share this information. Thus, MSU has avoided this concern.
How does Michigan deal with the regulatory component of identifying PAR, and how do they deal with the evolving landscape of risk assessment methods and science policies? Dr. Whalon commented that, once the database is established and categorized, it is a straightforward process to change weighting factors and data analysis. He noted that the key was to properly format the data so that it can be easily manipulated.
Are the slides used in the presentation available on the Web? Dr. Whalon stated that all of the slides are on the Web at "http://www.cips.msu.edu" and they are in Power Point format.
If starting at some baseline value another state wanted to implement a similar program, what resources are involved? Dr. Whalon responded that the PAR program was initially funded by the Agricultural Experiment Program at $25,000 per year. At this point, he added, the program costs $35,000 per year. Dr. Whalon stated that the Grants program was 1.8 million dollars last year, and the commodity buy-in to this program through the University system was 3.2 million dollars. Other organizations contributed with technical assistance. He commented that information on the pesticide database was difficult to determine because a lot of the data was available, but there were costs to set the program up. A figure for the infrastructure to set the program up would be one half to three quarters of a million dollars per state.
One member wanted to underscore Dr. Whalon's comment that the FQPA represents an opportunity for progress. She suggested using the Michigan experience to communicate to consumers about how successful the Michigan process has been in getting stakeholders to the table that have not talked together before. In addition, she stressed the necessity of clarifying messages, particularly that it is understood that pesticides are risky, but there are methods to minimize the risk. She also noted that consumers need to know that stakeholders are communicating and that the communication will continue, that questions are being asked about the risk of pesticides, and that some programs are being explored to address concerns about pesticides.
Transition Issues with USDA
Mr. Jennings provided the group with an overview of the elements of a transition strategy. A copy of the slides used for his presentation are in Docket # OPP00537. Mr. Jennings began his presentation by recognizing that change in pest management and crop production is difficult and expensive. However, he noted that a lot of work contributing to transition is underway in Michigan and many of the LGUs. Mr. Jennings commented that some of the issues USDA is dealing with are focused on how to package, promote, and prioritize the work that is already underway. In addition, he asked how should they feed the work into EPA's risk management process to contribute to sound regulatory decisions and a road map for the future? In this regard, he asked TRAC members to view USDA's work on transition as "a work in progress." He noted that in some ways the work has never been done before, while in other ways it consists of a lot of familiar steps because USDA is characterizing what agriculture has done in the past in response to regulatory actions that limit or restrict the use of a pest management tool. Mr. Jennings stated that what is new in the process is the up-front thinking and planning for groups of chemicals rather than responding to cases of individual pesticide uses.
To orient the group, Mr. Jennings presented an outline of a national transition strategy. As a starting point he noted that it would be necessary to establish priorities and figure out which crops should be addressed first. He stated the USDA currently plans to identify three or four high priority prototypes to test the system. To make this selection, he observed that it was critical to consider high consumption by infants and children, frequency of residue detection, and the ability to work with a well-organized grower group or an interested processor. Secondarily, Mr. Jennings stated that the approach to chemicals should be considered. While he noted that agriculture has previously addressed chemicals one at a time, EPA risk assessments have indicated a need to change this approach and it has been suggested that chemicals be addressed by class, or possibly multiple classes of chemicals. As an example, it may be appropriate to address OPs as a class or in combination with carbamates.
Mr. Jennings felt that another key element of a transition strategy would be a clear statement of the goals and a means to measure progress. In this regard, he commented that it would be important to consider the frequency and magnitude of residue detection. While Mr. Jennings observed that PDP data are a good source, they are expensive and typically focus on selected food groups for prescribed periods. He recognized the need to monitor and collect data from a broader group of foods over an extended period of time. A possible alternative to the PDP would be the NASS use surveys because it is cheaper and is not solely focused on OPs. Mr. Jennings added that USDA is currently considering expanding the NASS program similar to what is taking place in Michigan.
Expanding on Mr. Whalon's presentation, Mr. Jennings discussed some additional considerations for a transition strategy. He commented on the importance of understanding current chemical uses such as what pests are driving the use of chemicals, what tactics are available to reduce or eliminate chemical use, and how might they impact IPM or resistance management. Mr. Jennings also recognized the availability of alternative pest management tools as a key consideration. In considering alternative pest management tools, it is critical to note if the tools are registered, how they fit into IPM and resistance management, and whether there are barriers to adopting the alternatives. He noted that there are technical barriers to adopting some alternatives, as well as economic and social barriers. In this context, Mr. Jennings also commented on future options. He stated that USDA hope to have the pipeline database on the Web within a few weeks. Mr. Jennings noted that the pipeline database draws heavily on the MSU and IR-4 systems, in addition to the information on products that are in the queue at EPA.
In order to achieve some of the goals of a transition strategy, Mr. Jennings recognized the need for research to identify new tools. He felt it was also important to explore basic and applied research needs, in addition to determining the kind and level of grower education and training that is required to use the new technologies. Mr. Jennings also observed the potential benefit of incentive programs that USDA could offer to use new pest management systems and technologies.
Mr. Jennings then commented that for a successful transition strategy USDA, EPA, LGUs, growers, and public interest groups will have a lot to do. He summarized some of the specific tasks for each of these groups. The USDA will need to complete the crop profiles and databases, provide support for the LGUs, fund ARS and CSREES help them establish research priorities, and continue to focus the IR-4 program towards newer chemistry. Mr. Jennings commented that EPA would need to get the new technology on-line and foster incentive programs like the Environmental Stewardship Program. He also recognized grower organizations as key to the transition process because they have the technical expertise, the personnel to support the process and, because of their connection with their member growers, are key to education and training programs. Mr. Jennings stated that public interest groups and professional societies also have important roles in the process.
As USDA considers where a transition strategy should begin, Mr. Jennings noted that it would be helpful to evaluate lists of commodities that are consumed in high quantities by children and infants. He stressed that the list presented in his materials was not a hit list, but rather a potential place to begin considering which commodities might be prioritized in the transition process. Mr. Jennings observed that when focusing on a commodity it might be necessary to modify the strategy based on the characteristics of the different commodity markets. He explained that USDA currently plans to select three or four crops for which to begin developing transition strategies and to present the draft strategies in the next few months. Mr. Jennings reminded TRAC members that USDA plans to work with growers in this process.
After Mr. Jennings' presentation, Dr. Ehrmann asked TRAC members for questions and comments. A summary of their comments is presented below:
An important part of the definition for a pest control alternative is the word economical. It was suggested that this word be added as a general descriptor when referencing alternatives.
Add a question on unintended consequences resulting from the selection of pest control alternatives.
Under the USDA action items, move grower outreach to the top of the list because it will take a long time to accomplish and plan on explaining why this is happening.
All of the crops on the draft commodity list have multiple production regions, not just apples. Delete this qualification on the draft list for apples.
Does the database referenced under the transition strategy include active ingredients for which there is no tolerance? Mr. Jennings responded that the intent is to list ingredients that could or look like they should work that are not yet registered with the idea that part of EPA's action list would be to give that ingredient a higher priority. This would include both a new tolerance and an active ingredient that did not have a tolerance. This information will be available on the Web in two weeks. Mr. Pitts added that individuals in the IR-4 program are working with companies to identify products that are not yet in the registration process. What kind of feedback has USDA received on the quality of the crop profiles and what kind of quality assurance is in place for updating the profiles? Mr. Jennings stated that while there is variation in the quality of the profiles from crop to crop and state to state, the feed-back has generally been good and people feel that the information is useful. He explained that the LGUs are responsible for quality control and assurance and they use a peer review process.
Add registrants to the list of organizations with action items in the transition process because they have technical expertise to add to the process.
Add state lead agencies to the list of organizations with action items, particularly in regard to using 24c and Section 18.
Develop this preliminary list of transition strategy considerations into a strategy showing USDA's thinking on how it will address and prioritize these considerations to begin the next level of discussion. Mr. Pitts added that USDA would be working on some commodities over the next several months and gain experience as they work through that process.
The National Cotton Council offered to USDA their assistance with grower education programs.
Is the draft list of potential commodities of concern based only on children's consumption or on overall residues? Mr. Jennings clarified that the list was based only on children's consumption.
One member felt that imported food should be addressed in the transition strategy, particularly if the strategy will cause an increase in the consumption of imported food. Mr. Jennings stated that imports would be required to meet the same standards as domestic foods, with the exception of worker protection issues. Mr. Aidala agreed and stated that the biggest underlying issue is non-detection and meeting the safety standard. He commented that a secondary issue is worker risk and whether we are shifting the risk to workers to outside of the US. Another issue recognized by Mr. Aidala was whether FDA has the ability to monitor and enforce food quality standards for imported foods. Mr. Pitts reiterated that while the TRAC has not discussed imported foods extensively that is one of the reasons there has been a focus on the science policy papers on non-detection and early assessments. He added that through the individual risk assessments USDA and EPA are trying to assess now which commodities do or do not have risk issues. Also, Mr. Pitts commented that it is recognized that even with a good non-detection policy and early assessment policy in place, it is not possible to control all of what happens outside of the US from a worker perspective. He noted that Administration has proposed legislation that will enable FDA the authority to go overseas and sanction or halt uses that are inconsistent with US laws. Regardless of this type of effort, one participant questioned the ability of the US to control food production in other countries. Michael Kashtolk, FDA, commented that FDA has a major initiative to reduce microbial contamination in produce, particularly from international sources. He stated that FDA involved the international community in developing the guidance to address this issue and continued outreach to the international agricultural community regarding pathogens is a major part of what they are doing as part of good agricultural practices. Mr. Kashtolk stated that FDA is continuing to work with foreign agricultural interests and they visit farms abroad to address potential issues at the source. He stated that FDA is building a lot of bridges in foreign agriculture, which might be applied to changes in the US pesticide tolerance regulations. Mr. Kashtolk commented that, the more the US can succeed in communicating its requirements to the source of the produce abroad, the less it will have to rely on border control.
Another member wanted clarification on how the crop profiles are integrated into the EPA risk assessment process? Mr. Jennings deferred to EPA for a detailed answer on how they use this information. However, he commented that while some of the use/usage information might be used in the risk assessment context, crop profile information is more useful in the risk management and transition strategy process. Ms. Mulkey agreed with his comments and added that because a lot of the crop profile information is focused on state rather than national level information, EPA tends to use it in the risk management phase and on understanding use patterns in more detail. She also referenced the data matrix effort on which EPA and USDA collaborate. She noted that information from the matrices is used to give a more national snapshot of the data. In addition, Ms. Mulkey noted that the crop profiles provide a crosscheck on the matrices information.
A TRAC member observed that this list of concerns is the same as the list the TRAC saw a year ago. He asked for clarification on what about the transition strategy had changed since then and asked where USDA saw its greatest focus being. They also wanted to know when the commodities of focus in the transition process would be identified? Mr. Jennings reiterated that USDA plans to start developing transition strategies for three or four commodities by the end of the summer. He explained that over the last year, USDA has gained a greater focus on what is driving the risk assessments and had developed an understanding about what was necessary to begin the transition process. Mr. Pitts also provided some clarification on a process issue. He note that USDA has the responsibility to work with EPA to make sure that the individual chemicals fall within their individual risk cups as part of an iterative process in pilot process phases 1 through 6 as the risk assessments are finalized. Whereas, with regard to the work referenced by Mr. Jennings on the three to four commodities, USDA will work through assessments on the preliminary list of commodities to develop a strategy that covers EPA regulatory needs in addition to having a strategy that will not leave the growers flat-footed without alternative pest management tools. He emphasized that those who approach USDA and EPA early on will get the Agency's and the Department's full attention.
One member observed that agriculture is a biological system and will always be in transition. He noted that the impact of FQPA, while small in the larger context, is very important. He assumed that both EPA and USDA are thinking about transition in the context of not if, but when, changes will occur; what they will be; and what the magnitude of those changes will be in terms of the use of the chemicals that will be affected. He noted also that new products and new uses are critically important in the transition equation.
Another member asked if input from the LGUs, including data and interpretation would be placed in the Docket? Mr. Jennings did not know the answer to this question. Ms. Rossi commented that EPA is responding to these issues so this information could be included in the Docket. Ms. Mulkey added that EPA has thus far treated this information as part of an intergovernmental process and not a public process. She felt it would be useful to know how other stakeholders viewed this information. She stated that the advantage of keeping the status as intergovernmental is that there is a free flow of information between agencies and there are advantages to openness. Ms. Mulkey stated that EPA is open to comments on this question, but their current plan is to maintain the intergovernmental status. The member suggested that this issue be discussed at the next TRAC meeting.
Following these comments. Mr. Rominger shared some of his thoughts. He began by commenting that the discussion was very helpful to USDA. Mr. Rominger agreed with some of the statements earlier in the discussion and pointed out that he viewed USDA's role in transition and mitigation as important and that they would be playing a greater role in the process to come. However, he stressed that they will need help and that partnerships with organizations like Del Monte and grower groups will be necessary. He stated that USDA appreciated the help that had been offered, particularly from the grower groups in the educational process. Mr. Rominger commented that he hoped Larry Elworth would speak about some of the work that he has been doing with growers, as he viewed this as the kind of work that will be necessary in the future to help make sure that there is a reasonable, sensible, and economic transition strategy. Mr. Rominger commented that USDA has also been working on the import issue. He noted that it is an area where USDA has had experience with meat and poultry inspection. Mr. Rominger explained that because countries import these products to the US, USDA inspects their slaughtering and processing plants to make sure that their systems are comparable to that in the US. He referred to FDA's plans to increase the amount they are able to monitor agricultural practices in other countries and stated that USDA is and will continue to build on that experience by going to other countries to look at their production, processing and packaging systems. Mr. Rominger reiterated that USDA would continue to focus on imports because their job is to protect the consumers and the agriculture of this country. He stated that they would need help from all TRAC members to make the transition process work to the benefit of all.
Mr. Elworth responded to some of Mr. Rominger's comments. He stated that if the intent is to make it possible for growers to use different practices to keep them in business, then you have to start with growers in this process. Mr. Elworth observed that the federal government has the role of providing resources, adding expertise, and helping to coordinate. Growers, however, have the primary responsibility including pest management, determining economic viability, marketability, and stability. If the focus is implementation, it is necessary to work not only with the growers and their organizations for leadership, but also provide clear objectives. He noted that the tools that will be used in the future will be more complicated and they might not be as effective in the same ways and the transition to these tools will be expensive. Mr. Elworth added that to achieve results in the field for farmers is not an easy process. This process will require a lot of work and will involve managing the resources and programs skillfully. He expressed the hope that the transition process to be developed commits to the understanding and involvement of growers up front, commits to a process to bring them in to make the decisions about how transition will take place, and provides the resources for the technical and organizational investment it will take to make it possible for them to use the new tools and document their use for reference in the future. Mr. Elworth commented that the private sector is in a better position than the public sector to help achieve this.
A member added that the University of Florida has a Doctorate for Plant Medicine program and that is another tremendous resource base for this process. She noted that independent practitioners working in the field one on one is an effective way to assist with transition. Mr. Pitts commented that while USDA is currently focused on how to address individual chemicals and cumulative risk assessment, they are also working on the concept of regional centers. He stated that regional centers and regionalizing the research agenda is something that USDA hopes to progress with in the near future. In addition, he commented USDA plans to involve EPA, industry, and crop consultants in the work and priority setting of what they envision to be 12 crop production regions. Mr. Pitts noted that there is some support of this concept on the Hill and that USDA and EPA are talking about jointly seeking funds for this concept in upcoming budgets. He stated that in preparation for the last TRAC meeting, USDA hopes to provide some transition strategies and some additional discussion on the concept of regional centers and approaches to help fund the concept.
Dr. Ehrmann closed the discussion on transition with a few observations. He noted that there is a tension between the need for a transition process that engages all stakeholder communities, while at the same time trying not to pre-guess the results of the risk assessment process which is still underway. Dr. Ehrmann recognized that this combined with some of the other issues that the agricultural community is facing, such as economic viability, presents a tough challenge for all parties. He stated that the Department is inviting people to help them solve this puzzle.
Planning for the Final TRAC Meeting
Using the discussion on the transition process as a starting point, Dr. Ehrmann invited TRAC participants to begin to think about ideas for the timing for the final TRAC meeting, agenda items, and other issues relevant to how the TRAC should operate in the future. He asked Jay Vroom to begin the discussion to set the context for the discussion.
Mr. Vroom referred to a memorandum regarding TRAC forward, TRAC looking back, for his comments (presented in Docket # OPP00537.) He noted that there were three points in the memorandum. The first point recognized by Mr. Vroom was the 4/27/99 TRAC resignations. He stated that he appreciated the way the Department and the Agency handled the resignations and thanked them for preserving the process. He recommended that those who resigned be welcomed back, should they express interest in renewing their involvement. Mr. Vroom asked for some clarification on one of the remarks made by Mr. Robertson in his opening remarks for the TRAC meeting on 4/27/99 which was also captured in the third sentence of the third paragraph of the letter Mr. Robertson sent to representatives of the environmental community. The second point presented by Mr. Vroom regarded the FQPA safety factors. He observed that while there was a lot of progress with the safety factors, there is a real chance that products that are going to come through the pilot process in the future will be advantaged because the process is improving. For this reason, he felt it was important to make sure that the playing field gets leveled, especially across a class of chemicals like the OPs, before final steps are taken. His final point and suggestion was that EPA consider convening the Pesticide Program Dialogue Committee (PPDC) sometime before the next TRAC meeting to focus on worker protection and safety issues and allow the TRAC more advance time to prepare some case studies of what is going on in this arena. While there is a lot of room for improvement, Mr. Vroom observed that there are investments in this area and there are viable databases on worker exposure and health effects that already exist. In addition, Mr. Vroom noted that working through the PPDC on this issue might offer an additional opportunity to involve representatives from the environmental community who are members of the PPDC.
In response to Mr. Vroom's request for clarification of his opening remarks, Mr. Robertson commented that his remarks were consistent with remarks made at the first TRAC meeting at which EPA and USDA indicated that there was cause for concern about the class of OPs. Also at that meeting, Mr. Robertson remarked that Mr. Hansen stressed that there was no intention of canceling the entire class of OPs and that is certainly not what EPA's recent letter was intended to suggest. On the other hand, he pointed out that he believes that evidence to date still supports the notion that action will need to be taken regarding some of the OPs, as was stated at the first TRAC meeting. He commented that, while it would be possible to continue to address chemicals one by one, it makes more sense to him to work on them in a more comprehensive approach. He stated that Mr. Vroom's suggestion about focusing the efforts of the PPDC on worker risk is a good idea, and he felt that worker safety issues represent an area where EPA could improve their efforts at transparency. Mr. Robertson added that he believes discussion from the first day of the TRAC meeting confirmed that thought.
One TRAC member commented that regarding worker risk issues, there are different perspectives. In his experience, worker training has greatly helped to prevent exposure incidents. He stressed that current agricultural tools can be handled safely. Another TRAC member stated that because there is no national public surveillance system that has credibility, access to privately maintained databases would be beneficial to those individuals active in public health. He invited people to assist him in accessing information from these sources. A third member supported Mr. Vroom's suggestion to deal with worker issues within the PPDC. He observed that he and others felt that one outcome of this process is a more clearly articulated risk assessment process from the Agency. He hope that something similar could be done on worker risk through PPDC, which he felt, was a more appropriate forum. In addition, he expressed interest in hearing from the Agency and the Department on what they would like to accomplish at the final TRAC meeting. Another individual acknowledged that there will be a transition in American agriculture and that some changes have already been made. She observed that the current method of assessing worker risk does not encourage the creativity and diversity of practices that are being promoted when transition is discussed. She questioned whether it was appropriate to be considering a "command and control" approach to worker risk. As an alternative, she suggested that it might be time to set national performance standards with established acceptable exposure levels and leave it up to the region or the state to develop and manage the practices for the crops grown in their region.
To help TRAC members begin to think about the potential timing for the final TRAC meeting, Dr. Ehrmann commented that current plans would call for the final meeting to be held in September 1999.
A member urged the Agency to continue discussions with members of the environmental community and stressed the need to encourage them to rejoin the TRAC process. He felt their departure lessened the credibility of the TRAC process. In addition, he suggested that it would be helpful to have a science panel review some of the revised risk assessments as a control measure and to provide an external perspective on aspects of the assessment like the use of appropriate safety factors. Thirdly, he suggested that for future presentations when the decision process is reviewed, it is important to maintain one of the primary focuses of the FQPA and explain how children's health has been addressed and demonstrates the rationale for removing the children's safety factor.
Several TRAC members felt it was too soon to end the TRAC process. One individual felt that it was premature to complete the TRAC process because transition in agriculture is just beginning to be addressed and cumulative risk is yet to come. He felt that the TRAC process would not be complete without addressing cumulative risk. In a similar vein, another member stated that the prime topic at the final TRAC meeting should be cumulative risk, including progress, process used, and the tools that will be relied on to sort out what products will remain on the market and how that ties into transition. In addition, he observed that regulating pesticides by class represents a new approach and the potential leverage for or against individual pesticides could be great. Given the complexity of cumulative risk assessment, he felt that EPA and USDA would strongly benefit from the help of an advisory panel like TRAC. For this reason, they felt completing the TRAC process in September was premature.
A member of the TRAC suggested that EPA and USDA revisit the list of agenda ideas generated at the WG2 meeting as they developed the agenda for the final TRAC meeting. He agreed that cumulative risk should be on the agenda, in addition to data needs and a review of data collection activities (e.g., industry task groups, grower user groups, and ORD), the risk benefit issue, and the non-dietary residential risk process. Another member suggested that a representative from DHHS make a presentation on public health issues at the final TRAC meeting.
One individual commented that, if AZM is of concern in drinking water, it should be added to the list of compounds for which states are required to test.
Vern Highley, National Watermelon Association - expressed concern that the TRAC was nearing closure and asked what replacement forum would be used to address on-going and future TRAC issues? He encouraged EPA and USDA to extend TRAC indefinitely because it has been recognized as a successful process. In addition, the individual was discouraged that the environmental community withdrew from the process and encouraged EPA to work on trying to bring them back into the process. Without TRAC he observed that he would not have known about the progress in Michigan, which he felt represented the way of the future in agriculture. In addition, he referenced the legislative enhancement to FQPA addressing the need for more scientific data that would be introduced by Congressman Richard Pombo on 4/28/99. He said that TRAC is one of the Clinton Administration's most important committees and encouraged the TRAC to continue.
Following these remarks, Dr. Ehrmann invited Mr. Robertson to initiate the closing remarks for the meeting.
Mr. Robertson began by thanking all of the TRAC members. He commented that he was impressed with the discussions at the meeting and that this observation increased his disappointment at the recent resignations because the process suffered from their absence. He expressed the hope that these individuals would return to participate in the final TRAC meeting. To address some of the concern about the final TRAC meeting, Mr. Robertson felt there should be only one more TRAC meeting. He recalled that when the issue came up at the last TRAC meeting about whether there should be additional meetings, the Co-Chairs agreed that two additional meetings were appropriate. In addition, Mr. Robertson noted that Mr. Hansen stated that the last two TRAC meetings would involve less rigorous preparation (i.e., work group meetings) by EPA staff because the meetings have been consuming a lot of their time. While to date, this level of involvement has not detracted from their other duties, Mr. Robertson commented that EPA cannot continue to do both. He observed that, though the TRAC process will conclude after the last TRAC meeting, EPA and USDA will remain committed to the four key principles of a consultative process, sound science, transparency, and a reasonable transition for agriculture, as they implement FQPA. He commented that they would find processes like the PPDC to continue to work on some of the outstanding issues. Mr. Robertson stated that he would remain fully committed to continuing to participate actively and vigorously in helping guide FQPA implementation within EPA.
Regarding the subjects for discussion at the last TRAC meeting, Mr. Robertson agreed that the issue of cumulative risk would be very important to address. In this regard, he observed that USDA and EPA might also be discussing the progress on the "mini-cumulative analyses" they plan to perform on several OPs. He noted that USDA would have developments on transition to discuss. In addition, Mr. Robertson observed that EPA would be looking to institutionalize the pilot process for OPs and other classes of chemicals and they will be looking forward to additional input on that from the TRAC. Worker risk issues would continue to be of great concern to EPA and USDA and Mr. Robertson reiterated his intent to provide additional transparency in this area. He commented that EPA plans to continue to work with all of the stakeholders in addressing all of these issues, whether using the chemical by chemical approach or other approaches that would allow EPA to address chemicals by class. He closed his comments by thanking TRAC members, USDA and his colleagues at EPA who have worked hard to help support him and the TRAC. He especially thanked Mr. Rominger for his friendship and guidance in the process. He stated that he looked forward to continuing to work with everyone through the final TRAC meeting. He also looked forward to the continuing processes that will help insure that EPA does its job protecting public health and the environment and assuring a safe and stable food supply for the country in the most common sense and cost effective way.
Mr. Rominger commented that it had been a good meeting and that USDA continued to learn from the process as a result of the TRAC input. He commented on some of the observations that agriculture is in transition and that the "train has already left the station." Mr. Rominger agreed with this observation and added that based on his experience as a farmer, since chemicals were introduced to agriculture it seems as though there has been a continuous transition. He commented that FQPA has certainly put a lot more focus on transition and the resources necessary to help the transition process. He stated that USDA would provide a status report on their progress on transition at the next TRAC meeting. Mr. Rominger observed that the September meeting would be the last TRAC meeting, but it will not be the end of consultation and involvement for TRAC members. He stated that EPA and USDA will continue to need the input of the stakeholders one way or the other and that the PPDC might be one way to achieve that. Mr. Rominger supported the idea of convening a meeting of the PPDC prior to the next TRAC meeting and agreed that it would be important to include the perspective of TRAC members and others at that meeting. He added that if the PPDC continues to meet and address some of the outstanding TRAC issues, the group might need to be augmented to make sure that all interests are well represented. Whatever forum is selected, Mr. Rominger reiterated that they would need the continued consultation with the stakeholders as they progress with FQPA implementation. To him this discussion points out that while no wide spread cancellations of classes of chemicals are expected changes are inevitable for some specific chemicals and crops. He recognized that transition would require a lot of work and he looked forward to the continued participation of stakeholders at the next TRAC meeting and in some form in the future.
Dr. Ehrmann thanked TRAC members for their participation and adjourned the meeting.
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