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 Although the information provided here was accurate and current when first created, it is now outdated.

THURSDAY, April 8, 1999

Welcoming Remarks

John Ehrmann, Meridian Institute, welcomed participants to the Work Group II meeting of the U.S. Department of Agriculture (USDA) - U.S. Environmental Protection Agency (EPA) Tolerance Reassessment Advisory Committee (TRAC.) Dr. Ehrmann then initiated a round of introductions. A list of the TRAC Work Group II members and/or their attending alternates is presented in Docket # OPP00537. Following the introductions, Dr. Ehrmann turned to Jim Aidala, Associate Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances (OPPTS)/EPA, and Keith Pitts, Special Assistant to the Deputy Secretary, USDA, for opening remarks.

Mr. Aidala thanked Work Group II members and others for attending the meeting and stated that their extra effort was appreciated. He observed that the group had a lot to cover in the next two days, including various updates, risk assessment issues, and discussion of transition strategies. Mr. Aidala apologized that the meeting materials were not distributed earlier and explained that EPA and USDA were working hard to make sure the materials were ready for the meeting. He commented that the group would observe progress on probabilistic risk assessment in addition to seeing current work Aas it happens.@ Mr. Aidala stated that the desire of EPA and USDA was not to postpone this meeting but to hold it as scheduled and keep the process going.

Keith Pitts added that USDA had made a lot of progress on their working relationship with EPA through the TRAC process. He stated that the presentations for the day would show some of the progress in risk refinement and identify some of the areas where additional work is necessary. Mr. Pitts recognized the progress that had been made on risk assessments for the first nine organophosphates, including azinphos-methyl (AZM.) He also noted that USDA made some decisions that may help the group focus on transition issues. Mr. Pitts stated that he looked forward to hearing comments from the group.

After the introductory remarks, Dr. Ehrmann reviewed the agenda for the day as follows: Organophosphate pilot process;
Updated dietary risk assessment for AZM;
"Dry-run" technical briefing for bensulide; Gerber Agricultural Program presentation; and
Public comment.

Dr. Ehrmann then introduced Lois Rossi Director, Special Review and Registration Division, Office of Pesticide Programs (OPP)/EPA, 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 a status of: the organophosphates in the process; the EPA and USDA intergovernmental review process to develop revised risk assessments; and public meetings (to be called technical briefings) that are being planned. For the presentation, Ms. Rossi reviewed the handouts titled, Organophosphate Pilot Process Discussion, Phases 4 and 5 of the OP Pilot Public Participation Process, and The Status of OPs in the Pilot Public Participation Process. Among the highlights of her discussion, she noted that EPA has developed a methodology to use composite Pesticide Data Program (PDP) data to estimate single servings in probabilistic risk assessments. In addition, she stated that EPA is using the best available data to get the most realistic exposure estimates and they are determining the risk contributors (or "drivers") of the assessments and looking at the underlying assumptions. Ms. Rossi also explained that EPA is developing a standard format for an overview and a brief cover sheet for each risk assessment to provide the public with a clear description of the data and assumptions used in the risk assessment. She noted that EPA is also working on the process and timing for intergovernmental reviews involving the USDA and the Department of Health and Human Services (DHHS.) They intend to work with USDA to determine the amount of time necessary for the review of each risk assessment based on the complexity of the review. EPA also plans to sit down with USDA at the start of the USDA review process to provide them with a summary of what EPA knows about the pesticide. Ms. Rossi explained that the technical briefing is intended to provide the public with an explanation of the assumptions behind the risk assessment. She explained that Phase 5 of the overall process, the Public Participation Period, will begin soon after the technical briefing. Ms. Rossi closed her presentation by commenting that she looked forward to the discussion on this information. For other details about her presentation, please refer to the reference documents are available in Docket # OPP00537.

Allen Jennings, Office of Pest Management, USDA, began with the observation that this is a new and evolving process in which everyone is learning as they go. He commented that, in the process of reviewing the first four of nine organophosphates, USDA identified some opportunities for improvement in the review process. Mr. Jennings stated that, while their initial reviews were slower than expected because of the learning curve, USDA agreed that the timeline for review might need to be extended due to the complexity of some of the pesticides. He explained that the timeline is dependent on the elements of review outlined in the document titled, Reassessment Pilot: USDA Role and Timeline (see Docket # OPP00537 for details.) He agreed that the USDA review process would be better focused if initiated by EPA's initial technical briefing on the chemical. In addition, based on USDA's experience with the first four organophosphates, Mr. Jennings commented that they intended to provide EPA with comments as they become available instead of at the end of their review. Mr. Jennings also observed that, when considering the element of review provided by the Land Grant Team, it was important to remember that the role of the Team extends beyond the review process to their involvement with risk mitigation.

Following the opening remarks, Dr. Ehrmann asked Work Group II members for their reactions to the presentation, particularly on whether they felt the pilot process was working and whether they had any comments regarding the evolution from risk assessment to risk mitigation process.

One member requested that EPA clarify how the timeframe for review would change based on the complexity of the chemical. Ms. Rossi commented that the timeframe for the preliminary risk assessment would remain the same and may even improve as EPA gets used to conducting and presenting the preliminary risk assessments. She explained that the 90-day timeframe for risk refinement might or might not be sufficient depending upon the number of Monte-Carlo modeling runs required to identify the risk drivers.

Another individual asked when the results on residential and drinking water risk would be available. Ms. Rossi responded that the revised risk assessments include that information. Stephen Johnson, Acting Deputy Assistant Administrator, OPPTS, EPA, clarified that, early on, for some of the preliminary risk assessments, ecological and worker risk were not included. However now, he noted, these risk assessment issues have been integrated where previously omitted.

A member commented that, based on the description of the elements of Phase 5, it seemed as though there were three rounds of public comments. Ms. Rossi responded that they hoped that the focus in Phase 5 would be on risk mitigation. She added that when the technical briefing takes place there will be a document called, Response to Comments, so there will be an opportunity to view the Agency's responses and how they impact the risk assessment. Dr. Ehrmann added that the group would discuss risk management tomorrow under transitional issues, at which point there would be an opportunity for Work Group II members to comment in more detail on what happens between Phases 4 and 5 and the linkage between risk assessment and management.

An individual requested clarification on how EPA determines the level to which the risk assessment is refined. Ms. Rossi explained that the risk assessment process starts with a Tier I assessment. If risk is acceptable at that point, she stated that no additional levels of assessment would be required. Ms. Rossi added that there would be various levels of risk assessment required, as exemplified by the Tier 4 risk assessment of AZM. On a related issue, the individual expressed concern about the potential impact of future cumulative risk assessments on the level of risk posed by one chemical. Ms. Rossi commented that EPA is clear about reserving the right to reevaluate risk based upon the results of the cumulative risk assessment.

One member requested clarification on when the draft Reregistration Eligibility Decision (RED) was issued in the sequence of Phases. Ms. Rossi stated that the draft RED was issued at the end of Phase 5.

Several Work Group II members wanted to know who at EPA and USDA was involved in different parts of the review process. One individual was interested in how the contact person at USDA was identified and how they used information from the crop profiles. Mr. Jennings explained that a representative of USDA, himself, Therese Murtag, or others, uses the crop profile to determine which states are important for the chemical in question. From that information, the state liaison is identified and they direct USDA to the expert within the state. He stated that USDA then coordinates with the expert on the timing of the review. The individual was also interested in the number of reviewers from the Agricultural Research Service (ARS.) Mr. Jennings stated that there were five or six reviewers, depending upon the number of crops. He explained that they focus on the top three risk drivers. Another individual asked whom at DHHS took part in the review process. Marcia Mulkey, Director, OPP/EPA, responded that there were some changes in DHHS and it was difficult to provide that information at this time. The individual then asked who at USDA was involved with public health issues. Mr. Jennings stated that Teung Chin was the USDA representative.

One member requested that EPA comment on their plans to formalize the pilot process. Ms. Rossi responded that, while not codified in the Federal Register, the practices outlined in the pilot process had become a way of doing business for EPA and USDA. She observed that much of the pilot process could be applied to other pesticides. Mr. Aidala asked the member for his recommendation on the pilot project. He added that the issue is open and suggested that this could be a useful subject for future TRAC meetings. The member proposed that EPA consider an official Federal Register notice process to institutionalize the pilot process with the aim of increasing the predictability of the review process. Another member agreed and added that it was necessary to formalize the process because it has budgetary implications.

A member added that risk "drivers" were still the key issue. Ms. Rossi suggested that the term "risk contributor" reflected more accurately the concept of a pesticide contributing significantly to the risk cup as determined by consumption or use. The example used by the member to clarify their concern was a pesticide whose use on a consumable product represented a significant risk, while its other uses did not contribute measurably to the risk cup. The members wanted to know how EPA and USDA would preserve the less risky uses in this case. Ms. Rossi explained that this type of circumstance could be addressed within the 60-day comment period where EPA would focus first on the risk "driver" but not to the exclusion of the other uses. She also noted that identifying the risk contributors is the first step to determining risk mitigation measures and that, while looking at the overall risk and potential risk mitigation, EPA would begin by isolating which uses were causing the problem. Mr. Jennings clarified that USDA would begin by reviewing the data with EPA to make sure that they were using the best available data, such as crop profiles, for their evaluation. Using the Land Grant Universities, USDA would then focus their efforts on the risk "drivers" and might not address all uses on every commodity. Keith Pitts clarified that, while USDA looks at all contributors to the risk cup, it will prioritize significant risk contributors when identified. He added that the use of data from crop profiles would assure that commodities are addressed appropriately.

Another individual was interested in what EPA and USDA had learned from the intergovernmental review process on organophosphates regarding staff skills and the division of labor. Ms. Rossi responded that they had learned that it would be helpful to involve the Land Grant Universities earlier on in the process when the reregistration review is initiated. Mr. Jennings observed that there was a need to become more familiar with the worker and ecological risk elements of the risk assessment process and suggested that was an appropriate focus for an EPA workshop this summer.

One member wanted to know more about the adequacy of the 60-day comment period. Ms. Rossi indicated that initially the 60-day comment period was a challenge, and while they have thought about the need for more time, the timeframe might become more reasonable as the process of conducting preliminary risk assessments is refined.

Other members were interested in public access to how USDA addresses comments received during the 60-day period. They observed that major and minor uses were handled differently and indicated that it would be valuable to be able to access comments and responses via the Internet on a website. Mr. Jennings responded that this idea could be considered, but commented that the information would likely be posted after decisions were made.

Several individuals were concerned about when cumulative risk assessment would be addressed by the TRAC. One member felt it would be beneficial to have a preview of preliminary thoughts on the methodology proposed for cumulative risk assessment to anticipate the potential impact of the Food Quality Protection Act (FQPA) and help focus research agendas on appropriate alternatives. Ms. Mulkey commented that there is a need for both thorough scientific review of the methodology and for public input. She explained that the methodology is currently undergoing internal peer review and that the Scientific Advisory Panel (SAP) will review the proposed methodology in July 1999. Ms. Mulkey noted that, following the SAP review, EPA expects to initiate the public comment process. Mr. Jennings added that Work Group II members would address more on transition strategies in tomorrow's session and that USDA needs to be more prepared with alternatives before fully addressing cumulative risk.

One individual inquired if, after refining the risk assessment and identifying risk "drivers," EPA anticipated proposing risk mitigation measures if risk "drivers" remain a concern? Ms. Rossi explained that, in the revised risk assessment and the overview document, EPA would discuss the risk contributors and how to potentially address the risk. She reiterated that public participation is designed to start the discussion on risk management and mitigation. The individual asked for some indication of what EPA might propose to address risk exceedances. Ms. Rossi stated that measures might include limiting the reentry period and personal safety equipment.

A member requested clarification from USDA on whether, in addition to information on the use and percent of crop treated, the potential for health effects was considered. Mr. Jennings responded that there is a parallel effort to address exposure and those issues are addressed by the Land Grant Universities.

Following the discussion on the organophosphate pilot process, Dr. Ehrmann turned to Ms. Rossi to begin the presentation on the updated risk assessment for AZM.

Updated Dietary Risk Assessment for Azinphos-Methyl

Ms. Rossi began the presentation by explaining that she and other EPA staff intended to describe and explain the AZM acute dietary risk assessment and discuss possible additional data and refinements that could modify the results of the risk assessment. She stressed that the dietary risk assessment was a "work in progress," and that USDA is still conducting its review of the assessment, the methodology is still being refined, and the data used in the assessment is being examined. Ms Rossi explained that they chose to use AZM for the example because it represents a complex dietary assessment of a pesticide that is used on many crops, some of which are commodities commonly eaten by children. In addition, she noted that in this example EPA was able to show advances in a methodology using PDP data and the revisions based on the best available data. Ms. Rossi also commented that the purpose of the presentation was to provide an understanding of the risk assessment process and to highlight some of the issues they are dealing with. She stated that the AZM risk assessment has not been shared with anyone outside the federal government.

Ms. Rossi then introduced key members of the health risk assessment team for AZM and described their roles in the process as follows: Barry O'Keefe, Chemical Review Manager; Richard Dumas, Team Leader; Michael Metzger, Chemist, Health Effects Division (HED); Felicia Fort, Residue Chemist; Cathy Eiden, Chemist; Jess Rowland, Toxicologist; Tom Keily, Economist; and Neil Anderson, Biologist.

After the introductions, Ms. Rossi made a few additional comments about the presentation. She referenced the copies of the slides on the Acute Dietary Risk Assessment Methodology and the paper explaining the use of data in the Monte Carlo analysis titled, Explanation of Data Used in the Monte Carlo Analysis (both documents are presented in Docket # OPP00537.) Ms. Rossi requested input from Work Group II members on the content of the paper and whether the presentation improved the transparency of the process. She provided the group with some background on the preliminary risk assessment which indicated that there were acute dietary risks of concern based on a non-probabilistic model, Dietary Risk Evaluation System (DRES), tolerance level residues, 100% crop treated, and 1977-78 USDA consumption data. Ms. Rossi explained that the Agency initiated the 60-day public comment period on the preliminary assessment and received approximately 15 comments addressing AZM. She noted that the registrants felt the Agency should incorporate data in development, and public interest groups were concerned about how the 10X factor was applied and prompted the Agency to take action based in the results of the preliminary assessment. Growers raised a series of concerns about the potential negative impact of the risk assessment on apples, cherries and almonds.

Based on these comments, Ms. Rossi explained that the Agency revised the human health risk assessment in February and sent it to USDA for comments. She noted that the revised assessment included the Monte Carlo probabilistic model, monitoring data from PDP and the Food and Drug Administration (FDA), percent crop treated data, and updated USDA consumption data from 1989-91. Ms. Rossi summarized by stating that the revised risk assessment represents a substantial amount of progress towards meaningful, scientifically-sound risk assessments on which to base regulation. She then introduced Rich Dumas for an overview of the use of AZM, followed by a presentation from Dr. Michael Metzger on the dietary risk assessment.

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 Work Group II members to a paper recently completed by the Agency on pesticide use policy. This policy includes 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. Mr. Dumas summarized some of the public comments and introduced Dr. Metzger for a detailed description of the acute dietary risk assessment.

Dr. Metzger presented the AZM Case Study using a set of slides titled, Acute Dietary Risk Assessment Methodology, a copy of which is presented in Docket # OPP00537. In his presentation he reiterated much of what Ms. Rossi and Mr. Dumas included in their opening statements on the background and use of AZM, the preliminary risk assessment, public input, and the status of the review of the refined dietary risk assessment. He then reviewed the basic risk equation and explained the values used for the variables in the risk equation, including hazard (toxicity), uncertainty factors, and exposure based on consumption and residues. Dr. Metzger explained that, for the uncertainty factor, based on a complete toxicity database, the analysis of special sensitivity of infants and children supported the removal of the FQPA 10X safety factor. However, he noted that, because of the lack of a no observed adverse effect level (NOAEL), the Agency decided to apply a safety factor of 3X. The resulting uncertainty factor totaled 300X.

Dr. Metzger then explained that the Agency considered two types of dietary risk assessments, non-probabilistic and probabilistic, and decided to apply the probabilistic dietary Exposure Evaluation Model (DEEM^TM) Monte Carlo method for the acute dietary risk assessment of AZM. He described how the model works and explained how a new analytical method was used to adjust composite PDP data to reflect single servings. He noted that the method is being modified to minimize over-estimations, and it is undergoing additional internal review by EPA and USDA, as well as by external peers. In addition, the method will be considered by the Science Advisory Board (SAB) in May 1999. Dr. Metzger also explained what was used for residue data (PDP and FDA surveillance monitoring data) from nine commodity groups. He then presented a comparison of risk estimates (percent of the reference dose (RfD)) for food from the preliminary risk assessment and the later revised assessments, and stated that the major risk drivers were determined to be apples, peaches, pears, and cherries. Dr. Metzger also highlighted the improvements in the refined risk assessment since the preliminary assessment. He summarized his remarks by reiterating that the case study of AZM was a "work in progress."

Ms. Rossi commented on some other data refinements and related issues. She stated that there were additional data in the pipeline, some of which were submitted and included in the study, and some of which are due. She also commented that there are some new percent of crop treated and single-serving data included in the study and that additional data from an apple processing and cherry study are expected soon. Ms. Rossi stated that EPA would incorporate new, improved data, as they become available.

Dr. Metzger concluded with some comments on outstanding issues. He noted that there are a series of questions on the data inputs to the model, including calculation of use of estimated maximum percent of crop treated and decomposited distribution, and documenting methods and standard operating procedures. He also noted that there are questions about the output of the model such as whether the 99.9^th percentile results are driven by outliers, conducting additional sensitivity analysis, and providing transparency and clarity in risk characterization.

Following the presentation, Dr. Ehrmann invited clarifying questions from the group. The questions and responses are summarized below:

• What is the status of additional consumption data for infants less than one year in age? The data for infants from 0 to 6 months are forthcoming.
• In slide # 30 - Residue Data Used, what is the difference between a "range in field trial data" and "average field trial data?" There is greater mixing for nuts than there is for onions and cabbage.
• Is the consumption data disaggregated, especially for children (e.g., raw or processed)? The data are disaggregated to a large extent in the DEEM^TM system, as canned, cooked, or otherwise processed.
• In slide # 31- AZM Analysis to Date, clarify the meaning of current assessment of 105 percent for infants less than 1 year old with an uncertainty factor of 300X, relative to a rat's response of lower than 1.0 milligrams per kilogram per day (mg/kgBW/day.) It was explained that it would take 300 times the dose to see an effect in an animal.
• How does EPA intend to integrate the results of the Agency's recently completed paper on pesticide use? EPA will address the paper in the same way they address other policy papers by taking comment and evaluating the impact of the comments on the paper.
• In slide # 27 - Residue Data, it is not clear whether composited data are used based on a percentage of detectable residues or whether there are more or less than 30 detectable residues. It was explained that 30 detectable residues represent a small percent.
• How many subjects took part in the human oral study submitted on 3/22/99? There were over 60 people in the study.
• Why do the results of the EPA risk assessment differ from those of the Environmental Working Group (EWG)? It was noted that the EWG report would have to be reviewed to address this question.
• Is an uncertainty factor of 300X used because the relative sensitivity of animals and humans to pesticides is unknown? The response was affirmative.
• In slide # 22 - Using Monitoring Data in the Acute Dietary Risk Assessment, is Congress going to continue to support the PDP program? It was explained that PDP data are a priority to both EPA and USDA, and that funding for PDP single serving, drinking water residues, meat, poultry, and eggs was requested as part of the 2000 budget for USDA.
• Is there a guideline for requiring a NOAEL? A NOAEL is not a requirement but, because there was not NOAEL, EPA decided to apply a 3X uncertainty factor in this case.
• Were there any data outliers in the composite data? Yes there were. Some were higher and lower than the composite value. Some might have been over the tolerance level.
• Has the work that the state of California has done on worker risk been factored into the risk assessment of AZM? Yes, while the results of the worker risk element of the risk analysis were not presented, EPA has been working closely with the state of California on this and worker risk has been factored into the risk evaluation.

Following the questions of clarification, Work Group II members continued with discussion on the presentation. Several members commented that the AZM study was a good example of risk assessment refinement and that the presentation was clear and helpful.

One member felt there was a need for additional clarification of slide # 31 and the current assessment result of 105 percent for infants under 1 year in age in the 99.9 percentile. She interpreted this result to mean that AZM is 5 percent over the risk cup and wanted to know what the actual impact of this result would be on numbers of children at risk. Ms. Mulkey explained that EPA has struggled with the public health significance of a threshold like the 99.9 percentile of estimated daily exposure (a proportion of the population for which exposure to a specific level of pesticide residue must be safe,) and noted that they tried to address this issue more clearly in the EPA paper titled, Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern (presented in Docket # OPP00537.) Mr. Johnson confirmed that 105 percent represents an unacceptable risk. However, he noted that this result also prompts EPA to look carefully at the exceedance and evaluate whether there are forthcoming data and other outstanding issues that could alter this result and bring the value within the risk cup.

The member then asked for clarification on why 105 percent represents unacceptable risk when 100 percent is acceptable. Mr. Johnson responded that it is difficult to answer a statistical question like this in plain English. He noted that the statisticians have indicated that they cannot really say "in plain English" what the difference is. Mr. Jennings added that USDA wrestled with the question of what the results of the Monte Carlo analysis mean in the real world, or how the results would be reflected in the actual population, on a daily basis. And, while he feels they are not yet sure what is actually happening within the population at the 99.9 or other percentiles, they are evaluating the Monte Carlo modeling output closely. He noted that modeling was a good tool, but cautioned members not to try and over-interpret the results.

One individual commented on the importance of finding acute hazard data as a benchmark to the assessment of safety factors. In this context they questioned the need for an acute "gavage" study when divided doses given over time yield lower peak levels than a "gavage" dose. Ms. Rossi noted that this was a good question that needs some additional thought.

Another member expressed concern that all of the refinements to the risk assessment of AZM resulted in lowering the level of risk. The member was also not comfortable with the removal of the FQPA 10X safety factor for infants and children without a developmental neurotoxicity (DNT) study. She felt that the argument for not requiring the DNT study was out of date, and commented that EPA would not find sensitivities in children and infants if they do not look for them. The member was also confused about the emphasis on how, with PDP data, the Agency feels they can assure safe food when at the same time they have no confidence in the data outliers. In addition, she was concerned that EPA indicated that they would not address all of the organophosphates by the August 1999 deadline. Mr. Aidala acknowledged these concerns and commented that the efforts to refine the risk assessments were designed to clarify the "real" exposure, and that through risk refinement the level of risk may decrease or increase. He observed that, commonly, if the original risk evaluation was conservative, the results of refined assessments would tend to decrease.

An individual requested clarification on the guidelines on specific percentiles used in these risk assessments, like the 99.9 percentile discussed in previous TRAC meetings. Mr. Jennings commented that they have less confidence in consumption data outside the 95^th percentile because there are fewer data points. The member felt it would be helpful for comparison to see the results of different modeling runs at the different percentiles. Ms. Mulkey clarified that EPA evaluates all of the available consumption data and referred to the EPA paper on choosing the percentile of acute dietary exposure for more details. Ms. Rossi added that the data set included exposure data and that EPA looked at 100 percent of the exposure data and looked for data outliers, which they have not found.

A member was not comfortable with what she saw as a lack of concern on the part of EPA and USDA about the potential for acute risk that could vary and increase based on factors like unusually high pest infestation that might require increased pesticide application. It was explained that EPA tried to address possibilities like this by assuming the maximum percent of crop treated. The member observed that, even with this assumption for acute dietary risk, it was still unclear how the risk would change with the addition of cumulative risk, risk imposed by the use of additional organophosphates, ecological and worker risks. Mr. Aidala agreed that there is more work to do and that he hoped they would address some of these concerns in the presentation on bensulide. Another member added that the understanding of "real" risk could also change based on other factors like additional data and the results of USDA's review of the refined assessment.

One individual observed that the Agency, in its review of end point selection since the passage of FQPA, decided to base its selection on biological significance in the absence of statistically significant data. Ms. Rossi clarified that the Agency began reevaluating all of the organophosphates last July as part of their reassessment for consistency, doses, etc., and that they base their evaluation of effects on statistical and biological significance.

Another individual expressed concern about public reaction to refined risk assessments that may be modified based on additional data, and the combined effects of updated information on additional organophosphates and cumulative risk. Ms. Rossi noted that, as information on risk assessment is published, the Agency intends to address the potential impact of additional data, including the possibility of major refinements to the risk assessment. Mr. Aidala supported Ms. Rossi's response and added that it will be clear what the Agency does when additional data is received and when they have determined that there is enough data on which to base a decision. He acknowledged that there is always a tension between waiting for more information and the need to make decisions. Mr. Aidala suggested that it would be valuable to the Agency to hear from Work Group II members on what they feel is "enough data."

After the discussion on the AZM presentation, Dr. Ehrmann introduced Ms. Rossi for an overview of the presentation on the "Dry Run" of the technical briefing on bensulide.

"Dry Run" Technical Briefing for Bensulide

Ms. Rossi explained that the Agency and the Department are proposing to hold what are called "technical briefings" for the purpose of presenting the results of the risk assessments and to obtain recommendations on risk management proposals, prior to placing the revised risk assessment into the public docket. She noted that the technical briefings would be open to the public and announced in the Federal Register approximately two weeks prior to the briefing. Ms. Rossi noted that, in preparing the example briefing documents on bensulide, the Agency made an effort to present the information in a clear and concise manner to enable a wide audience to understand the risk assessment to allow for the fullest participation in the risk management decisions. She requested guidance from Work Group members on aspects of the presentation including the title of the technical briefings, the overview and summary documents prepared for the technical briefing, and the general content and approach of the briefings. Ms. Rossi suggested that, in its evaluation, the Work Group consider the following questions:

• Do the overview and summary documents provide a clearer understanding of the risk assessment?
• Should the technical briefing be a walk-through of these documents? If so, in what level of detail and should the focus be only on the areas where the level of risk concern is exceeded?
• What is the most effective way to announce the briefing and assure that interested stakeholders are notified?

Ms. Rossi then introduced the team members who worked on the bensulide review: Dr. Kitt Farwell, Toxicologist; Jeff Dawson, Chemist, evaluating worker exposure and risk; Loan Phan, Chemical Review Manager; and Jack Housenger, Associate Director, Special Review and Reregistration Division, and presenter. She noted that the presentation would review the human health assessment including dietary, residential, worker, and ecological risk.

Mr. Housenger provided the group with an overview of the technical briefing. Details about his presentation, including a copy of the slides for the presentation, and the Bensulide Summary and Overview of Bensulide Risk Assessment documents, are presented in Docket # OPP00537.

Mr. Housenger began with some background on bensulide. He noted that it was one of the first nine organophosphate risk assessments released to the public in August 1998. In addition, he stated that it is the only organophosphate herbicide, and, like other organophosphates, it causes cholinesterase inhibition. The public commented on the risk assessment, the assessment was modified, and USDA provided their comments to the Agency. The USDA comments were incorporated in the documents presented at this meeting for comment. He explained that the public comments on bensulide focused on the dermal absorption value and the duration of exposure for handlers and assumptions used in the occupational and residential risk assessment. Additional comments addressed various aspects of the 9 science policy issues.

Mr. Housenger explained that the Agency assessed both the acute and chronic dietary risk to bensulide using the DRES model and worst case assumptions. He described how the endpoints for each assessment were selected and stated that an uncertainty factor of 100 was applied for each. He noted that the FQPA safety factor was removed because there was no increase in sensitivities to infants and children. He commented that the assessments will be refined prior to the cumulative risk assessment with information on the percent of crop treated, anticipated residue values from monitoring or field trial data, and using the DEEM^MT model. He explained that, because there are no monitoring data for bensulide in drinking water, concentrations were estimated using a model called PRZM EXAMS. The modeling results show that acute and chronic exposures from contaminated drinking water are not expected; however, contaminated drinking water from a surface water source may pose a chronic risk concern, particularly from the application of bensulide to turf.

Mr. Housenger then detailed how occupational and residential risk assessments were conducted for bensulide. He explained that occupational and residential risk assessments consider all non-dietary exposures which are characterized as handler and post application exposures. These types of exposures include mixing/loading or applying pesticides, entering treated fields to harvest crops, or working in the yard after treating the lawn with pesticides. From these practices, Mr. Housenger noted that individuals might be exposed dermally, by inhaling vapors or dust, and children might ingest the pesticide orally after playing on a treated lawn. He stated that, for bensulide, there were four scenarios for handler and post application exposure. Mr. Housenger explained that these categories were further divided into 39 short-term exposure scenarios and 35 intermediate-term scenarios.

For the presentation, he discussed only short-term exposures, and how the target margin of exposure (MOE) was reached using what levels of protection. Mr. Housenger then presented an example of how an actual dose calculation was made for the short-term dermal risk assessment for bensulide. Following this example, he summarized some of the issues for the handler risk assessment, including: whether an intermediate-term risk assessment should be performed; whether there should be a label restriction restricting the use of bensulide on golf tees and greens; and restricting the application of bensulide by air, in greenhouses, and on sod farms. He then briefly addressed post application scenarios and some of the considerations made in assessing that risk. The results of the risk assessments indicate that there is little concern for exposure in agricultural scenarios, but for turf there is a concern for both workers entering treated areas and for adults and children exposed to treated lawns. Mr. Housenger also noted that EPA conducted an ecological risk assessment which also points to concerns largely from the use of bensulide on turf. He provided the group with an idea of how EPA might address the concerns raised in the risk assessment prior to the next TRAC meeting. Mr. Housenger closed the presentation with the statement that the next phase in the process is the public discussion on risk management options, which should focus on the use of bensulide on turf.

After the presentation on the technical briefing, Dr. Ehrmann asked Work Group II members to comment on the content, approach and format of the briefing.

Before the discussion began, Mr. Aidala explained that, historically, elements of the preceding presentation were addressed in the development of the RED. However, he indicated that the Agency and the Department want to expand the public participation rate by condensing the results of the risk assessment in the overview and the summary, and including an oral presentation of the information. He asked the group to consider if whether the technical briefing was worth doing in every instance, or on a selected basis? Ms. Rossi added that the key reason for the technical briefings was to establish a basis of common understanding of what the risk assessment says. Ms. Mulkey also noted that the technical briefings were also designed to make the risk assessments more accessible in response to comments from grower groups and others that the to 60-day comment period was not sufficient to cover the density of information included in the risk assessments.

Many members felt the presentation was informative and effective. It was noted that a clear oral presentation of a complicated risk assessment was very helpful. Several individuals commented that the content of the technical briefing was appropriate. Some additional suggestions are summarized below:

• Consider presenting some of the material in tabular form to allow for comparison.
• Make the information available on the Internet and foster two-way communication. Improving access to the information and input will be beneficial to state agencies and growers.
• Include information on incident data and highlight where worker exposure is a problem.
• The impact of pesticide drift should be addressed and is key in the risk assessment.
• There is a need to perform a Tier 4 risk assessment on all chemicals without using assumptions because the degree of risk refinement necessary to maintain safe food is still unknown.
• It would be helpful to have the overview and summary documents available as soon as possible and sometime within the 60-day comment period on the revised risk assessment, for side-by-side comparison with the risk assessment document.

Another individual commented that some of the assumptions on handling bensulide were not correct. Specifically, she noted that bensulide is applied before growth and water is used to move the pesticide into the soil. She stressed the importance of communicating with the registrant and the users to obtain accurate information on application and the potential for exposure.

A member observed that the evaluation of occupational risks was based on the assumption that all handlers comply 100 percent with personal protective measures. He asked for clarification on how the Agency addressed actual exposure to handlers and non-handlers during application, including enforcement measures to insure compliance. Ms. Mulkey responded that the Agency addresses non-compliance by focusing on compliance. She indicated that, while states take the lead role in enforcement, EPA plays a role also and they plan to focus increased attention on worker protection this year. Ms. Mulkey commented that this is an opportunity to increase compliance with labels. Mr. Dawson added that EPA is also trying to integrate into the compliance picture more information from residential exposure by reevaluating the residential standard operating procedures document and through monitoring studies. Ms. Rossi also stated that those kinds of considerations are evaluated when considering risk mitigation measures. In addition, it was noted that if a consistent pattern of misuse is observed, the risk is evaluated.

At the suggestion of gathering additional data to refine risk, one participant asked EPA to clarify its approach to addressing additional data needs and defining when there are enough data for decision-making on chemicals. Ms. Rossi commented that there is a substantial database because chemicals have been undergoing reregistration for a long time. She stated that, while there will always be a need for additional data, based on the substantial database, EPA is able to closely approximate "real" risk. The member acknowledged her explanation, but noted that the risk assessment process is dynamic and, as exemplified in the bensulide study, specific core data needs are being identified on a regular basis. He felt that people should have the opportunity to provide additional data within a reasonable timeframe when data needs are identified. Mr. Aidala explained the importance of understanding the context in which the data need is identified. For instance, he suggested that data should be collected when core data are missing, as opposed to collecting additional data that would be useful and could make a difference in 3 years. He suggested that, as a general rule, people should be able to collect additional data in the proper context and when it makes sense to do so. Mr. Johnson added that this issue has been an issue since the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was passed and TRAC was not provided a clear path on how to deal with it. He noted that data call-ins are used frequently, but call-ins could be a waste of time if required for all situations. He urged Work Group members to think about where to draw the line on data requirements and provide EPA with their suggestions as to EPA's approach, including ideas on setting timeframes for the receipt of additional data. Several participants were concerned about the discussion on potentially expanding the timeframe for individual chemicals to accommodate additional data collection, and stressed that EPA should stick to their established timetables. Another member was supportive of the technical briefing as a means for EPA and USDA to get input on the risk assessment prior to the next step of decision-making. It was helpful to him to have some clarity on what EPA does and does not know, however he felt the presentation was lacking because it did not define the extent to which EPA operates with uncertainty. In particular, he suggested that EPA should clarify its assumption of 100 percent compliance in the handling of bensulide and provide information on the impact to the public if 100 percent compliance is not achieved. He noted several other issues of uncertainty such as drift and labor enforcement, and asked about other areas of uncertainty about which the public should know. As another example, he referenced EPA's apparent assumption that pesticides are necessary to achieve pest management goals, when at other TRAC meetings it was implied that a reliance on pesticides is not necessary to achieve these goals. He suggested that he would have more confidence if the uncertainties were identified and explored in combination with the evaluation of pesticide alternatives.

Gerber Agriculture Program Presentation

Jan Relford, Senior Vice President, Research, Development and Quality Assurance, Gerber Products Company, presented an overview of the Gerber Agricultural Program. A copy of the slides for his presentation are in Docket # OPP00537. Mr. Relford began his presentation by stating that the goal of Gerber pest management systems is to eliminate residues from the finished product. He explained that management structures were developed throughout the company to support this goal and the company adopted a pesticide philosophy to maximize "no pesticide use" and shift as much production as possible to low risk biological materials as rapidly as possible. Further, risk and safety criteria are clearly defined and the risk posed by pesticides is quantitatively characterized. In addition, Gerber has initiated programs to modify practices that measurably reduce the risk of pesticide residue exposure. Mr. Relford also explained that through the Agricultural Research Group, Gerber plans and coordinates field trials for new technologies. Similarly, through the crop management associations, they scout crops and provide detailed supervision and implementation of Gerber practices in the field.

With this as a background on the company, Mr. Relford described how Gerber evaluates risk. He outlined a hazard analysis of control points including the soil, seeds, plants, growth, harvest and produce processing, and commented that different equipment is needed at different control points to insure that there is no chemical detection. Mr. Relford then summarized Gerber's integrated pest management successes for 1998. Some of the highlights of their program included: 100 percent of Michigan crops without organophosphates; carrots with no organophosphates; and peas with no insecticides or fungicides and most without herbicides. Mr. Relford also provided an overview of some of their work with alternatives to organophosphates and carbamates used in green bean production. He summarized his presentation by stating that Gerber is making progress and that the progress is consumer-driven.

After the presentation, Work Group members were invited to ask questions of clarification. One member asked if consumers know about the Gerber program? Mr. Relford responded that consumers do not know about what Gerber does and the company believes that people simply assume that the food is residual-free. The member also inquired how farmers working with Gerber respond to a new pest control program? Mr. Relford commented that Gerber generally approaches farmers with alternative programs as a partnership. In response, farmers are sometimes supportive and other times it is necessary to start with a small example of the alternative to prove that it works and then move on to requiring it for larger scale use. The member was encouraged by Gerber's use of partnerships and stressed that partnerships help foster consumer trust in the produce. Another individual commented that people learn from their peers and recommended that USDA look for growers who are farming without pesticides and urge them to teach others what they are doing.

Another individual asked whether growers for Gerber commit all of their crops to Gerber. Mr. Relford explained that Gerber commits to a specified volume of produce and certifies selected crops. It is then up to the grower to sell the rest.

A third member observed that custom growing for business is not always "the rule of thumb." In addition, he noted that the public ultimately dictates what the grower does and that, at this point, all customers do not demand organic produce.

Public Comment

There were no comments from the public.

FRIDAY, April 9, 1999

Dr. Ehrmann opened the second day of the Work Group II meeting with a review of the agenda for the day. The agenda topics included elements of transition, a presentation from Sarah Lynch, WWF, updates on the nine science policies, additional comments on the pilot program, agenda ideas for the TRAC April 27-28, 1999 meeting, and time for public comment. Dr. Ehrmann then turned to Allen Jennings for the presentation on the elements of transition.

Elements of Transition

Mr. Jennings provided the group with an overview of the core 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 some of the key staff involved with transition strategies including Therese Murtagh, Wilfred Burr, and Susan Deatheridge. He stated that the purpose of the presentation was to share USDA's current thinking on transition strategies and to hear input from the Work Group on where the USDA should go next in the process. Mr. Jennings noted that this was a new, open process for USDA, one in which they hoped to see broad stakeholder involvement.

To orient the group, Mr. Jennings reviewed a list of considerations USDA worked through to begin developing the strategy. One consideration was which crops to address first and what criteria should be used to select the crops (e.g., is the crop consumed in high quantities by infants and children?) The next consideration was whether chemicals should be addressed individually or by class, or in some other way? Another factor was how to state the goals and measure progress on the transition strategy. Suggestions included measuring the frequency and magnitude of residue detection, using the PDP or some other program to routinely monitor some foods, and grower extension programs and training. Current chemical uses were also a consideration, addressing issues like what pests drive the use of selected chemicals. Alternative pest controls represented an additional consideration, particularly how they fit into IPM and resistance management and whether they were registered alternatives or non-chemical approaches. Another consideration was future options such products in the "pipeline" and other promising alternatives. A final consideration was research and education needs including basic applied research needs, the need for grower education, and incentive programs.

Mr. Jennings then described how some of the different stakeholders affected by transition are and could be involved with transitional issues. He categorized their involvement as action items, commitments and schedules. Some of USDA's commitments included crop profile and pipeline databases, education and training through the extension services, and transition strategies. EPA's responsibilities included accelerated registration of alternatives through Sections 3, 24C, and 18, and flexible regulatory strategy. Grower Organizations, Land Grant Universities and Public Interest Groups could contribute technical expertise to the process. Mr. Jennings then referenced a draft commodity list to ground some of the ideas for transition strategies.

Keith Pitts added that, in addition to the budget from the TRAC process, the USDA is planning a meeting to review the year 2000 budget to help evaluate how it would best be applied to enhance USDA transition strategies.

After the opening remarks, Work Group II members asked clarifying questions and provided comments on the presentation.

Some members commented on the approach to chemicals considered in the transition strategy. They were concerned about the prospect of basing the approach on one chemical, and suggested that, in the absence of the results of a cumulative risk assessment, transitional strategies should address chemicals by class. They felt that the approach should hinge on the results of cumulative risk assessment and that proceeding otherwise would be like working in the dark. One individual commented that, in the absence of the results of the cumulative risk assessment, he was reluctant to stop using a pesticide until it was proven to be problematic. Another member observed that there have been questions about pesticides for years, and they hoped that there would be some interim way to address the current uncertainty about the impact of pesticides that would meet the needs of all. Mr. Jennings clarified that it is necessary to start the transition process now, and it is the intention of the Department to use a "chemical class" approach.

One member commented on alternative pest management tools, noting that farmers are already applying many of the alternatives referenced by Mr. Jennings, including moderating the pesticide spraying based on need, and other IPM programs, because the alternatives are more economical. He suggested adding "economical" as a criterion for alternative tools. Mr. Aidala commented that the economics and practicality of the alternative are automatically considered. Another member added that, in addition to economical, the criteria should include "environmental" to help prevent further strain on biodiversity. Mr. Aidala also stated that the Department and the Agency are trying to "look at big picture" and are evaluating all factors including resistance. In this regard, Mr. Aidala explained that EPA is meeting with grower groups and working with the Department to identify what alternatives are available.

Another member expressed concern about USDA's request for help from stakeholders outside the Department, such at the grower community, to make decisions on risk management strategies. While he was supportive of soliciting information on pesticide use from this and other communities, he cautioned against involving them in the decision-making process because it could foster competition between grower groups. Mr. Jennings explained that the Department is currently looking at a commodity approach which they do not see contributing to grower competition. He reiterated the need to get input on establishing a process now to assist in the transition from reliance on one pesticide to another that may run into problems later. Mr. Pitts added that USDA and EPA are trying to be proactive and initiate a process to address transitions that will be required once the cumulative assessments are completed.

An individual asked for clarification on whether, in the intergovernmental review, all elements of risk assessment were reviewed. Mr. Jennings responded affirmatively and explained that the review included the dietary, non-dietary and ecological assessments.

It was unclear to some how public health considerations fit into the risk assessment process. Mr. Jennings noted that the Department relies on the DHHS to address public health issues. Another individual suggested that the benefits of pesticide use to public health be addressed in the risk assessment process and the Agency and the Department consider making allowances for the benefits in the final determination of the risk cup. He noted that one way of doing this would be to use exemptions where benefits exceed the risks. The individual added that transition of pesticides in the urban environment is driven by the market place and stressed the need for USDA to involve pesticide professionals in this area when addressing transition and public health. Mr. Jennings commented that this was a good point.

One member observed that there were different elements of transition, one of which is regulatory transition. He noted that the elements of transition also included economics, the environment, farmers and agriculture. The member commented that it was necessary to view transition from the perspective of the farmer regarding how they can stay in business while at the same time making the necessary changes for transition. He suggested that USDA approach transition from the perspective of the farmer and make sure they are poised to support them in transition with economic, research and educational needs.

Another individual stated that there were barriers to adopting integrated pest management (IPM) approaches which could play an effective part in transition. He saw a need to provide better information about IPM to help people overcome the inertia that operates against implementing them. He urged USDA to consider how to make better use of limited funds to help overcome this inertia.

Also in this regard, another member commented on the need for USDA to consider pest management systems in addition to individual chemical replacements. As an example, when looking at a benefits assessment of a nematode problem, he saw the need to question farmers in the same region who do and do not have a nematode problem, on their management systems, including what is being done and why. With an understanding of the whole management system, a farmer would then be better equipped to evaluate alternatives such as the need for a softer chemical, different tilling methods or patterns, or other alternatives to chemical response. Mr. Pitts commented that USDA considers this approach and it is consistent with the definition of IPM.

An individual commented on the importance of viewing chemicals in terms of how they fit into a broader resistance management strategy. He noted that resistance differs from the way it was viewed in the past because of the number of changes in industry and the environment. In particular, he felt that changes in regulatory programs are driving towards a potential resistance crisis in the next decade. He observed that resistance was last studied by National Research Council (NRC) in 1986, at which time it was recommended that USDA assemble experts to identify resistance drivers to prevent a regulatory process that would accelerate the resistance problem. Mr. Pitts acknowledged these concerns and stated that the Department is evaluating where they are headed in this area. He commented that the Department is making an effort to combine information from regional census projects, technical expertise and how they regulate to help address this concern and they are asking NRC for input. Another individual observed that industry could take the same initiative.

Several members stated that outline presented by Mr. Jennings was good. One individual observed that transition meant moving away from certain chemicals and reducing the use of others. In this regard, he stressed the need for alternatives as well as a means to measure the progress and success of shifting to the alternatives. Another member found it disturbing to hear the suggestion that all organophosphates or other classes of chemicals might be cancelled. She commented that, basing decisions on sound science might result in the cancellation of some chemicals, while others would remain in use. In other words, they felt that uncertainty goes both ways. In addition, she felt it was important to look at reduction in frequency and use of chemicals as compared to the potential impact of pesticide cancellations.

One individual acknowledged that limited resources challenged transition. He felt that all TRAC members were committed to helping with transition by supporting appropriations and operations necessary for transitional efforts. In the interest of transparency, he also stressed the importance of stating the goals of transition and how progress towards achieving the goals will be measured. In addition, he requested clarification on who is taking the lead in transition. Mr. Pitts added that EPA is looking to USDA for recommendations and that EPA is in the lead. Mr. Aidala clarified that the Agency and the Department are dividing the responsibilities of transition based on who does what best. He commented that who is in the lead is for others to decide. The member noted that clarity and definition of the process would be helpful for all involved.

Presentation by Sarah Lynch, World Wildlife Fund

Following the discussion on the elements of transition, Sarah Lynch, WWF, provided the group with an overview of a collaborative effort between the WWF and the Wisconsin Potato and Vegetable Growers Association (WPVGA) to address toxic loadings to the Great Lakes Basin. A copy of her slides is presented in Docket # OPP00537. She explained that as these groups began to focus on the problem of toxic loading they acknowledged that there was an agro-environmental gridlock on the issue and that something needed to be done to break the gridlock. In addition, Ms. Lynch noted that the group agreed that shifting to biological IPM could be beneficial to both farmers and the environment. To achieve the shift, they agreed that active farmer participation was essential and it was necessary to establish some goals and timetable in order to accelerate change. Ms. Lynch reviewed what WWF and WPVGA considered to be critical elements of success, including setting measurable targets and timetables, establishing a process for monitoring progress towards meeting goals using a transparent, a credible measuring system, and rewarding progress for meeting the goals. She then explained that the groups established 1, 3, and 5-year goals for eliminating 11 high-risk pesticides, and a 10-year goal for accelerating the adoption of biologically based, lower risk IPM. Ms. Lynch also described how the growers and the environmentalists decided to measure progress towards these goals.

With this information as background, Ms. Lynch then summarized the results of the collaborative effort. She commented that after tracking the change in pesticide usage between 1995 and 1997 it was apparent that there was a 25 percent reduction in toxicity units for 11 high-risk pesticides and a 20 percent reduction in toxicity units for all pesticides. Ms. Lynch commented on the types of preventive practices used to achieve these reductions and explained how to provide the incentive to use a diverse set of tools for pest management WWF and the WPVGA established a point system which assigned points to different categories of preventive practices. Using a series of bar graphs, Ms. Lynch showed how much farmers are using different preventative practices. She also summarized the 1998 external budget for the collaborative effort, $278,000, and stated that it would take between $500,000 and $600,000 to "do the job right." Ms. Lynch closed her presentation with the comments that it takes choices, confidence, consumers, and courage to succeed with an effort like this. Work Group members were then invited to comment on her presentation.

The group asked some clarifying questions and commented on the estimated budget for external funds. A summary of their comments is presented below:

• Field research appears to represent a key component of the budget. How could this need be addressed more broadly? There is a need to rechannel USDA research activities to focus on the collaborative needs.
• Does this mean a need for new funds or a shift in the focus of research? It was noted that this is a tough question to answer.
• Assuming additional funds were made available, are the proportional allocations correct. The answer to this question was yes.
• Is it possible to provide information on the financial return of this program to the grower? It was explained that, given time and resources, this information could be developed.
• The time for University research is not included in the budget. The cost of this component of the budget would likely increase to something like $200,000.
• An estimate for the up front investment to initiate an effort like this is not included in the budget. It was acknowledged that building the relationships and confidence necessary for this effort was time consuming.
• How much did it cost the growers to make the shift to IPM? It was noted that the effort relied on people voting with their feet and the impetus was that the shift was economically viable. Economic viability was viewed as an essential and priority ingredient to success.
• Were products labeled differently? It was explained that products were not yet labeled differently.
• Additional funding is necessary in other arenas, such as University Extension Services.
• EPA should focus less on the risk assessments and more on implementing the use of less toxic pesticides. This kind of shift necessitates that industry is more open-minded in their use of pesticides.
• It is unclear whether this kind of collaborative approach, if it worked in all circumstances, would be economically viable for all parties. It was suggested by some that unless the system changed to selling an integrated product, it would not be economically viable.
• To some degree this is a philosophical discussion on the power of having a shared a vision for agriculture in the U.S. While this is an important discussion to have, it is also important to separate the discussion on philosophy from the scientific policy issues.
• Remember that consumer demand is a key driver in the selection of alternative pest management. Consumers do not yet feel that they are provided enough information on pesticide use to make informed choices. Agreeing on a way to get adequate information to the consumer would harness economic forces.
•  

Peter Robertson's Remarks

After the WWF presentation, Dr. Ehrmann introduced Peter Robertson, Acting Deputy Administrator, EPA, for some general remarks. Mr. Robertson began by explaining that both EPA and USDA agree that committing to the additional time and meetings for the TRAC process is valuable. He explained that while he has been coming up to speed on the process he has come to recognize that the

TRAC has progressed because the members have been willing to stay at the table and help EPA and USDA work through some very difficult issues. He thanked USDA enormously for their help in the process and stated that without their help the chance of success would be slim. Mr. Robertson stated that he was proud of what members of the TRAC had accomplished and observed that they had made major strides on the risk assessment process and on the nine science policies. However, he also recognized that there are more issues to yet address, some of which are being discussed at this meeting. Mr. Robertson recognized that the ongoing efforts of TRAC members is key to the successful implementation of FQPA. He noted that the next TRAC meeting was important, and that USDA and EPA need input from this session on the agenda for that meeting to make it what it should be. Mr. Robertson finished his remarks by stating that, while he could not stay for the rest of the meeting, he had learned a lot from what he had heard at this meeting.

Following Mr. Robertson's remarks, Dr. Ehrmann invited comments from the workgroup. One member complimented EPA and USDA staff for all of their hard work and progress on the risk assessment process and the science policies. Mr. Robertson responded that he appreciated hearing that. Several members cautioned that there were some dissenting voices on this opinion and some TRAC members continued to be concerned about the reluctance of EPA to take some concrete action on some of the pesticides, such as AZM, based on the results of the risk assessments. Mr. Robertson explained that, while the TRAC process is useful, there was no reluctance on the part of EPA to take action. He observed that there might be differences of opinion on that and the "proof will be in the pudding." Mr. Robertson commented that he hoped the commenter would remain at the table to make sure the actions taken are the best possible.

Another individual observed that some of the earlier comments on the challenges facing farmers as a result of FQPA implementation served as an important reminder that there are others watching as FQPA unfolds. In that regard, he suggested thinking about the need to harmonize the international component of FQPA implementation and how it will mesh with other related issues such as NAFTA.

Brief Update on Nine Science Policies

Dr. Ehrmann introduced William Jordan for a brief update on the nine science policies. Mr. Jordan referred the group to two background documents for the presentation which were titled, Data for Refining Anticipated Residue Estimates Used in Dietary Risk Assessments for Organophosphate Pesticides (the "bridging" paper,) and Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern. He also referenced a copy of the slides, which was titled, and Food Quality Protection Act TRAC Science Policy Issues. All of the documents are presented in Docket # OPP00537. Mr. Jordan provided the group with a status of the science policies. He explained that there were a total of 19 papers for the nine science policy issues, 10 of which have been issued, and one of which is final. He noted that EPA might have to reschedule the completion dates for some of the remaining papers. Mr. Jordan commented that, based on yesterday's discussion on the 99.9 percentile there was still some misunderstanding about where EPA sets the point for decision-making on pesticide residues. He also commented on the "bridging paper" on refining risk as it relates to the discussion on transition and stressed the importance of understanding the tools that are available for risk refinement.

Mr. Jordan acknowledged that, in some cases, it has taken EPA longer than expected to get the work done on the science policy papers. However, he noted that they would be busy over the next two months. They hope by the end of April to issue papers on: the statistical manipulation on composite residues and how to calculate decomposited values; the 10X FQPA safety factor; and early assessments. In May, he noted that EPA hopes to make available four additional papers on: approach to food exposure estimates; revised paper on thresholds; aggregate risk; and cholinesterase end point considerations. In addition, Mr. Jordan stated that EPA expects to issue a paper on human studies, contingent on the results of the SAB review, in April or May. He closed his presentation by thanking TRAC members for the thoughtful, comments from like-minded groups that EPA has received through the public comment process.

Additional Discussion on the Organophosphate Pilot Process

The group continued its discussion on additional data and defining "how much data is enough" in the risk assessment process. One member agreed that there has to be some limit on the submission of additional data for the risk assessment process. She advised that EPA view additional data in a fair way and accept data within a reasonable timeframe that affects decisions on risk, including data that should have been submitted or new data submitted because of new requirements. In this regard, Mr. Aidala asked all TRAC members to consider the parameters for additional data, such as the timing of submission and the purpose of the additional data. Another individual felt there was enough data and stressed the urgency for EPA to begin to make decisions on some of the pesticides, such as AZM.

A member suggested allowing the registrant to provide additional input on the risk assessment prior to the technical briefing to help assure the most up-to-date information is used and "real" risk is represented. Ms. Mulkey stated that EPA has historically struggled with the issue of when to integrate registrants in the risk assessment process and whether they should be integrated differently from other stakeholders. She explained that the intent of the 30-day error correction period was to provide for their input. She noted that one of the issues is that other stakeholders could also contribute valuable information just prior to the technical briefing. Another individual reiterated her support of public disclosure now taking place in the tolerance reassessment process.

One member commented on the transition strategies presented by Mr. Jennings. He felt that the listing was comprehensive and logical but that many of the Land Grant Universities and farmers have been applying these ideas for years. To him, the hard part of making decisions was yet to come.

Another individual expressed concern about how information on the risk assessment is presented to the public in advance of a regulatory decision because of the potential for negative public reaction. In addition, he felt that precedents are set with the earlier releases and those chemicals may receive the brunt of public reaction. He suggested that EPA build a mechanism to address these concerns into the release and review process. Mr. Aidala acknowledged this concern and asked TRAC members for input on how to properly balance the need for public disclosure and concern about potential reactions to the information.

An individual commented that the idea of a technical briefing was good. She added that she would like to see incident data included and expressed concern that worker and ecological risk were not included as part of the briefing. Ms. Rossi assured the member that future technical briefings would include all elements of risk.

In a similar vein, another member commented that it was unclear when and how worker safety issues were addressed in the context of risk management and the phases of the pilot process. He wanted to know if, as with dietary risk, input on worker safety issues was sought from the registrants and growers in Phase 5 of the pilot process and how it was integrated with other information on risk and risk mitigation to issue the final RED in Phase 6. In addition, he wanted to know how USDA was involved in this process as it relates to the drivers for risk mitigation. Ms. Rossi commented that historically when REDs were issued all elements of risk were considered in determining mitigation measures. She expected that the pilot process would work similarly. Ms. Rossi also clarified that if risks are determined to be unacceptable the registrant is consulted and a course for mitigation is discussed. In addition, she explained that in Phase 5 of the pilot process USDA comes prepared with ideas for risk mitigation. The member observed that the current process differs from the previous process because DHHS and other public health representatives are involved. Mr. Johnson added that the process differs from past practices because the Agency is receiving input from many sources, not just registrants. He noted that the intent of Phase 5 of the pilot process is to honor the commitment to transparency while at the same time hearing from those who wish to provide input. Mr. Jennings commented that the hope is to identify the risk drivers so that the technical briefing and meetings with the growers can focus on the worst first. He also recognized the need to balance the process of addressing the endpoints of dietary risk as required by statute, in addition to addressing ecological risk.

A member added that based on the substantial change observed in the results of the risk assessment for AZM it might make sense to provide an additional opportunity for registrant input in Phase 4 of the pilot process. As an example, another individual commented that the accuracy of the technical briefing on bensulide would have been improved if the registrant was given the opportunity to provide additional information. Ms. Mulkey commented that registrants generally provide additional information other than that required for error correction in the 30-day error correction period. Ms. Rossi agreed and stated that any additional data would have to be clearly rationalized.

For perspective, one member commented that worker risk is based on theory rather than actual measurement. He also stated that education on how to use pesticides could help to reduce the potential for worker risk.

Another member asked for the current status of the public health pest list. They were also interested in the status of the Memorandum of Understanding (MOU) between EPA and DHHS regarding public health issues. Ms. Mulkey responded that EPA is working on both issues. She commented that she would have to check on the status of the MOU for more details. Ms. Mulkey noted that the list in draft form but there is some discussion on what to include on the list. The member suggested that EPA and USDA consider including an update on these issues, in addition to presenting information on benefits and risk, at the next TRAC meeting.

Agenda Planning for the TRAC Meeting on April 27 28, 1999

A draft list of agenda ideas for the April 27 - 28, 1999 meeting was drawn from the discussion at the meeting and used as a starting point for agenda planning. The group considered the list and made some additional suggestions. The resulting modified list of agenda ideas for the next TRAC meeting is presented below.

• Data needs - timing
• Review of data collection activities (and other relevant data)
• Refining the Pilot Process
• Update of Risk Assessments
• Transition - mechanics of moving from risk assessment to risk management - specific suggestions on process
• Public health issues (invite the DHHS; discuss benefits)
• International context/import issues
• Cumulative risk
• Report from Work Group II
• Update on water and non-dietary risk.

It was suggested that TRAC members receive a copy of the agenda for the next TRAC meeting as soon as possible to provide sufficient time to prepare for the meeting. It was also suggested that the agenda and other meeting materials be posted on the web prior to the April 27 - 28, 1999 meeting.

Public Comment

Bruce Bernard, SRA Consulting - complimented EPA and USDA on the wide-ranging, balanced approach they took to addressing different subjects. He felt that the TRAC process was valuable and suggested that the Agency and the Department consider continuing the process. Mr. Bernard was supportive of EPA and USDA using the best available science and expressed the hope that they would continue to do so.

Dr. Ehrmann closed the meeting by thanking members for their time and commitment to the process.