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Meeting Summary
Omni Shoreham Hotel
Washington, D.C.
July 28, 1998
Opening Remarks
John Ehrmann, Meridian Institute, opened the meeting by welcoming participants to the fourth meeting of the U.S. Department of Agriculture (USDA) - U.S. Environmental Protection Agency (EPA) Tolerance Reassessment Advisory Committee (TRAC) which is constituted as a subcommittee to the National Advisory Council for Environmental Policy and Technology (NACEPT) of EPA. Dr. Ehrmann then initiated a round of introductions for the benefit of the public. A list of the TRAC members is presented in Docket # OPP00537.
Following the introductions, Dr. Ehrmann turned to Co-Chairs of the TRAC, Richard Rominger, Deputy Secretary, USDA, and Fred Hansen, Deputy Administrator of the EPA, for opening remarks.
Mr. Rominger welcomed members to the fourth session of the TRAC. He commented that July was an active month for meetings and hearings on the Food Quality Protection Act (FQPA). Mr. Rominger observed that, in addition to the two TRAC meetings, the following activities took place: EPA and USDA met with the California Assembly Committee on Agriculture for a hearing on FQPA implementation; EPA and USDA met with growers; EPA and USDA met with Congressmen Charles Stenholm and Marion Berry to provide them with an update on the TRAC and FQPA implementation; an FQPA field hearing was organized by Idaho Senator Larry Craig and Dick Kempthorne; and two additional hearings were to take place in New York and Canada.
Mr. Rominger noted that these were good meetings that were attended by producers and many others who shared information and inquired about risk assessments, data needs, and transition. He commented that those attending the meetings are looking to the TRAC for insight on these issues. Mr. Rominger stated that, at this meeting, the TRAC would consider and comment on an example of a dietary risk assessment of an organophosphate to demonstrate the assessment procedure and show how data is used. In addition, he noted that the group would begin to discuss transition, an issue that Work Group # 2 (WG2) will consider in greater detail in August. Mr. Rominger reflected that, as a result of FQPA, there will likely be the need for the transition away from some materials. He stressed that, while a few organophosphates may be eliminated and a few uses may be modified, organophosphates will not be eliminated as a whole. Mr. Rominger noted that transition is very important and that growers are concerned about the timing of transition, the status of research, and progress on identifying and registering new products. He challenged TRAC members to have a productive discussion on a set of principles that can guide transition. Mr. Rominger also noted that the group would hear an update on including the organophosphate risk assessments in the Public Docket. He asked TRAC members to help make the public discussion on the risk assessments productive to set the tone for future discussions on risk assessments. Mr. Rominger summarized by thanking TRAC members for their attendance at the meeting and stated that he looked forward to another productive meeting.
Mr. Hansen commented that the decision made at the last meeting to shorten this meeting to provide time for the Work Groups to meet and to add a fifth TRAC meeting was productive. He noted that the Work Groups would provide an overview of their progress later in the meeting. In addition, Mr. Hansen commented that the TRAC would hear a presentation from EPA and USDA on one organophosphate risk assessment, following up on the offer by Jay Vroom on behalf of the American Crop Protection Association. He observed that the presentation illustrates all of the issues of concern identified by the TRAC, and provides the foundation for a productive discussion. Mr. Hansen also stressed that the issues on transition are very important and noted that WG2 will meet in August to discuss transition in detail. He felt it is particularly important to address the concern noted by Mr. Rominger and by many growers about whether, in their review of organophosphates, the Agency would say "yes or no to all" organophosphates. He clarified that this would not be an all or nothing decision process. He noted that, key to the discussion will be considering what transition really means and how to focus on where there are no alternatives for high-value uses, while at the same time, meeting the requirements of FQPA.
In addition, Mr. Hansen felt it is important for the TRAC to focus on what it wants to accomplish as a group, with the understanding that the group is seeking convergence on as many issues as possible. He observed that the TRAC has made a lot of progress on the concept of sound science and transparency. Mr. Hansen also asked the group to think about how to continue effective stakeholder involvement in the process. He suggested that the TRAC consider forming a subgroup to develop some ideas on stakeholder involvement for the fifth TRAC meeting.
Mr. Hansen observed that, while the proposed >pilot= at the last TRAC meeting to make the preliminary risk assessments available to the public on a schedule was a step towards transparency, he recognized that there were some rough edges in the communication process. He invited members to provide input on how to improve the process and asked them to think of the >pilot= as a learning experience. Mr. Hansen also clarified that the policy on the application of the 10-fold safety factor for infants and children will be released at the end of the week following the TRAC meeting in response to a Freedom of Information Act (FOIA) request. Mr. Hansen closed his comments with the announcement that he will be leaving EPA to head up the transit system in Portland, Oregon. He assured TRAC members that he would complete the TRAC process before his departure from EPA in October, and stressed that the framework developed as a result of the TRAC meetings will be put in place and supported by the highest levels at EPA. Mr. Hansen thanked TRAC members and commented that he looked forward to a productive meeting.
Following Mr. Hansen=s remarks, Mr. Rominger stated that Mr. Hansen would be missed. He also thanked Mr. Vroom, the Gowan Company, and Novartis for their contributions to the development of the case on example organophosphate risk assessment planned for the meeting. In addition, he congratulated Gerber Products Company on their 70th birthday as a company.
Review of Recent Activities and Agenda
After the introductory remarks, Dr. Ehrmann reviewed the agenda for the meeting as follows:
Dr. Ehrmann then commented on the status of the TRAC process. He referred to the four major themes identified by the Vice President for the work of the TRAC: sound science; transparency; reasonable transition time; and consultative process. To address the need for sound science, Dr. Ehrmann observed that WG1 has progressed on the nine science policy issues and is developing a coherent approach related to science policy and the notice and comment process. He also noted that a revised version of the APlain English Guide to Risk Assessment@ will be completed by the September TRAC meeting. Dr. Ehrmann summarized the progress on transparency as follows: the notice and comment process on the science policy issues; release of the preliminary risk assessment; and WG2=s work on the straw risk management Decision Process and the Tolerance Reassessment Process. To address the need for reasonable transition, Dr. Ehrmann observed that, while there is more work to do, WG2 plans to discuss transition issues for two days in August in preparation for the September TRAC meeting. Dr. Ehrmann noted that the consultative process crosscuts many of the issues being addressed by the TRAC. He also commented that, as requested at the last TRAC meeting, the group will receive a template of anticipated work products prior to the September TRAC meeting to help clarify TRAC accomplishments, next steps, and what happens after the TRAC process. He observed that the TRAC has made a lot of progress. Dr. Ehrmann completed his comments by introducing a new member of the TRAC, Dr. Mark Miller, American Academe of Pediatrics. He then invited Steve Johnson, Deputy Director, Office of Pesticide Programs (OPP)/EPA, to present the Example Preliminary Organophosphate Risk Assessment.
Example Preliminary Organophosphate Risk Assessment Presentation
Mr. Johnson began his presentation by referring TRAC members to Staff Paper # 19 Case Study for Methidathion Risk Assessment: Process Overview (presented in Docket # OPP00537). He provided the group with an outline of his presentation and thanked Gowan, Novartis, and David Wallinga of NRDC for their participation in preparing the presentation. And, while preparing for the presentation was a collaborative effort, he noted that representatives of Gowan and Novartis are not necessarily in agreement with decisions EPA has made to date in the development of the risk assessment. Mr. Johnson commented that the trade name for Methidathion is Supercide. He explained that, while the focus of this presentation is on dietary risk, EPA also evaluates ecological, occupational, and residential risk when there are non-agricultural uses. In the case of Methidathion, Mr. Johnson noted that there are no residential, public health or non-occupational uses. He commented that, while preliminary modeling for the evaluation of drinking water exposure is complete, the risk assessment on drinking water is considered a work in progress and would not be part of his presentation.
Mr. Johnson stated that the objectives of the case study were to illustrate the dietary risk assessment process and its complexity, the tiered risk assessment process, and the drivers of the risk assessment (opportunities for refinement and mitigation). He explained that Methidathion is a good case study because it is registered for 22 food uses, it is not the most or least toxic, there are a range of use patterns, and it illustrates each of the nine science policy issues. He also noted that Methidathion is not as complicated as some of the organophosphates; there is no cumulative risk assessment, and there are no residential or public health exposures.
Overview of Methidathion
In comparison to other organophosphates, Mr. Johnson explained that Methidathion falls in the middle for acute toxicity (0.2 mg/Kg) and at the low end for chronic toxicity (0.15 mg/Kg). It is one of the 18 organophosphates for which the FQPA 10-fold safety factor was removed. For perspective, Mr. Johnson noted that, of the other 22 organophosphates, the safety factor was: retained for nine; reduced to 3-fold for 10; and there are three decisions pending. He explained that Methidathion is a broad spectrum, non-systemic insecticide used for food. It is a wetable powder applied at the dormant (before fruiting) stage from the ground or aerially. Its highest use (total pounds AI) is on citrus, nuts, Stone and Pome fruit. Methidathion is also used in a smaller quantity on artichokes, olives, cotton, and safflower. Mr. Johnson noted that Methidathion is used primarily in California, with some use in Florida, Georgia, New York, Oregon, Virginia, and Washington. He noted that the sources of use and usage information are labels, USDA, grower groups, published literature, and Companies, including processing studies.
Hazard Identification
For background, Mr. Johnson reminded members that there are two major components to a risk assessment: the hazard identification and the exposure which are multiplied together to determine risk. In the hazard identification, EPA uses submitted data and data in the literature to identify the hazard. Mr. Johnson explained that, under 40 CFR 158.340, EPA identifies a standard set of data required for a food use chemical like Methidathion. In some circumstances, Mr. Johnson stated that additional data on immunotoxicity and developmental neurotoxicity are required. He explained that currently, developmental neurotoxicity studies are required when there is suggestive evidence of neurotoxicity concerns for developing organisms in the developmental, reproductive or other routine studies. Mr. Johnson recognized that the concern about when the additional information is required is an aspect of one of the science policy issues. In the case of Methidathion, the standard database is complete and a decision was made not to require data on developmental neurotoxicity.
Mr. Johnson explained that EPA evaluates the database to identify the most sensitive endpoints for chronic and acute dietary effects. For Methidathion, a one-year dog study was used to determine the most sensitive chronic dietary endpoint based on liver pathology and decreased blood cholinesterase activity. He stated that, based on these results, EPA selected the no observed effect level (NOEL) of 0.15 mg/Kg/day. For the acute dietary endpoint, Mr. Johnson noted that a NOEL of 0.2 mg/Kg/day was established based on blood and brain cholinesterase activity in a 90-day rat feeding study. He commented that the Registrants are preparing an argument suggesting that the NOEL would be more accurately set a 1 mg/Kg/day, based on another acute rat study. Mr. Johnson explained that EPA decided, based upon the weight of evidence, the 0.2 mg/Kg/day value represented the more sensitive endpoint.
Following Mr. Johnson=s description of endpoints, a member asked if it was common for the acute and chronic levels to be similar. Mr. Johnson responded that it was not unusual for these values to be similar.
Mr. Johnson then described the derivation of the chronic reference dose (RfD). He explained that the chronic RfD is calculated by taking the NOEL and dividing it by uncertainty factors. Mr. Johnson reminded members of the 10-fold factor applied to address differences between species (interspecies), and the 10-fold factor applied to account for differences between human beings (intraspecies). He noted that, in cases where there is question about whether the database is complete and whether a NOEL has been achieved, EPA may also apply an additional uncertainty factor B increasing the 100-fold uncertainty factor to 3 or 10-fold. Mr. Johnson observed stated that EPA applied only the 100-fold uncertainty factor [(0.15 mg/Kg/day)/10 X 10) = 0.0015 mg/Kg/day] for Methidathion.
The FQPA Safety Factor Determination
After the explanation of the chronic RfD, Mr. Johnson explained that FQPA Safety Factor Committee in the EPA Health Effects Division (HED) decided to remove the additional safety factor for Methidathion. The decision was based on: an adequate and reliable hazard and exposure database; no issues on special susceptibility; and well-defined exposure (e.g., through diet only).
Mr. Hansen requested clarification on what is meant by an increase in the uncertainty factor and whether it relates to the FQPA safety factor. Mr. Johnson stated that the increase described is due to the uncertainties, and the FQPA safety factor pertains to retaining, reducing or removing the 10-fold safety factor.
Dietary Risk Assessment
Mr. Johnson began his overview of the dietary risk assessment with a review of risk and chronic and acute dietary analysis. He stated the risk is a function of exposure and hazard, where the exposure consists of dietary residues and food consumption, including drinking water. He explained that the hazard part of the equation is the RfD for chronic, and the NOEL for acute risk. Mr. Johnson noted that EPA calculates risk for chronic dietary analyses as a percent of the RfD (exposure/RfD), and the risk for acute dietary analyses is calculated as a margin-of-exposure (NOEL/exposure = MOE). He stated that, for chronic dietary analyses, lower percentages (below 100 percent) are good, and higher percentages (greater that 100 percent) are bad. For acute dietary analyses, the reverse is true.
Mr. Johnson then explained that, in the case of Methidathion, the level of concern for chronic dietary analyses is unacceptable for percent RfD=s greater than 100 (the reference dose is used up). The level of concern for acute dietary analyses is unacceptable if the MOE is less than 100. Because of Methidathion=s toxicity and exposure, Mr. Johnson noted that EPA determined the need for a chronic, acute, and acute probabilistic risk assessment. He introduced the Dietary Exposure Evaluation Model (DEEM, licensed to the Agency by Novigen) which replaces the Dietary Risk Evaluation System (DRES) software. Mr. Johnson noted two important features of DEEM: it uses 1989-91 USDA food consumption data; and it is capable of doing both probabilistic and non-probabilistic risk assessments (e.g., Monte-Carlo modeling).
With this information as background, Mr. Johnson summarized the modeling results for the three types of risk assessments. The results of a chronic dietary risk assessment for the overall U.S. population show that the Tier I or unrefined assessments are unacceptable (680 percent). With refinements such specific processing factors and actual percent of the crop treated, the refined chronic risk assessment yielded an acceptable risk (five- percent). He noted that there are still opportunities for refinement including: using monitoring data such as Pesticide Data Program (PDP) data, using residue data resulting from typical application rates, maximum PHI; use of percent crop treated; processing factors; knowledge of consumer practices; and other special studies. Mr. Johnson added that the ability for further refinement may become important when the cumulative risk assessment of organophosphates as performed as appropriate.
For the acute dietary risk assessment, Mr. Johnson explained that EPA considered the 22 sub-populations provided in the DEEM model and chose to evaluate the risk to children from one to six years of age because they were the most highly exposed sub-population. They results of the acute dietary risk assessment for this sub-population show unacceptable risk for both the non-probabilistic and probabilistic (Monte-Carlo) analyses (MOE is lower than 100 in both cases). Mr. Johnson noted that the 10-fold safety factor, if applied, would be a key risk driver because the results of these risk analyses would be substantially lower than acceptable value of less than 1000. In addition, he commented that, for the probabilistic analysis, EPA chose to use the limit of detection (LOD) values for commodities that showed no detectable concentration of residues.
One member requested clarification on why EPA chose to use the LOD instead of one-half the detection limit when concentrations were measured to be zero. Mr. Johnson explained that they performed the analysis using the LOD, half the limit of detection, and zero, and there was very little difference in the results. He noted that the current practice is to use half of the limit of detection, and observed that this is one of the science policy issues under discussion.
Mr. Johnson then commented on how different assumptions change the risk estimates (MOEs) for children from the ages of one to six. He noted that, for all of the commodities including orange juice from oranges with the peel, the risk was unacceptable. Mr. Johnson also observed that that the results of the study show how many variables can influence the outcome of the risk assessment, including variations in how fruit are processed, the percent crop treated, and the use of PDP data.
A member asked if, in the Monte-Carlo analysis, the 99.9th percentile was used. Mr. Johnson responded affirmatively and added that, following his presentation, representatives of the software manufacturer will provide information on how the results may vary using alternative percentiles.
Overall, based on the results of the sensitivity analysis, Mr. Johnson summarized that: citrus, in particular, orange juice, drives the risk assessment; children from one to six years old are the most sensitive population; and the data base includes the maximum application and minimum PHI and incorporates chemical-specific processing data for oranges. He explained that additional windows of opportunity for refinements to acute dietary risk assessments are the same as those for the chronic dietary risk assessment in this case.
Drinking Water Exposure
Mr. Johnson reiterated that the draft drinking water assessment was not completed in time to integrate in the presentation. He noted that drinking water is not a driver in this risk assessment. Mr. Johnson summarized that the fate characteristics of Methidathion are that it has low leaching potential in groundwater, and it will not persist in runoff to surface water. He explained that EPA used modeling and monitoring data to determine drinking water exposure, and that aggregate exposure based on drinking water and food is in progress.
Risk Assessment Summary
Mr. Johnson summarized as follows:
Following Mr. Johnson=s presentation, Mr. Hansen commented that the example was helpful in showing how EPA applies various steps in the risk assessment processes. In the ensuing discussions, he urged members to focus on the policy issues surrounding the subjects discussed. Dr. Ehrmann then invited some of the individuals who worked with EPA on the case study to provide some comments. He introduced David Whitacre, Novartis Crop Protection, for his comments.
Mr. Whitacre began by explaining why Novartis and Gowan selected Methidathion as a case study. They were interested in an example to highlight the risk assessment process and they thought this would also be a way to assess EPA=s progress on the risk assessment for the product. Mr. Whitacre stated that it was helpful to see the example and they feel that EPA has done a good job. He noted that the risk assessment was complex and recognized EPA staff for all of the hard work. Mr. Whitacre then noted that the process of refinement is very important to determine >real risk=. He observed that, while there is a lot of experience with evaluating and refining chronic risk, evaluating acute risk is relatively new. He commented that it is critical to develop a database for acute risk to prevent unnecessary product loss. Mr. Whitacre stated that, when Congress passed FQPA, they did not intend product loss. In addition, he commented that Novartis and Gowan did not agree with EPA=s use of sub-chronic data in the determination for acute risk for Methidathion. They felt that acute data should be used to determine acute risk and that additional refinement in this area was necessary. Based upon their interpretation of risk, they feel that there should be something like a five-fold factor applied to the numbers presented by EPA, and the RfD being used is approximately one-fifth of the acute NOEL value of 1 mg/Kg/day. Mr. Whitacre noted that there are a number of other refinements, including market share and market basket use patterns that should be applied to obtain a more representative acute risk value. He noted that, for acute risk, the model does not account for the fact that 95 percent of the market for citrus is in California, a fresh market, and the remaining percent of the product is used in the Florida market. Mr. Whitacre summarized by observing that the potential risk posed by drinking water and worker exposure is not fully evaluated. He noted that Novartis and Gowan will continue to seek an appropriate database to help insure the results of these evaluations more accurately reflect actual conditions.
Mr. Whitacre then referred members to two overheads (Docket # OPP00537). The first over-head was a bar graph constructed after the presentation was put together to show the difference between aggregating the results of the group of children from ages one to six, versus evaluating each age group separately. He noted that, while the evaluation for ages five and six were not complete, the results for individual ages one through four were similar to the results for the aggregated ages one through six. He noted that, because the database used to evaluate the individual age groups is not as robust as the database for the aggregate, the confidence interval will be more for the individual age groups.
The second overhead discussed by Mr. Whitacre addressed the question of what percentile to use for the Monte-Carlo model. He explained that the database considered was for Methidathion for children aggregated ages one through six. Mr. Whitacre noted that the graph showed the variation in the MOE versus the percentile of exposure (e.g., 99.9th percentile versus the 95th percentile). Mr. Whitacre observed that the MOE changes substantially with minor changes in the exposure percentile, thus demonstrating the sensitivity of this parameter.
After Mr. Whitacre=s comments, Dr. Ehrmann invited Ms. Cindy Baker, Gowan, to comment on the presentation. Ms. Baker added that Gowan was interested in offering Methidathion to see, from the standpoint of one product, what policies drive the risk assessments. She commented on the substantial differences in the MOE based upon the percentile of exposure selected and the policy put in place. Ms. Baker noted that she is not advocating that there be some "bright line" percentile, but she commented that EPA ought to regulate to the percentile where they have verified that the data are reliable. In addition, Ms. Baker identified the treatment of "non-detects" as another critical issue. In the case of an active ingredient like Methidathion which is applied pre-bloom, it may be appropriate to use zero instead of one-half the detection limit. She observed that the example cued-up a number of important issues for discussion of many of the science policy issues.
Following Ms. Baker=s comments, Dr. Ehrmann invited Eric Olson and Dr. David Wallinga, Natural Resources Defense Council (NRDC), for their input on the presentation. Mr. Olson began by stating that he was pleased to see the risk assessment process exemplified using a specific chemical because it grounded the discussion. He raised two key issues with the presentation: (1) the 10-fold safety factor combined with the "reasonable certainty of no harm" issue; and (2) EPA=s decision to use the percent of crop treated in the determination of acute risk. He stated that EPA=s decision to remove the 10-fold children=s safety factor from 22 out of 40 organophosphates was of significant concern to NRDC. He also noted that the EPA Scientific Advisory Panel (SAP) recommended that, for any chemical that is a neurotoxin, a developmental neurotoxicity study be performed. Mr. Olson turned to Dr. Wallinga to comment on this issue in more detail.
Dr. Wallinga referred to the ninth slide in Mr. Johnson=s presentation on what constitutes a complete toxicity database under 40 CFR 158.340, and the fact that developmental neurotoxicity studies are required conditionally. He noted that this type of study has been performed on only six or eight pesticides. He commented that this history is cause to question the effectiveness of the criteria. Dr. Wallinga noted that the SAP suggested requiring a developmental neurotoxicity study for toxicants that are neurotoxic at their March meeting, and that HED of OPP is considering the same. He commented that, because both of these groups are supportive of developmental neurotoxicity studies for this type of pesticide, he would assume that the test would be necessary to determine a "reasonable certainty of no harm" to children. For this reason, he commented that it was hard to understand how a determination of risk can be made for Methidathion under FQPA. In addition, he noted that the tests that are required, general developmental and reproductive tests, are not sensitive with respect to neurotoxic endpoints and cannot be extrapolated to be adequately protective of infants and children. Mr. Olson summarized the comments by stating that NRDC believes the 10-fold safety factor should be applied where a neurotoxicant has not had a developmental neurotoxicant study. He also noted that there were other reasons to continue to apply the 10-fold safety factor, including the lack of data on drift for an aerially sprayed pesticide, and limited monitoring data on ground water.
Mr. Olson then commented on the percent of crop treated issue. He stated that it was a fundamental issue and noted that, based on the statute, the percent of crop treated may only be used when assessing chronic dietary risk. Mr. Olson noted that EPA is using the percent of crop treated, in this case, for determining acute dietary risk. He noted that there is a potential for children drinking orange juice to be overexposed to the pesticide, and expressed concern that EPA reduced the assumed exposure based on the percent of crop treated for an acute exposure in a circumstance which is inappropriate and not authorized by law. Mr. Olson stated that EPA should first evaluate the four required criteria before using the percent of crop treated: reliable data showing the percent of food treated; the exposure estimate does not show overexposure to any sub-population; regional sensitivities be addressed; and the finding be reevaluated periodically. He noted that NRDC does not feel EPA has met these criteria in this circumstance and percent of crop treated should not be used for Methidathion. Mr. Olson closed his comments by stating that NRDC believes that further refinements of the risk assessment for Methidathion will show increased risk.
Dr. Ehrmann then invited members of WG1 to comment on the presentation.
One member stated that it was sometimes valid to use the percent of crop treated in the determination of acute dietary risk due to regional differences of production practices and the need for certain products relative to use. He noted that, in the case of Methidathion, orange juice was recognized as a key risk driver early on in the Risk Assessment Process, as were regional differences in the use pattern (e.g., five percent of the pesticide is used in Florida where most of the oranges are grown, and 95 percent of the pesticide is used in California where less than one percent of the oranges are used in juice). He stated that, in this case, there is a good reason for applying the percent of crop treated and the production process as part of the risk analysis. In addition, he noted that there is an additional concern about the use of PDP data in the study from frozen concentrated orange juice. He commented that a substantial portion of the oranges used to produce frozen orange juice is from other countries where pesticide regulation is not as stringent. He also clarified that, while peals may be included in the juice extraction procedure, the oranges are washed three times before the juice is extracted, and the peal is only co-mingled with the juice for a short period of time. He observed that, if more information on actual residues were used in the study, the risk value would be different. A member commented that peals are not included in the production of orange juice in the US. They noted that, if the peal were used in the production process, the juice would be worthless because the liminen from the peal would make the juice very bitter. They stated that it was inappropriate for EPA to consider the production of orange juice without peals as a refinement.
A member commented that it was important in this process to be aware of unintended consequences, particularly as they relate to exported fruit. He observed that, in the case of exporting fruit from the US to Brazil, the limited use of organophosphates as part of an integrated pest management (IPM) program, was essential to addressing Brazil=s requirement for fumigation of the fruit. He noted that, without the use of the organophosphate for which there was no alternative, the contract with Brazil could be lost.
Another member asked for clarification on the underlying data points for consumption and residue distributions for Mr. Whitacre=s overhead on the 99.9th percentile. Mr. Johnson explained that the data were not readily available and commented that those are real issues that will be addressed as part of the uncertainty analysis in the Risk Assessment.
Several members felt that it would be helpful to include an explanation on how the ground water and residential components would be integrated in the Risk Assessment. Mr. Johnson agreed, and added that, while there was not residential exposure in this case, it would have been helpful to include the ground-water component of this study.
One member asked EPA to consider an example of a Section 18 to help clarify a concern of WG2 on what happens when the risk cup is full. They posed the example of a recent request by sorghum seed producers in Kansas for a Section 18 for the control of mites and the use of Supercide a non-food use on a limited acreage. They explained that they had contacted EPA to ask if they could declare a crisis and move forward. They noted that EPA did not authorize the use of Supercide and authorized Capture (a synthetic pyrethroid used in Texas) as an alternative. The policy issue they identified in this circumstance was that Supercide has a time-limited tolerance and Capture does not. In addition, they noted that Supercide is a substantially less expensive alternative than the alternative supported by EPA. Another member commented that it was silly to be denying Section 18=s for products which are clearly not food uses. They suggested that serious thought be given to the proposal on Section 18=s presented by the PPDC.
Mr. Johnson responded that, since Texas has been authorized for a specific use under a Section 18 on a food use, a time-limited tolerance would have been established. He explained that, EPA staff are confident, based on professional judgement, they can establish a time-limited tolerance for a Section 18. In an emergency, they may approve the use and reestablish the tolerance.
A member of the SAP provided some clarification on developmental neurotoxicity. They observed that Dr. Wallinga=s comments were correct but they explained that the SAP currently considered the developmental neurotoxicity studies to be part of the Tier II risk assessment which would be triggered by indications in the standard studies. They noted that the majority of SAP members felt that, if the pesticide worked by affecting the central nervous system, it would be prudent to perform developmental neurotoxicity studies routinely. However, they added that the SAP also felt the Agency should revisit the database on both developmental neurotoxicity studies and standard toxicity studies to see if one of the developmental neurotoxicants would have been missed with the standard testing. One member requested a status of the Agency=s progress on this comparison for some indication of whether we are learning anything new.
Susan Makris, EPA, Health Effects Division, explained that the Agency is in the process of compiling this information and has performed a preliminary analysis. She noted that the preliminary analysis is based on only seven neurotoxicity studies. The Agency expects to add one to the analysis soon. Ms. Makris noted that the Agency is not ready to release the preliminary analysis because it is waiting for the results of preliminary assessments of two of the chemicals included in the preliminary analysis. In addition, she commented that, before the preliminary analysis is released to the public, the Agency plans to have a group of Agency neurotoxicologists and developmental toxicologists review it. She noted that the study will also be presented to the SAP to help determine when to require a developmental neurotoxicity study, what the studies mean, and what are the appropriate guidelines for the study. Ms. Makris noted that, based on the seven studies which have been evaluated, the developmental neurotoxicity study is a sensitive study and the NOEL for the neurotoxic endpoints are similar to the NOELs selected for the Risk Assessments.
Many members felt the case study presentation was helpful because it highlighted a number of the science policy issues. EPA staff and Registrants involved with the study were thanked for their hard work. Another member agreed, but stated that TRAC members would like to have seen detailed information like this earlier in the process. They also noted that, while the example is helpful, it is not a good example for cumulative risk assessment. A third member commented that the example highlighted the complexity of the law and the process.
Several members commented on how the detection limit was applied (e.g., use of zero, half of the detection limit, or the detection limit). One member noted that whether zero or half of the detection limit is used has a major impact on the results of the risk assessment. In some cases, they felt it was appropriate to use zero as the detection limit, and they suggested that EPA clarify circumstances for when it is appropriate to use zero for the detection limit.
Other members commented on the 10-fold safety factor. Some members felt there was a need for EPA to assure the community that they would use a fair and even-handed process to evaluate when and when not to apply the 10-fold safety factor. As an example of why a clear and fair process is necessary, one member described an experience with EPA where decisions on whether or not to apply the 10-fold safety factor changed over time, as did the requirement for a neurotoxicity study. They commented that, as a result of the experience, it was not only unclear whether EPA received all of their submissions, but the policy itself was unclear. Mr. Hansen responded that one of the principle reasons the TRAC process was initiated was to prevent circumstances like that in the future. Another member expressed concern and confusion on the application of the 10-fold safety factor with regard to the neurotoxicity studies, and suggested that there be some additional explanation and discussion on the issue. They were particularly concerned about what factors determine when a neurotoxicity study should be done. An additional concern was whether sufficient time would be provided to the Registrant to perform a neurotoxicity study if required. Mr. Johnson explained that time was allocated for the study, if required. He suggested that the pivotal policy question was, what is done in the interim?
Several members questioned the use of percent crop treated in the study, particularly for the assessment of acute dietary risk. Some members noted that actual residue values should be used to determine risk. They suggested that the issue of using percent crop treated to determine acute dietary risk be added to the WG1 agenda for more detailed discussion. One member suggested that representatives of the House Commerce Committee be present at that Work Group meeting for this discussion for insight on their interpretation of FQPA on this issue. They also proposed that the issue of percent crop treated be a topic for a combined Work Group discussion at the August Work Group meetings.
One member requested clarification on the studies used to determine toxicity in the example. They wanted to know if any of the toxicity tests involved human testing. Dr. Whitacre responded that no human testing was performed for this study. While he was aware of some testing with this chemical on human beings 30 years ago, none of that information was used in this study. He explained that the toxicity results were based on tests on rats. One member suggested that, if the human testing is to be discussed by the TRAC, that it be identified as a topic for Work Group discussion. Some other members supported having additional Work Group discussion on human testing.
Another member commented that most of the refinements and mitigation noted in the study adjusted the perception of risk rather than actually reducing the exposures occurring. They proposed that, as the group begins to address the impact of mitigation efforts, it prioritize mitigation efforts that actually reduce exposures (e.g., pre-market interval), not just the perception of risk. Mr. Hansen stated that this was an important point and commented that the focus of the example in Methidathion was on Risk Assessment and more work is required on Risk Management and mitigation. The member added that Risk Assessment should be part of the discussion to help identify opportunities for simple mitigation like adjusting the pre-market interval rather than reducing the perception of risk through refinements.
A member commented on making better use of cutting-edge laboratory technology in the risk assessment process and providing more "real-world" data in the risk assessment process. They suggested that, if the LOD is lowered with cutting-edge laboratory technology, more violative residues will be detected, but the concern about the risk assessment process would be reduced. Mr. Hansen added that advanced technology could also help to address the unlevel playing field for imported produce.
One member asked for clarification on when the grower groups were involved in developing the sources of data. They commented that the opportunity and timing of involvement from parties external to the Agency is one of the concerns for WG2. In addition, they commented on the importance of the grower community taking the opportunity to be involved in the process.
Following these comments, the Co-Chairs shared some of their impressions. Mr. Rominger stated that the presentation and discussion were valuable. He stressed that, while the group began its discussion by talking about higher usage crops, it was important to note that lower usages may also be extremely important for selected crops in resistance management or an IPM program. Mr. Rominger also observed the importance of USDA working closely with EPA to help obtain "real-world" data, such as PDP residue data, for the Risk Assessment process. Mr. Rominger then turned to Bob Epstein, USDA, PDP, for additional information on PDP data.
Mr. Epstein commented on the USDA PDP orange sampling program. He noted that approximately 3,000 oranges were sampled from 1991 B 1996 on a year round basis. Mr. Epstein noted that fresh oranges are primarily a domestic product (more than 99 percent). He observed that the sampling results for fresh oranges closely mimic the fresh produce available to the American public. In contrast, Mr. Epstein explained that the sources for concentrated orange juice, which USDA started sampling in 1997, are multi-national. He also noted that USDA differentiates the sampling results from full liquid concentrate from frozen orange juice. Mr. Epstein commented that USDA samples for all of the chemical compounds of concern to EPA. Mr. Rominger added that the use of USDA=s residue data on oranges would have an impact on the risk assessment because the actual residue values ranged between 0.002 and 0.034, in contrast to the tolerance of 2.0.
Mr. Hansen commented on how EPA currently views human health studies. He noted that EPA considers this to be an important issue and observed that there is a 1990 requirement dealing with human health studies as they relate to EPA laboratory studies and research funded by EPA. He commented that broader associated issues are under review by EPA and will be presented to their Science Advisory Board (SAB) for additional input.
Presentation on Collaboration for Pesticide Risk Reduction
Sarah Lynch, World Wildlife Fund (WWF), presented an overview of a collaborative effort between the WWF and Wisconsin Potato and Vegetable Growers Association (WPVGA) to look at problems and solutions to toxic loadings that were threatening the health of people and ecosystems in the Great Lakes Basin. A copy of the slides for her presentation are in Docket # OPP00537. She noted that, as a result of the long-term study, they recognized that there were the following areas of agreement between the two organizations
She provided the group with some history on the successful use of IPM by Wisconsin potato farmers and their resulting relationships with their commodity association, and the University of Wisconsin Research and Extension Team. With the passage of FQPA, she noted that the potato farmers realized that their existing IPM programs would need to change. They focused their efforts on integrating the safest means of growing their crops, including biologically-based IPM and using safer, less hazardous products. Ms. Lynch explained that this recognition prompted members of WPVGA to partner with WWF to establish credibility on potential IPM, better address consumer concerns, and increase funding potential. She then described the collaborative process, how reliance reduction was measured, first year results, and lessons learned. Ms. Lynch noted that the model used by WPVGA and WWF exemplifies critical elements of transition strategy by: setting collaborative goals and timetables for reliance reduction; making sure credible transparent methods were used for tracking progress; and recognizing the importance of fully engaging and empowering growers so they can bring their technical and problem-solving skills to finding the lower risk solutions.
Ms Lynch noted the three key goals of the collaboration: setting measurable targets and timetables in the steep reductions in the reliance on highly toxic pesticides; preserving wildlife habitat and ecosystem function; and gaining marketplace recognition. She added that the collaboration decided to focus on acute (e.g., extremely hazardous, including two organophosphates and two carbamates) and chronic toxicity (e.g., endocrine disruptors). They established timeframes for eliminating the use of the targeted pesticides using biologically-base and other IPM systems, and better integration of habitat management and ecosystem function in farming systems.
She explained that the group had developed field testing methods which were evolving based upon experience in the field. The key aspects of measuring progress were: a transparent and credible process involving a broad set of stakeholders in setting goals and evaluating progress; and establishing baselines and indicators to measure progress over time. Ms. Lynch noted that the group agreed to use 1995 NASS pesticide data as a baseline where applicable, and alternative baselines to measure progress along the continuum towards the use of less conventional methods of pest control like biologically-based IPM.
Ms. Lynch summarized the first year of results. She stated that the collaborative progressed in defining the IPM continuum by collecting supplementary data and assigning practice points to measure the shift in the IPM continuum. In addition, they measured changes in pesticide risk based on toxicity and calculated toxicity units for each pesticide to include human health, ecological, and bio-IPM impacts. Ms. Lynch then showed slides on the progress in reducing pesticide reliance in Wisconsin and national trends in toxicity units in the potato industry to emphasize her point. She summarized her presentation on the study by stating that it is possible to achieve significant reductions in pesticide risk and reliance economically through commodity association leadership, strong multidisciplinary field-oriented IPM research, and using safer chemical alternatives. Ms. Lynch concluded that WPVGA and others have chosen pest management programs that meet society=s preference for reduced reliance on pesticides and a healthier environment and the need for economic viability. She observed that USDA and EPA have a similar challenge; how to allocate limited human and financial resources entrusted to them by taxpayers.
Presentation on Pesticide Use in Organic Farming
Stephen Pavich, Pavich Family Farms (PFF), presented an overview of insect and disease management in organic grape production using PFF as an example. A copy of the slides for his presentation is contained in Docket # OPP00537. Mr. Pavich stated that table grapes in California, a minor crop, represent approximately $ 900,000,000 dollars as a crop, on 90,000 acres. He noted that PFF organic grapes represent three percent of that total. Mr. Pavich explained that PFF shifted to organic farming methods in part because conventional farming methods were not effective. They refined their organic farming methods over time based on experience to address key insect pests in California grape production, including variegated leafhoppers, grape leafhoppers, spider mites, grape leaf skeletonizers, and mealybugs. He noted that conventional table grape growers use many pesticides to manage these pests, a number of which are organophosphates or carbamates.
Mr. Pavich then described some of the tools in organic farm management. He noted that the primary focus of organic farming is the enhancement of soil microbial populations through the addition of compost, incorporation of cover crops, and management of known trace element deficiencies and excesses. Mr. Pavich explained that this approach strengthens the inner physiology of the plant and improves its response to disease and insects.
To understand more about the emphasis on soil microbiology, Mr. Pavich explained that they perform a complete soil assay of the bacteria and fungi in the soil. Using this information as a basis, they try to determine how bacteria and fungi work in relationship to plant and insect diseases. He noted that, in their soils, they have identified many different bacteria and fungi at high concentrations which secrete enzymes that bolster the plant=s natural immune systems. Mr. Pavich observed that healthy immune systems help plants to ward off insect damage and other stresses caused by disease and adverse physical conditions. He stated that, where there are 10 B 15 species of bacteria and fungi in conventional soils, there are 70 B 80 species in organic soils.
Mr. Pavich also commented on additional organic tools that are used at PFF. They occasionally use bacillus thuriengensis as a non-toxic alternative to combat the grape leaf skeletonizer. In addition, they occasionally use insecticidal soaps to suffocate pests. He stated that PFF selectively releases predators and parasites to control pests like lacewings, trichogramma, and mealy worms. PFF uses cover crops to enhance the habitat for natural enemies and to substantiate soil with additional organic matter. Practices like leaf pulling and canopy management, are routinely used by organic and conventional farmers.
Mr. Pavich provided the group with some information on the costs of conventional versus organic farming for disease management in the wet El Nino year of 1998. In this case, the cost of disease management using conventional methods was roughly $100 to $150 more per acre than the cost per acre using organic methods. The per acreage cost is less in an average year. He noted that PFF was as successful or more successful using organic methods than conventional systems.
In closing, Mr. Pavich commented on what he saw as research needs. They included: farmer empowerment; holistic, on-farm research; and surveys of organic farming successes. He suggested that 25 percent of the existing research funds be allocated to organic farming systems.
Discussion on the Collaboration on Pesticide Risk Reduction and Organic Farming Presentations
Following these presentations, Dr. Ehrmann invited TRAC members to comment. TRAC members were appreciative of the presentations. Several members asked questions of clarification and others commented on the substance of the presentations.
Some of the questions posed by members are summarized below:
One member commented on the use of a toxicity index in Ms. Lynch=s presentation. While he supported its use, he suggested that it be viewed holistically, along with ecological, environmental, and sustainable indices. If considered alone, he felt there was a danger of jeopardizing other elements of the farming system. For a sustainable index, he commented that farmer empowerment, equity, opportunity, profitability, and unit inputs should be part of determining the sustainability of a production practice. He noted for an environmental index; the ability of an agricultural system to withstand the stresses imposed by exceptional weather and regulatory changes should also be factors. He recognized the need for additional understanding of soil health and suggested that USDA look into supporting research in this area. In addition, he observed that farming systems differ and that some are more complex than others. As a result, an organic farming system may be more or less successful in different circumstances. Another member added that regional differences are important to consider when evaluating farming systems.
A member wanted additional information on the process EPA and USDA use to identify alternatives for pest control, and what percent of the USDA budget is allocated to researching alternatives. Mr. Rominger explained that information on the research budget was not readily available, but that USDA was shifting some of its emphasis to sustainable agriculture. Mr. Rominger noted that the Pest Management Alternatives Program is offering an opportunity to move in this direction, and the USDA State cooperators are compiling non-chemical alternatives in the crop profiles. He explained that there are 450 crop profiles underway with the State cooperators around the country, and close to 1,000 profiles will be underway soon. Dr. Lynn Goldman, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances (OPPTS), EPA, added that EPA is trying to anticipate future issues, and through the Memorandum of Understanding (MOU) EPA has with USDA, is attempting to engage in planning ahead and having a better feed-back loop on potential needs. Also, Dr. Goldman stated that EPA is working with grower groups and others in the context of the environmental stewardship program to develop a better understanding of the issues. Other members noted that, while there are budgetary constraints, there is a lot of research on pest alternatives taking place in the academic environments and through agricultural extension services. They suggested that more effort be made to make people aware of the research and the alternatives, and to utilize these resources. A member noted that Extension services are overworked and underfunded. They commented that it was important to be aware of this when increasing the amount of work expected of them.
Another member commented that the two presentations illustrated that there is no absolute on viable pest control alternatives. Alternatives will vary regionally and across pest complexes. Based on these examples, they stated that it was important to be open-minded when evaluating alternatives.
Following this discussion, Dr. Ehrmann invited representatives of WG1 and WG2 to provide the group with updates on Work Group discussions.
Work Group # 1 Meeting Review
Mr. Johnson presented an overview of WG1 discussions. A copy of WG1 materials is presented in Docket # OPP00537. A summary of the key topics of discussion is presented below:
After Mr. Johnson=s overview, Dr. Ehrmann invited other WG1 members to add to the overview, followed by comments from other TRAC members.
One WG1 member commented that the distinction between what is meant by "error" versus "refinement" should be added to the summary.
A member requested clarification on how EPA will address comments, including the Implementation Working Group=s (IWG) ARoad Map@ Report on a science-based framework for implementing FQPA. Several members felt that it was important for the Agency to include the ideas in the ARoad Map@ in the Docket, and to integrate EPA=s current thinking for comment in the FRN. Mr. Johnson explained that the Agency will probably put the document on current practices out for Notice and Comment, and, during the comment period, they expect to address all of the input received. Mr. Hansen stated that the IWG document is important, and has influenced EPA thinking, as has input from others. He also observed that the TRAC process had evolved since its submission, and that the Agency intends to address all of the input from TRAC members. Mr. Rominger recognized the perception that, if EPA publishes interim guidance which does not reflect the input of TRAC or the IWG, there may be a perception that EPA has not heard the input. He observed that there was a concern about transparency, and EPA could help by clarifying how it intends to proceed and address the recommendations from the TRAC. Mr. Johnson added that, in the FRN that packages all of the information on the science policy issues, EPA will describe how they are going to proceed, including how they plan to address input in what timeframe. Mr. Hansen suggested that the FRN might include an overview of the issues raised by the TRAC on selected issues, and ask for comment on the issue and the alternatives suggested. He indicated that the preamble for the FRN might be used as a vehicle to represent where some of the major debate is, and where comments would be appreciated. Many in the group were supportive of Mr. Hansen=s suggestion to include a summary of the issues on the science policies in the FRN.
A member of WG2 stated that it would be helpful for them to have a copy of the interim guidance on the science policy issues for reference in some of their discussions. Other members also expressed interest in obtaining the document as soon as possible. One member suggested that EPA view the timeline for Staff Paper # 20 and the attachments detailing current practices separately. Mr. Johnson stated that EPA intended to wait to provide the detail about current practices until after the FRN is completed as the framework that ties everything together. The group agreed that they would prefer EPA to issue the attachment sooner and before the FRN package was complete, and prior to the Work Group meetings. EPA agreed to do this.
Several members commented on how the issue of testing pesticides on humans will be addressed within the TRAC process. One member viewed the question of human testing as a recently identified science policy issue which should be addressed by the TRAC. Mr. Hansen shared his first reaction which was that human testing, while it was a very important issue, was not a topic for the TRAC. He observed that several TRAC members felt human testing was more appropriately a topic for WG1 to discuss and bring back to the final TRAC meeting. Mr. Hansen left it up to TRAC members to decide when it was appropriate to address the subject of human testing. Another member felt that discussion on the issue was more appropriately left to the SAP and the public comment process.
One member requested clarification on WG1=s discussion on two issues: a format for the Preliminary Risk Assessment; and how HED uses data on percent of crop treated and PDP data. Mr. Johnson responded that the issues had come up and there had been extensive discussion on the percent crop treated. He noted, however, that WG1 had not yet heard details on when the percent of crop treated was and was not used. Mr. Johnson explained that WG1 had not discussed the use of PDP data in detail. The member commented that it was important for WG1 to have these discussions to help reduce the mystery of how EPA uses information on the percent of crop treated and PDP data.
Following the discussion, Dr. Ehrmann summarized that the group suggested that EPA issue the documentation on interim guidance on science policy issues, separately from the draft of the FRN on the process for addressing the science policy issues, to enable TRAC members to start evaluating that information. In addition, he noted that Mr. Hansen and Mr. Rominger clarified that they plan to address input from the TRAC in the FRN to provide a broader, >real-time= perspective on how to proceed on the science policy issues. He also noted that potential Work Group issues include: percent crop treated/acute dietary risk; neurotoxicity studies; FQPA safety factor; and a potential combined meeting of WG1 and WG2 to address overlapping issues. Dr. Ehrmann recognized that there was still some question about whether an additional WG1 meeting was necessary, but he suggested that WG1 members assume the meeting will take place on August 14 until the group hears otherwise.
Work Group # 2 Meeting Review
Jim Aidala, Associate Assistant Administrator, OPPTS/EPA, provided the TRAC with an overview of the WG2 discussions. He characterized their discussions as robust, and focused on Staff Paper # 22 (presented in Docket # OPP00537). Mr. Aidala highlighted the key elements of discussion including clarification of the process modeled in the flow-chart (also known as the >zig-zag= chart). In the flow-chart; he explained that WG2 members meant to portray the need to perform individual risk assessments to establish the basic science on the individual chemicals, while at the same time conveying the reality that it will take time to work out some of the essential science policies, such as how to perform cumulative risk assessments (e.g., it will take at least a year before EPA can perform a cumulative dietary risk assessment for organophosphates). Mr. Aidala stated that the flow-chart was also an attempt to address the question of what EPA will do in the interim by showing that different parts of the process can be performed concurrently. He added that the flow-chart tries to break out activities between the Risk Assessment and Risk Management phases under FQPA and under FIFRA. Mr. Aidala summarized by stating that the key concept relayed by the flow-chart is that not everything will be completed before addressing cumulative risk. At the same time, he noted that the flow-chart is meant to give clarity to what may happen in light of FQPA at least for dietary risk.
Mr. Aidala stated that WG2 also discussed issues and decision points for the organophosphate tolerance reassessment process. In particular, he explained that the group focused on the first set of questions relating to the mitigation of individual organophosphate risk endpoints. He noted that they grappled once again with the fundamental question of whether to complete individual assessments before performing the cumulative risk assessments, or whether to proceed by doing things in parallel. As a way to summarize the group=s convergence on the central question, Mr. Aidala referred to the following operational statement developed by WG2.
Mr. Aidala then invited Ms. Kay Holcombe, Executive Vice President, Policy Directions, Inc., to offer her perceptions of the WG2 discussions. Ms. Holcombe agreed that the Work Group converged on the preceding statement. She felt that the statement deals with the issue of EPA proceeding with the activities that can be done without waiting for cumulative risk assessments and therefor not doing anything in the interim, or doing things that can be done and delaying action on cumulative risk assessments. Ms. Holcombe stated that WG2 did not agree with either of these approaches, and developed the preceding operational statement as an alternative. She identified the following issues the Work Group raised with respect to the parallel process:
Jeannine Kenney, Policy Analyst for Pesticides, Consumers Union, stated that Ms. Holcombe has presented a good summary of the discussions. She suggested that it would be more consistent with FQPA to use the word Ainformation@ instead of the word Adata@ in the phrase, Aavailable, reliable data.@ Ms. Kenney noted that there were a number of concerns raised by WG2 members from the environmental community about using a phased approach. In particular, she observed that, while no one wants the regulatory process to stop moving forward as new science policies are developed, some are concerned about EPA undertaking such a tremendous task that they delay progressing on the cumulative risk assessment and risk mitigation under the FQPA. Ms. Kenney also commented that WG2 did not discuss the other important issue of when will EPA address water and residential exposure in the process, particularly where there is no clear method to quantify the exposure. She noted that the key question is the timing of when these components of the risk assessment will be developed and implemented. Ms. Kenney felt it was important for drinking water to be assessed, regardless of the debate over the status of modeling capabilities.
Following these comments, Mr. Aidala noted that WG2 also began its discussion on transition. He deferred to Therese Murtagh, USDA, for comments on transition. Ms. Murtagh characterized the Work Group discussion on transition as a good opening discussion on establishing principles for transition, transition time tables, and the research and information to support transition. She stated that the Work Group considered the need for a definition of an alternative, and that an alternative cannot just be a Apaper@ alternative. It was noted that transition strategies need to include consideration of resistance and resistance management. In addition, she explained that the group discussed: prescriptive use; USDA research; the value of state partnering; involvement of growers; the need for FQPA research priorities; and the information USDA is compiling on alternatives in their Pipeline Database that will assist in outlining transition strategies. She stated that the discussion on transition will continue at the August 13 B 14 Work Group meeting. Mr. Aidala closed the overview by adding that WG2 raised questions on science policy issues which may be appropriate for combined Work Group discussion, including the issue of Ano detection@.
Mr. Hansen asked Jan Relford, Senior Vice President, Research, Development and Quality of Gerber Products Company, and other representatives from the food processing industry for their input on the interpretation of Ano detection." Mr. Relford stated that zero should be zero and technology should determine what zero is. He explained that, from a food processor=s perspective, changing the detection level from zero to 20 when the food processor has been striving for zero, does not provide incentive for the processor to strive for zero. Mr. Hansen wanted to know more specifically whether, when posed with a detection level of 20, a food processor would use zero, half of the detection level, or 19 as a guideline. Mr. Relford offered to provide the Work Groups with additional information on how his industry addressed the Ano detection level@ issue.
Dr. Ehrmann then asked for comments and questions from other Work Group and TRAC members.
One member asked for clarification on the flow-chart and how decisions on individual chemicals will be made. Mr. Aidala shared two examples to respond to this question. One example was where there are unacceptably high worker exposure concerns, on the basis of FIFRA, EPA would have to take action without waiting for additional analyses. He explained that the action would be take to protect human health and the environment. In addition, the decision would help to determine the approach to the cumulative risk assessment. A second example is when a chemical crop combination is determined, based on refined data, to be 150 percent of its own risk cup, EPA would take action to reduce the risk. He commented that these were circumstances where action should be taken due to risk, regardless of how or when the cumulative dietary or aggregate risk analysis takes place.
A member commented on the issue of the detection level. They felt that zero should equal zero and expressed concern that the grower community will loose uses as a result of calling zero something other than zero. Mr. Aidala added that WG2 also discussed a related issue of imports and how they will be accounted for in the risk assessment. He noted that the question and concern of growers would be, based on the policy on the level of detection, "could EPA be encouraging off-shore production?"
Another WG2 member added that the Work Group also began a discussion on data refinement, and at what point the Agency will call-in additional data. In particular, she explained that one of their questions is, are the data that are already submitted by Registrants on dissipation rates going to be sufficient for EPA to extrapolate residue levels. She commented that the group planned to continue to consider this issue.
One member added that, in the Work Group=s discussion on transition, it was noted that the alternatives identified for transition must be viable alternatives when cost is taken into consideration.
A member commented on what the Work Group convergence statement meant to her. She felt it meant, Ado what you know how to do based on the information you have.@ Mr. Hansen added that, implicit in this statement is striking a balance between taking action and avoiding changing the goal post as a result of finding new issues.
Another member observed that the Work Group continued to be confused about the distinction between the way the terms Arisk assessment@ and Arisk mitigation@ are used, and there may be need for clarification. In addition, they commented that the Work Group discussed ideas for regulatory action within transition. They noted that the group also commented on the way USDA is related to this set of issues. Based on the TRAC discussions, they felt USDA has a key role in involving and informing growers in risk assessment and risk mitigation, and in research.
One member was concerned that, with the phased cumulative approach, there was a greater potential for changing the goal post in the risk process. In addition, they were supportive of mitigating risk before the cumulative risk assessment was complete.
A member added that the Work Group also discussed the issue of whether some tolerances can be determined acceptable at an early stage based on their high value and a small contribution to risk. She commented that WG2 felt this was an issue that should be discussed by the full TRAC.
Public Comment
Vern F. Highley, on behalf of Imperial County and Other Agricultural Interests B Provided the group with an overview of a resolution from the National Association of Counties that was passed on July 18, 1998 in Portland, Oregon. The resolution referenced the FQPA and expressed a concern that, if the review of registered pesticides is not conducted properly, there is a risk of reduced use of key pesticides. He urged EPA to recognize the potential impact on agriculture and consumers as it makes its decisions on pesticides. Mr. Highley also asked EPA to be aware of similar impacts on public health, and asked them to work closely with USDA and maintain the transparency of the process.
Barbara J. Petersen, Novigen Scientists B observed confusion on what was meant by market share, percent crop treated, and how it can and is being used in risk assessments. She explained that whether the crop is treated is a key factor in probabilistic assessments. She referenced an overhead (presented in Docket # OPP00537) to exemplify how percent crop treated is factored into risk assessments. She noted that actual field data with the full amount of residue are used to represent the percent of the crop treated, and zero is assumed for the untreated crop areas.
Ryley West, Parent B explained that she had to close her childcare center in Ventura, California because the children were exposed to pesticide drift from the abutting farm. She noted that there are many homes located close to farms that may be similarly exposed to pesticides. Ms. West commented that she and others complained about the circumstances and no action was taken. She recognized that farmers have a right to farm, but also stated that homeowners have the right to protect their health. She noted that the County developed an ordinance called AThe Right to Farm,@ which required the seller of a property to disclose that when living in an agricultural environment, it is assumed that there will be application of pesticides. Ms. West commented that, as a result of poor representation, homeowners in other areas are organizing to protect their children and their rights.
Other Issues
Following the public comments, one member expressed concern that some of the information on the children and infants safety factor for some of risk assessments on the nine organophosphates that will be released on August 10, 1998, will be in conflict with, and less protective than, the information published last week for the Environmental Working Group FOIA request. He noted that this is an example of why many people are concerned about the release of the preliminary risk assessments. Mr. Johnson commented that EPA is aware that a number of the preliminary risk assessment were done months ago and that, since that time, HED Hazard Identification Committee have reconsidered all of the organophosphates, in addition to reconsidering the FPQA safety factor. He noted that it is recognized that there are preliminary risk assessments which may be based on different endpoints or different FQPA safety factors. Mr. Johnson noted that EPA is aware that refinement happens, and they plan to address this by clarifying what each risk assessment represents. Mr. Hansen added that they recognize that the current process is a >pilot= which will be modified based on experience.
Another member commented that reliable data were essential to effective decision-making, and that EPA should not make decisions without reliable data. He added that the Indoor Residential Group joint venture is progressing on the use and usage data and the data will be available within the established timeframe. He supported completing the development of a process for cumulative risk assessment before making decisions to avoid the need to move the goal post. In addition, he noted that his organization plans to submit comments on the use of pesticides in schools for the Docket.
Summary and Next Steps
Closing Comments
Mr. Rominger commented that the group had a good discussion that brought out a lot of the key issues for the Work Groups and the final TRAC. He noted that the discussions highlighted the responsibilities that USDA has to continue its data gather in efforts and to involve others in the process. Mr. Rominger stated that he will call on the Land Grant University, Extension Services, and the grower communities to work with USDA to develop crop profiles. He stressed the importance of accurate information and the need to involve growers in the process of revising risk assessments. Mr. Rominger thanked TRAC members for their time and energy and stated that their input is having an impact on how EPA and USDA do their business.
Mr. Hansen supported Mr. Rominger=s comments. He also observed that the group had made a lot of progress but still had some important issues to address. Mr. Hansen stated that the progress of the TRAC had thus far surpassed his expectations. He commented that he looked forward to hearing the Work Group results, and felt that there might be some value in some combined Work Group discussion. Mr. Hansen reiterated the potential need to establish a sub-group of TRAC members to follow-up on some of the TRAC initiatives. He added that he hoped WG2 would explore the possibility of taking minor uses off-the-table early on in the transition process to assist in the transition without adversely impacting the overall risk. He stating that he looked forward to hearing more of the TRAC discussions and thanked members for their continuing commitment to the process.
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