TESTIMONY OF JAMES V. AIDALA
TESTIMONY OF and KEITH PITTS
JAMES V. AIDALA
ASSOCIATE ASSISTANT ADMINISTRATOR
OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES
U.S. ENVIRONMENTAL PROTECTION AGENCY
SPECIAL ASSISTANT TO THE DEPUTY SECRETARY
U.S. DEPARTMENT OF AGRICULTURE
SUBCOMMITTEE ON DEPARTMENT OPERATIONS,
OVERSIGHT, NUTRITION, AND FORESTRY
COMMITTEE ON AGRICULTURE
U.S. HOUSE OF REPRESENTATIVES
Good morning Mr. Chairman and members of the subcommittee. We are pleased to appear before you today to discuss the Environmental Protection Agency's (EPA) and the U.S. Department of Agriculture's (USDA) implementation of the Food Quality Protection Act (FQPA). Since last June, when former EPA Deputy Administrator Fred Hansen and USDA Deputy Secretary Rominger appeared before you, we have made many important decisions. Mr. Peter Robertson has joined us as Acting Deputy Administrator to work side-by-side with Deputy Secretary Rominger. In our follow-up remarks this morning, we hope to provide you and your subcommittee with a brief summary of where we stand at the moment in implementing FQPA, and our future plans. Since the passage of FQPA, and especially in the past ten months, significant progress has been made in strengthening public health protections.
Today is Earth Day. While communities around the country are planting trees, collecting roadside trash, and learning the importance of recycling, we are reminded of the significance of this piece of legislation. FQPA was enacted to provide greater food safety, especially for infants and children, and all of us are fully committed to achieving the protections embodied in FQPA.
Earth Day also allows us to recognize that farmers play a significant role in our economy and in environmental protection. The Administration realizes that we need to meet the mandates of FQPA in a manner that provides assurance to our farmers that they will continue to have the critical tools they need to grow our food. Mr. Chairman, both EPA and USDA are committed to the principle that safer food does not need to come at the expense of American agriculture. We believe we can strengthen environmental protection while maintaining agricultural growth. This is essential for the successful implementation of FQPA.
One year ago this month, Vice President Gore asked both EPA and USDA to employ four guiding principles to serve as the cornerstones of our efforts to implement FQPA. First, we should ensure that our pesticide and food safety regulatory decisions are grounded in the best available science. Second, our regulatory process must be transparent and predictable, so that consumers can continue to have full confidence in the safety of our food supply, and pesticide producers and users can depend on a consistent process. Third, the Agency and the Department must work together to provide a reasonable transition for growers to newer, reduced risk pesticides and pest control practices. And fourth, we must continue to reach out and open the process for participation by all interested parties whose opinions and experiences are proving to be exceedingly valuable. Since FQPA's enactment, EPA and USDA have developed new policies, created new programs, and established new procedures-- all firmly rooted in these fundamental principles.
In August 1996, EPA was presented with a new food safety law. We knew we would have to work more closely with industry, growers and the environmental community to meet the challenges outlined in FQPA. We are indebted to the members of the Food Safety Advisory Committee and the Tolerance Reassessment Advisory Committee (TRAC) who helped us devise a process for developing complex science policies, and design an effective pilot program for refining risk assessments for the organophosphate pesticides, both founded on unprecedented stakeholder participation. The TRAC was established by EPA and USDA in May 1998, and has met five times since then. Two Working Groups were also established, and they have met a total of ten times. This morning we would like to describe for you how we are implementing the recommendations of the TRAC and highlight some of the outcomes and accomplishments.
Key Science Policies As FQPA was immediately effective, the Agency needed to put into place procedures that allowed for early decision-making, both in setting new tolerances for emergency exemptions and new registrations and in tolerance reassessments. The Food Safety Advisory Committee, established after FQPA was enacted into law, assisted EPA in developing an initial decision logic to ensure that the Agency could continue to make decisions while important science policies were being developed.
Last October, EPA and USDA announced a framework for addressing nine key science policy issues, based on work done with the TRAC. As part of the framework, EPA published a schedule for releasing for public comment draft documents on each of these science policy areas. To date, 11 papers out of 19, covering seven of the nine science policy areas, have been released for public comment. The Agency has also identified four additional related policy papers not on the original list, one of which has been released for comment. This paper focused on anticipated residue data for the organophosphates. A complete list of the science polices and their current schedule for public notice and comment is attached in Table 1. The nine issues include:
- applying the FQPA 10-fold safety factor
- using "Monte Carlo" analyses for dietary exposure assessment
- interpreting "no residues detected" for exposure assessments
- estimating dietary exposure
- factoring in drinking water exposure
- assessing residential exposure
- aggregating exposures from all non-occupational sources
- conducting cumulative risk assessment for organophosphates OP) or other pesticides with a common mechanism of toxicity
- selecting appropriate toxicity endpoints for risk assessments of organophosphate pesticides.
As proposed to the TRAC, the Agency has been applying the science policies, as appropriate, in making regulatory decisions for both new tolerance decisions and for tolerance reassessments at the same time the policies are being refined through peer review and public comment. Our approach is fully and clearly set forth in each of the science policy papers published. We are utilizing our interim science polices in our risk assessments with the full knowledge that, as these policies are further refined, some of our decisions may need to be revisited. EPA currently expects to have virtually all of its science policies finalized before organophosphate risk management decisions are completed.
The OP Pilot Process To implement FQPA effectively and fairly, a well-defined and clearly communicated process must be followed. Because of intense interest in and the potential impacts of the tolerance reassessment process for the organophosphate pesticides, EPA and USDA turned to the TRAC to provide advice on possible regulatory approaches to reassessing the organophosphate pesticides--one that is both consistent and predictable. The TRAC was asked to help find a more effective way for the public to participate at critical junctures in the development of OP risk assessment and risk management decisions.
As a result of the TRAC discussions, EPA and USDA have set forth a pilot process for the organophosphate pesticides, complete with self-imposed deadlines for releasing the preliminary risk assessments, further refining the risk assessments, and providing for public participation on risk mitigation measures and practical transition strategies. The six phases are as follows (a more comprehensive description of each of the phases can be found in Table 2 ):
Phase 1 - EPA completes the preliminary risk assessment and sends it to the registrant and USDA for review.
Phase 2 - EPA addresses the comments it has received and amends the document.
Phase 3 - EPA releases the preliminary risk assessment for public notice and comment.
Phase 4 - EPA addresses the comments received and refines the risk assessment. The refined risk assessment is shared with USDA for review.
Phase 5 - The refined risk assessment document is released for public notice and comment. If warranted, EPA solicits the submission of risk management proposals.
Phase 6 - USDA and EPA work together to develop risk management strategies which will serve as the basis of EPA's risk management decision.
Recently, EPA and USDA met with a Working Group of the TRAC and identified the objectives and activities of phase 4 and phase 5. The fundamental principles of these two phases are: (1) intergovernmental review of the refined risk assessment, (2) presentation of the findings in a clear and understandable way to affected stakeholders and the public, (3) public participation in risk mitigation approaches, and (4) USDA and EPA collaboration in designing an appropriate and acceptable method to lower the risk to an acceptable level.
Thus far, 27 organophosphate pesticides have made it to phase 4, refining the risk assessments. Ten OPs have been sent to USDA, and the Department has completed its review of the revised risk assessments for four of them. The Department relies on experts from a number of internal offices for its review, and often consults with experts from Land Grant Universities and Extension Service as well. USDA's review, led by the Office of Pest Management Policy (OPMP), focuses on how EPA utilizes the data provided by USDA, such as use and usage data, pesticide residue data, and food consumption data, as well as the assumptions used by EPA and on possible strategies for managing the risk. Our recent experience with this process is that data and information provided by USDA has greatly assisted in the refinement of OP risk assessments.
EPA and USDA believe that the pilot process has served as a useful model to provide greater transparency and to encourage greater public understanding and participation. In addition, this novel approach has definitely delivered positive results--the public's ideas and input have been extremely useful. We are pleased to see that, in many instances, the new notice and comment process is resulting in the submission of additional health and environmental effects data, use data, and other relevant information which EPA is using to refine the risk assessments. The bottom line is that this pilot process has improved timeliness and quality of the data submitted to the Agency, and required a higher degree of discipline of all parties, particularly the two government agencies present here today.
Reassessing the OPs While not all individual organophosphate tolerances will be reassessed by the first deadline, we are making significant progress with this group of chemicals. So far, over three hundred organophosphate tolerances have been reassessed through tolerance revocation actions resulting from voluntary cancellations by the registrants of nine of the chemicals. Preliminary risk assessments for 10 OPs are now being prepared and are scheduled to begin Phase 1 this spring. Two OPs are in Phase 2; none are in Phase 3; and 27 OPs are in Phase 4. We expect that the tolerance reassessment for all the organophosphate pesticides will be completed in the year 2000.
"A Reasonable Transition for Agriculture" FQPA set new standards for pesticide use in food and feed crop production, and both agencies recognize that how the law is implemented may have important and far reaching consequences. We are particularly conscious of the potential impacts on minor crop growers and integrated pest management programs. USDA and EPA will continue to work with growers and registrants to focus attention and resources on those situations where limited crop protection alternatives exist.
FQPA reinforced our commitment to bring new and safer technologies to the marketplace. To be sure that pesticide users have access to a range of safer pest control tools, EPA is assigning priority to and expediting the review of reduced risk pesticides which might be used as alternatives to riskier pesticides--with special emphasis on organophosphate alternatives. Of 27 new pesticide active ingredients registered in FY 1998, 14 were done as a result of expedited review.
Both EPA and USDA also are focusing on reducing the risks of existing pesticides in a manner that accommodates growers' needs. Many existing pesticides will almost certainly be found to meet the new standard. However, when the risk of a pesticide is above the safety standard set by law, EPA must take regulatory action to manage the risk. EPA has identified a range of regulatory approaches for achieving risk management. This includes a number of options from amending the product label (a lower application rate, longer pre-harvest interval, or decreased number of seasonal applications may be enough to bring the risk down to acceptable levels) to the elimination of some agricultural and non-agricultural uses. We all agree, the most appropriate approach is dependent upon the level of risk.
Through the course of our growing experience with risk assessments, the data used, and the analytical factors, USDA and EPA have come to realize that, in some cases, a limited subset of commodities may be the most significant contributors to the total risk. EPA, in its risk assessments, will attempt to identify those crops/uses that contribute most to the risk, so that both the government and the growers can work together to devise effective and sensible solutions.
USDA is taking the lead role, in cooperation with EPA, in developing transition strategies for growers. USDA's strategy is, regardless of whether there are pending regulatory pressures, it is prudent for USDA to begin to work with growers and processors of the commodities that are anticipated to be major risk contributors and to proactively research and develop additional pest management tools, and for EPA to aggressively pursue the registration of promising new pest management tools. This approach will focus early attention on finding sound and effective approaches for mitigating risks and also serve to facilitate the transition process by minimizing any negative impacts on growers as the regulatory decision-making process proceeds.
Earlier this month, USDA presented transition considerations to one of the TRAC Working Groups and received some valuable input from the TRAC membership and EPA. On the basis of this discussion, USDA's Office of Pest Management Policy will begin to engage willing commodity groups, crop consultants, and food processors in establishing a foundation for constructing and implementing broad-based, commodity-specific transition plans. With the resulting information from this process, and Congressional support for USDA's proposed FY2000 FQPA implementation budget, USDA believes that U.S. agriculture will be insured with aggressive and reliable pest management strategies and a new research and implementation infrastructure that stays far ahead of the always evolving pesticide regulatory process. Furthermore, the remaining TRAC meetings will focus on formulating ways to gain grower input on practical, feasible, and affordable mitigation measures.
In today's competitive global market, The Administration is also very concerned about ensuring a level playing field for domestic growers. All food sold in this country, whether grown domestically or elsewhere, will be subject to the same tolerance standards. Any imported produce containing residues above the tolerance level, or any food with quantifiable residues for a pesticide that does not have a U.S. tolerance or exemption from tolerance for that food, will be considered adulterated and subject to FDA's enforcement authorities. We are concerned that food coming into our ports meet our stringent standards. EPA and USDA are interested in finding new ways to address the issue of imported produce. Some possible options would include encouraging advancements in technology to improve the ability to detect minute residues; promoting increased monitoring by the government and the private sector, possibly including growers or distributors; or requiring some form of certification or testing on the production end to ensure that there is a U.S. tolerance established for the commodity and that residues are within that tolerance level. EPA will continue to work with USDA, the Food and Drug Administration, as well as with our major trading partners through the North American Free Trade Agreement (NAFTA) and other international forums to ensure all food consumed in the U.S. meets our standards.
Some of Our Accomplishments Although EPA faced an initial adjustment period, the Agency's pesticide program is now performing at historically high levels that reach or exceed pre-FQPA levels. The pace at which regulatory decisions are made, in all facets of the program, is impressive. For example, the antimicrobial division has virtually eliminated its backlog of pending actions; 83 new pesticides have been registered; the current review time for FIFRA Section 18 emergency exemption requests is the best in EPA's history; 63 Reregistration Eligibility Decision documents have been issued; and over two thousand existing tolerances have been reassessed.
EPA is pleased to report that it expects to meet the FQPA deadline of reassessing 33% of all food tolerances by August 1999. Although we are working hard to meet our risk- and hazard-based priorities, a number of pesticides which may pose high risk will not be reassessed in the first 33% given the complexities involved. As of January of this year, of the 9,728 tolerances subject to reassessment, EPA has reassessed 2,308 tolerances, of which 303 are for organophosphate pesticides. We expect to reassess approximately 1,000 more tolerances by August to surpass the 33% target. This "first third" will consist of reassessments from tolerance revocations, reregistrations, and registration actions.
EPA has also reassessed a number of non-OP priority pesticide tolerances including 220 tolerances of the carbamates, 50 tolerances of the organochlorine, 187 tolerances of pesticides which are probable (B1) human carcinogens, 105 tolerances of pesticides which are possible (B2) human carcinogens, and 145 tolerances for other, unquantified C carcinogens for a total of 437 tolerances altogether. Another class of high priority chemicals, identified as possible carcinogens, are the high hazard "inerts." There are three such ingredients, formaldehyde, rhodamine B, and phenol, with a total of 24 associated tolerances. Formaldehyde, which has 22 of the 24 tolerances, is currently under review and should be reassessed by August 1999.
Resource Needs The new statute has significantly redirected, and added to, our programs' priorities and responsibilities. With the development and implementation of new policies, procedures, and outreach projects, resource needs to support these new activities are growing. For this reason, additional funding is important for ensuring smooth implementation of FQPA.
Both Administrator Browner and Secretary Glickman have identified implementation of FQPA as one of their top priorities. For EPA, the Agency is seeking increased funding that will be dedicated to accelerate registration of new pesticides, including reduced risk and biopesticides. USDA is devoting significant effort and is requesting additional funding in its FY 2000 budget to help grower groups develop strategies that will result in reduced risk but still ensure adequate pest control.
An important part of achieving the Administration's goals in implementing FQPA as laid out in the Vice President's memo and the recommendations of the TRAC is winning Congressional support and approval of the President's Budget currently pending before Congress. The FY2000 budget provides targeted increases to FQPA and other high priority initiatives within overall legislated budget targets.
The Future FQPA implementation is proceeding significantly and efficiently. We now have a process in place through which we can successfully tackle all of the provisions of the law. While we know that there are still important issues that need to be resolved, we are confident that with continued broad stakeholder input, we will reach sound, open, and common-sense solutions. The FSAC and TRAC's contributions have been immeasurable. EPA and USDA will continue to seek broad stakeholder input and are exploring options, including use of the Pesticide Program Dialogue Committee and other forums, to provide stakeholder input on all pesticide issues.
Throughout the implementation process of FQPA, it is important not to lose sight of the fact that agriculture in this country, and throughout the world, is constantly changing. Farmers, like all others in business, must keep pace to remain profitable. New technologies, global markets, fluctuating commodity prices, and government regulations affect not only the producer, but everyone who shops at a grocery store. FQPA presents EPA, USDA, and our many stakeholders with a unique and important opportunity to help farmers and other pesticide users move to safer pest control tools and methods while improving public health protection.
Meeting the FQPA mandates demands an effective multi-front effort to complete the many necessary tasks. While the last three years have been busy, the last ten months have been even busier. As you can see, much has happened since the last time EPA and USDA appeared before your subcommittee. Indeed, significant progress has been made to date, and we are proceeding at an expeditious rate. We have reaffirmed our commitment to using sound science in all our decisions so that they are reasonable and consistent; we are committed to transparency so that our process can be understood and followed by registrants, growers, the environmental community, and all interested people; we have begun the development of transition strategies so that growers have the tools necessary to respond to changing pest control needs; and we are and will continue to extensively consult with all stakeholders on any issue related to pesticides so that we can achieve a workable, open, and accountable regulatory process.
Thank you for the invitation to appear before your subcommittee this morning. We will be happy to answer any questions you may have.
AND RELATED PAPERS
(As of 4/12/99)
Draft Released for Public Comment
Final Policy Published
|1. Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity||8/6/98||2/5/99|
|2. Office of Pesticide Programs' Science Policy on the Use of Data on Cholinesterase Inhibition for Risk Assessments||11/5/98||5/99|
|3. Guidance for the Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs||11/5/98||8/99|
|4. Proposed Threshold of Regulation Policy When a Food Use Does Not Require a Tolerance||12/4/98||5/99|
|5. Assigning Values to Nondetected/ Nonquantified Pesticide Residues in Human Health Dietary Exposure Assessments||12/4/98||6/99|
|6. A Statistical Method for Incorporating Nondetected Pesticide Residues into Human Health Dietary Exposure Assessments||12/4/98||6/99|
|7. A User's Guide to Available OPP Information on Assessing Dietary (Food) Exposure to Pesticides||1/4/99||5/99|
|8. Dietary (Drinking Water) Exposure Estimates||1/4/99||7/99|
|9. Framework for Assessing Non-Occupational/Non-Dietary (Residential) Exposure to Pesticides||1/4/99||6/99|
|10. Standard Operating Procedures (SOPs) for Residential Exposure Assessment||1/4/99||6/99|
|11. Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern (99.9 percentile)||4/7/99||9/99|
|12. 10X Task Force and OPP Guidance Documents (three documents altogether)||4/99||9/99|
|13. Standard Operating Procedures (SOPs) for Use of the FQPA Factor||4/99||9/99|
|14. Guidance for Performing Aggregate Exposure and Risk Assessment||5/99||10/99|
|15. SOP: Interim Guidance for Conducting Aggregate Exposure and Risk Assessment||5/99||10/99|
|16. Use of the Pesticide Data Program (PDP) in Acute Dietary Assessment||5/99||10/99|
|17. Cumulative Risk Assessment Guidance||9/99||2/00|
|18. Drinking Water Screening Level Assessment||8/99||1/00|
|19. SOP for Drinking Water Assessments, including Reservoir Model||8/99||1/00|
|Additional Related Policy Papers|
|1. Data for Refining Anticipated Residue Estimates Used in Dietary Risk Assessments for Organophosphate Pesticides||4/7/99||9/99|
|2. Interim Early Assessment Policy for Organosphosphate Pesticides||4/99||9/99|
|3. The Role of Use-Related Information in Pesticide Risk Assessment and Risk Management||4/99||9/99|
|4. Interim Human Testing Policy Guidance||6/99||11/99|
PILOT PROCESS FOR ORGANOPHOSPHATE TOLERANCE REASSESMENT (1)
|Registrant "Error Only" Review. EPA sends its preliminary risk assessment to the registrant(s) for a 30-day error correction review only. The registrant(s) are not allowed to comment on the assessment itself. The preliminary risk assessment is also shared with USDA. Both the registrant(s) and USDA are asked to correct any computational or other errors that EPA has made in developing its preliminary assessment.|
|Consideration of Registrants' and USDA's Comments. EPA summarizes and considers the comments it receives. EPA corrects any errors identified and amends the preliminary risk assessment document. During this phase EPA opens a Public Docket for the chemical.|
|Preliminary Risk Assessment is Released for Public Comment. EPA publishes a Federal Register Notice announcing the availability of the preliminary risk assessment. The public review period is 60 days. Registrant's, grower groups, other stakeholders, and the public at large are encouraged to submit data and other information that would aid EPA in refining the risk assessment. Suggestions for risk mitigation proposals to address any risk concerns identified in the document are also solicited. Stakeholder meetings may occur.|
|Refining the Risk Assessment. At the close of the comment period, EPA summarizes and considers the comments, data, and other information received during Phase 3. EPA refines the risk assessment and identifies any crops that are driving the risk. The document is sent to USDA for review. Following receipt of USDA's comments, EPA and USDA will hold a technical briefing.|
|Calls for Risk Management Ideas. EPA releases the refined risk assessment and announces in the Federal Register its availability along with a formal call for risk management proposals. Registrants, growers, other stakeholders, and the public are encouraged to respond and have 60-days in which to submit their proposals. EPA and USDA may hold stakeholder meetings.|
|Development of Risk Management Strategies. EPA considers all of the risk management proposal received. With input from USDA, EPA develops a set of risk management options that will ultimately contribute to the Agency's risk management decision for the pesticide chemical.|