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June 25, 1998

Good morning, Mr. Chairman and Members of the Subcommittee. I am pleased to appear before you today to discuss the Environmental Protection Agency's (EPA) implementation of the Food Quality Protection Act (FQPA).

Enactment of FQPA was an unprecedented example of cooperation among EPA, the U.S. Department of Agriculture (USDA), and the Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA); between the Administration and Congress; and between government and growers, pesticide producers, public interest groups and other stakeholders. This cooperation resolved years of controversy to assure better protection of the public, particularly our children. As a participant in the years of debate, and understanding the need for this law, EPA is committed to making FQPA work effectively and fairly and to honoring the intent of Congress.

Safeguarding our children's future is a hallmark of the Clinton Administration. We are confident that we are achieving better protection for children while preserving the strength of our Nation's agriculture and its farm communities. Implementing the law has presented significant new scientific challenges. It has resulted in unprecedented interaction between regulators and the regulated and among the multitude of stakeholders. EPA is committed to an open and transparent process to balance these varied interests and opinions with FQPA's statutory requirements.

Since enactment, EPA has accomplished much. Within a month after passage, we formed the Food Safety Advisory Committee (FSAC) which helped with the development of an interim decision logic that would allow us to make regulatory decisions which met the FQPA standard and that were immediately effective. As we have built on the interim logic, we have used peer review and stakeholders to discuss major new risk assessment approaches. In March 1997, EPA published an Implementation Plan detailing the steps that needed to be taken to implement FQPA. Realizing the importance of ensuring that pesticide users have the necessary tools, the Agency has continued to register important new pesticides and to provide emergency exemptions where needed. Since FQPA passed, the Agency has registered over 45 new active ingredients and granted around 650 emergency exemptions under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA has established or enhanced several new opportunities for stakeholder participation, such as the Food Safety Advisory Committee, the Pesticide Program Dialogue Committee, the Endocrine Disruptors Screening and Testing Advisory Committee, and the newly formed Tolerance Reassessment Advisory Committee. The Agency also published the schedule for tolerance reassessment, began the process of gathering usage information for regulatory purposes, and completed the bulk of the preliminary individual risk assessments for the organophosphate pesticides. We established a minor use team within the Pesticide Program. We also established an Antimicrobial Division, significantly reduced the antimicrobial backlog, and processed every application subject to FQPA provisions within the review times prescribed by the law.

As with any major change in law and regulatory process, initial implementation activities may raise concerns among the numerous stakeholders whose lives, livelihood and practices are potentially affected. In April, the Vice President requested EPA and USDA to ensure that implementation of FQPA follows four guiding principles. First, ensure that our pesticide and food safety regulatory decisions are grounded in the best available science. Second, the regulatory process must be transparent and predictable. Third, ease the transition to new pest management strategies for affected pesticide users. Finally, consult with the diverse stakeholders whose opinions and experience are essential to successful implementation of FQPA. I will use my time today to discuss our progress in each of these four areas.

At the core of FQPA are several basic concepts: risks are to be examined in an integrated or aggregated fashion; cumulative risk among chemicals that act in a common way must be considered; and protection must be provided where special sensitivities exist, particularly for infants and children. These are fundamental changes to the pesticide regulatory system but all of them have their roots in work that was already being done by the scientific community, by EPA, and by many others prior to enactment of FQPA.

To assist in this process of change, EPA issued a notice to all pesticide registrants within six months of enactment summarizing the law and outlining the interim logic to be used in making regulatory decisions while final scientific policies were developed. The logic was developed through discussions with the Food Safety Advisory Committee, a group which I chaired, consisting of the principal pesticide stakeholders formed in September 1996. This interim approach allowed us to make regulatory decisions that meet FQPA's standard and that could be refined if additional information became available, or as the science or our understanding of the science evolved. The interim decision logic allowed the Agency to continue to base its decisions on sound science, available reliable data, and reasonable assumptions, when necessary, to protect the public health.

As EPA's approach to implementing the scientific provisions of FQPA has evolved, the Agency has sought independent review. Since FQPA passed, EPA has made presentations at six meetings of the FIFRA Scientific Advisory Panel (SAP) on topics such as the FQPA safety factor, common mechanisms of toxicity, residential exposure assessment, testing methods for reproductive effects, and drinking water exposure assessment methods. We have worked closely with the International Life Sciences Institute (ILSI) on common mechanisms of toxicity and drinking water exposure. Just one week ago, the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC) and EPA reached a consensus on an approach to testing and screening for pesticide effects on the human endocrine system. Since many of the approaches to scientific issues under FQPA have potential to be used in areas other than pesticides, we formed intra-agency groups to address issues such as the additional safety factor, common mechanisms of toxicity, and drinking water risk assessments.

Making regulatory decisions using sound science and the best available data is very important to EPA. Pesticides are among the most thoroughly studied substances regulated by EPA. In addition to the wide range and high number of studies required from pesticide registrants, EPA has access to data on food consumption and on measured pesticide residues from USDA and FDA. EPA also receives advice from HHS on public health pesticides. There is also a growing body of data on pesticides in water compiled by the U.S. Geological Survey and others. Finally, we have been encouraging registrants and users to provide additional information they may have to ensure the best decision making possible.

In any particular case, when EPA evaluates a pesticide, final decisions will be based on the best data available. We rely on actual measured exposures supplemented with scientifically reviewed models which are themselves rich with data. Where additional data are critical to making a sound decision, EPA will require those data.

The scientific concepts embodied in FQPA are complex and the regulatory decisions flowing from their application can potentially affect many stakeholders. The Agency is working to assure that our science policies, our risk assessments of individual pesticides, and our process for decision making are all as transparent and open as possible. We recognize how important it is for us to properly communicate our policies so that the public can have confidence that it is being protected and growers and registrants are better able to plan for the future.

Transparency is one of the foremost topics we have been discussing with the newly formed TRAC. In particular, we have been working with the TRAC to identify how to improve the transparency of our implementation activities. TRAC workgroups have identified three primary areas to be addressed:

  1. development of a framework for refining risk assessment policies including the use of a ten-fold safety factor for infants and children, methods for drinking water exposure assessment, methods to conduct residential and other non-occupational exposure assessments, how to aggregate exposure from all sources, and how to conduct a cumulative risk assessment for groups of pesticides that operate with a common mechanism;
  2. development of a process for refining risk assessments for specific chemicals (e.g., organophosphates); and
  3. development of a process for making tolerance reassessment decisions that also provides for reasonable transition to new pest management strategies where needed.

The TRAC met this past Monday and Tuesday and expressed their support for the direction that the workgroup discussions were taking and specifically for the concept of a comprehensive framework addressing each of the three components. The TRAC is not only assisting EPA and USDA in building a framework for implementation, it is helping to forge a partnership of all parties that is necessary to successful implementation of FQPA. Once this framework is further refined EPA will, through notice and comment, make it available for broader public review. After comments have been received, the Agency will begin implementation of the approach articulated in the framework. It is important to note that in the interim, EPA will continue to use sound science and the process we have already established to make decisions on new pesticides, applications for emergency exemptions, and to continue the reassessment of older pesticides.

Pest management strategies are rapidly changing. This change represents an opportunity for a safer but still abundant and affordable food supply, and for better protection for workers exposed to pesticides and for our environment as well. It is likely that FQPA's new standard may result in modification or cancellation of some currently existing pesticide registrations. EPA wants stakeholders to be able to anticipate and plan for our actions and to have access to new pest management tools where they are needed. We need to balance the reassessment of tolerances to achieve the important health protections called for by FQPA with the introduction of new products and pest control methods to help ensure that a broad range of alternatives are available.

FQPA sets dates for EPA to accomplish tolerance reassessment: completing roughly one-third of the reassessments by August 1999, two-thirds by 2002, and the total by 2006. FQPA also requires EPA to give priority to those chemicals which appear to pose the greatest risk to public health. The Agency's schedule for reassessments was published in the Federal Register of August 3, 1997. Among others, EPA is giving priority to the reassessment of the organophosphates, a widely used class of pesticides.

It is our goal to complete the reassessment of the organophosphates in these early years of FQPA because of the significant risk issues posed by this class of chemicals. We are also reassessing tolerances for many other pesticides. We expect to have completed the reassessment of a large number of non-organophosphate pesticide tolerances by August 1999 and we remain on track to include reassessment of some or all of the organophosphate tolerances in the early phase of tolerance reassessment. Completion of tolerance reassessment will lead to either retention of a tolerance, or to modification in the levels of residues permitted under the tolerance, or to revocation of the tolerance after some appropriate period consistent with such principles as sound management of existing pesticide stocks, transition to alternative practices, and public health and environmental protection. The Agency is confident it can meet these goals, and meet them in the scientifically sound and open manner intended by Congress.

In the past few years, EPA has accelerated its efforts to provide better, safer choices for pesticide users. Prior to enactment of FQPA, EPA had significantly streamlined its registration process for new pesticides, increasing productivity and reducing review and decision times. The new work created by FQPA has had an effect on the registration program as well as our reregistration program. We recognize that there have been concerns over the pace of registering new pesticides post-FQPA. However, despite the delays experienced immediately after passage of FQPA, EPA has registered over 45 new pesticide active ingredients. Fiscal Year 1997, the first full fiscal year after the law passed, was the second best year ever for production of decisions by EPA's pesticide office. While decision making on new uses of already registered pesticides has been down, our productivity in that area is increasing as well. Our goal for Fiscal Year 1998 is to register 99 uses, both food and non-food, and to this point we have successfully registered about seventy-five percent of that total. I am also pleased to announce that the Administrator and I are allocating additional funding for the pesticide registration program, which will allow for the completion of reviews for additional new active ingredients above the projected total for Fiscal Year 1999.

In addition, the Agency has created two new programs aimed at expediting reviews and ultimately market entry of lower risk products and safer substitutes. First, we created the Biopesticides and Pollution Prevention Division within our Office of Pesticide Programs. The types of products registered in this division generally have a non-toxic mode of action. About half of all new active ingredients registered post-FQPA have been for biopesticides.

The second program, the Reduced-Risk Pesticide Program, was established in 1993. Applications that come in under this program are placed at the head of the review queue. This program clearly provides an incentive for companies to develop lower-risk products and safer substitute products. Since organophosphates are among the first pesticides being considered in tolerance reassessment, EPA recently proposed a draft policy to give expedited consideration to applications for reduced risk pesticides that may be alternatives to this class of chemicals.

EPA also works closely with USDA to ensure that the impact of our regulations and decisions on growers is considered. USDA has committed to enhance research and development of alternative pest control methods and EPA has committed to expediting review of any products that result from this effort. Our two agencies have a Memorandum of Understanding to foster cooperative efforts to provide replacements for pesticides that are likely to be subject to cancellation or suspension by EPA, or are subject to voluntary cancellation based on risk or economic concerns. This program is particularly important for minor use crops which may face a lack of safe and effective pest management alternatives.

EPA recognizes the unique situation that minor uses face and has a number of activities to facilitate new, and maintain existing, minor use registrations during this transition period. We have created a minor use team with an ombudsman within the Pesticide Program, and have broadened our communication efforts with growers and trade associations concerned about minor use issues. Registration applications for minor use pesticides receive expedited review.

FQPA added a new requirement that EPA establish tolerances for all emergency exemptions under FIFRA Section 18 which affected the Agency's ability to act quickly on requests in the first year after FQPA passed. Since FQPA passed, the Agency has approved approximately 650 emergency exemption requests. This year, we have significantly reduced the time needed to review Section 18 requests. EPA also soon expects to publish a proposed rule in the Federal Register addressing tolerance setting under Section 18, as required by FQPA. Similarly, under the direction of the Vice President's memo, EPA will be working with USDA and other concerned stakeholders to determine ways to streamline the Section 18 process.

As I have mentioned throughout my testimony, because one key to proper implementation of FQPA is consultation with interested stakeholders, we have created new mechanisms to consult with stakeholders and take advantage of their input as much as possible. We need to consult with growers and registrants so that they have an understanding of our process and are able to provide us with data necessary to make regulatory decisions. We need to consult with consumers so that they are confident that the food they purchase and feed their families is safe. We need to consult with environmental/public interest groups and public health officials to ensure that we are providing adequate protection for the public, particularly infants and children. Consultation allows us to consider all views and leads to more credible regulation.

General consultation between USDA and EPA has increased as well, building on the Memorandum of Understanding between the two agencies for work on pesticides. As Deputy Secretary Rominger's testimony indicates, USDA has formed a new office to deal specifically with pesticide issues and to act as liaison with EPA's Pesticide Program. The two agencies have formed a senior manager-level working group to coordinate and advance mutual work on a variety of pesticide issues and to support the efforts of the TRAC.

While the newly formed TRAC has been asked to focus on the reassessment of tolerances for organophosphate pesticides, their advice will assist EPA and USDA not only with that group of chemicals but also with tolerance reassessment as a whole. As I noted earlier, some of the issues that the Committee is addressing include: developing an appropriate process for making tolerance reassessment decisions under FQPA; the proper framework for deciding the types and amount of scientific information needed to make decisions; ways to increase the pace of decision making to provide growers with newer and safer pesticides and new uses of registered pesticides; strategies for reducing risk to acceptable levels while retaining pesticides of the highest public value; identifying opportunities for reasonable transition mechanisms; and fostering improved communication and understanding among stakeholders and assuring appropriate public participation in Agency decision making.

The Agency takes the results of all of these consultations very seriously. Given the sometimes widely divergent perspectives of the many pesticide stakeholders, it is not always possible to develop policies that are unanimously supported. But, because we are all committed to achieving the protections offered by FQPA and to maintaining an abundant and affordable food supply, EPA, USDA, HHS, and our stakeholders will be able to meet the goals of FQPA in a sound and timely fashion.

FQPA is an important public health protection statute. It provides for a consistent, health-based standard that will provide greater protection for consumers, particularly infants and children. It promotes newer, safer methods of pest control. It provides consumers with more information so that they can make more informed choices about what they feed their families. I believe that the U.S. has the safest, most affordable, and most abundant food supply in the world and that status should be further enhanced by FQPA. There is no reason that FQPA's standards cannot be met while maintaining the tools that growers need, and this Administration is committed to ensuring that goal is met.

We are using sound science so that our decisions are reasonable and consistent; we are working to ensure transparency so that our process can be understood and followed by registrants, growers, and the public; we have begun work to establish an adequate transition policy so that growers and other users have the tools necessary to respond to changes in pest management; and we will continue to consult with all stakeholders. We are achieving a workable, balanced process that allows us to meet FQPA's standards while maintaining the strength of U.S. agriculture. I look forward to working with you as we implement this important law. Thank you for inviting me to appear before your Subcommittee this morning. I would be happy to answer any questions that you may have.

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