Depression. Fortunately, with some luck, some brains, and some student loans, I was able to attend some of the Nation's leading universities. From there, I have been fortunate to be able to devote my career to public service and environmental protection. For me, serving in this position will provide an opportunity to give back some of what society has afforded me.

I look forward to working with the Congress as we move forward on finding better solutions to today's environmental and public health challenges. Thank you for the opportunity to appear before you today. I'll be glad to answer any questions you may have.

RESPONSES BY JAMES V. AIDALA TO ADDITIONAL QUESTIONS FROM SENATOR SMITH

Question 1. As the Assistant Administrator for Toxic Substances at the Environmental Protection Agency, with oversight of all pesticide and industrial chemical toxicity testing, what will you do to prioritize Agency funds and other resources toward the research, development, validation and implementation of non-animal test methods into the programs you oversee?

Response. The Office of Prevention, Pesticides, and Toxic Substances (OPPTS) is working closely with EPA's Office of Research and Development (ORD), and with other Federal agencies including the National Institute for Environmental Health Sciences (NIEHS) (which has been designated by Congress as the Federal Government's lead agency for alternative testing methods development) and the National Toxicology Program, to address the validation of alternative, nonanimal test methods.

EPA has prepared an Interagency Agreement (JAG) with NIEHS in which EPA commits to provide $250,000 this fiscal year, and an additional $250,000 in fiscal year 2001, for alternative test method development. EPA and NIEHS are sponsoring a workshop this Fall under the auspices of the Interagency Coordinating Committee on Validation of Alternative Methods (ICCVAM), to address the validation status of various alternative non-animal test methods for predicting acute toxicity. The funds committed through the IAG will be used to fund research on and validation of the most promising techniques. In addition, the Office of Science Coordination and Policy within the Of lice of Prevention, Pesticides, and Toxic Substances is examining making available additional funds to support future workshops on alternative test method development and validation.

Question 2. In 1999, the EPA invested approximately $70,000 into a rapid, costeffective, humane test method, commonly referred to as the High Throughput PreScreen (HTPS). It is my understanding that Congress appropriated significant funds for the research and development of the HTPS for incorporation into the Endocrine Disruptor Screening Program.

Why has EPA discontinued consideration of this promising method?

Response. The results of the Agency's $70,000 feasibility demonstration study of the HTPS process were deemed unreliable following external scientific peer review by a joint committee of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel and the EPA Science Advisory Board. Nonetheless, EPA continues to evaluate other methodologies to screen and prioritize chemicals under the EDSP. At this time, it appears that similar information can be more efficiently derived from computer simulation models that predict endocrine activity from the molecular structure of chemicals. The Agency is actively pursuing development of these models including their validation using non-animal receptor binding

assays.

The proposed use of a Quantitative Structure Activity Relationship (QSAR) computer simulation approach in lieu of HTPS was well received at a June 2000 public workshop on endocrine disrupter priority setting. The workshop included representatives from industry, state government, and public health, environmental, and animal welfare groups. The Agency is continuing to develop several alternative nonanimal in vitro screening assays using conventional bench methods.

Question 3. Where is the remainder of the appropriation?

Response. The $70,000 appropriation for the feasibility demonstration study of HTPS has been expended. No other funds were specifically appropriated for use in the development of the HTPS.

The balance of the Congressional appropriation for the Endocrine Disruptor Screening Program (EDSP) is being expended on a variety of activities. For example, a portion of the funds are being expended in support of the development and evaluation of alternative test methods, including non-animal test methods. Further, EPA continues to evaluate the potential usefulness of the HTPS as well as other methodologies to screen and prioritize chemicals under the EDSP. A significant portion

of the funds are being expended for the standardization and validation of test methods being considered for use under the EDSP. Because many of the endocrine disrupter screens and tests involve cutting-edge science, few of them have actually been formally standardized or validated through inter-laboratory comparisons.

Finally, to ensure continued public participation in the development and implementation of the EDSP, EPA is supporting various workshops and will charter a new Federal Advisory Committee to address standardization and validation of EDSP screening and testing protocols.

Question 4. You may know of concerns I raised with Administrator Browner concerning the High Production Volume Chemical Testing Program. I have a copy of the October 14, 1999 agreement between the EPA, Chemical Manufacturers Association, Environmental Defense Fund and animal protection advocates. In the agreement, the EPA commits to incorporating animal protection considerations into all future EPA testing programs. What concrete efforts will you make as the Assistant Administrator for Toxic Substances to address reducing and replacing the use of animals in toxicity testing?

Response. The Agency has emphasized on numerous occasions and in various forums that it is committed to reducing the number of animals used for testing, and to replacing animals in testing with validated in vitro (non-animal) test systems when they are reasonably and practically available for use in the HPV challenge program. These goals must be balanced with the need to conduct scientifically sound chemical hazard/risk assessments in support of the Agency's mission. The October 14, 1999, letter, which was written in the specific context of the High Production Volume Challenge Program, embodies several key principles, designed to minimize the use of animals, which are applicable to the Agency's chemical information programs. The principles include: encouraging participating companies to conduct a qualitative analysis to determine if there is sufficient data, maximizing the use of existing and scientifically adequate data to minimize further testing, and encouraging the use of categories of related chemicals and structure-activity relationships. These principles are intended to reduce the absolute number of chemical substances that may need to be tested and ensure that duplicative testing is avoided.

In addition, EPA actively supports validation of alternative test methods through the Agency's role as a Co-Chair, along with the National Institute for Environmental Health Sciences (NIEHS), of the Interagency Coordinating Committee on Validation of Alternative Methods (ICCVAM)). For example, EPA recently concurred with ICCVAM that the Local Lymph Node Assay (a test for allergic contact dermatitis) and the Corrositex® method (a test to measure skin corrosivity) can be used as valid alternatives under the appropriate circumstances. These alternative test methods will reduce pain and suffering of test animals and replace animals in testing with validated non-animal test systems, respectively. In addition, as noted above, EPA is committing $500,000 over the remainder of this fiscal year and next fiscal year for research on and validation of promising alternative test methods for predicting acute toxicity. An example of EPA's efforts in the international arena is the Agency's work through the Organization for Economic Cooperation and Development (OECD) and ICCVAM to modify the Up and Down Procedure (OECD 425)—an alternative acute toxicity test which reduces the number of animals by more than 70 percent as compared to the standard LD50 test-so that it can be used to evaluate dose response relationships (which are routinely used to evaluate the toxicity of pesticide active ingredients).

RESPONSES BY JAMES V. AIDALA TO ADDITIONAL QUESTIONS FROM SENATOR GRAHAM

Question 1. I have been informed of some concerns regarding EPA's policies related to tolerance revocation for voluntarily canceled uses where the Agency has any concern about the dietary risk from the product. Specifically, in addition to approving the voluntary cancellation of uses requested by the registrant, I have been told that EPA now intends to revoke the corresponding tolerances within 180 days of canceling the specific uses. This would make any food containing such residues adulterated.

We have been advised that numerous groups have indicated to you that the premature revocation of tolerances could cause significant market disruption both domestically and internationally. They have indicated that, without the protection afforded by a tolerance, commercial buyers will be reluctant to purchase foods (including fresh and processed foods) which may have been treated with the voluntarily canceled pesticide.

I understand that in response to this concern, the EPA has referenced the "Safe Harbor" or newly termed "channels of trade" provisions of section 408(1)(5) of the

Federal Food, Drug, and Cosmetic Act. Can you describe exactly how this provision will resolve the concerns raised by agricultural interests in my state?

Response. EPA and the Food and Drug Administration (FDA) each recently published proposed policies for public comment on channels of trade. The channels of trade provision you cite in the FQPA allows marketing of food crops which were legally treated with a pesticide, even if the pesticide is subsequently canceled and its tolerances revoked. FDA recently issued guidance for public comment on how it intends to apply the channels of trade provision to crops treated with the pesticide, methyl parathion. In essence, FDA will treat domestic and imported crops the same and will make allowances for those commodities which may have methyl parathion residues past the date of tolerance revocation, such as frozen foods, to remain in trade. To minimize the burden of providing confirmation that crops were legally treated, FDA cites examples of documentation which most processors regularly maintain. FDA is considering issuing generic guidance to expand the principles of the methyl parathion decision to other pesticides. As it has with FQPA decisions, EPA will continue to work with the U.S. Department of Agriculture (USDA), FDA, and other stakeholders, including the agricultural community, to ensure that legally treated crops are not adversely affected by tolerance reassessment, and that food is allowed to be distributed through commerce.

Question 2. Vice President Gore's memorandum in 1997 recognized the need for a transition period to newer pest management tools. General statistics aside, when you cancel a use, what specific steps are taken to assure that an efficacious alternative pest management tool is immediately available prior to cancellation?

We are working closely with USDA and the agricultural community to ensure that our decisions are based on accurate information, which includes analyses of available alternatives. EPA, in cooperation with USDA, is providing a transition that works for agriculture. EPA and USDA are working to identify opportunities for reasonable transition and strategic management planning for agriculture and public health use pesticides. EPA's goal is to ensure greater protection of public health, while also ensuring that farmers have the tools necessary for food production. To address the concerns of all interested parties, EPA and USDA have established the Committee to Advise on Reassessment and Transition (CARAT), which met for the first time June 23, 2000. This committee is bringing together expertise from all perspectives, including agricultural representatives, to help guide EPA and USDA implementation of FQPĂ. CARAT is developing recommendations for reducing risks from older, riskier pesticides, with a focus on ensuring that farmers are provided a reasonable transition to safer pest management strategies, including chemical and non-chemical alternatives. CARAT will also discuss the process for developing strategic pest management plans for agriculture and public health uses of pesticides, and work to ensure that high priority is given to risk management strategies for pesticides most likely to lead to exposures to children. In creating CARAT, EPA and USDA reaffirm their commitment to the key principles established by the Vice President: use of sound science in protecting public health; consultation with the public and other agencies; increased transparency; and, reasonable transition for agriculture.

EPA has also developed a priority system to expedite review of applications for new pesticides to address pest control needs potentially impacted by FQPA. For instance, since organophosphate (OP) pesticides are one of the classes given priority for tolerance reassessment, the Agency has instituted a policy to give priority consideration to applications for organophosphate alternatives. Since the passage of FQPA, almost 25 OP alternatives have been identified-some completely new chemicals and almost half of them have already been registered. For example, spinosad, tebufenozide, methoxyfenozide, and pyriproxyfen have recently been registered as OP alternatives for use on apples, a crop which has historically high OP use. In fact, along with "reduced-risk" pesticides and other prioritized pesticide registrations, hundreds of new uses are now available. Likewise, EPA gives priority to applications for new minor use pesticides, methyl bromide alternatives, and for pesticides which may help address vulnerable crop/pest combinations.

In addition to the registration process, EPA has instituted programmatic changes to facilitate transition for agriculture. For example, through its regions, the Agency initiated an Agriculture Initiative program. This Initiative, currently being piloted in four EPA regions, helps fund projects such as the gathering of use/usage data and the education of growers regarding alternative methods of pest control. The Agency also formed a Minor Use team to work more closely with minor crop growers and USDA.

Question 3. I understand that before a pesticide can be on the market, it must undergo up to 120 scientific tests required by EPA to determine human health, safe

ty, and environmental effects. Once EPA concludes that a pesticide has met FQPA's safety standards is it EPA's belief that the pesticide is safe for use? Does this safety determination apply to all approved uses (i.e., on a farm, in schools, around the home, on a golf course, and in other locations for which the product is intended)? Response. Yes, the decision to allow use of a pesticide means that EPA has determined that the uses specified on the label are within acceptable risk limits based on EPA's rigorous scientific review of available information. Still, those who are applying it and the public have to exercise caution and follow strict label requirements. In tolerance reassessment, FQPA specifically requires EPA to review potential risks to children, aggregate risks, and cumulative risks to ensure the pesticide meets today's more stringent scientific and regulatory standards.

Question 4. EPA-approved pesticides help protect Florida citizens from serious diseases such as malaria and encephalitis through vector-control programs. Loss of these pesticides will threaten public protection from disease-carrying mosquitoes, rodents, and cockroaches. The Food Quality Protection Act specifically directs EPA to work with FDA to ensure that public health pesticides continue to be available to prevent such disease outbreaks. What is EPA doing to ensure continued availability of these pesticides or reliable and effective alternatives in order to protect children and adults?

EPA, in coordination with the Centers for Disease Control (CDC), developed a process to consult and advise on public health uses of pesticides so that critical public health use pesticides are available. To date, this process has been used in the review of 11 pesticides. In addition, the Agency and the CDC have discussed processes to ensure availability of public health pesticides including possible fee waivers, expedited processing of applications for new public health pesticides, and a possible mechanism to coordinate development of supporting data for public health pesticides facing regulatory action.

Following passage of FQPA, EPA appointed a public health official who is charged with implementing the public health provisions of the law and serves as the point of contact for coordination with FDA, CDC, USDA and state and local public health officials. The Agency also established a public health steering committee which developed a consultative process with other Federal agencies and holds monthly coordination calls with CDC. EPA and CDC will shortly finalize a Memorandum of Understanding (MOW) to provide a framework for joint efforts and coordination. Although the MOU is not final, the two agencies have already begun many joint activities. For example, CDC and EPA have worked closely together in responding to West Nile Virus concerns and in the use of mosquito-control pesticides, and in addressing public health uses in the reassessment of OPs, such as chlorpyrifos and methyl parathion. EPA and FDA have also worked together in the review of some public health uses of malathion.

Question 5. The medical community strongly recommends a diet rich in fruits and vegetables for better nutrition and disease prevention. How would the health of the American public be affected if FQPA reduced the availability of fresh fruits and vegetables, or priced them out of reach of low-income consumers?

The American food supply is one of the safest and most abundant in the world. EPA strongly endorses the recommendations for a diet rich in fruits and vegetables. The need to maintain the variety and productivity of U.S. agriculture is very much a part of our approach. Implementation of FQPA will provide even more protection for consumers, particularly infants and children, while maintaining the availability for a wide selection of fruits and vegetables. While FQPA sets a tough health-based safety standard for pesticides, EPA is committed to balancing the provisions with the need to maintain pest control options for agriculture. EPA, in cooperation with USDA, will ensure a that a reasonable transition responsive to the needs of agricultural producers is provided to ensure that this balance is maintained.

Question 6. As you implement FQPA, it is important to involve stakeholders, including farmers, mosquito control officials and others, to make sure their information and concerns are considered. What are your goals for the new Committee to Advise on Reassessment and Transition and what do you want to see it accomplish? Will this be a permanent advisory committee or will you allow it to sunset?

Response. We are working closely with USDA and the agricultural community to ensure that our decisions are based on accurate information, which includes analyses of available alternatives. EPA, in cooperation with USDA, is providing a transition that works for agriculture. EPA and USDA are working to identify opportunities for reasonable transition and strategic management planning for agriculture and public health use pesticides. EPA's goal is to ensure greater protection of public health, while also ensuring that farmers have the tools necessary for food production. To address the concerns of all interested parties, EPA and USDA have estab

lished the Committee to Advise on Reassessment and Transition (CARAT), which met for the first time June 23, 2000. This committee is bringing together expertise from all perspectives, including farmers, mosquito control officials, industry representatives and others, to help guide EPA and USDA implementation of FQPA. CARAT is developing recommendations for reducing risks from older, riskier pesticides, with a focus on ensuring that farmers are provided a reasonable transition to safer pest management strategies, including chemical and non-chemical alternatives. ĈARAT will also discuss the process for developing strategic pest management plans for agriculture and public health uses of pesticides, and work to ensure that high priority is given to risk management strategies for pesticides most likely to lead to exposures to children. In creating CARAT, EPA and USDA reaffirm their commitment to the key principles established by the Vice President: use of sound science in protecting public health; consultation with the public and other agencies; increased transparency; and, reasonable transition for agriculture.

The CARAT has been established for a 2-year term, through June 2002, and at that time EPA and USDA will determine whether to extend the committee.

Question 7. Can you describe the registration process that is underway for methyl bromide alternatives including timetables?

Response. EPA gives expedited review and top priority registration review to all potential methyl bromide alternatives. Each new application of a potential methyl bromide alternative is screened by EPA/USDA's Joint Workgroup on Methyl Bromide Alternatives. Once a submission is verified as a legitimate methyl bromide alternative, it is placed at the top of EPA's work plan for review by Agency scientists. Actions receiving expedited review are typically ready for a registration decision within 18-22 months, as opposed to non-expedited reviews which can take 32-40 months to complete. The EPA/USDA Workgroup has been actively meeting with growers, academics, university extension experts, and registrants to identify potential methyl bromide alternatives, coordinate research, and identify regulatory barriers that have to be addressed. EPA is sensitive to the importance of methyl bromide in agriculture and stands ready to work with the agricultural community to ensure that adequate pest control alternatives to methyl bromide are available.

Question 8. In your meeting with my staff you indicated that the process to identify methyl bromide alternatives and the process of FQPA implementation are handled in different divisions of EPA. I am concerned that the process to register methyl bromide alternatives may be compromised in the push to implement FQPA. Can you describe the difference between these two processes and describe how EPA is ensuring that methyl bromide alternatives identification proceeds in a timely manner?

As mentioned above, EPA has assigned highest priority to reviewing registration applications for alternatives methyl bromide. Tolerance reassessment and pesticide reregistration reviews are conducted by personnel dedicated to these separate activities. Generally, there is no conflict between the demands to review pesticide applications for methyl bromide applications and the demands posed by tolerance reassessment. Since these alternatives are the No. 1 priority, they receive expedited treatment, and are not compromised by tolerance reassessment or by any possible increase in registration review workload.

RESPONSES BY JAMES V. AIDALA TO ADDITIONAL QUESTIONS FROM SENATOR BAUCUS

Question 1. It is important that implementation of FQPA be based on the best available and reliable information. For those cases in which pesticides or their uses are canceled, what is EPA doing to help farmers identify alternative products that can be used? With regard to the cancellation of chlorpyrifos, what action is EPA taking to prevent any disruption in grain marketing?

Response. We are working closely with USDA and the agricultural community to ensure that our decisions are based on accurate information, which includes analyses of available alternatives. EPA, in cooperation with USDA, is providing a transition that works for agriculture. EPA and USDA are working to identify opportunities for reasonable transition and strategic management planning for agriculture and public health use pesticides. EPA's goal is to ensure greater protection of public health, while also ensuring that farmers have the tools necessary for food production. To address the concerns of all interested parties, EPA and USDA have established the Committee to Advise on Reassessment and Transition (CARAT), which met for the first time June 23, 2000. This committee is bringing together expertise from all perspectives, including farmers, industry representatives and others, to help guide EPA and USDA implementation of FQPA. CARAT is developing recommendations for reducing risks from older, riskier pesticides, with a focus on en