[Federal Register Volume 64, Number 134 (Wednesday, July 14, 1999)] [Notices] [Pages 37977-37980] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-17318] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-00609; FRL-6088-6] Pesticides; Policy Issues Related to the Food Quality Protection Act AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: To assure that EPA's policies related to implementing the Food Quality Protection Act are transparent and open to public participation, EPA is soliciting comments on a draft science policy paper entitled ``The Role of Use-Related Information in Pesticide Risk Assessment and Risk Management.'' This notice is the tenth in a series concerning science policy documents related to the Food Quality Protection Act and developed through the Tolerance Reassessment Advisory Committee. DATES: Written comments, identified by docket control number OPP-00609 should be submitted by September 13, 1999. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as [[Page 37978]] provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To ensure proper receipt by EPA, your comments must identify docket control number OPP-00609 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Debby Sisco, Environmental Protection Agency (7503C), 401 M St., SW., Washington, DC 20460, telephone number: (703) 308-8121; fax: (703) 305-8091; e-mail address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Notice Apply to Me? You may be potentially affected by this notice if you manufacture or formulate pesticides. Potentially affected categories and entities may include, but are not limited to: ------------------------------------------------------------------------ Examples of Categories NAICS potentially affected entities ------------------------------------------------------------------------ Pesticide Producers 32532 Pesticide manufacturers Pesticide formulators ------------------------------------------------------------------------ This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed could also be affected. If available, the North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this notice affects certain entities. If you have any questions regarding the applicability of this announcement to you, consult the person listed in the ``FOR FURTHER INFORMATION CONTACT'' section. B. How Can I Get Additional Information or Copies of This Document or Other Documents? 1. Electronically. You may obtain electronic copies of this document and the draft science policy paper from the Office of Pesticide Programs Home Page at http://www.epa.gov/pesticides/. On the Office of Pesticide Programs Home Page select ``TRAC'' and then look up the entry for this document. You can also go directly to the listings at the EPA Home Page at http://www.epa.gov/. On the Home Page select ``Laws and Regulations'' and then look up the entry for this document under ``Federal Register--Environmental Documents.'' You can go directly to the Federal Register listings at http://www.epa.gov/ fedrgstr/. 2. Fax on demand. You may request a faxed copy of this document, as well as supporting information, by using a faxphone to call (202) 401- 0527 and selecting item 6039. You may also follow the automated menu. 3. In person or by phone. If you have any questions or need additional information about this action, you may contact the technical person identified in the ``FOR FURTHER INFORMATION CONTACT'' section. In addition, the official record for the draft science policy paper listed in the ``SUMMARY'' section, including the public version, has been established under docket control number OPP-00609 (including comments and data submitted electronically as described below). This record not only includes the documents that are physically located in the docket, but also includes all the documents that are referenced in those documents. A public version of each record, including printed, paper versions of any electronic comments, which does not include any information claimed as Confidential Business Information (CBI), is available for inspection in Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Public Information and Records Integrity Branch the telephone number is (703) 305-5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, you must identify docket control number OPP-00609 in the subject line on the first page of your response. 1. By mail. Submit written comments to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 2. In person or by courier. Deliver written comments to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. 3. Electronically. Submit your comments and/or data electronically by e-mail to: [email protected]. Do not submit any information electronically that you consider to be CBI. Submit electronic comments as an ASCII file, avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard computer disks in WordPerfect 5.1/6.1 or ASCII file format. All comments and data in electronic form must be identified by the docket control number. Electronic comments on this notice may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI Information That I Want to Submit to the Agency? You may claim information that you submit in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public docket by EPA without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please call the Public Information and Records Integrity Branch. The PIRIB telephone number is (703) 305-5805. E. What Should I Consider As I Prepare My Comments for EPA? EPA invites you to provide your views on the various draft science policy papers, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider. You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide solid technical information and/or data to support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate. 5. Indicate what you support, as well as what you disagree with. 6. Provide specific examples to illustrate your concerns. 7. Make sure to submit your comments by the deadline in this notice. 8. At the beginning of your comments (e.g., as part of the ``Subject'' heading), be sure to properly identify the document you are commenting on. You [[Page 37979]] can do this by providing docket control number OPP-00609, along with the name, date, and Federal Register citation. II. Background On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. Effective upon signature, the FQPA significantly amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Among other changes, FQPA established a stringent health-based standard (``a reasonable certainty of no harm'') for pesticide residues in foods to assure protection from unacceptable pesticide exposure; provided heightened health protections for infants and children from pesticide risks; required expedited review of new, safer pesticides; created incentives for the development and maintenance of effective crop protection tools for farmers; required reassessment of existing tolerances over a 10-year period; and required periodic re-evaluation of pesticide registrations and tolerances to ensure that scientific data supporting pesticide registrations will remain up-to-date in the future. Subsequently, the Agency established the Food Safety Advisory Committee (FSAC) as a subcommittee of the National Advisory Council for Environmental Policy and Technology (NACEPT) to assist in soliciting input from stakeholders and to provide input to EPA on some of the broad policy choices facing the Agency and on strategic direction for the Office of Pesticide Programs. The Agency has used the interim approaches developed through discussions with FSAC to make regulatory decisions that met FQPA's standard, but that could be revisited if additional information became available or as the science evolved. As EPA's approach to implementing the scientific provisions of FQPA has evolved, the Agency has sought independent review and public participation, often through presentation of many of the science policy issues to the FIFRA Scientific Advisory Panel (SAP), a group of independent, outside experts who provide peer review and scientific advice to OPP. In addition, as directed by Vice President Albert Gore, EPA has been working with the U.S. Department of Agriculture (USDA) and another subcommittee of NACEPT, the Tolerance Reassessment Advisory Committee (TRAC), chaired by the EPA Deputy Administrator and the USDA Deputy Secretary, to address FQPA issues and implementation. TRAC comprises more than 50 representatives of affected user, producer, consumer, public health, environmental, states and other interested groups. The TRAC has met six times as a full committee from May 27 through April 29, 1999. The Agency has been working with the TRAC to ensure that its science policies, risk assessments of individual pesticides, and process for decision making are transparent and open to public participation. An important product of these consultations with TRAC is the development of a framework for addressing key science policy issues. The Agency decided that the FQPA implementation process and related policies would benefit from initiating notice and comment on the major science policy issues. The TRAC identified nine science policy issue areas they believed were key to implementation of FQPA and tolerance reassessment. The framework calls for EPA to provide one or more documents for comment on each of the nine issues by announcing their availability in the Federal Register. In accordance with the framework described in a separate notice published in the Federal Register of October 29, 1998 (63 FR 58038) (FRL-6041-5), EPA has been issuing a series of draft documents concerning nine science policy issues identified by the TRAC related to the implementation of FQPA. In addition to the nine science policy issues, the Agency has decided to make available several more draft policy documents which are related to the implementation of FQPA, but which are not purely science policy issues. This notice announces the availability of a draft document as identified in the ``SUMMARY'' section. III. Summary of ``The Role of Use-Related Information in Pesticide Risk Assessment and Risk Management'' In assessing the risks of pesticides and in making risk management (regulatory) decisions, EPA uses a wide range of data and information, such as how each pesticide is applied, where it is used, and how much is actually used. This paper summarizes the types of use-related information used by EPA in risk assessment and risk management, where the data come from, and how the Agency employs these data. EPA pesticide use data come from a variety of sources for both agricultural and non-agricultural pesticides use sites. There are three general categories of methods for obtaining use data: Agreements with other regulatory entities that produce pesticide-use data; purchases from vendors whose business is to obtain pesticide-use data; and voluntary submissions of data from interested parties who have developed such data. EPA also obtains use information from a variety of interested parties. For example, registrants who are going through the special review and/or reregistration process may have submitted data in support of a new use, risk mitigation, or in support of a registrant sponsored risk study. Individual states submit data in support of emergency exemption (FIFRA section 18) requests. Growers and food processors have also submitted use data. Additionally, state departments of agriculture, as part of their extension program efforts, provide use data or pesticide use recommendations for crops grown under their jurisdictions. The kinds of pesticide use information which risk assessors use in developing human dietary risk assessments are equally important to those who develop drinking water and ecological risk assessments. This use-related information is used to assess human exposure to pesticides in drinking water; to assess fish and wildlife exposure to pesticides; and to interpret monitoring results and develop models that can be used to accurately estimate pesticide concentrations in drinking water and surface and ground water. Use-related information plays a vital, even critical role in EPA's formulation of risk management decisions for pesticides in registration, reregistration, tolerance reassessment, and special review. The availability or lack of use-related information can significantly influence the outcome of EPA's regulatory decisions about pesticides under review, especially if they pose significant risks. The way in which use information has been incorporated into risk assessments has changed since the passage of the Food Quality Protection Act in 1996. EPA has been working to enhance its pesticide use data base by working more closely with the U.S. Department of Agriculture, California EPA, registrants, and grower groups as well as other stakeholders. The draft science policy paper lists projects EPA is currently working on for this purpose. IV. Questions/Issues for Comment While comments are invited on any aspect of the draft science policy paper, EPA is particularly interested in comments on the following questions and issues. 1. Is the EPA's description of the kinds of use and usage data obtained and evaluated by EPA complete? Are [[Page 37980]] there other data or sources which the Agency should consider? 2. Are the ways in which usage data are employed in risk assessment and risk management of pesticides clear? V. Policies Not Rules Each draft policy document discussed in this notice is intended to provide guidance to EPA personnel and decision-makers, and to the public. As a guidance document and not a rule, the policy in this guidance is not binding on either EPA or any outside parties. Although this guidance provides a starting point for EPA risk assessments, EPA will depart from its policy where the facts or circumstances warrant. In such cases, EPA will explain why a different course was taken. Similarly, outside parties remain free to assert that a policy is not appropriate for a specific pesticide or that the circumstances surrounding a specific risk assessment demonstrate that a policy should be abandoned. EPA has stated in this notice that it will make available revised guidance after consideration of public comment. Public comment is not being solicited for the purpose of converting any policy document into a binding rule. EPA will not be codifying this policy in the Code of Federal Regulations. EPA is soliciting public comment so that it can make fully informed decisions regarding the content of each guidance document. The ``revised'' guidance will not be unalterable. Once a ``revised'' guidance document is issued, EPA will continue to treat it as guidance, not a rule. Accordingly, on a case-by-case basis EPA will decide whether it is appropriate to depart from the guidance or to modify the overall approach in the guidance. In the course of inviting comment on each guidance document, EPA would welcome comments that specifically address how a guidance document can be structured so that it provides meaningful guidance without imposing binding requirements. VI. Contents of Docket Documents that are referenced in this notice will be inserted in the docket under docket control number OPP-00609. In addition, the documents referenced in the framework notice, which published in the Federal Register on October 29, 1998 (63 FR 58038) have also been inserted in the docket under docket control number OPP-00557. List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, pesticides and pests. Dated: June 29, 1999. Susan H. Wayland, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances. [FR Doc. 99-17318 Filed 7-13-99; 8:45 am] BILLING CODE 6560-50-F