[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)] [Notices] [Pages 16967-16970] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-8259] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-00591; FRL-6071-1] 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 (FQPA) are transparent and open to public participation, EPA is soliciting comments on a draft policy paper entitled ``Data for Refining Anticipated Residue Estimates Used in Dietary Risk Assessments for Organophosphate Pesticides.'' This notice is the sixth in a series concerning science policy documents related to FQPA and developed through the Tolerance Reassessment Advisory Committee (TRAC). DATES: Submit written comments for this policy paper, identified by docket control number OPP-00591, on or before June 7, 1999. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section of this document. FOR FURTHER INFORMATION CONTACT: Margaret Rice, Environmental Protection Agency (7508), 401 M St., SW., Washington, DC 20460; telephone number: (703) 308-8039; fax: 703-308-8041; e-mail: [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: [[Page 16968]] ------------------------------------------------------------------------ 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 technical person listed in the ``FOR FURTHER INFORMATION CONTACT'' section of this document. 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 science policy paper at http://www.epa.gov/ pesticides/. On the Office of Pesticide Program 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 the Federal Register - - Environmental Documents entry for this document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/) to obtain this notice and the science policy paper. 2. Fax on Demand. You may request to receive a faxed copy of this document, as well as supporting information, by using a faxphone to call (202) 401-0527 and selecting item 6033. 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 person identified in the ``FOR FURTHER INFORMATION CONTACT'' section of this document. In addition, the official record for the science policy paper listed in the ``SUMMARY'' section of this document, including the public version, has been established under docket control number OPP- 00591 (including comments and data submitted electronically as described below). 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 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. Be sure to include docket control number OPP-00591 in your correspondence. 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. 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 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 can do this by providing the docket control number assigned to the notice, 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 [[Page 16969]] 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 five times as a full committee from May 27 through September 16, 1998. 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 believe 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 other policy documents which are related to the implementation of FQPA, but which are not purely science policy issues. This notice announces the availability of one of those draft documents as identified in Unit I.C. of this document. III. Summary of Draft Paper The Food Quality Protection Act (FQPA) of 1996 requires EPA to reassess all existing tolerances, based on available information, according to new, more stringent standards. Among these new standards are specific determinations regarding the potential for increased sensitivity of infants, children, and other subpopulations to the pesticide, assessment of the potential for aggregate exposures from various sources (such as the diet, drinking water, and pesticide uses in and around the home) and cumulative assessments of pesticides with a common mechanism of toxicity. EPA anticipates that refinements, beyond those routinely applied to EPA's dietary exposure assessments, will be key to developing more realistic estimates of the actual residues on food as EPA proceeds through the aggregate and particularly the cumulative assessment of pesticides which have a similar toxic effect via a common mechanism of toxicity, for example, the organophosphates (OPs). Having more realistic estimates of residues ultimately improves the Agency's ability to make informed regulatory decisions that fully protect public health and sensitive subpopulations, including infants and children. This document describes the types of data that can be used to refine residue estimates, outlines the basic characteristics of useful data, discusses how residue data and usage data are linked, and explains how EPA will use these types of data in its dietary exposure assessments. Bridging studies, which are used to quantify the difference in residues resulting from various application rates, are described in some detail. Also discussed are: 1. Residue decline studies, which can be used to quantify the differences in residues resulting from various pre-harvest intervals (PHIs). 2. Residue degradation studies, which characterize the decreasing amounts of residues over time. 3. Cooking and processing data. 4. Market basket data. 5. Data to quantify residues in meat and milk after cooking and pasteurization. Finally, interested parties may provide existing and available data of the types described in this document to EPA. The practical experience of working with existing data will enable the Agency to refine both current assessments and the guidance that is being developed for conducting new studies. IV. Questions/Issues for Comment While comments are invited on any aspect of the draft policy paper, EPA is particularly interested in comments on the following questions and issues. 1. EPA proposes to review existing bridging, residue decline and other data and to develop guidance for conducting these kinds of studies. The purpose of these multi-rate, multi-PHI studies is to be able to use the full range of expected residue values (based on the full range of application rates and PHIs) in dietary exposure assessments and thereby produce more realistic estimates of dietary risk. Is this a reasonable and efficient approach? What other approaches should EPA consider? 2. EPA believes that between one and three field trials conducted at different locations (with three different application rates at each field trial and three independent samples collected at each rate or PHI) are needed to demonstrate the mathematical relationship between application rate or PHI and amount of residue. Is this sampling regime adequate to characterize the range of potential residues? 3. In developing its guidance, EPA has assumed that the relationship between application rates and/or PHIs and resulting residue levels is not necessarily the same for all chemicals. Is there any information available to suggest that this assumption is incorrect? Is there any information available to suggest that the relationship between application rates and/or PHIs and resulting residue levels for the organophosphates as a class may be similar? 4. EPA is willing to consider data on the prevalence of food processing practices, along with data to quantify residue reductions from such practices. Should information on the extent of food processing practices be validated? If so, how could this be accomplished? V. Policies Not Rules The 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. [[Page 16970]] 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 the docket control number OPP-00591. 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: March 26, 1999. Marylouise M. Uhlig, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances. [FR Doc. 99-8259 Filed 4-6-99; 8:45 am] BILLING CODE 6560-50-F