[Federal Register Volume 64, Number 217 (Wednesday, November 10, 1999)] [Notices] [Pages 61346-61348] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-29451] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-00577A; FRL-6389-7] Pesticides; Policy Issues Related to the Food Quality Protection Act AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: EPA is announcing the availability of the revised version of the pesticide science policy document entitled ``Estimating the Drinking Water Component of a Dietary Exposure Assessment.'' This notice is the fourteenth in a series concerning science policy documents related to the Food Quality Protection Act and developed through the Tolerance Reassessment Advisory Committee. FOR FURTHER INFORMATION CONTACT: Nelson Thurman or Sid Abel, Environmental Protection Agency (7506C), 401 M St., SW., Washington, DC 20460; telephone numbers: (703) 308-0465 or (703) 305-7346; fax: (703) 305-6309; e-mail: [email protected] and [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you manufacture or formulate pesticides. Potentially affected categories and entities may include, but are not limited to: ------------------------------------------------------------------------ Examples of Category 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. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action affects certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under ``FOR FURTHER INFORMATION CONTACT.'' B. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, the science policy documents, and certain other related documents that might be available electronically, from the Office of Pesticide Programs' Home Page at http://www.epa.gov/pesticides/. On the Office of Pesticide Programs' Home Page select ``FQPA'' and then look up the entry for this document under ``Science Policies.'' 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 to this document under ``Federal Register -- Environmental Documents.'' You can go directly to the Federal Register listings http://www.epa.gov/fedrgstr/. 2. Fax on demand. You may request to receive a faxed copy of the revised science policy paper, as well as supporting information, by using a faxphone to call (202) 401-0527. Select item 6044 for the paper entitled ``Estimating the Drinking Water Component of a Dietary Exposure Assessment.'' You may also follow the automated menu. 3. In person. The Agency has established an official record for this action under docket control number OPP-00577A. In addition, the documents referenced in the framework notice, which published in the Federal Register on October 29, 1998 (63 FR 58038) (FRL-6041-5) have also been inserted in the docket under docket control number OPP-00557. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), 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 PIRIB telephone number is (703) 305-5805. II. Background for the Tolerance Reassessment Advisory Committee (TRAC) 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 [[Page 61347]] 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 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, 1998 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 it believes 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), EPA is announcing through the Federal Register the availability of a series of draft documents concerning nine science policy issues identified by the TRAC related to the implementation of FQPA. After receiving and reviewing comments from the public and others, EPA is also issuing revised science policy documents which reflect changes made in response to comments. In addition to comments received in response to these Federal Register notices, EPA will consider comments received during the TRAC meetings. Each of these issues is evolving and in a different stage of refinement. Accordingly, as the issues are further refined by EPA in consultation with USDA and others, they may also be presented to the SAP. III. Summary of Revised Science Policy Guidance Document This Federal Register notice announces the availability of a revised version of the Office of Pesticide Programs' (OPP) science policy guidance document that has been re-titled ``Estimating the Drinking Water Component of a Dietary Exposure Assessment.'' This science policy paper describes changes in OPP's approach to estimating pesticide concentrations in drinking water as part of its assessment of dietary exposures to pesticides. This document was developed from the science policy paper entitled ``Science Policy 5: Estimating the Drinking Water Component of a Dietary Exposure Assessment (12/22/98 Draft),'' that was released for public comment on January 4, 1999 (64 FR 162) (FRL-6054-8). The Agency received comments from various organizations. Each of the commentors offered recommendations for improving the science policy. All comments were extensively evaluated and considered by the Agency. This revised version embodies many recommendations of the commentors, as well as recommendations from a May 1999 FIFRA Scientific Advisory Panel which evaluated the proposed approach for incorporating a ``crop area adjustment factor'' along with a drinking water reservoir scenario in the Agency's surface water screening models. The public comments, as well as a detailed summary of the Agency's response to the comments are also available in the docket for this notice. For some time the Agency has been using screening models to estimate pesticide concentrations in ground water and surface water to identify those food-use pesticides that are not expected to contribute enough exposure via drinking water to result in unacceptable levels of aggregate risk. The Agency uses monitoring data, where available and reliable, to refine its assessments in those cases where the use of the screening models does not result in ``clearing'' (i.e., indicate a low risk) the pesticide from a drinking water perspective. This paper's description of the models and approaches EPA generally intends to follow is not meant to restrict interested parties from commenting on the appropriateness of these models and approaches, either generally or in regard to a specific application, or from proposing new or different models or approaches. In response to public comments, OPP made a number of significant changes to its drinking water assessment approaches, primarily to refine existing screening methods for identifying pesticides which may be present in drinking water at levels of concern. These refinements will enable OPP to more accurately determine whether a pesticide has the potential to result in significant risks to the public and sensitive populations such as infants and children. Specifically, in 1999, OPP will change its screening level drinking water assessment by replacing the ``farm field pond'' scenario in its surface water screening models with a ``drinking water reservoir'' scenario and will begin incorporating into the model a factor to account for the area surrounding the reservoir that is cropped. To start, percent cropped area factors will be used for corn, soybeans, cotton, and wheat. Additional factors for other major crops will be added in late 1999 and early 2000. These changes will improve EPA's initial screening assessment by making it more accurate. The Agency is also evaluating several watershed-scale surface water models for use in future drinking water assessments. EPA will also continue to use SCI-GROW (Screening Concentration In GROund Water) as an initial screening model for ground water sources of drinking water. An evaluation of models and procedures for a second- tier assessment of pesticide exposure in ground water is beginning. In the meantime, the Agency will rely on ground water monitoring studies to estimate concentrations in ground water for those pesticides which do not pass through the SCI-GROW screen. The Agency believes its risk assessments would be strengthened by additional monitoring data and is working on a number of levels to fill in the gaps in monitoring data and acquire more high quality data on pesticide concentrations in drinking water sources. Efforts range from requesting monitoring and runoff studies on [[Page 61348]] individual pesticides to working with the U.S. Geological Survey (USGS) to obtain more regional- and national-scale monitoring data on multiple pesticides to exploring design considerations for a national survey of pesticides in drinking water with various government agencies and industry groups and associations. Also as a result of the comments, OPP has identified two issues regarding drinking water that will be addressed in separate science policy papers within the next 6 months. EPA plans to issue papers on the following issues: (1) approaches for utilizing available data and models to develop quantitative estimates of pesticide concentrations in drinking water and estimates of people exposed for pesticides which pose a particularly high potential for contaminating drinking water; and (2) the effectiveness of water treatment in reducing pesticide levels in drinking water and an approach for addressing treatment issues in the assessment process. IV. Issues Raised in Comments EPA published a draft version of the document described in Unit III. on January 4, 1999 (64 FR 162) and comments were filed under docket control number OPP-00577. The public comment period ended on February 26, 1999. The Agency received comments from eight different organizations. All comments were considered by the Agency in revising the document. Many of the comments were similar in content, and pertained to general issues concerning the proposed policy or specific sections within the draft document. The comments addressed a broad range of issues and, in many instances, provided no general consensus. These differences in opinion highlight the difficulties the Agency faces in improving its existing science-based policy for estimating pesticide concentrations in drinking water. The Agency grouped the comments according to the nature of the comment and the issue or section of the document which they addressed. For the substantive comments that follow, contrasting opinions are presented, along with EPA's response. The full text of the Agency's comments and response to the comments document is available as described in Unit I.B.1. V. Policies Not Rules The 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. List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests. Dated: November 2, 1999. Susan H. Wayland, Deputy Assistant Administrator for Prevention, Pesticides and Toxic Substances. [FR Doc. 99-29451 Filed 11-9-99; 8:45 am] BILLING CODE 6560-50-F