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Carbaryl; Availability of Revised Risk Assessments
[Federal Register: April 2, 2003 (Volume 68, Number 63)] [Notices] [Page 16030-16032] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr02ap03-70] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-2003-0101; FRL-7299-5] Carbaryl; Availability of Revised Risk Assessments AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the availability of the revised risk assessments and related documents for the carbamate pesticide, carbaryl. In addition, this notice starts a 60-day public participation period during which the public is encouraged to submit risk management ideas or proposals. These actions are in response to a joint initiative between EPA and the U.S. Department of Agriculture (USDA) to increase transparency in the tolerance reassessment process for pesticides. DATES: Comments, identified by docket ID number OPP-2003-0101, must be received by EPA on or before June 2, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Anthony Britten, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8179; e-mail address: britten.anthony@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, nevertheless, a wide range of stakeholders will be interested in obtaining the revised risk assessments and submitting risk management comments on carbaryl, including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the use of pesticides on food. As such, the Agency has not attempted to specifically describe all the entities potentially affected by this action. 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 Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0101. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.regulations.gov/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select ``search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket, but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will [[Page 16031]] be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked ``late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select ``search,'' and then key in docket ID number OPP-2003-0101. The system is an ``anonymous access'' system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment. ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP-2003-0101. In contrast to EPA's electronic public docket, EPA's e-mail system is not an ``anonymous access'' system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the following mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0101. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2003-0101. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1. D. How Should I Handle CBI Information that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA 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 the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? 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 copies of any technical information and/or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Background A. What Action is EPA Taking in this Notice? EPA is making available for public viewing the revised risk assessments and related documents for the carbamate chemical, carbaryl. These documents have been developed as part of the public participation process that EPA and USDA are now using for involving the public in the reassessment of pesticide tolerances under the Food Quality Protection Act (FQPA), and the reregistration of individual pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A goal of the public participation process is to find a more effective way for the public to participate at critical junctures in the Agency's development of assessments and risk management decisions. EPA and USDA began implementing this process in August 1998, to increase transparency and opportunities for stakeholder consultation. The documents being released to the public through this notice provide information on the revisions that were made to the carbaryl preliminary risk assessments, which were released to the public August 28, 2002 (67 FR 55233) (FRL-7194-2), through a notice in the Federal Register. [[Page 16032]] In addition, this notice starts a 60-day public participation period during which the public is encouraged to submit risk management proposals or otherwise comment on risk management for carbaryl. The Agency is providing an opportunity, through this notice, for interested parties to provide written risk management proposals or ideas to the Agency on carbaryl. Such comments and proposals could address ideas about how to manage dietary, residential, occupational, or ecological risks on specific carbaryl use sites or crops across the U.S. or in a particular geographic region of the country. To address dietary risk, for example, commenters may choose to discuss the feasibility of lower application rates, increasing the time interval between application and harvest (``pre-harvest intervals'') modifications in use, or suggest alternative measures to reduce residues contributing to dietary exposure. For residential risk, commenters may suggest lowering application rates, modification in use, or other measures to reduce exposures to homeowners. For occupational risks, commenters may suggest personal protective equipment or technologies to reduce exposure to workers and pesticide handlers. For ecological risks, commenters may suggest ways to reduce environmental exposure, for example, exposure to birds, fish, mammals, and other non-target organisms. All comments and proposals must be received by EPA on or before June 2, 2003 at the addresses given under Unit I. Comments and proposals will become part of the Agency record for carbaryl. On February 24, 2003, EPA received from Bayer CropScience, the technical registrant for carbaryl, a submission titled ``Evaluation of Potential Aggregate Human Health Risks Associated with Agricultural and Consumer Uses of Carbaryl.'' In this submission, Bayer estimates the potential aggregate human health risks associated with dietary (food) and residential exposures to carbaryl. Bayer conducted the analysis using the Cumulative and Aggregate Risk Evaluation System (CARES), version 1.3., which is a software model that provides a probabilistic assessment of human health risks. The software has been reviewed by the FIFRA Science Advisory Panel (SAP), and was found to be an acceptable model for assessing aggregate risks. EPA is currently reviewing the carbaryl-specific CARES assessment submitted by the registrant. EPA did not receive this submission in time to completely or comprehensively review it prior to publishing this notice, but is releasing the Agency's revised human health risk assessment for carbaryl now to allow time for public comment before June 30, 2003, which is the court-ordered deadline for EPA to make a reregistration eligibility decision for carbaryl. Also, to allow as much time as possible for the public to comment on the registrant's submission, EPA has placed it in the official public docket for carbaryl and briefly discussed it in EPA's revised human health risk assessment. Depending on the results of the Agency's full review of the registrant's submission and comments received from the public, EPA might further amend, at some future time, its revised human health risk assessment for carbaryl, particularly aggregate risks from food, drinking water, and residential exposures. Bayer's current submission does not include a dietary drinking water component in its aggregate assessment of carbaryl's human health risks, but the registrant has informed the Agency that this information will be submitted shortly, and EPA will also endeavor to make this information publically available as quickly as possible. However, because this information will not be received until later. EPA does not believe it will be able to provide an analysis of this information during the comment period. List of Subjects Environmental protection, Chemicals, Pesticides and pests. Dated: March 26, 2003. Lois Ann Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [FR Doc. 03-7982 Filed 4-1-03; 8:45 am] BILLING CODE 6560-50-S