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Carbaryl Interim Reregistration Eligibility Decision; Notice of Availability
[Federal Register: October 27, 2004 (Volume 69, Number 207)] [Notices] [Page 62663-62666] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr27oc04-57] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-2003-0376; FRL-7679-9] Carbaryl Interim Reregistration Eligibility Decision; Notice of Availability AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the availability of EPA's Interim Reregistration Eligibility Decision (IRED) for the N-methyl carbamate pesticide carbaryl, and opens a public comment period on this decision. The Agency's risk assessments and other related documents also are available in the Carbaryl Docket. Carbaryl is an insecticide registered for use on agricultural crops, ornamentals, and turf (sod farms). Carbaryl is used by the U.S. Department of Agriculture (USDA) for grasshopper control. Carbaryl is also registered for residential use for flea control on pets and for use in homes and gardens. EPA has reviewed carbaryl through the public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards. DATES: Comments, identified by docket identification (ID) number OPP- 2003-0376, must be received on or before December 27, 2004. 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; fax number: (703) 308-8005; 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, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be 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 ID number OPP-2003-0376. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related [[Page 62664]] 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, 1801 S. Bell St., 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 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-2003-0376. 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-2003-0376. 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 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-2003-0376. 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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP-2003-0376. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1. D. How Should I Submit CBI to the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket [[Page 62665]] or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is 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 docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket 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 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 your estimate. 5. Provide specific examples to illustrate your concerns. 6. Offer alternatives. 7. Make sure to submit your comments by the comment period deadline identified. 8. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments. II. Background A. What Action is the Agency Taking? Under section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to ensure that they meet current scientific and regulatory standards. EPA completed an IRED for the N-methyl carbamate pesticide carbaryl on June 30, 2003, and is now issuing this document for public comment. Carbaryl is an insecticide registered for use on agricultural crops, sod, and for residential use on pets and in homes and gardens. Carbaryl is also used by USDA for grasshopper control. The Carbaryl IRED presents the Agency's conclusions on the risks posed by exposure to carbaryl alone; however, section 408(b)(2)(D)(v) of the Federal Food, Drug, and Cosmetic Act (FFDCA) directs the Agency also to consider available information on the cumulative risk from substances sharing a common mechanism of toxicity. Because the N-methyl carbamate pesticides share a common mechanism of toxicity, cholinesterase inhibition, the Agency will evaluate the cumulative risk posed by this group before making final reregistration eligibility decisions on individual N-methyl carbamates. During the pendency of the carbamate cumulative assessment, the Agency is proceeding with risk assessments and interim risk management for individual carbamate pesticides. EPA has determined that, but for the cumulative risk assessment, the data base to support carbaryl reregistration is substantially complete and that products containing carbaryl will be eligible for reregistration, provided the risks are mitigated in the manner described in the IRED. Upon submission of any required product specific data under section 4(g)(2)(B) of FIFRA and any necessary changes to the registration and labeling (either to address concerns identified in the IRED or as a result of product specific data), and after assessing N-methyl carbamate cumulative risks, EPA will make a final reregistration decision under section 4(g)(2)(C) of FIFRA for products containing carbaryl. When the Agency finalizes decisions for carbaryl and other N-methyl carbamate pesticides, further risk mitigation may be required for carbaryl. Although the Carbaryl IRED was signed on June 30, 2003, certain components of the document, which did not affect the final regulatory decision, were undergoing final editing at that time. These components, including the list of additional generic data requirements, summary of labeling changes, appendices, and other relevant information, have been added to the Carbaryl IRED document. In addition, subsequent to signature, EPA identified several minor errors and ambiguities in the document. Therefore, for the sake of accuracy, EPA also has included the appropriate error corrections, amendments, and clarifications. All of these changes are described in detail in an errata memorandum which is included in the public docket for carbaryl. Following signature of the IRED, EPA received new pharmacokinetic data from BayerCrop Science to refine the risk estimates from residential lawn broadcast applications of carbaryl liquid formulations. They also submitted a proposed method for using the data in a deterministic calculation of the risks. EPA is planning to seek independent scientific review of this information through a Scientific Advisory Panel meeting in December 2004. The new data and EPA's preliminary review of the data are included in the docket also. The reregistration program is being conducted under Congressionally mandated time frames, and EPA recognizes the need both to make timely reregistration decisions and to involve the public in finding ways to effectively mitigate pesticide risks. Through the Agency's public participation process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for carbaryl. The Agency is issuing the carbaryl IRED for public comment. The comment period is intended to provide an additional opportunity for public input and a mechanism for initiating any necessary amendments to the IRED. All comments should be submitted using the methods in Unit I. of the SUPPLEMENTARY INFORMATION, and must be received by EPA on or before the closing date. These comments will become part of the Agency docket for carbaryl. Comments received after the close of the comment period will be marked ``late.'' EPA is not required to consider these late comments. The Agency will carefully consider all comments received by the closing date. If any comment significantly affects the document, EPA will publish an amendment to the IRED in the Federal Register. In the absence of substantive comments requiring changes, the risk management decisions reflected in the carbaryl IRED will be implemented without further notice. These decisions may be supplemented by further risk mitigation measures when EPA considers its cumulative assessment of the N-methyl carbamate pesticides. B. What is the Agency's Authority for Taking this Action? Section 4(g)(2) of FIFRA, as amended in 1988 and 1996, directs that, after submission of all data concerning a pesticide active ingredient, ``the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,'' before calling in product [[Page 62666]] specific data on individual end-use products and either reregistering products or taking other ``appropriate regulatory action.'' Section 408(q) of FFDCA, 21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for pesticide residues in effect as of August 2, 1996, to determine whether the tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by August 3, 2006. List of Subjects Environmental protection, Pesticides and pests. Dated: October 21, 2004. Peter Caulkins, Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs. [FR Doc. 04-24038 Filed 10-26-04; 8:45 am] BILLING CODE 6560-50-S