Triclosan; Reregistration Eligibility Decision; Availability
Federal Register: October 29, 2008 (Volume 73, Number 210)
Notices
Page 64331-64333
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr29oc08-63
ENVIRONMENTAL PROTECTION AGENCY
EPA-HQ-OPP-2007-0513; FRL-8388-8
Triclosan; Reregistration Eligibility Decision; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
SUMMARY: This notice announces the availability of EPA's Reregistration
Eligibility Decision (RED) for the pesticide triclosan, and opens a public comment period on this document. The Agency's risk assessments and other related documents also are available in the triclosan Docket.
Triclosan is regulated by both the U.S. EPA and the U.S. Food and Drug
Administration (FDA). The EPA regulates the antimicrobial uses of triclosan when used as a bacteriostat, fungistat, mildewstat, and deodorizer. EPA has reviewed triclosan through the public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs as mentioned in Unit II.A. of the SUPPLEMENTARY
INFORMATION. EPA is ensuring that all pesticides meet current health and safety standards.
DATES: Comments must be received on or before December 29, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0513, by one of the following methods:
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Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP- 2007-0513. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e- mail. The regulations.gov website is an ``anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e- mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Heather Garvie, Antimicrobials
Division (7510P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 308-0034; fax number: (703) 305-5620; e- mail address: garvie.heather @epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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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.
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What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, 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 claimed as CBI. In addition to one complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified.
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Background
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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 has completed a RED for the pesticide, triclosan under section 4(g)(2)(A) of FIFRA. Triclosan is regulated by both EPA and the U.S.
Food and Drug Administration (FDA). EPA regulates the antimicrobial uses of triclosan when used as a bacteriostat, fungistat, mildewistat, and deodorizer. Triclosan is used in commercial, institutional and industrial premises and equipment; residential and public access premises; and as material preservative. Commercial, institutional and industrial premises and equipment uses include conveyor belts, fire hoses, dye bath vats and ice making equipment. As a material preservative, triclosan is used in many products including adhesives, fabrics, vinyl, plastics (toys, toothbrushes), polyethylene, polyurethane, polypropylene, floor wax emulsions, textiles (footwear, clothing), caulking compounds, sealants, rubber, and latex paints.
There are a multitude of residential and public access premises uses including direction application to HVAC coils (limited to commercial applicators), and use as a materials
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preservative in toys, paints, mattresses, clothing, brooms, mulch, floors, shower curtains, awnings, tents, toilet bowls, urinals, garbage cans, refuse container liners, insulation, concrete mixtures, grouts, and upholstery fabrics. The FDA-regulated uses include hand soaps, toothpaste, deodorants, laundry detergent, fabric softeners, facial tissues, antiseptics for wound care, and medical devices. Although these uses are not regulated under pesticide law, EPA considered these exposures in the aggregate risk assessment. EPA used population-based biological monitoring data to assess the co-occurrence of uses to develop an aggregate exposure assessment.
EPA has determined that the data base to support reregistration is substantially complete and that products containing triclosan are eligible for reregistration provided the risks are mitigated either in the manner described in the RED or by another means that achieves equivalent risk reduction. 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 RED or as a result of product specific data), EPA will make a final reregistration decision under section 4(g)(2)(C) of
FIFRA for products containing triclosan.
Although the triclosan RED was signed on September 18, 2008, certain components of the document, which did not affect the final regulatory decision, were undergoing final editing at that time. These components, the appendices, have been added to the triclosan RED document.
EPA is applying the principles of public participation to all pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14, 2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these programs, EPA is tailoring its public participation process to be commensurate with the level of risk, extent of use, complexity of issues, and degree of public concern associated with each pesticide.
Due to its uses, risks, and other factors, triclosan was reviewed through the modified 4-Phase process. Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for triclosan.
The reregistration program is being conducted under congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. The Agency is issuing the triclosan RED for public comment. This comment period is intended to provide an additional opportunity for public input and a mechanism for initiating any necessary amendments to the RED. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. These comments will become part of the
Agency Docket for triclosan. 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 and will provide a Response to Comments Memorandum in the
Docket and regulations.gov. If any comment significantly affects the document, EPA also will publish an amendment to the RED in the Federal
Register. In the absence of substantive comments requiring changes, the triclosan RED will be implemented as it is now presented.
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What is the Agency's Authority for Taking this Action?
Section 4(g)(2) of FIFRA, as amended, 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 specific data on individual end-use products and either reregistering products or taking other ``appropriate regulatory action.''
List of Subjects
Environmental protection, Pesticides and pests, antimicrobials, triclosan.
Dated: October 23, 2008.
Joan Harrigan Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.
FR Doc. E8-25829 Filed 10-28-08; 8:45 am
BILLING CODE 6560-50-S
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