[Federal Register Volume 73, Number 210 (Wednesday, October 29, 2008)]
[Notices]
[Pages 64331-64333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25829]


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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.

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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:

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. 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.

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 
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

[[Page 64333]]

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.

B. 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