[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]
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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:
[[Page 64332]]
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