[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Notices]
[Pages 76461-76463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30850]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0548; FRL-8852-8]
Petition for a Ban on Triclosan; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice makes available for review and public comment a
petition submitted by Beyond Pesticides, and Food & Water Watch
(hereafter referred to as ``the petitioners'') to the Environmental
Protection Agency (hereafter referred to as ``EPA'' or ``the Agency''),
asking EPA to use its authority under various statutes to regulate
triclosan. Triclosan is an antimicrobial substance used in pesticide
products, hand sanitizers, toothpaste, and other consumer products. The
petitioners claim that the ``pervasive and widespread use'' of
triclosan poses significant risks to human health and the environment.
In addition, the petitioners claim that the agency failed to address
the impacts posed by triclosan's degradation products on human health
and the environment, failed to conduct separate assessments for
triclosan residues in contaminated drinking water and food, and is
complacent in seriously addressing concerns related to antibacterial
resistance and endocrine disruption. EPA has established a public
docket, which contains a copy of the petition and will contain all
comments received in response to this notice. The docket may be
accessed as described in this notice.
DATES: Comments must be received on or before February 7, 2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0548, by one of the following methods:
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-
2010-0548. When commenting, please specify the statute to which your
comments refer (FIFRA, FFDCA, SDWA, CWA, or ESA) and the specific
issue(s) raised in the petition regarding that statute on which you are
commenting. 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 Web site 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
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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: Timothy F. McMahon, Antimicrobials
Division (7510P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-6342; fax number: (703) 308-8481; e-
mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are a
business engaged in the manufacturing of pesticides and other
agricultural chemicals. Potentially affected entities may include, but
are not limited to:
Pesticide and other agricultural and chemical
manufacturing (NAICS 325320) e.g., businesses engaged in the
manufacture of pesticides.
Pulp and paperboard industries (NAICS 322110 and 322130).
Antimicrobial pesticides (NAICS 32561).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. 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 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.
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.
3. Environmental justice. EPA defines Environmental Justice as the
fair treatment and meaningful involvement of all people regardless of
race, color, national origin, or income with respect to the
development, implementation, and enforcement of environmental laws,
regulations, and policies. To help address potential environmental
justice issues, the Agency seeks information on any groups or segments
of the population who, as a result of their location, cultural
practices, or other factors, may bear disproportionate adverse impacts
from exposure to the pesticide discussed in this document, compared to
the general population.
II. What action is the Agency taking?
Through this notice, the Agency is making the petition and other
correspondence submitted by Beyond Pesticides, and Food & Water Watch
available for public review and comment. Any public comments received
on this petition will be included in the electronic docket and reviewed
by the Agency. Following review of the petition and any comments
received in response to this notice, EPA will issue its decision and
response to the petition.
Triclosan is an antimicrobial active ingredient that is contained
in a variety of bacteriostats, fungistats, mildewstats, and deodorizer
products. There are currently 20 antimicrobial registrations, which EPA
regulates under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). There are also consumer uses of triclosan, such as its use in
soaps and cleansers that are regulated by the Food and Drug
Administration (FDA) under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
In 2008, EPA completed a Reregistration Eligibility Decision (RED)
document for triclosan. This RED document described the conclusions of
EPA's comprehensive review of the potential risks to human health and
the environment resulting from the registered pesticidal uses of
triclosan. In conducting the review for the RED, EPA considered all
available data on triclosan, including data on endocrine effects,
developmental and reproductive toxicity, chronic toxicity, and
carcinogenicity. The 2008 EPA assessment also relied in part on 2003-
2004 biomonitoring data available from the National Health and
Nutrition Examination Survey (NHANES) which reported measurements of
urinary concentrations of triclosan in the U.S. population. Therefore,
the 2008 EPA assessment was inclusive of all triclosan-related
exposures (i.e., EPA and FDA regulated uses).
The 2008 RED also considered new research data on the thyroid
effects of triclosan in laboratory animals made available through the
EPA's Office of Research and Development (ORD). Since the 2008
assessment, additional data on effects of triclosan on estrogen have
also been made available from ORD. The ORD studies on the thyroid and
estrogen effects led EPA to determine that additional research on the
potential health consequences of endocrine effects of triclosan is
warranted. This research is underway and will help characterize the
human
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relevance and potential risk of the results observed from initial
laboratory animal studies. In addition, EPA will be updating the
assessment of triclosan exposure in the 2008 RED using the newly
released 2005-2006 NHANES urinary monitoring results. The Agency will
pay close attention to this ongoing research and will amend the
regulatory decision if the science supports such a change. Also, the
Agency has previously indicated that because of the amount of research
being planned and currently in progress, it will undertake another
comprehensive review of triclosan beginning in 2013.
Triclosan is also recognized as an emerging contaminant of concern
by EPA's Office of Water. Through its authority under the Clean Water
Act, EPA is conducting an effects assessment for triclosan that may be
used by States and authorized Tribes to establish water quality
standards for triclosan.
Under the Safe Drinking Water Act, EPA evaluated triclosan for
inclusion on the third contaminant candidate list (CCL 3). The CCL 3
was published on October 8, 2009 (74 FR 51850) and includes
contaminants that are currently unregulated in drinking water, that are
known or anticipated to occur in public water systems, and which may
require regulation under the Safe Drinking Water Act. EPA developed the
CCL 3 using a multi-step process recommended by the National Academies
of Science and the National Drinking Water Advisory Council. EPA
considered the best available occurrence and health effects data to
evaluate a universe of approximately 7,500 contaminants, from which EPA
identified the list of 116 contaminants that present the greatest
public health concern in drinking water. Triclosan was included in the
universe of contaminants evaluated. However, EPA determined triclosan
did not present as great a public health concern in drinking water as
the contaminants that were selected for the CCL 3 list.
A related petition was filed with FDA by the same organizations
that filed the EPA petition. The Agency is also aware of FDA's ongoing
effort to finalize the topical antimicrobial over-the-counter (OTC)
drug monograph under which some products containing triclosan are
regulated. EPA and FDA intend to collaborate and share information
throughout the public comment and petition response process as well as
FDA's ongoing rule development.
III. Summary of the Petition
The Agency received a petition from Beyond Pesticides, and Food &
Water Watch on January 28, 2010 that seeks relief under several
regulatory statutes. Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act
(FFDCA), the petitioners ask EPA to act to cancel and suspend the
registration of pesticides containing triclosan. Under the Clean Water
Act (CWA), the petitioners request that the Administrator impose
technology-based effluent limitations, health-based toxic pollutant
water quality pretreatment requirements, and biosolids regulation for
triclosan. Under the Safe Drinking Water Act (SDWA), the petitioners
request that the Administrator conduct a comprehensive assessment of
the appropriateness of regulating triclosan under SDWA. Under the
Endangered Species Act (ESA), the petitioners request that the
Administrator comply fully with ESA, including consultation and
biological assessment requirements. EPA has established a public
docket, which contains a copy of the petition and will contain all
comments received in response to this Notice. The docket may be
accessed as described in this Notice. The statutes mentioned and the
specific relief requested under each statute is summarized as follows:
FIFRA. The petition states that ``The hazards associated
with Triclosan use and exposure during the pendency of a long review
does not meet EPA's statutory duty to protect health and the
environment. That is, because scientific studies demonstrate that the
substance is used so pervasively that it is present in most people's
bodies, EPA must take the most protective steps provided for under the
statute to protect public health. In this regard, petitioners request
that EPA (1) issue a notice of cancellation of the registrations of all
products containing triclosan, pursuant to 7 U.S.C. 136d(b)(1), and (2)
at the same time issue an emergency order pursuant to 7 U.S.C.
136d(c)(3) to suspend immediately those registrations.''
Clean Water Act. The petition states that ``numerous
studies, including those of EPA, have established the substantial
presence, and therefore serious threat, of triclosan to human health
and the environment through the means of pollution of the nation's
navigable waters. EPA's failures in this regard, in petitioners' view,
are ``arbitrary, capricious,'' and otherwise ``not in accordance with
law.'' Therefore, the Administrator should use her authority under the
Act to evaluate these health and environmental effects thoroughly and
act decisively, based on the abundance of scientific evidence and the
express requirements of the CWA, to require proper regulation of
triclosan. She should use her authority to impose technology-based
effluent limitations, health-based pollutant water quality pretreatment
requirements, and biosolids regulation.
Safe Drinking Water Act. The petition states that ``EPA's
reregistration decision sets the stage for a violation of the SWDA, in
that triclosan would be allowed to contaminate drinking water at levels
that threaten human health and the environment. For this reason,
petitioners request that the Administrator conduct a comprehensive
assessment of the appropriateness of regulating triclosan under the
SDWA.''
Endangered Species Act. The petition states that ``because
triclosan is present in the large environment, EPA's registration of
that substance creates potential jeopardy for listed threatened and
endangered species and may destroy or adversely modify designated
critical habitats. This presence has been abundantly demonstrated
throughout this petition. Accordingly, Petitioners request that the
Administrator comply fully with the ESA, including the consultation and
biological assessment requirements. Petitioners note, in this regard,
that notwithstanding FIFRA's primary rule in regulating pesticides,
courts have held that EPA must comply with ESA in its administration of
FIFRA.''
List of Subjects
Environmental protection, Antimicrobials, triclosan, Pesticides and
pests.
Dated: December 2, 2010.
Joan Harrigan-Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. 2010-30850 Filed 12-7-10; 8:45 am]
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