[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 76462]]

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

[[Page 76463]]

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]
BILLING CODE 6560-50-P