Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices 76461 

Center, Room 3334 EPA West Building, 

1301 Constitution Ave., NW., 

Washington, DC. The EPA Docket 

Center Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is 202–566–1744. 

Such deliveries are only accepted 

during the docket’s normal hours of 

operation, and special arrangements 

should be made for deliveries of boxed 

information. If you provide comments 

by mail or hand delivery, please submit 

three copies of the comments. For 

attachments, provide an index, number 

pages consecutively with the comments, 

and submit an unbound original and 

three copies. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–ORD–2010– 

0991. Please ensure that your comments 

are submitted within the specified 

comment period. Comments received 

after the closing date will be marked 

‘‘late,’’ and may only be considered if 

time permits. It is EPA’s policy to 

include all comments it receives in the 

public docket without change and to 

make the comments available online at 

http://www.regulations.gov, including 

any personal information provided, 

unless a 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 http:// 

www.regulations.gov or e-mail. The 

http://www.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 http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public 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. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: Documents in the docket are 

listed in the http://www.regulations.gov 

index. 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 materials, such as 

copyrighted material, are publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in http:// 

www.regulations.gov or in hard copy at 

the OEI Docket in the EPA Headquarters 

Docket Center. 

Dated: December 2, 2010. 

Darrell A. Winner, 

Acting Director, National Center for 

Environmental Assessment. 

[FR Doc. 2010–30848 Filed 12–7–10; 8:45 am] 

BILLING CODE 6560–50–P 

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 online 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
76462 Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices 

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: 

mcmahon.tim@epa.gov. 

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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Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2010–0008; FRL–8852–5] 

Pesticide Products; Registration 

Applications 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces receipt 

of applications to register new uses for 

pesticide products containing currently 

registered active ingredients, pursuant 

to the provisions of section 3(c) of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), as amended. 

EPA is publishing this Notice of such 

applications, pursuant to section 3(c)(4) 

of FIFRA. 


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