[Federal Register Volume 73, Number 89 (Wednesday, May 7, 2008)]
[Notices]
[Pages 25700-25702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-9945]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0513; FRL-8150-1]


Triclosan Risk Assessment; Notice of Availability and Risk 
Reduction Options

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the availability of EPA's risk 
assessment(s), and related documents for the pesticide triclosan, and 
opens a public comment period on these documents (Phase 3 of 4Phase 
Process). The public is encouraged to suggest risk management ideas or 
proposals to address the risks identified. EPA is developing a 
Reregistration Eligibility Decision (RED) for triclosan through a 
modified, 4-Phase public participation process that the Agency uses to 
involve the public in developing pesticide reregistration decisions. 
Through this program, EPA is ensuring that all pesticides meet current 
health and safety standards.

DATES:  Comments must be received on or before July 7, 2008.

ADDRESSES:  Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-0513, 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 
Bld.g), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 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 Federal 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

[[Page 25701]]

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 in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. 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 Drive, 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 
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) 308-8154; fax number: (703) 308-0034; e-
mail address: [email protected]

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?

    EPA is releasing for public comment its human health and 
environmental fate and effects risk assessments and related documents 
for triclosan, and soliciting public comment on risk management ideas 
or proposals. Triclosan is currently registered as an antimicrobial 
agent for use in the manufacture of a variety of products as a 
materials preservative in paints, fabrics, and plastics, tents, tile 
and in commercial, institutional, and industrial premises and equipment 
such as conveyor belts, and ice machines. EPA developed the risk 
assessment(s) and risk characterization for triclosan through a 
modified version of its public process for making pesticide 
reregistration eligibility and tolerance reassessment decisions. 
Through these programs, EPA is ensuring that pesticides meet current 
standards under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).
    The primary use sites for triclosan are use as a materials 
preservative in paints, fabrics, and plastics, tents, tile and in 
commercial, institutional, and industrial premises and equipment. EPA 
is providing an opportunity, through this notice, for interested 
parties to provide comments and input on the Agency's risk assessment 
for triclosan. Such comments and input could address, for example, the 
availability of additional data to further refine the risk assessments, 
such as an acute freshwater invertebrate study, and information on the 
quantity of triclosan degradates (e.g., triclosan methyl) occurring in 
surface waters, biosolids, soil, fish, or shellfish from triclosan 
antimicrobial pesticide use. This information could refine the Agency's 
risk assessment methodologies and assumptions as applied to this 
specific pesticide.
    Through this notice, EPA also is providing an opportunity for 
interested parties to provide risk management proposals or otherwise 
comment on risk management for triclosan. There are risks of concern 
associated with the use of triclosan from occupational exposure for 
workers applying paint, using some application methods; and the 
application of triclosan in paper making. In targeting these risks of 
concern, the Agency solicits information on effective and practical 
risk reduction measures.
    EPA seeks to achieve environmental justice, the fair treatment and 
meaningful involvement of all people, regardless of race, color, 
national origin, or income, in 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 
have atypical, unusually high exposure to triclosan, compared to the 
general population.

[[Page 25702]]

    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, the Agency is tailoring its public participation process to 
be commensurate with the level of risk, extent of use, complexity of 
the issues, and degree of public concern associated with each 
pesticide. For triclosan, a modified, 4-Phase process with 1 comment 
period and ample opportunity for public consultation seems appropriate 
in view of its refined risk assessment, and/or other factors. However, 
if as a result of comments received during this comment period EPA 
finds that additional issues warranting further discussion are raised, 
the Agency may lengthen the process and include a second comment 
period, as needed.
    All comments should be submitted using the methods in ADDRESSES, 
and must be received by EPA on or before the closing date. 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.

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.''
    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to 
review tolerances and exemptions for pesticide residues in effect as of 
August 2, 1996, to determine whether the tolerance or exemption meets 
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review 
is to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests, antimicrobials, 
triclosan.

    Dated: April 29, 2008.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E8-9945 Filed 5-6-07; 8:45 a.m.]
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