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GLIN==> Triclosan risk assessment

triclosan is a chlorinated compound used as a antibacteria agent
which has become common in surface water systems from 
discharges by municipal wastewater treatment plants.....

[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Page 25700-25702]
 From the Federal Register Online via GPO Access [wais.access.gpo.gov]


[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.


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: <A HREF="http://www.regulations.gov";>http://www.regulations.gov</A>.
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
<A HREF="http://www.regulations.gov";>http://www.regulations.gov</A>, 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
<A HREF="http://www.regulations.gov";>http://www.regulations.gov</A>, 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 <A HREF="http://www.regulations.gov";>http://www.regulations.gov</A>, 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: <A HREF="mailto:garvie.heather@epa.gov";>garvie.heather@epa.gov</A>


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

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
    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,

    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.]


Comments: http://www.epa.gov/fedrgstr/comments.htm
Search: http://epa.gov/fedreg/search.htm
EPA's Federal Register: http://epa.gov/fedreg/

Alex J. Sagady & Associates        http://www.sagady.com

Environmental Enforcement, Permit/Technical Review, Public Policy, 
Expert Witness Review and Litigation Investigation on Air, Water and 
Waste/Community Environmental and Resource Protection
Prospectus at:  http://www.sagady.com/sagady.pdf 

657 Spartan Avenue,  East Lansing, MI  48823  
(517) 332-6971; ajs@sagady.com

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