[Federal Register: October 10, 2007 (Volume 72, Number 195)]
[Notices]
[Page 57569-57571]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc07-60]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0833; FRL-8150-7]
Sodium Fluoride 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, and related documents for the pesticide Sodium Fluoride and
opens a public comment period on these documents. 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 Sodium Fluoride 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 December 10, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0833, 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'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-
2007-0833 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.
[[Page 57570]]
Do not submit information that you consider to be CBI or otherwise
protected through regulations.gov or e-mail. The 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
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
website 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 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: SanYvette Williams, Antimicrobials
Division (7510P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7702; fax number: (703) 308-6467; e-
mail address: williams.sanyvette@epa.gov.
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 Sodium Fluoride and soliciting public comment on risk management
ideas or proposals. Sodium Fluoride is currently registered for
commercial use only as a wood preservative for utility poles and
railroad ties. Sodium Fluoride products are used as supplemental wood
treatments and are not intended for primary wood preservative or
pressure treated wood preservation. EPA developed the risk assessments
and risk characterization for Sodium Fluoride 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).
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for Sodium Fluoride. Such comments and input could address,
for example, the availability of additional data to further refine the
risk assessments, such as a dermal absorption study or a repeated dose
dermal toxicity study (90-day) to determine the route-specific NOAEL.
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 Sodium Fluoride. There are risks of
concern associated with brush on applications of sodium fluoride to
distribution and transmission utility poles. 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
[[Page 57571]]
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 Sodium fluoride compared to the general
population.
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 Sodium Fluoride a modified, 4-Phase process with 1
comment period and ample opportunity for public consultation seems
appropriate in view of its refined risk assessments 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 Sodium Fluoride. 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.''
List of Subjects
Environmental protection, Pesticides and pests, antimicrobials,
sodium fluoride.
Dated: September 26, 2007.
Betty Shackleford,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E7-19940 Filed 10-9-07; 8:45 am]
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