[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Notices]
[Pages 57569-57571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19940]


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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: [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 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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