

[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Notices]               
[Page 44518-44520]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au07-64]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0436; FRL-8133-8]

 
Oxydemeton-Methyl; Proposal to Terminate Special Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's proposed determination to 
terminate the Special Review of oxydemeton-methyl (ODM). On October 5, 
1987, in the Federal Register, EPA initiated a Special Review of ODM 
because of its potential to adversely affect reproduction of workers 
who mix, load, and apply products containing ODM. Since the initiation 
of the Special Review, additional data and more comprehensive reviews 
of potential risks associated with ODM exposure have been completed, 
including those described in the 2002 Interim Reregistration 
Eligibility Decision (IRED) for ODM. During the reregistration process 
EPA conducted a public, intensive review of ODM risks. In the 2002 IRED 
and subsequent label amendments, the Agency addressed the occupational 
risk concerns, including risks associated with potential reproductive 
effects. There continues to be evidence of reproductive effects; 
however, there is no evidence that these effects inhibit the ability of 
organisms to reproduce. Similarly, further data and analysis have 
addressed the concern for heritable effects. With the label amendments 
that have been made since the initiation of Special Review, ODM 
exposure is expected to be below the levels where any reproductive 
effects occur. Because the risks that were the basis of the Special 
Review are no longer of concern, the Agency is proposing to terminate 
the Special Review of ODM.

DATES: Comments must be received on or before September 7, 2007.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-0436, 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-
2007-0436. 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 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 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: Richard P. Dumas, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8015; fax 
number: (703) 308-8005; e-mail address: dumas.richard@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

[[Page 44519]]

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?

    On October 5, 1987, (52 FR 37248; FRL-3273-1) EPA initiated a 
Special Review of oxydemeton-methyl (ODM) because of its potential to 
adversely affect reproduction of workers who mix, load, and apply 
products containing ODM. The Agency's concerns regarding reproductive 
effects were based primarily on the results of a two-generation rat 
reproduction study and interim progress reports from an ongoing male 
rat reproductive toxicity study. Observed reproductive effects were 
decreased parental body weight, parental testes weight and fertility 
index, vacuolation of the corpus epididymus, decreased litter size, 
decreased pup weight and increased pup mortality.
    Since the initiation of the Special Review, additional data and 
more comprehensive reviews of potential risks associated with ODM 
exposure have been completed, including those described in the 2002 
Interim Reregistration Eligibility Decision (IRED) for ODM. In 
addition, during the reregistration process EPA conducted an intensive 
and public review of whether or not ODM registrations, meet the Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA) standard for 
registration. In the 2002 IRED and subsequent label amendments, the 
Agency addressed the occupational risk concerns, including risk 
associated with potential reproductive effects. There continues to be 
evidence of reproductive effects; however, there is no evidence that 
these effects inhibit the ability of organisms to reproduce. Similarly, 
further data and analysis have addressed the concern for heritable 
effects. With the label amendments that have been made since the 
initiation of Special Review, ODM exposure is expected to be below the 
levels where any reproductive effects occur. Because the risks that 
were the basis of the Special Review are no longer of concern, the 
Agency is proposing to terminate the Special Review of ODM.
    The final risk management decision regarding the risk to workers 
exposed to ODM was completed with the 2002 IRED. A detailed description 
of the rationale and supporting documents can be found in http://www.regulations.gov
 under EPA-HQ-OPP-2005-0281. As described above and 

in the 2002 IRED, concerns regarding reproductive effects were 
addressed under FIFRA and no further action is required at this time. 
As such, EPA is proposing to terminate the Special Review of ODM.

B. What is the Agency's Authority for Taking this Action?

    A pesticide product may be sold or distributed in the United States 
only if it is registered or exempt from registration under the Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (7 U.S.C. 
136 et seq.). Before a product can be registered it must be shown that 
it can be used without causing ``unreasonable adverse effects on the 
environment,'' FIFRA section 3(c)(5). The term ``unreasonable adverse 
effects on the environment'' is defined in FIFRA section 2(bb) as ``any 
unreasonable risk to man or the environment, taking into account the 
economic, social, and environmental costs and benefits of the use of 
any pesticide.'' The burden of proving that a pesticide meets this 
standard for registration is, at all times, on the proponent of initial 
or continued registration. If at any time the Agency determines that a 
pesticide no longer meets this standard, the Administrator may cancel 
this registration under section 6 of FIFRA.
    The Special Review process provides a mechanism to permit public 
participation in EPA's deliberations prior to issuance of any Notice of 
Final Determination describing the regulatory action which the 
Administrator has selected. The Special Review process, which was 
previously called the Rebuttable Presumption Against Registration 
(RPAR), is described in 40 CFR part 154, published in the Federal 
Register of November 27, 1985 (50 FR 49003, 49015; FRL 2914-6). The 
purpose of this process is to determine whether some or all 
registrations of a particular active ingredient or ingredients meet the 
FIFRA standard for registration, or whether amendment of the terms and 
conditions of registration or cancellation of portions or all of the 
registrations is appropriate.
    Prior to formal initiation of a Special Review, a preliminary 
notification is sent to registrants and applicants for registration 
pursuant to 40 CFR 154.21 announcing that the Agency is considering 
commencing a Special Review. Registrants and applicants for 
registration are allowed 30 days from receipt of the notification to 
comment on the Agency's proposal to commence a Special Review.
    If the Agency determines, after issuance of a notification pursuant 
to 40 CFR 154.21, that it will initiate a Special Review, 40 CFR 
154.23(c) requires the Administrator to publish a Notice of Special 
Review in the Federal Register. To conclude the Special Review after a 
Special Review has been initiated, 40 CFR 154.31 requires the 
Administrator to first publish a Notice of Preliminary Determination in 
the Federal Register. This Notice concerning the ODM is being issued 
pursuant to 40 CFR 154.31.
    That regulation requires the Administrator to respond to all 
significant comments received on the Notice of Special Review and, 
among other things, make a preliminary determination of whether any of 
the applicable risk criteria have been satisfied. Finally, after 
receipt and evaluation of comments on the Notice of Preliminary 
Determination, 40 CFR 154.33 requires that the Administrator publish in 
the Federal Register a Notice of Final Determination, including the 
reasons for the determination.

List of Subjects

    Environmental protection, Pesticides, Pests.


[[Page 44520]]


    Dated: July 30, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.

[FR Doc. E7-15113 Filed 8-7-07; 8:45 am]

BILLING CODE 6560-50-S
