Document ID: EPA-HQ-OPP-2007-0436-0003
Agency: epa
Document Type: Notice
Title: Oxydemeton-Methyl; Final Determination to Terminate Special Review
Posted Date: 2007-11-16T05:00Z

[Federal Register: November 16, 2007 (Volume 72, Number 221)]
[Notices]               
[Page 64620-64621]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no07-68]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0436; FRL-8151-2]

 
Oxydemeton-Methyl; Final Determination to Terminate Special 
Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On August 8, 2007, EPA proposed to terminate the Special 
Review of oxydemeton-methyl (ODM) because the risks that were the basis 
of the Special Review are no longer of concern. The Agency offered an 
opportunity to provide comment to the proposal. The Agency received no 
substantive comments in response to the proposal and EPA is announcing 
its final determination to terminate the Special Review of ODM.

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?

    You may be potentially affected by this action if you as a member 
of the general public or a stakeholder such as 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. This listing is not intended to be exhaustive, 
but rather provides a guide for readers regarding entities likely to be 
affected by this action. Other types of entities not listed in this 
unit could also be affected. 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2007-0436. 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 Office of Pesticide Programs (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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr.

II. Background

A. What Action is the Agency Taking?

    On October 5, 1987, 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

[[Page 64621]]

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, 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, on August 8, 2007, EPA announced its proposed decision to 
terminate the Special Review of ODM. The Agency received one comment to 
that notice. The commenter offered no substantive information to alter 
EPA's understanding of ODM risks. This notice announces EPA's final 
determination 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 25, 1985 (50 FR 49015). 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.
    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. This Notice is being issued pursuant to 
40 CFR 154.33.

List of Subjects

    Environmental protection, Pesticides, Pests.

    Dated: November 8, 2007.
 James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
[FR Doc. E7-22362 Filed 11-15-07; 8:45 am]

BILLING CODE 6560-50-S