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Oxydemeton-Methyl; Final Determination to Terminate Special Review

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Environmental Protection Agency (EPA).




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.

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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:

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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, 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​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 Start Printed Page 64621concerns 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 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.

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Dated: November 8, 2007.

James Jones,

Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.

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[FR Doc. E7-22362 Filed 11-15-07; 8:45 am]