E7-24739. Dichlorvos (DDVP); Final Determination to Terminate Special Review

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

On September 26, 2007, EPA issued in the Federal Register, a notice proposing to terminate the Special Review of dichlorvos (DDVP) because the risks that were the basis of the Special Review are no longer of concern. The Agency offered an opportunity to provide comment on 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 DDVP.

FOR FURTHER INFORMATION CONTACT:

Susan Bartow, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: bartow.susan @epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are 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-2006-0396. 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 [phone].

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 February 24, 1988, the Agency published a Notice of Special Review Position Document 1 (PD 1) for pesticide products containing DDVP based on concerns for cancer, cholinesterase inhibition, and liver effects (53 FR 5542). On September 28, 1995, the Agency published a Notice of Preliminary Determination to Cancel Certain Registrations and a Draft Notice of Intent to Cancel (PD 2/3) (60 FR 50337). In the 1995 PD 2/3, the Agency determined that exposure to DDVP from the registered uses posed a carcinogenic risk of concern as well as risks of concern for cholinesterase inhibition. However, with respect to liver effects, the Agency determined that this endpoint was no longer of regulatory concern. Since the initiation of Special Review and publication of the PD 2/3, additional data have become available. Based in part on these data, the Agency has changed its assessment of some of the risks associated with DDVP, and modified the terms and conditions of DDVP registrations, accordingly. Moreover, during the recently concluded reregistration process for DDVP, EPA conducted an intensive and public review of whether DDVP registrations meet the FIFRA standard for registration, culminating in the Agency's 2006 Reregistration Eligibility Decision (RED) for DDVP. Through the reregistration processes the Agency resolved remaining concerns regarding cancer and cholinesterase effects. Accordingly, EPA has revised its assessment of DDVP since the time when the PD 1 and the PD 2/3 were published, respectively. Based on the RED, requested label amendments, and the voluntary cancellation of uses by the registrant pursuant to section 6(f) of FIFRA, EPA has determined that the risks that were the basis of the Special Review are no longer of concern. Therefore, on September 26, 2007, EPA announced its preliminary determination to terminate the Special Review of DDVP. The Agency did not receive any comments in response to its preliminary determination. This notice announces EPA's final determination to terminate the Special Review of DDVP. To the extent that the Agency further revises its assessment of DDVP, it will do so outside of the Special Review context.

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 154.25(c) requires the Administrator to publish a Notice of Special Review in the Federal Register. To conclude a 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: December 14, 2007.

James Jones,

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