[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72709-72710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24739]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0396; FRL-8341-1]


Dichlorvos (DDVP); Final Determination to Terminate Special 
Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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: (703) 603-0065; fax 
number: (703) 308-8005; e-mail address: [email protected].

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 (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 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

[[Page 72710]]

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.
[FR Doc. E7-24739 Filed 12-20-07; 8:45 am]
BILLING CODE 6560-50-S