[Federal Register: December 21, 2007 (Volume 72, Number 245)]
[Notices]
[Page 72709-72710]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de07-79]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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 (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