[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Notices]
[Page 44518-44520]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au07-64]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0436; FRL-8133-8]
Oxydemeton-Methyl; Proposal to Terminate Special Review
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces EPA's proposed determination to
terminate the Special Review of oxydemeton-methyl (ODM). On October 5,
1987, in the Federal Register, EPA initiated a Special Review of ODM
because of its potential to adversely affect reproduction of workers
who mix, load, and apply products containing ODM. 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. During the reregistration process
EPA conducted a public, intensive review of ODM risks. In the 2002 IRED
and subsequent label amendments, the Agency addressed the occupational
risk concerns, including risks 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.
DATES: Comments must be received on or before September 7, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0436, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0436. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
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 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.
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?
This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including 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. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. 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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or
[[Page 44519]]
CD ROM the specific information that is claimed as CBI. In addition to
one complete version of the comment that includes information claimed
as CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
On October 5, 1987, (52 FR 37248; FRL-3273-1) 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 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 and 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, EPA is proposing 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 27, 1985 (50 FR 49003, 49015; FRL 2914-6). 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. This Notice concerning the ODM is being issued
pursuant to 40 CFR 154.31.
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.
List of Subjects
Environmental protection, Pesticides, Pests.
[[Page 44520]]
Dated: July 30, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-15113 Filed 8-7-07; 8:45 am]
BILLING CODE 6560-50-S