[Federal Register Volume 74, Number 76 (Wednesday, April 22, 2009)]
[Notices]
[Pages 18374-18376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9231]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0186; FRL-8410-7]
Clomazone and Fomesafen Registration Review Draft Ecological Risk
Assessments; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's draft
ecological risk assessments for the registration review of both
clomazone and fomesafen and opens a public comment period on these
documents. At the same time, EPA is initiating consultation for
clomazone and fomesafen with the U.S. Fish and Wildlife Service and the
National Marine Fisheries Service regarding potential effects to
species listed as endangered or threatened under the Endangered Species
Act. Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed comprehensive draft ecological risk
assessments, including endangered species effects determinations, for
all clomazone and fomesafen uses. After reviewing comments received
during the public comment period, EPA will issue final risk
assessments, explain any changes from the draft risk assessments, and
respond to comments. Once the ecological risk assessments have been
finalized, the Agency will issue its proposed registration review
decisions for these pesticides and seek public comment on any proposed
risk mitigation. Through this program, EPA is ensuring that each
pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.
DATES: Comments must be received on or before June 22, 2009.
ADDRESSES: Submit your comments identified by the docket identification
(ID) number for the specific pesticide of interest provided in the
table in Unit III.A., 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 Facility'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 the docket ID numbers listed
in the table in Unit III.A. for the pesticides you are commenting on.
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
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 at http://www.regulations.gov. 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: For pesticide specific information,
contact: The chemical review manager identified in the table in Unit
III.A. for the pesticide of interest.
For general questions on the registration review program, contact:
Kevin Costello, Special Review and Reregistration Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5026; fax number: (703) 308-8090; e-mail address:
costello.kevin @epa.gov.
For general questions on OPP's Endangered Species Protection
Program, contact: Arty Williams, Environmental Fate and Effects
Division (7507P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7695; fax number: (703) 308-4776 ; e-
mail address: [email protected].
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, farmworker, 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.
[[Page 18375]]
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 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.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.
II. Authority
EPA is conducting its registration review of clomazone and
fomesafen pursuant to section 3(g) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations
for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of
FIFRA provides, among other things, that the registrations of
pesticides are to be reviewed every 15 years. Under FIFRA section 3(a),
a pesticide product may be registered or remain registered only if it
meets the statutory standard for registration given in FIFRA section
3(c)(5). When used in accordance with widespread and commonly
recognized practice, the pesticide product must perform its intended
function without unreasonable adverse effects on the environment; that
is, without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.
III. Registration Reviews
What Action is the Agency Taking?
As directed by FIFRA section 3(g), EPA is reviewing registered
pesticides containing clomazone or fomesafen to ensure that they
continue to satisfy the FIFRA standard for registration--that is, that
these pesticides can still be used without unreasonable adverse effects
on human health or the environment. Clomazone is a broad spectrum
herbicide used to control annual grasses and broadleaf weeds in a wide
variety of crops and locations. EPA has completed a comprehensive draft
ecological risk assessment, including an endangered species effects
determination, for all clomazone uses. Fomesafen is a pre-plant, pre-
emergence and post-emergence herbicide used on soybeans, snap beans,
dry beans, and cotton to control broadleaf weeds, grasses, and sedges.
It is also registered for use on agricultural fallow/idle land,
nonagricultural uncultivated areas/soils, pine (forest/shelterbelt) and
pine (seed orchard). EPA has completed a comprehensive draft ecological
risk assessment, including an endangered species effects determination
for all fomesafen uses.
At present, EPA is announcing the availability of EPA's draft
ecological risk assessments for the cases identified in the following
table and is opening the public comment period on these documents.
Table--Registration Review Cases with Ecological Risk Assessments
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Registration
Review Case Chemical Review Manager,
Name and Docket ID Number Telephone Number, E-mail
Number Address
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Clomazone EPA-HQ-OPP-2006-0113 Karen Santora, (703) 347-
(Case 8781
No.7203) [email protected]
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Fomesafen EPA-HQ-OPP-2006-0239 Wilhelmena Livingston, (703)
(Case 308-8025
No.7211) [email protected]
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Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft ecological risk
assessments for clomazone and fomesafen. Such comments and input could
address, among other things, the Agency's risk assessment methodologies
and assumptions, as applied to these draft risk assessments. The Agency
will consider all comments received during the public comment period
and make changes, as appropriate, to the draft ecological risk
assessments. EPA will then issue revised risk assessments, explain any
changes to the draft ecological risk assessments, and respond to
comments. Once the ecological risk assessments have been finalized, the
Agency will issue its proposed registration review decisions for these
pesticides and seek public comment on the proposed risk mitigation.
Concurrent with opening the public comment periods for the draft
ecological risk assessments for clomazone and fomesafen, the Agency
will initiate consultation with the U.S. Fish and
[[Page 18376]]
Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS)
(jointly referred to as ``the Services'') regarding potential effects
from these pesticides to federally listed threatened or endangered
species (listed species) and habitat designated as critical to such
species. The result of consultation will be a biological opinion issued
by the Services that expresses whether they believe the pesticide's use
is likely to jeopardize the continued existence of any listed species
or destroy or adversely modify habitat designated as critical to any
listed species. If the Services determine there is likely jeopardy or
adverse modification, they will provide reasonable and prudent
alternatives to the action. If the Services conclude the action will
result in ``take'' of any individuals of a listed species, they will
specify reasonable and prudent measures to minimize such impact. The
Agency will review and consider both the public comments received on
the draft ecological risk assessments and, if provided, the information
in the Service's biological opinions when developing its proposed
registration review decisions.
As described in detail in the ``Clomazone Summary Document
Registration Review: Initial Docket (January 2007), Section IV--Human
Health Effects Scoping Document'' (see docket ID number EPA-HQ-OPP-
2006-0113), the Agency believes that the human health assessments
completed prior to registration review are adequate, and there are no
dietary risks that exceed the Agency's level of concern. In addition,
there are no residential uses of clomazone and all worker margins of
exposure (MOEs) are below the Agency's level of concern. Thus, no
additional human health data are needed for the registration review of
clomazone.
Also, as described in detail in the ``Fomesafen Summary Document
Registration Review: Initial Docket (March 2007), Section IV - Human
Health Effects Scoping Document'' (see docket ID number EPA-HQ-OPP-
2006-0239), the Agency believes that the human health assessments
completed prior to registration review are adequate and there are no
dietary risks that exceed the Agency's level of concern. In addition,
there are no residential uses of fomesafen. The occupational scenarios
do not result in risk concerns, with the exception of inhalation risks
to mixer/loaders for aerial application. This risk was mitigated below
the Agency's level of concern with the following change that is
currently on the label: ``In addition, for aerial applications, mixers
and loaders handling more than 140 gallons of Reflex Herbicide in any
single workday must wear dust/mist filtering NIOSH-approved respirator
with any N, R, P, or HE filter.''
1. Other related information. More information on EPA's review of
these cases is available on the Registration Review Status web page,
http://www.epa.gov/oppsrrd1/registration_review/reg_review_status.htm. Information such as the active ingredients in each case,
may be found in the registration review schedule on the Agency's
website at http://www.epa.gov/oppsrrd1/registration_review/schedule.htm. Information on the Agency's registration review program
and its implementing regulation is available at http://www.epa.gov/oppsrrd1/registration_review.
2. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
Submitters must clearly identify the source of any
submitted data or information.
Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.
List of Subjects
Environmental protection, Registration review, Pesticides and
pests.
Dated: April 13, 2009.
Richard P. Keigwin, Jr.,
Director, Special Review and Reregistration Review Program.
[FR Doc. E9-9231 Filed 4-21-09; 8:45 am]
BILLING CODE 6560-50-S