Clomazone and Fomesafen Registration Review Draft Ecological Risk Assessments; Notice of Availability, 18374-18376 [E9-9231]
Download as PDF
18374
Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
Dated: April 8, 2009.
Richard C. Karl,
Director, Superfund Division, Region 5.
[FR Doc. E9–9211 Filed 4–21–09; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2009–0186; FRL–8410–7]
Clomazone and Fomesafen
Registration Review Draft Ecological
Risk Assessments; Notice of
Availability
dwashington3 on PROD1PC60 with NOTICES
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
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
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15:31 Apr 21, 2009
Jkt 217001
interest provided in the table in Unit
III.A., by one of the following methods:
• Federal eRulemaking Portal: https://
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 https://
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 email. 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 https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
PO 00000
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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 https://
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; email 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:
williams.arty@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,
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.
E:\FR\FM\22APN1.SGM
22APN1
Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
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
18375
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
Registration Review Case Name and Number
Chemical Review Manager, Telephone Number, E-mail Address
Docket ID Number
EPA-HQ-OPP-2006-0113
Karen Santora, (703) 347-8781
santora.karen@epa.gov
Fomesafen (Case No.7211)
dwashington3 on PROD1PC60 with NOTICES
Clomazone (Case No.7203)
EPA-HQ-OPP-2006-0239
Wilhelmena Livingston, (703) 308-8025
livingston.wilhelmena@epa.gov
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
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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
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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
E:\FR\FM\22APN1.SGM
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dwashington3 on PROD1PC60 with NOTICES
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Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
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
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15:31 Apr 21, 2009
Jkt 217001
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, https://
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
https://www.epa.gov/oppsrrd1/
registration_review/schedule.htm.
Information on the Agency’s registration
review program and its implementing
regulation is available at https://
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.
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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
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0513; FRL–8410–5]
Triclosan; Notice of Receipt of
Requests for Amendments To Delete
Uses in Certain Pesticide Registrations
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: In accordance with section
6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), as amended, EPA is issuing a
notice of receipt of request for
amendments by registrants to delete
uses in certain pesticide registrations.
Section 6(f)(1) of FIFRA provides that a
registrant of a pesticide product may at
any time request that any of its pesticide
registrations be amended to delete one
or more uses. FIFRA further provides
that, before acting on the request, EPA
must publish a notice of receipt of any
request in the Federal Register.
DATES: The deletions are effective
October 19, 2009, unless the Agency
receives a written withdrawal request
on or before October 19, 2009. The
Agency will consider a withdrawal
request postmarked no later than
October 19, 2009.
Users of these products who desire
continued use on sites being deleted
should contact the applicable registrant
on or before October 19, 2009.
ADDRESSES: Submit your withdrawal
request, identified by docket
identification (ID) number EPA–HQ–
OPP–2007–0513, by one of the
following methods:
• 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.
E:\FR\FM\22APN1.SGM
22APN1
Agencies
[Federal Register Volume 74, Number 76 (Wednesday, April 22, 2009)]
[Notices]
[Pages 18374-18376]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9231]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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 https://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: williams.arty@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, 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
----------------------------------------------------------------------------------------------------------------
Registration
Review Case Chemical Review Manager,
Name and Docket ID Number Telephone Number, E-mail
Number Address
-------------------------------------------------------------------------------------
Clomazone EPA-HQ-OPP-2006-0113 Karen Santora, (703) 347-
(Case 8781
No.7203) santora.karen@epa.gov
----------------------------------------------------------------------------------------------------------------
Fomesafen EPA-HQ-OPP-2006-0239 Wilhelmena Livingston, (703)
(Case 308-8025
No.7211) livingston.wilhelmena@epa.gov
----------------------------------------------------------------------------------------------------------------
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,
https://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 https://www.epa.gov/oppsrrd1/registration_review/schedule.htm. Information on the Agency's registration review program
and its implementing regulation is available at https://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