Document ID: EPA-HQ-OPP-2009-0186-0001
Agency: epa
Document Type: Notice
Title: Clomazone and Fomesafen Registration Review Draft Ecological Risk Assessments
Posted Date: 2009-04-22T04:00Z

[Federal Register: April 22, 2009 (Volume 74, Number 76)]
[Notices]               
[Page 18374-18376]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap09-44]                         

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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: 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
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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.go
                                                          v
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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