[Federal Register: November 16, 2007 (Volume 72, Number 221)]
[Notices]
[Page 64624-64626]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no07-71]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2002-0262; FRL-8339-5]
Endosulfan Updated Risk Assessments, Notice of Availability, and
Solicitation of Usage Information
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's updated human
health and ecological effects risk assessments for the organochlorine
pesticide endosulfan, based in part on data recently submitted by
endosulfan registrants as required in the 2002 Reregistration
Eligibility Decision (RED). The Agency is seeking comment on these
updated risk assessments as part of EPA's Post-RED process regarding
endosulfan (see Note to Reader in the endosulfan docket for more
detail). In addition, this notice solicits public comment on EPA's
analysis of endosulfan usage information since the 2002 RED, and its
preliminary determinations regarding endosulfan's importance to growers
and availability of alternatives.
DATES: Comments must be received on or before January 16, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2002-0262, 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-
2002-0262. 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
[[Page 64625]]
in regulations.gov. To access the electronic docket, go tohttp://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
website 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: Tracy L. Perry, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0128; fax
number: (703) 308-8005; e-mail address:perry.tracy@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 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?
EPA is making available the Agency's updated risk assessments for
endosulfan, last issued for comment through a Federal Register notice
announcing the availability of the 2002 Reregistration Eligibility
Decision (RED) published on November 6, 2002 (67 FR 67617) (FRL-7275-5
). EPA also is soliciting public comment on the Agency's analysis of
endosulfan usage information since the 2002 RED, and its preliminary
determinations regarding endosulfan's importance to growers and
availability of alternatives.
Endosulfan is a broad spectrum contact insecticide and acaricide
registered for use on a wide variety of vegetables, fruits, cereal
grains, and cotton, as well as ornamental shrubs, trees, vines, and
ornamentals for use in commercial agricultural settings. Endosulfan is
formulated as a liquid emulsifiable concentrate and a wettable powder.
There are currently three endosulfan registrants: Makhteshim-Agan of
North America, Makheteshim Chemical Works, Ltd., and Drexel Chemical
Company. Bayer CropScience recently canceled all U.S. registrations of
endosulfan products, effective July 16, 2007.
In its 2002 RED, EPA identified use of endosulfan to pose dietary,
occupational, and ecological risks of concern. However, the Agency
determined that these risks could likely be mitigated to levels below
concern through the deletion of use on five crops and changes to
pesticide labeling and formulation. Accordingly, EPA concluded that
endosulfan was eligible for reregistration provided that: (1)
Additional required data were submitted by the registrants confirming
this decision; and (2) the risk mitigation measures outlined in the RED
were adopted, and label amendments made to reflect these measures.
EPA's updated assessment of the potential human health effects of
endosulfan is based on the review of a recently submitted developmental
neurotoxicity (DNT) study, which was required in the reregistration
eligibility decision for endosulfan. Based on the toxicological effects
observed in the DNT, the Agency selected a different endpoint than used
in the 2002 RED assessment to evaluate short- and intermediate-term
dermal exposure for occupational handlers. Using the revised dermal
endpoint, many of the occupational handler scenarios exceed the
Agency's level of concern even with maximum Personal Protective
Equipment (PPE) and engineering controls. In addition, for many of the
occupational postapplication scenarios, the restricted-entry interval
(REI) would be several to multiple days longer than the REIs required
in the 2002 RED.
In addition, EPA has updated the ecological effects assessment for
endosulfan based on studies required in the 2002 RED and on additional
information drawn from the published literature on endosulfan
bioaccumulation, monitoring and transport, and ecological incidence. In
general, although preliminary, the new information suggests that parent
endosulfan and its sulfate degradate may pose greater risks than the
2002 RED outlined. While the parent may readily undergo degradation
under some environmental conditions, the sulfate degradate is
persistent and represents a source for endosulfan to enter aquatic and
terrestrial food chains. While endosulfan is not expected to
[[Page 64626]]
biomagnify appreciably in aquatic food webs, the compound does
bioconcentrate in aquatic organisms to a significant extent. Also,
there is direct evidence (measured residues) that endosulfan
bioaccumulates in terrestrial systems and indirect evidence (modeling)
that endosulfan has a significant potential to biomagnify in certain
terrestrial food webs. In addition, EPA continues to be concerned about
endosulfan's volatility and its ability to migrate to sites distant
from use areas, such as the Arctic, through various environmental media
(air, water, and sediment).
EPA is providing an opportunity, through this notice, for
interested parties to comment on the Agency's updated human health and
ecological effects assessments for endosulfan. Risks of concern
associated with the use of endosulfan are: (1) Occupational handler
risks for many use scenarios, even with maximum PPE and engineering
controls; (2) risk to aquatic and terrestrial organisms; and (3)
potential for significant adverse effects to vulnerable populations and
ecosystems, based on the ability for endosulfan and its sulfate
degradate to migrate to sites distant from use areas. In addition, the
Agency is soliciting public comment on EPA's analysis of endosulfan
usage information since the 2002 RED, and its preliminary
determinations regarding endosulfan's importance to growers and
availability of alternatives.
All comments should be submitted using the methods inADDRESSES, and
must be received by EPA on or before the closing date. Comments and
proposals will become part of the Agency Docket for endosulfan.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments.
B. What is the Agency's Authority for Taking this Action?
Section 4(g)(2) of FIFRA, as amended, directs that, after
submission of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in
product-specific data on individual end-use products and either
reregistering products or taking other ``appropriate regulatory
action.''
List of Subjects
Environmental protection, Pesticides and pests.
Dated: November 8, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-22385 Filed 11-15-07; 8:45 am]
BILLING CODE 6560-50-S