Endosulfan Updated Risk Assessments, Notice of Availability, and Solicitation of Usage Information, 64624-64626 [E7-22385]
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Federal Register / Vol. 72, No. 221 / Friday, November 16, 2007 / Notices
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?
mstockstill on PROD1PC66 with NOTICES
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
What Action is the Agency Taking?
EPA requests public comment during
the next 60 days on a petition (available
in docket ID number EPA–HQ–OPP–
2007–0944) received from Sinapu,
VerDate Aug<31>2005
21:48 Nov 15, 2007
Jkt 214001
Public Employees for Environmental
Responsibility (PEER), Beyond
Pesticides, Forest Guardians, Predator
Defense, Western Wildlife Conservancy,
Sierra Club, The Rewilding Institute,
Animal Defense League of Arizona, and
Animal Welfare Institute requesting that
the Agency cancel all uses of M-44
sodium cyanide capsules and sodium
fluoroacetate (compound 1080). The
petitioners claim that sodium cyanide
M-44 capsules and compound 1080
cannot perform their intended functions
without causing unreasonable adverse
effects on the environment and posing
an imminent hazard. See 136 et seq. of
FIFRA. The sodium cyanide and sodium
fluoroacetate reregistration eligibility
decisions (REDs) are available in the
electronic docket at https://
www.regulations.gov under docket
number EPA–HQ–OPP–2007–0944 or at
https://www.epa.gov/pesticides/
reregistration/status.htm.
List of Subjects
Environmental protection, pesticides,
and predators.
Dated: November 5, 2007.
Steven Bradbury,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. E7–22369 Filed 11–15–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2002–0262; FRL–8339–5]
Endosulfan Updated Risk
Assessments, Notice of Availability,
and Solicitation of Usage Information
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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.
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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: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’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 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
DATES:
E:\FR\FM\16NON1.SGM
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Federal Register / Vol. 72, No. 221 / Friday, November 16, 2007 / Notices
in regulations.gov. To access the
electronic docket, go tohttps://
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 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:
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; email address:perry.tracy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
mstockstill on PROD1PC66 with NOTICES
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
VerDate Aug<31>2005
21:48 Nov 15, 2007
Jkt 214001
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.
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Endosulfan is formulated as a liquid
emulsifiable concentrate and a wettable
powder. There are currently three
endosulfan registrants: MakhteshimAgan 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
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Federal Register / Vol. 72, No. 221 / Friday, November 16, 2007 / Notices
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.
mstockstill on PROD1PC66 with NOTICES
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 enduse products and either reregistering
products or taking other ‘‘appropriate
regulatory action.’’
List of Subjects
Environmental protection, Pesticides
and pests.
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21:48 Nov 15, 2007
Jkt 214001
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
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8495–5; Docket ID No. EPA–HQ–ORD–
2007–1083]
Draft Toxicological Review of 1,2,3Trichloropropane: In Support of the
Summary Information in the Integrated
Risk Information System (IRIS)
Environmental Protection
Agency (EPA).
ACTION: Notice of Public Comment
Period.
AGENCY:
SUMMARY: EPA is announcing a public
comment period for the external review
draft document titled, ‘‘Toxicological
Review of 1,2,3-Trichloropropane: In
Support of Summary Information on the
Integrated Risk Information System
(IRIS)’’ (NCEA–S–1669). The EPA
intends to consider comments and
recommendations from the public and
the expert panel meeting, which will be
scheduled at a later date and announced
in the Federal Register, when EPA
finalizes the draft document. The public
comment period will provide
opportunities for all interested parties to
comment on the document. EPA intends
to forward public comments, submitted
in accordance with this notice, to the
external peer-review panel prior to the
workshop for their consideration.
EPA is releasing this draft document
solely for the purpose of predissemination public review under
applicable information quality
guidelines. This document has not been
formally disseminated by EPA. It does
not represent and should not be
construed to represent any Agency
policy or determination.
The draft document is available via
the Internet on NCEA’s home page
under the Recent Additions and the
Data and Publications menus at
www.epa.gov/ncea. When finalizing the
draft document, EPA intends to
consider any public comments that EPA
receives in accordance with this notice.
DATES: The public comment period
begins November 16, 2007, and ends
January 15, 2008. Technical comments
should be in writing and must be
received by EPA by January 15, 2008.
EPA intends to submit comments from
the public received by this date for
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consideration by the external peerreview panel.
ADDRESSES: The draft ‘‘Toxicological
Review of 1,2,3-Trichloropropane: In
Support of Summary Information on the
Integrated Risk Information System
(IRIS)’’ is available via the Internet on
the National Center for Environmental
Assessment’s (NCEA) home page under
the Recent Additions and the Data and
Publications menus at www.epa.gov/
ncea. A limited number of paper copies
are available from the Technical
Information Staff, NCEA–W; telephone:
202–564–3261; facsimile: 202–565–
0050. If you are requesting a paper copy,
please provide your name, mailing
address, and the document title.
Comments may be submitted
electronically via www.regulations.gov,
by mail, by facsimile, or by hand
delivery/courier. Please follow the
detailed instructions as provided in the
SUPPLEMENTARY INFORMATION section of
this notice.
FOR FURTHER INFORMATION CONTACT: For
information on the public comment
period, contact the Office of
Environmental Information Docket;
telephone: 202–566–1752; facsimile:
202–566–1753; or e-mail:
ORD.Docket@epa.gov.
If you have questions about the
document, contact Martin Gehlhaus,
IRIS Staff, National Center for
Environmental Assessment, (8601D),
U.S. EPA, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460; telephone:
202–564–1596; facsimile: 202–565–
0075; gehlhaus.martin@epa.gov (e-mail).
SUPPLEMENTARY INFORMATION:
I. Summary of Information About the
Integrated Risk Information System
(IRIS)
IRIS is a database that contains
potential adverse human health effects
information that may result from
chronic (or lifetime) exposure to specific
chemical substances found in the
environment. The database (available on
the Internet at www.epa.gov/iris)
contains qualitative and quantitative
health effects information for more than
500 chemical substances that may be
used to support the first two steps
(hazard identification and doseresponse evaluation) of a risk
assessment process. When supported by
available data, the database provides
oral reference doses (RfDs) and
inhalation reference concentrations
(RfCs) for chronic health effects, and
oral slope factors and inhalation unit
risks for carcinogenic effects. Combined
with specific exposure information,
government and private entities can use
IRIS data to help characterize public
E:\FR\FM\16NON1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 221 (Friday, November 16, 2007)]
[Notices]
[Pages 64624-64626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22385]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: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'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
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
[[Page 64625]]
in regulations.gov. To access the electronic docket, go tohttps://
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 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: 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
