Ethylene Oxide; Preliminary Determination to Terminate Special Review, 64318-64320 [E8-25674]
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Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Notices
List of Subjects
Environmental protection, Carbaryl,
Pesticides.
National Center for Environmental
Assessment, U.S. EPA; telephone: 703–
347–8561; facsimile: 703–347–8691; email nceadc.comment@epa.gov.
Dated: October 21, 2008.
Steven Bradbury,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. E8–25664 Filed 10–28–08; 8:45 am]
Dated: October 23, 2008.
Rebecca Clark,
Acting Director, National Center for
Environmental Assessment.
[FR Doc. E8–25805 Filed 10–28–08; 8:45 am]
BILLING CODE 6560–50–S
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8736–3; Docket ID No. EPA–HQ–ORD–
2008–00461]
[EPA–HQ–OPP–2005–0283; FRL–8380–9]
Draft Toxicological Review of
Tetrachloroethylene
(Perchloroethylene): In Support of the
Summary Information in the Integrated
Risk Information System (IRIS);
Correction
Ethylene Oxide; Preliminary
Determination to Terminate Special
Review
Environmental Protection
Agency (EPA).
ACTION: Notice of Peer-Review Meeting;
correction.
AGENCY:
jlentini on PROD1PC65 with NOTICES
SUMMARY: EPA announced on October
16, 2008 (73 FR 61416), that the
National Academy of Sciences (NAS)
will convene an independent panel of
experts and organize and conduct a
review of the draft document titled,
‘‘Toxicological Review of
Tetrachloroethylene
(Perchloroethylene): In Support of
Summary Information on the Integrated
Risk Information System (IRIS)’’ (EPA/
635/R–08/011A). The document
contained an incorrect meeting location.
Correction
In the Federal Register of October 16,
2008, in FR Doc. E8–24595, on page
61417, in the first column, correct the
ADDRESSES section to read:
The peer-review panel meeting will
be held at The National Academy of
Sciences, 2100 C Street, NW., Room
150, Washington, DC 20418. For details
about registering for and attending the
meeting, please see the NAS’s Web site
at https://www8.nationalacademies.org/
cp/projectview.aspx?key=48697.
FOR FURTHER INFORMATION CONTACT:
Questions regarding information,
registration, access or services for
individuals with disabilities, or logistics
for the external peer-review panel
meeting should be directed to NAS. For
further information, please see the
NAS’s Web site https://
www8.nationalacademies.org/cp/
projectview.aspx?key=48697. For
technical information about the
document, please contact the
Information Management Team,
VerDate Aug<31>2005
17:17 Oct 28, 2008
Jkt 217001
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces EPA’s
preliminary determination to terminate
the Special Review of ethylene oxide
(ETO). On January 27, 1978, EPA
initiated Special Review based on
developmental toxicity, mutagenicity,
and neurotoxic effects in workers (43 FR
3801). In the early 1980s, the
carcinogenicity of ETO became of
concern and was added to the Special
Review. Since the initiation of the
Special Review, additional data and
more comprehensive reviews of
potential risks associated with ETO
exposure have been completed,
including those described in the 2006
Tolerance Reassessment and Risk
Management Decision (TRED) (https://
www.epa.gov/oppsrrd1/REDs/
ethylene_oxide_tred.pdf) and the 2008
Reregistration Eligibility Decision (RED)
(https://www.epa.gov/oppsrrd1//REDs/
ethylene-oxide-red.pdf) for ETO. In the
2008 RED, the Agency addressed
occupational risk concerns that were the
focus of the Special Review. During the
reregistration process EPA conducted a
public, intensive review of ETO risks
and benefits to determine whether or
not ETO registrations meet the Federal
Insecticide, Fungicide, Rodenticide Act
(FIFRA) standard for registration. The
Agency determined that the benefits of
ETO use outweigh the occupational
risks associated with its use provided
that the risk mitigation measures
outlined in the RED are adopted and
label amendments are made to reflect
those measures. Because the risks that
were the basis of the Special Review
have been evaluated and the Agency has
made a determination under FIFRA, as
outlined above, the Agency is proposing
to terminate the Special Review of ETO.
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Comments must be received on
or before November 28, 2008.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2005–0283, 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
docket ID number EPA–HQ–OPP–2005–
0283. 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\29OCN1.SGM
29OCN1
Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Notices
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:
Susan Bartow, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: 703-603-0065;
fax number: 703-308-8005; e-mail
address: bartow.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
jlentini on PROD1PC65 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
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
VerDate Aug<31>2005
17:17 Oct 28, 2008
Jkt 217001
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?
On January 27, 1978, EPA initiated
Special Review based on developmental
toxicity, mutagenicity, and neurotoxic
effects in workers (43 FR 3801). In the
early 1980s, the carcinogenicity of ETO
became of concern and was added to the
Special Review. Since the initiation of
the Special Review, additional data and
more comprehensive reviews of
potential risks associated with ETO
exposure have been completed,
including those described in the 2006
TRED (https://www.epa.gov/oppsrrd1/
REDs/ethylene_oxide_tred.pdf) and the
2008 RED (https://www.epa.gov/
oppsrrd1//REDs/ethylene-oxide-red.pdf)
for ETO. In the 2008 RED, the Agency
addressed occupational risk concerns
that were the focus of the Special
Review. During the reregistration
process EPA conducted a public,
intensive review of ETO risks and
benefits to determine whether or not
ETO registrations meet the FIFRA
standard for registration. The Agency
determined that the benefits of ETO use
outweigh the occupational risks
associated with its use provided that the
risk mitigation measures outlined in the
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Fmt 4703
Sfmt 4703
64319
RED are adopted and label amendments
are made to reflect those measures. The
final risk management decision
regarding the risk to workers exposed to
ETO was completed with the 2008 RED.
A detailed description of the rationale
and supporting documents can be found
in https://www.regulations.gov under
EPA–HQ–OPP–2005–0203. As
described above and in the 2008 RED,
concerns were addressed under FIFRA
and no further action is required at this
time. Because the risks that were the
basis of the Special Review have been
evaluated and the Agency has made a
determination under FIFRA, as outlined
above, the Agency is proposing to
terminate the Special Review of ETO.
B. What is the Agency’s Authority for
Taking this Action?
A pesticide product may be sold or
distributed in the United States only if
it is registered or exempt from
registration under the Federal
Insecticide, Fungicide and Rodenticide
Act (FIFRA) as amended (7 U.S.C. 136
et seq.). Before a product can be
registered it must be shown, among
other things, that it can be used without
causing ‘‘unreasonable adverse effects
on the environment,’’ FIFRA section
3(c)(5). The term unreasonable adverse
effects on the environment means:
(1) Any unreasonable risk to man or
the environment, taking into account
the economic, social, and environmental
costs and benefits of the use of any
pesticide; or
(2) A human dietary risk from
residues that result from a use of a
pesticide in or on any food inconsistent
with the standard under section 408 of
the Federal Food, Drug and Cosmetic
Act FIFRA section 2(bb).
The burden of proving that a pesticide
meets this standard for registration is, at
all times, on the proponent of initial or
continued registration. If at any time the
Agency determines that a pesticide no
longer meets this standard, the
Administrator may cancel this
registration under section 6 of FIFRA.
The Special Review process provides
a mechanism to permit public
participation in EPA’s deliberations
prior to issuance of any Notice of Final
Determination pursuant to a Special
Review describing the regulatory action
which the Administrator has selected.
The Special Review process, which was
previously called the Rebuttable
Presumption Against Registration
(RPAR) process, is set forth in 40 CFR
part 154, published in the Federal
Register of November 27, 1985 (50 FR
49015). The purpose of this process is
to help the Agency determine whether
to initiate procedures to cancel, deny, or
E:\FR\FM\29OCN1.SGM
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64320
Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Notices
reclassify registration of a pesticide
product because uses of that product
may cause unreasonable adverse effects
on the environment, in accordance with
FIFRA.
Prior to formal initiation of a Special
Review, a preliminary notification is
sent to registrants and applicants for
registration pursuant to 40 CFR 154.21
announcing that the Administrator may
initiate a Special Review of a pesticide
use. Registrants and applicants for
registration are allowed 30 days from
receipt of the notification to comment
on the Agency’s preliminary notification
that it may commence a Special Review.
If the Agency determines, after
issuance of a notification pursuant to 40
CFR 154.21, that it will initiate a Special
Review, 40 CFR 154.25(c) requires the
Administrator to publish a Notice of
Special Review in the Federal Register.
To conclude the Special Review after a
Special Review has been initiated, 40
CFR 154.31 requires the Administrator
to first publish a Notice of Preliminary
Determination in the Federal Register.
This notice concerning ETO is being
issued pursuant to 40 CFR 154.31.
That regulation requires the
Administrator to respond to all
significant comments received on the
Notice of Special Review and, among
other things, make a preliminary
determination of whether any of the
applicable risk criteria have been
satisfied. Finally, after receipt and
evaluation of comments on the Notice of
Preliminary Determination, 40 CFR
154.33 requires that the Administrator
publish in the Federal Register a Notice
of Final Determination, including the
reasons for the determination.
List of Subjects
Environmental protection, Pesticides,
Pests.
Dated: October 21, 2008.
James B. Gulliford
Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances.
[FR Doc. E8–25674 Filed 10–28–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
jlentini on PROD1PC65 with NOTICES
[EPA–HQ–OPP–2007–1019; FRL–8387–5]
Nicotine; Notice of Receipt of Request
to Voluntarily Cancel a Pesticide
Registration
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
VerDate Aug<31>2005
17:17 Oct 28, 2008
Jkt 217001
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 a request by the
registrant to voluntarily cancel its
registration for a product containing the
pesticide nicotine. The request would
terminate nicotine use on greenhousegrown ornamentals. The request would
terminate the last nicotine product
registered for use in the United States.
EPA intends to grant this request at the
close of the comment period for this
announcement unless the Agency
receives substantive comments within
the comment period that would merit its
further review of the request, or unless
the registrant withdraws its request
within this period. Upon acceptance of
this request, any sale, distribution, or
use of products listed in this notice will
be permitted only if such sale,
distribution, or use is consistent with
the terms as described in the final order.
DATES: Comments must be received on
or before April 27, 2009.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2007–1019, 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
docket ID number EPA–HQ–OPP–2007–
1019. 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
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
‘‘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: Jill
Bloom, 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–
8019; fax number: (703) 308–7070; email address: bloom.jill@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
E:\FR\FM\29OCN1.SGM
29OCN1
]]>Agencies
[Federal Register Volume 73, Number 210 (Wednesday, October 29, 2008)]
[Notices]
[Pages 64318-64320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25674]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0283; FRL-8380-9]
Ethylene Oxide; Preliminary Determination to Terminate Special
Review
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces EPA's preliminary determination to
terminate the Special Review of ethylene oxide (ETO). On January 27,
1978, EPA initiated Special Review based on developmental toxicity,
mutagenicity, and neurotoxic effects in workers (43 FR 3801). In the
early 1980s, the carcinogenicity of ETO became of concern and was added
to the Special Review. Since the initiation of the Special Review,
additional data and more comprehensive reviews of potential risks
associated with ETO exposure have been completed, including those
described in the 2006 Tolerance Reassessment and Risk Management
Decision (TRED) (https://www.epa.gov/oppsrrd1/REDs/ethylene_oxide_
tred.pdf) and the 2008 Reregistration Eligibility Decision (RED)
(https://www.epa.gov/oppsrrd1//REDs/ethylene-oxide-red.pdf) for ETO. In
the 2008 RED, the Agency addressed occupational risk concerns that were
the focus of the Special Review. During the reregistration process EPA
conducted a public, intensive review of ETO risks and benefits to
determine whether or not ETO registrations meet the Federal
Insecticide, Fungicide, Rodenticide Act (FIFRA) standard for
registration. The Agency determined that the benefits of ETO use
outweigh the occupational risks associated with its use provided that
the risk mitigation measures outlined in the RED are adopted and label
amendments are made to reflect those measures. Because the risks that
were the basis of the Special Review have been evaluated and the Agency
has made a determination under FIFRA, as outlined above, the Agency is
proposing to terminate the Special Review of ETO.
DATES: Comments must be received on or before November 28, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0283, 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 docket ID number EPA-HQ-OPP-
2005-0283. 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 64319]]
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: Susan Bartow, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: 703-603-0065; fax number:
703-308-8005; e-mail address: bartow.susan@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?
On January 27, 1978, EPA initiated Special Review based on
developmental toxicity, mutagenicity, and neurotoxic effects in workers
(43 FR 3801). In the early 1980s, the carcinogenicity of ETO became of
concern and was added to the Special Review. Since the initiation of
the Special Review, additional data and more comprehensive reviews of
potential risks associated with ETO exposure have been completed,
including those described in the 2006 TRED (https://www.epa.gov/
oppsrrd1/REDs/ethylene_oxide_tred.pdf) and the 2008 RED (https://
www.epa.gov/oppsrrd1//REDs/ethylene-oxide-red.pdf) for ETO. In the 2008
RED, the Agency addressed occupational risk concerns that were the
focus of the Special Review. During the reregistration process EPA
conducted a public, intensive review of ETO risks and benefits to
determine whether or not ETO registrations meet the FIFRA standard for
registration. The Agency determined that the benefits of ETO use
outweigh the occupational risks associated with its use provided that
the risk mitigation measures outlined in the RED are adopted and label
amendments are made to reflect those measures. The final risk
management decision regarding the risk to workers exposed to ETO was
completed with the 2008 RED. A detailed description of the rationale
and supporting documents can be found in https://www.regulations.gov
under EPA-HQ-OPP-2005-0203. As described above and in the 2008 RED,
concerns were addressed under FIFRA and no further action is required
at this time. Because the risks that were the basis of the Special
Review have been evaluated and the Agency has made a determination
under FIFRA, as outlined above, the Agency is proposing to terminate
the Special Review of ETO.
B. What is the Agency's Authority for Taking this Action?
A pesticide product may be sold or distributed in the United States
only if it is registered or exempt from registration under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (7 U.S.C.
136 et seq.). Before a product can be registered it must be shown,
among other things, that it can be used without causing ``unreasonable
adverse effects on the environment,'' FIFRA section 3(c)(5). The term
unreasonable adverse effects on the environment means:
(1) Any unreasonable risk to man or the environment, taking into
account the economic, social, and environmental costs and benefits of
the use of any pesticide; or
(2) A human dietary risk from residues that result from a use of a
pesticide in or on any food inconsistent with the standard under
section 408 of the Federal Food, Drug and Cosmetic Act FIFRA section
2(bb).
The burden of proving that a pesticide meets this standard for
registration is, at all times, on the proponent of initial or continued
registration. If at any time the Agency determines that a pesticide no
longer meets this standard, the Administrator may cancel this
registration under section 6 of FIFRA.
The Special Review process provides a mechanism to permit public
participation in EPA's deliberations prior to issuance of any Notice of
Final Determination pursuant to a Special Review describing the
regulatory action which the Administrator has selected. The Special
Review process, which was previously called the Rebuttable Presumption
Against Registration (RPAR) process, is set forth in 40 CFR part 154,
published in the Federal Register of November 27, 1985 (50 FR 49015).
The purpose of this process is to help the Agency determine whether to
initiate procedures to cancel, deny, or
[[Page 64320]]
reclassify registration of a pesticide product because uses of that
product may cause unreasonable adverse effects on the environment, in
accordance with FIFRA.
Prior to formal initiation of a Special Review, a preliminary
notification is sent to registrants and applicants for registration
pursuant to 40 CFR 154.21 announcing that the Administrator may
initiate a Special Review of a pesticide use. Registrants and
applicants for registration are allowed 30 days from receipt of the
notification to comment on the Agency's preliminary notification that
it may commence a Special Review.
If the Agency determines, after issuance of a notification pursuant
to 40 CFR 154.21, that it will initiate a Special Review, 40 CFR
154.25(c) requires the Administrator to publish a Notice of Special
Review in the Federal Register. To conclude the Special Review after a
Special Review has been initiated, 40 CFR 154.31 requires the
Administrator to first publish a Notice of Preliminary Determination in
the Federal Register. This notice concerning ETO is being issued
pursuant to 40 CFR 154.31.
That regulation requires the Administrator to respond to all
significant comments received on the Notice of Special Review and,
among other things, make a preliminary determination of whether any of
the applicable risk criteria have been satisfied. Finally, after
receipt and evaluation of comments on the Notice of Preliminary
Determination, 40 CFR 154.33 requires that the Administrator publish in
the Federal Register a Notice of Final Determination, including the
reasons for the determination.
List of Subjects
Environmental protection, Pesticides, Pests.
Dated: October 21, 2008.
James B. Gulliford
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-25674 Filed 10-28-08; 8:45 am]
BILLING CODE 6560-50-S
