Ethylene Oxide; Revised Risk Assessments, Notice of Availability and Solicitation of Risk Reductions, 29997-29999 [E7-10341]
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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
avicide used to control nuisance birds.
EPA developed the risk assessments and
risk characterization for 4aminopyridine through a modified
version of its public process for making
pesticide reregistration eligibility
decisions. Through these programs, EPA
is ensuring that pesticides meet current
standards under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
and the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA).
4-aminopyridine is a restricted use
avicide with flock alarming properties
that controls nuisance birds. When
consumed by birds, baits containing 4aminopyridine elicit alarm and distress
reactions among target species.
Individual birds that consume the
treated bait will react by flapping their
wings erratically and issuing audible
distress calls which, depending on the
reactivity of the species, is supposed to
frighten away the remainder of the
flock. Reactions of individual birds are
expected to vary by species, as will the
reaction of the flock to a distressed
member. 4-aminopyridine is registered
for use on crows, pigeons, grackles,
starlings, cowbirds, gulls, and house
sparrows, and certain blackbird species
in and around structures, feed lots,
airports, land fill sites, and in California
for protecting vineyards and sprouting
agricultural seeds.
EPA is providing an opportunity,
through this notice, for interested
parties to provide comments and input
on the Agency’s risk assessment for 4aminopyridine. Such comments and
input could address, for example, the
availability of additional data to further
refine the risk assessments, such as nontarget incident information or use rate
information, or could address the
Agency’s risk assessment methodologies
and assumptions as applied to this
specific pesticide.
Through this notice, EPA also is
providing an opportunity for interested
parties to provide risk management
proposals or otherwise comment on risk
management for 4-aminopyridine. Risks
of concern associated with the use of 4aminopyridine are: Acute risk to birds,
and potential risk to secondary
predators feeding on affected species. In
targeting these risks of concern, the
Agency solicits information on effective
and practical risk reduction measures.
EPA seeks to achieve environmental
justice, the fair treatment and
meaningful involvement of all people,
regardless of race, color, national origin,
or income, in the development,
implementation, and enforcement of
environmental laws, regulations, and
VerDate Aug<31>2005
19:13 May 29, 2007
Jkt 211001
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, unusually high exposure to 4aminopyridine, compared to the general
population.
EPA is applying the principles of
public participation to all pesticides
undergoing reregistration and tolerance
reassessment. The Agency’s Pesticide
Tolerance Reassessment and
Reregistration; Public Participation
Process, published in the Federal
Register on May 14, 2004, (69 FR 26819)
(FRL–7357–9), explains that in
conducting these programs, the Agency
is tailoring its public participation
process to be commensurate with the
level of risk, extent of use, complexity
of the issues, and degree of public
concern associated with each pesticide.
For 4-aminopyridine, a modified, 4Phase process with one comment period
seems appropriate in view of its limited
use and small number of users.
However, if as a result of comments
received during this comment period
EPA finds that additional issues
warranting further discussion are raised,
the Agency may lengthen the process
and include a second comment period,
as needed.
All comments should be submitted
using the methods in ADDRESSES, and
must be received by EPA on or before
the closing date. Comments will become
part of the Agency Docket for 4aminopyridine. 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 enduse products and either reregistering
products or taking other ‘‘appropriate
regulatory action.’’
Section 408(q) of the FFDCA, 21
U.S.C. 346a(q), requires EPA to review
tolerances and exemptions for pesticide
residues in effect as of August 2, 1996,
to determine whether the tolerance or
exemption meets the requirements of
section 408(b)(2) or (c)(2) of FFDCA.
This review is to be completed by
August 3, 2006.
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29997
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: May 22, 2007.
Margaret J. Rice,
Acting Director, Special Review and
Reregistration Division, Office of Pesticide
Programs.
[FR Doc. E7–10228 Filed 5–29–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2005–0203; FRL–8130–1]
Ethylene Oxide; Revised Risk
Assessments, Notice of Availability
and Solicitation of Risk Reductions
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s revised risk
assessments for the fumigant/sterilant
pesticide ethylene oxide (ETO). In
addition, this notice solicits public
comment on risk reduction options to
protect ETO workers and a revised
alternatives assessment. The Agency is
having this second Phase–5 to focus on
ETO’s risks to workers under FIFRA.
The public is encouraged to suggest risk
management ideas or proposals to
address the risks identified. EPA is
developing a Reregistration Eligibility
Decision (RED) for ETO through the full,
6-Phase public participation process
that the Agency uses to involve the
public in developing pesticide
reregistration and tolerance
reassessment decisions. Through these
programs, EPA is ensuring that all
pesticides meet current health and
safety standards.
DATES: July 30, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2005–0203, 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,
E:\FR\FM\30MYN1.SGM
30MYN1
sroberts on PROD1PC70 with NOTICES
29998
Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2005–
0203. 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 Federal 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 email 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
in regulations.gov. To access the
electronic docket, go to https://
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
web site 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–
VerDate Aug<31>2005
19:13 May 29, 2007
Jkt 211001
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
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
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; email 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
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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
revised risk assessments, initially issued
for comment through a Federal Register
notice published on August 3, 2005, (70
FR 44632) (FRL–7729–2); a response to
comments; and related documents for
ETO. EPA also is soliciting public
comment on risk reduction options for
ETO relating to workers risks revised
alternatives assessment for identified
risks of concern. EPA developed the risk
assessments for ETO as part of its public
process for making pesticide
reregistration eligibility and tolerance
reassessment decisions. Through these
programs, EPA is ensuring that
pesticides meet current standards under
the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
ETO is a fumigant/sterilant used to
sterilize medical or laboratory
equipment, pharmaceuticals, aseptic
packaging, musical instruments, and
beekeeping equipment or to reduce
microbial load on cosmetics, whole and
ground spices or other seasoning
materials, and artifacts, archival
material or library objects.
EPA is providing an opportunity,
through this notice, for interested
parties to provide risk management
proposalsor occupational issues or
otherwise comment on risk management
for ETO. Risks of concern associated
with the use of ETO are as follows: The
Agency’s occupational exposure
assessment for ETO’s use as a sterilant
indicates that cancer risks are of
concern at the current regulatory levels
established by the Occupational Safety
E:\FR\FM\30MYN1.SGM
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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
sroberts on PROD1PC70 with NOTICES
and Health Administration (OSHA) and
recommended by the National Institute
of Occupational Safety and Health
(NIOSH). Non-cancer worker exposure/
risk is estimated to be of concern at the
OSHA permissible exposure limit (PEL),
but not of concern at the NIOSH
recommended exposure limit (REL).
Based on available data, the Agency
anticipates the following activities to
result in potential worker exposure to
ETO: Inhalation exposure to ETO during
sterilization activities; dermal exposure
to ethylene glycol and the halohydrins
during post-sterilization activities; and
inhalation exposure to off-gassed ETO
from treated items during poststerilization activities. In targeting these
risks of concern, the Agency solicits
information on effective and practical
risk reduction measures. A revised
paper outlining various ETO
alternatives is also included as a
separate document in the ETO docket
EPA–HQ–OPP–2005–0203. The Agency
is interested in information related to
these alternatives.
EPA is applying the principles of
public participation to all pesticides
undergoing reregistration and tolerance
reassessment. The Agency’s Pesticide
Tolerance Reassessment and
Reregistration; Public Participation
Process, published in the Federal
Register on May 14, 2004, (69 FR 26819)
(FRL–7357–9) explains that in
conducting these programs, EPA is
tailoring its public participation process
to be commensurate with the level of
risk, extent of use, complexity of issues,
and degree of public concern associated
with each pesticide. Due to its uses,
risks, and other factors, ETO is being
reviewed through the full 6-Phase
public participation process.
All comments should be submitted
using the methods in ADDRESSES, and
must be received by EPA on or before
the closing date. Comments and
proposals will become part of the
Agency Docket for ETO. Comments
received after the close of the comment
period will be marked ‘‘late’’ EPA is not
required to consider these late
comments.
After considering comments received,
EPA will develop and issue the ETO
RED.
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
VerDate Aug<31>2005
19:13 May 29, 2007
Jkt 211001
products and either reregistering
products or taking other ‘‘appropriate
regulatory action.’’
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: May 16, 2007.
Peter Caulkins,
Acting Director, Special Review and
Reregistration Division, Office of Pesticide
Programs.
[FR Doc. E7–10341 Filed 5–30–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0306; FRL–8131–7]
Pesticide Products; Registration
Applications
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces receipt
of applications to register pesticide
products containing new active
ingredients not included in any
currently registered products pursuant
to the provisions of section 3(c)(4) of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended.
DATES: July 30, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2007–0306, 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–2007–
0306. 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
PO 00000
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Fmt 4703
Sfmt 4703
29999
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 Federal 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 email 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
in regulations.gov. To access the
electronic docket, go to https://
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
web site 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:
Alan Reynolds, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Pages 29997-29999]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10341]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0203; FRL-8130-1]
Ethylene Oxide; Revised Risk Assessments, Notice of Availability
and Solicitation of Risk Reductions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of EPA's revised risk
assessments for the fumigant/sterilant pesticide ethylene oxide (ETO).
In addition, this notice solicits public comment on risk reduction
options to protect ETO workers and a revised alternatives assessment.
The Agency is having this second Phase-5 to focus on ETO's risks to
workers under FIFRA. The public is encouraged to suggest risk
management ideas or proposals to address the risks identified. EPA is
developing a Reregistration Eligibility Decision (RED) for ETO through
the full, 6-Phase public participation process that the Agency uses to
involve the public in developing pesticide reregistration and tolerance
reassessment decisions. Through these programs, EPA is ensuring that
all pesticides meet current health and safety standards.
DATES: July 30, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0203, 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,
[[Page 29998]]
excluding legal holidays). Special arrangements should be made for
deliveries of boxed information. The Docket telephone number is (703)
305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0203. 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 Federal 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 in regulations.gov. To access the electronic docket, go to
https://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 web
site 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 Building), 2777 S. Crystal Drive, 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
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?
EPA is making available the Agency's revised risk assessments,
initially issued for comment through a Federal Register notice
published on August 3, 2005, (70 FR 44632) (FRL-7729-2); a response to
comments; and related documents for ETO. EPA also is soliciting public
comment on risk reduction options for ETO relating to workers risks
revised alternatives assessment for identified risks of concern. EPA
developed the risk assessments for ETO as part of its public process
for making pesticide reregistration eligibility and tolerance
reassessment decisions. Through these programs, EPA is ensuring that
pesticides meet current standards under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).
ETO is a fumigant/sterilant used to sterilize medical or laboratory
equipment, pharmaceuticals, aseptic packaging, musical instruments, and
beekeeping equipment or to reduce microbial load on cosmetics, whole
and ground spices or other seasoning materials, and artifacts, archival
material or library objects.
EPA is providing an opportunity, through this notice, for
interested parties to provide risk management proposalsor occupational
issues or otherwise comment on risk management for ETO. Risks of
concern associated with the use of ETO are as follows: The Agency's
occupational exposure assessment for ETO's use as a sterilant indicates
that cancer risks are of concern at the current regulatory levels
established by the Occupational Safety
[[Page 29999]]
and Health Administration (OSHA) and recommended by the National
Institute of Occupational Safety and Health (NIOSH). Non-cancer worker
exposure/risk is estimated to be of concern at the OSHA permissible
exposure limit (PEL), but not of concern at the NIOSH recommended
exposure limit (REL). Based on available data, the Agency anticipates
the following activities to result in potential worker exposure to ETO:
Inhalation exposure to ETO during sterilization activities; dermal
exposure to ethylene glycol and the halohydrins during post-
sterilization activities; and inhalation exposure to off-gassed ETO
from treated items during post-sterilization activities. In targeting
these risks of concern, the Agency solicits information on effective
and practical risk reduction measures. A revised paper outlining
various ETO alternatives is also included as a separate document in the
ETO docket EPA-HQ-OPP-2005-0203. The Agency is interested in
information related to these alternatives.
EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, EPA is tailoring its public participation process to be
commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
Due to its uses, risks, and other factors, ETO is being reviewed
through the full 6-Phase public participation process.
All comments should be submitted using the methods in ADDRESSES,
and must be received by EPA on or before the closing date. Comments and
proposals will become part of the Agency Docket for ETO. Comments
received after the close of the comment period will be marked ``late''
EPA is not required to consider these late comments.
After considering comments received, EPA will develop and issue the
ETO RED.
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: May 16, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-10341 Filed 5-30-07; 8:45 am]
BILLING CODE 6560-50-S
