Ethylene Oxide (ETO) Revised Risk Assessments; Notice of Availability, and Solicitation of Risk Reduction Options (Phase 5 of 6-Phase Process), 9110-9112 [E6-2463]
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Federal Register / Vol. 71, No. 35 / Wednesday, February 22, 2006 / Notices
System of Records (18–11–12), which
contains the applicant’s information to
receive an ED PIN, will be matched
against SSA’s Master Files of Social
Security Number Holders and SSN
Applications System, SSA/OEEAS, 60–
0058, which maintains records about
each individual who has applied for and
obtained an SSN.
cprice-sewell on PROD1PC66 with NOTICES
5. Privacy Impact Assessment
Section 208 of the E-Government Act
of 2002 (44 U.S.C. 3501 note) requires
ED to conduct the following privacy
impact assessment of this information
collection:
The information collected by ED
under this computer matching
agreement is the verification of SSNs
and citizenship by SSA, for the purpose
of assisting ED to satisfy its obligation
to ensure that an individual applying for
financial assistance meets the
requirements imposed under the HEA.
This verification is mandated by the
HEA. The information obtained from
SSA by ED will only be used as
provided for under Section X of the
agreement. Notice that ED verifies an
individual’s SSN through a computer
matching agreement with agencies such
as SSA is provided to individuals in the
Privacy and Security section of the Free
Application for Federal Student Aid
(FAFSA), and in Federal student loan
program forms; submission of a FAFSA
and participation in the Federal student
loan programs are voluntary. The
information obtained from SSA under
this computer matching agreement will
be secured pursuant to the procedures
described in Section IX of the
agreement. No new system of records is
being created for this collection because,
as noted above, routine uses permitting
the disclosure of records to allow for the
verification of SSNs are already
included in the Systems of Records
Notices for Federal student aid
programs. Thus, this collection
comports with applicable Privacy Act
standards and Section 208.
6. Effective Dates of the Matching
Program
This matching program must be
approved by the Data Integrity Board of
each agency. This matching agreement
will become effective on: (1) April 10,
2006; (2) 40 days after the approved
agreement is sent to Congress and OMB
(or later if OMB objects to some or all
of the agreement); or (3) 30 days after
publication of this notice in the Federal
Register, whichever date is last.
The matching program will continue
for 18 months after the effective date
and may be extended for an additional
12 months thereafter, if the conditions
VerDate Aug<31>2005
14:35 Feb 21, 2006
Jkt 208001
specified in 5 U.S.C. 552(o)(2)(D) have
been met.
7. Address for Receipt of Public
Comments or Inquiries
Individuals wishing to comment on
this matching program, or to obtain
additional information about the
program, including a copy of the
computer matching agreement between
ED and SSA, should contact Ms. Marya
Dennis, Management and Program
Analyst, U.S. Department of Education,
Union Center Plaza, 830 First Street,
NE., Washington, DC 20202–5454.
Telephone: (202) 377–3385. If you use a
telecommunications device for the deaf
(TDD), you may call the Federal Relay
Service (FRS) at 1–800–877–8339.
Individuals with disabilities may
obtain this document in an alternative
format (e.g., Braille, large print,
audiotape or computer diskette) on
request to the contact person listed in
the preceding paragraph.
Electronic Access to This Document
You may view this document, as well
as all other documents of this
Department published in the Federal
Register, in text or Adobe Portable
Document Format (PDF) on the Internet
at the following site: https://www.ed.gov/
news/fedregister/.
To use PDF you must have Adobe
Acrobat Reader, which is available free
at this site. If you have questions about
using PDF, call the U.S. Government
Printing Office (GPO), toll free, at 1–
888–293–6498; or in the Washington,
DC, area at (202) 512–1530.
Note: The official version of this document
is the document published in the Federal
Register. Free Internet access to the official
edition of the Federal Register and the Code
of Federal Regulations is available on GPO
Access at: https://www.gpoaccess.gov/nara/
index.html.
Dated: February 15, 2006.
Theresa S. Shaw,
Chief Operating Officer, Federal Student Aid.
[FR Doc. E6–2504 Filed 2–21–06; 8:45 am]
BILLING CODE 4000–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2005–0203; FRL–7764–4 ]
Ethylene Oxide (ETO) Revised Risk
Assessments; Notice of Availability,
and Solicitation of Risk Reduction
Options (Phase 5 of 6-Phase Process)
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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Fmt 4703
Sfmt 4703
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 for
ETO. 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: Comments must be received on
or before April 24, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2005–0203, by
one of the following methods:
• https://www.regulations.gov/.
Follow the on-line instructions for
submitting comments.
• Mail. Public Information and
Records Integrity Branch (PIRIB)
(7502C), Office of Pesticide Programs
(OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001.
Hand delivery. Public Information
and Records Integrity Branch (PIRIB)
(7502C), Office of Pesticide Programs
(OPP), Environmental Protection
Agency, Rm. 119, Crystal Mall #2, 1801
S. Bell St., Arlington, VA, Attention:
Docket ID number EPA–HQ–OPP–2005–
0203. The docket facility is open from
8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the docket facility
is (703) 305–5805. Such deliveries are
only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
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 public
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
E:\FR\FM\22FEN1.SGM
22FEN1
Federal Register / Vol. 71, No. 35 / Wednesday, February 22, 2006 / Notices
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 captured automatically and
included as part of the comment that is
placed in the public 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. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/docket.htm/.
Docket. All documents in the docket
are listed in the regulation.gov index.
Although, listed in the index, some
information is not publicly available,
i.e., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
either electronically at https://
www.regulations.gov/ or in hard copy at
the Public Information and Records
Integrity Branch (PIRIB) (7502C), Office
of Pesticide Programs (OPP),
Environmental Protection Agency, Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
docket facility is (703) 305– 5805.
FOR FURTHER INFORMATION CONTACT:
Susan Bartow, Special Review and
Reregistration Division (7508C), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 603–
0065; fax number: (703) 308–8041; email address: bartow.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
cprice-sewell on PROD1PC66 with NOTICES
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; the medical industry; the spice
industry; pesticide users; and members
of the public interested in the sale,
VerDate Aug<31>2005
14:35 Feb 21, 2006
Jkt 208001
distribution, or use of pesticides. Since
others may also 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
www.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
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
PO 00000
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Fmt 4703
Sfmt 4703
9111
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 is also soliciting public
comment on risk reduction options for
ETO. 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, and
aseptic packaging, 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
proposals or otherwise comment on risk
management for ETO. Risks of concern
associated with the use of ETO are as
follows: The dietary risk assessment
indicates that for all supported
commodities, the acute dietary exposure
estimates for ethylene chlorohydrin (a
reaction product of ETO) are above the
Agency’s level of concern. In addition,
the Agency’s occupational exposure
assessment for ETO’s use as a sterilant
for the spice and medical industries
indicates that cancer risk are of concern
at the current regulatory levels
established by the Occupational Safety
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. Based on
available data, the Agency anticipates
the following spice and medical
industry-related activities to result in
potential worker exposure to ETO:
Inhalation exposure to ETO during
sterilization activities; inhalation
exposure to off-gassed ETO from treated
items during post-sterilization activities.
A summary of these potential risks of
concern as well as specific questions for
which the Agency is requesting input,
are provided in a separate document
titled Request for Additional
Information and Risk Management
Suggestions for the Reregistration of
Ethylene Oxide. In targeting these risks
of concern, the Agency solicits
E:\FR\FM\22FEN1.SGM
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Federal Register / Vol. 71, No. 35 / Wednesday, February 22, 2006 / Notices
information on effective and practical
risk reduction measures. In addition, a
paper outlining benefits of various ETO
uses is also included as a separate
document. The Agency is interested in
information related to these benefits.
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.
cprice-sewell 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 end-use
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.
List of Subjects
Environmental protection, Pesticides
and pests.
VerDate Aug<31>2005
14:35 Feb 21, 2006
Jkt 208001
Dated: February 15, 2006.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. E6–2463 Filed 2–21–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA-HQ-OPP–2005–0062;FRL–7760–9]
Boric Acid/Sodium Borate Salts Risk
Assessment; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s risk assessment,
and related documents for the pesticide
boric acid/sodium borate salts, and
opens a 60 day public comment period
on these documents. The public is
encouraged to suggest risk management
ideas or proposals to address the risks
identified. EPA is developing a
tolerance reassessment decision (TRED)
for boric acid/sodium borate salts
through a modified, 4–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: Comments must be received on
or before April 24, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2005–0062, by
one of the following methods:
• https://www.regulations.gov/. Follow
the on-line instructions for submitting
comments.
• Mail: Public Information and
Records Integrity Branch (PIRIB)
(7502C), Office of Pesticide Programs
(OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001.
Hand Delivery: Public Information
and Records Integrity Branch (PIRIB)
(7502C), Office of Pesticide Programs
(OPP), Environmental Protection
Agency, Rm. 119, Crystal Mall #2, 1801
S. Bell St., Arlington, VA, Attention:
Docket ID number EPA–HQ–OPP–
2005–0062. The docket facility is open
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
docket facility is (703) 305–5805. Such
deliveries are only accepted during the
Docket’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2005–
0062. EPA’s policy is that all comments
received will be included in the public
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 captured automatically and
included as part of the comment that is
placed in the public 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. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/docket.htm/.
Docket: All documents in the docket
are listed in the regulation.gov index.
Although listed in the index, some
information is not publicly available,
i.e., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
either electronically at https://
www.regulations.gov/ or in hard copy at
the Public Information and Records
Integrity Branch (PIRIB) (7502C), Office
of Pesticide Programs (OPP),
Environmental Protection Agency, Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
docket facility is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Nathan Mottl, Special Review and
Reregistration Division (7508C), Office
E:\FR\FM\22FEN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 35 (Wednesday, February 22, 2006)]
[Notices]
[Pages 9110-9112]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2463]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0203; FRL-7764-4 ]
Ethylene Oxide (ETO) Revised Risk Assessments; Notice of
Availability, and Solicitation of Risk Reduction Options (Phase 5 of 6-
Phase Process)
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 for ETO. 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: Comments must be received on or before April 24, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0203, by one of the following methods:
https://www.regulations.gov/. Follow the on-line
instructions for submitting comments.
Mail. Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
Hand delivery. Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-2005-0203. The
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the docket
facility is (703) 305-5805. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
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 public 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
[[Page 9111]]
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 captured
automatically and included as part of the comment that is placed in the
public 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. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at https://www.epa.gov/epahome/
docket.htm/.
Docket. All documents in the docket are listed in the
regulation.gov index. Although, listed in the index, some information
is not publicly available, i.e., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at https://www.regulations.gov/ or in hard copy at the Public
Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. The docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the docket facility
is (703) 305- 5805.
FOR FURTHER INFORMATION CONTACT: Susan Bartow, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 603-0065; fax
number: (703) 308-8041; 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; the medical
industry; the spice industry; pesticide users; and members of the
public interested in the sale, distribution, or use of pesticides.
Since others may also 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
www.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 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 is also soliciting public
comment on risk reduction options for ETO. 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, and aseptic packaging, 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 proposals or otherwise
comment on risk management for ETO. Risks of concern associated with
the use of ETO are as follows: The dietary risk assessment indicates
that for all supported commodities, the acute dietary exposure
estimates for ethylene chlorohydrin (a reaction product of ETO) are
above the Agency's level of concern. In addition, the Agency's
occupational exposure assessment for ETO's use as a sterilant for the
spice and medical industries indicates that cancer risk are of concern
at the current regulatory levels established by the Occupational Safety
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. Based on available data, the Agency anticipates the
following spice and medical industry-related activities to result in
potential worker exposure to ETO: Inhalation exposure to ETO during
sterilization activities; inhalation exposure to off-gassed ETO from
treated items during post-sterilization activities.
A summary of these potential risks of concern as well as specific
questions for which the Agency is requesting input, are provided in a
separate document titled Request for Additional Information and Risk
Management Suggestions for the Reregistration of Ethylene Oxide. In
targeting these risks of concern, the Agency solicits
[[Page 9112]]
information on effective and practical risk reduction measures. In
addition, a paper outlining benefits of various ETO uses is also
included as a separate document. The Agency is interested in
information related to these benefits.
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.''
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.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: February 15, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-2463 Filed 2-21-06; 8:45 am]
BILLING CODE 6560-50-S
