Ethylene Oxide; Tolerance Reassessment Decision for Low Risk Pesticide; Notice of Availability, 45548-45550 [E6-12906]
Download as PDF
45548
Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Notices
Agency Docket for methyl bromide.
Comments received after the close of the
comment period will be marked ‘‘late.’’
EPA is not required to consider these
late comments.
The Agency will carefully consider all
comments received by the closing date
and will provide a Response to
Comments Memorandum in the Docket
and https://www.regulations.gov. If any
comment significantly affects the
document, EPA also will publish an
amendment to the RED in the Federal
Register. In the absence of substantive
comments requiring changes, the methyl
bromide RED will be implemented as it
is now presented.
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 productspecific data on individual end-use
products and either reregistering
products or taking other ‘‘appropriate
regulatory action.’’
Section 408(q) of the Federal Food,
Drug, and Cosmetic Act (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: August 2, 2006.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. E6–12898 Filed 8–8–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2005–0203; FRL–8083–3]
Ethylene Oxide; Tolerance
Reassessment Decision for Low Risk
Pesticide; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s Tolerance
Reassessment Decision (TRED) for the
pesticide ethylene oxide, and opens a
VerDate Aug<31>2005
19:05 Aug 08, 2006
Jkt 208001
public comment period on this
document, related risk assessments, and
other support documents. EPA has
reviewed this pesticide ethylene oxide
through a modified, streamlined version
of the public participation process that
the Agency uses to involve the public in
developing pesticide tolerance
reassessment and reregistration
decisions. Through the tolerance
reassessment program, EPA is ensuring
that all pesticides meet current health
and food safety standards.
DATES: Comments must be received on
or before October 10, 2006.
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 Building), 2777 S.
Crystal Drive, 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 telephone number is (703) 3055805.
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 https://
www.regulations.gov or E-mail. The
Federal https://www.regulations.gov Web
site 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 https://www.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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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. 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.
Joy
Schnackenbeck, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001;
telephone number: (703) 308-8072; fax
number: (703) 308-7070; E-mail
address:schnackenbeck.joy@epa.gov.
FOR FURTHER INFORMATION CONTACT:
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.
E:\FR\FM\09AUN1.SGM
09AUN1
Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Notices
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through https://
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 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.
jlentini on PROD1PC65 with NOTICES
II. Background
EPA has reassessed the uses of
ethylene oxide (ETO), and reassessed
the four existing tolerances or legal
residue limits established for residues of
this fumigant/sterilant. Additional
tolerances are to be proposed for
ethylene chlorhydrin (ECH), a reaction
product of ETO. As a fumigant/sterilant,
ETO is used to sterilize medical or
laboratory equipment, pharmaceuticals,
and aseptic packaging (21 CFR part
201), or to reduce microbial load on
cosmetics, whole and ground spices or
VerDate Aug<31>2005
19:05 Aug 08, 2006
Jkt 208001
other seasoning materials (40 CFR part
180) and artifacts, archival material or
library objects. Sterilization/fumigation
with ETO must be performed only in
vacuum or gas tight chambers designed
for use with ETO. It is applied by
commercial applicators only; there are
no residential uses of ETO.
The Agency is now issuing for
comment the resulting Report on Food
Quality Protection Act (FQPA)
Tolerance Reassessment Progress and
Risk Management Decision for ethylene
oxide, known as a TRED, as well as
related risk assessments and technical
support documents. This TRED will be
followed by a Reregistration Eligibility
Decision (RED) for ETO, scheduled for
2007. The RED will be prepared once
the Agency’s Office of Research and
Development (ORD) completes its
assessment of ETO carcinogenicity.
These results will be incorporated into
the Office of Pesticide Programs’ (OPP)
risk assessment for ETO and a RED will
be prepared.
EPA developed the ETO TRED
through a modified, streamlined version
of its public process for making
tolerance reassessment and
reregistration eligibility decisions.
Through these programs, the Agency is
ensuring that pesticides meet current
standards under the Federal Food, Drug,
and Cosmetic Act (FFDCA) and the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended
by FQPA. EPA must review tolerances
and tolerance exemptions that were in
effect when the FQPA was enacted, to
ensure that these existing pesticide
residue limits for food and feed
commodities meet the safety standard
established by the new law. Tolerances
are considered reassessed once the
safety finding has been made or a
revocation occurs. EPA has reviewed
and made the requisite safety finding for
the ETO tolerances.
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 of 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 issues, and degree of public concern
associated with each pesticide. EPA can
expeditiously reach decisions for
pesticides like ETO, which pose no risk
concerns after risk mitigation. This
mitigation includes the voluntary
cancellation of ethylene oxide use on
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
45549
basil and the mandatory requirement of
a sterilization method that uses a single
sterilization chamber to pre-condition
and aerate with an alternating vacuum
and aeration purging procedure which
reduces ethylene oxide and reaction
product residues. Once EPA assesses
uses and risks for such low risk
pesticides, the Agency may go directly
to a decision and prepare a document
summarizing its findings, such as the
ETO TRED.
The tolerance reassessment program
is being conducted under
Congressionally mandated time frames,
and EPA recognizes the need both to
make timely decisions and to involve
the public in finding ways to effectively
mitigate pesticide risks. ETO, however,
poses no risks after mitigation. The
Agency therefore is issuing the ETO
TRED, its risk assessments, and related
support documents simultaneously for
public comment. The comment period
is intended to provide an opportunity
for public input and a mechanism for
initiating any necessary amendments to
the TRED. All comments should be
submitted using the methods in
ADDRESSES, and must be received by
EPA on or before the closing date. These
comments 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.
EPA will carefully consider all
comments received by the closing date
and will provide a Response to
Comments Memorandum in the docket
and https://www.regulations.gov. If any
comment significantly affects the
document, EPA also will publish an
amendment to the TRED in the Federal
Register. In the absence of substantive
comments requiring changes, the
decisions reflected in the TRED will be
implemented as presented.
B. What is the Agency’s Authority for
Taking this 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.
E:\FR\FM\09AUN1.SGM
09AUN1
45550
Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Notices
Dated: August 1, 2006.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. E6–12906 Filed 8–8–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2005–0558; FRL–8085–4]
Coppers Reregistration Eligibility
Decision; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s Reregistration
Eligibility Decision (RED) for coppercontaining pesticides and opens a
public comment period on this
document and its supporting
documents. The Agency’s risk
assessments and other related
documents also are available in the
coppers docket. Coppers are used in
agriculture as a broad-spectrum
fungicide and bactericide on virtually
all food and ornamental crops, for algae
control in catfish aquaculture, and in
direct aquatic applications as an
algaecide, herbicide, molluscicide, and
leech control. Coppers are also
registered for antimicrobial applications
including use as an anti-foulant and
preservative. EPA has reviewed coppers
through the 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 October 10, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2005–0558, 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 Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
VerDate Aug<31>2005
19:05 Aug 08, 2006
Jkt 208001
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 3055805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2005–
0558. 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. 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.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Rosanna Louie, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001;
telephone number: (703) 308-0037; fax
number: (703) 308-7070; e-mail address:
louie.rosanna@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.
E:\FR\FM\09AUN1.SGM
09AUN1
Agencies
[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Notices]
[Pages 45548-45550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12906]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0203; FRL-8083-3]
Ethylene Oxide; Tolerance Reassessment Decision for Low Risk
Pesticide; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of EPA's Tolerance
Reassessment Decision (TRED) for the pesticide ethylene oxide, and
opens a public comment period on this document, related risk
assessments, and other support documents. EPA has reviewed this
pesticide ethylene oxide through a modified, streamlined version of the
public participation process that the Agency uses to involve the public
in developing pesticide tolerance reassessment and reregistration
decisions. Through the tolerance reassessment program, EPA is ensuring
that all pesticides meet current health and food safety standards.
DATES: Comments must be received on or before October 10, 2006.
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
Building), 2777 S. Crystal Drive, 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 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 https://
www.regulations.gov or E-mail. The Federal https://www.regulations.gov
Web site 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 https://www.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.
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: Joy Schnackenbeck, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8072; fax
number: (703) 308-7070; E-mail address:schnackenbeck.joy@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.
[[Page 45549]]
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
https://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 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
EPA has reassessed the uses of ethylene oxide (ETO), and reassessed
the four existing tolerances or legal residue limits established for
residues of this fumigant/sterilant. Additional tolerances are to be
proposed for ethylene chlorhydrin (ECH), a reaction product of ETO. As
a fumigant/sterilant, ETO is used to sterilize medical or laboratory
equipment, pharmaceuticals, and aseptic packaging (21 CFR part 201), or
to reduce microbial load on cosmetics, whole and ground spices or other
seasoning materials (40 CFR part 180) and artifacts, archival material
or library objects. Sterilization/fumigation with ETO must be performed
only in vacuum or gas tight chambers designed for use with ETO. It is
applied by commercial applicators only; there are no residential uses
of ETO.
The Agency is now issuing for comment the resulting Report on Food
Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision for ethylene oxide, known as a TRED, as well as
related risk assessments and technical support documents. This TRED
will be followed by a Reregistration Eligibility Decision (RED) for
ETO, scheduled for 2007. The RED will be prepared once the Agency's
Office of Research and Development (ORD) completes its assessment of
ETO carcinogenicity. These results will be incorporated into the Office
of Pesticide Programs' (OPP) risk assessment for ETO and a RED will be
prepared.
EPA developed the ETO TRED through a modified, streamlined version
of its public process for making tolerance reassessment and
reregistration eligibility decisions. Through these programs, the
Agency is ensuring that pesticides meet current standards under the
Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by
FQPA. EPA must review tolerances and tolerance exemptions that were in
effect when the FQPA was enacted, to ensure that these existing
pesticide residue limits for food and feed commodities meet the safety
standard established by the new law. Tolerances are considered
reassessed once the safety finding has been made or a revocation
occurs. EPA has reviewed and made the requisite safety finding for the
ETO tolerances.
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 of 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
issues, and degree of public concern associated with each pesticide.
EPA can expeditiously reach decisions for pesticides like ETO, which
pose no risk concerns after risk mitigation. This mitigation includes
the voluntary cancellation of ethylene oxide use on basil and the
mandatory requirement of a sterilization method that uses a single
sterilization chamber to pre-condition and aerate with an alternating
vacuum and aeration purging procedure which reduces ethylene oxide and
reaction product residues. Once EPA assesses uses and risks for such
low risk pesticides, the Agency may go directly to a decision and
prepare a document summarizing its findings, such as the ETO TRED.
The tolerance reassessment program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public in finding ways to
effectively mitigate pesticide risks. ETO, however, poses no risks
after mitigation. The Agency therefore is issuing the ETO TRED, its
risk assessments, and related support documents simultaneously for
public comment. The comment period is intended to provide an
opportunity for public input and a mechanism for initiating any
necessary amendments to the TRED. All comments should be submitted
using the methods in ADDRESSES, and must be received by EPA on or
before the closing date. These comments 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.
EPA will carefully consider all comments received by the closing
date and will provide a Response to Comments Memorandum in the docket
and https://www.regulations.gov. If any comment significantly affects
the document, EPA also will publish an amendment to the TRED in the
Federal Register. In the absence of substantive comments requiring
changes, the decisions reflected in the TRED will be implemented as
presented.
B. What is the Agency's Authority for Taking this 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.
[[Page 45550]]
Dated: August 1, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-12906 Filed 8-8-06; 8:45 am]
BILLING CODE 6560-50-S