Methyl Bromide Revised Risk Assessment for Uses in Enclosures, Chambers and Structural Food Processing/Storage Facilities; Notice of Availability and Solicitation of Risk Reduction Options, 15728-15730 [E6-4568]
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Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
active ingredients subject to
reregistration under this section for
which tolerances or exemptions from
tolerances are required under the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.), not later than the
last date for tolerance reassessment
established under section 408(q)(1)(C) of
that Act (21 U.S.C. 346a(q)(1)(C)) * * *’’
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. A tolerance or
exemption meets the requirements of
section 408(b)(2) or (c)(2), respectively,
if ‘‘the Administrator determines the
pesticide chemical residue is safe,’’ i.e.,
‘‘that there is a reasonable certainty that
no harm will result from aggregate
exposure to the pesticide chemical
residue, including all anticipated
dietary exposures and all other
exposures for which there is reliable
information.’’ 21 U.S.C. 346a(b)(2)(A),
(c)(2)(A). In making this safety finding,
FFDCA requires the Administrator to
consider, among other factors,
‘‘available information concerning the
cumulative effects of such residues and
other substances that have a common
mechanism of toxicity * * *’’ 21 U.S.C.
346a(b)(2)(D)(v), (c)(2)(B).
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: March 21, 2006.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. E6–4505 Filed 3–28–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2005–0123; FRL–7768–7]
Methyl Bromide Revised Risk
Assessment for Uses in Enclosures,
Chambers and Structural Food
Processing/Storage Facilities; Notice
of Availability and Solicitation of Risk
Reduction Options
Environmental Protection
Agency (EPA).
ACTION: Notice.
hsrobinson on PROD1PC68 with NOTICES
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s revised risk
assessment for the pesticide methyl
bromide’s uses in enclosures, chambers
VerDate Aug<31>2005
15:39 Mar 28, 2006
Jkt 208001
and structural food processing/storage
facilities. In addition, this notice solicits
public comment on risk reduction
options for methyl bromide’s
commodity uses. 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 uses in enclosures, chambers and
structural food processing/storage
facilities of methyl bromide (i.e. uses
that result in a food tolerance) 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 May 30, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2005–0123, 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–
0123. 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–
2005–0123. 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
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Fmt 4703
Sfmt 4703
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be 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:
Steven Weiss, Special Review and
Reregistration Division (7508C), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 308–
8293; fax number: (703)308–8005; email address: weiss.steven@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
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Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
hsrobinson on PROD1PC68 with NOTICES
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
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 assessment for methyl
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15:39 Mar 28, 2006
Jkt 208001
bromide use in enclosures, chambers
and structural food processing/storage
facilities, initially issued for comment
through a Federal Register notice
published on July 13, 2005, 70 FR
40336, (FRL–7721–3) a response to
comments; and related documents for
methyl bromide. EPA also is soliciting
public comment on risk reduction
options for methyl bromide’s uses in
enclosures, chambers and structural
food processing/storage facilities and
EPA’s initial assessment of the impacts
of these risk reduction options. EPA
developed the risk assessment for
methyl bromide 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).
The risk assessment includes methyl
bromide uses that have accompaning
food residue tolerances such as postharvest fumigation of food commodities
in chambers at ports or specialized
structural fumigations at food
processing facilities. Although some
methyl bromide uses such as fumigation
of timber, wood products, and industrial
equipment do not require a food residue
tolerance, they have been included in
this assessment since they are
performed in similar facilities and were
assessed with similar methods.
EPA plans to release a revised
assessment (Phase 5) for all other uses
of methyl bromide, mainly soil fumigant
applications, later this year. The Agency
is delaying the soil fumigant component
of methyl bromide reregistration in
response to stakeholder comments that
the risks, benefits, and risk management
of soil fumigation uses of methyl
bromide and its alternatives should be
considered in the same general time
frame. Alternatives currently in the
reregistration process include metam
sodium, dazomet, and chloropicrin. In
particular, stakeholders have noted that
chloropicrin is frequently applied in
conjunction with methyl bromide and
thus commenters have asserted that it
makes sense to consider risk
management strategies jointly for these
chemicals. The Agency agrees with this
logic and thus has separated the
assessments so that risk management
decisions can be made as expeditiously
as feasible for all uses.
EPA estimated the methyl bromide
usage in the U.S. for 2004 based on
information from the methyl bromide
critical use exemption process, U.S.
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15729
Department of Agriculture, Animal and
Plant Health Inspection Service, and
EPA proprietary sources. Based on these
sources EPA estimates there was a total
of 23 million pounds of methyl bromide
used in the U.S. in 2004 with 3 million
pounds used on commodities, food
processing facilities, and food
quarantine uses, and 20 million pounds
used for all other uses, mainly pre-plant
soil applications.
Application rates for commodity
fumigations can range from 1 to 20 lb ai/
1000 ft3 but most are in the 1 to 9 lb ai/
1000 ft3 range. Likewise, structural
fumigations are in the 1 to 9 lb ai/1000
ft3 range. For structural, commodity and
other types of applications, an
application rate of 9 lb ai/1000 ft3 was
used as the basis for risk assessment
purposes.
EPA is providing an opportunity,
through this notice, for interested
parties to provide risk management
proposals or otherwise comment on risk
management for methyl bromide.
Regarding risks to humans from methyl
bromide commodity uses, there are no
aggregate dietary risks of concern
resulting from acute and chronic
exposures (food and water only). Risks
of concern associated with the use of
methyl bromide commodity uses are:
1. Occupational exposures during
treatment and aeration processes and;
2. Bystander exposure during
treatment and aeration processes. In
targeting these risks of concern, the
Agency solicits information on effective
and practical risk reduction measures.
EPA’s Office of Atmospheric
Programs (OAP) has also estimated the
number of UV-related skin cancer
incidents and deaths due to ozone
depletion caused by methyl bromide’s
uses in enclosures, chambers, and
structural food processing/storage
facilities. OAP’s assessment is also
included in the docket for public
comment. The Agency believes it is
appropriate to consider these cancer
risks as part of the reregistration process
because the risks clearly result from use
of methyl bromide products registered
for use under FIFRA.
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
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Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Notices
with each pesticide. Due to its uses,
risks, and other factors, methyl bromide
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 methyl bromide.
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 for comment the methyl
bromide RED.
the chloroacetanilide pesticide
acetochlor. The Agency’s risk
assessments and other related
supporting documents also are available
in the acetochlor docket. Through the
tolerance reassessment program, EPA is
ensuring that all pesticides meet current
health and food safety standards. This
decision is being released concurrent
with the Notice of Availability of the
cumulative risk assessment for the
chloroacetanilide pesticides which
include acetochlor and alachlor. See
EPA–HQ–OPP–2006–0202 in the Notice
section of this issue of the Federal
Register.
B. What is the Agency’s Authority for
Taking this Action?
Felicia Fort, Special Review and
Reregistration Division (7508C), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 305–
7478; fax number: (703) 308–8005; email address: fort.felicia@epa.gov.
SUPPLEMENTARY INFORMATION:
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: March 22, 2006.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. E6–4568 Filed 3–28–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2005–0227; FRL–7770–6]
Acetochlor; Tolerance Reassessment
Decision
Environmental Protection
Agency (EPA).
ACTION: Notice.
hsrobinson on PROD1PC68 with NOTICES
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s Report on Food
Quality Protection Act (FQPA)
Tolerance Reassessment Progress and
Risk Management Decision (TRED) for
VerDate Aug<31>2005
15:39 Mar 28, 2006
Jkt 208001
FOR FURTHER INFORMATION CONTACT:
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. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established a
docket for this action under Docket
identification number (ID) [EPA–HQ–
OPP–2005–0227; FRL–7770–6]. 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), Rm. 119,
Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
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under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/.
II. Background
A. What Action is the Agency Taking?
EPA has assessed risks associated
with use of the chloroacetanilide
pesticide acetochlor, and reached a
tolerance reassessment and risk
management decision reassessing 12
existing tolerances or legal residue
limits for acetochlor. Acetochlor, 2–
chloro-N-(ethoxymethyl)-N-(2–ethyl-6–
methylphenyl)acetamide, is a
preemergence herbicide used for the
control of weeds and is registered for
use on field corn and popcorn. Corn
fields treated with acetochlor may later
be rotated to grain sorghum (milo),
soybeans, wheat, and tobacco, according
to the currently registered use pattern.
Corn and the rotational crops listed
above were considered in the risk
assessment supporting the acetochlor
TRED. There are no risks of concern
associated with the use of acetochlor.
The Agency is now issuing a Report on
Food Quality Protection Act (FQPA)
Tolerance Reassessment Progress and
Risk Management Decision for
acetochlor, known as a TRED, as well as
related technical support documents.
EPA must review tolerances and
tolerance exemptions that were in effect
when FQPA was enacted in August
1996, 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 acetochlor tolerances
included in this notice.
The acetochlor TRED presents the
Agency’s tolerance reassessment
conclusions for acetochlor alone;
however, section 408(b)(2)(D)(v) of the
Federal Food, Drug and Cosmetic Act
(FFDCA) directs the Agency also to
consider available information on the
cumulative risk from substances sharing
a common mechanism of toxicity.
Because the chloroacetanilides
pesticides share a common mechanism
of toxicity, due to their ability to cause
nasal turbinate tumors, the Agency
evaluated the cumulative risk posed by
this group before making its final
tolerance reassessment decision on the
chloroacetanilide pesticide, acetochlor.
EPA has determined that the cumulative
risk associated with chloroacetanilide
pesticides, which include acetochlor
and alachlor, is below the Agency’s
level of concern. Therefore, the 12
tolerances established for residues of
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]]>Agencies
[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Notices]
[Pages 15728-15730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4568]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0123; FRL-7768-7]
Methyl Bromide Revised Risk Assessment for Uses in Enclosures,
Chambers and Structural Food Processing/Storage Facilities; Notice of
Availability and Solicitation of Risk Reduction Options
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of EPA's revised risk
assessment for the pesticide methyl bromide's uses in enclosures,
chambers and structural food processing/storage facilities. In
addition, this notice solicits public comment on risk reduction options
for methyl bromide's commodity uses. 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 uses in enclosures, chambers and structural food processing/
storage facilities of methyl bromide (i.e. uses that result in a food
tolerance) 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 May 30, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0123, 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-
2005-0123. 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-
2005-0123. 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 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: Steven Weiss, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8293; fax
number: (703)308-8005; e-mail address: weiss.steven@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
[[Page 15729]]
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
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 assessment for
methyl bromide use in enclosures, chambers and structural food
processing/storage facilities, initially issued for comment through a
Federal Register notice published on July 13, 2005, 70 FR 40336, (FRL-
7721-3) a response to comments; and related documents for methyl
bromide. EPA also is soliciting public comment on risk reduction
options for methyl bromide's uses in enclosures, chambers and
structural food processing/storage facilities and EPA's initial
assessment of the impacts of these risk reduction options. EPA
developed the risk assessment for methyl bromide 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).
The risk assessment includes methyl bromide uses that have
accompaning food residue tolerances such as post-harvest fumigation of
food commodities in chambers at ports or specialized structural
fumigations at food processing facilities. Although some methyl bromide
uses such as fumigation of timber, wood products, and industrial
equipment do not require a food residue tolerance, they have been
included in this assessment since they are performed in similar
facilities and were assessed with similar methods.
EPA plans to release a revised assessment (Phase 5) for all other
uses of methyl bromide, mainly soil fumigant applications, later this
year. The Agency is delaying the soil fumigant component of methyl
bromide reregistration in response to stakeholder comments that the
risks, benefits, and risk management of soil fumigation uses of methyl
bromide and its alternatives should be considered in the same general
time frame. Alternatives currently in the reregistration process
include metam sodium, dazomet, and chloropicrin. In particular,
stakeholders have noted that chloropicrin is frequently applied in
conjunction with methyl bromide and thus commenters have asserted that
it makes sense to consider risk management strategies jointly for these
chemicals. The Agency agrees with this logic and thus has separated the
assessments so that risk management decisions can be made as
expeditiously as feasible for all uses.
EPA estimated the methyl bromide usage in the U.S. for 2004 based
on information from the methyl bromide critical use exemption process,
U.S. Department of Agriculture, Animal and Plant Health Inspection
Service, and EPA proprietary sources. Based on these sources EPA
estimates there was a total of 23 million pounds of methyl bromide used
in the U.S. in 2004 with 3 million pounds used on commodities, food
processing facilities, and food quarantine uses, and 20 million pounds
used for all other uses, mainly pre-plant soil applications.
Application rates for commodity fumigations can range from 1 to 20
lb ai/1000 ft3 but most are in the 1 to 9 lb ai/1000
ft3 range. Likewise, structural fumigations are in the 1 to
9 lb ai/1000 ft3 range. For structural, commodity and other
types of applications, an application rate of 9 lb ai/1000
ft3 was used as the basis for risk assessment purposes.
EPA is providing an opportunity, through this notice, for
interested parties to provide risk management proposals or otherwise
comment on risk management for methyl bromide. Regarding risks to
humans from methyl bromide commodity uses, there are no aggregate
dietary risks of concern resulting from acute and chronic exposures
(food and water only). Risks of concern associated with the use of
methyl bromide commodity uses are:
1. Occupational exposures during treatment and aeration processes
and;
2. Bystander exposure during treatment and aeration processes. In
targeting these risks of concern, the Agency solicits information on
effective and practical risk reduction measures.
EPA's Office of Atmospheric Programs (OAP) has also estimated the
number of UV-related skin cancer incidents and deaths due to ozone
depletion caused by methyl bromide's uses in enclosures, chambers, and
structural food processing/storage facilities. OAP's assessment is also
included in the docket for public comment. The Agency believes it is
appropriate to consider these cancer risks as part of the
reregistration process because the risks clearly result from use of
methyl bromide products registered for use under FIFRA.
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
[[Page 15730]]
with each pesticide. Due to its uses, risks, and other factors, methyl
bromide 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 methyl bromide.
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 for comment
the methyl bromide 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: March 22, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-4568 Filed 3-28-06; 8:45 am]
BILLING CODE 6560-50-S
