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
[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Notices]
[Page 15728-15730]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-75]
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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.
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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:
? http://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 http://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 http://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
http://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
http://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]
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