[Federal Register: January 6, 2006 (Volume 71, Number 4)]
[Proposed Rules]
[Page 901-903]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja06-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0252; FRL-7755-6]
Iodomethane; Pesticide Chemical Not Requiring a Tolerance or an
Exemption from Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to designate the use of the active
ingredient, iodomethane as a non-food use pesticide when applied as a
pre-plant soil fumigant for peppers, strawberries and tomatoes by
adding an entry to 40 CFR 180.2020 noting the non-food use
determination. This determination is based on the Agency's evaluation
of data which indicates that residues of iodomethane (CH3I)
are quickly degraded or metabolized into non-toxic degradates and
subsequently incorporated into natural plant constituents. The effect
of this proposed designation is that EPA does not require that a
tolerance or exemption from tolerance under section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, be established as
a condition of registration of the pesticide under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et.
seq.
DATES: Comments must be received on or before February 6, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0252, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Website: EDOCKET, EPA's electronic public docket
and comment system was replaced on November 25, 2005 by an enhanced
federal-wide electronic docket management and comment system located at
http://www.regulations.gov/. Follow the on-line instructions.
E-mail: Comments may be sent by e-mail to
opp-docket@epa.gov, Attention: Docket ID Number EPA-HQ-OPP-2005-0252.
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, Attention: Docket ID Number EPA-HQ-OPP-2005-0252.
Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), 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-2005-0252. 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-
2005-0252. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.epa.gov/edocket/, 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 EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, 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 EDOCKET or regulations.gov, your e-mail address
will be automatically captured 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
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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 EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. 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, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET 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.
FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9354; e-mail address: waller.mary@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, 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 rulemaking 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 and Statutory Findings
On February 4, 2002 and February 18, 2005, the Agency received
applications to register pesticide products containing the new active
ingredient, iodomethane as a pre-plant fumigant for peppers,
strawberries, and tomatoes. The registrant, Arysta LifeScience North
America, Corp. (formerly known as Arvesta Corp.) asserted that the uses
should be considered non-food uses based on data submitted with the
applications.
EPA on its own initiative, under section 408 of the FFDCA, 21
U.S.C. 346a, is proposing to add an entry to 40 CFR 180.2020 noting the
non-food use determination for iodomethane when used as a pre-plant
fumigant for peppers, strawberries and tomatoes. This determination is
based on the Agency's evaluation of metabolism and crop field trial
data which included analysis for residues of iodomethane
(CH3I) and free iodide (I-). Analytical method descriptions
and validations used to measure iodomethane and free iodide were also
submitted to the Agency.
The Agency does not believe that there is a reasonable expectation
of iodomethane residues per se in peppers, strawberries and tomatoes at
harvest. Iodomethane is quickly metabolized/degraded into iodide at
levels lower than those which would cause toxic effects, and into other
non-toxic degradates which are incorporated into natural plant
constituents. Iodide, the major degradate, is an ubiquitous, naturally-
occurring component of all soils, plants, and animals, and as such,
there is an existing background level of iodine and iodide in the
environment which varies depending on the naturally-occurring sources
of iodine chemicals in the region. As a result, enforcement of
tolerances would not be possible since no iodide-free samples are
available and residue field trials showed evidence of control samples
with higher iodide residues than iodomethane treated samples.
Additionally, iodine is an essential human dietary nutrient, and
iodomethane residues must dissipate in the soil prior to planting as
the chemical is phytotoxic. Therefore, the Agency concludes that
tolerances are not required for iodomethane.
EPA lists in 40 CFR 180.2020 pesticide chemical uses EPA has
determined do not need a tolerance or exemption from the requirement of
a tolerance based on EPA's finding that
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they are not likely to result in residues in or on food. It is under
these provisions that the EPA proposes to designate the pre-plant
fumigant use of iodomethane on peppers, strawberries and tomatoes as a
non-food use because the use is not likely to result in residues in or
on food for the reasons described in Unit II of this document.
III. Conclusion
A nonfood use determination is proposed for iodomethane when
applied as a pre-plant soil fumigant for peppers, strawberries, and
tomatoes.
IV. Statutory and Executive Order Reviews
This proposed rule establishes a non-food use determination under
section 408(e) of the FFDCA in response to an application for
registration of a pesticide product submitted to the Agency. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Pursuant to the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby
certifies that this proposed action will not have significant negative
economic impact on a substantial number of small entities. Listing a
pesticide use as not requiring a tolerance or exemption from tolerance
clarifies that regulation under the FFDCA is unnecessary as to that use
and thus has no negative economic impact. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This
proposed rule directly regulates growers, food processors, food
handlers and food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this
proposed rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This proposed rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 30, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.2020 the table is amended by adding alphabetically
the following entry to read as follows:
Sec. 180.2020 Non-food determinations.
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Pesticide Chemical CAS Reg. No. Limits Uses
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Iodomethane (CH3I) 74-88-4 When applied as a pre-plant Peppers, strawberries and tomatoes
fumigant
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[FR Doc. E6-26 Filed 1-5-06; 8:45 am]
BILLING CODE 6560-50-S