Federal Register: January 6, 2006 (Volume 71, Number 4)
DOCID: FR Doc E6-26
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
EPA ID: [EPA-HQ-OPP-2005-0252; FRL-7755-6]
NOTICE: PROPOSED RULES
ACTION: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:
DOCUMENT ACTION: Proposed rule.
Iodomethane; Pesticide Chemical Not Requiring a Tolerance or an Exemption from Tolerance
DATES: Comments must be received on or before February 6, 2006.
EPA is proposing to designate the use of the active
ingredient, iodomethane as a nonfood use pesticide when applied as a
preplant soil fumigant for peppers, strawberries and tomatoes by adding an entry to 40 CFR 180.2020 noting the nonfood use
determination. This determination is based on the Agency's evaluation of data which indicates that residues of iodomethane (CH
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:
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 ECFR 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 email. 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 preplant 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 nonfood 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
nonfood use determination for iodomethane when used as a preplant
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
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 nontoxic 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 naturallyoccurring sources of iodine chemicals in the region. As a result, enforcement of tolerances would not be possible since no iodidefree 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
they are not likely to result in residues in or on food. It is under these provisions that the EPA proposes to designate the preplant fumigant use of iodomethane on peppers, strawberries and tomatoes as a nonfood 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 preplant soil fumigant for peppers, strawberries, and tomatoes.
IV. Statutory and Executive Order Reviews
This proposed rule establishes a nonfood 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 1044). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome 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 104113, 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:
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 Nonfood determinations.
* * * * *
Pesticide Chemical CAS Reg. No. Limits Uses * * * * * * * Iodomethane (CH3I) 74884 When applied as a preplant Peppers, strawberries and tomatoes fumigant * * * * * * * [FR Doc. E626 Filed 1506; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT
Mary L. Waller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3089354; email address: firstname.lastname@example.org.