Document ID: EPA-HQ-OPP-2005-0252-0001
Agency: epa
Document Type: Proposed Rule
Title: Iodomethane; Pesticide Chemical Not Requiring a Tolerance or an Exemption from Tolerance
Posted Date: 2006-01-06T14:59:45Z

[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

[[Page 902]]

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

[[Page 903]]

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