[Federal Register Volume 70, Number 55 (Wednesday, March 23, 2005)]
[Rules and Regulations]
[Pages 14551-14556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5720]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0011; FRL-7699-3]


Thiophanate-methyl; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of thiophanate-methyl and its metabolite methyl 2-
benzimidazoyl carbamate (MBC) in or on cotton and cotton, gin 
byproducts. This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on cotton. This regulation establishes a maximum permissible level for 
residues of thiophanate-methyl in these feed commodities. These 
tolerances will expire and are revoked on December 31, 2007.

DATES: This regulation is effective March 23, 2005. Objections and 
requests for hearings must be received on or before May 23, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0011. 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: Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

    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 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions discussed above. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

[[Page 14552]]

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/.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing tolerances for combined residues of the 
fungicide thiophanate-methyl, and its metabolite MBC, in or on cotton 
at 0.05 parts per million (ppm) and cotton gin byproducts at 5.0 ppm. 
These tolerances will expire and are revoked on December 31, 2007. EPA 
will publish a document in theFederal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean 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.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Thiophanate-methyl on Cotton and FFDCA 
Tolerances

    On July 20, 2004, the State of Florida utilized the crisis 
exemption authority as provided under FIFRA section 18 for use of 
thiophanate-methyl on cotton. According to the State, fusarium hardlock 
of cotton has been identified as a severe economic disease during the 
last 4 years. This disease has become a problem since the state began 
to grow primarily genetically modified (GMOs) varieties of cotton. 
Cotton yields have been reduced up to 50% as a result of the disease. 
To date, thiophanate-methyl is the only pesticide that has been 
identified to control this disease on cotton. EPA has authorized under 
FIFRA section 18 the use of thiophanate-methyl on cotton for control of 
fusarium hardlock in Florida. After having reviewed the submission, EPA 
concurs that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of thiophanate-methyl in or 
on cotton. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance 
under section 408(l)(6) of the FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although these tolerances will expire and are revoked on December 31, 
2007, under section 408(l)(5) of the FFDCA, residues of the pesticide 
not in excess of the amounts specified in the tolerance remaining in or 
on cotton and cotton gin byproducts after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by these tolerances at the time of that application. EPA will take 
action to revoke these tolerances earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether thiophanate-
methyl meets EPA's registration requirements for use on cotton or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
as a basis for registration of thiophanate-methyl by a State for 
special local needs under FIFRA section 24(c). Nor do these tolerances 
serve as the basis for any State other than Florida to use this 
pesticide on this crop under section 18 of FIFRA without following all 
provisions of EPA's regulations implementing FIFRA section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemption for thiophanate-methyl, contact the Agency's 
Registration Division at the address provided under FOR FURTHER 
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961 (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA , EPA has 
reviewed the available scientific data and other relevant information 
in support of this action. EPA has sufficient data to assess the 
hazards of thiophanate-methyl and to make a determination on aggregate 
exposure, consistent with section 408(b)(2) of the FFDCA, for a time-
limited tolerance for combined residues of thiophanate-methyl in or on 
cotton at 0.05 ppm and cotton, gin byproducts at 5.0 ppm.
    Residue data were submitted for cotton. Cotton is not consumed by 
humans, any inadvertent exposure to residues of thiophanate-methyl from 
this emergency exemption will result from the consumption of meat or 
milk since cotton gin byproducts and cottonseed (meal, hulls) are 
animal feed items. Currently there are tolerances for residues of 
thiophanate-methyl in or on milk and ruminant meat, meat byproducts, 
liver, and fat. Since there is

[[Page 14553]]

an established dry apple pomace tolerance at 40 ppm and peanut forage/
hay tolerances exist at 15 ppm, the Agency has determined that adding 
cotton feed items to the animal diet will not increase the dietary 
burden and therefore, the current tolerances on animal commodities are 
adequate.
    The Agency conducted dietary exposure assessments for the cotton 
use under section 18 of FIFRA. Using the Dietary Exposure Evaluation 
Model software with the Food Commodity Intake Database 
(DEEMTM-FCID version 2.02) an analysis evaluated the 
individual food consumption as reported by respondents in the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to thiophanate-methyl for each commodity. The 
addition of cotton did not result in any increase in dietary exposure 
compared to existing uses. Further, there are no new residential uses 
being proposed since the Agency's previous risk assessment. Therefore, 
establishing tolerances for residues of thiophanate-methyl in or on 
cotton and cotton gin byproducts will not increase the most recent 
estimated aggregate risks resulting from use of thiophanate-methyl, as 
discussed in the Federal Register of July 23, 2003 (68 FR 43465) (FRL-
7317-5) final rule establishing a time-limited tolerance for combined 
residues of thiophanate methyl and its metabolite MBC in or on fruiting 
vegetables. Refer to the July 23, 2003 Federal Register document for a 
detailed discussion of the aggregate risk assessments and determination 
of safety. Additionally, a summary of the toxicological dose and 
endpoints for thiophanate methyl for use in human risk assessment is 
discussed in the final rule published in the Federal Register of August 
28, 2002 (67 FR 55137) (FRL-7192-1). EPA relies upon these risk 
assessments and the findings made in the July 23, 2003 Federal Register 
document in support of this action. Below is a summary of the aggregate 
risk assessments.
    The acute and chronic dietary risk estimates for thiophanate methyl 
were less than 100% of the acute and chronic Population Adjusted Doses 
(aPAD and cPAD) at the 99.9th exposure percentile for the 
general U.S. population and all population subgroups. The acute and 
chronic dietary risk estimates for MBC +2-AB were also less than 100% 
of the aPAD and cPAD at the 99.9th exposure percentile for 
the general U.S. population and all population subgroups. EPA generally 
has no concern for exposures below 100% of the PADs, because the PADs 
represent the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. The 
most highly exposed subgroup for all risk estimates calculated was 
children 1-2 years. Table 1 summarizes the percentages of aPADs and 
cPADs for all scenarios for the overall U.S. population and for the 
most highly exposed population subgroup (children 1-2 years).

                           Table 1.--Acute and chronic dietary risk estimates for Thiophanate Methyl Existing and Proposed Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          cPAD Utilized                                MBC
               Population Subgroup                      aPAD Utilized      --------------------------------------------------------------------------  +2-
                                                                                       TM                   MBC +2-AB                    TM
----------------------------------------------------------------------------------------------------------------------------------------------------- -----
U.S. population                                                         6%                       2%                      <1%                      <1%
-------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                               22%                      58%                       2%                      10%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The acute drinking water assessment, based on simultaneous dietary 
exposure to both MBC and thiophanate methyl (which was converted to MBC 
equivalents) resulted in Drinking Water Levels of Concern (DWLOCs) for 
the Overall U.S. Population of 5,833 parts per billion (ppb), and for 
children (1-2 years) of 72 ppb (the population subgroup with the lowest 
DWLOC). All acute DWLOCs were well above the acute Estimated 
Environmental Concentrations (EECs) for groundwater and surfacewater, 
at 3 and 44 ppb, respectively.
    The chronic drinking water assessment, based on simultaneous 
dietary exposure to both MBC and thiophanate methyl (which was 
converted to MBC equivalents) resulted in chronic DWLOCs for the 
Overall U.S. Population of 870 ppb, and for children (1-2 years) of 22 
ppb (the population subgroup with the lowest DWLOC). All chronic DWLOCs 
were well above the chronic EEC for groundwater of 3 ppb. The chronic 
DWLOCs were also above the chronic EEC for surfacewater of 23-24 ppb, 
except for that of the most highly exposed subgroup, children (1-2 
years), which is slightly below the EEC with a chronic DWLOC of 22 ppb. 
However, given the conservative nature of the screening-level approach 
to estimated drinking water risks, and the equivalent levels of the 
chronic DWLOC and EEC (22-23-24 ppb), the Agency does not believe this 
represents a significant risk or concern for chronic aggregate 
exposures.
    Short-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Thiophanate methyl and MBC are currently 
registered for uses that could result in short-term residential 
exposure and the Agency has determined that it is appropriate to 
aggregate chronic food and water and short-term exposures for 
thiophanate methyl and MBC. All residential exposures are considered to 
be short-term. The Margins of Exposure (MOEs) (converted to MBC 
equivalents) for aggregate short-term exposure to thiophanate methyl 
are as follows: oral exposure of children (1-6 years) is 670; dermal 
exposure of children (1-6 years) is 1,000; and dermal exposure of 
females (13-50 years) is 1,315. The MOEs for aggregate exposure to MBC 
from the use of MBC as an in-can paint preservative are 670 for dermal 
exposure and 770 for exposure via inhalation. The MOEs (converted to 
MBC equivalents) for the total thiophanate methyl and MBC aggregate 
exposure are as follows: 630 for oral and dermal exposure of children 
(1-years); 770 for exposure via inhalation for females (13-50 years); 
and 620 for oral and dermal exposure for females (13-50 years). 
Although the MOEs below 1,000 exceed the Agency's level of concern, 
when considering the conservative method of exposure estimation and the 
negotiated risk mitigation whereby the registrant has agreed to conduct 
hand-press studies to help refine this assessment, the risks do not 
exceed the Agency's level of concern.
    The total thiophanate methyl and MBC+2-AB dietary cancer risk is 
1.1 x 10-6 for existing and proposed new uses. The cancer 
risk from non-occupational residential exposure is 1.1 x 
10-6.

[[Page 14554]]

 Therefore, aggregate cancer risk is 2.2 x 10-6. This risk 
estimate includes cancer risk from both thiophanate methyl and MBC+2-AB 
on food including all existing uses and section 18 uses, thiophanate 
methyl exposure from treating ornamentals, thiophanate methyl exposure 
from performing post-application lawn activities, and exposure from 
applying paint containing MBC. This is considered to be a high-end risk 
scenario since it is not expected that someone would treat ornamentals, 
perform high exposure post-application activities, and apply paint 
containing MBC every year for 70 years. Therefore, this estimate is 
considered to be a conservative estimate. Additionally, the cancer risk 
estimate for drinking water is based on the highest EEC, which is also 
a very high-end risk estimate since it is based on the maximum rate 
being applied every season for 70 years. The risk estimate calculations 
also assumed that the modeled surface water EEC is equivalent to 
concentrations in finished drinking water. Thus, food plus water plus 
non-occupational residential cancer risk is 2.2 x 10-6 which 
is within the range considered as negligible. Therefore, the risks do 
not exceed the Agency's level of concern.
    Based on these risk assessments, EPA concludes that there is a 
reasonable certainty that no harm will result to the general 
population, and to infants and children from aggregate exposure to 
thiophanate-methyl residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    Canada, Codex, and Mexico do not have maximum residue limits for 
residues of thiophanate-methyl in or on cotton or byproducts of cotton. 
Therefore, harmonization is not an issue.

VI. Conclusion

    Therefore, tolerances are established for combined residues of 
thiophanate-methyl, thiophanate-methyl and its metabolite (methyl 2-
benzimidazoyl carbamate (MBC), in or on cotton at 0.05 ppm and cotton, 
gin byproducts at 5.0 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0011 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before May 23, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2.Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by the docket ID number OPP-2005-0011, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section 
408 of the FFDCA. 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 rule has been exempted from review

[[Page 14555]]

under Executive Order 12866 due to its lack of significance, this 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 final 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). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
tolerances in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. 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 final 
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 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 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 rule.

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 25, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.371 is amended by alphabetically adding commodities to 
the table in paragraph (b) to read as follows:


Sec.  180.371  Thiophanate-methyl; tolerances for residues.

    (b) * * *

----------------------------------------------------------------------------------------------------------------
                      Commodity                             Parts per million        Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Cotton                                                                        0.05                      12/31/07
----------------------------------------------------------------------------------------------------------------
Cotton, gin byproducts                                                         5.0                      12/31/07
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------


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[FR Doc. 05-5720 Filed 3-22-05; 8:45 am]
BILLING CODE 6560-50-S