

[Federal Register: June 7, 2006 (Volume 71, Number 109)]
[Rules and Regulations]               
[Page 32849-32853]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn06-20]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0404; FRL-8069-5]

 
Methoxyfenozide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
methoxyfenozide in or on soybean aspirated grain fractions, soybean 
forage, soybean hay, soybean hulls, and soybean seed. Dow AgroSciences 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective June 7, 2006. Objections and 
requests for hearings must be received on or before August 7, 2006, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0404. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (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 in the electronic docket athttp://www.regulations.gov, or, if 

only available in hard copy, at the OPP Regulatory Public Docket in Rm. 
S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The 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: Mark Suarez, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0120; e-mail address:suarez.mark@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 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 underFOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document 

electronically through the EPA Internet under the ``Federal Register'' 
listings athttp://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.


[[Page 32850]]

C. Can I File an Objection or Hearing Request?

    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. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0404 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 August 7, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0404, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of August 13, 2004 (69 FR 50192) (FRL-7364-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3F6794) by DowAgroSciences, 9330 Zionsville Road 308-2E225, 
Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.544 
be amended by establishing a tolerance for residues of the insecticide 
methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on soybean 
aspirated grain at 200 parts per million (ppm), soybean forage at 45 
ppm, soybean hay at 65 ppm, soybean hulls at 3.0 ppm, soybean meal at 
0.1 ppm, soybean oil at 1.0 ppm, and soybean seed at 2.0 ppm. That 
notice included a summary of the petition prepared by Dow AgroSciences, 
the registrant. There were no comments received in response to the 
notice of filing.
    The registrant subsequently revised Section F of the petition to 
concur with the tolerances found to be supported by the Agency based on 
the available data used for the risk assessment. In the revised Section 
F, Dow AgroSciences requested that 40 CFR 180.544 be amended by 
establishing a tolerance for residues of the insecticide 
methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on soybean 
aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80 
ppm, soybean hulls at 2.0 ppm, and soybean seed at 1.0 ppm.
    Section 408(b)(2)(A)(i) of 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 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 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. . . 
.''
    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 FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.


III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of 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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of methoxyfenozide on 
soybean aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean 
hay at 80 ppm, soybean hulls at 2.0 ppm, and soybean seed at 1.0 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific informationon the studies received and the nature of 
the toxic effects caused by methoxyfenozide as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/EPA-PEST/2002/September/Day-20/p23996.htm
.


B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of

[[Page 32851]]

additional cancer cases. More information can be found on the general 
principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm
.

    A summary of the toxicological endpoints for methoxyfenozide used 
for human risk assessment is shown in Table 1 of this unit:

   Table 1.--Summary of Toxicological Dose and Endpoints for Methoxyfenozide for Use in Human Risk Assessment
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          Exposure/Scenario                Dose (mg/kg/day)             Endpoint                  Study
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Acute dietary                          None                     No appropriate endpoint  None
                                                                 was identified in the
                                                                 oral toxicity studies
                                                                 including the acute
                                                                 neurotoxicity study in
                                                                 rats and
                                                                 thedevelopmental
                                                                 toxicity studies in
                                                                 rats and rabbits
                                      --------------------------------------------------------------------------
                                       UF = N/A                            Acute RfD = Not Applicable
----------------------------------------------------------------------------------------------------------------
Chronic dietary (Non cancer)           NOAEL = 10.2 mg/kg/day   Hematological changes    2--Year combined
                                                                 (decreased RBC,          chronic feeding/
                                                                 hemoglobin and/or        carcinogenicity, rats
                                                                 hematocrit), liver
                                                                 toxicity (increased
                                                                 weights, hypertrophy),
                                                                 histopathological
                                                                 changes in thyroid
                                                                 (increased follicular
                                                                 cell hypertrophy,
                                                                 altered colloid),
                                                                 possible adrenal
                                                                 toxicity (increased
                                                                 weights).
                                      --------------------------------------------------------------------------
All population subgroups               UF =100 FQPA = 1X        Chronic RfD = 0.10 mg/kg/day Chronic Population
                                                                 Adjusted Dose (cPAD) = 0.10 mg/kg/day This cPAD
                                                                 applies to All population subgroups.
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate- Term, and    None                     No systemic toxicity     None
 Long-Term (Dermal)                                              was seen at the limit
                                                                 dose following
                                                                 repeated dermal
                                                                 application to rats
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate-Term, and     None                     Based on low vapor       None
 Long-Term (Inhalation)                                          pressure, the low
                                                                 acute toxicity of both
                                                                 the technical and
                                                                 formulated products as
                                                                 well as the
                                                                 application rate and
                                                                 application method,
                                                                 there is minimal
                                                                 concern for inhalation
                                                                 exposure.
----------------------------------------------------------------------------------------------------------------
Cancer                                 None                     Methoxyfenozide has      None
                                                                 been classified as
                                                                 ``not likely to be a
                                                                 human carcinogen.''
                                                                 The classification is
                                                                 based on the lack of
                                                                 evidence of
                                                                 carcinogenicity in
                                                                 male and female rats
                                                                 as well as in male and
                                                                 female mice and on the
                                                                 lack of genotoxicity
                                                                 in an acceptable
                                                                 battery of
                                                                 mutagenicity studies
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.544) for the residues of methoxyfenozide, in or 
on a variety of raw agricultural commodities, animal (cattle, goat, 
hog, horse, poultry, and sheep) meats and fats, and milk. Risk 
assessments were conducted by EPA to assess dietary exposures from 
methoxyfenozide in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No appropriate endpoint was 
identified in the oral toxicity studies including the acute 
neurotoxicity study in rats and the developmental toxicity studies in 
rats and rabbits. Therefore, acute dietary exposure assessments were 
not conducted.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: Drinking water will contain the highest estimate drinking 
water concentration (EDWC), 100% of all existing and proposed crops are 
treated, and all resulting residues are at tolerance levels.
    iii. Cancer. Because methoxyfenozide has been classified as ``not 
likely to be a human carcenogen,'' an exposure assessment for the 
purpose of assessing cancer risk is not needed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for methoxyfenozide in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of methoxyfenozide. Further information

[[Page 32852]]

regarding EPA drinking water models used in pesticide exposure 
assessment is discussed in Unit III.C.2 of the final rule previously 
published in the Federal Register of July 5, 2000 (65 FR 41355) (FRL-
6496-5).
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System and Screening Concentrations in Groundwater models, the 
estimated environmental concentrations (EECs) of methoxyfenozide for 
acute exposures are estimated to be 43 parts per billion (ppb) for 
surface water and 3.5 ppb for ground water. The EECs for chronic 
exposures are estimated to be 30 ppb, based on surface water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Methoxyfenozide is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to methoxyfenozide and any 
other substances and methoxyfenozide does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that methoxyfenozide 
has a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website athttp://www.epa.gov/pesticides/cumulative
.


D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
margin of exposure analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional uncertainty factors and/or special FQPA safety factors, as 
appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
prenatal or postnatal sensitivity, as discussed in Unit IV.C. of the 
final rule previously published in the Federal Register of August 31, 
2005 (70 FR 51597) (FRL-7732-3).
    3. Conclusion. There is a complete toxicity data base 
formethoxyfenozide and exposure data are complete or are estimated 
based on data that reasonably accounts for potential exposures. The 
Agency has determined that the FQPA Safety Factor can be reduced to 1X 
in assessing the risk posed by this chemical. The basis for this 
determination is discussed in Unit IV.C.5 of the final rule previously 
published in the Federal Register of August 31, 2005.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. No appropriate endpoint was identified in the oral 
toxicity studies including the acute neurotoxicity study in rats and 
the developmental toxicity studies in rats and rabbits. Therefore, no 
acute dietary risk is expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
methoxyfenozide from food and drinking water will utilize 23% of the 
cPAD for the U.S. population, 32% of the cPAD for all infants < 1-year 
old, and 56% of the cPAD for children 1-2 years old, the highest 
exposed subgroup. There are no residential uses for methoxyfenozide 
that result in chronic residential exposure to methoxyfenozide.
    3. Short-term and Intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Methoxyfenozide is not registered for use 
on any sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which does 
not exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Methoxyfenozide has 
been classified as ``not likely'' to be a human carcinogen. The 
classification is based on the lack of evidence of carcinogenicity in 
male and female rats as well as in male and female mice and on the lack 
of genotoxicity in an acceptable battery of mutagenicity studies. 
Therefore, methoxyfenozide is not expected to pose a cancer risk.
    5. Determination of safety. 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 methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (TR 34-00-28) was previously 
developed by Rohm and Haas; high performance liquid chromatography 
(HPLC) with positive ion electrospray (E.I.) tandem mass spectrometry 
(LC/MS/MS)) 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: 
residuemethods@epa.gov.


B. International Residue Limits

    There are no established or proposed Codex, Canadian, or Mexican 
limits for residues of methoxyfenozide in or on plant or animal 
commodities. Therefore, no compatibility issues exist regarding the 
proposed U.S. tolerances.

V. Conclusion

    Therefore, the tolerance is established for residues of 
methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-2-(3,5- 
dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, in or on soybean 
aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80 
ppm, soybean hulls at 2.0 ppm, and soybean seeds at 1.0 ppm. The 
original petition (PP 3F6794) and notice of filing (Docket 
identification number OPP-2004-0184) contained additional proposed 
tolerances for soybean, oil and

[[Page 32853]]

soybean, meal. Dow AgroSciences the registrant submitted a revised 
Section F of the petition for the removal of soybean, oil and soybean, 
meal from the tolerance expression.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition 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 rule has been 
exempted from review 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 
petition under section 408(d) of FFDCA, such as the tolerance 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 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.

VII. 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: May 22, 2006.
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 180.544 is amended by alphabetically adding commodities to 
the table in paragraph (a)(1) to read as follows:


Sec.  180.544  Methoxyfenozide; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Soybean, aspirated grain fractions.........................          160
Soybean, forage............................................           30
Soybean, hay...............................................           80
Soybean, hulls.............................................          2.0
Soybean, seed..............................................          1.0
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E6-8828 Filed 6-6-06; 8:45 am]

BILLING CODE 6560-50-S
