Document ID: EPA-HQ-OPP-2009-0020-0001
Agency: epa
Document Type: Rule
Title: Methoxyfenozide; Pesticide Tolerances for Emergency Exemptions
Posted Date: 2009-05-13T04:00Z

[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Rules and Regulations]               
[Page 22464-22469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my09-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0020; FRL-8410-3]

 
Methoxyfenozide; 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 
residues of the insecticide methoxyfenozide per se, in or on sorghum, 
forage; sorghum, grain; and sorghum, stover. This action is in response 
to a crisis exemption issued by the Louisiana Department of Agriculture 
under section 18 of the Federal Insecticide, Fungicide and Rodenticide 
Act (FIFRA) authorizing use of the pesticide on grain sorghum. This 
regulation establishes a maximum permissible level for residues of 
methoxyfenozide in these feed commodities. The time-limited tolerances 
expire and will be revoked on December 31, 2012.

DATES: This regulation is effective May 13, 2009. Objections and 
requests for hearings must be received on or before July 13, 2009, 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-2009-0020. All documents in the 
docket are listed in the docket index available in http://
www.regulations.gov. 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 at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Stacey Groce, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-2505; e-mail address: groce.stacey@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.

[[Page 22465]]

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

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, 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-
2009-0020 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 July 13, 2009.
    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-2009-0020, 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 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances 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 sorghum, forage at 30.0 parts 
per million (ppm); sorghum, grain at 0.05 ppm; and sorghum, stover at 
60.0 ppm. These time-limited tolerances expire and will be revoked on 
December 31, 2012. EPA will publish a subsequent document in the 
Federal Register to remove the revoked tolerances from the CFR.
    Section 408(l)(6) of 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 time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA to other tolerances and 
exemptions. Section 408(e) of 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 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. . . 
.''
    Section 18 of 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.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Methoxyfenozide on Various Commodities: 
Sorghum, forage; Sorghum, grain; and Sorghum, stover and FFDCA 
Tolerances

    The Louisiana Department of Agriculture requested an emergency 
exemption for use of methoxyfenozide on grain sorghum to control the 
southwestern corn borer and sugarcane borer, and issued a crisis 
exemption for this use pursuant to 40 CFR part 166, subpart C. The 
Louisiana Department of Agriculture provided information indicating 
that the southwestern corn borer and sugarcane borer are serious pests 
that commonly infest grain sorghum. Methoxyfenozide has been authorized 
under FIFRA section 18 for use on sorghum, forage, sorghum, grain, and 
sorghum, stover to control southwestern corn borer and sugarcane borer 
in Louisiana under the crisis provision.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of the 
insecticide methoxyfenozide per se in or on sorghum, forage; sorghum, 
grain; and sorghum, stover. In doing so, EPA considered the safety 
standard in section 408(b)(2) of FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of 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 this tolerance 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of FFDCA. Although these time-limited tolerances 
expire and will be revoked on December 31, 2012, under section 
408(l)(5) of FFDCA, residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on sorghum, forage; 
sorghum, grain; and sorghum, stover after that date will not be 
unlawful, provided the pesticide was applied in a manner that was 
lawful under FIFRA, and the residues do not exceed a level that was 
authorized by these time-limited tolerances at the time of that 
application. EPA will take action to revoke these time-limited 
tolerances

[[Page 22466]]

earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
methoxyfenozide meets FIFRA's registration requirements for use on 
sorghum, forage; sorghum, grain; and sorghum, stover or whether 
permanent tolerances for these uses would be appropriate. Under these 
circumstances, EPA does not believe that these time-limited tolerance 
decisions serve as a basis for registration of methoxyfenozide by a 
State for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for persons in any State other than 
Louisiana to use this pesticide on the applicable crops under FIFRA 
section 18 absent the issuance of an emergency exemption applicable 
within that State. For additional information regarding the emergency 
exemption for methoxyfenozide, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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. . . 
.''
    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), 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 expected as a result of this emergency exemption request and 
the time-limited tolerances 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 sorghum, 
forage at 30.0 parts per million (ppm); sorghum, grain at 0.05 ppm; and 
sorghum, stover at 60.0 ppm. EPA's assessment of exposures and risks 
associated with establishing time-limited tolerances follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for methoxyfenozide used 
for human risk assessment can be found in the document entitled, 
``Methoxyfenozide. Human Health Risk Assessment for Proposed Section 18 
Use on Grain Sorghum,'' dated November 20, 2008, by going to http://
www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2009-0020-0002 in that docket. Locate and 
click on the hyperlink for docket ID number EPA-HQ-OPP-2009-0020. 
Double-click on the document to view the referenced information on page 
23 of 34.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to methoxyfenozide, EPA considered exposure under the time-
limited tolerances established by this action as well as exposures 
pursuant to existing methoxyfenozide tolerances in (40 CFR 180.544). 
EPA assessed dietary exposures from methoxyfenozide in food as follows:
    i. Acute exposure. No appropriate toxicological endpoint 
attributable to a single exposure was identified in the available 
toxicological studies for methoxyfenozide; therefore, a quantitative 
acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of food Intake by Individuals 
(CSFII). As to residue levels in food, an unrefined chronic dietary 
analysis for methoxyfenozide was conducted using tolerance levels and 
100% crop-treated for all existing and proposed uses. Drinking water 
was incorporated directly into the dietary assessment using the chronic 
concentration for surface water generated by the PRZM-EXAMS model at 
33.1 ppb. The results of the analysis indicate that chronic risk from 
the dietary (food and drinking water) exposure to methoxyfenozide will 
not exceed EPA's level of concern for the general U.S. population and 
all population subgroups.
    iii. Cancer. Methoxyfenozide is not likely to be carcinogenic to 
humans; therefore, a cancer exposure assessment was not conducted. This 
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.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment

[[Page 22467]]

for methoxyfenozide. Tolerance level residues and/or 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for methoxyfenozide in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of methoxyfenozide. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/
index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System(PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
methoxyfenozide for acute dietary exposures are estimated to be 52.2 
parts per billion (ppb) for surface water and 7.43 ppb for ground 
water. The estimated drinking water concentrations (EDWCs) for chronic 
dietary exposures for non-cancer assessments are estimated to be 33.1 
ppb for surface water and 7.43 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. An acute dietary endpoint was 
not identified; therefore, a quantitative assessment of risk was not 
conducted for methoxyfenozide. For chronic dietary risk assessment, the 
water concentration of 33.1 ppb was used to assess the contribution 
from drinking 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 any specific use patterns 
that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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.''
    EPA has not found methoxyfenozide to share a common mechanism of 
toxicity with 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 assumed that 
methoxyfenozide does not have 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 at http://
www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is not a concern for 
prenatal and/ or postnatal toxicity resulting from exposure to 
methoxyfenozide. The prenatal and postnatal toxicology database for 
methoxyfenozide includes rat and rabbit developmental toxicity studies 
and a 2-generation reproductive study. There was no increased 
susceptibility in fetuses as compared to maternal animals observed 
following in utero exposures.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for methoxyfenozide is complete for 
assessment of potential hazard to infants and children.
    ii. There is no indication that methoxyfenozide is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that methoxyfenozide results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
database. The exposure assessments will not underestimate the potential 
dietary (food and drinking water) or nondietary exposures for infants 
and children from use of methoxyfenozide. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to methoxyfenozide in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
methoxyfenozide.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified, therefore, dietary exposure presents no acute risks of 
concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
methoxyfenozide from food and water will utilize 56% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for methoxyfenozide.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
     Methoxyfenozide is not registered for any use patterns that would 
result in residential exposure. Therefore, the

[[Page 22468]]

short-term aggregate risk is the sum of the risk from exposure to 
methoxyfenozide through food and water. Thus, the chronic aggregate 
exposure for the most exposed group is below EPA's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Methoxyfenozide is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to methoxyfenozide through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Methoxyfenozide is 
classified as a ``not likely'' human carcinogen and thus is not 
expected to pose a cancer risk to humans. This 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.
    6. 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, or to infants and children, from aggregate 
exposure to methoxyfenozide residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high pressure liquid 
chromatography with mass spectrometry (HPLC/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 currently no Canadian, Mexican, or Codex maximum residue 
limits (MRLs) for methoxyfenozide on the commodities for which 
tolerances are being established.

VI. Conclusion

    Therefore, time-limited tolerances are established 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 sorghum, forage at 30.0 ppm; sorghum, grain at 0.05 ppm; and 
sorghum, stover at 60.0 ppm. These tolerances expire and will be 
revoked on December 31, 2012.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) 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 final 
rule has been exempted from review under Executive Order 12866, this 
final rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established in accordance 
with sections 408(e) and 408(l)(6) of 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: April 28, 2009.
Daniel J. Rosenblatt,
Acting 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 adding paragraph (b) to read as 
follows:

Sec.  180.544  Methoxyfenozide; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established 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 the 
specified agricultural commodities, resulting from

[[Page 22469]]

use of the pesticide pursuant to FFIFRA section 18 emergency 
exemptions. The tolerances expire and will be revoked on the date 
specified in the table.

----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/revocation
                           Commodity                               Parts per million               date
----------------------------------------------------------------------------------------------------------------
Sorghum, forage                                                                    30.0        December 31, 2012
Sorghum, grain                                                                     0.05        December 31, 2012
Sorghum, stover                                                                    60.0        December 31, 2012
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E9-10757 Filed 5-12-09; 8:45 am]

BILLING CODE 6560-50-S