Document ID: EPA-HQ-OPP-2009-0012-0003
Agency: epa
Document Type: Rule
Title: Methoxyfenozide; Pesticide Tolerances
Posted Date: 2009-09-02T04:00Z

[Federal Register: September 2, 2009 (Volume 74, Number 169)]
[Rules and Regulations]               
[Page 45330-45335]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se09-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0012; FRL-8433-8]

 
Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
methoxyfenozide in or on citrus oil and fruit, citrus, group 10 with 
regional registrations; and corn, pop, grain; corn, pop, stover; pea, 
dry seed; and pomegranate. The Interregional Research Project No. 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 2, 2009. Objections and 
requests for hearings must be received on or before November 2, 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-2009-0012. All documents in the 
docket are listed in the docket index available at 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.),

[[Page 45331]]

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: Sidney Jackson, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 305-7610; e-mail address: jackson.sidney@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 those 
engaged in the following activities:
     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 to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    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 EPA's tolerance regulations 
at 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 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. 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-2009-0012 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 as required by 40 CFR part 178 
on or before November 2, 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 this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0012, 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. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), 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 
8E7447) by IR-4, IR-4 Project Headquarters, 500 College Rd. East, Suite 
201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.544 
be amended by establishing tolerances for residues of the insecticide 
methoxyfenozide; 3,5-dimethylbenzoic acid N-tert-butyl-N'-(3-hydroxy-2-
methylbenzoyl) hydrazide, RH-151,055 glucose conjugate of RH-117,236; 
3,5-dimethylbenzoic acid N-tert-butyl-N-[3([beta]-D-glucopyranosyloxy)-
2-methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate 
of RH-117,236 in or on fruit, citrus, group 10 at 2.0 parts per million 
(ppm), and citrus oil at 70 ppm for tolerances with regional 
registrations; and pea and bean, dried shelled, except soybean, 
subgroup 6C at 0.35 ppm; pomegranate at 0.6 ppm; corn, pop, grain at 
0.05 ppm; corn, pop, stover at 125 ppm; and corn, pop, forage at 30 
ppm. That notice referenced a summary of the petition prepared by Dow 
AgroSciences, LLC, the registrant, which is available to the public in 
the docket, http://www.regulations.gov. There were no comments received 
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised certain petitioned-for tolerances for methoxyfenozide residues 
as follows:
    Increase the tolerance for fruit, citrus, group 10 from 2.0 to 10 
ppm, and the tolerance for citrus oil from 70 to 100 ppm.
    Delete proposed tolerance for the commodity pea and bean, dried 
shelled, except soybean, subgroup 6C at 0.35 ppm, and replace with the 
commodity pea, dry seed with a tolerance at 2.5 ppm.
    Delete proposed tolerance for commodity corn, pop, forage at 30 
ppm. The reasons for these changes are explained in Unit IV.C.4.

III. 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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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

[[Page 45332]]

aggregate exposure for the petitioned-for 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 fruit, citrus, group 10 at 10 ppm and citrus oil at 100 ppm, with 
regional registrations; and pea, dry seed at 2.5 ppm; pomegranate at 
0.6 ppm; corn, pop, grain at 0.05 ppm; and corn, pop, stover at 125 
ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    Methoxyfenozide is not acutely toxic and not a dermal sensitizer. 
Minimal or no toxic effects were observed in studies in which 
methoxyfenozide was administered by the dermal or inhalation routes of 
exposure.
    Toxicology studies conducted with methoxyfenozide demonstrate that 
it has few or no biologically significant toxic effects at relatively 
low-dose levels in many animal studies and only mild or no toxic 
effects at relatively high-dose levels.
    In subchronic and chronic oral studies in rats, the most 
toxicologically significant effects were mild anemia and mild effects 
on the liver, thyroid gland, and adrenal gland. In subchronic and 
chronic oral studies in dogs, the predominant toxic effect was anemia, 
which was often accompanied by signs of a compensatory response.
    The database indicates that only the dietary route of exposure is 
of concern, and only for chronic durations. The chronic population 
adjusted dose (cPAD) is 0.1 milligrams/kilograms/day (mg/kg/day) based 
on changes in blood counts, liver toxicity, histopathological changes 
in thyroid, and possible adrenal toxicity observed at the lowest-
observed-adverse-effect-level (LOAEL) of 411 mg/kg/day in a chronic 
toxicity study in rats.
    Methoxyfenozide is not neurotoxic and is not a developmental or 
reproductive toxicant. There was no evidence for increased 
susceptibility of rat or rabbit fetuses to in utero exposure or rat 
pups to postnatal exposure.
    There is no evidence of carcinogenic potential in rats and mice 
studies, and no genotoxicity effects in an acceptable battery of 
mutagenicity studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by methoxyfenozide as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies 
can be found at http://www.regulations.gov in document Methoxyfenozide. 
Human Health Risk Assessment for Proposed Section 3 Uses on Dried Pea 
and Bean Subgroup 6C (Except Soybean), Pomegranate, Popcorn, and Citrus 
Crop Group 10 (Regional Use), and Conditional Registrations for Uses 
and/or Tolerances on Leaf Vegetables, Rotational Crops, Stone Fruits, 
and Poultry Commodities, dated July 22, 2009, page 24 in docket ID 
number EPA-HQ-OPP-2009-0012.

B. 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 cPAD. The 
aPAD and cPAD are calculated by dividing the POD by all applicable UFs. 
Aggregate short-, intermediate-, 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 at http://www.regulations.gov in 
document Methoxyfenozide. Human Health Risk Assessment for Proposed 
Section 3 Uses on Dried Pea and Bean Subgroup 6C (Except Soybean), 
Pomegranate, Popcorn, and Citrus Crop Group 10 (Regional Use), and 
Conditional Registrations for Uses and/or Tolerances on Leaf 
Vegetables, Rotational Crops, Stone Fruits, and Poultry Commodities, 
dated July 22, 2009, page 28 in docket ID number EPA-HQ-OPP-2009-0012.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to methoxyfenozide, EPA considered exposure under the 
petitioned-for tolerances as well as all existing methoxyfenozide 
tolerances in (40 CFR 180.544). EPA assessed 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 such effects were identified in the 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 United States 
Department of Agriculture 1994-1996 and 1998 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII). As to residue levels in 
food, chronic dietary exposure analysis for methoxyfenozide was 
conducted using tolerance level residues, and 100 percent crop treated 
(PCT) for all existing and proposed uses. Dietary Exposure Evaluation 
Model (Version 7.81) default processing factors were used for most 
processed commodities that do not have individual tolerances; the only 
exception was an EPA determined processing factor for orange juice.
    iii. Cancer. Methoxyfenozide is classified as ``not likely to be a 
human carcinogen.'' There was no evidence of carcinogenicity in the 
combined chronic/carcinogenicity studies in the rat and no genotoxicity 
shown in mutagenicity studies. Therefore, a cancer dietary exposure 
assessment was not performed.

[[Page 45333]]

    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for methoxyfenozide. The Agency assumed 100 PCT and tolerance-level 
residues for all existing and proposed uses.
    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 chronic exposures for non-cancer assessments are 
estimated to be 33.1 parts per billion (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.
    For chronic dietary risk assessment, the water concentration of 
value 33.1 ppb was used to assess the contribution to 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 EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. 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 Food Quality 
Protection Act (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. Based on the results in the developmental toxicity 
studies in rats and rabbits and in the 2-generation reproduction study 
in rats, no increased sensitivity of fetuses or pups (as compared to 
adults) was demonstrated for methoxyfenozide. There are no concerns or 
residual uncertainties for prenatal/postnatal toxicity following 
exposure to methoxyfenozide.
    3. Conclusion. EPA has determined that reliable data show 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, with the 
exception of the required immunotoxicity study. The toxicology database 
for methoxyfenozide demonstrates that the most toxicologically 
significant effects were mild anemia and mild effects on the liver, 
thyroid gland, and adrenal gland; the immune system is not a primary 
target organ. Increased spleen weights and hyperplasia in bone morrow 
of rib and sternum were observed in subchronic and chronic oral studies 
in dogs; however, these effects were considered a compensatory response 
of anemia. The overall weight of evidence suggests that methoxyfenozide 
does not directly target the immune system, and observed effects were 
related to the anemic response to the exposure. Immunotoxicity study is 
required as a part of new data requirements in the 40 CFR part 158 for 
conventional pesticide registration; however, the Agency does not 
believe that conducting a functional immunotoxicity study will result 
in a lower POD than currently used for overall risk assessment; 
therefore, a database uncertainty factor (UFDB) is not needed to 
account for the lack of the study.
    ii. Based on weight-of-the-evidence considerations as follows, a 
developmental neurotoxicity (DNT) study in rats is not required to 
support the registration of methoxyfenozide:
    Other than the decreased hindlimb grip strength observed at 3 hours 
in male rats following a single oral dose of methoxyfenozide, no signs 
of neurotoxicity were observed in this study or in any other study on 
methoxyfenozide.
    The developmental toxicity studies in rats and rabbits and the 2-
generation reproduction study in rats indicated no need for a 
developmental neurotoxicity study to resolve any concerns arising in 
these studies.
    No other observations in any of the toxicology studies on 
methoxyfenozide suggested the need for a developmental neurotoxicity 
study.
    iii. In developmental toxicity studies in rats and rabbits, no 
increased susceptibility in fetuses as compared to maternal animals was 
observed following in utero exposures.
    iv. In a 2-generation reproduction study in rats, no increased 
susceptibility in pups as compared to adults was observed following in 
utero and postnatal exposures.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues for all existing and proposed 
uses. EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to methoxyfenozide in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by methoxyfenozide.

E. 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

[[Page 45334]]

risks, EPA calculates the probability of additional cancer cases given 
the estimated aggregate exposure. Short-, intermediate-, 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 and no acute dietary endpoint was selected. 
Methoxyfenozide is not expected to pose an acute risk to any population 
subgroup.
    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 69% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. There are no registered 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 short-term aggregate 
risk is the sum of the risk from exposure to methoxyfenozide through 
food and water and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-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 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 ``not likely to be carcinogenic to humans'' based on the 
lack of evidence of carcinogenicity in rats and mice, and lack of 
genotoxicity in an acceptable battery of mutagenicity studies. 
Methoxyfenozide is not expected to pose a cancer risk to humans.
    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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methodologies are available, e.g., high 
performance liquid chromatography with ultraviolet or mass spectrometry 
detection (HPLC/UV or MS), for enforcing methoxyfenozide tolerances. 
Depending on the plant commodity, the limit of quantitation (LOQ) for 
methoxyfenozide in primary crop commodities is 0.01-0.05 ppm.
    Adequate enforcement methodology (HPLC/UV or 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 Codex maximum residue limits established for 
methoxyfenozide on commodities involved in this action.

C. Revisions to Petitioned-For Tolerances

    EPA made certain revisions to the tolerance levels, added or 
deleted tolerances, or otherwise modified the petition as proposed in 
the notice of filing for the following reasons:
    1. EPA increased the proposed tolerance for fruit, citrus, group 10 
from 2.0 to 10 ppm. For citrus fruits, the residue values from 
individual of citrus fruits were used to calculate the Maximum Residue 
Level (MRL) for methoxyfenozide tolerances. The highest recommended MRL 
from the orange data is 10 ppm and, therefore, the Agency's recommended 
tolerance for citrus, fruits, crop group 10 is 10 ppm.
    2. The Agency increased the proposed tolerance for citrus oil from 
70 to 100 ppm. Based on the 56X processing factor for oil and the 
highest average field trial (HAFT) residues of 1.67 ppm for citrus 
fruits, the maximum expected residues in oil would be 93.5 ppm. 
Therefore, EPA concluded that a tolerance of 100 ppm is appropriate for 
citrus oil.
    3. EPA revised the proposed tolerance for the commodity pea and 
bean, dried shelled, except soybean, subgroup 6C at 0.35 ppm, to a 
tolerance at 2.5 ppm for the commodity pea, dry seed. For pea, dry seed 
a separate tolerance was calculated using the data from the new trials, 
adjusting the residues from two trials (0.5X) to the 1X rate using 
proportionality (0.30 ppm), using only the residue data from the four 
field trials conducted at 1X (0.35 ppm), and using the previously 
reviewed data for the back-eyed and southern pea trials (2.5 ppm). The 
highest tolerance recommendation of 2.5 ppm was chosen for the 
tolerance for pea, dry seed. Due to the >10X difference between the pea 
and bean tolerances, a pea and bean, dried shelled, except soybean 
(subgroup 6C) tolerance is not established for subgroup 6C as it is 
inappropriate. Therefore, EPA concluded that the current bean, dry seed 
tolerance at 0.24 ppm should be retained and a tolerance be established 
at 2.5 ppm for pea, dry seed.
    4. EPA is not establishing the proposed tolerance for the commodity 
corn, pop, forage at 30 ppm. Available residue data for field corn 
support the proposed tolerances of 0.05 and 125 ppm in/on popcorn grain 
and stover, respectively. No tolerance is required for popcorn forage 
as it is not a regulated livestock feedstuff.
    5. In establishing the new tolerances with regional registration 
for citrus in paragraph (c) of 40 CFR 180.544, EPA has used its 
preferred method of setting forth the tolerance expression which 
involves separate sentences addressing:
    i. The coverage of the tolerance.
    ii. The specific residues to be measured in determining compliance 
with the tolerance levels.
EPA considers this new approach to writing tolerance expressions to be 
both consistent with the statute and a clarification of what EPA 
intended in its prior tolerance expression format. Accordingly, in most 
instances where EPA amends an existing tolerance regulation to add 
additional commodities, EPA believes there is good cause to change to 
the overall tolerance expression for all commodities without prior 
notice. The existing tolerance expression for methoxyfenozide, however, 
is somewhat unusual in its reference to ``methoxyfenozide per se.'' 
Thus, even though EPA does not believe that the existing tolerance 
expression was intended to be interpreted in a manner different from 
the new clarified approach, EPA will not modify the existing tolerance 
expression in paragraph (a)(1) of 40 CFR 180.544 without prior notice.

[[Page 45335]]

V. Conclusion

    Therefore, 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 fruit, 
citrus, group 10 at 10 ppm and citrus oil at 100 ppm with regional 
registrations; and pea, dry seed at 2.5 ppm; pomegranate at 0.6 ppm; 
corn, pop, grain at 0.05 ppm; and corn, pop, stover at 125 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 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 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.
    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).

VII. 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: August 25, 2009.
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 the following 
commodities to the table in paragraph (a)(1) and by revising paragraph 
(c) to read as follows:

Sec.  180.544  Methoxyfenozide; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Corn, pop, grain.....................................               0.05
Corn, pop, stover....................................                125
                                * * * * *
Pea, dry seed........................................                2.5
                                * * * * *
Pomegranate..........................................                0.6
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances are 
established for residues of the insecticide methoxyfenozide, including 
its metabolites and degradates. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only 
methoxyfenozide, benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide.

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Citrus, Oil....................................                      100
Fruit, citrus, group 10........................                       10
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-21190 Filed 9-1-09; 8:45 am]

BILLING CODE 6560-50-S