Pesticide Tolerances: Methoxyfenozide
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
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.
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.),
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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:
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General Information
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.
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Other Considerations
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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.
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International Residue Limits
There are currently no Codex maximum residue limits established for methoxyfenozide on commodities involved in this action.
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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.
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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.
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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).
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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
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FR Doc. E9-21190 Filed 9-1-09; 8:45 am
BILLING CODE 6560-50-S
