67104 Federal Register / Vol. 74, No. 242 / Friday, December 18, 2009 / Rules and Regulations

Senate, the U.S. House of commodities listed in the following available in hard copy, at the OPP Representatives, and the Comptroller table. Compliance with the tolerance Regulatory Public Docket in Rm. S– General of the United States prior to levels specified below is to be 4400, One Potomac Yard (South Bldg.), publication of this final rule in the determined by measuring only the sum 2777 S. Crystal Dr., Arlington, VA. The Federal Register. This final rule is not of dinotefuran, (RS)-1-methyl-2-nitro-3- Docket Facility is open from 8:30 a.m. a ‘‘major rule’’ as defined by 5 U.S.C. ((tetrahydro-3-furanyl)methyl)guanidine to 4 p.m., Monday through Friday, 804(2). in or on the commodities listed in the excluding legal holidays. The Docket table below: Facility telephone number is (703) 305– List of Subjects in 40 CFR Part 180 * * * * * 5805. Environmental protection, [FR Doc. E9–30131 Filed 12–17–09; 8:45 am] FOR FURTHER INFORMATION CONTACT: Administrative practice and procedure, BILLING CODE 6560–50–S Barbara Madden, Registration Division Agricultural commodities, Pesticides (7505P), Office of Pesticide Programs, and pests, Reporting and recordkeeping Environmental Protection Agency, 1200 requirements. ENVIRONMENTAL PROTECTION Pennsylvania Ave., NW., Washington, Dated: December 10, 2009. AGENCY DC 20460–0001; telephone number: (703) 305-6463; e-mail address: G. Jeffrey Herndon, 40 CFR Part 180 [email protected]. Acting Director, Registration Division, Office of Pesticide Programs. [EPA–HQ–OPP–2008–0773; FRL–8801–8] SUPPLEMENTARY INFORMATION: ■ Therefore, 40 CFR chapter I is Prometryn; Pesticide Tolerances I. General Information amended as follows: AGENCY: Environmental Protection A. Does this Action Apply to Me? PART 180—[AMENDED] Agency (EPA). You may be potentially affected by this action if you are an agricultural ■ 1. The authority citation for part 180 ACTION: Final rule. producer, food manufacturer, or continues to read as follows: SUMMARY: This regulation establishes pesticide manufacturer. Potentially Authority: 21 U.S.C. 321(q), 346a and 371. tolerances for the residues of prometryn affected entities may include, but are in or on celeriac, roots; celeriac, tops; not limited to those engaged in the ■ 2. Section 180.603 is amended by cilantro, leaves; coriander, dried leaves; following activities: revising the introductory text in leaf petioles subgroup 4B; okra; parsley, • Crop production (NAICS code 111). paragraphs (a)(1) and (2); and leaves; parsley, dried leaves; and • Animal production (NAICS code alphabetically adding ‘‘Brassica, leafy increases the tolerance level for carrot, 112). greens subgroup 5B’’ and ‘‘Turnip, root. Additionally, the tolerance for • Food manufacturing (NAICS code greens’’ to the table in paragraph (a)(1) celery is removed since it is included in 311). to read as follows: the leafy petioles subgroup 4B and the • Pesticide manufacturing (NAICS regional tolerance for parsley leaves is code 32532). § 180.603 Dinotefuran; tolerances for This listing is not intended to be residues. removed since it is superseded by the tolerance established in this action. exhaustive, but rather to provide a guide (a) * * * (1) Tolerances are established for readers regarding entities likely to be for residues of dinotefuran, (RS)-1- Interregional Research Project No. 4 (IR- 4) requested these tolerances under the affected by this action. Other types of methyl-2-nitro-3-((tetrahydro-3- entities not listed in this unit could also furanyl)methyl)guanidine, including its Federal Food, Drug, and Cosmetic Act (FFDCA). be affected. The North American metabolites and degradates, in or on the Industrial Classification System commodities listed in the following DATES: This regulation is effective (NAICS) codes have been provided to table. Compliance with the tolerance December 18, 2009. Objections and assist you and others in determining levels specified below is to be requests for hearings must be received whether this action might apply to determined by measuring only the sum on or before February 16, 2010, and certain entities. If you have any of dinotefuran and its metabolites DN, must be filed in accordance with the questions regarding the applicability of 1-methyl-3-(tetrahydro-3- instructions provided in 40 CFR part this action to a particular entity, consult furylmethyl)guanidine, and UF, 1- 178 (see also Unit I.C. of the the person listed under FOR FURTHER methyl-3-(tetrahydro-3- SUPPLEMENTARY INFORMATION). INFORMATION CONTACT. furylmethyl)urea, calculated as the ADDRESSES: EPA has established a stoichiometric equivalent of docket for this action under docket B. How Can I Access Electronic Copies dinotefuran, in or on the commodities identification (ID) number EPA–HQ– of this Document? listed in the table below: OPP–2008–0773. All documents in the In addition to accessing electronically docket are listed in the docket index available documents at http:// Commodity Parts per million available at http://www.regulations.gov. www.regulations.gov, you may access Although listed in the index, some this Federal Register document ***** Brassica, leafy greens, information is not publicly available, electronically through the EPA Internet subgroup 5B ...... 15.0 e.g., Confidential Business Information under the ‘‘Federal Register’’ listings at *****(CBI) or other information whose http://www.epa.gov/fedrgstr. You may Turnip, greens ...... 15.0 disclosure is restricted by statute. also access a frequently updated *****Certain other material, such as electronic version of EPA’s tolerance copyrighted material, is not placed on regulations at 40 CFR part 180 through (2) Tolerances are established for the Internet and will be publicly the Government Printing Office’s e-CFR residues of dinotefuran, (RS)-1-methyl- available only in hard copy form. cite at http://www.gpoaccess.gov/ecfr. 2-nitro-3-((tetrahydro-3- Publicly available docket materials are To access the OPPTS harmonized test furanyl)methyl)guanidine, including its available in the electronic docket at guidelines referenced in this document metabolites and degradates, in or on the http://www.regulations.gov, or, if only electronically, please go to http://

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www.epa.gov/oppts and select ‘‘Test the herbicide prometryn, 2,4- at 0.05 ppm; celeriac, tops at 0.20 ppm; Methods & Guidelines’’ on the left-side bis(isopropylamino)-6-methylthio-s- cilantro, leaves at 3.5 ppm; coriander, navigation menu. triazine, in or on carrots at 0.7 parts per dried leaves at 9.0 ppm; leaf petioles million (ppm); celeriac, roots at 0.05 subgroup 4B at 0.50 ppm; okra at 0.05 C. Can I File an Objection or Hearing ppm; celeriac, tops at 0.05 ppm; ppm; parsley, leaves at 0.60 ppm; and Request? cilantro, fresh at 4.0 ppm, cilantro, dried parsley, dried leaves at 1.5 ppm. EPA’s Under section 408(g) of FFDCA, 21 at 15 ppm; okra at 0.05 ppm; parsley, assessment of exposures and risks U.S.C. 346a, any person may file an leaves at 0.7 ppm, (all the preceding in associated with establishing tolerances objection to any aspect of this regulation PP 8E7434); and leaf petiole subgroup follows. and may also request a hearing on those 4B at 0.5 ppm (PP 8E7436). That notice A. Toxicological Profile objections. You must file your objection referenced a summary of the petition or request a hearing on this regulation prepared by Syngenta Crop Protection, EPA has evaluated the available in accordance with the instructions Inc., the registrant, on behalf of IR-4, toxicity data and considered its validity, provided in 40 CFR part 178. To ensure which is available to the public in the completeness, and reliability as well as proper receipt by EPA, you must docket, http://www.regulations.gov. the relationship of the results of the identify docket ID number EPA–HQ– There were no comments received in studies to human risk. EPA has also OPP–2008–0773 in the subject line on response to the notice of filing. considered available information the first page of your submission. All Based upon review of the data concerning the variability of the requests must be in writing, and must be supporting the petition, EPA has sensitivities of major identifiable mailed or delivered to the Hearing Clerk modified carrot, roots from 0.7 ppm to subgroups of consumers, including as required by 40 CFR part 178 on or 0.45 ppm; celeriac, tops from 0.05 ppm infants and children. before February 16, 2010. to 0.20 ppm; cilantro, leaves from 4.0 Prometryn demonstrated minimal In addition to filing an objection or ppm to 3.5 ppm; coriander, dried leaves acute toxicity via the oral, dermal, and hearing request with the Hearing Clerk from 15.0 ppm to 9.0 ppm; parsley, inhalation routes. Prometryn is mildly as described in 40 CFR part 178, please leaves from 0.7 ppm to 0.60 ppm. EPA irritating to the eyes, slightly irritating submit a copy of the filing that does not also revised several commodity terms to the skin, and is not a skin sensitizer. contain any CBI for inclusion in the and determined that a tolerance is In a 28–day feeding study in mice, public docket that is described in required for parsley, dried leaves at 1.5 prometryn caused decreased body ADDRESSES. Information not marked ppm.The reasons for these changes are weight and/or mortality at doses that confidential pursuant to 40 CFR part 2 explained in Unit IV.C. exceed the limit dose. No evidence of may be disclosed publicly by EPA local or systemic toxicity was observed III. Aggregate Risk Assessment and without prior notice. Submit this copy, in a 21–day dermal toxicity study in Determination of Safety identified by docket ID number EPA– rabbits. In a chronic oncogenicity study HQ–OPP–2008–0773, by one of the Section 408(b)(2)(A)(i) of FFDCA in mice, decreased body-weight gain at following methods: allows EPA to establish a tolerance (the the highest dose tested was the only • Federal eRulemaking Portal: http:// legal limit for a pesticide chemical adverse effect observed. In a combined www.regulations.gov. Follow the on-line residue in or on a food) only if EPA chronic toxicity/carcinogenicity study instructions for submitting comments. determines that the tolerance is ‘‘safe.’’ in rats, decreased body weight, body- • Mail: Office of Pesticide Programs Section 408(b)(2)(A)(ii) of FFDCA weight gains, and renal toxicity (OPP) Regulatory Public Docket (7502P), defines ‘‘safe’’ to mean that ‘‘there is a (mineralized concretions) were observed Environmental Protection Agency, 1200 reasonable certainty that no harm will at the highest dose only. There was no Pennsylvania Ave., NW., Washington, result from aggregate exposure to the evidence of carcinogenicity in either DC 20460–0001. pesticide chemical residue, including study and prometryn was non- • Delivery: OPP Regulatory Public all anticipated dietary exposures and all mutagenic when tested in a battery of Docket (7502P), Environmental other exposures for which there is genotoxicity assays. Following long- Protection Agency, Rm. S–4400, One reliable information.’’ This includes term exposure of dogs to prometryn, Potomac Yard (South Bldg.), 2777 S. exposure through drinking water and in multi-organ toxicity (degenerative Crystal Dr., Arlington, VA. Deliveries residential settings, but does not include hepatic changes, renal tubule are only accepted during the Docket occupational exposure. Section degeneration, bone marrow atrophy) Facility’s normal hours of operation 408(b)(2)(C) of FFDCA requires EPA to was observed at the highest dose tested. (8:30 a.m. to 4 p.m., Monday through give special consideration to exposure Prometryn is neither a developmental Friday, excluding legal holidays). of infants and children to the pesticide nor a reproductive toxicant. Adverse Special arrangements should be made chemical residue in establishing a effects were observed primarily at the for deliveries of boxed information. The tolerance and to ‘‘ensure that there is a highest doses tested; offspring toxicity Docket Facility telephone number is reasonable certainty that no harm will was observed at the same doses as (703) 305–5805. result to infants and children from maternal/parental toxicity. In the aggregate exposure to the pesticide developmental toxicity study in the rat, II. Petition for Tolerance chemical residue....’’ decreased body weight and food In the Federal Register of December 3, Consistent with section 408(b)(2)(D) consumption, and clinical signs of 2008 (73 FR 73640) (FRL–8390–4), EPA of FFDCA, and the factors specified in toxicity were observed in dams; issued a notice pursuant to section section 408(b)(2)(D) of FFDCA, EPA has decreased fetal body weight, and 408(d)(3) of FFDCA, 21 U.S.C. reviewed the available scientific data incomplete ossification of sternebrae 346a(d)(3), announcing the filing of and other relevant information in and metacarpals were observed at the pesticide petitions (PP 8E7434 and support of this action. EPA has same dose in offspring. In the 8E7436) by IR-4, 500 College Road East, sufficient data to assess the hazards of developmental toxicity study in rabbits, Suite 201W, Princeton, New Jersey and to make a determination on decreased food consumption and 08540. The petition requested that 40 aggregate exposure for the petitioned-for increased incidence of resorptions, CFR 180.222 be amended by tolerances for residues of prometryn on abortions, and post-implantation loss establishing tolerances for residues of carrot, roots at 0.45 ppm; celeriac, roots were observed in maternal animals that

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led to a decreased number of viable probability of an occurrence of the iii. Cancer. Prometryn was classified litters and live fetuses at the highest adverse effect greater than that expected by the Agency in Group E (‘‘Evidence of dose tested. In the 2-generation rat in a lifetime. For more information on non-carcinogenicity for humans’’), production study, decreased food the general principles EPA uses in risk based on the lack of oncogenic effects at consumption, body weight, and body- characterization and a complete any dose in both rats and mice. weight gain were observed in parental description of the risk assessment Therefore an exposure assessment to animals, and decreased body weight process, see http://www.epa.gov/ evaluate cancer risks is not needed for was observed in offspring at the same pesticides/factsheets/riskassess.htm. this chemical. dose. There was no evidence of toxicity A summary of the toxicological iv. Anticipated residue and percent to the reproductive organs in the study. endpoints for prometryn used for crop treated (PCT) information. EPA did Specific information on the studies human risk assessment can be found at not use anticipated residue or PCT received and the nature of the adverse http://www.regulations.gov in the information in the dietary assessment effects caused by prometryn as well as document ‘‘Section 3 Registration for prometryn. Tolerance level residues the no-observed-adverse-effect-level Request to Add New Uses on Carrot, and 100% CT were assumed for all food (NOAEL) and the lowest-observed- Celeriac, Cilantro, Okra, Parsley, and commodities. adverse-effect-level (LOAEL) from the Leaf Petioles (Crop Subgroup 4B). 2. Dietary exposure from drinking toxicity studies can be found at http:// Human–Health Risk Assessment,’’ at water. The Agency used screening level www.regulations.gov in the document page 19 in docket ID number EPA–HQ– water exposure models in the dietary ‘‘Section 3 Registration Request to Add OPP–2008–0773. exposure analysis and risk assessment New Uses on Carrot, Celeriac, Cilantro, C. Exposure Assessment for prometryn in drinking water. These Okra, Parsley, and Leaf Petioles (Crop simulation models take into account 1. Dietary exposure from food and Subgroup 4B). Human–Health Risk data on the physical, chemical, and fate/ feed uses. In evaluating dietary Assessment,’’ at page 36 in docket ID transport characteristics of prometryn. exposure to prometryn, EPA considered number EPA–HQ–OPP–2008–0773. Further information regarding EPA exposure under the petitioned-for drinking water models used in pesticide B. Toxicological Endpoints tolerances as well as all existing For hazards that have a threshold prometryn tolerances in 40 CFR exposure assessment can be found at below which there is no appreciable 180.222. EPA assessed dietary http://www.epa.gov/oppefed1/models/ risk, a toxicological point of departure exposures from prometryn in food as water/index.htm. (POD) is identified as the basis for follows: Based on the First Index Reservoir derivation of reference values for risk i. Acute exposure. Quantitative acute Screening Tool (FIRST), and Screening assessment. The POD may be defined as dietary exposure and risk assessments Concentration in Ground Water (SCI- the highest dose at which no adverse are performed for a food-use pesticide if GROW) models, the estimated drinking effects are observed (the NOAEL) in the a toxicological study has indicated the water concentrations (EDWCs) of toxicology study identified as possibility of an effect of concern prometryn for acute exposures are appropriate for use in risk assessment. occurring as a result of a 1–day or single estimated to be 377.4 parts per billion However, if a NOAEL cannot be exposure. Such effects (increased (ppb) for surface water and 23.2 ppb for determined, the lowest dose at which incidence of resorptions, abortions, and ground water. For chronic exposures for adverse effects of concern are identified post-implantation loss and decreased non-cancer assessments are estimated to (the LOAEL) or a Benchmark Dose number of live fetuses) were identified be 157.9 ppb for surface water and 23.2 (BMD) approach is sometimes used for in the toxicological studies for ppb for ground water. risk assessment. Uncertainty/safety prometryn for the population subgroup For acute dietary risk assessment, the factors (UFs) are used in conjunction females 13 to 49 years old; no such water concentration value of 377.4 ppb with the POD to take into account effects were identified for the general was used to assess the contribution to uncertainties inherent in the population or other population drinking water. For chronic dietary risk extrapolation from laboratory animal subgroups. assessment, the water concentration data to humans and in the variations in In estimating acute dietary exposure, value of 157.9 ppb was used to assess sensitivity among members of the EPA used food consumption the contribution to drinking water. human population as well as other information from the U.S. Department of 3. From non-dietary exposure. The unknowns. Safety is assessed for acute Agriculture (USDA) 1994–1996 term ‘‘residential exposure’’ is used in and chronic dietary risks by comparing Nationwide Continuing Surveys of Food this document to refer to non- aggregate food and water exposure to Intake by Individuals (CSFII). As to occupational, non-dietary exposure the pesticide to the acute population residue levels in food, EPA assumed (e.g., for lawn and garden pest control, adjusted dose (aPAD) and chronic that all food commodities contain indoor pest control, termiticides, and population adjusted dose (cPAD). The tolerance level residues and that 100% flea and tick control on pets). aPAD and cPAD are calculated by of all crops are treated with prometryn. Prometryn is not registered for any dividing the POD by all applicable UFs. EPA also used the default processing specific use patterns that would result Aggregate short-, intermediate-, and factors for all processed commodities. in residential exposure. chronic-term risks are evaluated by ii. Chronic exposure. In conducting 4. Cumulative effects from substances comparing food, water, and residential the chronic dietary exposure assessment with a common mechanism of toxicity. exposure to the POD to ensure that the EPA used the food consumption data Section 408(b)(2)(D)(v) of FFDCA margin of exposure (MOE) called for by from the USDA 1994–1996 and 1998 requires that, when considering whether the product of all applicable UFs is not CSFII. As to residue levels in food, EPA to establish, modify, or revoke a exceeded. This latter value is referred to assumed that all food commodities tolerance, the Agency consider as the Level of Concern (LOC). contain tolerance level residues and that ‘‘available information’’ concerning the For non-threshold risks, the Agency 100% of all crops are treated with cumulative effects of a particular assumes that any amount of exposure prometryn. EPA also used the default pesticide’s residues and ‘‘other will lead to some degree of risk. Thus, processing factors for all processed substances that have a common the Agency estimates risk in terms of the commodities. mechanism of toxicity.’’

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EPA has not found prometryn to share does not directly target the nervous or aPAD for females 13 to 49 years old, the a common mechanism of toxicity with the immune system. In addition, population group receiving the greatest any other substances, and prometryn prometryn does not belong to a class of exposure. No adverse effect resulting does not appear to produce a toxic chemicals (e.g., the organotins, heavy from a single-oral exposure was metabolite produced by other metals, halogenated aromatic identified for the remaining population substances. For the purposes of this hydrocarbons) that would be expected groups and no acute dietary endpoint tolerance action, therefore, EPA has to be immunotoxic. Although an was selected. Therefore, prometryn is assumed that prometryn does not have immunotoxicity study and acute and not expected to pose an acute risk. a common mechanism of toxicity with subchronic neurotoxicity studies are 2. Chronic risk. Using the exposure other substances. For information required as a part of new data assumptions described in this unit for regarding EPA’s efforts to determine requirements in the 40 CFR part 158 for chronic exposure, EPA has concluded which chemicals have a common conventional pesticide registration, the that chronic exposure to prometryn mechanism of toxicity and to evaluate Agency does not believe that conducting from food and water will utilize 30% of the cumulative effects of such a functional immunotoxicity study or the cPAD for all infants < 1 year old, the chemicals, see EPA’s website at http:// acute and subchronic neurotoxicity population group receiving the greatest www.epa.gov/pesticides/cumulative. studies will result in a lower POD than exposure. There are no residential uses that currently use for overall risk D. Safety Factor for Infants and for prometryn. assessment, and therefore, a database Children 3. Short- and intermediate-term risk. uncertainty factor is not needed to Short- and intermediate-term aggregate 1. In general. Section 408(b)(2)(C) of account for lack of these studies. exposure takes into account short-term FFDCA provides that EPA shall apply ii. There is no indication that and intermediate-term residential an additional tenfold (10X) margin of prometryn is a neurotoxic chemical and exposure plus chronic exposure to food safety for infants and children in the there is no need for a developmental and water (considered to be a case of threshold effects to account for neurotoxicity study or additional UFs to background exposure level). prenatal and postnatal toxicity and the account for neurotoxicity. Prometryn is not registered for any completeness of the database on toxicity iii. There is no evidence that use patterns that would result in and exposure unless EPA determines prometryn results in increased residential exposure. Therefore, the based on reliable data that a different susceptibility in in utero rats or rabbits short- and intermediate-term aggregate margin of safety will be safe for infants in the prenatal developmental studies or risk is the sum of the risk from exposure and children. This additional margin of in young rats in the 2–generation to prometryn through food and water safety is commonly referred to as the reproduction study. and will not be greater than the chronic FQPA SF. In applying this provision, iv. There are no residual uncertainties aggregate risk. EPA either retains the default value of identified in the exposure databases. 4. Aggregate cancer risk for U.S. 10X, or uses a different additional safety The dietary food exposure assessments population. As discussed in Unit factor when reliable data available to were performed based on 100% CT and III.C.1.iii., the Agency has concluded EPA support the choice of a different tolerance-level residues. EPA made that prometryn is not likely to be factor. conservative (protective) assumptions in carcinogenic to humans, therefore, a 2. Prenatal and postnatal sensitivity. the ground and surface water modeling cancer risk is not of concern for this Developmental toxicity studies showed used to assess exposure to prometryn in chemical. no increased sensitivity of fetuses when drinking water. These assessments will 5. Determination of safety. Based on compared to maternal animals following not underestimate the exposure and these risk assessments, EPA concludes in utero exposures of rats or rabbits. The risks posed by prometryn. multi-generation reproduction study in that there is a reasonable certainty that rats showed no increased sensitivity of E. Aggregate Risks and Determination of no harm will result to the general offspring when compared to parental Safety population, or to infants and children animals. No evidence of developmental EPA determines whether acute and from aggregate exposure to prometryn anomalies of the fetal nervous system chronic pesticide exposures are safe by residues. was observed in the prenatal comparing aggregate exposure estimates IV. Other Considerations developmental toxicity studies in either to the aPAD and cPAD. The aPAD and rats or rabbits up to maternally toxic cPAD represent the highest safe A. Analytical Enforcement Methodology dose levels. exposures, taking into account all Adequate enforcement methodology 3. Conclusion. EPA has determined appropriate SFs. EPA calculates the (gas chromatography/flame photometric that reliable data show the safety of aPAD and cPAD by dividing the POD by detection/sulfur (GC/FPD/S)) is infants and children would be all applicable UFs. For linear cancer available to enforce the tolerance adequately protected if the FQPA SF risks, EPA calculates the probability of expression. The method may be were reduced to 1X. That decision is additional cancer cases given the requested from: Chief, Analytical based on the following findings: estimated aggregate exposure. Short-, Chemistry Branch, Environmental i. The toxicity database for prometryn intermediate-, and chronic-term risks Science Center, 701 Mapes Rd., Ft. is complete except for acute and are evaluated by comparing the Meade, MD 20755–5350; telephone subchronic neurotoxicity studies and estimated aggregate food, water, and number: (410) 305–2905; e-mail address: immunotoxicity testing. Recent changes residential exposure to the POD to [email protected]. to 40 CFR part 158 make these studies ensure that the MOE called for by the (OPPTS Guideline 870.7800) required product of all applicable UFs is not B. International Residue Limits for pesticide registration; however, the exceeded. There are currently no established toxicology database for prometryn does 1. Acute risk. Using the exposure Codex MRLs for prometryn. not show any evidence of treatment- assumptions discussed in this unit for related effects on the nervous or acute exposure, the acute dietary C. Revisions to Petitioned-for Tolerances immune system. The overall weight-of- exposure from food and water to Based upon review of the data evidence suggests that this chemical prometryn will occupy 16% of the supporting the petition, EPA has

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modified carrot, roots from 0.7 ppm to Reduction Act (PRA), 44 U.S.C. 3501 et Federal Register. This final rule is not 0.45 ppm; celeriac, tops from 0.05 ppm seq., nor does it require any special a ‘‘major rule’’ as defined by 5 U.S.C. to 0.20 ppm; cilantro, leaves from 4.0 considerations under Executive Order 804(2). ppm to 3.5 ppm; coriander, dried leaves 12898, entitled Federal Actions to from 15.0 ppm to 9.0 ppm; parsley, Address Environmental Justice in List of Subjects in 40 CFR Part 180 leaves from 0.7 ppm to 0.60 ppm. EPA Minority Populations and Low-Income Environmental protection, revised these tolerance levels based on Populations (59 FR 7629, February 16, Administrative practice and procedure, analysis of the residue field trial data 1994). Agricultural commodities, Pesticides using the Agency’s tolerance Since tolerances and exemptions that and pests, Reporting and recordkeeping spreadsheet in accordance with the are established on the basis of a petition requirements. Agency’s Guidance for Setting Pesticide under section 408(d) of FFDCA, such as Tolerances Based on Field Trial Data. the tolerance in this final rule, do not Dated: December 8, 2009. EPA also revised the commodity term require the issuance of a proposed rule, Lois Rossi, for cilantro dried to coriander, dried the requirements of the Regulatory Director, Registration Division, Office of leaves, to be in compliance with correct Flexibility Act (RFA) (5 U.S.C. 601 et Pesticide Programs. seq.) do not apply. commodity definition. Additionally, ■ Therefore, 40 CFR chapter I is EPA determined that a tolerance is This final rule directly regulates amended as follows: required for parsley, dried leaves at 1.5 growers, food processors, food handlers, ppm. Additionally, the tolerance for and food retailers, not States or tribes, PART 180—[AMENDED] celery is removed since it is included in nor does this action alter the the leaf petioles subgroup 4B and the relationships or distribution of power ■ 1. The authority citation for part 180 regional tolerance for parsley leaves is and responsibilities established by continues to read as follows: removed since it is superseded by the Congress in the preemption provisions Authority: 21 U.S.C. 321(q), 346a and 371. of section 408(n)(4) of FFDCA. As such, tolerance established in this action. ■ 2. In § 180.222, in the table to the Agency has determined that this paragraph (a) by revising the entry for V. Conclusion action will not have a substantial direct ‘‘carrot, roots’’; by removing footnote 1, Therefore, tolerances are established effect on States or tribal governments, and the entry for ‘‘celery,’’ and by for residues of prometryn, 2,4- on the relationship between the national adding alphabetically entries for bis(isopropylamino)-6-methylthio-s- government and the States or tribal ‘‘celeriac, roots’’; ‘‘celeriac, tops’’; triazine, in or on celeriac, roots at 0.05 governments, or on the distribution of ‘‘cilantro, leaves’’; ‘‘coriander, dried ppm; celeriac, tops at 0.20 ppm; power and responsibilities among the cilantro, leaves at 3.5 ppm; coriander, various levels of government or between leaves’’; ‘‘leaf petioles subgroup 4B’’; dried leaves at 9.0 ppm; leaf petioles the Federal Government and Indian ‘‘okra’’; ‘‘parsley, leaves’’; and ‘‘parsley, subgroup 4B at 0.50 ppm; okra at 0.05 tribes. Thus, the Agency has determined dried leaves’’ to read as follows, and in ppm; parsley, leaves at 0.60 ppm; that Executive Order 13132, entitled the table to paragraph (c) by removing parsley, dried leaves at 1.5 ppm and Federalism (64 FR 43255, August 10, the entry for ‘‘parsley, leaves.’’ increases the tolerance level for carrot, 1999) and Executive Order 13175, § 180.222 Prometryn; tolerances for root to 0.45 ppm. Additionally, the entitled Consultation and Coordination residues. tolerance for celery is removed since it with Indian Tribal Governments (65 FR (a) * * * is included in the leafy petioles 67249, November 9, 2000) do not apply subgroup 4B and the regional tolerance to this final rule. In addition, this final Commodity Parts per million for parsley leaves is removed since it is rule does not impose any enforceable superseded by the tolerance established duty or contain any unfunded mandate Carrot, roots ...... 0.45 in this action. as described under Title II of the Celeriac, roots ...... 0.05 Unfunded Mandates Reform Act of 1995 Celeriac, tops ...... 0.20 VI. Statutory and Executive Order Cilantro, leaves ...... 3.5 Reviews (UMRA) (Public Law 104–4). This action does not involve any Coriander, dried leaves .. 9.0 ***** This final rule establishes tolerances technical standards that would require under section 408(d) of FFDCA in Leaf petioles subgroup Agency consideration of voluntary 4B ...... 0.50 response to a petition submitted to the consensus standards pursuant to section Okra ...... 0.05 Agency. The Office of Management and 12(d) of the National Technology Parsley, dried leaves ...... 1.5 Budget (OMB) has exempted these types Transfer and Advancement Act of 1995 Parsley, leaves ...... 0.60 of actions from review under Executive (NTTAA), Public Law 104–113, section ***** Order 12866, entitled Regulatory 12(d) (15 U.S.C. 272 note). Planning and Review (58 FR 51735, * * * * * October 4, 1993). Because this final rule VII. Congressional Review Act [FR Doc. E9–30040 Filed 12–17–09; 8:45 am] has been exempted from review under The Congressional Review Act, 5 Executive Order 12866, this final rule is U.S.C. 801 et seq., generally provides BILLING CODE 6560–50–S not subject to Executive Order 13211, that before a rule may take effect, the entitled Actions Concerning Regulations agency promulgating the rule must ENVIRONMENTAL PROTECTION That Significantly Affect Energy Supply, submit a rule report to each House of AGENCY Distribution, or Use (66 FR 28355, May the Congress and to the Comptroller 22, 2001) or Executive Order 13045, General of the United States. EPA will 40 CFR Part 180 entitled Protection of Children from submit a report containing this rule and Environmental Health Risks and Safety other required information to the U.S. [EPA–HQ–OPP–2008–0704; FRL–8803–4] Risks (62 FR 19885, April 23, 1997). Senate, the U.S. House of Fluoxastrobin; Pesticide Tolerances This final rule does not contain any Representatives, and the Comptroller information collections subject to OMB General of the United States prior to AGENCY: Environmental Protection approval under the Paperwork publication of this final rule in the Agency (EPA).

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