Fenamidone; Pesticide Tolerances, 13877-13882 [2014-05399]

Download as PDF Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations III. EPA’s Final Action For the reasons discussed in our December 11, 2013 proposal see 78 FR 75293), EPA is approving California’s attainment SIP for the Los Angeles County lead nonattainment area for the 2008 lead NAAQS. This SIP submittal addresses CAA requirements and EPA regulations for expeditious attainment of the 2008 lead NAAQS for the Los Angeles County lead nonattainment area. For the reasons discussed in our proposed rulemaking, EPA is proposing to approve under CAA section 110(k)(3) the following elements of the South Coast lead attainment SIP: 1. The SIP’s base year emissions inventory as meeting the requirements of CAA section 172(c)(3) and 40 CFR 51.117(e)(1); 2. the attainment demonstration, including air quality modeling, that demonstrates attainment as expeditiously as practicable, as meeting the requirements of CAA section 172(c)(1); 3. the RACM/RACT demonstration, as meeting the requirements of CAA section 172(c)(1); 4. the RFP demonstration, as meeting the requirements of CAA section 172(c)(2); 5. and contingency measures, as meeting the requirements of the CAA section 172(c)(9). tkelley on DSK3SPTVN1PROD with RULES VI. Statutory and Executive Order Reviews Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA’s role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action: • is not a ‘‘significant regulatory action’’ subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); • is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); VerDate Mar<15>2010 16:15 Mar 11, 2014 Jkt 232001 • does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); • does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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 the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Lead, Reporting and recordkeeping requirements. Authority: 42 U.S.C. 7401 et seq. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 13877 Dated: February 11, 2014. Jared Blumenfeld, Regional Administrator, EPA Region IX. Part 52, Chapter I, title 40 of the Code of Federal Regulations is amended as follows: PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for Part 52 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. Subpart F—California 2. Section 52.220 is amended by adding paragraph (c)(433) to read as follows: ■ § 52.220 Identification of plan. * * * * * (c) * * * (433) The following plan was submitted on June 20, 2012, by the Governor’s Designee. (i) [Reserved] (ii) Additional materials. (A) South Coast Air Quality Management District. (1) Final 2012 Lead State Implementation Plan—Los Angeles County (May 2012) (‘‘2012 Los Angeles County Lead SIP’’), adopted May 4, 2012. (2) SCAQMD Board Resolution 12–11, dated May 4, 2012, adopting the 2012 Los Angeles County Lead SIP. (B) State of California Air Resources Board. (1) CARB Resolution 12–20, dated May 24, 2012, adopting the 2012 Los Angeles County Lead SIP. [FR Doc. 2014–05227 Filed 3–11–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0161; FRL–9906–99] Fenamidone; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of fenamidone in or on ginseng; bean, succulent, except cowpea; onion, blub, subgroup 3–07A; and onion, green, subgroup 3–07B. This regulation additionally removes several individual tolerances that are superseded by inclusion in crop subgroup tolerances. Interregional SUMMARY: E:\FR\FM\12MRR1.SGM 12MRR1 13878 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation is effective March 12, 2014. Objections and requests for hearings must be received on or before May 12, 2014, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2013–0161, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov . SUPPLEMENTARY INFORMATION: ADDRESSES: I. General Information tkelley on DSK3SPTVN1PROD with RULES 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance VerDate Mar<15>2010 16:15 Mar 11, 2014 Jkt 232001 regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 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–2013–0161 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 12, 2014. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). 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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2013–0161, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/ dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of June 5, 2013 (78 FR 33785) (FRL–9386–2), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 announcing the filing of a pesticide petition (PP 3E8150) by IR–4, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR 180.579 be amended by establishing tolerances for residues of the fungicide fenamidone, 4H-imidazol-4-one, 3,5-dihydro-5methyl-2-(methylthio)-5-phenyl-3(phenylamino)-,(S)-, in or on ginseng at 0.80 parts per million (ppm); bean, succulent at 0.80 ppm; onion, bulb, subgroup 03–07A at 0.20 ppm; and onion, green, subgroup 03–07B at 1.5 ppm. The petition additionally requested to remove the established tolerances in or on garlic at 0.20 ppm; garlic, great headed at 0.20 ppm; leek at 1.5 ppm; onion, bulb at 0.20 ppm; onion, green at 1.5 ppm; onion, welsh at 1.5 ppm; shallot, bulb at 0.20 ppm; and shallot, fresh leaves at 1.5 ppm, as they will be superseded by the tolerances described in this unit. That document referenced a summary of the petition prepared on behalf of IR–4 by Bayer CropScience, the registrant, which is available 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 determined that cowpea should not be included in the tolerance in or on bean, succulent. The reason for this change is explained in Unit IV.C. 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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data E:\FR\FM\12MRR1.SGM 12MRR1 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations tkelley on DSK3SPTVN1PROD with RULES and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fenamidone including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with fenamidone follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The target organs in subchronic toxicity studies for fenamidone were generally the liver; rarely, the thyroid or spleen were also affected. Target organs for chronic toxicity studies were the liver in the mouse and dog, and the liver and thyroid in the rat. In the chronic toxicity rat study, diffuse C-cell hyperplasia of the thyroid in both sexes was the most sensitive indicator of toxicity, and at higher doses follicular cells and the liver were also affected. The similarity in the systemic noobserved-adverse-effect-levels (NOAELs) and the type of toxicity observed (primarily liver) for the subchronic rat studies with the parent and plant metabolites (RPA 412636, RPA 412708, and RPA 410193) demonstrated that, on a subchronic basis, plant metabolites were not more toxic than the parent. In the acute neurotoxicity study in rats, clinical signs included staining of the anogenital region, mucous in the feces, hunched posture, and unsteady gait. In the subchronic neurotoxicity study in rats, marginal decreases in brain weights were observed only in high dose males. Additionally, decreased brain weight occurred in the rat reproduction study. In a developmental neurotoxicity study in Wistar rats, no neurobehavioral effects and no neuropathological changes were observed at any dose in the offspring, but decreased body weight was observed during pre- and post-weaning. In prenatal developmental toxicity studies in rabbits and rats, there were no developmental effects up to the highest dose tested (HDT). Maternal toxicity in these studies was observed as increased liver weights in maternal rabbits and decreased body weight gains and food consumption in maternal rats. In the reproduction study in rats, decreased absolute brain weight in F2 female pups VerDate Mar<15>2010 16:15 Mar 11, 2014 Jkt 232001 occurred at the same dose levels as decreased absolute brain weight in F1 parental females. There were no effects on fertility or other measured reproductive parameters conducted with fenamidone. An immunotoxicity study in rats showed a potential immunosuppression at the HDT; however, the existing risk assessment points of departure are lower and are therefore protective of this potential effect. No carcinogenic potential was observed in chronic studies in rat, mice, and dog; therefore, EPA has determined that fenamidone is not likely to be a human carcinogen by all relevant routes of exposure. All mutagenicity studies were negative for both the parent and plant metabolites, except the parent induced mutant colonies at the tk locus and increased chromosomal aberrations in human peripheral blood. Specific information on the studies received and the nature of the adverse effects caused by fenamidone as well as the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in document: ‘‘Fenamidone: Human Health Risk Assessment to Support the Section (3) Registration and the Establishment of Tolerances for Uses on Ginseng, Succulent Beans (Except Cowpea), Bulb Onion (Subgroup 3–07A), and Green Onion (Subgroup 3–07B).’’ at pp. 30–34 in docket ID number EPA–HQ–OPP– 2013–0161. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL of concern are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For nonthreshold 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 expected in a lifetime. For more PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 13879 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 fenamidone used for human risk assessment is discussed in Unit III.B., Table 1 of the final rule published in the Federal Register of November 16, 2011 (76 FR 70890) (FRL– 9325–4). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fenamidone, EPA considered exposure under the petitioned-for tolerances as well as all existing fenamidone tolerances in 40 CFR 180.579. EPA assessed dietary exposures from fenamidone 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. Such effects were identified for fenamidone. In estimating acute dietary exposure, EPA used Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM–FCID) Version 3.16, which uses food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, ‘‘What We Eat in America’’ (NHANES/WWEIA) from 2003 through 2008. As to residue levels in food, EPA used maximum field trial residues for plant commodities and residues at the limit of quantitation for livestock commodities, assumed 100 percent crop treated (PCT) estimates for all commodities, and incorporated DEEMTM default processing factors, when applicable. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the same dietary risk assessment assumptions as for the acute dietary risk assessment. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fenamidone does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. EPA did not use PCT information in the dietary assessment for fenamidone; 100 PCT were assumed for all food commodities. However, anticipated residues were used as maximum field trial residues for plant E:\FR\FM\12MRR1.SGM 12MRR1 tkelley on DSK3SPTVN1PROD with RULES 13880 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations commodities and residues at the limit of quantitation for livestock commodities. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fenamidone in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of fenamidone. 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 PRZM Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of fenamidone for surface water are expected to be 41.7 parts per billion (ppb) for acute exposures and 11.9 ppb for chronic exposures for noncancer assessments. For groundwater, the EDWC of 207 ppb is estimated for all acute and chronic exposures. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute and chronic dietary risk assessments, the water concentration value of 207 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 nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fenamidone 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 VerDate Mar<15>2010 16:15 Mar 11, 2014 Jkt 232001 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 fenamidone to share a common mechanism of toxicity with any other substances, and fenamidone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fenamidone 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 Web site 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 Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The pre- and postnatal toxicity database for fenamidone includes rat and rabbit developmental toxicity studies, a rat developmental neurotoxicity study (DNT), and a 2-generation reproduction toxicity study in rats. No evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses to in utero exposure was observed in the developmental toxicity studies. There was no developmental toxicity in rabbit fetuses up to 100 milligrams/kilograms/ day (mg/kg/day), the HDT; maternal toxicity was exhibited as an increase in absolute liver weight, observed at 30 and 100 mg/kg/day. In the rat developmental study, decreased fetal body weight and incomplete fetal ossification were observed, but were considered secondary to maternal toxicity observed as decreased body weight and food consumption at the limit dose (1,000 mg/kg/day). No quantitative or qualitative evidence of PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 increased susceptibility was observed in the 2-generation reproduction study in rats. In that study, both the parental and offspring LOAELs were based on decreased absolute brain weight in female F1 adults and female F2 offspring at 89.2 mg/kg/day. Parental effects consisting of decreased body weight and food consumption and increased liver and spleen weights were noted at the same level as decreased pup body weight. There were no reproductive effects up to the HDT. The results of the DNT study indicated an increased susceptibility of offspring. There was no maternal toxicity at the HDT (429 mg/kg/day). Effects in the offspring included decreased body weight (9–11%) and body weight gain (8–20%) during preweaning, and decreased body weight (4– 6%) during post-weaning at 429 mg/kg/ day (LOAEL). There were no neurobehavioral effects and no neuropathological changes at any dose in the offspring. 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 fenamidone is complete. ii. The concern for the increased susceptibility observed in the DNT is low because: a. There were no neurobehavioral or neuropathological changes in the offspring at any dose; b. A clear NOAEL for the adverse effects in the study was identified; and c. The endpoints used for the various risk assessment scenarios are much more sensitive than that of the decreased bodyweight of the offspring. Therefore, based on the information above, the available data and the selection of risk assessment endpoints, EPA has determined that all endpoints used in the risk assessment for fenamidone are protective of neurotoxic effects. Accordingly, additional uncertainty factors (UFs) to account for neurotoxicity are not necessary. iii. There is no evidence that fenamidone results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT, maximum field trial residues for plant commodities, and residues at the limit of quantitation for livestock commodities. EPA made conservative E:\FR\FM\12MRR1.SGM 12MRR1 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations tkelley on DSK3SPTVN1PROD with RULES (protective) assumptions in the ground and surface water modeling used to assess exposure to fenamidone in drinking water. These assessments will not underestimate the exposures and risks posed by fenamidone. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fenamidone will occupy 4.8% of the aPAD for children 1–2 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fenamidone from food and water will utilize 89% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. There are no residential uses for fenamidone. 3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposures take into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Short- and intermediate-term adverse effects were identified; however, fenamidone is not registered for any use patterns that would result in short- or intermediateterm residential exposures. Short- and intermediate-term risk is assessed based on short- or intermediate-term residential exposure plus chronic dietary exposure. Because there are no short- or intermediate-term residential exposures and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediateterm risks are necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediateterm risks for fenamidone. 4. Aggregate cancer risk for U.S. population. Based on the lack of VerDate Mar<15>2010 16:15 Mar 11, 2014 Jkt 232001 evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fenamidone is not expected to pose a cancer risk to humans. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to fenamidone residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, a liquid chromatography with tandem mass spectrometry detection (LC/MS/ MS), is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for fenamidone. C. Revisions to Petitioned-For Tolerances Based on the data supporting the petition, EPA has determined that cowpea should not be included in the bean, succulent tolerance at 0.80 ppm, as was proposed. The bean, succulent definition includes cowpea, and cowpea has forage and hay associated uses that are considered significant livestock feedstuffs. Because of the significant livestock feedstuffs for cowpea, the Agency requires a feeding study in order to determine the dietary burden PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 13881 associated with cowpea. Because an appropriate feeding study has not been submitted for fenamidone, cowpea has been excluded from the tolerance in or on bean, succulent. V. Conclusion Therefore, tolerances are established for residues of fenamidone, 4HImidazol-4-one, 3,5-dihydro-5methyl-2-(methylthio)-5-phenyl-3 (phenylamino)-,(S)-, in or on bean, succulent, except cowpea at 0.80 ppm; ginseng at 0.80 ppm; onion, bulb, subgroup 3–07A at 0.20 ppm; and onion, green, subgroup 3–07B at 1.5 ppm. This regulation additionally removes established tolerances at 0.20 ppm in or on garlic; garlic, great headed; onion, bulb; and shallot, bulb. Finally, this regulation removes established tolerances at 1.5 ppm in or on leek; onion, green; onion, welsh; and shallot, fresh leaves. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under FFDCA section 408(d) 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 FFDCA section 408(d), 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, E:\FR\FM\12MRR1.SGM 12MRR1 13882 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Rules and Regulations nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 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) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action 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: February 28, 2014. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. tkelley on DSK3SPTVN1PROD with RULES Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. ■ 2. In § 180.579: VerDate Mar<15>2010 16:15 Mar 11, 2014 Jkt 232001 a. Remove the commodities ‘‘Garlic’’; ‘‘Garlic, great headed’’; ‘‘Leek’’; ‘‘Onion, bulb’’; ‘‘Onion, green’’; ‘‘Onion, welsh’’; ‘‘Shallot, bulb’’; and ‘‘Shallot, fresh leaves’’ from the table in paragraph (a)(1). ■ b. Add alphabetically the following commodities to the table in paragraph (a)(1). The amendments read as follows: ■ than operation, maintenance, and fiveyear reviews, have been completed. However, this deletion does not preclude future actions under Superfund. This direct final deletion is effective May 12, 2014 unless EPA receives adverse comments by April 11, 2014. If adverse comments are received, EPA will publish a timely withdrawal of § 180.579 Fenamidone; tolerances for the direct final deletion in the Federal residues. Register informing the public that the (a) * * * deletion will not take effect. (1) * * * ADDRESSES: Submit your comments, identified by Docket ID no. EPA–HQ– Parts per Commodity million SFUND–1983–0002, by one of the following methods: Bean, succulent, except • http://www.regulations.gov. Follow cowpea ................................ 0.80 on-line instructions for submitting comments. * * * * * • Email: connelly.terry@epa.gov. Ginseng .................................. 0.80 • Fax: 617 918–0373. • Mail: Terrence Connelly, US EPA * * * * * Onion, bulb, subgroup 3–07A 0.20 Region 1, 5 Post Office Square, Suite Onion, green, subgroup 3– 100, Boston, MA 02109—3919. 07B ...................................... 1.5 • Hand delivery: US EPA Region 1, 5 Post Office Square, Suite 100, Boston, * * * * * MA 02109–3912. Such deliveries are only accepted during the Docket’s * * * * * normal hours of operation, and special [FR Doc. 2014–05399 Filed 3–11–14; 8:45 am] arrangements should be made for BILLING CODE 6560–50–P deliveries of boxed information. Instructions: Direct your comments to Docket ID no. EPA–HQ–SFUND–1983– ENVIRONMENTAL PROTECTION 0002. EPA’s policy is that all comments AGENCY received will be included in the public docket without change and may be 40 CFR Part 300 made available online at http:// [EPA–HQ–SFUND–1983–0002; FRL 9907– www.regulations.gov, including any 66-Region 1] personal information provided, unless the comment includes information National Oil and Hazardous claimed to be Confidential Business Substances Pollution Contingency Information (CBI) or other information Plan; National Priorities List: Deletion whose disclosure is restricted by statute. of the O’Connor Superfund Site Do not submit information that you consider to be CBI or otherwise AGENCY: Environmental Protection protected through http:// Agency. www.regulations.gov or email. The ACTION: Direct final rule. http://www.regulations.gov Web site is SUMMARY: The Environmental Protection an ‘‘anonymous access’’ system, which Agency (EPA) Region 1 is publishing a means EPA will not know your identity direct final Notice of Deletion of the or contact information unless you O’Connor Superfund Site (Site), located provide it in the body of your comment. in Augusta, Maine, from the National If you send an email comment directly Priorities List (NPL). The NPL, to EPA without going through http:// promulgated pursuant to section 105 of www.regulations.gov, your email the Comprehensive Environmental address will be automatically captured Response, Compensation, and Liability and included as part of the comment Act (CERCLA) of 1980, as amended, is that is placed in the public docket and an appendix of the National Oil and made available on the Internet. If you Hazardous Substances Pollution submit an electronic comment, EPA Contingency Plan (NCP). This direct recommends that you include your final deletion is being published by EPA name and other contact information in with the concurrence of the State of the body of your comment and with any Maine, through the Maine Department disk or CD–ROM you submit. If EPA of Environmental Protection, because cannot read your comment due to EPA has determined that all appropriate technical difficulties and cannot contact response actions under CERCLA, other you for clarification, EPA may not be PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 DATES: E:\FR\FM\12MRR1.SGM 12MRR1

Agencies

[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Rules and Regulations]
[Pages 13877-13882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05399]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0161; FRL-9906-99]


Fenamidone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fenamidone in or on ginseng; bean, succulent, except cowpea; onion, 
blub, subgroup 3-07A; and onion, green, subgroup 3-07B. This regulation 
additionally removes several individual tolerances that are superseded 
by inclusion in crop subgroup tolerances. Interregional

[[Page 13878]]

Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 12, 2014. Objections and 
requests for hearings must be received on or before May 12, 2014, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0161, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2013-0161 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 12, 2014. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0161, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 3E8150) 
by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The 
petition requested that 40 CFR 180.579 be amended by establishing 
tolerances for residues of the fungicide fenamidone, 4H-imidazol-4-one, 
3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-,(S)-, in 
or on ginseng at 0.80 parts per million (ppm); bean, succulent at 0.80 
ppm; onion, bulb, subgroup 03-07A at 0.20 ppm; and onion, green, 
subgroup 03-07B at 1.5 ppm. The petition additionally requested to 
remove the established tolerances in or on garlic at 0.20 ppm; garlic, 
great headed at 0.20 ppm; leek at 1.5 ppm; onion, bulb at 0.20 ppm; 
onion, green at 1.5 ppm; onion, welsh at 1.5 ppm; shallot, bulb at 0.20 
ppm; and shallot, fresh leaves at 1.5 ppm, as they will be superseded 
by the tolerances described in this unit. That document referenced a 
summary of the petition prepared on behalf of IR-4 by Bayer 
CropScience, the registrant, which is available 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 
determined that cowpea should not be included in the tolerance in or on 
bean, succulent. The reason for this change is explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data

[[Page 13879]]

and other relevant information in support of this action. EPA has 
sufficient data to assess the hazards of and to make a determination on 
aggregate exposure for fenamidone including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with fenamidone follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The target organs in subchronic toxicity studies for fenamidone 
were generally the liver; rarely, the thyroid or spleen were also 
affected. Target organs for chronic toxicity studies were the liver in 
the mouse and dog, and the liver and thyroid in the rat. In the chronic 
toxicity rat study, diffuse C-cell hyperplasia of the thyroid in both 
sexes was the most sensitive indicator of toxicity, and at higher doses 
follicular cells and the liver were also affected. The similarity in 
the systemic no-observed-adverse-effect-levels (NOAELs) and the type of 
toxicity observed (primarily liver) for the subchronic rat studies with 
the parent and plant metabolites (RPA 412636, RPA 412708, and RPA 
410193) demonstrated that, on a subchronic basis, plant metabolites 
were not more toxic than the parent.
    In the acute neurotoxicity study in rats, clinical signs included 
staining of the anogenital region, mucous in the feces, hunched 
posture, and unsteady gait. In the subchronic neurotoxicity study in 
rats, marginal decreases in brain weights were observed only in high 
dose males. Additionally, decreased brain weight occurred in the rat 
reproduction study. In a developmental neurotoxicity study in Wistar 
rats, no neurobehavioral effects and no neuropathological changes were 
observed at any dose in the offspring, but decreased body weight was 
observed during pre- and post-weaning.
    In prenatal developmental toxicity studies in rabbits and rats, 
there were no developmental effects up to the highest dose tested 
(HDT). Maternal toxicity in these studies was observed as increased 
liver weights in maternal rabbits and decreased body weight gains and 
food consumption in maternal rats. In the reproduction study in rats, 
decreased absolute brain weight in F2 female pups occurred at the same 
dose levels as decreased absolute brain weight in F1 parental females. 
There were no effects on fertility or other measured reproductive 
parameters conducted with fenamidone.
    An immunotoxicity study in rats showed a potential 
immunosuppression at the HDT; however, the existing risk assessment 
points of departure are lower and are therefore protective of this 
potential effect. No carcinogenic potential was observed in chronic 
studies in rat, mice, and dog; therefore, EPA has determined that 
fenamidone is not likely to be a human carcinogen by all relevant 
routes of exposure. All mutagenicity studies were negative for both the 
parent and plant metabolites, except the parent induced mutant colonies 
at the tk locus and increased chromosomal aberrations in human 
peripheral blood.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenamidone as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document: ``Fenamidone: 
Human Health Risk Assessment to Support the Section (3) Registration 
and the Establishment of Tolerances for Uses on Ginseng, Succulent 
Beans (Except Cowpea), Bulb Onion (Subgroup 3-07A), and Green Onion 
(Subgroup 3-07B).'' at pp. 30-34 in docket ID number EPA-HQ-OPP-2013-
0161.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL of concern are 
identified. Uncertainty/safety factors are used in conjunction with the 
POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 fenamidone used for 
human risk assessment is discussed in Unit III.B., Table 1 of the final 
rule published in the Federal Register of November 16, 2011 (76 FR 
70890) (FRL-9325-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenamidone, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenamidone tolerances in 40 CFR 
180.579. EPA assessed dietary exposures from fenamidone 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. Such effects were identified 
for fenamidone. In estimating acute dietary exposure, EPA used Dietary 
Exposure Evaluation Model software with the Food Commodity Intake 
Database (DEEM-FCID) Version 3.16, which uses food consumption data 
from the U.S. Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, ``What We Eat in America'' (NHANES/WWEIA) 
from 2003 through 2008. As to residue levels in food, EPA used maximum 
field trial residues for plant commodities and residues at the limit of 
quantitation for livestock commodities, assumed 100 percent crop 
treated (PCT) estimates for all commodities, and incorporated 
DEEMTM default processing factors, when applicable.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the same dietary risk assessment assumptions as 
for the acute dietary risk assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenamidone does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use PCT 
information in the dietary assessment for fenamidone; 100 PCT were 
assumed for all food commodities. However, anticipated residues were 
used as maximum field trial residues for plant

[[Page 13880]]

commodities and residues at the limit of quantitation for livestock 
commodities. Section 408(b)(2)(E) of FFDCA authorizes EPA to use 
available data and information on the anticipated residue levels of 
pesticide residues in food and the actual levels of pesticide residues 
that have been measured in food. If EPA relies on such information, EPA 
must require pursuant to FFDCA section 408(f)(1) that data be provided 
5 years after the tolerance is established, modified, or left in 
effect, demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fenamidone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenamidone. 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 PRZM Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of fenamidone for surface water 
are expected to be 41.7 parts per billion (ppb) for acute exposures and 
11.9 ppb for chronic exposures for non-cancer assessments. For 
groundwater, the EDWC of 207 ppb is estimated for all acute and chronic 
exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute and chronic dietary 
risk assessments, the water concentration value of 207 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). Fenamidone 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 
fenamidone to share a common mechanism of toxicity with any other 
substances, and fenamidone does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that fenamidone 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 Web site 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 Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The pre- and postnatal 
toxicity database for fenamidone includes rat and rabbit developmental 
toxicity studies, a rat developmental neurotoxicity study (DNT), and a 
2-generation reproduction toxicity study in rats. No evidence of 
increased quantitative or qualitative susceptibility of rat or rabbit 
fetuses to in utero exposure was observed in the developmental toxicity 
studies. There was no developmental toxicity in rabbit fetuses up to 
100 milligrams/kilograms/day (mg/kg/day), the HDT; maternal toxicity 
was exhibited as an increase in absolute liver weight, observed at 30 
and 100 mg/kg/day. In the rat developmental study, decreased fetal body 
weight and incomplete fetal ossification were observed, but were 
considered secondary to maternal toxicity observed as decreased body 
weight and food consumption at the limit dose (1,000 mg/kg/day). No 
quantitative or qualitative evidence of increased susceptibility was 
observed in the 2-generation reproduction study in rats. In that study, 
both the parental and offspring LOAELs were based on decreased absolute 
brain weight in female F1 adults and female F2 offspring at 89.2 mg/kg/
day. Parental effects consisting of decreased body weight and food 
consumption and increased liver and spleen weights were noted at the 
same level as decreased pup body weight. There were no reproductive 
effects up to the HDT.
    The results of the DNT study indicated an increased susceptibility 
of offspring. There was no maternal toxicity at the HDT (429 mg/kg/
day). Effects in the offspring included decreased body weight (9-11%) 
and body weight gain (8-20%) during pre-weaning, and decreased body 
weight (4-6%) during post-weaning at 429 mg/kg/day (LOAEL). There were 
no neurobehavioral effects and no neuropathological changes at any dose 
in the offspring.
    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 fenamidone is complete.
    ii. The concern for the increased susceptibility observed in the 
DNT is low because:
    a. There were no neurobehavioral or neuropathological changes in 
the offspring at any dose;
    b. A clear NOAEL for the adverse effects in the study was 
identified; and
    c. The endpoints used for the various risk assessment scenarios are 
much more sensitive than that of the decreased bodyweight of the 
offspring.
    Therefore, based on the information above, the available data and 
the selection of risk assessment endpoints, EPA has determined that all 
endpoints used in the risk assessment for fenamidone are protective of 
neurotoxic effects. Accordingly, additional uncertainty factors (UFs) 
to account for neurotoxicity are not necessary.
    iii. There is no evidence that fenamidone results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT, maximum field trial residues for plant commodities, and 
residues at the limit of quantitation for livestock commodities. EPA 
made conservative

[[Page 13881]]

(protective) assumptions in the ground and surface water modeling used 
to assess exposure to fenamidone in drinking water. These assessments 
will not underestimate the exposures and risks posed by fenamidone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fenamidone will occupy 4.8% of the aPAD for children 1-2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenamidone from food and water will utilize 89% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for fenamidone.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposures take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, fenamidone 
is not registered for any use patterns that would result in short- or 
intermediate-term residential exposures. Short- and intermediate-term 
risk is assessed based on short- or intermediate-term residential 
exposure plus chronic dietary exposure. Because there are no short- or 
intermediate-term residential exposures and chronic dietary exposure 
has already been assessed under the appropriately protective cPAD 
(which is at least as protective as the POD used to assess short-term 
risk), no further assessment of short- or intermediate-term risks are 
necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short- and intermediate-term risks for fenamidone.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fenamidone is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to fenamidone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a liquid chromatography with 
tandem mass spectrometry detection (LC/MS/MS), is available to enforce 
the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for fenamidone.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA has determined that 
cowpea should not be included in the bean, succulent tolerance at 0.80 
ppm, as was proposed. The bean, succulent definition includes cowpea, 
and cowpea has forage and hay associated uses that are considered 
significant livestock feedstuffs. Because of the significant livestock 
feedstuffs for cowpea, the Agency requires a feeding study in order to 
determine the dietary burden associated with cowpea. Because an 
appropriate feeding study has not been submitted for fenamidone, cowpea 
has been excluded from the tolerance in or on bean, succulent.

V. Conclusion

    Therefore, tolerances are established for residues of fenamidone, 
4H-Imidazol-4-one, 3,5-dihydro-5- methyl-2-(methylthio)-5-phenyl-3 
(phenylamino)-,(S)-, in or on bean, succulent, except cowpea at 0.80 
ppm; ginseng at 0.80 ppm; onion, bulb, subgroup 3-07A at 0.20 ppm; and 
onion, green, subgroup 3-07B at 1.5 ppm. This regulation additionally 
removes established tolerances at 0.20 ppm in or on garlic; garlic, 
great headed; onion, bulb; and shallot, bulb. Finally, this regulation 
removes established tolerances at 1.5 ppm in or on leek; onion, green; 
onion, welsh; and shallot, fresh leaves.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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,

[[Page 13882]]

nor does this action alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). 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) (2 U.S.C. 
1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: February 28, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.579:
0
a. Remove the commodities ``Garlic''; ``Garlic, great headed''; 
``Leek''; ``Onion, bulb''; ``Onion, green''; ``Onion, welsh''; 
``Shallot, bulb''; and ``Shallot, fresh leaves'' from the table in 
paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in 
paragraph (a)(1). The amendments read as follows:


Sec.  180.579  Fenamidone; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, succulent, except cowpea............................          0.80
 
                                * * * * *
Ginseng...................................................          0.80
 
                                * * * * *
Onion, bulb, subgroup 3-07A...............................          0.20
Onion, green, subgroup 3-07B..............................          1.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-05399 Filed 3-11-14; 8:45 am]
BILLING CODE 6560-50-P