83 FR 9703 - Fluopicolide; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 45 (March 7, 2018)
Federal Register Volume 83, Issue 45 (March 7, 2018)
| Page Range | 9703-9712 | |
| FR Document | 2018-04533 |
[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)] [Rules and Regulations] [Pages 9703-9712] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04533] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0257; FRL-9973-44] Fluopicolide; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of fluopicolide in or on multiple commodities which are identified and discussed later in this document. In addition, this regulation removes several previously established tolerances that are superseded by this final rule. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 7, 2018. Objections and requests for hearings must be received on or before May 7, 2018, 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-2016-0257, is available at http://www.regulations.gov or at the Office of Pesticide Programs [[Page 9704]] Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton 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: Michael L. Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. 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-2016-0257 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 7, 2018. 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-2016-0257, 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 Wednesday, June 22, 2016 (81 FR 40594) (FRL-9947-32), 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 6E8464) by IR-4 Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.627 be amended by establishing tolerances for residues of the fungicide, fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2- pyridinyl]methyl]benzamide], including its metabolites and degradates, in or on the commodities: Basil, dried leaves at 200 parts per million (ppm); basil, fresh leaves at 30 ppm; bean, succulent at 0.9 ppm; citrus, dried pulp at 0.048 ppm; citrus, oil at 1.94 ppm; hop, dried cones at 15 ppm; fruit, citrus, group 10-10 at 0.02 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; and vegetable, fruiting, crop group 8-10 at 1.60 ppm. That document referenced a summary of the petition prepared by Valent, the registrant, which is available in the docket, http://www.regulations.gov. Two similar anonymous public comments were received in response to the notice of filing. The Agency's response to the comments is included in Unit IV.C. Based upon review of the data supporting the petition, EPA is establishing certain tolerances that differ from what the petitioner requested. The reasons for these changes are explained in Unit IV.D. 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 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 fluopicolide including exposure resulting from the tolerances established by this action. Fluopicolide shares a metabolite, 2,6-dichlorobenzamide (BAM), with another active ingredient, dichlobenil. Residues of BAM are assessed independently of fluopicolide and dichlobenil because it has its own toxicity database and endpoints of concern. The BAM assessment considers residues resulting from both fluopicolide and dichlobenil uses. EPA's safety finding for [[Page 9705]] fluopicolide considers the aggregate exposures to fluopicolide alone as well as the aggregate exposure to BAM from both fluopicolide and dichlobenil uses. A. Toxicological Profile EPA has evaluated the available toxicity database 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. Fluopicolide. Fluopicolide has low acute toxicity by the oral, dermal, and inhalation routes. Following subchronic and chronic exposures, increased liver weights and/or liver hypertrophy were observed in rats and mice. Additional liver lesions were seen in mice, including oval cell proliferation in a 90-day oral toxicity study and altered cell foci in the carcinogenicity study. Treatment-related effects in rats also included kidney and thyroid effects; however, these effects were not seen consistently across studies in the fluopicolide database. In the 28-day oral toxicity study in rats, there were indications of nephrotoxicity including pale kidneys and microscopic lesions (granulation, proteinaceous material, and hydronephrosis). Kidney effects were not observed in any other studies, except the reproduction toxicity study where slightly increased organ weights and kidney lesions were observed in parental animals. Thyroid toxicity was only observed in the combined chronic/carcinogenicity study in rats and consisted of increased thyroid weights, gross pathological observation of enlarged thyroids, and increased incidence of cystic follicular hyperplasia in males (slight to moderate severity). Evidence of increased quantitative susceptibility was seen in the rat developmental toxicity study. Developmental effects (delayed ossification and fetal growth) were only seen at a relatively high dose (700 mg/kg/day) in the absence of maternal effects. There was no evidence of susceptibility in the rabbit developmental toxicity and rat reproduction toxicity studies. In the rabbit developmental toxicity study, late abortions/premature deliveries were observed at 60 mg/kg/ day. Additional effects at this dose included late maternal deaths and decreased crown rump length in fetuses. In the rat reproduction toxicity study, offspring effects (decreased body weight) were seen in the presence of parental effects (kidney effects). There is no evidence of neurotoxicity, immunotoxicity, or mutagenicity in the fluopicolide toxicity database. Due to the absence of treatment-related tumors in two adequate rodent carcinogenicity studies, fluopicolide is classified as ``Not Likely to be Carcinogenic to Humans''. BAM. Acute toxicity studies on BAM demonstrated moderate acute toxicity via the oral route of exposure. In subchronic and chronic toxicity studies, the primary oral effects seen in the rat and dog were body weight changes. Adverse liver effects, including hepatocellular alterations and increased liver weights, were also observed. Toxicity to the olfactory sensory neurons has been observed following intraperitoneal exposure of mice to BAM, indicating potential neurotoxicity; however, no effects on the olfactory system were observed via the oral route. There is no evidence that BAM is either mutagenic or clastogenic nor is there evidence of endocrine mediated toxicity. A BAM combined chronic toxicity/carcinogenicity study in the rat is available; however, in the absence of a carcinogenicity study data for a second species, EPA has assumed that BAM's carcinogenic potential is similar to that of dichlobenil, the parent compound having the greatest carcinogenicity potential. Dichlobenil is classified as ``Group C, possible human carcinogen.'' Therefore, EPA has concluded that quantification of cancer risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to dichlobenil, and therefore, to BAM. Specific information on the studies received and the nature of the adverse effects caused by fluopicolide and BAM, as well as the no- observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse- effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: Fluopicolide and 2,6-Dichlorobenzamide (BAM). Human Health Risk Assessment to Support Registration for Application of Fluopicolide on Basil, Succulent Bean, Hops, Small Vine Climbing Subgroup 13-07F, and Citrus Fruit Group 10-10 and Crop Group Conversion for Fruiting Vegetables 8-10, dated December 5, 2017 at pages 19-25 in docket ID number EPA-HQ-OPP-2016-0257. 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 no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for fluopicolide and BAM used for human risk assessment is shown in Table 1 and Table 2, respectively, of this unit. [[Page 9706]] Table 1--Summary of Toxicological Doses and Endpoints for Fluopicolide for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (All populations).. An endpoint attributable to a single dose was not identified from the available data. ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) Maternal NOAEL = 20 cRfD = cPAD = 0.2 Developmental Toxicity Study in mg/kg/day. mg/kg/day. Rabbits. UFA = 10x........... LOAEL (maternal) = 60 mg/kg/day UFH = 10x........... based on death, abortions/ FQPA SF = 1X........ premature deliveries, and decreased food consumption. Co-critical: Chronic/Oncogenicity Study in Rats. NOAEL = 31.5 mg/kg/day. LOAEL = 109.4 mg/kg/day based on increased thyroid weight and increased incidence of thyroid lesions. Incidental oral short- and Maternal NOAEL = 20 LOC for MOE <100... Developmental Toxicity Study in intermediate-term (1-30 days, mg/kg/day. Rabbits. and 1-6 months). UFA = 10x........... LOAEL (maternal) = 60 mg/kg/day UFH = 10x........... based on death, abortions/ FQPA SF = 1X........ premature deliveries, decreased food consumption and body-weight gain. Dermal short- and intermediate- Maternal NOAEL = 20 LOC for MOE <100... Developmental Toxicity Study in term (1-30 days, and 1-6 months). mg/kg/day. Rabbits. UFA = 10x........... LOAEL (maternal) = 60 mg/kg/day UFH = 10x........... based on death, abortions/ FQPA SF = 1X (when premature deliveries, decreased applicable). food consumption and body-weight DAF = 5%............ gain. Co-critical: Chronic/Oncogenicity Study in Rats. NOAEL = 31.5 mg/kg/day. LOAEL = 109.4 mg/kg/day based on increased thyroid weight and increased incidence of thyroid lesions. Inhalation short- and Maternal NOAEL = 20 LOC for MOE <100... Developmental Toxicity Study in intermediate-term (1-30 days, mg/kg/day. Rabbits. and 1-6 months). Inhalation assumed LOAEL (maternal) = 60 mg/kg/day equivalent to oral. based on death, abortions/ UFA = 10x........... premature deliveries, decreased UFH = 10x........... food consumption. FQPA SF = 1X, when Co-critical: Chronic/Oncogenicity applicable. Study in Rats. NOAEL = 31.5 mg/kg/day. LOAEL = 109.4 mg/kg/day based on and increased thyroid weight and increased incidence of thyroid lesions. ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Classification: ``Not Likely to be Carcinogenic to Humans'' based on the absence of treatment-related tumors in two adequate rodent carcinogenicity studies. ---------------------------------------------------------------------------------------------------------------- Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect- level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). Table 2--Summary of Toxicological Doses and Endpoints for 2,6-Dichlorobenzamide (BAM) for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (All populations).. LOAEL = 100 mg/kg/ aRfD = aPAD = 0.1 Dose-range finding assay for in day. mg/kg/day. vivo mouse erythrocyte UFA = 10x........... micronucleus assay. UFH = 10x........... LOAEL = 100 mg/kg/day based on FQPA SF/UFL= 10x.... lethargy after a single oral dose. Chronic dietary (All populations) NOAEL = 4.5 mg/kg/ cRfD = cPAD = 0.045 Chronic toxicity (dog). day. mg/kg/day. LOAEL = 12.5 mg/kg/day based on UFA = 10x........... decreased body weight and body UFH = 10x........... weight gain. FQPA SF = 1X........ Incidental oral short- and NOAEL = 14 mg/kg/day LOC for MOE <100... 90-day oral (rat). intermediate-term (1-30 days, UFA = 10x........... LOAEL = 49 mg/kg/day based on and 1-6 months). UFH = 10x........... decreased body weight gain (M) FQPA SF = 1X........ and reduced skeletal muscle tone (day 4 only in males; days 91 and 92 only in females). [[Page 9707]] Dermal short- and intermediate- NOAEL = 25 mg/kg/day LOC for MOE <100... 5-day dermal using dichlobenil term (1-30 days and 1-6 months). UFA = 10x........... (mouse; literature study). UFH = 10x........... LOAEL = 50 mg/kg/day based on FQPA SF = 1X (when olfactory epithelial damage. applicable). Inhalation short- and NOAEL = 12.1 mg/m\3\ LOC for MOE <100... 28-day inhalation using intermediate-term (1-30 days and UFA = 3X............ dichlobenil (rat). 1-6 months). UFH = 10X........... LOAEL = 21 mg/m\3\ based on nasal FQPA SF = 1X (when degeneration. applicable). ---------------------------------------------------------------------------------------------------------------- Cancer........................... Classification: unclassified; parent herbicide dichlobenil classified as ``Group C, possible human carcinogen'' with RfD approach utilized for quantification of human risk ---------------------------------------------------------------------------------------------------------------- UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation in sensitivity among members of the human population (intraspecies), FQPA SF = FQPA Safety Factor, UFL = use of a LOAEL to extrapolate a NOAEL, NOAEL = no-observed adverse-effect level, LOAEL = lowest-observed adverse-effect level, RfD = reference dose (a = acute, c = chronic), PAD = population-adjusted dose, MOE = margin of exposure, LOC = level of concern, N/A = not applicable. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluopicolide and its metabolite BAM, EPA considered exposure under the petitioned-for tolerances as well as all existing fluopicolide tolerances in 40 CFR 180.627 and the exposures from BAM from existing dichlobenil tolerances under 40 CFR 180.231. EPA assessed dietary exposures from fluopicolide and its metabolite BAM in food as follows: a. 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. i. Fluopicolide. A toxicity endpoint attributable to a single dose has not been identified in the toxicological studies for fluopicolide; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. BAM. Such effects were identified for BAM. In estimating acute dietary exposures to BAM, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. EPA conducted a partially refined acute dietary exposure assessment. As to residue levels in food, EPA assumed maximum BAM residue from either the fluopicolide or dichlobenil field trial data. The acute assessment assumed 100% crop treated for all commodities, except apples, blueberries, cherries, peaches, pears, and raspberries. These values reflect the dichlobenil percent crop treated estimates as fluopicolide is not registered for application to these crops. Default processing factors were used for commodities where empirical processing data were not available b. Chronic exposure--i. Fluopicolide. In estimating chronic dietary exposure, EPA used Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID, Version 3.16). The software uses 2003-2008 food consumption data from the U.S. Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The chronic analysis assumed tolerance-level residues or maximum field trial residues, 100% crop treated, default processing factors, and modeled drinking water estimates. ii. BAM. In estimating chronic dietary exposures, EPA conducted a partially refined chronic dietary exposure assessment using DEEM-FCID (ver. 3.16) and USDA's NHANES/WWEIA (2003 through 2008). The chronic dietary assessment assumed the maximum BAM residue from either the fluopicolide or dichlobenil field trial data. The chronic assessment assumed 100% crop treated for all commodities except apple. These values reflect the dichlobenil percent crop treated estimates as fluopicolide is not registered for application to these crops. Default processing factors were used for commodities where empirical processing data were not available. c. Cancer. Fluopicolide has been classified as ``not likely to be carcinogenic to humans.'' Therefore, a cancer dietary exposure assessment was not conducted for the parent fluopicolide. Additionally, EPA has determined BAM's potential for carcinogenicity is similar to that of dichlobenil, which is classified as ``group C, possible human carcinogen.'' Quantification of cancer risk is based on the reference dose (RfD) approach which requires comparison of the chronic exposure to the RfD. Using this methodology will adequately account for all chronic toxic effects, including carcinogenicity, likely to result from exposure to BAM. Hence, a separate cancer exposure assessment to BAM was not conducted. d. Anticipated residue and percent crop treated (PCT) information. 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 [[Page 9708]] submitted no later than 5 years from the date of issuance of these tolerances. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue. Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group. Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. EPA did not use anticipated residue or PCT information in the dietary assessment for fluopicolide. Tolerance level residues or maximum field trial residues and 100 PCT were assumed for all food commodities. EPA used anticipated residues and PCT information for the acute and chronic dietary risk assessments for BAM. The BAM acute assessment assumed 100 PCT for all commodities except apples (2.5%), blueberries (2.5%), cherries (2.5%), peaches (2.5%), pears (5%) and raspberries (20%). The BAM chronic assessment assumed 100 PCT for all commodities except apples (1%). These values reflect the dichlobenil percent crop treated estimates as fluopicolide is not registered for application to these crops. Default processing factors were used for commodities where empirical processing data were not available. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 2.5%. The maximum PCT figure is the highest observed maximum value reported within the most recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except for situations in which the maximum PCT is less than 2.5%. In cases where the estimated value is less than 2.5% but greater than 1%, the average and maximum PCT used are 2.5%. If the estimated value is less than 1%, 1% is used as the average PCT and 2.5% is used as the maximum PCT. The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which BAM may be found in a particular area. 2. Dietary exposure from drinking water. The Agency used screening- level water exposure models in the dietary exposure analysis and risk assessment for fluopicolide in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluopicolide. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. No monitoring data are available for fluopicolide or BAM. Drinking water residues of fluopicolide (parent) estimates were generated using maximum annual application rate of 0.375 lbs ai/acre, and the surface water concentration calculator (SWCC version 1.106) for surface water, and the pesticide root zone model for groundwater (PRZM-GW version 1.07). The estimated drinking water concentrations (EDWCs) of fluopicolide for non-cancer chronic exposures are 12.90 ppb for surface water and 103 ppb for ground water. Estimates of BAM residues in drinking water were generated using the Provisional Cranberry Model (PCM) and Pesticide Water Concentration Calculator (PWC) for surface water, and the PRZM-GW model for groundwater. BAM drinking water concentrations can result from the application of dichlobenil and fluopicolide. The BAM estimates resulting from application of dichlobenil are higher than those resulting from application of fluopicolide. The acute and chronic analyses assumed a BAM drinking water concentration of 239 ppb and 206 ppb, respectively, based on the PRZM-GW model from turf use (worst case scenario). Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment for BAM, the water concentration value of 239 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 206 ppb and 103 ppb were used to assess the contribution to drinking water for BAM and fluopicolide, respectively. 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). Fluopicolide is currently registered for the following uses that could result in residential exposures: Residential turf grass and recreational sites; however, all registered fluopicolide product labels with residential use sites require that handlers wear specific clothing and/or use personal protective equipment (PPE). Therefore, the Agency has concluded that these products are not intended to be used by homeowners and did not conduct residential handler assessments. There is potential for post-application exposure for individuals entering areas that have been previously treated with fluopicolide. EPA assessed the following residential exposure scenarios for fluopicolide: Post-application exposure to children, youth, and adults from treated lawns, turf, gardens, trees, and golf courses. In the case of BAM, the Agency considered the potential for residential exposures to BAM from dichlobenil and fluopicolide uses. As noted above, fluopicolide is registered for use on residential turfgrass and recreational [[Page 9709]] sites, such as golf courses. These uses may also result in short-term dermal post-application exposure to BAM to youth and adults from treated gardens. Post-application exposures from treated turf is not expected since BAM was not detected in turf transferable residue studies with fluopicolide. As discussed above, residential handler assessments were not performed for fluopicolide; therefore, a residential handler assessment for BAM is also not required. Residential handler exposure to BAM resulting from the application of dichlobenil is not expected. While dichlobenil is currently registered for residential uses on ornamental plants, they are approved for professional applicator use only. Post- application exposure of adults and children to dichlobenil and BAM exposure from the use of dichlobenil products on ornamental plants is expected to be negligible and, therefore, was not assessed. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 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.'' Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fluopicolide and any other substances. Fluopicolide shares a common metabolite, BAM, with dichlobenil. EPA's assessment of BAM from pesticide use of fluopicolide and dichlobenil has been updated for the current assessment and no risks of concern were identified. For the purposes of this tolerance action, therefore, EPA has not assumed that fluopicolide (parent) and its metabolite BAM have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. 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 FQPA Safety Factor (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. For fluopicolide, there is no evidence of increased susceptibility in the rabbit developmental or rat reproduction toxicity studies. There was evidence of increased quantitative susceptibility in the rat developmental toxicity study; however, the developmental effects were only seen at a relatively high dose (700 mg/kg/day), the effects are well-characterized with a clear NOAEL, and the selected endpoints are protective of the observed effects. For BAM, there was no evidence of increased susceptibility in the rabbit developmental study. 3. Conclusion for fluopicolide. 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 fluopicolide is complete. ii. There is no indication that fluopicolide is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence of increased susceptibility in the rabbit developmental or rat reproduction toxicity studies. Although there is evidence of increased quantitative susceptibility in the rat developmental toxicity study, the developmental effects were only seen at a relatively high dose, the effects are well characterized with a clear NOAEL, and the selected endpoints are protective of the observed effects. There are no residual uncertainties concerning prenatal and postnatal toxicity for fluopicolide. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to fluopicolide in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by fluopicolide. 4. Conclusion for BAM: EPA is retaining the FQPA SF of 10X for the acute dietary exposure scenario for the general population to account for the use of a LOAEL to extrapolate to a NOAEL. For all other exposure scenarios, the FQPA SF has been reduced to 1X. That decision is based on the following findings: i. Acute, subchronic, and chronic oral studies are available for BAM and utilized for endpoint selection. For the dermal and inhalation routes of exposures, the Agency is relying on dichlobenil toxicity data, where olfactory toxicity was observed. Based on a comparison of toxicity via the intraperitoneal route of exposure, higher doses of BAM are needed to induce levels of olfactory toxicity that are similar to those caused by dichlobenil; therefore, the endpoints based on dichlobenil are considered protective of potential BAM toxicity. ii. Although there is potential neurotoxicity in the olfactory system from BAM exposure, concern is low since the effects are well- characterized and selected endpoints based on dichlobenil are protective of these effects. iii. There is no evidence of increased susceptibility in the developmental rabbit study. iv. The assessments of BAM are unlikely to underestimate exposure and risks. Acute and chronic dietary assessments assumed maximum BAM residues from field trial data as well as conservative (protective) assumptions of BAM exposure in drinking water. Similar conservative assumptions were used to assess post-application exposure of children to BAM. 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 [[Page 9710]] PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected for fluopicolide. Therefore, fluopicolide is not expected to pose an acute risk. In the case of BAM, using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to BAM will occupy 81% of the aPAD for children 1 to <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 fluopicolide from food and water will utilize 15% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. In the case of BAM, chronic exposure to BAM from food and water will utilize 26% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluopicolide or BAM is not expected. 3. Short-term/intermediate-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluopicolide is currently registered for uses that could result in short-term residential exposure and may result in post-application exposures of BAM. The Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to fluopicolide and BAM. There are no intermediate-term exposures expected for fluopicolide or BAM; however, the short-term aggregate assessment is considered protective of intermediate-term since the same endpoints were selected to evaluate short- and intermediate-term exposures. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined fluopicolide short-term food, water, and residential exposures for children 1-2 years old and children 6-11 years old result in aggregate MOEs of 490 and 670, respectively. In addition, an aggregate assessment conducted for adults resulted in an MOE of 500. Because EPA's level of concern for fluopicolide is a MOE of 100 or below, these MOEs are not of concern. For BAM, dermal and inhalation exposures may not be combined with oral exposures due to different toxicological effects used as the basis of the selected endpoints. As a result, the aggregate risk estimates are equivalent to the dietary risk estimates and are not of concern. 4. Aggregate cancer risk for U.S. population. Due to the absence of treatment-related tumors in two adequate rodent carcinogenicity studies, fluopicolide is classified as ``not likely to be carcinogenic to humans''; therefore, a quantitative cancer assessment is not required. EPA has assumed BAM's potential for carcinogenicity is similar to that of dichlobenil, which is classified as ``group C, possible human carcinogen.'' Quantification of cancer risk is based on the RfD approach which requires comparison of the chronic exposure to the RfD. Therefore, the chronic risks discussed in Unit III.E.2. are considered protective of both non-cancer and cancer effects. 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 fluopicolide residues, including its metabolite. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (liquid chromatography with tandem mass spectroscopy (LC/MS/MS) enforcement method RM-43C-2) is available to enforce the tolerance expression. Enforcement methodology (LC/MS/MS Method, Methods 00782, 00782/M001, 00782/M002, and 00782/M003) is available to adequately enforce the tolerance expression for BAM. The methods 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: [email protected]. 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. Codex has not established MRLs for basil, hop, bean, or citrus. The fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F tolerance is harmonized with Codex grape MRL. Codex established a tolerance for ``Fruiting vegetables other than cucurbits'' at 1.0 ppm. Based on the field trial data and the Organization for Economic Cooperation and Development (OECD) calculator, using the labeled application scenario may result in residues greater than 1.0 ppm in/on fruiting vegetables. As a result, harmonization of the vegetable, fruiting, crop group 8-10 tolerance with the Codex MRL could result in food containing residues exceeding tolerances despite legal application of the pesticide, which would not be appropriate. C. Response to Comments on Notice of Filing Two anonymous public comments were received on the notice of filing that center around opposing IR-4 and the uses of pesticides (toxic chemicals), such as fluopicolide, on food commodities including grape, citrus and basil, claiming these chemicals are harmful to human health. EPA's Response: Aside from assertions that chemicals are toxic and linked to adverse human health effects, the commenters provided no information supporting these assertions that EPA could use to evaluate the safety of fluopicolide or BAM. The existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. When new or amended tolerances are requested for residues of a pesticide in food or feed, the Agency evaluates all available data and assesses the potential for risk from aggregate exposure to the pesticide. As discussed in this rule, EPA examined all relevant data for fluopicolide and BAM and has concluded that there is a reasonable certainty that no harm will result from [[Page 9711]] aggregate human exposure to fluopicolide, including residues of its metabolite BAM. The commenters have presented no information to support reconsideration of that conclusion. D. Revisions to Petitioned-For Tolerances The established tolerances differ from the petitioner's requests as follows: i. EPA is establishing a tolerance for ``basil fresh leaves'' at 40 ppm, rather than 30 ppm, as a result of removing certain inadequate residue data from the tolerance calculation. ii. The petitioner requested a tolerance for residues of fluopicolide for the general category of ``bean, succulent'' at 0.9 ppm. This term is defined in EPA's regulations as including a variety of beans in succulent form (see 40 CFR 180.1(g)). At this time, EPA is establishing tolerances for only those beans included in the succulent bean definition that are also supported by the submitted snap bean field trial data. Those specific succulent beans are the following: ``bean, moth, succulent'', ``bean, yardlong, succulent'' (species of the Vigna genus), ``bean, runner, succulent'', ``bean, snap, succulent'', and ``bean, wax, succulent'' (species of the Phaseolus genus). Tolerances for the other beans contained within the definition of ``bean, succulent'' as contained in 180.1(g) are not being established at this time due to lack of adequate residue data. In addition, the Agency has adjusted the tolerance values for these beans (from 0.9 to 0.90) to be consistent with its current guidance on significant figures. iii. Because all reported residue data on crops supporting the ``fruit, citrus, crop group 10-10'' were below the 0.01 ppm limit of quantitation, EPA is establishing a tolerance for this group at 0.01 ppm. iv. The petitioner's requested tolerances for ``citrus, dried pulp'' at 0.048 ppm and ``citrus, oil'' at 1.94 ppm were based on the petitioned-for tolerance level for citrus group 10-10 at 0.02 ppm. Using the 0.01 ppm tolerance level for group 10-10 as indicated in the previous paragraph and applying appropriate processing factors yields tolerances of 0.03 for citrus, dried pulp and 1.0 for citrus, oil. V. Conclusion Therefore, tolerances are established for residues of the fungicide fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2- pyridinyl]methyl]benzamide], including its metabolites and degradates (determined by measuring the parent only), in or on Basil, fresh leaves at 40 ppm; Basil, dried leaves at 200 ppm; Bean, moth, succulent at 0.90 ppm; Bean, snap, succulent at 0.90 ppm; Bean, runner, succulent at 0.90 ppm; Bean, wax, succulent at 0.90 ppm; Bean, yardlong, succulent at 0.90 ppm; Citrus, dried pulp at 0.03 ppm; Citrus, oil at 1.0 ppm; Fruit, citrus, crop group 10-10 at 0.01 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; Hop, dried cones at 15 ppm; and Vegetable, fruiting, crop group 8-10 at 1.6 ppm. Also, the tolerances for ``Grape'' and ``Vegetable, fruiting, group 8'' in the table in paragraph (a) and for ``Hop, dried, cones'' in the table in paragraph (b) are deleted as they are superseded by this action. Finally, in an additional housekeeping measure, the expired tolerances for ``Potato, processed potato waste'' at 1.0 ppm and ``Vegetable, tuberous and corm, subgroup 1C'' at 0.3 ppm are deleted since they have no effect anymore and have been replaced by lower tolerances for those commodities as discussed in the Federal Register of September 26, 2016 (81 FR 65924). VI. Statutory and Executive Order Reviews This action 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 action has been exempted from review under Executive Order 12866, this action 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); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This action 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 action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (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 (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 20, 2018. Michael L. Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: [[Page 9712]] 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. 180.627: 0 a. In the table to paragraph (a): 0 i. Add alphabetically the entries ``Basil, dried leaves''; ``Basil, fresh leaves''; ``Bean, moth, succulent''; ``Bean, runner, succulent''; ``Bean, snap, succulent''; ``Bean, wax, succulent''; ``Bean, yardlong, succulent''; ``Citrus, dried pulp''; ``Citrus, oil''; ``Fruit, citrus, crop group 10-10''; and ``Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F''; 0 ii. Remove the entry for ``Grape''; 0 iii. Add alphabetically the entry ``Hop, dried cones''; 0 iv. Remove the entry for ``Potato, processed potato waste \1\ ''; 0 v. Add alphabetically the entry ``Vegetable, fruiting, crop group 8- 10''; and 0 vi. Remove the entries for ``Vegetable, fruiting, group 8'' and ``Vegetable, tuberous and corm, subgroup 1C \1\ '' and footnote 1 of the table. 0 b. Revise paragraph (b). The additions and revision read as follows: Sec. 180.627 Fluopicolide; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Basil, dried, leaves........................................ 200 Basil, fresh leaves......................................... 40 Bean, moth, succulent....................................... 0.90 Bean, runner, succulent..................................... 0.90 Bean, snap, succulent....................................... 0.90 Bean, wax, succulent........................................ 0.90 Bean, yardlong, succulent................................... 0.90 ------------------------------------------------------------------------ * * * * * Citrus, dried pulp.......................................... 0.03 Citrus, oil................................................. 1.0 Fruit, citrus, crop group 10-10............................. 0.01 Fruit, small, vine climbing, except fuzzy kiwifruit, 2.0 subgroup 13-07F............................................ * * * * * Hop, dried cones............................................ 15 * * * * * Vegetable, fruiting, crop group 8-10........................ 1.6 * * * * * ------------------------------------------------------------------------ (b) Section 18 emergency exemptions. [Reserved] * * * * * [FR Doc. 2018-04533 Filed 3-6-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Rules and Regulations 9703
OMB control OMB control on that direct final rule during that
29 CFR citation 29 CFR citation
No. No. comment period we are withdrawing
the direct final rule in this document.
We will address all significant
* * * * * * * * * * comments in any subsequent final
1910.1024 ............................. 1218–0267
action, which would be based on the
* * * * * parallel proposed rule also published on
* * * * * [FR Doc. 2018–04579 Filed 3–6–18; 8:45 am]
December 11, 2017 (82 FR 58154). As
BILLING CODE 4510–26–P
stated in the direct final rule and the
PART 1915—[AMENDED] parallel proposed rule, there will not be
■ 3. The authority citation for part 1915 a second comment period on this action.
ENVIRONMENTAL PROTECTION
continues to read as follows: AGENCY List of Subjects in 40 CFR Part 82
Authority: 33 U.S.C. 941; 29 U.S.C. 653, Environmental protection,
655, 657; Secretary of Labor’s Order No. 12– 40 CFR Part 82 Administrative practice and procedure,
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62 [EPA–HQ–OAR–2017–0472; FRL–9975–19– Air pollution control, Incorporation by
FR 111), 3–2000 (65 FR 50017), 5–2002 (67 OAR] reference, Recycling, Reporting and
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75 RIN 2060–AT53 recordkeeping requirements,
FR 55355), or 1–2012 (77 FR 3912); 29 CFR Stratospheric ozone layer.
part 1911; and 5 U.S.C. 553, as applicable. Protection of Stratospheric Ozone: Dated: February 28, 2018.
Revision to References for E. Scott Pruitt,
Subpart A—General
Refrigeration and Air Conditioning Administrator.
■ 4. Amend section 1915.8 by adding to Sector To Incorporate Latest Edition of
the table, in the proper numerical Certain Industry, Consensus-Based Accordingly, the amendments to
sequence, the entry ‘‘1915.1024’’ to read Standards; Withdrawal appendix R to subpart G of 40 CFR part
as follows: 82 published on December 11, 2017 (82
AGENCY: Environmental Protection FR 58122) are withdrawn effective
§ 1915.8 OMB control numbers under the Agency (EPA). March 7, 2018.
Paperwork Reduction Act. ACTION: Withdrawal of direct final rule. [FR Doc. 2018–04521 Filed 3–6–18; 8:45 am]
* * * * * BILLING CODE 6560–50–P
SUMMARY: The Environmental Protection
OMB control Agency (EPA) received adverse
29 CFR citation No. comment on the direct final rule titled ENVIRONMENTAL PROTECTION
‘‘Protection of Stratospheric Ozone: AGENCY
Revision to References for Refrigeration
* * * * *
and Air Conditioning Sector to 40 CFR Part 180
1915.1024 ............................. 1218–0267
Incorporate Latest Edition of Certain
Industry, Consensus-based Standards,’’ [EPA–HQ–OPP–2016–0257; FRL–9973–44]
* * * * *
published on December 11, 2017.
Fluopicolide; Pesticide Tolerances
* * * * * Therefore, through this document we
are withdrawing that direct final rule. AGENCY: Environmental Protection
PART 1926—[AMENDED] DATES: The direct final rule published at Agency (EPA).
82 FR 58122 on December 11, 2017 is ACTION: Final rule.
■ 5. The authority citation for part 1926
withdrawn effective March 7, 2018.
is revised to read as follows: SUMMARY: This regulation establishes
FOR FURTHER INFORMATION CONTACT:
Authority: 40 U.S.C. 3701 et seq.; 29 U.S.C. tolerances for residues of fluopicolide in
653, 655, 657; Secretary of Labor’s Order No.
Chenise Farquharson, Stratospheric
Protection Division, Office of or on multiple commodities which are
12–71 (36 FR 8754), 8–76 (41 FR 25059), 9– identified and discussed later in this
83 (48 FR 35736), 1–90 (55 FR 9033), 6–96 Atmospheric Programs (Mail Code
(62 FR 111), 3–2000 (65 FR 50017), 5–2002 6205T), U.S. Environmental Protection document. In addition, this regulation
(67 FR 65008), 5–2007 (72 FR 31160), 4–2010 Agency, 1200 Pennsylvania Avenue removes several previously established
(75 FR 55355), or 1–2012 (77 FR 3912), as NW, Washington, DC 20460; telephone tolerances that are superseded by this
applicable; and 29 CFR part 1911. number: (202) 564–7768; email address: final rule. Interregional Research Project
farquharson.chenise@epa.gov. Number 4 (IR–4) requested these
Subpart A—General tolerances under the Federal Food,
SUPPLEMENTARY INFORMATION: The EPA
Drug, and Cosmetic Act (FFDCA).
■ 6. Amend § 1926.5 by adding to the received adverse comment on the direct
final rule ‘‘Protection of Stratospheric DATES: This regulation is effective
table, in the proper numerical sequence,
the entry ‘‘1926.1124’’ to read as Ozone: Revision to References for March 7, 2018. Objections and requests
follows: Refrigeration and Air Conditioning for hearings must be received on or
Sector to Incorporate Latest Edition of before May 7, 2018, and must be filed
§ 1926.5 OMB control numbers under the Certain Industry, Consensus-based in accordance with the instructions
Paperwork Reduction Act.
Standards,’’ published on December 11, provided in 40 CFR part 178 (see also
* * * * * 2017 (82 FR 58122). The direct final rule Unit I.C. of the SUPPLEMENTARY
daltland on DSKBBV9HB2PROD with RULES
stated that if the Agency received INFORMATION).
OMB control adverse comment by January 25, 2018,
29 CFR citation No. ADDRESSES: The docket for this action,
the direct final rule would not take identified by docket identification (ID)
effect and EPA would publish a timely number EPA–HQ–OPP–2016–0257, is
* * * * * withdrawal in the Federal Register. available at http://www.regulations.gov
1926.1124 ............................. 1218–0267 Because we received adverse comment or at the Office of Pesticide Programs
VerDate Sep<11>2014 16:31 Mar 06, 2018 Jkt 244001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\07MRR1.SGM 07MRR1](https://thefederalregister.org/doc/83_FR_9748/page/1.svg)
![9704 Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Rules and Regulations
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– citrus, oil at 1.94 ppm; hop, dried cones
in the Environmental Protection Agency OPP–2016–0257 in the subject line on at 15 ppm; fruit, citrus, group 10–10 at
Docket Center (EPA/DC), West William the first page of your submission. All 0.02 ppm; fruit, small, vine climbing,
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing except fuzzy kiwifruit, subgroup 13–07F
Constitution Ave. NW, Washington, DC must be in writing, and must be at 2.0 ppm; and vegetable, fruiting, crop
20460–0001. The Public Reading Room received by the Hearing Clerk on or group 8–10 at 1.60 ppm. That document
is open from 8:30 a.m. to 4:30 p.m., before May 7, 2018. Addresses for mail referenced a summary of the petition
Monday through Friday, excluding legal and hand delivery of objections and prepared by Valent, the registrant,
holidays. The telephone number for the hearing requests are provided in 40 CFR which is available in the docket, http://
Public Reading Room is (202) 566–1744, 178.25(b). www.regulations.gov. Two similar
and the telephone number for the OPP In addition to filing an objection or anonymous public comments were
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk received in response to the notice of
the visitor instructions and additional as described in 40 CFR part 178, please filing. The Agency’s response to the
information about the docket available submit a copy of the filing (excluding comments is included in Unit IV.C.
at http://www.epa.gov/dockets. any Confidential Business Information Based upon review of the data
FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket. supporting the petition, EPA is
Michael L. Goodis, Director, Information not marked confidential establishing certain tolerances that
Registration Division (7505P), Office of pursuant to 40 CFR part 2 may be differ from what the petitioner
Pesticide Programs, Environmental disclosed publicly by EPA without prior requested. The reasons for these changes
Protection Agency, 1200 Pennsylvania notice. Submit the non-CBI copy of your are explained in Unit IV.D.
Ave. NW, Washington, DC 20460–0001; objection or hearing request, identified
III. Aggregate Risk Assessment and
main telephone number: (703) 305– by docket ID number EPA–HQ–OPP–
Determination of Safety
7090; email address: RDFRNotices@ 2016–0257, by one of the following
methods: Section 408(b)(2)(A)(i) of FFDCA
epa.gov.
• Federal eRulemaking Portal: http:// allows EPA to establish a tolerance (the
SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online legal limit for a pesticide chemical
instructions for submitting comments. residue in or on a food) only if EPA
I. General Information
Do not submit electronically any determines that the tolerance is ‘‘safe.’’
A. Does this action apply to me? information you consider to be CBI or Section 408(b)(2)(A)(ii) of FFDCA
You may be potentially affected by other information whose disclosure is defines ‘‘safe’’ to mean that ‘‘there is a
this action if you are an agricultural restricted by statute. reasonable certainty that no harm will
producer, food manufacturer, or • Mail: OPP Docket, Environmental result from aggregate exposure to the
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ pesticide chemical residue, including
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. all anticipated dietary exposures and all
Classification System (NAICS) codes is NW, Washington, DC 20460–0001. other exposures for which there is
not intended to be exhaustive, but rather • Hand Delivery: To make special reliable information.’’ This includes
provides a guide to help readers arrangements for hand delivery or exposure through drinking water and in
determine whether this document delivery of boxed information, please residential settings, but does not include
applies to them. Potentially affected follow the instructions at http:// occupational exposure. Section
entities may include: www.epa.gov/dockets/contacts.html. 408(b)(2)(C) of FFDCA requires EPA to
• Crop production (NAICS code 111). Additional instructions on give special consideration to exposure
• Animal production (NAICS code commenting or visiting the docket, of infants and children to the pesticide
112). along with more information about chemical residue in establishing a
• Food manufacturing (NAICS code dockets generally, is available at http:// tolerance and to ‘‘ensure that there is a
311). www.epa.gov/dockets. reasonable certainty that no harm will
• Pesticide manufacturing (NAICS II. Summary of Petitioned-For
result to infants and children from
code 32532). aggregate exposure to the pesticide
Tolerance
chemical residue. . . .’’
B. How can I get electronic access to In the Federal Register of Wednesday, Consistent with FFDCA section
other related information? June 22, 2016 (81 FR 40594) (FRL– 408(b)(2)(D), and the factors specified in
You may access a frequently updated 9947–32), EPA issued a document FFDCA section 408(b)(2)(D), EPA has
electronic version of EPA’s tolerance pursuant to FFDCA section 408(d)(3), 21 reviewed the available scientific data
regulations at 40 CFR part 180 through U.S.C. 346a(d)(3), announcing the filing and other relevant information in
the Government Printing Office’s e-CFR of a pesticide petition (PP 6E8464) by support of this action. EPA has
site at http://www.ecfr.gov/cgi-bin/text- IR–4 Headquarters, Rutgers, The State sufficient data to assess the hazards of,
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ University of New Jersey, 500 College and to make a determination on
40tab_02.tpl. Road East, Suite 201 W, Princeton, NJ aggregate exposure for fluopicolide
08540. The petition requested that 40 including exposure resulting from the
C. How can I file an objection or hearing CFR 180.627 be amended by tolerances established by this action.
request? establishing tolerances for residues of Fluopicolide shares a metabolite, 2,6-
Under FFDCA section 408(g), 21 the fungicide, fluopicolide [2,6- dichlorobenzamide (BAM), with another
U.S.C. 346a, any person may file an dichloro-N-[[3-chloro-5- active ingredient, dichlobenil. Residues
objection to any aspect of this regulation (trifluoromethyl)-2-pyridinyl]methyl] of BAM are assessed independently of
daltland on DSKBBV9HB2PROD with RULES
and may also request a hearing on those benzamide], including its metabolites fluopicolide and dichlobenil because it
objections. You must file your objection and degradates, in or on the has its own toxicity database and
or request a hearing on this regulation commodities: Basil, dried leaves at 200 endpoints of concern. The BAM
in accordance with the instructions parts per million (ppm); basil, fresh assessment considers residues resulting
provided in 40 CFR part 178. To ensure leaves at 30 ppm; bean, succulent at 0.9 from both fluopicolide and dichlobenil
proper receipt by EPA, you must ppm; citrus, dried pulp at 0.048 ppm; uses. EPA’s safety finding for
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![Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Rules and Regulations 9711
aggregate human exposure to ppm; Basil, dried leaves at 200 ppm; require the issuance of a proposed rule,
fluopicolide, including residues of its Bean, moth, succulent at 0.90 ppm; the requirements of the Regulatory
metabolite BAM. The commenters have Bean, snap, succulent at 0.90 ppm; Flexibility Act (RFA) (5 U.S.C. 601 et
presented no information to support Bean, runner, succulent at 0.90 ppm; seq.), do not apply.
reconsideration of that conclusion. Bean, wax, succulent at 0.90 ppm; Bean, This action directly regulates growers,
yardlong, succulent at 0.90 ppm; Citrus, food processors, food handlers, and food
D. Revisions to Petitioned-For
dried pulp at 0.03 ppm; Citrus, oil at 1.0 retailers, not States or tribes, nor does
Tolerances
ppm; Fruit, citrus, crop group 10–10 at this action alter the relationships or
The established tolerances differ from 0.01 ppm; Fruit, small, vine climbing,
the petitioner’s requests as follows: distribution of power and
except fuzzy kiwifruit, subgroup 13–07F responsibilities established by Congress
i. EPA is establishing a tolerance for at 2.0 ppm; Hop, dried cones at 15 ppm;
‘‘basil fresh leaves’’ at 40 ppm, rather in the preemption provisions of FFDCA
and Vegetable, fruiting, crop group 8–10 section 408(n)(4). As such, the Agency
than 30 ppm, as a result of removing at 1.6 ppm. Also, the tolerances for
certain inadequate residue data from the has determined that this action will not
‘‘Grape’’ and ‘‘Vegetable, fruiting, group have a substantial direct effect on States
tolerance calculation. 8’’ in the table in paragraph (a) and for
ii. The petitioner requested a or tribal governments, on the
‘‘Hop, dried, cones’’ in the table in
tolerance for residues of fluopicolide for relationship between the national
paragraph (b) are deleted as they are
the general category of ‘‘bean, government and the States or tribal
superseded by this action. Finally, in an
succulent’’ at 0.9 ppm. This term is governments, or on the distribution of
additional housekeeping measure, the
defined in EPA’s regulations as power and responsibilities among the
expired tolerances for ‘‘Potato,
including a variety of beans in succulent various levels of government or between
processed potato waste’’ at 1.0 ppm and
form (see 40 CFR 180.1(g)). At this time, the Federal Government and Indian
‘‘Vegetable, tuberous and corm,
EPA is establishing tolerances for only tribes. Thus, the Agency has determined
subgroup 1C’’ at 0.3 ppm are deleted
those beans included in the succulent that Executive Order 13132, entitled
since they have no effect anymore and
bean definition that are also supported have been replaced by lower tolerances ‘‘Federalism’’ (64 FR 43255, August 10,
by the submitted snap bean field trial for those commodities as discussed in 1999) and Executive Order 13175,
data. Those specific succulent beans are the Federal Register of September 26, entitled ‘‘Consultation and Coordination
the following: ‘‘bean, moth, succulent’’, 2016 (81 FR 65924). with Indian Tribal Governments’’ (65 FR
‘‘bean, yardlong, succulent’’ (species of 67249, November 9, 2000) do not apply
the Vigna genus), ‘‘bean, runner, VI. Statutory and Executive Order to this action. In addition, this action
succulent’’, ‘‘bean, snap, succulent’’, Reviews does not impose any enforceable duty or
and ‘‘bean, wax, succulent’’ (species of This action establishes tolerances contain any unfunded mandate as
the Phaseolus genus). Tolerances for the under FFDCA section 408(d) in described under Title II of the Unfunded
other beans contained within the response to a petition submitted to the Mandates Reform Act (UMRA) (2 U.S.C.
definition of ‘‘bean, succulent’’ as Agency. The Office of Management and 1501 et seq.).
contained in 180.1(g) are not being Budget (OMB) has exempted these types This action does not involve any
established at this time due to lack of of actions from review under Executive technical standards that would require
adequate residue data. In addition, the Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary
Agency has adjusted the tolerance Planning and Review’’ (58 FR 51735, consensus standards pursuant to section
values for these beans (from 0.9 to 0.90) October 4, 1993). Because this action 12(d) of the National Technology
to be consistent with its current has been exempted from review under Transfer and Advancement Act
guidance on significant figures. Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note).
iii. Because all reported residue data not subject to Executive Order 13211,
on crops supporting the ‘‘fruit, citrus, entitled ‘‘Actions Concerning VII. Congressional Review Act
crop group 10–10’’ were below the 0.01 Regulations That Significantly Affect
Pursuant to the Congressional Review
ppm limit of quantitation, EPA is Energy Supply, Distribution, or Use’’ (66
Act (5 U.S.C. 801 et seq.), EPA will
establishing a tolerance for this group at FR 28355, May 22, 2001); Executive
submit a report containing this rule and
0.01 ppm. Order 13045, entitled ‘‘Protection of
other required information to the U.S.
iv. The petitioner’s requested Children from Environmental Health
Senate, the U.S. House of
tolerances for ‘‘citrus, dried pulp’’ at Risks and Safety Risks’’ (62 FR 19885,
Representatives, and the Comptroller
0.048 ppm and ‘‘citrus, oil’’ at 1.94 ppm April 23, 1997); or Executive Order
General of the United States prior to
were based on the petitioned-for 13771, entitled ‘‘Reducing Regulations
publication of the rule in the Federal
tolerance level for citrus group 10–10 at and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action Register. This action is not a ‘‘major
0.02 ppm. Using the 0.01 ppm tolerance
does not contain any information rule’’ as defined by 5 U.S.C. 804(2).
level for group 10–10 as indicated in the
previous paragraph and applying collections subject to OMB approval List of Subjects in 40 CFR Part 180
appropriate processing factors yields under the Paperwork Reduction Act
tolerances of 0.03 for citrus, dried pulp (PRA) (44 U.S.C. 3501 et seq.), nor does Environmental protection,
and 1.0 for citrus, oil. it require any special considerations Administrative practice and procedure,
under Executive Order 12898, entitled Agricultural commodities, Pesticides
V. Conclusion ‘‘Federal Actions to Address and pests, Reporting and recordkeeping
Therefore, tolerances are established Environmental Justice in Minority requirements.
for residues of the fungicide
daltland on DSKBBV9HB2PROD with RULES
Populations and Low-Income Dated: February 20, 2018.
fluopicolide [2,6-dichloro-N-[[3-chloro- Populations’’ (59 FR 7629, February 16, Michael L. Goodis,
5-(trifluoromethyl)-2- 1994). Director, Registration Division, Office of
pyridinyl]methyl]benzamide], including Since tolerances and exemptions that Pesticide Programs.
its metabolites and degradates are established on the basis of a petition
(determined by measuring the parent under FFDCA section 408(d), such as Therefore, 40 CFR chapter I is
only), in or on Basil, fresh leaves at 40 the tolerance in this final rule, do not amended as follows:
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![9712 Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Rules and Regulations
PART 180—[AMENDED] AGENCY FOR INTERNATIONAL Government property, . . . , shall
DEVELOPMENT mean Government-furnished property,
■ 1. The authority citation for part 180 non-expendable personal property title
continues to read as follows: 48 CFR Part 752 to which vests in the U.S. Government,
Authority: 21 U.S.C. 321(q), 346a and 371. and all contractor acquired mobile IT
RIN 0412–AA85
equipment’’) or by updating the
■ 2. In § 180.627: definition of non-expendable personal
■ a. In the table to paragraph (a): USAID Acquisition Regulation (AIDAR)
Regarding Government Property— property to include mobile IT
■ i. Add alphabetically the entries
USAID Reporting Requirements equipment regardless of service life or
‘‘Basil, dried leaves’’; ‘‘Basil, fresh
unit cost (‘‘Non-expendable personal
leaves’’; ‘‘Bean, moth, succulent’’; AGENCY: U.S. Agency for International property, for purposes of this contract,
‘‘Bean, runner, succulent’’; ‘‘Bean, snap, Development. is defined as personal property . . . and
succulent’’; ‘‘Bean, wax, succulent’’;
ACTION: Final rule. that has a unit cost of more than $500.
‘‘Bean, yardlong, succulent’’; ‘‘Citrus,
Non-expendable personal property
dried pulp’’; ‘‘Citrus, oil’’; ‘‘Fruit, citrus, SUMMARY: The U.S. Agency for includes mobile IT equipment
crop group 10–10’’; and ‘‘Fruit, small, International Development (USAID) is regardless of expected service life or
vine climbing, except fuzzy kiwifruit, issuing a final rule to amend the USAID unit cost’’).
subgroup 13–07F’’; Acquisition Regulation (AIDAR) that
■ ii. Remove the entry for ‘‘Grape’’;
Response: The comment was
clarifies accountability for all mobile considered and revisions have been
■ iii. Add alphabetically the entry Information Technology equipment.
‘‘Hop, dried cones’’; made to this final AIDAR rule.
DATES: Effective date: April 6, 2018. The format of the required Annual
■ iv. Remove the entry for ‘‘Potato,
processed potato waste 1 ’’; FOR FURTHER INFORMATION CONTACT: Report of Government Property in
■ v. Add alphabetically the entry Carol Ketrick, Telephone: 202–567– Contractor’s Custody is corrected to read
‘‘Vegetable, fruiting, crop group 8–10’’; 4676 or Email: cketrick@usaid.gov. that all mobile IT equipment is
and SUPPLEMENTARY INFORMATION: accountable and must be reported. The
■ vi. Remove the entries for ‘‘Vegetable, format of the required Annual Report of
I. Background Government Property in the Contractor’s
fruiting, group 8’’ and ‘‘Vegetable,
tuberous and corm, subgroup 1C 1 ’’ and On November 29, 2016, USAID Custody is corrected to read that all
footnote 1 of the table. published a proposed rule at 81 FR Contractor acquired mobile IT
■ b. Revise paragraph (b). 85916 revising the Agency for equipment must be reported.
The additions and revision read as International Development Acquisition III. Regulatory Planning and Review
follows: Regulation (AIDAR) to strengthen and
clarify existing policy and procedures This rule is not an E.O. 13771
§ 180.627 Fluopicolide; tolerances for for accountability of all USAID mobile regulatory action because this rule is not
residues. significant under E.O. 12866 Regulatory
Information Technology (IT) equipment
(a) * * * and access to agency facilities and Planning and Review, dated September
information systems. This final rule 30, 1993. This rule is not a major rule
Parts per clarifies the reporting requirements for under 5 U.S.C. 804.
Commodity million
all mobile IT equipment in the AIDAR IV. Regulatory Flexibility Act
Basil, dried, leaves ..................... 200 clause section 752.245–70, Government
Basil, fresh leaves ...................... 40 Property—USAID reporting The rule will not have an impact on
Bean, moth, succulent ................ 0.90 requirements. The clause is amended to a substantial number of small entities
Bean, runner, succulent ............. 0.90 clarify that all mobile Information within the meaning of the Regulatory
Bean, snap, succulent ................ 0.90 Technology (IT) equipment is identified Flexibility Act, 5 U.S.C. 601, et seq.
Bean, wax, succulent ................. 0.90 as accountable. This includes both Therefore, an Initial Regulatory
Bean, yardlong, succulent .......... 0.90 Flexibility Analysis has not been
mobile IT equipment that is USAID-
owned and furnished to the contractor, performed.
* * * * * as well as contractor acquired mobile IT V. Paperwork Reduction Act
Citrus, dried pulp ........................ 0.03 equipment, title to which vests in the
Citrus, oil ..................................... 1.0 U.S. Government. The rule clarifies but does not
Fruit, citrus, crop group 10–10 ... 0.01 establish a new collection of
Fruit, small, vine climbing, ex- II. Discussion and Analysis information that requires the approval
cept fuzzy kiwifruit, subgroup One respondent submitted a comment of the Office of Management and Budget
13–07F .................................... 2.0 on the proposed rule. under the Paperwork Reduction Act (44
USAID reviewed and considered the U.S.C. chapter 35).
* * * * *
public comment in the development of
Hop, dried cones ........................ 15 List of Subjects in 48 CFR Part 75
this final rule. A discussion of the
* * * * * comment received is provided as Government procurement.
Vegetable, fruiting, crop group follows: For the reasons discussed in the
8–10 ........................................ 1.6 Comment: The respondent suggested preamble, USAID amends 48 CFR
alternative clarifying revisions to the chapter 7 as set forth below:
* * * * * language in AIDAR section 752.245–70.
daltland on DSKBBV9HB2PROD with RULES
Specifically, the comment stated: PART 752—SOLICITATION
(b) Section 18 emergency exemptions. It would be clearer if the definition of PROVISIONS AND CONTRACT
[Reserved] ‘‘government property’’ in (a)(2) was CLAUSES
* * * * * updated to include contractor acquired
[FR Doc. 2018–04533 Filed 3–6–18; 8:45 am] mobile IT equipment. Either by ■ 1. The authority citation for 48 CFR
BILLING CODE 6560–50–P updating the clause itself (‘‘The term part 752 continues to read as follows:
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Document Created: 2018-03-07 01:27:24
Document Modified: 2018-03-07 01:27:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective March 7, 2018. Objections and requests for hearings must be received on or before May 7, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael L. Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, | |
| FR Citation | 83 FR 9703 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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