82 FR 5409 - Acequinocyl; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 11 (January 18, 2017)
Federal Register Volume 82, Issue 11 (January 18, 2017)
| Page Range | 5409-5415 | |
| FR Document | 2016-31823 |
[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)] [Rules and Regulations] [Pages 5409-5415] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31823] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0829; FRL-9956-85] Acequinocyl; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of acequinocyl in or on multiple commodities which are identified and discussed later in this document. Interregional Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective January 18, 2017. Objections and requests for hearings must be received on or before March 20, 2017, 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-2015-0829, 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), 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 Goodis, 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). [[Page 5410]] 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-2015-0829 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 March 20, 2017. 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-2015-0829, 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 May 19, 2016 (81 FR 31581) (FRL-9946- 02), 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 5E8422) by Interregional Research Project Number 4 (IR-4), Rutgers University, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.599 be amended by establishing tolerances for residues of the insecticide acequinocyl in or on avocado at 0.4 parts per million (ppm); bean, dry, seed at 0.03 ppm; vegetable, cucurbit, group 9 at 0.2 ppm; tea, plucked leaves at 40 ppm; cherry subgroup 12-12A at 1.0 ppm; fruit, citrus, group 10-10 at 0.20 ppm; fruit, pome, group 11-10 at 0.40 ppm; nut, tree, group 14-12 at 0.02 ppm; and vegetable, fruiting, group 8-10 at 0.70 ppm. The petition also requested that upon establishment of the above tolerances, to remove the existing tolerances for cucumber at 0.15 ppm; melon, subgroup 9A at 0.15 ppm; cherry, sweet at 0.50 ppm; cherry, tart at 1.0 ppm; fruit, citrus, group 10 at 0.20 ppm; fruit, pome, group 11 at 0.40 ppm; nut, tree, group 14 at 0.02 ppm; pistachio at 0.02 ppm; vegetable, fruiting, group 8 at 0.70 ppm; and okra at 0.70 ppm. That document referenced a summary of the petition prepared by Arysta LifeScience, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has modified the levels at which some of the tolerances are being established. The reason for these changes is 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 acequinocyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acequinocyl 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 of acequinocyl are the liver (hepatocyte vacuolization, brown pigmented cells and perivascular inflammatory cells in liver) and hematopoietic system (hemorrhage, increased clotting factor times and increased platelet counts). There was no evidence of neurotoxicity and immunotoxicity and there was no evidence of carcinogenic potential in either the rat or mouse, or in the genotoxicity and mutagenicity studies. In rats and rabbits, there was no evidence of increased quantitative or qualitative fetal susceptibility. In both species there were clinical signs and gross necropsy findings seen in maternal animals at similar or lower doses than those producing resorptions. In rabbits, there were increased incidences of late resorptions at the highest dose tested. In the rat two-generation reproductive toxicity study, there was evidence of apparent increased quantitative postnatal susceptibility. Offspring effects at the mid- and high-doses consisted of swollen body parts, protruding eyes, clinical signs, delays in pupil development, and increased mortality occurring mainly after weaning. No parental effects were observed up to the highest dose tested; however, hematological parameters, such as changes in partial and activated partial [[Page 5411]] thromboplastin times, were not measured in parental animals and changes in these parameters would have been expected at the same doses as offspring effects based on rat studies in the acequinocyl toxicological database. There were no effects on reproductive parameters. Specific information on the studies received and the nature of the adverse effects caused by acequinocyl 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 the document titled ``Acequinocyl. Human Health Risk Assessment To Support the Petition for Tolerance for Residues in/ on Dry Beans, Cucurbit Vegetables, Group 9, Avocado and Tea (Without U.S. Registration) and Crop Group Conversions for Citrus Fruit Group 10-10, Tree Nut Group 14-12, and Fruiting Vegetable Group 8-10'' at page 30 in docket ID number EPA-HQ-OPP-2015-0829. 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. Since the last assessment for acequinocyl (Federal Register of April 13, 2016, (81 FR 21752) (FRL-9944-34)), the endpoints for acequinocyl were revisited and updated based upon the available data. An acute dietary endpoint for the general population has been selected to be consistent with current Agency practices. A summary of the updated toxicological endpoints for acequinocyl used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Acequinocyl 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 (General population NOAEL = 7.3 mg/kg/ Acute RfD = 0.073 Reproduction and fertility effects including infants and children). day UFA = 10x. mg/kg/day. in rats Offspring LOAEL (M/F) = UFH = 10x........... aPAD = 0.073 mg/kg/ 58.9 based on hemorrhagic FQPA SF = 1x........ day. effects, swollen body parts, protruding eyes, clinical signs, delays in pupil development and increased mortality post weaning. ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL = 2.7 mg/kg/ Chronic RfD = 0.027 18-month carcinogenicity study in day UFA = 10x. mg/kg/day. mice; LOAEL = 7.0 mg/kg/day based UFH = 10x........... cPAD = 0.027 mg/kg/ on clinical chemistry and FQPA SF = 1x........ day. microscopic non-neoplastic lesions (brown pigmented cells and perivascular inflammatory cells in liver). Dermal short-term (1 to 30 days). Dermal study NOAEL = LOC for MOE = 100.. 28-dermal toxicity in rats. 200 mg/kg/day. LOAEL (M/F) = 1000 mg/kg/day based UFA = 10x........... on increased clotting factor UFH = 10x........... times in males. FQPA SF = 1x........ Cancer (Oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans. ---------------------------------------------------------------------------------------------------------------- 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). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acequinocyl, EPA considered exposure under the petitioned- for tolerances as well as all existing acequinocyl tolerances in 40 CFR 180.599. EPA assessed dietary exposures from acequinocyl 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 acequinocyl. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues and 100 percent crop treated (PCT) for all proposed and registered uses. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance level residues and 100 PCT for all proposed and registered uses. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that acequinocyl does not pose a cancer risk to humans. Therefore, [[Page 5412]] a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for acequinocyl. Tolerance level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for acequinocyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of acequinocyl. 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. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), Provisional Cranberry Model, and Screening Concentration in Ground Water (SCI-GROW) Model, the estimated drinking water concentrations (EDWCs) of acequinocyl for acute exposures are estimated to be 6.69 parts per billion (ppb) for surface water and 3.6 x 10-3 ppb for ground water, and for chronic exposures are estimated to be 6.69 ppb for surface water and [gteqt]3.6 x 10-3 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 6.69 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 6.69 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). Acequinocyl is currently registered for the following uses that could result in residential exposures: use on ornamentals for landscapes, gardens, and trees. EPA assessed residential exposure using the following assumptions: There is a potential for residential exposure associated with handler (i.e., mixing, loading and applying); however, all registered acequinocyl product labels with residential use sites (e.g., ornamentals for landscapes, gardens, and trees) require that handlers wear specific clothing (e.g., long-sleeve shirt/long pants) and/or use personal protective equipment (PPE). Therefore, the Agency has made the assumption that these products are not for homeowner use, and has not conducted a quantitative residential handler assessment. Only short-term post-application dermal exposure is anticipated for the registered residential uses. The quantitative exposure/risk assessment for residential post-application exposures assessed dermal exposures to adults for activities associated with gardening, dermal exposures to children (6 to <11 years old) for activities associated with playing in and around gardens and gardening, dermal exposures to adults associated with handling trees and retail plants, and dermal exposures to children (6 to <11 years old) for activities associated with playing in and around trees and retail plants. 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.'' EPA has not found acequinocyl to share a common mechanism of toxicity with any other substances, and acequinocyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acequinocyl 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://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. There is no evidence of an increased quantitative or qualitative fetal susceptibility in rats or rabbits. In isolation, there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study; however, but the concern is low since: (1) The effects in pups are well characterized with a clear NOAEL; and (2) the effects are protected for by the selected endpoints. Therefore, there are no residual uncertainties for pre-/post-natal toxicity. Additionally, taking into consideration the full database, there would be no susceptibility to offspring since assessment of parental animals in the two-generation reproductive toxicity study were limited. If additional evaluations had been performed, including all hematological measurements, then it would be expected that effects on the hematopoietic system observed in the other oral rat studies would have been seen at the same doses eliciting offspring effects. Therefore, using a weight-of-evidence approach that puts the offspring findings in the two-generation reproductive toxicity study in context with the full toxicological database, there is no concern for susceptibility to offspring since parental toxicity would be anticipated at the same dose as offspring effects. 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 acequinocyl is complete. ii. There is no indication that acequinocyl 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 an increased quantitative or qualitative fetal susceptibility in rats or rabbits, but in isolation there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study. However, the [[Page 5413]] concern is low for the reasons outlined above in section III.D.2. 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 and surface water modeling used to assess exposure to acequinocyl 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 acequinocyl. 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 acequinocyl will occupy 71% 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 acequinocyl from food and water will utilize 70% of the cPAD for children 1-2 years 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 acequinocyl is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acequinocyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to acequinocyl. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1200 for adults and 890 for children 6-12 years old. Because EPA's level of concern for acequinocyl is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, acequinocyl is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure 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 intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for acequinocyl. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, acequinocyl is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to acequinocyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (two high-performance liquid chromatography methods with tandem mass-spectroscopy detection (HPLC/ MS/MS) for determining residues in/on fruit and nut commodities (Morse Methods Meth-133 and Meth-135) 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: [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. The Codex has not established any MRLs for acequinocyl. C. Response to Comments A comment was submitted by the Center for Biological Diversity and was primarily concerned about EPA's consideration of the impacts of acequinocyl on the environment, pollinators, and endangered species. This comment is not relevant to the Agency's evaluation of safety of the acequinocyl tolerances under section 408 of the FFDCA, which requires the Agency to evaluate the potential harms to human health, not effects on the environment. Two other comments were submitted in response to the Notice of Filing that stated, in part, that this chemical ``should not be used at all in America or anywhere in the world'' and that ``no residue should be permitted on any food or other plant.'' The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the 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. The citizens' comments appear to be directed at the underlying statute and not EPA's implementation of it; the citizens have made no contention that EPA has acted in violation of the statutory framework. D. Revisions to Petitioned-For Tolerances The petitioned-for tolerance of 0.4 for residues on avocado is being increased to 0.50 ppm as EPA corrected some residue levels in the field trials for degradation during storage and declared two of the trials to be replicates. The [[Page 5414]] data that EPA used in Organization for Economic Co-operation and Development (OECD) Maximum Residue Limits (MRL) Tolerance Worksheet for avocado was thus slightly different from the petitioner's data. The tolerance level of 0.15 ppm for residues in dry beans is based upon the OECD MRL tolerance worksheet. The difference is based on EPA using slightly different residue levels that were corrected for degradation during storage. The tolerance level of 0.30 ppm for residues in/on cucurbit vegetables is based upon the OECD MRL tolerance worksheet. The difference is based on EPA using slightly different residue levels that were corrected for degradation during storage. The data that EPA used in MRL tolerance spreadsheet for summer squash was slightly different from the petitioner's data. Concerning the crop group conversions, the tolerance level for residues in/on citrus fruit was modified to be harmonized with the Canadian MRL. V. Conclusion Therefore, tolerances are established for residues of acequinocyl, including its metabolites and degradates, in or on avocado at 0.50 ppm; bean, dry, seed at 0.15 ppm; cherry, subgroup 12-12A at 1.0 ppm; fruit, citrus, group 10-10 at 0.35 ppm; fruit, pome, group 11-10 at 0.40 ppm; nut, tree, group 14-12 at 0.02 ppm; tea, plucked leaves at 40 ppm; vegetable, cucurbit, group 9 at 0.30 ppm; and vegetable, fruiting, group 8-10 at 0.70 ppm. In addition, the existing tolerances on cherry, sweet; cherry, tart; cucumber; fruit, citrus, group 10; fruit, pome, group 11; melon, subgroup 9A; nut, tree, group 14; okra; pistachio; and vegetable, fruiting, group 8 are removed as unnecessary since they are now covered by the new tolerances. 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) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). 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: December 15, 2016. Daniel J. Rosenblatt, Acting 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. 180.599, in the table in paragraph (a); 0 a. Add alphabetically the entries ``Avocado''; ``Bean, dry, seed''; ``Cherry, subgroup 12-12A''; ``Fruit, citrus, group 10-10''; ``Fruit, pome, group 11-10''; ``Nut, tree, group 14-12''; ``Tea, plucked leaves'' (and a footnote); ``Vegetable, cucurbit, group 9''; and ``Vegetable, fruiting, group 8-10''; and 0 b. Remove the entries for ``cherry, sweet''; ``cherry, tart''; ``cucumber''; ``fruit, citrus, group 10''; ``fruit, pome, group 11''; ``melon, subgroup 9A''; ``nut, tree, group 14''; ``okra''; ``pistachio''; and ``vegetable, fruiting, group 8'' from the table in paragraph (a). The additions read as follows: Sec. 180.599 Acequinocyl; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * Avocado.................................................... 0.50 Bean, dry, seed............................................ 0.15 * * * * Cherry, subgroup 12-12A.................................... 1.0 * * * * Fruit, citrus, group 10-10................................. 0.35 Fruit, pome, group 11-10................................... 0.40 * * * * Nut, tree, group 14-12..................................... 0.02 * * * * Tea, plucked leaves \1\.................................... 40 Vegetable, cucurbit, group 9............................... 0.30 Vegetable, fruiting, group 8-10............................ 0.70 ------------------------------------------------------------------------ \1\ There are no U.S. registrations as of January 18, 2017 for use on tea. [[Page 5415]] * * * * * [FR Doc. 2016-31823 Filed 1-17-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Rules and Regulations 5409
will use to determine and record the (p) Particulate Matter CEMS. If you ACTION: Final rule.
time and cause of the alarm as well as are using a CEMS to measure particulate
the corrective actions taken to minimize matter emissions to meet requirements SUMMARY: This regulation establishes
emissions as specified in paragraphs of this subpart, you must install, certify, tolerances for residues of acequinocyl in
(e)(4)(i) and (ii) of this section. operate and maintain the particulate or on multiple commodities which are
matter CEMS as specified in paragraphs identified and discussed later in this
* * * * *
(p)(1) through (4) of this section. document. Interregional Project Number
(ii) The cause of the alarm must be 4 (IR–4) requested these tolerances
alleviated by taking the necessary * * * * *
under the Federal Food, Drug, and
corrective action(s) that may include, ■ 5. Section 63.1656 is amended by
Cosmetic Act (FFDCA).
but not be limited to, those listed in revising paragraphs (b)(7) introductory
text, (b)(7)(i) and (ii), and (b)(7)(v) to DATES: This regulation is effective
paragraphs (e)(4)(ii)(A) through (F) of
read as follows: January 18, 2017. Objections and
this section.
requests for hearings must be received
* * * * * § 63.1656 Performance testing, test on or before March 20, 2017, and must
(h) Shop building opacity. In order to methods, and compliance demonstrations. be filed in accordance with the
demonstrate continuous compliance * * * * * instructions provided in 40 CFR part
with the opacity standards in § 63.1623, (b) * * * 178 (see also Unit I.C. of the
you must comply with the requirements (7) Method 9 of appendix A–4 of 40 SUPPLEMENTARY INFORMATION).
§ 63.1625(d)(1) and one of the CFR part 60 to determine opacity. ADDRESSES: The docket for this action,
monitoring options in paragraphs (h)(1) ASTM D7520–16, ‘‘Standard Test identified by docket identification (ID)
or (2) of this section. The selected Method for Determining the Opacity of number EPA–HQ–OPP–2015–0829, is
option must be consistent with that a Plume in the Outdoor Ambient available at http://www.regulations.gov
selected during the initial performance Atmosphere’’ may be used (incorporated or at the Office of Pesticide Programs
test described in § 63.1625(d)(2). by reference, see § 63.14) with the Regulatory Public Docket (OPP Docket)
Alternatively, you may use the following conditions: in the Environmental Protection Agency
provisions of § 63.8(f) to request (i) During the digital camera opacity Docket Center (EPA/DC), West William
approval to use an alternative technique (DCOT) certification Jefferson Clinton Bldg., Rm. 3334, 1301
monitoring method. procedure outlined in Section 9.2 of Constitution Ave. NW., Washington, DC
* * * * * ASTM D7520–16, the owner or operator 20460–0001. The Public Reading Room
(j) Requirements for sources using or the DCOT vendor must present the is open from 8:30 a.m. to 4:30 p.m.,
CMS. If you demonstrate compliance plumes in front of various backgrounds Monday through Friday, excluding legal
with any applicable emissions limit of color and contrast representing holidays. The telephone number for the
through use of a continuous monitoring conditions anticipated during field use Public Reading Room is (202) 566–1744,
system (CMS), where a CMS includes a such as blue sky, trees and mixed and the telephone number for the OPP
continuous parameter monitoring backgrounds (clouds and/or a sparse Docket is (703) 305–5805. Please review
system (CPMS) as well as a continuous tree stand). the visitor instructions and additional
emissions monitoring system (CEMS), (ii) The owner or operator must also information about the docket available
you must develop a site-specific have standard operating procedures in at http://www.epa.gov/dockets.
monitoring plan and submit this site- place including daily or other frequency
FOR FURTHER INFORMATION CONTACT:
specific monitoring plan, if requested, at quality checks to ensure the equipment
Michael Goodis, Registration Division
least 60 days before your initial is within manufacturing specifications
(7505P), Office of Pesticide Programs,
performance evaluation (where as outlined in Section 8.1 of ASTM
Environmental Protection Agency, 1200
applicable) of your CMS. Your site- D7520–16.
Pennsylvania Ave. NW., Washington,
specific monitoring plan must address * * * * * DC 20460–0001; main telephone
the monitoring system design, data (v) Use of this approved alternative number: (703) 305–7090; email address:
collection and the quality assurance and does not provide or imply a certification RDFRNotices@epa.gov.
quality control elements outlined in this or validation of any vendor’s hardware
SUPPLEMENTARY INFORMATION:
paragraph and in § 63.8(d). You must or software. The onus to maintain and
install, operate and maintain each CMS verify the certification and/or training of I. General Information
according to the procedures in your the DCOT camera, software and operator
A. Does this action apply to me?
approved site-specific monitoring plan. in accordance with ASTM D7520–16
Using the process described in and these requirements is on the You may be potentially affected by
§ 63.8(f)(4), you may request approval of facility, DCOT operator and DCOT this action if you are an agricultural
monitoring system quality assurance vendor. producer, food manufacturer, or
and quality control procedures * * * * * pesticide manufacturer. The following
alternative to those specified in [FR Doc. 2017–00156 Filed 1–17–17; 8:45 am] list of North American Industrial
paragraphs (j)(1) through (6) of this BILLING CODE 6560–50–P
Classification System (NAICS) codes is
section in your site-specific monitoring not intended to be exhaustive, but rather
plan. provides a guide to help readers
ENVIRONMENTAL PROTECTION determine whether this document
* * * * *
AGENCY applies to them. Potentially affected
(k) If you have an operating limit that
entities may include:
mstockstill on DSK3G9T082PROD with RULES
requires the use of a CPMS, you must 40 CFR Part 180 • Crop production (NAICS code 111).
install, operate and maintain each • Animal production (NAICS code
continuous parameter monitoring [EPA–HQ–OPP–2015–0829; FRL–9956–85]
112).
system according to the procedures in • Food manufacturing (NAICS code
paragraphs (k)(1) through (7) of this Acequinocyl; Pesticide Tolerances
311).
section. AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
* * * * * Agency (EPA). code 32532).
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![5414 Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Rules and Regulations
data that EPA used in Organization for Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major
Economic Co-operation and April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2).
Development (OECD) Maximum contain any information collections
List of Subjects in 40 CFR Part 180
Residue Limits (MRL) Tolerance subject to OMB approval under the
Worksheet for avocado was thus slightly Paperwork Reduction Act (PRA) (44 Environmental protection,
different from the petitioner’s data. The U.S.C. 3501 et seq.), nor does it require Administrative practice and procedure,
tolerance level of 0.15 ppm for residues any special considerations under Agricultural commodities, Pesticides
in dry beans is based upon the OECD Executive Order 12898, entitled and pests, Reporting and recordkeeping
MRL tolerance worksheet. The ‘‘Federal Actions to Address requirements.
difference is based on EPA using Environmental Justice in Minority Dated: December 15, 2016.
slightly different residue levels that Populations and Low-Income
were corrected for degradation during Daniel J. Rosenblatt,
Populations’’ (59 FR 7629, February 16,
storage. The tolerance level of 0.30 ppm 1994). Acting Director, Registration Division, Office
for residues in/on cucurbit vegetables is of Pesticide Programs.
Since tolerances and exemptions that
based upon the OECD MRL tolerance are established on the basis of a petition Therefore, 40 CFR chapter I is
worksheet. The difference is based on under FFDCA section 408(d), such as amended as follows:
EPA using slightly different residue the tolerance in this final rule, do not
levels that were corrected for require the issuance of a proposed rule, PART 180—[AMENDED]
degradation during storage. The data the requirements of the Regulatory
that EPA used in MRL tolerance Flexibility Act (RFA) (5 U.S.C. 601 et ■ 1. The authority citation for part 180
spreadsheet for summer squash was seq.), do not apply. continues to read as follows:
slightly different from the petitioner’s This action directly regulates growers, Authority: 21 U.S.C. 321(q), 346a and 371.
data. Concerning the crop group food processors, food handlers, and food
conversions, the tolerance level for ■ 2. In § 180.599, in the table in
retailers, not States or tribes, nor does
residues in/on citrus fruit was modified paragraph (a);
this action alter the relationships or
to be harmonized with the Canadian distribution of power and ■ a. Add alphabetically the entries
MRL. responsibilities established by Congress ‘‘Avocado’’; ‘‘Bean, dry, seed’’; ‘‘Cherry,
V. Conclusion in the preemption provisions of FFDCA subgroup 12–12A’’; ‘‘Fruit, citrus, group
section 408(n)(4). As such, the Agency 10–10’’; ‘‘Fruit, pome, group 11–10’’;
Therefore, tolerances are established ‘‘Nut, tree, group 14–12’’; ‘‘Tea, plucked
for residues of acequinocyl, including has determined that this action will not
have a substantial direct effect on States leaves’’ (and a footnote); ‘‘Vegetable,
its metabolites and degradates, in or on cucurbit, group 9’’; and ‘‘Vegetable,
avocado at 0.50 ppm; bean, dry, seed at or tribal governments, on the
relationship between the national fruiting, group 8–10’’; and
0.15 ppm; cherry, subgroup 12–12A at
government and the States or tribal ■ b. Remove the entries for ‘‘cherry,
1.0 ppm; fruit, citrus, group 10–10 at
0.35 ppm; fruit, pome, group 11–10 at governments, or on the distribution of sweet’’; ‘‘cherry, tart’’; ‘‘cucumber’’;
0.40 ppm; nut, tree, group 14–12 at 0.02 power and responsibilities among the ‘‘fruit, citrus, group 10’’; ‘‘fruit, pome,
ppm; tea, plucked leaves at 40 ppm; various levels of government or between group 11’’; ‘‘melon, subgroup 9A’’; ‘‘nut,
vegetable, cucurbit, group 9 at 0.30 the Federal Government and Indian tree, group 14’’; ‘‘okra’’; ‘‘pistachio’’;
ppm; and vegetable, fruiting, group 8–10 tribes. Thus, the Agency has determined and ‘‘vegetable, fruiting, group 8’’ from
at 0.70 ppm. In addition, the existing that Executive Order 13132, entitled the table in paragraph (a).
tolerances on cherry, sweet; cherry, tart; ‘‘Federalism’’ (64 FR 43255, August 10, The additions read as follows:
cucumber; fruit, citrus, group 10; fruit, 1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination § 180.599 Acequinocyl; tolerances for
pome, group 11; melon, subgroup 9A; residues.
nut, tree, group 14; okra; pistachio; and with Indian Tribal Governments’’ (65 FR
vegetable, fruiting, group 8 are removed 67249, November 9, 2000) do not apply (a) * * *
as unnecessary since they are now to this action. In addition, this action
covered by the new tolerances. does not impose any enforceable duty or Commodity Parts per
contain any unfunded mandate as million
VI. Statutory and Executive Order described under Title II of the Unfunded
Reviews Mandates Reform Act (UMRA) (2 U.S.C. * * * *
This action establishes tolerances 1501 et seq.). Avocado .................................... 0.50
under FFDCA section 408(d) in This action does not involve any Bean, dry, seed ........................ 0.15
response to a petition submitted to the technical standards that would require
Agency. The Office of Management and Agency consideration of voluntary * * * *
Budget (OMB) has exempted these types consensus standards pursuant to section Cherry, subgroup 12–12A ........ 1.0
of actions from review under Executive 12(d) of the National Technology
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act * * * *
Fruit, citrus, group 10–10 ......... 0.35
Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
Fruit, pome, group 11–10 ......... 0.40
October 4, 1993). Because this action
VII. Congressional Review Act
has been exempted from review under * * * *
Executive Order 12866, this action is Pursuant to the Congressional Review Nut, tree, group 14–12 ............. 0.02
mstockstill on DSK3G9T082PROD with RULES
not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will
entitled ‘‘Actions Concerning submit a report containing this rule and * * * *
Regulations That Significantly Affect other required information to the U.S. Tea, plucked leaves 1 ............... 40
Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of Vegetable, cucurbit, group 9 .... 0.30
FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller Vegetable, fruiting, group 8–10 0.70
Order 13045, entitled ‘‘Protection of General of the United States prior to 1 There are no U.S. registrations as of Janu-
Children from Environmental Health publication of the rule in the Federal ary 18, 2017 for use on tea.
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![Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Rules and Regulations 5415
* * * * * inpatient health plan’s (PIHP’s), or arrangement for a specific set of services
[FR Doc. 2016–31823 Filed 1–17–17; 8:45 am] prepaid ambulatory health plan’s and enrollees covered under the
BILLING CODE 6560–50–P (PAHP’s) expenditures under the contract; graduate medical education
contract. (GME) payments; or federally-qualified
In the May 6, 2016 Federal Register health center (FQHC) or rural health
DEPARTMENT OF HEALTH AND (81 FR 27498), we published the clinic (RHC) wrap around payments. We
HUMAN SERVICES ‘‘Medicaid and Children’s Health noted that section 1903(m)(2)(A) of the
Insurance Program (CHIP) Programs; Social Security Act (the Act) requires
Centers for Medicare & Medicaid Medicaid Managed Care, CHIP that capitation payments to managed
Services Delivered in Managed Care, and care plans be actuarially sound; we
Revisions Related to Third Party interpret this requirement to mean that
42 CFR Part 438 Liability’’ final rule (‘‘May 6, 2016 final payments under the managed care
rule’’), which finalized the June 1, 2015 contract must align with the provision
[CMS–2402–F]
proposed rule. In the final rule, we of services to beneficiaries covered
RIN 0938–AT10 finalized, with some revisions, the under the contract. We provided that
proposal which limited state direction these pass-through payments are not
Medicaid Program; The Use of New or of payments, including pass-through consistent with our regulatory standards
Increased Pass-Through Payments in payments as defined below. for actuarially sound rates because they
Medicaid Managed Care Delivery In the November 22, 2016 Federal do not tie provider payments with the
Systems Register (81 FR 83777), we published provision of services. The final rule
the ‘‘Medicaid Program; The Use of New contains a detailed description of the
AGENCY: Centers for Medicare &
or Increased Pass-Through Payments in policy rationale (81 FR 27587 through
Medicaid Services (CMS), HHS.
Medicaid Managed Care Delivery 27592).
ACTION: Final rule.
Systems’’ proposed rule (‘‘November 22, In an effort to provide a smooth
SUMMARY: This rule finalizes changes to 2016 proposed rule’’). This rule finalizes transition for network providers, to
the pass-through payment transition the November 22, 2016 proposed rule as support access for the beneficiaries they
periods and the maximum amount of discussed below. This final rule is serve, and to provide states and
pass-through payments permitted consistent with the intent of the May 6, managed care plans with adequate time
annually during the transition periods 2016 final rule to provide transition to design and implement payment
under Medicaid managed care periods for states that already use pass- systems that link provider
contract(s) and rate certification(s). This through payments—these transition reimbursement with services covered
final rule prevents increases in pass- periods allow states to implement under the contract or associated quality
through payments and the addition of changes to existing pass-through outcomes, we finalized transition
new pass-through payments beyond payments over a period of time to periods related to pass-through
those in place when the pass-through minimize disruption and to ensure payments for the specified provider
payment transition periods were continued financial support for safety- types to which states make most pass-
established, in the final Medicaid net providers. As we discussed in the through payments under Medicaid
managed care regulations effective July November 22, 2016 proposed rule, this managed care programs: Hospitals,
5, 2016. final rule is also consistent with the physicians, and nursing homes (81 FR
CMCS Informational Bulletin (CIB) 27590 through 27592). As finalized,
DATES: Effective Date: These regulations
concerning ‘‘The Use of New or § 438.6(d)(2) and (3) provide a 10-year
are effective on March 20, 2017. Increased Pass-Through Payments in transition period for hospitals, subject to
FOR FURTHER INFORMATION CONTACT: John Medicaid Managed Care Delivery limitations on the amount of pass-
Giles, (410) 786–1255. Systems,’’ which was published on July through payments. For MCO, PIHP, or
SUPPLEMENTARY INFORMATION: 29, 2016. PAHP contracts beginning on or after
I. Background A. Summary of the Medicaid Managed July 1, 2027, states will not be permitted
Care May 6, 2016 Final Rule to require pass-through payments for
In the June 1, 2015 Federal Register hospitals. The final rule also provides a
(80 FR 31098), we published the We finalized a policy to limit state 5-year transition period for pass-through
‘‘Medicaid and Children’s Health direction of payments, including pass- payments to physicians and nursing
Insurance Program (CHIP) Programs; through payments, at § 438.6(c) and (d) facilities. For MCO, PIHP, or PAHP
Medicaid Managed Care, CHIP in the May 6, 2016 final rule (81 FR contracts beginning on or after July 1,
Delivered in Managed Care, Medicaid 27587 through 27592). Specifically, 2022, states will not be permitted to
and CHIP Comprehensive Quality under the final rule (81 FR 27588), we require pass-through payments for
Strategies, and Revisions Related to defined pass-through payments at physicians or nursing facilities. These
Third Party Liability’’ proposed rule § 438.6(a) as any amount required by the transition periods provide states,
(‘‘June 1, 2015 proposed rule’’). As part state (and considered in calculating the network providers, and managed care
of the actuarial soundness proposals, we actuarially sound capitation rate) to be plans significant time and flexibility to
proposed to define actuarially sound added to the contracted payment rates integrate current pass-through payment
capitation rates as those sufficient to paid by the MCO, PIHP, or PAHP to arrangements into allowable payment
provide for all reasonable, appropriate, hospitals, physicians, or nursing structures under actuarially sound
and attainable costs that are required facilities that is not for the following capitation rates, including enhanced fee
mstockstill on DSK3G9T082PROD with RULES
under the terms of the contract, purposes: A specific service or benefit schedules or the other approaches
including furnishing of covered services provided to a specific enrollee covered consistent with § 438.6(c).
and operation of the managed care plan under the contract; a provider payment As finalized in the May 6, 2016 final
for the duration of the contract. Among methodology permitted under rule, § 438.6(d) limits the amount of
the proposals was a general rule that the § 438.6(c)(1)(i) through (iii) for services pass-through payments to hospitals as a
state may not direct the managed care and enrollees covered under the percentage of the ‘‘base amount,’’ which
organization’s (MCO’s), prepaid contract; a subcapitated payment is defined in paragraph (a) and
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Document Created: 2018-02-01 15:19:16
Document Modified: 2018-02-01 15:19:16
| 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 January 18, 2017. Objections and requests for hearings must be received on or before March 20, 2017, 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 Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 82 FR 5409 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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