Federal Register / Vol. 84, No. 56 / Friday, March 22, 2019 / Rules and Regulations 10695

ENVIRONMENTAL PROTECTION not intended to be exhaustive, but rather • Hand Delivery: To make special AGENCY provides a guide to help readers arrangements for hand delivery or determine whether this document delivery of boxed information, please 40 CFR Part 180 applies to them. Potentially affected follow the instructions at http:// entities may include: [EPA–HQ–OPP–2017–0671; FRL–9987–25] www.epa.gov/dockets/contacts.html. • Crop production (NAICS code 111). • Additional instructions on Mandipropamid; Pesticide Tolerances Animal production (NAICS code 112). commenting or visiting the docket, AGENCY: Environmental Protection • Food manufacturing (NAICS code along with more information about Agency (EPA). 311). dockets generally, is available at http:// • www.epa.gov/dockets. ACTION: Final rule. Pesticide manufacturing (NAICS code 32532). II. Summary of Petitioned-For SUMMARY: This regulation establishes B. How can I get electronic access to Tolerance tolerances for residues of other related information? mandipropamid in or on multiple In the Federal Register of July 24, You may access a frequently updated commodities which are identified and 2018 (83 FR 34968) (FRL–9980–31), electronic version of EPA’s tolerance discussed later in this document. EPA issued a document pursuant to regulations at 40 CFR part 180 through Interregional Research Project Number 4 FFDCA section 408(d)(3), 21 U.S.C. (IR–4) requested these tolerances under the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/text- 346a(d)(3), announcing the filing of a the Federal Food, Drug, and Cosmetic pesticide petition (PP 7E8629) by IR–4, Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. IR–4 Project Headquarters, Rutgers, The DATES: This regulation is effective State University of NJ, 500 College Road March 22, 2019. Objections and requests C. How can I file an objection or hearing East, Suite 201W, Princeton, NJ 08540. for hearings must be received on or request? The petition requested that 40 CFR part before May 21, 2019, and must be filed Under FFDCA section 408(g), 21 180 be amended by establishing in accordance with the instructions U.S.C. 346a, any person may file an tolerances for residues of provided in 40 CFR part 178 (see also objection to any aspect of this regulation mandipropamid, 4-chloro-N-[2-(3- Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those methoxy-4-(2- INFORMATION). objections. You must file your objection propynyloxy)phenyl]ethyl]-a-(2- ADDRESSES: The docket for this action, or request a hearing on this regulation propynyloxy)-benzeneacetamide], in or identified by docket identification (ID) in accordance with the instructions on the raw agricultural commodities: number EPA–HQ–OPP–2017–0671, is provided in 40 CFR part 178. To ensure Asparagus bean, edible podded at 0.90 available at http://www.regulations.gov proper receipt by EPA, you must parts per million (ppm); Bean or at the Office of Pesticide Programs identify docket ID number EPA–HQ– (Phaseolus spp.), edible podded at 0.90 Regulatory Public Docket (OPP Docket) OPP–2017–0671 in the subject line on ppm; Bean (Vigna spp.), edible podded in the Environmental Protection Agency the first page of your submission. All at 0.90 ppm; Brassica, leafy greens, Docket Center (EPA/DC), West William objections and requests for a hearing subgroup 4–16B at 25 ppm; Catjang Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be bean, edible podded at 0.90 ppm; Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or Celtuce at 20 ppm; Chinese longbean, 20460–0001. The Public Reading Room before May 21, 2019. Addresses for mail is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and edible podded at 0.90 ppm; Citrus, dried Monday through Friday, excluding legal hearing requests are provided in 40 CFR pulp at 0.14 ppm; Citrus, oil at 2.2 ppm; holidays. The telephone number for the 178.25(b). Cowpea, edible podded at 0.90 ppm; Public Reading Room is (202) 566–1744, In addition to filing an objection or Florence fennel at 20 ppm; French bean, and the telephone number for the OPP hearing request with the Hearing Clerk edible podded at 0.90 ppm; Fruit, citrus, Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please group 10–10 at 0.5 ppm; Garden bean, the visitor instructions and additional submit a copy of the filing (excluding edible podded at 0.90 ppm; Goa bean, information about the docket available any Confidential Business Information edible podded at 0.90 ppm; Green bean, at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. edible podded at 0.90 ppm; Guar bean, FOR FURTHER INFORMATION CONTACT: Information not marked confidential edible podded at 0.90 ppm; Jackbean, Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be edible podded at 0.90 ppm; Kidney (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior bean, edible podded at 0.90 ppm; Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your Kohlrabi at 3 ppm; Lablab bean, edible Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified podded at 0.90 ppm; Leaf petiole 20460–0001; main telephone number: by docket ID number EPA–HQ–OPP– vegetable subgroup 22B at 20 ppm; (703) 305–7090; email address: 2017–0671, by one of the following Leafy greens subgroup 4–16A at 25 [email protected]. methods: ppm; Moth bean, edible podded at 0.90 • Federal eRulemaking Portal: http:// SUPPLEMENTARY INFORMATION: ppm; Mung bean, edible podded at 0.90 www.regulations.gov. Follow the online ppm; Navy bean, edible podded at 0.90 instructions for submitting comments. I. General Information ppm; Rice bean, edible podded at 0.90 Do not submit electronically any A. Does this action apply to me? ppm; Scarlet runner bean, edible information you consider to be CBI or You may be potentially affected by other information whose disclosure is podded at 0.90 ppm; Snap bean, edible this action if you are an agricultural restricted by statute. podded at 0.90 ppm; Sword bean, edible producer, food manufacturer, or • Mail: OPP Docket, Environmental podded at 0.90 ppm; Urd bean, edible pesticide manufacturer. The following Protection Agency Docket Center (EPA/ podded at 0.90 ppm; Vegetable soybean, list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. edible podded at 0.90 ppm; Vegetable, Classification System (NAICS) codes is NW, Washington, DC 20460–0001. Brassica, head and stem, group 5–16 at

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3 ppm; Velvet bean, edible podded at EPA’s assessment of exposures and risks was no evidence of genotoxicity in 0.90 ppm; Wax bean, edible podded at associated with mandipropamid bacterial reverse gene mutation, 0.90 ppm; Winged pea, edible podded at follows. mammalian in vitro forward gene 0.90 ppm; and Yardlong bean, edible mutation, mammalian in vivo A. Toxicological Profile podded at 0.90 ppm. clastogenicity, or unscheduled DNA Additionally, the petition requested to EPA has evaluated the available synthesis assays. Therefore, amend 40 CFR 180.637 by removing the toxicity data and considered its validity, mandipropamid is classified as ‘‘not tolerances for residues of completeness, and reliability as well as likely to be carcinogenic to humans.’’ mandipropamid in or on the raw the relationship of the results of the Specific information on the studies agricultural commodities Bean, snap at studies to human risk. EPA has also received and the nature of the adverse 0.90 ppm; Brassica, head and stem, considered available information effects caused by mandipropamid as subgroup 5A at 3 ppm; Brassica, leafy concerning the variability of the well as the no-observed-adverse-effect- greens, subgroup 5B at 25 ppm; and sensitivities of major identifiable level (NOAEL) and the lowest-observed- Vegetable, leafy except Brassica, group subgroups of consumers, including adverse-effect-level (LOAEL) from the 4 at 20 ppm. infants and children. toxicity studies can be found at http:// Subchronic and chronic studies That document referenced a summary www.regulations.gov in the document indicate that the liver and kidney are of the petition prepared by Syngenta titled ‘‘Mandipropamid. Aggregate the primary target organs for Crop Protection, the registrant, which is Human Health Risk Assessment mandipropamid. Liver effects observed available in the docket, http:// Supporting Section 3 Registration of in subchronic studies with rats, mice www.regulations.gov. There were no Proposed New Uses on Citrus Fruits and dogs included periportal comments received in response to the Group 10–10 and Succulent Beans, hypertrophy (rats), increased notice of filing. Along with Various Crop Group and Based upon review of the data eosinophilia (rats and mice), increased Subgroup Conversions’’ on pages 35–39 supporting the petition, EPA has plasma albumin, total protein, in docket ID number EPA–HQ–OPP– modified the levels at which some cholesterol, and gamma-glutamyl 2017–0671. tolerances are being established as well transferase (rats), increased liver as some of the commodities in which weights (rats, mice and dogs), increased B. Toxicological Points of Departure/ tolerances are being established. The liver enzymes (dogs), increased pigment Levels of Concern reason for these changes are explained in hepatocytes and Kupffer cells (dogs), in Unit IV.C. and centrilobular hepatocyte Once a pesticide’s toxicological vacuolation (dogs). In the chronic dog profile is determined, EPA identifies III. Aggregate Risk Assessment and study, increases in microscopic pigment toxicological points of departure (POD) Determination of Safety in the liver, and increased liver enzymes and levels of concern to use in Section 408(b)(2)(A)(i) of FFDCA were observed. In the chronic rat and evaluating the risk posed by human allows EPA to establish a tolerance (the mouse studies, liver toxicity was not exposure to the pesticide. For hazards legal limit for a pesticide chemical observed. Nephrotoxicity was observed that have a threshold below which there residue in or on a food) only if EPA in the chronic rat study; however, in the is no appreciable risk, the toxicological determines that the tolerance is ‘‘safe.’’ chronic mouse study, only decreased POD is used as the basis for derivation Section 408(b)(2)(A)(ii) of FFDCA body weight and food utilization were of reference values for risk assessment. defines ‘‘safe’’ to mean that ‘‘there is a observed. The findings of liver toxicity PODs are developed based on a careful reasonable certainty that no harm will and nephrotoxicity are consistent with analysis of the doses in each result from aggregate exposure to the the results from metabolism studies, in toxicological study to determine the pesticide chemical residue, including which radioactivity levels in liver and dose at which no adverse effects are all anticipated dietary exposures and all kidney were typically higher than other observed (the NOAEL) and the lowest other exposures for which there is tissues. There were no consistent sex- dose at which adverse effects of concern reliable information.’’ This includes related differences in target organ are identified (the LOAEL). Uncertainty/ exposure through drinking water and in toxicity, although male rats appeared to safety factors are used in conjunction residential settings, but does not include be more sensitive to body weight effects. with the POD to calculate a safe occupational exposure. Section No evidence of neurotoxicity was exposure level—generally referred to as 408(b)(2)(C) of FFDCA requires EPA to observed in the database, including rat a population-adjusted dose (PAD) or a give special consideration to exposure acute or subchronic neurotoxicity reference dose (RfD)—and a safe margin of infants and children to the pesticide studies. No systemic or dermal toxicity of exposure (MOE). For non-threshold chemical residue in establishing a was observed in the rat following risks, the Agency assumes that any tolerance and to ‘‘ensure that there is a dermal exposure for 28 days up to the amount of exposure will lead to some reasonable certainty that no harm will limit dose. degree of risk. Thus, the Agency result to infants and children from No evidence of increased pre- or estimates risk in terms of the probability aggregate exposure to the pesticide postnatal quantitative or qualitative of an occurrence of the adverse effect chemical residue . . . .’’ susceptibility was observed. No fetal or expected in a lifetime. For more Consistent with FFDCA section maternal toxicity was observed in information on the general principles 408(b)(2)(D), and the factors specified in developmental toxicity studies in the rat EPA uses in risk characterization and a FFDCA section 408(b)(2)(D), EPA has and rabbit. Decreased pup weights were complete description of the risk reviewed the available scientific data observed in the rat two-generation assessment process, see http:// and other relevant information in reproduction study in the presence of www2.epa.gov/pesticide-science-and- support of this action. EPA has decreased parental body weight and assessing-pesticide-risks/assessing- sufficient data to assess the hazards of food utilization. human-health-risk-pesticides. and to make a determination on There was no evidence of a treatment- A summary of the toxicological aggregate exposure for mandipropamid related increase in tumor incidence in endpoints for mandipropamid used for including exposure resulting from the the mouse carcinogenicity study or the human risk assessment is shown in tolerances established by this action. rat chronic/carcinogenicity study. There Table 1 of this unit.

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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MANDIPROPAMID FOR USE IN HUMAN HEALTH RISK ASSESSMENT

Point of departure and RfD, PAD, LOC for Exposure/scenario uncertainty/safety factors risk assessment Study and toxicological effects

Acute dietary(All populations, including infants No appropriate endpoint for a single exposure was identified in the database. and children, and females 13–49).

Chronic dietary (All populations) ...... NOAEL= 5 mg/kg/day ...... Chronic RfD = 0.05 mg/kg/day Chronic toxicity study—dog. UFA = 10x cPAD = 0.05 mg/kg/day LOAEL = 40 mg/kg/day, UFH = 10x based on increased inci- FQPA SF = 1x dence and severity of mi- croscopic pigment in the liver, and increased alkaline phosphatase activity in both sexes, as well as increased alanine aminotransferase activity in males.

Cancer (Oral, dermal, inhalation) ...... Classified as not likely to be carcinogenic to humans. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. 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 Tolerance-level residues associated with pesticide-risks/about-water-exposure- 1. Dietary exposure from food and the proposed new uses and crop group models-used-pesticide. Based on the FQPA Index Reservoir feed uses. In evaluating dietary conversions were also used in the Screening Tool (FIRST) and Pesticide exposure to mandipropamid, EPA assessment. The Agency’s 2018 Default Root Zone Model Ground Water (PRZM considered exposure under the Processing Factors were used for all GW), the estimated drinking water petitioned-for tolerances as well as all processed commodities for which they concentrations (EDWCs) of existing mandipropamid tolerances in were available. The empirical mandipropamid for chronic exposures 40 CFR 180.637. EPA assessed dietary processing factor from the grape are estimated to be 9.0 ppb for surface exposures from mandipropamid in food processing study was used for grape water and 79 ppb for ground water. as follows: wine/sherry (1.5X). A processing factor was not used for grape raisin because a Modeled estimates of drinking water i. Acute exposure. Quantitative acute concentrations were directly entered dietary exposure and risk assessments tolerance is currently established in raisin. Similarly, processing factors into the dietary exposure model. For the are performed for a food-use pesticide, chronic dietary risk assessment, the if a toxicological study has indicated the were not used for citrus oil and dried pulp because the Agency is establishing water concentration value of 79 ppb was possibility of an effect of concern used to assess the contribution to occurring as a result of a 1-day or single separate tolerances in these commodities. drinking water. exposure. No such effects were 3. From non-dietary exposure. The iii. Cancer. Based on the lack of identified in the toxicological studies term ‘‘residential exposure’’ is used in evidence of carcinogenicity or for mandipropamid; therefore, a this document to refer to non- genotoxicity, the Agency has classified quantitative acute dietary exposure occupational, non-dietary exposure mandipropamid as ‘‘not likely to be a assessment is unnecessary. (e.g., for lawn and garden pest control, human carcinogen’’ and therefore, there ii. Chronic exposure. In conducting indoor pest control, termiticides, and is no concern for cancer risk. the chronic dietary exposure flea and tick control on pets). assessment, EPA used Dietary Exposure iv. Anticipated residue and percent Mandipropamid is not registered for Evaluation Model software with the crop treated (PCT) information. EPA did any specific use patterns that would Food Commodity Intake Database not use anticipated residue or PCT result in residential exposure. (DEEM–FCID) Version 3.16, which uses information in the dietary assessment 4. Cumulative effects from substances food consumption data from the U.S. for mandipropamid. Tolerance level with a common mechanism of toxicity. Department of Agriculture’s (USDA’s) residues and 100 PCT were assumed for Section 408(b)(2)(D)(v) of FFDCA National Health and Nutrition all food commodities except as noted in requires that, when considering whether Examination Survey, ‘‘What We Eat in section III.C.ii. to establish, modify, or revoke a America’’ (NHANES/WWEIA) from 2. Dietary exposure from drinking tolerance, the Agency consider 2003 through 2008. As to residue levels water. The Agency used screening level ‘‘available information’’ concerning the in food, the chronic dietary risk water exposure models in the dietary cumulative effects of a particular assessment assumed tolerance-level exposure analysis and risk assessment pesticide’s residues and ‘‘other residues in all commodities with for mandipropamid in drinking water. substances that have a common existing tolerances except tuberous and These simulation models take into mechanism of toxicity.’’ corm vegetable subgroup 1C. For the account data on the physical, chemical, EPA has not found mandipropamid to chronic dietary risk assessment, this and fate/transport characteristics of share a common mechanism of toxicity subgroup was assessed at 0.115 ppm, mandipropamid. Further information with any other substances, and which assumes tolerance-level residues regarding EPA drinking water models mandipropamid does not appear to of parent mandipropamid (0.09 ppm), used in pesticide exposure assessment produce a toxic metabolite produced by and includes metabolite SYN 500003 in can be found at http://www2.epa.gov/ other substances. For the purposes of parent-equivalents (at 0.025 ppm). pesticide-science-and-assessing- this tolerance action, therefore, EPA has

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assumed that mandipropamid does not conservative (protective) assumptions in intermediate-term risk for have a common mechanism of toxicity the ground and surface water modeling mandipropamid. with other substances. For information used to assess exposure to 4. Aggregate cancer risk for U.S. regarding EPA’s efforts to determine mandipropamid in drinking water. population. Based on the lack of which chemicals have a common These assessments will not evidence of carcinogenicity in two mechanism of toxicity and to evaluate underestimate the exposure and risks adequate rodent carcinogenicity studies, the cumulative effects of such posed by mandipropamid. mandipropamid is not expected to pose chemicals, see EPA’s website at http:// E. Aggregate Risks and Determination of a cancer risk to humans. www2.epa.gov/pesticide-science-and- 5. Determination of safety. Based on Safety assessing-pesticide-risks/cumulative- these risk assessments, EPA concludes assessment-risk-pesticides. EPA determines whether acute and that there is a reasonable certainty that chronic dietary pesticide exposures are no harm will result to the general D. Safety Factor for Infants and safe by comparing aggregate exposure Children population, or to infants and children estimates to the acute PAD (aPAD) and from aggregate exposure to 1. In general. Section 408(b)(2)(C) of chronic PAD (cPAD). For linear cancer mandipropamid residues. FFDCA provides that EPA shall apply risks, EPA calculates the lifetime an additional tenfold (10X) margin of probability of acquiring cancer given the IV. Other Considerations safety for infants and children in the estimated aggregate exposure. Short-, A. Analytical Enforcement Methodology case of threshold effects to account for intermediate-, and chronic-term risks prenatal and postnatal toxicity and the are evaluated by comparing the There is an adequate enforcement completeness of the database on toxicity estimated aggregate food, water, and method available for the quantitation of and exposure unless EPA determines residential exposure to the appropriate mandipropamid in plant commodities. based on reliable data that a different PODs to ensure that an adequate MOE Method RAM 415/01, using high margin of safety will be safe for infants exists. performance liquid chromatography and children. This additional margin of 1. Acute risk. An acute aggregate risk with tandem mass spectrometric safety is commonly referred to as the assessment takes into account acute detection (LC/MS/MS), has been FQPA Safety Factor (SF). In applying exposure estimates from dietary adequately validated by an independent this provision, EPA either retains the consumption of food and drinking laboratory. It has a validated limit of default value of 10X, or uses a different water. No adverse effect resulting from quantitation (LOQ) of 0.01 ppm. An additional safety factor when reliable a single oral exposure was identified acceptable confirmatory method is also data available to EPA support the choice and no acute dietary endpoint was available. of a different factor. selected. Therefore, mandipropamid is The method may be requested from: 2. Prenatal and postnatal sensitivity. not expected to pose an acute risk. Chief, Analytical Chemistry Branch, No evidence of increased pre- or 2. Chronic risk. Using the exposure Environmental Science Center, 701 postnatal quantitative or qualitative assumptions described in this unit for Mapes Rd., Ft. Meade, MD 20755–5350; susceptibility was observed. No fetal or chronic exposure, EPA has concluded telephone number: (410) 305–2905; maternal toxicity was observed in that chronic exposure to email address: residuemethods@ developmental toxicity studies in the rat mandipropamid from food and water epa.gov. will utilize 49% of the cPAD for and rabbit. Decreased pup weights were B. International Residue Limits observed in the rat two-generation children 1–2 years old, the population reproduction study in the presence of group receiving the greatest exposure. In making its tolerance decisions, EPA decreased parental body weight and There are no residential uses for seeks to harmonize U.S. tolerances with food utilization. mandipropamid. international standards whenever 3. Conclusion. EPA has determined 3. Short- and intermediate-term risk. possible, consistent with U.S. food that reliable data show the safety of Short- and intermediate-term aggregate safety standards and agricultural infants and children would be exposure takes into account short- and practices. EPA considers the adequately protected if the FQPA SF intermediate-term residential exposure international maximum residue limits were reduced to 1x. That decision is plus chronic exposure to food and water (MRLs) established by the Codex based on the following findings: (considered to be a background Alimentarius Commission (Codex), as i. The toxicity database for exposure level). Short- and required by FFDCA section 408(b)(4). mandipropamid is complete. intermediate-term adverse effects were The Codex Alimentarius is a joint ii. There is no indication that identified; however, mandipropamid is United Nations Food and Agriculture mandipropamid is a neurotoxic not registered for any use patterns that Organization/World Health chemical and there is no need for a would result in either short- or Organization food standards program, developmental neurotoxicity study or intermediate-term residential exposure. and it is recognized as an international additional UFs to account for Short- and intermediate-term risk is food safety standards-setting neurotoxicity. assessed based on short- and organization in trade agreements to iii. There is no evidence that intermediate-term residential exposure which the United States is a party. EPA mandipropamid results in increased plus chronic dietary exposure. Because may establish a tolerance that is susceptibility in in utero rats or rabbits there is no short- or intermediate-term different from a Codex MRL; however, in the prenatal developmental studies or residential exposure and chronic dietary FFDCA section 408(b)(4) requires that in young rats in the 2-generation exposure has already been assessed EPA explain the reasons for departing reproduction study. under the appropriately protective from the Codex level. iv. There are no residual uncertainties cPAD (which is at least as protective as There are no harmonization issues identified in the exposure databases. the POD used to assess short-term risk), with Codex regarding the new use on The dietary food exposure assessments no further assessment of short- or citrus fruits because Codex has not were performed based on 100 PCT and intermediate-term risk is necessary, and established MRLs for mandipropamid in tolerance-level residues except as noted EPA relies on the chronic dietary risk citrus commodities. Additionally, in section III.C.ii. EPA made assessment for evaluating short- and Codex has not established an MRL in

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snap beans, so this is not a commodities), yielding a result of 0.67 removed as unnecessary since they are harmonization issue. Regarding the ppm. Per the rounding protocol in the covered by the new tolerances. updated crop group/subgroup Organization for Economic Cooperation VI. Statutory and Executive Order conversions, the tolerance in leafy and Development (OECD) MRL Reviews vegetable group 4–16 is harmonized Calculator User Guide, this result was with the corresponding Codex MRLs. increased to 0.70 ppm. This action establishes tolerances The tolerance in Brassica head and stem Similarly, the proposed tolerance in under FFDCA section 408(d) in vegetable group 5–16, and the citrus oil (2.2 ppm) was incorrectly response to a petition submitted to the individual tolerance in kohlrabi, is based on the oil processing factor (45X) Agency. The Office of Management and harmonized with the Codex MRLs in multiplied by the LAFT of 0.049 ppm Budget (OMB) has exempted these types cabbage and Chinese napa cabbage, but from the orange field trials. As for dried of actions from review under Executive not the Codex MRL in broccoli. There pulp, EPA based the tolerance in citrus Order 12866, entitled ‘‘Regulatory are no Codex MRLs in Brussels sprouts, oil on the processing factor (45X) Planning and Review’’ (58 FR 51735, cauliflower or kohlrabi. The EPA is not multiplied by the HAFT of 0.231 ppm October 4, 1993). Because this action harmonizing with the Codex MRL in from the lemon field trials, yielding a has been exempted from review under broccoli because it is lower than the result of 10.4 ppm. Per the rounding Executive Order 12866, this action is U.S. tolerance in Brassica head and protocol in the OECD’s MRL Calculator not subject to Executive Order 13211, stem vegetable group 5–16; setting a User Guide this result was increased to entitled ‘‘Actions Concerning Regulations That Significantly Affect lower tolerance in broccoli could result 15 ppm. in violative residues for U.S. growers. Energy Supply, Distribution, or Use’’ (66 The tolerance in leaf petiole subgroup V. Conclusion FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of 22B, with individual tolerances in Therefore, tolerances are established Children from Environmental Health celtuce and Florence fennel, is for residues of mandipropamid in or on Risks and Safety Risks’’ (62 FR 19885, harmonized with the Codex MRL in Asparagus bean, edible podded at 0.90 April 23, 1997), nor is it considered a celery. ppm; Bean (Phaseolus spp.), edible regulatory action under Executive Order podded at 0.90 ppm; Bean (Vigna spp.), C. Revisions to Petitioned-For 13771, entitled ‘‘Reducing Regulations edible podded at 0.90 ppm; Catjang Tolerances and Controlling Regulatory Costs’’ (82 bean, edible podded at 0.90 ppm; EPA’s tolerance levels are expressed FR 9339, February 3, 2017). This action to provide sufficient precision for Celtuce at 20 ppm; Chinese longbean, does not contain any information enforcement purposes, and this may edible podded at 0.90 ppm; Citrus, dried collections subject to OMB approval include the addition of trailing zeros pulp at 0.70 ppm; Citrus, oil at 15 ppm; under the Paperwork Reduction Act (0.50 ppm rather than the proposed 0.5 Cowpea, edible podded at 0.90 ppm; (PRA) (44 U.S.C. 3501 et seq.), nor does ppm). The Agency does this in order to Fennel, Florence, fresh leaves and stalk it require any special considerations avoid the situation where rounding of at 20 ppm; French bean, edible podded under Executive Order 12898, entitled an observed violative residue to the at 0.90 ppm; Fruit, citrus, group 10–10 ‘‘Federal Actions to Address level of precision of the tolerance at 0.50 ppm; Garden bean, edible Environmental Justice in Minority expression would result in a residue podded at 0.90 ppm; Goa bean, edible Populations and Low-Income being considered non-violative (such as podded at 0.90 ppm; Green bean, edible Populations’’ (59 FR 7629, February 16, 0.54 ppm being rounded to 0.5 ppm). podded at 0.90 ppm; Guar bean, edible 1994). EPA made this revision for Fruit, citrus, podded at 0.90 ppm; Jackbean, edible Since tolerances and exemptions that group 10–10, Kohlrabi, and Vegetable, podded at 0.90 ppm; Kidney bean, are established on the basis of a petition Brassica, head and stem, group 5–16. edible podded at 0.90 ppm; Kohlrabi at under FFDCA section 408(d), such as Because the petitioner proposed 3.0 ppm; Lablab bean, edible podded at the tolerances in this final rule, do not separate tolerances in both subgroups 4– 0.90 ppm; Leaf petiole vegetable require the issuance of a proposed rule, 16A and 4–16B at 25 ppm, the Agency subgroup 22B at 20 ppm; Moth bean, the requirements of the Regulatory is establishing a single tolerance in leafy edible podded at 0.90 ppm; Mung bean, Flexibility Act (RFA) (5 U.S.C. 601 et vegetable group 4–16 at 25 ppm rather edible podded at 0.90 ppm; Navy bean, seq.), do not apply. than separate tolerances in the two edible podded at 0.90 ppm; Rice bean, This action directly regulates growers, subgroups. In addition, the Agency edible podded at 0.90 ppm; Scarlet food processors, food handlers, and food revised the commodity terminology to runner bean, edible podded at 0.90 retailers, not States or tribes, nor does use the correct commodity definition for ppm; Snap bean, edible podded at 0.90 this action alter the relationships or Florence fennel, which is Fennel, ppm; Sword bean, edible podded at 0.90 distribution of power and Florence, fresh leaves and stalk. ppm; Urd bean, edible podded at 0.90 responsibilities established by Congress The proposed tolerance in citrus dried ppm; Vegetable, Brassica, head and in the preemption provisions of FFDCA pulp (0.14 ppm) was incorrectly based stem, group 5–16 at 3.0 ppm; Vegetable, section 408(n)(4). As such, the Agency on the dried pulp processing factor leafy, group 4–16 at 25 ppm; Vegetable has determined that this action will not (2.9X) multiplied by the lowest average soybean, edible podded at 0.90 ppm; have a substantial direct effect on States field trial value (LAFT) of 0.049 ppm Velvet bean, edible podded at 0.90 ppm; or tribal governments, on the from the orange field trials. However, Wax bean, edible podded at 0.90 ppm; relationship between the national per Office of Chemical Safety and Winged pea, edible podded at 0.90 ppm; government and the States or tribal Pollution Prevention (OCSPP) Residue and Yardlong bean, edible podded at governments, or on the distribution of Chemistry Test Guideline 860.1520, 0.90 ppm. power and responsibilities among the EPA based the tolerance on the Additionally, the existing tolerances various levels of government or between processing factor (2.9X) multiplied by in/on Bean, snap at 0.90 ppm; Brassica, the Federal Government and Indian the highest average field trial value head and stem, subgroup 5A at 3 ppm; tribes. Thus, the Agency has determined (HAFT) of 0.231 ppm from the lemon Brassica, leafy greens, subgroup 5B at 25 that Executive Order 13132, entitled field trials (which had the highest HAFT ppm; and Vegetable, leafy except ‘‘Federalism’’ (64 FR 43255, August 10, of the three representative Brassica, group 4 at 20 ppm are 1999) and Executive Order 13175,

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entitled ‘‘Consultation and Coordination podded’’; ‘‘Green bean, edible podded’’; Parts per with Indian Tribal Governments’’ (65 FR ‘‘Guar bean, edible podded’’; ‘‘Jackbean, Commodity million 67249, November 9, 2000) do not apply edible podded’’; ‘‘Kidney bean, edible to this action. In addition, this action podded’’; ‘‘Kohlrabi’’; ‘‘Lablab bean, Scarlet runner bean, edible pod- does not impose any enforceable duty or edible podded’’; ‘‘Leaf petiole vegetable ded ...... 0.90 Snap bean, edible podded ...... 0.90 contain any unfunded mandate as subgroup 22B’’; ‘‘Moth bean, edible Sword bean, edible podded ...... 0.90 described under Title II of the Unfunded podded’’; ‘‘Mung bean, edible podded’’; Urd bean, edible podded ...... 0.90 Mandates Reform Act (UMRA) (2 U.S.C. ‘‘Navy bean, edible podded’’; ‘‘Rice Vegetable, Brassica, head and 1501 et seq.). bean, edible podded’’; ‘‘Scarlet runner stem, group 5–16 ...... 3.0 This action does not involve any bean, edible podded’’; ‘‘Snap bean, technical standards that would require edible podded’’; ‘‘Sword bean, edible ***** Agency consideration of voluntary podded’’; ‘‘Urd bean, edible podded’’; Vegetable, leafy, group 4–16 ..... 25 consensus standards pursuant to section ‘‘Vegetable, Brassica, head and stem, Vegetable soybean, edible pod- ded ...... 0.90 12(d) of the National Technology group 5–16’’; and ‘‘Vegetable, leafy, Transfer and Advancement Act group 4–16’’; ***** (NTTAA) (15 U.S.C. 272 note). ■ f. Remove the entry for ‘‘Vegetable, Velvet bean, edible podded ...... 0.90 leafy except Brassica, group 4’’; and VII. Congressional Review Act Wax bean, edible podded ...... 0.90 ■ g. Add alphabetically the entries Winged pea, edible podded ...... 0.90 Pursuant to the Congressional Review ‘‘Vegetable soybean, edible podded’’; Yardlong bean, edible podded ... 0.90 Act (5 U.S.C. 801 et seq.), EPA will ‘‘Velvet bean, edible podded’’; ‘‘Wax submit a report containing this rule and bean, edible podded’’; ‘‘Winged pea, * * * * * other required information to the U.S. edible podded’’; and ‘‘Yardlong bean, [FR Doc. 2019–05406 Filed 3–21–19; 8:45 am] Senate, the U.S. House of edible podded’’. BILLING CODE 6560–50–P Representatives, and the Comptroller The additions read as follows: General of the United States prior to publication of the rule in the Federal § 180.637 Mandipropamid; tolerances for residues. DEPARTMENT OF HEALTH AND Register. This action is not a ‘‘major HUMAN SERVICES rule’’ as defined by 5 U.S.C. 804(2). (a) * * * Centers for Medicare & Medicaid List of Subjects in 40 CFR Part 180 Parts per Commodity million Services Environmental protection, Administrative practice and procedure, Asparagus bean, edible podded 0.90 42 CFR Part 455 Agricultural commodities, Pesticides and pests, Reporting and recordkeeping ***** Office of Inspector General requirements. Bean (Phaseolus spp.), edible podded ...... 0.90 42 CFR Part 1007 Dated: March 14, 2019. Bean (Vigna spp.), edible pod- Michael Goodis, ded ...... 0.90 RIN 0936–AA07 Director, Registration Division, Office of Catjang bean, edible podded ..... 0.90 Pesticide Programs. Celtuce ...... 20 Medicaid; Revisions to State Medicaid Chinese longbean, edible pod- Fraud Control Unit Rules Therefore, 40 CFR chapter I is ded ...... 0.90 amended as follows: Citrus, dried pulp ...... 0.70 AGENCIES: Office of Inspector General Citrus, oil ...... 15 (OIG) and Centers for Medicare & PART 180—[AMENDED] Cowpea, edible podded ...... 0.90 Medicaid Services (CMS), Department Fennel, Florence, fresh leaves of Health and Human Services (HHS). ■ 1. The authority citation for part 180 and stalk ...... 20 continues to read as follows: French bean, edible podded ...... 0.90 ACTION: Final rule. Fruit, citrus, group 10–10 ...... 0.50 Authority: 21 U.S.C. 321(q), 346a and 371. SUMMARY: This final rule amends the ■ 2. In § 180.637, in the table to ***** regulation governing State Medicaid paragraph (a): Garden bean, edible podded ...... 0.90 Fraud Control Units (MFCUs or Units). ■ a. Add alphabetically the entry The rule incorporates statutory changes ‘‘Asparagus bean, edible podded’’; ***** affecting the Units as well as policy and ■ b. Remove the entry for ‘‘Bean, snap’’; Goa bean, edible podded ...... 0.90 practice changes that have occurred ■ c. Add alphabetically the entries since the regulation was initially issued ‘‘Bean (Phaseolus spp.), edible podded’’ ***** in 1978. These changes include a Green bean, edible podded ...... 0.90 recognition of OIG’s delegated authority; and ‘‘Bean (Vigna spp.), edible podded’’; Guar bean, edible podded ...... 0.90 ■ d. Remove the entries for ‘‘Brassica, Unit authority, functions, and head and stem, subgroup 5A’’ and ***** responsibilities; disallowances; and ‘‘Brassica, leafy greens, subgroup 5B’’; Jackbean, edible podded ...... 0.90 issues related to organization, and Kidney bean, edible podded ...... 0.90 prosecutorial authority, staffing, ■ e. Add alphabetically the entries Kohlrabi ...... 3.0 recertification, and the Units’ ‘‘Catjang bean, edible podded’’; Lablab bean, edible podded ...... 0.90 relationship with Medicaid agencies. ‘‘Celtuce’’; ‘‘Chinese longbean, edible Leaf petiole vegetable subgroup The rule is designed to assist the podded’’; ‘‘Citrus, dried pulp’’; ‘‘Citrus, 22B ...... 20 MFCUs in understanding their Moth bean, edible podded ...... 0.90 oil’’; ‘‘Cowpea, edible podded’’; Mung bean, edible podded ...... 0.90 authorities and responsibilities under ‘‘Fennel, Florence, fresh leaves and Navy bean, edible podded ...... 0.90 the grant program, clarify the stalk’’; ‘‘French bean, edible podded’’; flexibilities the MFCUs have to operate ‘‘Fruit, citrus, group 10–10’’; ‘‘Garden ***** their programs, and reduce bean, edible podded’’; ‘‘Goa bean, edible Rice bean, edible podded ...... 0.90 administrative burden, where

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