80 FR 25953 - Fenazaquin; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 87 (May 6, 2015)
Federal Register Volume 80, Issue 87 (May 6, 2015)
| Page Range | 25953-25958 | |
| FR Document | 2015-10375 |
[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)] [Rules and Regulations] [Pages 25953-25958] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10375] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0075; FRL-9925-97] Fenazaquin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of fenazaquin in or on almonds and cherries. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 6, 2015. Objections and requests for hearings must be received on or before July 6, 2015, 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-2006-0075, 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: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing 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-2006-0075 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 July 6, 2015. 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-2006-0075, 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 April 20, 2011 (76 FR 22067) (FRL-8869- 7), 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 1F7825) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition requested that 40 CFR 180.632 be amended by establishing tolerances for residues of the insecticide fenazaquin, 4-[2-[4-(1,1- dimethylethyl)phenyl]ethoxy]quinazoline, in or on fruit, pome group at 0.35 parts per million (ppm); cucurbit group at 0.25 ppm; almond, hulls at 4.5 ppm; apple, wet pomace at 0.6 ppm; berry fruit group at 0.6 ppm; [[Page 25954]] vegetable, fruiting group at 0.25 ppm; grape at 0.9 ppm; hop at 2.0 ppm; mint at 6.0 ppm; stone fruit group at 1.5 ppm; strawberry at 1.5 ppm; tree nut group at 0.02 ppm; alfalfa, forage at 4.5 ppm; alfalfa, hay at 8.0 ppm; avocado at 0.15 ppm; citrus fruit group at 0.3 ppm; citrus, oil at 2.5 ppm; cotton, seed (undelinted) at 0.5 ppm; cotton, gin byproducts at 12.0 ppm; bean, shelled dry subgroup at 0.2 ppm; bean, edible podded subgroup at 0.3 ppm; beans and pea, succulent subgroup at 0.02 ppm; corn, field, grain at 0.15 ppm; corn, field, forage at 9.0 ppm; corn, field, stover at 30 ppm; corn, field, aspirated grain fractions at 9.0 ppm; corn, field, refined oil at 0.6 ppm; corn, sweet at 0.04 ppm; and corn, sweet, forage at 9.0 ppm. That document referenced a summary of the petition prepared by Gowan Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon EPA review of the data supporting the petition, Gowan Company, the registrant, revised their petition by limiting their request for tolerances to almond and cherry. The reason for these changes are explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data 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 fenazaquin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fenazaquin 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 most consistently observed effects of fenazaquin exposure across species, genders, and treatment durations were decreases in body weight, food consumption, and food efficiency. Other effects noted were mild dehydration and certain clinical signs seen at relatively high dose levels in the acute neurotoxicity study. These clinical signs, which included increased foot splay, decreased motor activity, sluggish arousal, unusual posture, abnormal gait, and altered response to auditory stimuli were seen in the absence of any neuropathological changes and were not considered to be related to neurotoxicity. In a 90-day study in hamsters, treated animals had an increased incidence of testicular hypospermatogenesis and reduced testicular and prostate weight; however, these findings were not replicated in the hamster carcinogenicity study which suggest the effects were transient or reversible. Fenazaquin did not cause any developmental or reproductive toxicity at the doses tested in rats and rabbits. In the rat study, developmental toxicity was not observed in the presence of maternal toxicity (i.e. decreases in body weight gain, food consumption, and food efficiency). In the rabbit study, no developmental or maternal toxicity was seen. In the reproduction study, systemic toxicity manifested in parental animals as excessive salivation and decreased body weight and food intake; in offspring as decreased body weight gain; and there was no observed reproductive toxicity. Therefore, there is no developmental toxicity or reproductive susceptibility with respect to fetal and developing young animals with in utero and postnatal exposures. Carcinogenicity was evaluated in the hamster instead of the mouse because the hamster was found to be more sensitive to the effects of fenazaquin than mice due to slower elimination kinetics for hamster. In a three-month feeding study in the mouse, it was found that 6-22x higher dose levels were required to elicit a comparable effect in mice than in the hamster. The results of the rat and hamster carcinogenicity studies demonstrated no increase in treatment-related tumor incidence. Therefore, fenazaquin was classified as ``Not likely to be Carcinogenic to Humans.'' The database for fenazaquin shows no evidence of mutagenicity, genotoxicity, neurotoxicity, or immunotoxicity. Fenazaquin did not demonstrate any systemic toxicity in a 21-day dermal toxicity study in rabbits up to the limit dose (1,000 milligram/kilogram/day (mg/kg/ day)). Fenazaquin has high acute oral toxicity, low acute toxicity by dermal and inhalation routes of exposure, is not a skin irritant, is minimally irritating to the eye, and is considered to be a dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by fenazaquin as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Fenazaquin: Human Health Risk Assessment for Proposed New Uses on Almonds and Cherries on page 30 in docket ID number EPA-HQ-OPP-2006-0075. 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 [[Page 25955]] EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for fenazaquin used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Fenazaquin 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 = 15 mg/kg/day Acute RfD = 0.15 mg/ [Immunotoxicity--Rat]. including infants and children UFA = 10x........... kg/day. LOAEL = 30 mg/kg/day based on and females 13-50 years of age). UFH = 10x........... aPAD = 0.15 mg/kg/ clinical signs (general ataxia/ FQPA SF = 1x........ day. hypoactivity) observed in 1 animal on Day 02 and 3 animals on Day 03 of dosing. Chronic dietary (All populations) NOAEL = 5 mg/kg/day. Chronic RfD = 0.05 Co-Critical: Subchronic Toxicity-- UFA = 10x........... mg/kg/day. Dog. UFH = 10x........... cPAD = 0.05 mg/kg/ LOAEL = 15 mg/kg/day based on FQPA SF = 1x........ day. decreased body weight and food consumption/efficiency. Chronic Toxicity--Dog. LOAEL = 12 mg/kg/day based on decreased body weight and food consumption/efficiency. Incidental oral short-term (1 to NOAEL = 5 mg/kg/day. LOC for MOE = 100.. Co-Critical: Subchronic and 30 days). UFA = 10x........... Chronic Toxicity--Dog. UFH = 10x........... Same as Chronic Dietary. FQPA SF = 1x........ Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 100.. Co-Critical: Subchronic and days) and Intermediate Term (1 study NOAEL = 5 mg/ Chronic Toxicity--Dog. to 6 months). kg/day (inhalation Same as Chronic Dietary. absorption rate = 100%). UFA = 10x........... UFH = 10x........... FQPA SF = 1x........ ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be Carcinogenic to Humans'' based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. ---------------------------------------------------------------------------------------------------------------- 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). UFDB = to account for the absence of data or other data deficiency. 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 fenazaquin, EPA considered exposure under the petitioned- for tolerances as well as all existing fenazaquin tolerances in 40 CFR 180.632. EPA assessed dietary exposures from fenazaquin 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 fenazaquin. 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 (NHANS/WWEIA). As to residue levels in food, EPA included tolerance level residues for all registered and proposed crops and 100 percent crop treated (PCT). Default processing factors were used for all processed commodities. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA included tolerance level residues for all registered and proposed crops and 100 PCT. Default processing factors were used for all processed commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fenazaquin does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for fenazaquin. 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 fenazaquin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fenazaquin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm. Based on the Tier II Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) for surface water, the estimated drinking water concentrations (EDWCs) of fenazaquin for acute and chronic exposures were estimated to be 5.74 parts per billion (ppb) and 2.09 ppb, [[Page 25956]] respectively, and were entered directly into the dietary exposure model. The groundwater EDWC from the screening concentration in ground water (SCI-GROW) model was estimated to be 0.704 ppb. The modeled estimates were corrected for the default percent cropped area of 0.87. The drinking water assessment was conducted using the total toxic residue (TTR) approach. The residues considered in the assessment include fenazaquin (parent), Metabolite 1, and Metabolite 29. 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). Fenazaquin is currently registered for the following uses that could result in residential exposures: Ornamental uses. EPA assessed residential exposure using the following assumptions: EPA assessed potential exposures for residential handlers using several application methods including handwand and backpack sprayers to treat ornamental plants. MOEs were calculated for the inhalation route of exposure only since no systemic toxicity associated with dermal exposure to fenazaquin was observed. Adult post-applications exposures were not quantitatively assessed since no dermal hazard was identified for fenazaquin and inhalation exposures are typically negligible in outdoor settings. Furthermore, the inhalation exposure assessment performed for residential handlers is representative of worst case inhalation exposures and is considered protective for post-application inhalation scenarios. Since there is no residential incidental oral exposure expected for children 1<2 years old on ornamental plants, a post- application exposure assessment was not conducted and the aggregate assessment for children will only include exposure from food and water. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf. 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 fenazaquin to share a common mechanism of toxicity with any other substances, and fenazaquin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fenazaquin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Susceptibility/sensitivity in the developing animals was evaluated in developmental toxicity studies in rats and rabbits as well as a reproduction and fertility study in rats. The data showed no evidence of sensitivity/ susceptibility in the developing or young animal. Clear NOAELs and LOAELs are available for all the parental and offspring effects. Therefore, there are no residual prenatal or postnatal concerns. 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 fenazaquin is considered complete and sufficient for assessing susceptibility to infants and children. ii. There is no indication that fenazaquin 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 that fenazaquin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fenazaquin in drinking water. EPA also made conservative assumptions in the non-dietary residential exposures estimates including maximum application rates and standard values for unit exposures, amount handled. These assessments will not underestimate the exposure and risks posed by fenazaquin. 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 fenazaquin will occupy 10% 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 fenazaquin from food and water will utilize 10% 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 fenazaquin 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). Fenazaquin 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 fenazaquin. [[Page 25957]] 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 5,200 for adults. Because EPA's level of concern for fenazaquin is a MOE of 100 or below, the MOE is not of concern. Since there is no residential exposure expected for children, there is no potential that a short-term aggregate risk for children could be higher than the dietary (food and drinking water) risk. 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, fenazaquin 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 fenazaquin. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fenazaquin 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 fenazaquin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (high performance liquid chromatography and tandem mass spectrometry (HPLC-MS/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [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 a MRL for fenazaquin. C. Revisions to Petitioned-For Tolerances EPA's review of the data supporting the petition, showed that there was not sufficient data to support some of the tolerances originally proposed by the registrant. Gowan Company, the registrant, revised their petition by limiting their request for tolerances to almond and cherry, which are supported by the available data. The Organization of Economic Cooperation and Development (OECD) tolerance derivation procedures indicates the need for the following changes in the proposed tolerances: Cherries from 1.5 ppm to 2.0 ppm and almond hull from 0.6 ppm to 4.0 ppm. The Agency is also revising the tolerance expression to clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of fenazaquin not specifically mentioned and (2) compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression. V. Conclusion Therefore, tolerances are established for residues of fenazaquin, 4-[2-[4-(1,1-dimethylethyl)phenyl]ethoxy]quinazoline, in or on almond at 0.02 ppm, almond hulls at 4.0 ppm, and cherry at 2.0 ppm. 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 [[Page 25958]] 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: April 27, 2015. Susan Lewis, 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. 180.632, the section heading and paragraph (a) are revised to read as follows: Sec. 180.632 Fenazaquin; Tolerances for residues. (a) General. Tolerances are established for residues of the insecticide fenazaquin, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only fenazaquin, or 4-[2-[4-(1,1-dimethylethyl)phenyl]ethoxy]quinazoline. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Almond..................................................... 0.02 Almond, hulls.............................................. 4.0 Apple...................................................... 0.2 Cherry..................................................... 2.0 Citrus Oil................................................. 10 Fruit, Citrus, Group 10 except Grape fruit................. 0.5 Pear....................................................... 0.2 ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-10375 Filed 5-5-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25953
other required information to the U.S. ADDRESSES: The docket for this action, or request a hearing on this regulation
Senate, the U.S. House of identified by docket identification (ID) in accordance with the instructions
Representatives, and the Comptroller number EPA–HQ–OPP–2006–0075, is provided in 40 CFR part 178. To ensure
General of the United States prior to available at http://www.regulations.gov proper receipt by EPA, you must
publication of the rule in the Federal or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
Register. This action is not a ‘‘major Regulatory Public Docket (OPP Docket) OPP–2006–0075 in the subject line on
rule’’ as defined by 5 U.S.C. 804(2). in the Environmental Protection Agency the first page of your submission. All
Docket Center (EPA/DC), West William objections and requests for a hearing
List of Subjects in 40 CFR Part 180
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
Environmental protection, Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
Administrative practice and procedure, 20460–0001. The Public Reading Room before July 6, 2015. Addresses for mail
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and pests, Reporting and recordkeeping Monday through Friday, excluding legal hearing requests are provided in 40 CFR
requirements. holidays. The telephone number for the 178.25(b).
Dated: April 10, 2015. Public Reading Room is (202) 566–1744, In addition to filing an objection or
Robert McNally, and the telephone number for the OPP hearing request with the Hearing Clerk
Director, Biopesticides and Pollution Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
Prevention Division, Office of Pesticide the visitor instructions and additional submit a copy of the filing (excluding
Programs. information about the docket available any Confidential Business Information
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
Therefore, 40 CFR chapter I is
FOR FURTHER INFORMATION CONTACT:
Information not marked confidential
amended as follows:
Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be
PART 180—[AMENDED] (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
■ 1. The authority citation for part 180 Pennsylvania Ave. NW., Washington, objection or hearing request, identified
continues to read as follows: DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
Authority: 21 U.S.C. 321(q), 346a and 371. number: (703) 305–7090; email address: 2006–0075, by one of the following
RDFRNotices@epa.gov. methods:
■ 2. Add § 180.1330 to subpart D to read • Federal eRulemaking Portal: http://
as follows: SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
§ 180.1330 1-Octanol; exemption from the I. General Information instructions for submitting comments.
requirement of a tolerance. Do not submit electronically any
A. Does this action apply to me? information you consider to be CBI or
An exemption from the requirement
of a tolerance is established for residues You may be potentially affected by other information whose disclosure is
of 1-octanol in or on root and tuber this action if you are an agricultural restricted by statute.
vegetables when applied as a plant producer, food manufacturer, or • Mail: OPP Docket, Environmental
growth regulator in accordance with pesticide manufacturer. The following Protection Agency Docket Center (EPA/
label directions and good agricultural list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
practices. Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
not intended to be exhaustive, but rather • Hand Delivery: To make special
[FR Doc. 2015–10364 Filed 5–5–15; 8:45 am]
provides a guide to help readers arrangements for hand delivery or
BILLING CODE 6560–50–P
determine whether this document delivery of boxed information, please
applies to them. Potentially affected follow the instructions at http://
entities may include: www.epa.gov/dockets/contacts.html.
ENVIRONMENTAL PROTECTION
AGENCY • Crop production (NAICS code 111). Additional instructions on
• Animal production (NAICS code commenting or visiting the docket,
40 CFR Part 180 112). along with more information about
• Food manufacturing (NAICS code dockets generally, is available at http://
[EPA–HQ–OPP–2006–0075; FRL–9925–97] 311). www.epa.gov/dockets.
Fenazaquin; Pesticide Tolerances • Pesticide manufacturing (NAICS II. Summary of Petitioned-For
code 32532). Tolerance
AGENCY: Environmental Protection
Agency (EPA). B. How can I get electronic access to In the Federal Register of April 20,
other related information? 2011 (76 FR 22067) (FRL–8869–7), EPA
ACTION: Final rule.
You may access a frequently updated issued a document pursuant to FFDCA
SUMMARY: This regulation establishes electronic version of EPA’s tolerance section 408(d)(3), 21 U.S.C. 346a(d)(3),
tolerances for residues of fenazaquin in regulations at 40 CFR part 180 through announcing the filing of a pesticide
or on almonds and cherries. Gowan the Government Printing Office’s e-CFR petition (PP 1F7825) by Gowan
Company requested these tolerances site at http://www.ecfr.gov/cgi-bin/text- Company, P.O. Box 5569, Yuma, AZ
under the Federal Food, Drug, and idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 85366. The petition requested that 40
Cosmetic Act (FFDCA). 40tab_02.tpl. CFR 180.632 be amended by
DATES: This regulation is effective May establishing tolerances for residues of
6, 2015. Objections and requests for C. How can I file an objection or hearing the insecticide fenazaquin, 4-[2-[4-(1,1-
tkelley on DSK3SPTVN1PROD with RULES
hearings must be received on or before request? dimethylethyl)phenyl]
July 6, 2015, and must be filed in Under FFDCA section 408(g), 21 ethoxy]quinazoline, in or on fruit, pome
accordance with the instructions U.S.C. 346a, any person may file an group at 0.35 parts per million (ppm);
provided in 40 CFR part 178 (see also objection to any aspect of this regulation cucurbit group at 0.25 ppm; almond,
Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those hulls at 4.5 ppm; apple, wet pomace at
INFORMATION). objections. You must file your objection 0.6 ppm; berry fruit group at 0.6 ppm;
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![Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25955
EPA uses in risk characterization and a www.epa.gov/pesticides/factsheets/ human risk assessment is shown in
complete description of the risk riskassess.htm. Table 1 of this unit.
assessment process, see http:// A summary of the toxicological
endpoints for fenazaquin used for
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENAZAQUIN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure
and RfD, PAD, LOC for
Exposure/scenario Study and toxicological effects
uncertainty/safety risk assessment
factors
Acute dietary (General popu- NOAEL = 15 mg/kg/ Acute RfD = 0.15 [Immunotoxicity—Rat].
lation including infants and day. mg/kg/day. LOAEL = 30 mg/kg/day based on clinical signs (general ataxia/
children and females 13–50 UFA = 10x aPAD = 0.15 mg/kg/ hypoactivity) observed in 1 animal on Day 02 and 3 animals
years of age). UFH = 10x day on Day 03 of dosing.
FQPA SF = 1x
Chronic dietary (All populations) NOAEL = 5 mg/kg/ Chronic RfD = 0.05 Co-Critical: Subchronic Toxicity—Dog.
day. mg/kg/day. LOAEL = 15 mg/kg/day based on decreased body weight and
UFA = 10x cPAD = 0.05 mg/kg/ food consumption/efficiency.
UFH = 10x day Chronic Toxicity—Dog.
FQPA SF = 1x LOAEL = 12 mg/kg/day based on decreased body weight and
food consumption/efficiency.
Incidental oral short-term (1 to NOAEL = 5 mg/kg/ LOC for MOE = 100 Co-Critical: Subchronic and Chronic Toxicity—Dog.
30 days). day. Same as Chronic Dietary.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 100 Co-Critical: Subchronic and Chronic Toxicity—Dog.
days) and Intermediate Term study NOAEL = 5 Same as Chronic Dietary.
(1 to 6 months). mg/kg/day (inhala-
tion absorption
rate = 100%).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Cancer (Oral, dermal, inhala- Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of significant tumor increases
tion). in two adequate rodent carcinogenicity studies.
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). UFDB = to account for the ab-
sence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies).
C. Exposure Assessment tolerance level residues for all registered not use anticipated residue and/or PCT
1. Dietary exposure from food and and proposed crops and 100 percent information in the dietary assessment
feed uses. In evaluating dietary crop treated (PCT). Default processing for fenazaquin. Tolerance level residues
exposure to fenazaquin, EPA considered factors were used for all processed and 100 PCT were assumed for all food
exposure under the petitioned-for commodities. commodities.
tolerances as well as all existing ii. Chronic exposure. In conducting 2. Dietary exposure from drinking
fenazaquin tolerances in 40 CFR the chronic dietary exposure assessment water. The Agency used screening level
180.632. EPA assessed dietary EPA used the food consumption data water exposure models in the dietary
exposures from fenazaquin in food as from the USDA 2003–2008 National exposure analysis and risk assessment
follows: Health and Nutrition Examination for fenazaquin in drinking water. These
i. Acute exposure. Quantitative acute Survey, What We Eat in America simulation models take into account
dietary exposure and risk assessments (NHANES/WWEIA). As to residue levels data on the physical, chemical, and fate/
are performed for a food-use pesticide, in food, EPA included tolerance level transport characteristics of fenazaquin.
if a toxicological study has indicated the residues for all registered and proposed Further information regarding EPA
possibility of an effect of concern crops and 100 PCT. Default processing drinking water models used in pesticide
occurring as a result of a 1-day or single factors were used for all processed exposure assessment can be found at
exposure. commodities. http://www.epa.gov/oppefed1/models/
Such effects were identified for iii. Cancer. Based on the data water/index.htm.
fenazaquin. In estimating acute dietary summarized in Unit III.A., EPA has Based on the Tier II Pesticide Root
exposure, EPA used food consumption concluded that fenazaquin does not Zone Model/Exposure Analysis
tkelley on DSK3SPTVN1PROD with RULES
information from the United States pose a cancer risk to humans. Therefore, Modeling System (PRZM/EXAMS) for
Department of Agriculture (USDA) a dietary exposure assessment for the surface water, the estimated drinking
2003–2008 National Health and purpose of assessing cancer risk is water concentrations (EDWCs) of
Nutrition Examination Survey, What We unnecessary. fenazaquin for acute and chronic
Eat in America (NHANS/WWEIA). As to iv. Anticipated residue and percent exposures were estimated to be 5.74
residue levels in food, EPA included crop treated (PCT) information. EPA did parts per billion (ppb) and 2.09 ppb,
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![Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25957
Using the exposure assumptions B. International Residue Limits Budget (OMB) has exempted these types
described in this unit for short-term In making its tolerance decisions, EPA of actions from review under Executive
exposures, EPA has concluded the seeks to harmonize U.S. tolerances with Order 12866, entitled ‘‘Regulatory
combined short-term food, water, and international standards whenever Planning and Review’’ (58 FR 51735,
residential exposures result in aggregate possible, consistent with U.S. food October 4, 1993). Because this action
MOEs of 5,200 for adults. Because EPA’s safety standards and agricultural has been exempted from review under
level of concern for fenazaquin is a MOE practices. EPA considers the Executive Order 12866, this action is
of 100 or below, the MOE is not of international maximum residue limits not subject to Executive Order 13211,
concern. Since there is no residential (MRLs) established by the Codex entitled ‘‘Actions Concerning
exposure expected for children, there is Alimentarius Commission (Codex), as Regulations That Significantly Affect
no potential that a short-term aggregate required by FFDCA section 408(b)(4). Energy Supply, Distribution, or Use’’ (66
risk for children could be higher than The Codex Alimentarius is a joint FR 28355, May 22, 2001) or Executive
the dietary (food and drinking water) United Nations Food and Agriculture Order 13045, entitled ‘‘Protection of
risk. Organization/World Health Children from Environmental Health
4. Intermediate-term risk. Organization food standards program, Risks and Safety Risks’’ (62 FR 19885,
Intermediate-term aggregate exposure and it is recognized as an international April 23, 1997). This action does not
takes into account intermediate-term food safety standards-setting contain any information collections
residential exposure plus chronic organization in trade agreements to subject to OMB approval under the
exposure to food and water (considered which the United States is a party. EPA Paperwork Reduction Act (PRA) (44
to be a background exposure level). may establish a tolerance that is U.S.C. 3501 et seq.), nor does it require
An intermediate-term adverse effect different from a Codex MRL; however, any special considerations under
was identified; however, fenazaquin is FFDCA section 408(b)(4) requires that Executive Order 12898, entitled
not registered for any use patterns that EPA explain the reasons for departing ‘‘Federal Actions to Address
would result in intermediate-term from the Codex level. Environmental Justice in Minority
residential exposure. The Codex has not established a MRL Populations and Low-Income
Intermediate-term risk is assessed for fenazaquin. Populations’’ (59 FR 7629, February 16,
based on intermediate-term residential 1994).
exposure plus chronic dietary exposure. C. Revisions to Petitioned-For Since tolerances and exemptions that
Because there is no intermediate-term Tolerances are established on the basis of a petition
residential exposure and chronic dietary EPA’s review of the data supporting under FFDCA section 408(d), such as
exposure has already been assessed the petition, showed that there was not the tolerance in this final rule, do not
under the appropriately protective sufficient data to support some of the require the issuance of a proposed rule,
cPAD (which is at least as protective as tolerances originally proposed by the the requirements of the Regulatory
the POD used to assess intermediate- registrant. Gowan Company, the Flexibility Act (RFA) (5 U.S.C. 601 et
term risk), no further assessment of registrant, revised their petition by seq.), do not apply.
intermediate-term risk is necessary, and limiting their request for tolerances to This action directly regulates growers,
EPA relies on the chronic dietary risk almond and cherry, which are food processors, food handlers, and food
assessment for evaluating intermediate- supported by the available data. The retailers, not States or tribes, nor does
term risk for fenazaquin. Organization of Economic Cooperation this action alter the relationships or
5. Aggregate cancer risk for U.S. and Development (OECD) tolerance distribution of power and
population. Based on the lack of derivation procedures indicates the responsibilities established by Congress
evidence of carcinogenicity in two need for the following changes in the in the preemption provisions of FFDCA
adequate rodent carcinogenicity studies, proposed tolerances: Cherries from 1.5 section 408(n)(4). As such, the Agency
ppm to 2.0 ppm and almond hull from has determined that this action will not
fenazaquin is not expected to pose a
0.6 ppm to 4.0 ppm. The Agency is also have a substantial direct effect on States
cancer risk to humans.
6. Determination of safety. Based on revising the tolerance expression to or tribal governments, on the
clarify that (1) as provided in FFDCA relationship between the national
these risk assessments, EPA concludes
section 408(a)(3), the tolerance covers government and the States or tribal
that there is a reasonable certainty that
metabolites and degradates of governments, or on the distribution of
no harm will result to the general
fenazaquin not specifically mentioned power and responsibilities among the
population, or to infants and children
and (2) compliance with the specified various levels of government or between
from aggregate exposure to fenazaquin
tolerance levels is to be determined by the Federal Government and Indian
residues.
measuring only the specific compounds tribes. Thus, the Agency has determined
IV. Other Considerations mentioned in the tolerance expression. that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
A. Analytical Enforcement Methodology V. Conclusion 1999) and Executive Order 13175,
Adequate enforcement methodology Therefore, tolerances are established entitled ‘‘Consultation and Coordination
(high performance liquid for residues of fenazaquin, with Indian Tribal Governments’’ (65 FR
chromatography and tandem mass 4-[2-[4-(1,1-dimethylethyl) 67249, November 9, 2000) do not apply
spectrometry (HPLC–MS/MS)) is phenyl]ethoxy]quinazoline, in or on to this action. In addition, this action
available to enforce the tolerance almond at 0.02 ppm, almond hulls at 4.0 does not impose any enforceable duty or
expression. ppm, and cherry at 2.0 ppm. contain any unfunded mandate as
The method may be requested from: described under Title II of the Unfunded
tkelley on DSK3SPTVN1PROD with RULES
Chief, Analytical Chemistry Branch, VI. Statutory and Executive Order Mandates Reform Act (UMRA) (2 U.S.C.
Environmental Science Center, 701 Reviews 1501 et seq.).
Mapes Rd., Ft. Meade, MD 20755–5350; This action establishes tolerances This action does not involve any
telephone number: (410) 305–2905; under FFDCA section 408(d) in technical standards that would require
email address: residuemethods@ response to a petition submitted to the Agency consideration of voluntary
epa.gov. Agency. The Office of Management and consensus standards pursuant to section
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![25958 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations
12(d) of the National Technology DEPARTMENT OF HEALTH AND address ONLY: Centers for Medicare &
Transfer and Advancement Act HUMAN SERVICES Medicaid Services, Department of
(NTTAA) (15 U.S.C. 272 note). Health and Human Services, Attention:
Centers for Medicare & Medicaid CMS–6107–IFC, P.O. Box 8013,
VII. Congressional Review Act Services Baltimore, MD 21244–8013.
Pursuant to the Congressional Review Please allow sufficient time for mailed
Act (5 U.S.C. 801 et seq.), EPA will 42 CFR Part 423 comments to be received before the
submit a report containing this rule and [CMS–6107–IFC] close of the comment period.
other required information to the U.S. 3. By express or overnight mail. You
RIN 0938–AS60 may send written comments to the
Senate, the U.S. House of
Representatives, and the Comptroller following address ONLY: Centers for
Medicare Program; Changes to the
General of the United States prior to Medicare & Medicaid Services,
Requirements for Part D Prescribers
publication of the rule in the Federal Department of Health and Human
Register. This action is not a ‘‘major AGENCY: Centers for Medicare & Services, Attention: CMS–6107–IFC,
rule’’ as defined by 5 U.S.C. 804(2). Medicaid Services (CMS), HHS. Mail Stop C4–26–05, 7500 Security
ACTION: Interim final rule with comment Boulevard, Baltimore, MD 21244–1850.
List of Subjects in 40 CFR Part 180 period. 4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
Environmental protection, SUMMARY: This interim final rule with your written comments ONLY to the
Administrative practice and procedure, comment period revises requirements following addresses prior to the close of
Agricultural commodities, Pesticides related to beneficiary access to covered the comment period: a. For delivery in
and pests, Reporting and recordkeeping Part D drugs. Under these revised Washington, DC—Centers for Medicare
requirements. requirements, pharmacy claims and & Medicaid Services, Department of
Dated: April 27, 2015. beneficiary requests for reimbursement Health and Human Services, Room 445–
Susan Lewis, for Medicare Part D prescriptions, G, Hubert H. Humphrey Building, 200
written by prescribers other than Independence Avenue SW.,
Director, Registration Division, Office of
physicians and eligible professionals Washington, DC 20201.
Pesticide Programs.
who are permitted by state or other (Because access to the interior of the
Therefore, 40 CFR chapter I is applicable law to prescribe medications, Hubert H. Humphrey Building is not
amended as follows: will not be rejected at the point of sale readily available to persons without
or denied by the plan if all other Federal government identification,
PART 180—[AMENDED] requirements are met. In addition, a commenters are encouraged to leave
plan sponsor will not reject a claim or their comments in the CMS drop slots
■ 1. The authority citation for part 180 deny a beneficiary request for located in the main lobby of the
continues to read as follows: reimbursement for a drug when building. A stamp-in clock is available
Authority: 21 U.S.C. 321(q), 346a and 371. prescribed by a prescriber who does not for persons wishing to retain a proof of
meet the applicable enrollment or opt- filing by stamping in and retaining an
■ 2. In § 180.632, the section heading out requirement without first providing extra copy of the comments being filed.)
and paragraph (a) are revised to read as provisional coverage of the drug and b. For delivery in Baltimore, MD—
follows: individualized written notice to the Centers for Medicare & Medicaid
beneficiary. This interim final rule with Services, Department of Health and
§ 180.632 Fenazaquin; Tolerances for comment period also revises certain
residues. Human Services, 7500 Security
terminology to be consistent with Boulevard, Baltimore, MD 21244–1850.
(a) General. Tolerances are existing policy and to improve clarity. If you intend to deliver your
established for residues of the DATES: comments to the Baltimore address, call
insecticide fenazaquin, including its Effective date: These regulations are telephone number (410) 786–9994 in
metabolites and degradates, in or on the effective on June 1, 2015. advance to schedule your arrival with
commodities in the table below. Applicability date: The provisions at one of our staff members.
Compliance with the tolerance levels § 423.120(c)(6) are applicable January 1, Comments erroneously mailed to the
specified below is to be determined by 2016. addresses indicated as appropriate for
measuring only fenazaquin, or 4-[2-[4- Comment date: To be assured
hand or courier delivery may be delayed
(1,1-dimethylethyl)phenyl] consideration, comments must be
and received after the comment period.
ethoxy]quinazoline. received at one of the addresses
For information on viewing public
provided below, no later than 5 p.m. on
comments, see the beginning of the
Parts per July 6, 2015.
Commodity SUPPLEMENTARY INFORMATION section.
million ADDRESSES: In commenting, please refer
FOR FURTHER INFORMATION CONTACT:
to file code CMS–6107–IFC. Because of
Almond ...................................... 0.02 staff and resource limitations, we cannot Frank Whelan, (410) 786–1302 for
Almond, hulls ............................ 4.0 accept comments by facsimile (FAX) enrollment issues.
Apple ......................................... 0.2 transmission. Lisa Thorpe, (410) 786–3048, for
Cherry ....................................... 2.0 You may submit comments in one of provisional coverage, notice, and all
Citrus Oil ................................... 10 four ways (please choose only one of the other issues.
Fruit, Citrus, Group 10 except SUPPLEMENTARY INFORMATION:
ways listed)
tkelley on DSK3SPTVN1PROD with RULES
Grape fruit ............................. 0.5 Inspection of Public Comments: All
1. Electronically. You may submit
Pear .......................................... 0.2 comments received before the close of
electronic comments on this regulation
to http://www.regulations.gov. Follow the comment period are available for
* * * * * viewing by the public, including any
the ‘‘Submit a comment’’ instructions.
[FR Doc. 2015–10375 Filed 5–5–15; 8:45 am] 2. By regular mail. You may mail personally identifiable or confidential
BILLING CODE 6560–50–P written comments to the following business information that is included in
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Document Created: 2015-12-16 07:40:54
Document Modified: 2015-12-16 07:40:54
| 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 May 6, 2015. Objections and requests for hearings must be received on or before July 6, 2015, 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 | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 80 FR 25953 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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