81 FR 5600 - Cyazofamid; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 22 (February 3, 2016)
Federal Register Volume 81, Issue 22 (February 3, 2016)
| Page Range | 5600-5605 | |
| FR Document | 2016-01993 |
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)] [Rules and Regulations] [Pages 5600-5605] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01993] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0263; FRL-9940-46] Cyazofamid; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of cyazofamid in or on the herb subgroup 19A and the bulb vegetable group 3-07. Interregional Research Project Number 4 (IR-4) requested the herb subgroup 19A tolerances, and ISK Biosciences requested the bulb vegetable group 3-07 tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 3, 2016. Objections and requests for hearings must be received on or before April 4, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0263, 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 Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. [[Page 5601]] C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0263 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 April 4, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0263, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of May 20, 2015 (80 FR 28925) (FRL-9927- 39), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions: One by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077 (PP 5F8352) that requested to establish tolerances in 40 CFR 180.601 for residues of the fungicide cyazofamid and its metabolite (4- chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile) in or on bulb vegetables (crop group 3-07) at 2.0 parts per million (ppm); and one by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540 (PP 5E8350) that requested to establish tolerances in 40 CFR 180.601 for residues of the fungicide cyazofamid in or on the herb subgroup 19A at 90 ppm and also to remove the existing tolerances for residues of cyazofamid and its metabolite in or on basil, dried leaves at 90 ppm and basil, fresh leaves at 30 ppm upon approval of the herb subgroup 19A tolerances. That document referenced summaries of the two petitions prepared by ISK Biosciences, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notices of filing. 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 cyazofamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyazofamid follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The target organ for cyazofamid in rats is the kidney, with an increased incidence of basophilic tubules, increased urinary volume, pH, and protein noted in male rats after subchronic exposure. Female rats were less sensitive, with only a marginal increase in urinary volume, and pH. These findings were noted in a 90-day oral toxicity study, and similar findings were noted in the 28-day oral toxicity range-finding study in rats. In the two-generation reproductive study in rats, there was an increased incidence of inflammation and nephropathy in the high-dose male rats as compared to the controls. Basophilic tubules are indicative of a regenerative process, but they can be more difficult to identify in older animals (i.e., tubular basophilia can be obscured by nephropathy or included as part of the nephropathy constellation). No kidney effects were observed in the chronic oral toxicity study in rats; however, this study did not test up to doses as high as those eliciting kidney effects in the subchronic and two-generation reproduction toxicity studies. The only relevant finding in the dog was an incidence of parathyroid cysts in males at the limit dose in the chronic study. The pre- and post-natal toxicology database for cyazofamid includes rat and rabbit developmental toxicity studies and a two-generation reproduction toxicity study in rats. The prenatal developmental study in rats showed evidence of increased quantitative susceptibility following in utero exposure as a marginally increased incidence of bent ribs was noted in fetuses at the limit dose, whereas no maternal toxicity was noted. No adverse effects were seen in a route-specific dermal toxicity study. Skin lesions were observed in males following oral exposure in the mouse carcinogenicity study, and are thought to be caused by an allergic reaction to systemic exposure because they did not occur following exposure via the dermal route. Cyazofamid is classified as ``not likely to be carcinogenic to humans'' based on the lack of evidence for carcinogenicity in mice and rats and a lack of mutagenic potential. [[Page 5602]] Specific information on the studies received and the nature of the adverse effects caused by cyazofamid as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled, ``Cyazofamid. Human Health Risk Assessment for Proposed New Uses on Use on Crop Subgroup 19A, Peppers and Tomatoes Grown in Greenhouses, and on Bulb Vegetables Crop Group 03-07'' on pp. 32 in docket ID number EPA-HQ-OPP-2015-0263. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population- adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for cyazofamid used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Cyazofamid for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/Scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (All Populations).. No appropriate toxicological effect attributable to a single dose was observed. Therefore, a dose and endpoint were not identified for this risk assessment. ------------------------------------------------------------------------------ Chronic dietary (All populations) NOAEL= 94.8 mg/kg/ Chronic RfD = 0.948 18-Month Mouse Oral day. mg/kg/day. Carcinogenicity. UFA = 10x........... cPAD = 0.948 mg/kg/ LOAEL = 985 mg/kg/day based on UFH = 10x........... day. increased skin lesions. FQPA SF = 1x........ Incidental oral short-term (1 to NOAEL= 171 mg/kg/day LOC for MOE = 100.. Co-critical 90-Day and chronic 30 days). UFA = 10x........... oral toxicity studies in rats. UFH = 10x........... LOAEL= 295 mg/kg based on FQPA SF = 1x........ increased incidence of basophilic tubules in the kidneys, increased urinary volume, pH, & protein. Inhalation short-term (1 to 30 Oral study NOAEL= LOC for MOE = 100.. Co-critical 90-Day and chronic days). 171 mg/kg/day. oral toxicity studies in rats. UFA = 10x........... LOAEL= 295 mg/kg based on UFH = 10x........... increased incidence of basophilic FQPA SF = 1x........ tubules in the kidneys, increased urinary volume, pH, & protein. ------------------------------------------------------------------------------ Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be Carcinogenic to Humans'' based on the absence of treatment-related tumors in two adequate rodent carcinogenicity studies. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect- level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cyazofamid, EPA considered exposure under the petitioned- for tolerances as well as all existing cyazofamid tolerances in 40 CFR 180.601. EPA assessed dietary exposures from cyazofamid 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. No such effects were identified in the toxicological studies for cyazofamid; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that cyazofamid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for cyazofamid. Tolerance-level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. Available environmental fate studies suggest cyazofamid is not very [[Page 5603]] mobile and quickly degrades into a number of degradation products under different environmental conditions. The highest estimated chronic drinking water concentrations resulted from modeling which assumed application of 100% molar conversion of the parent into the terminal degradate CTCA. EPA used these estimates of CTCA (4-chloro-5-p- tolylimidazole-2-carboxylic acid) in its dietary exposure assessments, a conservative approach that likely overestimates the exposure contribution from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for cyazofamid and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyazofamid and its degradates. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of the degradate CTCA for chronic exposures are estimated to be 133.5 parts per billion (ppb) for surface water and 211 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 211 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticide, and flea and tick control on pets). Cyazofamid is currently registered for use on turf at golf courses, sod farms, seed farms, college and professional sports fields, residential and commercial lawns, and on ornamental plants in landscapes and those grown in commercial greenhouses and nurseries. EPA assessed residential exposure using the following scenarios: Adult handlers. The worst-case scenario was determined to be short-term inhalation exposures from mixing, loading, and applying cyazofamid to turf; and Children. The worst-case scenario was determined to be short-term post-application incidental oral exposure from hand-to-mouth activities on turf. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found cyazofamid to share a common mechanism of toxicity with any other substances, and cyazofamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyazofamid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The developmental rabbit and two-generation reproduction toxicity study in rats did not show any evidence of increased susceptibility developmental or offspring, respectively. However, there was increased quantitative susceptibility in the rat developmental study; concentrations up to the limit dose did not cause maternal systemic toxicity, but there was an increased incidence of bent ribs. Concern is low based on the following: (1) The increase was marginal, (2) bent ribs are considered a variation rather than a malformation, (3) the effect was only seen at the limit dose, (4) there is a clear NOAEL for the effect, and (5) the selected endpoints address any concerns for this effect. 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 cyazofamid is complete. ii. There is no indication that cyazofamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity. iii. As noted in Section D.2., there was increased quantitative susceptibility in the rat developmental study, however, concern is low due to the reasons cited. 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 cyazofamid and its degradates in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cyazofamid. 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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was [[Page 5604]] selected. Therefore, cyazofamid is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyazofamid from food and water will utilize 2% 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 cyazofamid 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). Cyazofamid 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 cyazofamid. 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 14,000 for adults and 6,100 for children 1-2 years old. Because EPA's level of concern for cyazofamid is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, cyazofamid 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 cyazofamid. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, cyazofamid 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 cyazofamid residues. IV. Other Considerations A. Analytical Enforcement Methodology An enforcement method for non-fatty commodities is available, FDA's Multi-residue Protocol D (without cleanup). The method completely recovers (>80% recovery) cyazofamid and its metabolite (4-chloro-5-(4- methylphenyl)-1H-imidazole-2-carbonitrile). In addition, the high- performance liquid chromatography method with ultraviolent light detection (HPLC/UV) method is acceptable for use as a single analyte enforcement method provided a confirmatory method such as the liquid chromatography method with tandem mass-spectrometric detection (LC/MS/ MS) method is used. 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 Aliment-arius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Aliment-arius 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. There are no Codex MRLs established for cyazofamid in/on the commodities included in this action. V. Conclusion Therefore, tolerances are established for residues of cyazofamid (4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1- sulfonamide) and is metabolite (4-chloro-5-(4-methylphenyl)-1H- imidazole-2-carbonitrile) in or on the herb subgroup 19A at 90 ppm; and bulb vegetables, group 3-07 at 2.0 ppm. In addition, the existing tolerances for residues of cyazofamid and its metabolite (4-chloro-5- (4-methylphenyl)-1H-imidazole-2-carbonitrile) in or on basil, dried leaves and basil, fresh leaves are removed as unnecessary. 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 tolerances 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 [[Page 5605]] that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 21, 2016. 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. 180.601, in the table in paragraph (a): 0 a. Remove the entries for ``Basil, dried leaves'' and ``Basil, fresh leaves''. 0 b. Add alphabetically entries for ``Bulb vegetables, group 3-07'' and ``Herb subgroup 19A''. The additions read as follows: Sec. 180.601 Cyazofamid; tolerances for residues. (a) General. * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Bulb vegetables, group 3-07................................ 2.0 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Herb subgroup 19A.......................................... 90 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2016-01993 Filed 2-2-16; 8:45 am] BILLING CODE 6560-50-P
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Global Expedited Package Services SUPPLEMENTARY INFORMATION:
(IMRS)—Non-Published Rates
(GEPS)—Non-Published Rates 3 Customized Delivery I. General Information
Global Expedited Package Services
(GEPS)—Non-Published Rates 4 Stacy L. Ruble, A. Does this action apply to me?
Global Expedited Package Services Secretary.
(GEPS)—Non-Published Rates 5 [FR Doc. 2016–01947 Filed 2–2–16; 8:45 am]
You may be potentially affected by
Global Expedited Package Services this action if you are an agricultural
BILLING CODE 7710–FW–P
(GEPS)—Non-Published Rates 6 producer, food manufacturer, or
Global Expedited Package Services pesticide manufacturer. The following
(GEPS)—Non-Published Rates 7 list of North American Industrial
Global Expedited Package Services ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is
(GEPS)—Non-Published Rates 8 AGENCY
Global Expedited Package Services
not intended to be exhaustive, but rather
(GEPS)—Non-Published Rates 9 40 CFR Part 180 provides a guide to help readers
Priority Mail International Regional Rate determine whether this document
Boxes—Non-Published Rates [EPA–HQ–OPP–2015–0263; FRL–9940–46] applies to them. Potentially affected
Outbound Competitive International entities may include:
Cyazofamid; Pesticide Tolerances
Merchandise Return Service Agreement • Crop production (NAICS code 111).
with Royal Mail Group, Ltd. AGENCY: Environmental Protection
Priority Mail International Regional Rate • Animal production (NAICS code
Agency (EPA). 112).
Boxes Contracts
ACTION: Final rule.
Priority Mail International Regional Rate • Food manufacturing (NAICS code
Boxes Contracts 1 311).
Competitive International Merchandise
SUMMARY: This regulation establishes
Return Service Agreements with Foreign tolerances for residues of cyazofamid in • Pesticide manufacturing (NAICS
Postal Operators or on the herb subgroup 19A and the code 32532).
Inbound International* bulb vegetable group 3–07. Interregional
B. How can I get electronic access to
International Business Reply Service Research Project Number 4 (IR–4)
(IBRS) Competitive Contracts
other related information?
requested the herb subgroup 19A
International Business Reply Service tolerances, and ISK Biosciences You may access a frequently updated
tkelley on DSK3SPTVN1PROD with RULES
Competitive Contract 1 requested the bulb vegetable group 3–07 electronic version of EPA’s tolerance
International Business Reply Service tolerances under the Federal Food,
Competitive Contract 3 regulations at 40 CFR part 180 through
Inbound Direct Entry Contracts with
Drug, and Cosmetic Act (FFDCA). the Government Printing Office’s e-CFR
Customers DATES: This regulation is effective site at http://www.ecfr.gov/cgi-bin/text-
Inbound Direct Entry Contracts with February 3, 2016. Objections and idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Foreign Postal Administrations requests for hearings must be received 40tab_02.tpl.
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![Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 5605
that Executive Order 13132, entitled SUPPLEMENTARY INFORMATION: This is a
‘‘Federalism’’ (64 FR 43255, August 10, Parts per summary of the Commission’s Order on
Commodity
1999) and Executive Order 13175, million Reconsideration in GN Docket No. 09–
entitled ‘‘Consultation and Coordination 51, WC Docket No. 07–245, and FCC
with Indian Tribal Governments’’ (65 FR 15–151, adopted November 17, 2015
* * * * *
67249, November 9, 2000) do not apply and released November 24, 2015. The
to this action. In addition, this action Bulb vegetables, group 3–07 ... 2.0 full text of this document is available for
does not impose any enforceable duty or public inspection during regular
contain any unfunded mandate as business hours in the FCC Reference
* * * * * Information Center, Portals II, 445 12th
described under Title II of the Unfunded
Street SW., Room CY–A257,
Mandates Reform Act (UMRA) (2 U.S.C. Herb subgroup 19A .................. 90 Washington, DC 20554. It is available on
1501 et seq.). the Commission’s Web site at http://
This action does not involve any www.fcc.gov.
* * * * *
technical standards that would require
I. Introduction
Agency consideration of voluntary * * * * *
consensus standards pursuant to section [FR Doc. 2016–01993 Filed 2–2–16; 8:45 am]
1. In this Order on Reconsideration
12(d) of the National Technology (Order), the Commission builds on its
BILLING CODE 6560–50–P
Transfer and Advancement Act prior efforts to harmonize pole
(NTTAA) (15 U.S.C. 272 note). attachment rates that cable and telecom
service providers pay utility pole
VII. Congressional Review Act FEDERAL COMMUNICATIONS owners. The Communications Act of
COMMISSION 1934, as amended (Act), contains two
Pursuant to the Congressional Review formulas for calculating pole attachment
Act (5 U.S.C. 801 et seq.), EPA will 47 CFR Part 1
rates, a formula adopted in 1978
submit a report containing this rule and [GN Docket No. 09–51, WC Docket No. 07– applicable to cable television systems
other required information to the U.S. 25; FCC 15–151] solely providing cable service, and a
Senate, the U.S. House of formula adopted in 1996 applicable to
Representatives, and the Comptroller Pole Attachment Rates telecommunications carriers providing
General of the United States prior to AGENCY: Federal Communications telecommunications service. Following
publication of the rule in the Federal Commission. the implementation of the 1996 Act
Register. This action is not a ‘‘major ACTION: Final rule.
through 2011, rates calculated using the
rule’’ as defined by 5 U.S.C. 804(2). telecom rate formula have typically
SUMMARY: In this document, the been higher than rates calculated using
List of Subjects in 40 CFR Part 180 Commission builds on its prior efforts to the cable formula in similar
harmonize pole attachment rates that circumstances. In 2011, the Commission
Environmental protection,
cable and telecom service providers pay revised the formulas as described in
Administrative practice and procedure, greater detail below to improve
Agricultural commodities, Pesticides utility pole owners. The
Communications Act of 1934, as efficiency, reduce potentially excessive
and pests, Reporting and recordkeeping costs of network deployment and
amended (Act), contains two formulas
requirements. accelerate broadband buildout, and
for calculating pole attachment rates, a
Dated: January 21, 2016. formula adopted in 1978 applicable to eliminate the wide disparity between
Susan Lewis, cable television systems solely the telecom and cable rate formulas. The
providing cable service, and a formula 2011 revisions sought to bring the
Director, Registration Division, Office of
Pesticide Programs. adopted in 1996 applicable to telecom and cable rates into parity. In
telecommunications carriers providing the intervening time, the Commission
Therefore, 40 CFR chapter I is telecommunications service. has seen that its revisions did not fully
amended as follows: achieve that objective. Today, the
DATES: Effective April 1, 2016.
Commission takes the next logical step
PART 180—[AMENDED] ADDRESSES: You may submit comments, in achieving the goals set forth in 2011.
identified by WC Docket No. 07–245, 2. As detailed below, the Commission
■ 1. The authority citation for part 180 GN Docket No. 09–51 and FCC 15–151, takes these actions in response to a
continues to read as follows: by any of the following methods: Petition for Reconsideration or
• Federal Communications Clarification in this proceeding. The
Authority: 21 U.S.C. 321(q), 346a and 371. Commission’s Web site: http:// rule revisions that the Commission
■ 2. In § 180.601, in the table in apps.fcc.gov/ecfs/. Follow the adopts amend the Commission’s rules
instructions for submitting comments. by defining ‘‘cost,’’ for the purpose of
paragraph (a):
• People with Disabilities: Contact the calculating the rates that
■ a. Remove the entries for ‘‘Basil, dried FCC to request reasonable telecommunications carriers pay for
leaves’’ and ‘‘Basil, fresh leaves’’. accommodations (accessible format pole attachments, as a percentage of
■ b. Add alphabetically entries for documents, sign language interpreters, fully allocated costs that will depend on
‘‘Bulb vegetables, group 3–07’’ and CART, etc.) by email: FCC504@fcc.gov whether the average number of
‘‘Herb subgroup 19A’’. or phone: 202–418–0530 or TTY: 202– attaching entities in a service area is 2,
tkelley on DSK3SPTVN1PROD with RULES
418–0432. 3, 4, or 5. The rates that attachers pay
The additions read as follows:
FOR FURTHER INFORMATION CONTACT: to attach to poles are currently
§ 180.601 Cyazofamid; tolerances for Jonathan Reel, Wireline Competition determined, among other things, by
residues. Bureau, Competition Policy Division, whether the attacher is a ‘‘cable
(202) 418–0637, or send an email to television system solely . . . provid[ing]
(a) General. * * *
jonathan.reel@fcc.gov. cable service’’ or a ‘‘telecommunications
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Document Created: 2016-02-03 00:39:53
Document Modified: 2016-02-03 00:39:53
| 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 February 3, 2016. Objections and requests for hearings must be received on or before April 4, 2016, 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 | 81 FR 5600 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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