82 FR 48000 - Triflumezopyrim; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 198 (October 16, 2017)
Federal Register Volume 82, Issue 198 (October 16, 2017)
| Page Range | 48000-48005 | |
| FR Document | 2017-22356 |
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)] [Rules and Regulations] [Pages 48000-48005] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22356] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0142; FRL-9966-13] Triflumezopyrim; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of triflumezopyrim in or on rice, grain and rice, hulls. E.I. Dupont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 16, 2017. Objections and requests for hearings must be received on or before December 15, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0142, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- 0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). 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. To access the OCSPP test [[Page 48001]] guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0142 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 December 15, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0142, 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 25, 2016 (81 FR 24044) (FRL-9944- 86), 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 6E8448) by E.I. Dupont de Nemours and Company, 974 Centre Road, Wilmington, DE 19805. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide triflumezopyrim (2,4-dioxo-1-(5-pyrimidinylmethyl)-3-[3- (trifluoromethyl)phenyl]-2H-pyrido[1,2-a]pyrimidinium inner salt), in or on rice, grain at 0.20 parts per million (ppm). That document referenced a summary of the petition prepared by E.I. Dupont de Nemours and 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 review of the data supporting the petition, EPA has revised the tolerance for rice, grain to 0.40 ppm based on the OECD tolerance calculation procedure. Additionally, EPA is requiring a tolerance for rice, hull at 1.0 ppm. The reason for these changes are explained in Unit IV.D. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .'' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for triflumezopyrim including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with triflumezopyrim 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 common adverse effect observed across the triflumezopyrim toxicological database was a decrease in absolute bodyweight in dogs and rats in both sexes following subchronic and chronic exposures. No additional non-cancer effects relevant for human health risk assessment were noted in the subchronic rat and dog oral toxicity studies. No effects were seen in the mice and rabbit studies, including the dermal toxicity study. Chronic exposures in rats resulted in an increased incidence of bile duct hyperplasia in the presence of decreases in absolute bodyweight (~70 milligrams/kilogram/day (mg/kg/day)). Additional lesions were seen in the liver, testes, and uterus at a higher dose (~400 mg/kg/day). The rat combined chronic/carcinogenicity study showed an increase in uterine and liver tumors at a dose of ~400 mg/kg/day, which is considered excessive for evaluating carcinogenic potential. The remaining doses were not considered excessive and did not show treatment-related tumors in either sex. Liver tumors in male mice during the mouse carcinogenicity study were considered treatment- related. The proposed mode of action (constitutive androstane receptor (CAR)-mediated proliferation) for the liver tumors in male mice was adequately supported by mechanistic data that clearly identified the sequence of events, dose-response concordance and temporal relationship for this tumor type. Triflumezopyrim is classified as ``not likely to be carcinogenic to humans at dose levels that do not cause a significant induction in CYP2B activity.'' Based on the mechanistic studies provided, significant induction in CYP2B only occurred at 7,000 ppm (727 mg/kg/day in male mice); the chronic reference dose used for the Agency's safety assessment is based on a no observed adverse effect level of 17 mg/kg/day. As a result, the Agency concludes that the chronic reference dose will be protective of potential carcinogenicity, which can be assessed through a non-linear approach. There is no mutagenicity concern based on the results from the in vitro and in vivo genetic toxicity studies. [[Page 48002]] Evidence of increased quantitative susceptibility in the rat developmental toxicity study was observed in the form of incomplete ossification of the parietal skull in the fetuses of dams treated with a relatively high dose (200 mg/kg/day) in the absence of any maternal toxicity. There was no evidence of susceptibility in the rat reproduction toxicity or rabbit developmental toxicity study. Possible signs of neurotoxicity were observed in the acute neurotoxicity (ACN) in rats as well as in the 28-day subchronic oral toxicity study in dogs. An overall decrease in motor activity was observed in the ACN study on the day of dosing. Animals also showed slight decreases in body temperature and number of rearing movements, as well as increases in the incidence of high posture, at a dose 4x higher than what elicited the decrease in motor activity. The 28-day subchronic oral toxicity study in dogs showed neurobehavioral signs such as slight impairment of forelimb and/or hindlimb strength and effects on pupil constriction. However, the neurobehavioral signs were not seen in studies of longer duration in dogs. Although evidence of neurotoxicity was seen in the ACN study in rats and 28-day oral toxicity study in dogs, concern is low since: (1) Effects are well-characterized with clearly established NOAEL/LOAEL values; (2) no additional neurotoxic effects were seen in the toxicological database including the subchronic neurotoxicity study (SCN); (3) there were no corroborating neuropathological findings; (4) the neurobehavioral signs in the dog were not observed in studies of longer durations in dogs; and (5) the selected endpoints for risk assessment are protective of these effects. Specific information on the studies received and the nature of the adverse effects caused by Triflumezopyrim 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 Triflumezopyrim: Human Health Risk Assessment to Establish Tolerances for Rice Without U.S. Registration at page 21 in docket ID number EPA-HQ-OPP-2016-0142. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-human-health-risk-assessments-pesticides. A summary of the toxicological endpoints for Triflumezopyrim used for human risk assessment is shown in the Table below. Summary Table of Toxicological Doses and Endpoints for Triflumezopyrim 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).. NOAEL = 100 mg/kg/ aPAD = 1.0 mg/kg/ Acute neurotoxicity study (rats). day. day. LOAEL = 500 mg/kg/day based on UFA = 10x........... decreased motor activity on day UFH = 10x........... of dosing. FQPA SF = 1x........ ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL = 17 mg/kg/day cPAD = 0.17 mg/kg/ Combined chronic/carcinogenicity UFA = 10x........... day. study (rats). LOAEL = 71/74 (M/F) UFH = 10x........... mg/kg/day based on decreased FQPA SF = 1x........ absolute bodyweights in females and increased incidence of bile duct hyperplasia in males. ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Not likely to be carcinogenic to humans at dose levels that do not cause a significant induction in CYP2B activity. Quantification of risk using a non- linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity. ---------------------------------------------------------------------------------------------------------------- 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). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to triflumezopyrim, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from triflumezopyrim 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 triflumezopyrim. In estimating acute dietary exposure, EPA used food [[Page 48003]] consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat In America (NHANES/WWEIA). As to residue levels in food, EPA used an unrefined dietary analysis and incorporated tolerance-level residues and assumed 100% of all rice was treated. 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 used an unrefined dietary analysis and incorporated tolerance-level residues and assumed 100% of all rice was treated. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that triflumezopyrim is not likely to cause cancer to humans at dose levels that do not cause a significant increase in CYP2B activity. Additionally, there is no chronic risk from exposure to triflumezopyrim and the chronic reference dose is protective of potential carcinogenicity. 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 triflumezopyrim. Tolerance-level residues and/or 100% CT were assumed for all food commodities. 2. Dietary exposure from drinking water. Because there are no domestic registrations for triflumezopyrim in the United States, dietary exposure (acute and chronic) from imported commodities is the only source of exposure assessed. Residues from imported commodities are not expected to reach drinking water sources. 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). Triflumezopyrim is not registered for any specific use patterns that would result in residential exposure. 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 triflumezopyrim to share a common mechanism of toxicity with any other substances, and triflumezopyrim does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that triflumezopyrim 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 FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There was no evidence of increased susceptibility in the rabbit developmental or the rat reproduction toxicity studies; however, there was evidence of increased quantitative susceptibility in the rat developmental study in rats where an increased incidence of incomplete ossification of the parietal skull was seen in the absence of maternal toxicity. Concern is low since: (1) The effect is well-characterized with clearly established NOAEL/LOAEL values; and (2) the selected endpoints for this chemical are protective of these effects. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for assessing risks for all populations. That decision is based on the following findings: i. The toxicity database for triflumezopyrim is complete. ii. Although there is evidence of neurotoxicity in the ACN study in rats and 28-day oral toxicity study in dogs for triflumezopyrim, the concern is low since: (1) The effects are well-characterized with clearly established NOAEL/LOAEL values; (2) no additional neurotoxic effects were seen in the toxicological database including the SCN; (3) there were no corroborating neuropathological findings; (4) the neurobehavioral signs in the dog were not observed in studies of longer durations in dogs; and (5) the selected endpoints for this chemical are protective of these effects. As a result, there is no need to require a developmental neurotoxicity study or retain the 10X to account for potential neurotoxic effects. iii. Although there was evidence of increased quantitative susceptibility in the rat developmental toxicity study where incomplete ossification of the parietal skull in the fetuses of dams treated with a relatively high dose (200 mg/kg/day) was observed in the absence of any maternal toxicity, concern is low since: (1) The effect is well- characterized with clearly established NOAEL/LOAEL values and (2) the selected endpoints for this chemical are protective of these effects. There was no evidence of increased susceptibility in the rabbit developmental or the rat reproduction toxicity studies. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on considering that 100% of all rice was treated and using tolerance- level residues. Since the metabolites were found at insignificant levels in the metabolism studies, triflumezopyrim is considered the only residue of concern. These assessments will not underestimate the exposure and risks posed by triflumezopyrim. 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 triflumezopyrim will occupy <1% of the aPAD for all infants <1 year old, the population group receiving the greatest exposure. [[Page 48004]] 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to triflumezopyrim from food will utilize <1% of the cPAD for all infants <1 year old, the population group receiving the greatest exposure. There are no residential uses for triflumezopyrim. 3. Short-term and Intermediate-term risk. Triflumezopyrim is not registered for any use patterns that would result in short-term or intermediate-term residential exposure. Because there are no residential uses for triflumezopyrim, as a result, aggregate risk estimates for short- and intermediate-term exposure are equivalent to the chronic dietary risk estimates and are not of concern. 4. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has determined that triflumezopyrim is not likely to be carcinogenic to humans at doses that do not cause a significant induction in CYP2B activity. Because there is no chronic risk from exposure to triflumezopyrim and the chronic reference dose is protective of potential carcinogenicity, triflumezopyrim is not expected to pose a cancer risk. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to triflumezopyrim residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (DuPont Liquid chromatography Mass spectrometry/mass spectrometry (LC/MS/MS) methods 36348 and 45170) 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 triflumezopyrim. C. Revisions to Petitioned-For Tolerances EPA is establishing a tolerance for rice, grain at 0.40 ppm, rather than at 0.20 ppm as requested, in addition to establishing a tolerance for rice, hulls of 1.0 ppm. The rice grain tolerance is based on the OECD tolerance calculation procedure with the inputted residues adjusted proportionally to reflect the maximum application rate. The raw agricultural commodity of ``rice, grain'' consists of the rice kernel, as well as the rice hull. The rice hull is considered a processed commodity for rice, and where residues concentrate in processed commodities, a higher tolerance to cover those residues is warranted. Because the available data indicates a higher level of residues on the rice hull, EPA is establishing a separate tolerance to cover those residues. V. Conclusion Therefore, tolerances are established for residues of triflumezopyrim, (2,4-dioco-1-(5-pyrimidinylmethyl)-3-[3- (trifluoromethyl)phenyl]-2H-pyrido[1,2-a]pyrimidinium inner salt), in or on rice, grain at 0.40 and rice, hulls at 1.0 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 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). [[Page 48005]] List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 7, 2017. Richard P. Keigwin, Jr., Director, 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. Add Sec. 180.107 to subpart C to read as follows: Sec. [emsp14]180.107 Triflumezopyrim; tolerance for residues. (a) General. Tolerances are established for residues of the insecticide triflumezopyrim, including its metabolites and degradates, in or on the following food commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only triflumezopyrim (2,4-dioxo-1-(5-pyrimidinylmethyl)-3-[3- (trifluoromethyl)phenyl]-2H-pyrido[1,2-a] pyrimidinium inner salt) in or on the commodity. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Rice, grain *........................................... 0.40 Rice, hulls *........................................... 1.0 ------------------------------------------------------------------------ * There are no U.S. registrations for the use of triflumezopyrim on these commodities. (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 2017-22356 Filed 10-13-17; 8:45 am] BILLING CODE 6560-50-P
![48000 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
Since tolerances and exemptions that Dated: September 6, 2017. DATES: This regulation is effective
are established on the basis of a petition Richard P. Keigwin, Jr., October 16, 2017. Objections and
under FFDCA section 408(d), such as Acting Director, Office of Pesticide Programs. requests for hearings must be received
the tolerance in this final rule, do not Therefore, 40 CFR chapter I is on or before December 15, 2017, and
require the issuance of a proposed rule, amended as follows: must be filed in accordance with the
the requirements of the Regulatory instructions provided in 40 CFR part
Flexibility Act (RFA) (5 U.S.C. 601 et PART 180—[AMENDED] 178 (see also Unit I.C. of the
seq.), do not apply. SUPPLEMENTARY INFORMATION).
■ 1. The authority citation for part 180 ADDRESSES: The docket for this action,
This action directly regulates growers, continues to read as follows: identified by docket identification (ID)
food processors, food handlers, and food
Authority: 21 U.S.C. 321(q), 346a and 371. number EPA–HQ–OPP–2016–0142, is
retailers, not States or tribes, nor does available at http://www.regulations.gov
this action alter the relationships or ■ 2. Add § 180.109 to subpart C to read
as follows: or at the Office of Pesticide Programs
distribution of power and Regulatory Public Docket (OPP Docket)
responsibilities established by Congress § 180.109 Fenpicoxamid; Tolerances for in the Environmental Protection Agency
in the preemption provisions of FFDCA residues. Docket Center (EPA/DC), West William
section 408(n)(4). As such, the Agency (a) General. Tolerances are Jefferson Clinton Bldg., Rm. 3334, 1301
has determined that this action will not established for residues of fenpicoxamid Constitution Ave. NW., Washington, DC
have a substantial direct effect on States including its metabolites and 20460–0001. The Public Reading Room
or tribal governments, on the degradates, in or on the commodities in is open from 8:30 a.m. to 4:30 p.m.,
relationship between the national the table below. Compliance with the Monday through Friday, excluding legal
government and the States or tribal tolerance levels for fenpicoxamid is to holidays. The telephone number for the
governments, or on the distribution of be determined by measuring only Public Reading Room is (202) 566–1744,
power and responsibilities among the fenpicoxamid ([[4-methoxy-2- and the telephone number for the OPP
various levels of government or between [[[(3S,7R,8R,9S)-9-methyl-8-(2-methyl-1- Docket is (703) 305–5805. Please review
the Federal Government and Indian oxopropoxy)-2,6-dioxo-7- the visitor instructions and additional
tribes. Thus, the Agency has determined (phenylmethyl)-1,5-dioxonan-3- information about the docket available
that Executive Order 13132, entitled yl]amino]carbonyl]-3- at http://www.epa.gov/dockets.
‘‘Federalism’’ (64 FR 43255, August 10, pyridinyl]oxy]methyl 2- FOR FURTHER INFORMATION CONTACT:
1999) and Executive Order 13175, methylpropanoate) in or on the Michael L. Goodis, Registration Division
entitled ‘‘Consultation and Coordination commodity. (7505P), Office of Pesticide Programs,
with Indian Tribal Governments’’ (65 FR Environmental Protection Agency, 1200
Parts per Pennsylvania Ave. NW., Washington,
67249, November 9, 2000) do not apply Commodity million
to this action. In addition, this action DC 20460–0001; main telephone
does not impose any enforceable duty or Banana* ................................ 0.15 number: (703) 305–7090; email address:
contain any unfunded mandate as Wheat, grain* ........................ 0.60 RDFRNotices@epa.gov.
described under Title II of the Unfunded Rye, grain* ............................ 0.60 SUPPLEMENTARY INFORMATION:
Mandates Reform Act (UMRA) (2 U.S.C. *There are no U.S. registrations for use of I. General Information
1501 et seq.). fenpicoxamid on this commodity.
A. Does this action apply to me?
This action does not involve any (b) Section 18 emergency exemptions.
[Reserved] You may be potentially affected by
technical standards that would require
(c) Tolerances with regional this action if you are an agricultural
Agency consideration of voluntary
registrations. [Reserved] producer, food manufacturer, or
consensus standards pursuant to section
(d) Indirect or inadvertent residues. pesticide manufacturer. The following
12(d) of the National Technology list of North American Industrial
[Reserved]
Transfer and Advancement Act Classification System (NAICS) codes is
[FR Doc. 2017–22357 Filed 10–13–17; 8:45 am]
(NTTAA) (15 U.S.C. 272 note). not intended to be exhaustive, but rather
BILLING CODE 6560–50–P
VII. Congressional Review Act provides a guide to help readers
determine whether this document
Pursuant to the Congressional Review ENVIRONMENTAL PROTECTION applies to them. Potentially affected
Act (5 U.S.C. 801 et seq.), EPA will AGENCY entities may include:
submit a report containing this rule and • Crop production (NAICS code 111).
other required information to the U.S. 40 CFR Part 180 • Animal production (NAICS code
Senate, the U.S. House of 112).
[EPA–HQ–OPP–2016–0142; FRL–9966–13] • Food manufacturing (NAICS code
Representatives, and the Comptroller
General of the United States prior to Triflumezopyrim; Pesticide Tolerances 311).
• Pesticide manufacturing (NAICS
publication of the rule in the Federal AGENCY: Environmental Protection code 32532).
Register. This action is not a ‘‘major Agency (EPA).
rule’’ as defined by 5 U.S.C. 804(2). B. How can I get electronic access to
ACTION: Final rule. other related information?
List of Subjects in 40 CFR Part 180
jstallworth on DSKBBY8HB2PROD with RULES
SUMMARY: This regulation establishes You may access a frequently updated
Environmental protection, tolerances for residues of electronic version of EPA’s tolerance
Administrative practice and procedure, triflumezopyrim in or on rice, grain and regulations at 40 CFR part 180 through
Agricultural commodities, Pesticides rice, hulls. E.I. Dupont de Nemours and the Government Printing Office’s e-CFR
and pests, Reporting and recordkeeping Company requested these tolerances site at http://www.ecfr.gov/cgi-bin/text-
requirements. under the Federal Food, Drug, and idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Cosmetic Act (FFDCA). 40tab_02.tpl. To access the OCSPP test
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![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 48001
guidelines referenced in this document pesticide petition (PP 6E8448) by E.I. A. Toxicological Profile
electronically, please go to http:// Dupont de Nemours and Company, 974
www.epa.gov/ocspp and select ‘‘Test Centre Road, Wilmington, DE 19805. EPA has evaluated the available
Methods and Guidelines.’’ The petition requested that 40 CFR part toxicity data and considered its validity,
180 be amended by establishing completeness, and reliability as well as
C. How can I file an objection or hearing the relationship of the results of the
tolerances for residues of the insecticide
request? studies to human risk. EPA has also
triflumezopyrim (2,4-dioxo-1-(5-
Under FFDCA section 408(g), 21 pyrimidinylmethyl)-3-[3- considered available information
U.S.C. 346a, any person may file an (trifluoromethyl)phenyl]-2H-pyrido[1,2- concerning the variability of the
objection to any aspect of this regulation a]pyrimidinium inner salt), in or on sensitivities of major identifiable
and may also request a hearing on those rice, grain at 0.20 parts per million subgroups of consumers, including
objections. You must file your objection (ppm). That document referenced a infants and children. The most common
or request a hearing on this regulation summary of the petition prepared by E.I. adverse effect observed across the
in accordance with the instructions Dupont de Nemours and Company, the triflumezopyrim toxicological database
provided in 40 CFR part 178. To ensure registrant, which is available in the was a decrease in absolute bodyweight
proper receipt by EPA, you must docket, http://www.regulations.gov. in dogs and rats in both sexes following
identify docket ID number EPA–HQ– There were no comments received in subchronic and chronic exposures. No
OPP–2016–0142 in the subject line on response to the notice of filing. additional non-cancer effects relevant
the first page of your submission. All Based upon review of the data for human health risk assessment were
objections and requests for a hearing supporting the petition, EPA has revised noted in the subchronic rat and dog oral
must be in writing, and must be the tolerance for rice, grain to 0.40 ppm toxicity studies. No effects were seen in
received by the Hearing Clerk on or based on the OECD tolerance the mice and rabbit studies, including
before December 15, 2017. Addresses for calculation procedure. Additionally, the dermal toxicity study.
mail and hand delivery of objections EPA is requiring a tolerance for rice, Chronic exposures in rats resulted in
and hearing requests are provided in 40 hull at 1.0 ppm. The reason for these an increased incidence of bile duct
CFR 178.25(b). changes are explained in Unit IV.D. hyperplasia in the presence of decreases
In addition to filing an objection or
III. Aggregate Risk Assessment and in absolute bodyweight (∼70 milligrams/
hearing request with the Hearing Clerk
Determination of Safety kilogram/day (mg/kg/day)). Additional
as described in 40 CFR part 178, please
lesions were seen in the liver, testes,
submit a copy of the filing (excluding Section 408(b)(2)(A)(i) of FFDCA and uterus at a higher dose (∼400 mg/
any Confidential Business Information allows EPA to establish a tolerance (the kg/day). The rat combined chronic/
(CBI)) for inclusion in the public docket. legal limit for a pesticide chemical carcinogenicity study showed an
Information not marked confidential residue in or on a food) only if EPA increase in uterine and liver tumors at
pursuant to 40 CFR part 2 may be determines that the tolerance is ‘‘safe.’’ a dose of ∼400 mg/kg/day, which is
disclosed publicly by EPA without prior Section 408(b)(2)(A)(ii) of FFDCA considered excessive for evaluating
notice. Submit the non-CBI copy of your defines ‘‘safe’’ to mean that ‘‘there is a carcinogenic potential. The remaining
objection or hearing request, identified reasonable certainty that no harm will doses were not considered excessive
by docket ID number EPA–HQ–OPP– result from aggregate exposure to the and did not show treatment-related
2016–0142, by one of the following pesticide chemical residue, including tumors in either sex. Liver tumors in
methods: all anticipated dietary exposures and all male mice during the mouse
• Federal eRulemaking Portal: http://
other exposures for which there is carcinogenicity study were considered
www.regulations.gov. Follow the online
reliable information.’’ This includes treatment-related. The proposed mode
instructions for submitting comments.
exposure through drinking water and in of action (constitutive androstane
Do not submit electronically any
residential settings, but does not include receptor (CAR)-mediated proliferation)
information you consider to be CBI or
occupational exposure. Section for the liver tumors in male mice was
other information whose disclosure is
408(b)(2)(C) of FFDCA requires EPA to adequately supported by mechanistic
restricted by statute.
give special consideration to exposure data that clearly identified the sequence
• Mail: OPP Docket, Environmental
of infants and children to the pesticide of events, dose-response concordance
Protection Agency Docket Center (EPA/
chemical residue in establishing a and temporal relationship for this tumor
DC), (28221T), 1200 Pennsylvania Ave.,
tolerance and to ‘‘ensure that there is a type. Triflumezopyrim is classified as
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special reasonable certainty that no harm will ‘‘not likely to be carcinogenic to humans
arrangements for hand delivery or result to infants and children from at dose levels that do not cause a
delivery of boxed information, please aggregate exposure to the pesticide significant induction in CYP2B
follow the instructions at http:// chemical residue . . . .’’ activity.’’ Based on the mechanistic
www.epa.gov/dockets/contacts.html. Consistent with FFDCA section studies provided, significant induction
Additional instructions on 408(b)(2)(D), and the factors specified in in CYP2B only occurred at 7,000 ppm
commenting or visiting the docket, FFDCA section 408(b)(2)(D), EPA has (727 mg/kg/day in male mice); the
along with more information about reviewed the available scientific data chronic reference dose used for the
dockets generally, is available at http:// and other relevant information in Agency’s safety assessment is based on
www.epa.gov/dockets. support of this action. EPA has a no observed adverse effect level of 17
sufficient data to assess the hazards of mg/kg/day. As a result, the Agency
jstallworth on DSKBBY8HB2PROD with RULES
II. Summary of Petitioned-For and to make a determination on concludes that the chronic reference
Tolerance aggregate exposure for triflumezopyrim dose will be protective of potential
In the Federal Register of April 25, including exposure resulting from the carcinogenicity, which can be assessed
2016 (81 FR 24044) (FRL–9944–86), tolerances established by this action. through a non-linear approach. There is
EPA issued a document pursuant to EPA’s assessment of exposures and risks no mutagenicity concern based on the
FFDCA section 408(d)(3), 21 U.S.C. associated with triflumezopyrim results from the in vitro and in vivo
346a(d)(3), announcing the filing of a follows. genetic toxicity studies.
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![48004 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
2. Chronic risk. Using the exposure Organization food standards program, subject to OMB approval under the
assumptions described in this unit for and it is recognized as an international Paperwork Reduction Act (PRA) (44
chronic exposure, EPA has concluded food safety standards-setting U.S.C. 3501 et seq.), nor does it require
that chronic exposure to organization in trade agreements to any special considerations under
triflumezopyrim from food will utilize which the United States is a party. EPA Executive Order 12898, entitled
<1% of the cPAD for all infants <1 year may establish a tolerance that is ‘‘Federal Actions to Address
old, the population group receiving the different from a Codex MRL; however, Environmental Justice in Minority
greatest exposure. There are no FFDCA section 408(b)(4) requires that Populations and Low-Income
residential uses for triflumezopyrim. EPA explain the reasons for departing Populations’’ (59 FR 7629, February 16,
3. Short-term and Intermediate-term from the Codex level. 1994).
risk. Triflumezopyrim is not registered The Codex has not established a MRL
Since tolerances and exemptions that
for any use patterns that would result in for triflumezopyrim.
are established on the basis of a petition
short-term or intermediate-term C. Revisions to Petitioned-For under FFDCA section 408(d), such as
residential exposure. Because there are Tolerances the tolerance in this final rule, do not
no residential uses for triflumezopyrim, require the issuance of a proposed rule,
as a result, aggregate risk estimates for EPA is establishing a tolerance for
rice, grain at 0.40 ppm, rather than at the requirements of the Regulatory
short- and intermediate-term exposure Flexibility Act (RFA) (5 U.S.C. 601 et
are equivalent to the chronic dietary risk 0.20 ppm as requested, in addition to
establishing a tolerance for rice, hulls of seq.), do not apply.
estimates and are not of concern.
4. Aggregate cancer risk for U.S. 1.0 ppm. The rice grain tolerance is This action directly regulates growers,
population. As discussed in Unit III.A., based on the OECD tolerance food processors, food handlers, and food
EPA has determined that calculation procedure with the inputted retailers, not States or tribes, nor does
triflumezopyrim is not likely to be residues adjusted proportionally to this action alter the relationships or
carcinogenic to humans at doses that do reflect the maximum application rate. distribution of power and
not cause a significant induction in The raw agricultural commodity of responsibilities established by Congress
CYP2B activity. Because there is no ‘‘rice, grain’’ consists of the rice kernel, in the preemption provisions of FFDCA
chronic risk from exposure to as well as the rice hull. The rice hull is section 408(n)(4). As such, the Agency
triflumezopyrim and the chronic considered a processed commodity for has determined that this action will not
reference dose is protective of potential rice, and where residues concentrate in have a substantial direct effect on States
carcinogenicity, triflumezopyrim is not processed commodities, a higher or tribal governments, on the
expected to pose a cancer risk. tolerance to cover those residues is relationship between the national
5. Determination of safety. Based on warranted. Because the available data government and the States or tribal
these risk assessments, EPA concludes indicates a higher level of residues on governments, or on the distribution of
that there is a reasonable certainty that the rice hull, EPA is establishing a power and responsibilities among the
no harm will result to the general separate tolerance to cover those various levels of government or between
population, or to infants and children residues. the Federal Government and Indian
from aggregate exposure to V. Conclusion tribes. Thus, the Agency has determined
triflumezopyrim residues. that Executive Order 13132, entitled
Therefore, tolerances are established ‘‘Federalism’’ (64 FR 43255, August 10,
IV. Other Considerations for residues of triflumezopyrim, (2,4- 1999) and Executive Order 13175,
dioco-1-(5-pyrimidinylmethyl)-3-[3- entitled ‘‘Consultation and Coordination
A. Analytical Enforcement Methodology
(trifluoromethyl)phenyl]-2H-pyrido[1,2- with Indian Tribal Governments’’ (65 FR
Adequate enforcement methodology a]pyrimidinium inner salt), in or on 67249, November 9, 2000) do not apply
(DuPont Liquid chromatography Mass rice, grain at 0.40 and rice, hulls at 1.0 to this action. In addition, this action
spectrometry/mass spectrometry (LC/ ppm. does not impose any enforceable duty or
MS/MS) methods 36348 and 45170) is contain any unfunded mandate as
available to enforce the tolerance VI. Statutory and Executive Order
Reviews described under Title II of the Unfunded
expression. The method may be Mandates Reform Act (UMRA) (2 U.S.C.
requested from: Chief, Analytical This action establishes tolerances 1501 et seq.).
Chemistry Branch, Environmental under FFDCA section 408(d) in
Science Center, 701 Mapes Rd., Ft. response to a petition submitted to the This action does not involve any
Meade, MD 20755–5350; telephone Agency. The Office of Management and technical standards that would require
number: (410) 305–2905; email address: Budget (OMB) has exempted these types Agency consideration of voluntary
residuemethods@epa.gov. of actions from review under Executive consensus standards pursuant to section
Order 12866, entitled ‘‘Regulatory 12(d) of the National Technology
B. International Residue Limits Planning and Review’’ (58 FR 51735, Transfer and Advancement Act
In making its tolerance decisions, EPA October 4, 1993). Because this action (NTTAA) (15 U.S.C. 272 note).
seeks to harmonize U.S. tolerances with has been exempted from review under VII. Congressional Review Act
international standards whenever Executive Order 12866, this action is
possible, consistent with U.S. food not subject to Executive Order 13211, Pursuant to the Congressional Review
safety standards and agricultural entitled ‘‘Actions Concerning Act (5 U.S.C. 801 et seq.), EPA will
practices. EPA considers the Regulations That Significantly Affect submit a report containing this rule and
jstallworth on DSKBBY8HB2PROD with RULES
international maximum residue limits Energy Supply, Distribution, or Use’’ (66 other required information to the U.S.
(MRLs) established by the Codex FR 28355, May 22, 2001) or Executive Senate, the U.S. House of
Alimentarius Commission (Codex), as Order 13045, entitled ‘‘Protection of Representatives, and the Comptroller
required by FFDCA section 408(b)(4). Children from Environmental Health General of the United States prior to
The Codex Alimentarius is a joint Risks and Safety Risks’’ (62 FR 19885, publication of the rule in the Federal
United Nations Food and Agriculture April 23, 1997). This action does not Register. This action is not a ‘‘major
Organization/World Health contain any information collections rule’’ as defined by 5 U.S.C. 804(2).
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![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 48005
List of Subjects in 40 CFR Part 180 SUMMARY: In this document, the Synopsis
Environmental protection, Commission announces that the Office As required by the Paperwork
Administrative practice and procedure, of Management and Budget (OMB) has Reduction Act of 1995 (44 U.S.C. 3507),
Agricultural commodities, Pesticides approved, for a period of six months, the FCC is notifying the public that it
and pests, Reporting and recordkeeping the information collection associated received final OMB approval on October
requirements. with the Commission’s Procedures for 6, 2017, for the information collection
Commission Review of State Opt-Out requirements contained in the
Dated: September 7, 2017. Request from the FirstNet Radio Access
Richard P. Keigwin, Jr., modifications to the Commission’s rules
Network, Report and Order (Report and in 47 CFR 90.532. Under 5 CFR part
Director, Office of Pesticide Programs. Order)’s rules and procedures for 1320, an agency may not conduct or
Therefore, 40 CFR chapter I is administering the state opt-out process sponsor a collection of information
amended as follows: as provided under the Middle Class Tax unless it displays a current, valid OMB
Relief and Job Creation Act of 2012, as Control Number.
PART 180—[AMENDED] well delineating the specific standards No person shall be subject to any
by which the Commission will evaluate penalty for failing to comply with a
■ 1. The authority citation for part 180 state opt-out applications. This collection of information subject to the
continues to read as follows: document is consistent with the Report Paperwork Reduction Act that does not
Authority: 21 U.S.C. 321(q), 346a and 371. and Order, which stated that the display a current, valid OMB Control
■ 2. Add § 180.107 to subpart C to read Commission would publish a document Number. The OMB Control Number is
as follows: in the Federal Register announcing the 3060–1245.
effective date of those rules. The foregoing notice is required by
§ 180.107 Triflumezopyrim; tolerance for
DATES: The amendments to 47 CFR the Paperwork Reduction Act of 1995,
residues.
90.532(b) and (c) published at 82 FR Public Law 104–13, October 1, 1995,
(a) General. Tolerances are and 44 U.S.C. 3507.
46690, October 6, 2017, are effective
established for residues of the The total annual reporting burdens
November 6, 2017.
insecticide triflumezopyrim, including and costs for the respondents are as
its metabolites and degradates, in or on FOR FURTHER INFORMATION CONTACT: For follows:
the following food commodities in the additional information about the OMB Control Number: 3060–1245.
table below. Compliance with the information collection, contact Nicole OMB Approval Date: October 6, 2017.
tolerance levels specified below is to be Ongele, FCC, at (202) 418–2991 or via OMB Expiration Date: April 30, 2018.
determined by measuring only email PRA@fcc.gov and to Title: Procedures for Commission
triflumezopyrim (2,4-dioxo-1-(5- Nicole.Ongele@fcc.gov. Review of State Opt-Out Request from
pyrimidinylmethyl)-3-[3- SUPPLEMENTARY INFORMATION: This the FirstNet Radio Access Network.
(trifluoromethyl)phenyl]-2H-pyrido[1,2- document announces that, on October 6, Form Number: N/A.
a] pyrimidinium inner salt) in or on the 2017, OMB approved this information Respondents: State, local or tribal
commodity. collection under the emergency governments.
processing of the Paperwork Reduction Number of Respondents and
Commodity Parts per Act (PRA), 5 CFR 1320.13, for a period Responses: 55 respondents; 110
million responses.
of six months, the information
Estimated Time per Response: 0.25
Rice, grain * .......................... 0.40 collection requirements relating to the hours per initial notification.
Rice, hulls * ........................... 1.0 State opt-out rules contained in the
Frequency of Response: One-time
Commission’s Report and Order, FCC
* There are no U.S. registrations for the use reporting requirement.
of triflumezopyrim on these commodities. 17–75, published at 82 FR 46690, Obligation to Respond: Required to
October 6, 2017. The OMB Control obtain or retain benefits. Statutory
(b) Section 18 emergency exemptions. Number is 3060–1245. The Commission
[Reserved] authority for requiring licensees to
publishes this document as an submit this information enter into the
(c) Tolerances with regional announcement of the effective date of
registrations. [Reserved] written agreements is contained in the
the rules. If you have any comments on Middle Class Tax Relief and Job
(d) Indirect or inadvertent residues.
the burden estimates listed below, or Creation Act of 2012, Public Law 112
[Reserved]
how the Commission can improve the 96, 126 Stat. 156 §§ 6001–6303, 6413
[FR Doc. 2017–22356 Filed 10–13–17; 8:45 am] collections and reduce any burdens (codified at 47 U.S.C. 1401–1443, 1457).
BILLING CODE 6560–50–P caused thereby, please contact Nicole Total Annual Burden: 26,414 hours.
Ongele, Federal Communications Total Annual Cost: No cost.
Commission, Room 1–A620, 445 12th Nature and Extent of Confidentiality:
FEDERAL COMMUNICATIONS Street SW., Washington, DC 20554. Alternative state plans are very likely to
COMMISSION Please include the OMB Control contain proprietary information as well
Number, 3060–1245, in your as information whose disclosure could
47 CFR Part 90 correspondence. The Commission will compromise network security. Parties
[PS Docket No. 16–269, FCC 17–75] also accept your comments via email at may therefore seek confidential
PRA@fcc.gov. treatment of any filing under our Part 0
Procedures for Commission Review of To request materials in accessible rules, including the use of a protective
jstallworth on DSKBBY8HB2PROD with RULES
State Opt-Out Request From the formats for people with disabilities order process to allow other those
FirstNet Radio Access Network (Braille, large print, electronic files, granted party status to the restricted
AGENCY: Federal Communications audio format), send an email to fcc504@ proceeding access to the information on
Commission. fcc.gov or call the Consumer and a confidential basis.
ACTION: Final rule; announcement of
Governmental Affairs Bureau at (202) Privacy Act: No impact(s).
effective date. 418–0530 (voice), (202) 418–0432 Needs and Uses: The purpose of
(TTY). requiring this collection is to comply
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Document Created: 2017-10-14 01:42:52
Document Modified: 2017-10-14 01:42:52
| 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 October 16, 2017. Objections and requests for hearings must be received on or before December 15, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- | |
| FR Citation | 82 FR 48000 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
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