81 FR 7982 - Fluridone; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 31 (February 17, 2016)
Federal Register Volume 81, Issue 31 (February 17, 2016)
| Page Range | 7982-7987 | |
| FR Document | 2016-03220 |
[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)] [Rules and Regulations] [Pages 7982-7987] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03220] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0913; FRL-9941-69] Fluridone; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a tolerance for residues of fluridone in or on cotton, undelinted seed. SePRO Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 17, 2016. Objections and requests for hearings must be received on or before April 18, 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-2014-0913, 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. 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-2014-0913 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 18, 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-2014-0913, 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 6, 2015 (80 FR 18327) (FRL-9924- 00), 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 4F8308) by SePRO Corporation, 11550 North Meridian Street, Suite 600, Carmel, IN 46032. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of [[Page 7983]] the herbicide fluridone, 1-methyl-3-phenyl-5-(3- (trifluoromethyl)phenyl)-4(1H)-pyridinone, in or on cotton, undelinted seed at 0.1 parts per million (ppm). That document referenced a summary of the petition prepared by SePRO Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice 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 fluridone including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with fluridone 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 liver and kidneys were identified as the primary target organs based on a multitude of organ specific effects noted across the toxicity database. All model species exhibited indications of liver toxicity that were often accompanied by body weight effects. Mice were the most sensitive species examined, and dogs were the most tolerant. Rat sensitivity was comparable (chronic exposure) to or slightly less (subchronic exposure) than mice; however, rats were the only species to exhibit minor kidney effects in addition to liver and body weight toxicity. Progression of toxicity from subchronic to chronic exposures was not observed in mice and was limited (2-fold difference) in rats. No evidence of fetal sensitivity was observed in rats or rabbits. Body weight effects in the F 2 rat offspring during the lactation period were suggestive of susceptibility in the young. However, this evidence is considered equivocal because the effects were isolated to the F2 offspring, body weight of the F2 offspring returned to control levels after the lactation period and no subsequent evidence of susceptibility was observed in progeny of the F2 generation. Furthermore, the offspring effects occurred at doses 2 to 4.5 times higher than the target organ and body weight toxicity noted in adult rodents. While these effects are considered equivocal, susceptibility will be assumed to be present in the young in the absence of more definitive toxicity data. Behavioral anomalies, physiological effects, and locomotor impairment consistent with neurotoxicity were only observed following acute gavage exposure to doses that likely exceeded linear pharmacokinetics and were at least 13 to 26 times higher than the lowest doses causing liver and kidney effects in rodents. No signs of neurotoxicity were identified in the rest of the toxicity database. Toxicity from repeated dose dermal exposures was limited to irritation effects on the skin (erythema, desquamation, epidermal fissures). No evidence of immunotoxicity, mutagenicity, or carcinogenicity were noted in the toxicity database. Fluridone did not demonstrate mutagenic behavior either in vitro or in vivo nor did exposure result in an increased incidence of tumors. The EPA concluded that fluridone should be classified as ``not likely'' to be a human carcinogen. Specific information on the studies received and the nature of the adverse effects caused by fluridone 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 Fluridone. Human Health Risk Assessment for Registration Review and to Support the Registration of the Use on Cotton on pages 47 thru 72 in docket ID number EPA-HQ-OPP-2014-0913. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. The 2-year mouse study was used for the residential points of departures (PODs) for short- and intermediate-term incidental oral, dermal and inhalation exposure. The mouse chronic endpoint was considered appropriate for short-and intermediate-term fluridone exposures because mice were the most sensitive species and there was no progression of toxicity from subchronic to chronic exposure. The guideline dermal study was not used to set endpoints for the dermal assessment, because the study did not address concerns for the possible sensitivity in the young observed in the 3-generation reproduction study. The systemic NOAEL from the dermal study is 384 milligram/kilogram/day (mg/kg/day), but there is equivocal, yet suggestive evidence of offspring toxicity at 112 mg/kg/day. The NOAEL from the 2-year mouse cancer study is 38.5 mg/kg/day after accounting for route-to-route extrapolation (dermal absorption factor of 39%) and is therefore protective of the equivocal offspring effects. The chronic mouse oral [[Page 7984]] endpoint was used for the inhalation assessment as well, because a route-specific inhalation study was not available. Without a route specific study, inhalation exposure was assumed to be equivalent to oral exposure. A summary of the toxicological endpoints for fluridone used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Fluridone 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 = 125 mg/kg/ Acute RfD = 1.25 mg/ Acute Neurotoxicity--Rat. day. kg/day. LOAEL = 650 mg/kg/day based on UFA = 10x........... aPAD = 1.25 mg/kg/ decreased ambulatory counts and UFH = 10x........... day. the prevalence of functional FQPA SF = 1x........ observational battery (FOB) anomalies in males and females. ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL= 15 mg/kg/day. Chronic RfD = 0.15 2-year cancer study--Mouse. UFA = 10x.......... mg/kg/day. LOAEL = 50 mg/kg/day based on UFH = 10x........... cPAD = 0.15 mg/kg/ increased alkaline phosphatase FQPA SF = 1x........ day. activity and increased incidence of hepatocellular hyperplasia. ---------------------------------------------------------------------------------------------------------------- Incidental oral short-term (1 to NOAEL= 15 mg/kg/day. LOC for MOE = 100.. 2-year cancer study--Mouse. 30 days) and intermediate-term. UFA = 10x.......... LOAEL = 50 mg/kg/day based on UFH = 10x........... increased alkaline phosphatase FQPA SF = 1x........ activity and increased incidence of hepatocellular hyperplasia. ---------------------------------------------------------------------------------------------------------------- Dermal short-term (1 to 30 days) Oral study NOAEL = LOC for MOE = 100.. 2-year cancer study--Mouse. and intermediate-term (1 to 6 15 mg/kg/day LOAEL = 50 mg/kg/day based on months). (dermal absorption increased alkaline phosphatase rate = 39%). activity and increased incidence UFA = 10x........... of hepatocellular hyperplasia. UFH = 10x........... FQPA SF = 1x........ ---------------------------------------------------------------------------------------------------------------- Inhalation short-term (1 to 30 Oral study NOAEL= 15 LOC for MOE = 100.. 2-year cancer study--Mouse. days) and intermediate-term (1 mg/kg/day LOAEL = 50 mg/kg/day based on to 6 months). (inhalation increased alkaline phosphatase absorption rate = activity and increased incidence 100%). of hepatocellular hyperplasia. UFA = 10x........... UFH = 10x........... FQPA SF = 1x........ ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Fluridone is classified as ``not likely'' to be a human carcinogen. Quantitative cancer risk assessment is not required. ---------------------------------------------------------------------------------------------------------------- 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 fluridone, EPA considered exposure under the petitioned-for tolerances as well as all existing fluridone tolerances in 40 CFR 180.420. EPA assessed dietary exposures from fluridone 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 fluridone. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. 100 percent crop treated (PCT), tolerance residues, and default processing factors were assumed for this assessment. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/ WWEIA. This dietary survey was conducted from 2003 to 2008. 100 PCT, tolerance residues, and default processing factors were assumed. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fluridone 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 and/or PCT information in the dietary assessment for fluridone. Tolerance-level residues and/or 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening- level water exposure models in the dietary exposure analysis and risk assessment for fluridone in drinking water. These simulation models take into account data on the physical, chemical, and fate/ [[Page 7985]] transport characteristics of fluridone. 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 First Index Reservoir Screening Tool (FIRST) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of fluridone for acute exposures are estimated to be 24 parts per billion (ppb) for surface water and 34 ppb for ground water. For chronic exposures they are estimated to be 21 ppb for surface water and 32 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 34 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 32 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fluridone is currently registered for the following uses that could result in residential exposures: From use on ponds (including a homeowner use), lakes, reservoirs, and rivers. EPA assessed residential exposure using the following assumptions: Adult applicators may be exposed (dermal and inhalation) while applying the pesticide to residential ponds. Residential handler exposure is expected to be short-term in duration only. Intermediate-term and chronic exposures are not likely because of the intermittent nature of applications by homeowners. There is also potential for residential post-application exposure (dermal, inhalation and incidental ingestion) for adults and children (3 to <6 years old) swimming in treated water. Residential post-application exposure is expected to be short term in duration only. 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 fluridone to share a common mechanism of toxicity with any other substances, and fluridone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluridone 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. There was no evidence of qualitative susceptibility in fetuses in the rat and rabbit developmental study. Equivocal susceptibility was observed in the young from the F2 population in the reproductive study during the lactation phase (based decreased body weight); however, body weight of the F2 offspring returned to control levels after the lactation period and no evidence of susceptibility was observed in the F3 offspring. 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 fluridone is complete. Though EPA relied on an oral study to assess inhalation exposures, a subchronic inhalation study is not required based on a weight-of-evidence (WOE) approach that considered the physical/chemical properties of fluridone including low vapor pressure, low acute inhalation toxicity, and the large short- and intermediate-term inhalation MOEs calculated. ii. The combination of behavioral anomalies and impaired physiological and locomotor function in the acute neurotoxicity (ACN) study were suggestive of neurotoxicity following high dose acute exposure. However, the concern for neurotoxicity is low because the adverse effects in the ACN study were only seen at relatively high gavage doses (650-2000 mg/kg/day); there were no corresponding neurohistopathological findings; there were no indications of neurotoxicity in the rest of the toxicity database; and the endpoints selected for risk assessment are protective of these adverse effects. iii. There is no evidence that fluridone results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies. There was equivocal susceptibility observed in the young from the F2 population in the reproductive study during the lactation phase (decreased body weight); however, body weight of the F2 offspring returned to control levels after the lactation period, and no evidence of susceptibility was observed in the F3 offspring. The PODs selected to assess risk are protective of the equivocal susceptibility in young animals. 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 fluridone in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluridone. 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 [[Page 7986]] 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 fluridone will occupy 1.3% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluridone from food and water will utilize 5.5% 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 fluridone 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). Fluridone 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 fluridone. 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 1,500 for adults and 1,600 for children. Because EPA's level of concern for fluridone is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. An intermediate-term adverse effect was identified; however, fluridone 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 fluridone. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fluridone 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 fluridone residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology [high performance liquid chromatography (HPLC) method (originally submitted as method AM-AA-CA- RO52-AA-755)] is available in the Pesticide Analytical Manual (PAM) Volume II for residues of fluridone in plant commodities, including cotton. 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 fluridone in cotton. V. Conclusion Therefore, a tolerance is established for residues of fluridone, 1- methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, in or on cotton, undelinted seed at 0.1 ppm. Additionally, the tolerances for cotton, undelinted seed at 0.1 ppm in paragraphs (b) and (d) are removed, since they are superseded by this action. 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). [[Page 7987]] 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: February 8, 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. 180.420, is amended: 0 i. By alphabetically adding ``cotton, undelinted seed'' to the table in paragraph (a)(2); 0 ii. By removing and reserving the text of paragraph (b); 0 iii. By removing ``cotton, undelinted seed'' from the table in paragraph (d). The addition reads as follows: Sec. 180.420 Fluridone; tolerances for residues. (a) * * * (2) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Cotton, undelinted seed................................. 0.1 * * * * * ------------------------------------------------------------------------ (b) Section 18 emergency exemptions. [Reserved]. * * * * * [FR Doc. 2016-03220 Filed 2-16-16; 8:45 am] BILLING CODE 6560-50-P
![7982 Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Rules and Regulations
§ 52.1620 Identification of plan. (e) * * *
* * * * *
EPA APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE NEW MEXICO SIP
State
Applicable geographic
Name of SIP provision submittal/ EPA approval date Explanation
or nonattainment area effective date
* * * * * * *
Infrastructure and Interstate Albuquerque-Bernalillo County .... 7/26/2013 2/17/16, [insert Federal
Transport for the 2010 NO2 Register citation].
NAAQS.
[FR Doc. 2016–03130 Filed 2–16–16; 8:45 am] Environmental Protection Agency, 1200 must be in writing, and must be
BILLING CODE 6560–50–P Pennsylvania Ave. NW., Washington, received by the Hearing Clerk on or
DC 20460–0001; main telephone before April 18, 2016. Addresses for
number: (703) 305–7090; email address: mail and hand delivery of objections
ENVIRONMENTAL PROTECTION RDFRNotices@epa.gov. and hearing requests are provided in 40
AGENCY SUPPLEMENTARY INFORMATION: CFR 178.25(b).
In addition to filing an objection or
40 CFR Part 180 I. General Information hearing request with the Hearing Clerk
[EPA–HQ–OPP–2014–0913; FRL–9941–69] A. Does this action apply to me? as described in 40 CFR part 178, please
submit a copy of the filing (excluding
You may be potentially affected by any Confidential Business Information
Fluridone; Pesticide Tolerances
this action if you are an agricultural (CBI)) for inclusion in the public docket.
AGENCY: Environmental Protection producer, food manufacturer, or Information not marked confidential
Agency (EPA). pesticide manufacturer. The following pursuant to 40 CFR part 2 may be
ACTION: Final rule. list of North American Industrial disclosed publicly by EPA without prior
Classification System (NAICS) codes is notice. Submit the non-CBI copy of your
SUMMARY: This regulation establishes a not intended to be exhaustive, but rather objection or hearing request, identified
tolerance for residues of fluridone in or provides a guide to help readers by docket ID number EPA–HQ–OPP–
on cotton, undelinted seed. SePRO determine whether this document 2014–0913, by one of the following
Corporation requested these tolerances applies to them. Potentially affected methods:
under the Federal Food, Drug, and entities may include: • Federal eRulemaking Portal: http://
Cosmetic Act (FFDCA). • Crop production (NAICS code 111). www.regulations.gov. Follow the online
DATES: This regulation is effective • Animal production (NAICS code instructions for submitting comments.
February 17, 2016. Objections and 112). Do not submit electronically any
requests for hearings must be received • Food manufacturing (NAICS code information you consider to be CBI or
on or before April 18, 2016, and must 311). other information whose disclosure is
be filed in accordance with the • Pesticide manufacturing (NAICS restricted by statute.
instructions provided in 40 CFR part code 32532). • Mail: OPP Docket, Environmental
178 (see also Unit I.C. of the B. How can I get electronic access to Protection Agency Docket Center (EPA/
SUPPLEMENTARY INFORMATION). other related information? DC), (28221T), 1200 Pennsylvania Ave.
ADDRESSES: The docket for this action,
NW., Washington, DC 20460–0001.
You may access a frequently updated • Hand Delivery: To make special
identified by docket identification (ID) electronic version of EPA’s tolerance arrangements for hand delivery or
number EPA–HQ–OPP–2014–0913, is regulations at 40 CFR part 180 through delivery of boxed information, please
available at http://www.regulations.gov the Government Printing Office’s e-CFR follow the instructions at http://
or at the Office of Pesticide Programs site at http://www.ecfr.gov/cgi-bin/text- www.epa.gov/dockets/contacts.html.
Regulatory Public Docket (OPP Docket) idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Additional instructions on
in the Environmental Protection Agency 40tab_02.tpl. commenting or visiting the docket,
Docket Center (EPA/DC), West William along with more information about
Jefferson Clinton Bldg., Rm. 3334, 1301 C. How can I file an objection or hearing
request? dockets generally, is available at
Constitution Ave. NW., Washington, DC http://www.epa.gov/dockets.
20460–0001. The Public Reading Room Under FFDCA section 408(g), 21
is open from 8:30 a.m. to 4:30 p.m., U.S.C. 346a, any person may file an II. Summary of Petitioned-for Tolerance
Monday through Friday, excluding legal objection to any aspect of this regulation In the Federal Register of April 6,
holidays. The telephone number for the and may also request a hearing on those 2015 (80 FR 18327) (FRL–9924–00),
Public Reading Room is (202) 566–1744, objections. You must file your objection EPA issued a document pursuant to
asabaliauskas on DSK5VPTVN1PROD with RULES
and the telephone number for the OPP or request a hearing on this regulation FFDCA section 408(d)(3), 21 U.S.C.
Docket is (703) 305–5805. Please review in accordance with the instructions 346a(d)(3), announcing the filing of a
the visitor instructions and additional provided in 40 CFR part 178. To ensure pesticide petition (PP 4F8308) by
information about the docket available proper receipt by EPA, you must SePRO Corporation, 11550 North
at http://www.epa.gov/dockets. identify docket ID number EPA–HQ– Meridian Street, Suite 600, Carmel, IN
FOR FURTHER INFORMATION CONTACT: OPP–2014–0913 in the subject line on 46032. The petition requested that 40
Susan Lewis, Registration Division the first page of your submission. All CFR part 180 be amended by
(7505P), Office of Pesticide Programs, objections and requests for a hearing establishing tolerances for residues of
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![7986 Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Rules and Regulations
estimated aggregate food, water, and fluridone is not expected to pose a October 4, 1993). Because this action
residential exposure to the appropriate cancer risk to humans. has been exempted from review under
PODs to ensure that an adequate MOE 6. Determination of safety. Based on Executive Order 12866, this action is
exists. these risk assessments, EPA concludes not subject to Executive Order 13211,
1. Acute risk. Using the exposure that there is a reasonable certainty that entitled ‘‘Actions Concerning
assumptions discussed in this unit for no harm will result to the general Regulations That Significantly Affect
acute exposure, the acute dietary population, or to infants and children Energy Supply, Distribution, or Use’’ (66
exposure from food and water to from aggregate exposure to fluridone FR 28355, May 22, 2001) or Executive
fluridone will occupy 1.3% of the aPAD residues. Order 13045, entitled ‘‘Protection of
for children 1–2 years old, the Children from Environmental Health
IV. Other Considerations
population group receiving the greatest Risks and Safety Risks’’ (62 FR 19885,
exposure. A. Analytical Enforcement Methodology April 23, 1997). This action does not
2. Chronic risk. Using the exposure Adequate enforcement methodology contain any information collections
assumptions described in this unit for [high performance liquid subject to OMB approval under the
chronic exposure, EPA has concluded chromatography (HPLC) method Paperwork Reduction Act (PRA) (44
that chronic exposure to fluridone from (originally submitted as method AM– U.S.C. 3501 et seq.), nor does it require
food and water will utilize 5.5% of the AA–CA–RO52–AA–755)] is available in any special considerations under
cPAD for children 1–2 years old the the Pesticide Analytical Manual (PAM) Executive Order 12898, entitled
population group receiving the greatest Volume II for residues of fluridone in ‘‘Federal Actions to Address
exposure. Based on the explanation in plant commodities, including cotton. Environmental Justice in Minority
Unit III.C.3., regarding residential use Populations and Low-Income
patterns, chronic residential exposure to B. International Residue Limits
Populations’’ (59 FR 7629, February 16,
residues of fluridone is not expected. In making its tolerance decisions, EPA 1994).
3. Short-term risk. Short-term seeks to harmonize U.S. tolerances with Since tolerances and exemptions that
aggregate exposure takes into account international standards whenever are established on the basis of a petition
short-term residential exposure plus possible, consistent with U.S. food under FFDCA section 408(d), such as
chronic exposure to food and water safety standards and agricultural the tolerance in this final rule, do not
(considered to be a background practices. EPA considers the
exposure level). Fluridone is currently require the issuance of a proposed rule,
international maximum residue limits the requirements of the Regulatory
registered for uses that could result in (MRLs) established by the Codex
short-term residential exposure, and the Flexibility Act (RFA) (5 U.S.C. 601 et
Alimentarius Commission (Codex), as seq.), do not apply.
Agency has determined that it is required by FFDCA section 408(b)(4).
appropriate to aggregate chronic This action directly regulates growers,
The Codex Alimentarius is a joint food processors, food handlers, and food
exposure through food and water with United Nations Food and Agriculture
short-term residential exposures to retailers, not States or tribes, nor does
Organization/World Health this action alter the relationships or
fluridone. Using the exposure Organization food standards program,
assumptions described in this unit for distribution of power and
and it is recognized as an international responsibilities established by Congress
short-term exposures, EPA has food safety standards-setting
concluded the combined short-term in the preemption provisions of FFDCA
organization in trade agreements to section 408(n)(4). As such, the Agency
food, water, and residential exposures which the United States is a party. EPA
result in aggregate MOEs of 1,500 for has determined that this action will not
may establish a tolerance that is
adults and 1,600 for children. Because have a substantial direct effect on States
different from a Codex MRL; however,
EPA’s level of concern for fluridone is or tribal governments, on the
FFDCA section 408(b)(4) requires that
a MOE of 100 or below, these MOEs are relationship between the national
EPA explain the reasons for departing
not of concern. government and the States or tribal
from the Codex level.
4. Intermediate-term risk. An governments, or on the distribution of
The Codex has not established a MRL
intermediate-term adverse effect was power and responsibilities among the
for fluridone in cotton.
identified; however, fluridone is not various levels of government or between
registered for any use patterns that V. Conclusion the Federal Government and Indian
would result in intermediate-term Therefore, a tolerance is established tribes. Thus, the Agency has determined
residential exposure. Intermediate-term for residues of fluridone, 1-methyl-3- that Executive Order 13132, entitled
risk is assessed based on intermediate- phenyl-5-(3-(trifluoromethyl)phenyl)- ‘‘Federalism’’ (64 FR 43255, August 10,
term residential exposure plus chronic 4(1H)-pyridinone, in or on cotton, 1999) and Executive Order 13175,
dietary exposure. Because there is no undelinted seed at 0.1 ppm. entitled ‘‘Consultation and Coordination
intermediate-term residential exposure Additionally, the tolerances for cotton, with Indian Tribal Governments’’ (65 FR
and chronic dietary exposure has undelinted seed at 0.1 ppm in 67249, November 9, 2000) do not apply
already been assessed under the paragraphs (b) and (d) are removed, to this action. In addition, this action
appropriately protective cPAD (which is since they are superseded by this action. does not impose any enforceable duty or
at least as protective as the POD used to contain any unfunded mandate as
assess intermediate-term risk), no VI. Statutory and Executive Order described under Title II of the Unfunded
further assessment of intermediate-term Reviews Mandates Reform Act (UMRA) (2 U.S.C.
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risk is necessary, and EPA relies on the This action establishes tolerances 1501 et seq.).
chronic dietary risk assessment for under FFDCA section 408(d) in This action does not involve any
evaluating intermediate-term risk for response to a petition submitted to the technical standards that would require
fluridone. Agency. The Office of Management and Agency consideration of voluntary
5. Aggregate cancer risk for U.S. Budget (OMB) has exempted these types consensus standards pursuant to section
population. Based on the lack of of actions from review under Executive 12(d) of the National Technology
evidence of carcinogenicity in two Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
adequate rodent carcinogenicity studies, Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
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![Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Rules and Regulations 7987
VII. Congressional Review Act ENVIRONMENTAL PROTECTION Edmonds, National Program Chemicals
AGENCY Division, Office of Pollution Prevention
Pursuant to the Congressional Review and Toxics, Environmental Protection
Act (5 U.S.C. 801 et seq.), EPA will 40 CFR Part 745 Agency, 1200 Pennsylvania Ave. NW.,
submit a report containing this rule and Washington, DC 20460–0001; telephone
[EPA–HQ–OPPT–2014–0304; FRL–9941–61]
other required information to the U.S. number: 202–566–0758; email address:
Senate, the U.S. House of RIN 2070–AK02 edmonds.marc@epa.gov.
Representatives, and the Comptroller For general information contact: The
General of the United States prior to Lead-Based Paint Programs;
TSCA-Hotline, ABVI-Goodwill, 422
publication of the rule in the Federal Amendment to Jurisdiction-Specific
South Clinton Ave., Rochester, NY
Certification and Accreditation
Register. This action is not a ‘‘major 14620; telephone number: (202) 554–
Requirements and Renovator
rule’’ as defined by 5 U.S.C. 804(2). 1404; email address: TSCA-Hotline@
Refresher Training Requirements
epa.gov.
List of Subjects in 40 CFR Part 180 AGENCY: Environmental Protection SUPPLEMENTARY INFORMATION:
Environmental protection, Agency (EPA).
Administrative practice and procedure, ACTION: Final rule. I. Executive Summary
Agricultural commodities, Pesticides SUMMARY: EPA is finalizing revisions to A. Does this action apply to me?
and pests, Reporting and recordkeeping the Lead Renovation, Repair, and You may be potentially affected by
requirements. Painting (RRP) rule, and the Lead-based this action if you operate a training
Dated: February 8, 2016. Paint (LBP) Activities rule. The program required to be accredited under
Susan Lewis, revisions are intended to improve the 40 CFR 745.225, if you are a firm or
Director, Registration Division, Office of
day-to-day function of these programs individual who must be certified to
Pesticide Programs. by reducing burdens to industry and conduct lead-based paint activities in
EPA, and by clarifying language for accordance with 40 CFR 745.226, or if
Therefore, 40 CFR chapter I is training providers, while retaining the you are an individual who must be
amended as follows: protections provided by the original certified to conduct renovation activities
rules. First, EPA is modifying the in accordance with 40 CFR 745.90. This
PART 180—[AMENDED] requirement that the renovator refresher rule applies only in States, territories,
training for individuals have a hands-on and tribal areas that do not have
■ 1. The authority citation for part 180 component. Second, the Agency is authorized programs pursuant to 40 CFR
continues to read as follows: removing jurisdiction-specific 745.324. For further information
Authority: 21 U.S.C. 321(q), 346a and 371. certification and accreditation regarding the authorization status of
requirements under the LBP Activities States, territories, and Tribes, contact
■ 2. In § 180.420, is amended: program in States where EPA the National Lead Information Center at
■ i. By alphabetically adding ‘‘cotton, administers the program. Previously, 1–800–424–LEAD (5323).
undelinted seed’’ to the table in this program required that training The following list of North American
paragraph (a)(2); providers, firms and individuals seek Industrial Classification System
certification in each jurisdiction (e.g., a (NAICS) codes is not intended to be
■ ii. By removing and reserving the text State) where the organization or person exhaustive, but rather provides a guide
of paragraph (b); wanted to work. Third, EPA is adding to help readers determine whether this
■ iii. By removing ‘‘cotton, undelinted clarifying language to the requirements document applies to them. Potentially
seed’’ from the table in paragraph (d). for training providers under both the affected entities may include:
The addition reads as follows: RRP and LBP Activities programs. • Building construction (NAICS code
DATES: This final rule is effective 236), e.g., single-family housing
§ 180.420 Fluridone; tolerances for February 17, 2016. construction, multi-family housing
residues. ADDRESSES: The docket for this action, construction, residential remodelers.
(a) * * * identified by docket identification (ID) • Specialty trade contractors (NAICS
number HQ–OPPT–2014–0304, is code 238), e.g., plumbing, heating, and
(2) * * * available at http://www.regulations.gov air-conditioning contractors, painting
or at the Office of Pollution Prevention and wall covering contractors, electrical
Parts per and Toxics Docket (OPPT Docket), contractors, finish carpentry contractors,
Commodity million
Environmental Protection Agency drywall and insulation contractors,
Docket Center (EPA/DC), West William siding contractors, tile and terrazzo
* * * * * Jefferson Clinton Bldg., Rm. 3334, 1301 contractors, glass and glazing
Cotton, undelinted seed ....... 0.1 Constitution Ave. NW., Washington, contractors.
DC. The Public Reading Room is open • Real estate (NAICS code 531), e.g.,
* * * * * from 8:30 a.m. to 4:30 p.m., Monday lessors of residential buildings and
through Friday, excluding legal dwellings, residential property
(b) Section 18 emergency exemptions. holidays. The telephone number for the managers.
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[Reserved].
Public Reading Room is (202) 566–1744, • Child day care services (NAICS
and the telephone number for the OPPT code 624410).
* * * * * Docket is (202) 566–0280. Please review • Elementary and secondary schools
[FR Doc. 2016–03220 Filed 2–16–16; 8:45 am]
the visitor instructions and additional (NAICS code 611110), e.g., elementary
BILLING CODE 6560–50–P information about the docket available schools with kindergarten classrooms.
at http://www.epa.gov/dockets. • Other technical and trade schools
FOR FURTHER INFORMATION CONTACT: For (NAICS code 611519), e.g., training
technical information contact: Marc providers.
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Document Created: 2016-02-17 01:17:11
Document Modified: 2016-02-17 01:17:11
| 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 17, 2016. Objections and requests for hearings must be received on or before April 18, 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 7982 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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