81 FR 1526 - Propyzamide; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 8 (January 13, 2016)
Federal Register Volume 81, Issue 8 (January 13, 2016)
| Page Range | 1526-1531 | |
| FR Document | 2016-00534 |
[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)] [Rules and Regulations] [Pages 1526-1531] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00534] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0680; FRL-9940-90] Propyzamide; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a tolerance for residues of propyzamide, also known as pronamide, in or on leaf lettuce. Dow AgroSciences, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective January 13, 2016. Objections and requests for hearings must be received on or before March 14, 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-2014-0680, 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. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances. 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 the request by the docket ID number EPA-HQ-OPP-2014-0680 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 March 14, 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-2014-0680, 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 [[Page 1527]] 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 Wednesday, December 17, 2014 (79 FR 75109) (FRL-9918-90), 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 4F8301) by Dow AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.317 be amended by establishing a tolerance for residues of the herbicide pronamide (propyzamide) and its metabolite containing the 3,5- dichlorobenzoyl moiety calculated as 3,5-dichloro-N-(1,1-dimethyl-2- propynyl)benzamide, in or on lettuce, leaf at 1.0 part per million (ppm). That document referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available in the docket EPA-HQ-OPP-2014-0680 at 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 propyzamide including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with propyzamide 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. Propyzamide has low acute toxicity via the oral, dermal, and inhalation routes of exposure, is non-irritating to the eyes or skin, and is not a dermal sensitizer. The primary target organ for propyzamide is the liver. There are other target organs as well, including the thyroid, testes, and pituitary, but effects on these organs are secondary to primary effects on the liver. Liver-related effects include increases in absolute and relative liver weights, hypertrophy, elevated levels of enzymes associated with liver damage, and histopathology of liver cells. Adverse liver effects were consistently observed in every animal species studied, with progression towards more severe effects over time ultimately leading to tumorigenesis in rats and mice. Based on the studies submitted, the rat is the most sensitive species. In most studies, there is no gender sensitivity in response to propyzamide. Propyzamide is a carcinogen in rats and mice, causing liver tumors in mice, thyroid tumors in male rats, and testicular tumors in rats. Based on MOA studies, tumorigenesis for all three tumor types has been shown to be mediated by liver enzymes induced in response to treatment with propyzamide. In mice, the MOA data clearly show rapid induction of Cyp2b10 associated with the constitutive androstane nuclear receptor (CAR), as well as induction of peroxisomes and peroxisomal enzymes such as Cyp4a10 associated with a second nuclear receptor, PPAR-[alpha]. Induction of the nuclear receptors leads to mitogenesis followed by hepatocellular proliferation and eventually, liver tumors. In rats, propyzamide induces Cyp2b1 200-fold over background levels, but has no effect on other CYPs commonly associated with carcinogenic modes of action. In the rat Cyp2b1 is a biological marker for the CAR receptor. The CAR pathway is associated with the activation of uridine diphosphate glucuronyl transferase (UGT) which catalyzes the condensation of glucuronic acid with thyroxine (T4), leading to enhanced biliary excretion of T4. Eventually the continued stimulus to produce more T4 leads to the formation of thyroid follicular tumors. In male rats, the tumorigenic dose of propyzamide for both thyroid tumors and Leydig cell tumors is 1,000 ppm in the diet (34-75 mg/kg/day based on age of the rats). Tumor precursor effects such as decreases in T4 levels, increases in liver weight, liver hypertrophy, and elevated testosterone metabolism occur at doses below or equivalent to the tumorigenic dose. In nearly every oral repeated-dose study of propyzamide as well as in the 28-day dermal toxicity study in rats, there were dose-related decreases in body weight, body weight gain, and food consumption. Typically, these effects on body weight occurred at or above effects on the liver such as hypertrophy or increases in liver weight. There was evidence of neurotoxicity in rats based on an increase in landing foot splay in females and decreases in motor activity in both genders in the acute neurotoxicity study. In the subchronic neurotoxicity study however, there was no evidence of neurotoxicity following dietary administration, and only body-weight effects were observed. There was no evidence of neurotoxicity in the rest of the toxicology database across other species or other strains of rat. There was no evidence of immunotoxicity. There was no evidence of quantitative or qualitative increased susceptibility in the fetuses or the offspring of rats or rabbits following pre- and/or postnatal exposure to propyzamide. In the prenatal developmental toxicity study in rabbits and the multi- generation reproduction study in rats, any observed toxicity to the fetuses or offspring occurred at equivalent or higher doses than effects to parental animals. Specific information on the studies received and the nature of the adverse effects caused by propyzamide 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 ``Pronamide Human Health Risk Assessment for Registration Review and to Support New Section 3 Use on Leaf Lettuce (Revised)'' on pages 14-22 in docket ID number EPA-HQ-OPP- 2014-0680. [[Page 1528]] 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://www.epa.gov/pesticides-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for propyzamide used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Propyzamide 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).. LOAEL = 40 mg/kg/day Acute RfD = 0.04 mg/ Acute Neurotoxicity Rat Study UFA = 10x........... kg/day. No NOAEL established. UFH = 10x........... aPAD = 0.04 mg/kg/ LOAEL = 40 mg/kg/day based on UFL = 10x........... day. increased landing foot splay and FQPA SF = 1x........ decreased motor activity. ---------------------------------------------------------------------------------------------------------------- Acute dietary (Females 13-49 No endpoint attributable to a single exposure was identified, including years of age). developmental toxicity studies in rats and rabbits. ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) LOAEL = 40 mg/kg/day Chronic RfD = 0.04 POD = 4 mg/kg/day based on a UFA = 10x........... mg/kg/day. weight-of-evidence approach from UFH = 10x........... cPAD = 0.04 mg/kg/ the following rat studies: UFL = 10x........... day. Acute Neurotoxicity Study. FQPA SF = 1x........ No NOAEL established. LOAEL = 40 mg/kg/day based on increased landing foot splay and decreased motor activity POD = 4 mg/kg/day (LOAEL of 40 mg/ kg/day /10x UFL) Subchronic Neurotoxicity Study NOAEL = 2.38 mg/kg/day LOAEL = 11.28 mg/kg/day based on significant decreases in body weight, body weight gain, and food consumption in males Combined Chronic Toxicity/ Carcinogenicity Study NOAEL = 8.46/10.69 mg/kg/day LOAEL = 42.59/55.09 mg/kg/day based on increased relative liver weight and histopathological lesions in the liver, thyroid, and ovaries Male Pubertal Study NOAEL = 2.5 mg/kg/day LOAEL = 10 mg/kg/day based on decreased serum T4 ---------------------------------------------------------------------------------------------------------------- Incidental oral short-term (1 to LOAEL = 40 mg/kg/day LOC for MOE = 1,000 Same as Chronic dietary section 30 days). above UFA = 10x UFH = 10x........... UFL = 10x........... FQPA SF = 1x........ ---------------------------------------------------------------------------------------------------------------- Dermal short-term (1 to 30 days) NOAEL = 100 mg/kg/ LOC for MOE = 100.. Subchronic Dermal Toxicity Rat and intermediate-term (1 to 6 day (dermal Study months). absorption rate = LOAEL = 500 mg/kg/day based on 24%). decreases in body weight and food consumption UFA = 10x UFH = 10x........... FQPA SF = 1x........ ---------------------------------------------------------------------------------------------------------------- [[Page 1529]] Cancer (oral, dermal, inhalation) Classification: ``Not Likely to be Carcinogenic to Humans'' at doses that do not result in induction of hepatic cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes. ---------------------------------------------------------------------------------------------------------------- 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). UFL = use of a LOAEL to extrapolate a NOAEL. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to propyzamide, EPA considered exposure under the petitioned- for tolerance as well as all existing propyzamide tolerances in 40 CFR 180.317. EPA assessed dietary exposures from propyzamide 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 propyzamide. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed that propyzamide residues were present at tolerance levels in all commodities for which tolerances have been established or proposed, and that 100% of the crops were treated with propyzamide. 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 assumed that propyzamide residues were present at tolerance levels in all commodities for which tolerances have been established or proposed, and that 100% of the crops were treated with propyzamide. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that propyzamide does not pose a cancer risk to humans at doses that do not result in induction of hepatic cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endrocrine axes. The MOAs were adequately supported by studies that clearly identified the sequence of key events, dose-response concordance and temporal relationship to the particular tumor type. Quantification of carcinogenic risk is not required. The chronic RfD would be protective of both carcinogenic and non-carcinogenic effects observed in the mouse and rat carcinogenicity studies and MOA studies conducted at higher doses. 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 propyzamide. Tolerance-level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used Tier II screening level water exposure models in the dietary exposure analysis and risk assessment for propyzamide in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of propyzamide. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the Tier II Surface Water Concentration Calculator (SWCC) and Pesticide Root Zone Model Ground Water (PRZM-GW), the estimated drinking water concentrations (EDWCs) of propyzamide for acute exposures are estimated to be 102 parts per billion (ppb) for surface water and 21 ppb for ground water; for chronic exposures for non-cancer assessments are estimated to be 47 ppb for surface water and 18.6 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 102 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 47 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). Propyzamide is currently registered for the following uses that could result in residential exposures: Turf grass and golf courses. EPA assessed residential exposure using the following assumptions: Post-application dermal and incidental oral exposures for children 1 to < 2 years old (physical activities on turf and hand-to-mouth ingestion of treated soil); and post-application dermal exposure for children 6 to < 11 years old (golfing), children 11 to < 16 years old (golfing and mowing), and adults (golfing, mowing, and physical activities on turf). Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.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 propyzamide to share a common mechanism of toxicity with any other substances, and propyzamide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that propyzamide 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 [[Page 1530]] the cumulative effects of such chemicals, see EPA's Web site at http://www.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 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 quantitative or qualitative increased susceptibility in developing fetuses or in offspring of rats or rabbits following prenatal and/or postnatal exposure to propyzamide. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF was reduced to 1X. This decision is based on the following findings: i. The toxicity database for propyzamide is complete. ii. There is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity despite evidence of neurotoxicity in the acute study based on the increase in landing foot splay in female rats and the decrease in motor activity seen in both genders on day 1. This decision is based on no evidence of neurotoxicity in the subchronic study at dose levels tested via different routes of administration, and no evidence of neurotoxicity in the rest of the toxicology database across other species and other strains of rat. iii. There is no evidence that propyzamide results in increased susceptibility in in utero rabbits in the prenatal developmental toxicity study or in young rats in the two-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to propyzamide in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by propyzamide. 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 propyzamide will occupy 46% of the aPAD for all infants < 1 year old, the population subgroup receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic dietary exposure to propyzamide from food and water will utilize 11% of the cPAD for children 1 to 2 years old, the population subgroup receiving the greatest exposure. Based on the explanation in Unit III.C.3. regarding residential use patterns, chronic residential exposure to residues of propyzamide 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 background exposure level). Propyzamide 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. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded that the combined short-term food, water, and residential exposure results in an aggregate MOE of 1,700 for children 1 to < 2 years old (chronic dietary exposure with post- application incidental oral exposure from turf use). Because EPA's level of concern for propyzamide is a MOE of 1,000 or below, this MOE is not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be background exposure level). Propyzamide is currently registered for uses that could result in intermediate-term residential exposure. However, since the maximum single and yearly application rates are the same, the short-term assessment is protective of intermediate-term incidental oral exposure. 5. Aggregate cancer risk for U.S. population. As discussed in Unit III.C.iii., Propyzamide is classified as ``Not Likely to be Carcinogenic to Humans'' at doses that do not result in induction of hepatic cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes. Therefore, quantification of aggregate cancer risk is not required. 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 propyzamide residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodologies are available to enforce the tolerance expression of residues in/on plant commodities (PAM II Method I, using gas-liquid chromatography with electron-capture detection (GLC/ECD)) and livestock commodities (Method GRM 02.21, using gas chromatography with negative-ion chemical ionization mass spectrometry detection (GC/MS)). These methods 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, [[Page 1531]] 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 any MRLs for propyzamide. V. Conclusion Therefore, tolerances are established for residues of propyzamide (pronamide), 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide, in or on lettuce, leaf at 1.0 ppm. VI. Statutory and Executive Order Reviews This action establishes a tolerance 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 31, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. In Sec. 180.317, add alphabetically ``Lettuce, leaf'' to the table in paragraph (a) to read as follows: Sec. 180.317 Propyzamide; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Lettuce, leaf........................................... 1.0 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2016-00534 Filed 1-12-16; 8:45 am] BILLING CODE 6560-50-P
![1526 Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations
and pests, Reporting and recordkeeping PART 180—[AMENDED] § 180.960 Polymers; exemptions from the
requirements. requirement of a tolerance.
Dated: January 4, 2016. ■ 1. The authority citation for part 180 * * * * *
continues to read as follows:
G. Jeffery Herndon,
Acting Director, Registration Division, Office Authority: 21 U.S.C. 321(q), 346a and 371.
of Pesticide Programs. ■ 2. In § 180.960, alphabetically add the
Therefore, 40 CFR chapter I is following polymer to the table to read as
amended as follows: follows:
Polymer CAS No.
* * * * * * *
2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl
ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol, min-
imum number average molecular weight (in amu), 2,600 ......................................................................................................... 1515872–09–9
* * * * * * *
[FR Doc. 2016–00533 Filed 1–12–16; 8:45 am] information about the docket available C. How can I file an objection or hearing
BILLING CODE 6560–50–P at http://www.epa.gov/dockets. request?
FOR FURTHER INFORMATION CONTACT: Under FFDCA section 408(g), 21
Susan Lewis, Registration Division U.S.C. 346a, any person may file an
ENVIRONMENTAL PROTECTION
(7505P), Office of Pesticide Programs, objection to any aspect of this regulation
AGENCY
Environmental Protection Agency, 1200 and may also request a hearing on those
40 CFR Part 180 Pennsylvania Ave. NW., Washington, objections. You must file your objection
DC 20460–0001; main telephone or request a hearing on this regulation
[EPA–HQ–OPP–2014–0680; FRL–9940–90] number: (703) 305–7090; email address: in accordance with the instructions
RDFRNotices@epa.gov. provided in 40 CFR part 178. To ensure
Propyzamide; Pesticide Tolerances
SUPPLEMENTARY INFORMATION:
proper receipt by EPA, you must
AGENCY: Environmental Protection identify the request by the docket ID
Agency (EPA). I. General Information number EPA–HQ–OPP–2014–0680 in
ACTION: Final rule. A. Does this action apply to me? the subject line on the first page of your
submission. All objections and requests
SUMMARY: This regulation establishes a You may be potentially affected by for a hearing must be in writing, and
tolerance for residues of propyzamide, this action if you are an agricultural must be received by the Hearing Clerk
also known as pronamide, in or on leaf producer, food manufacturer, or on or before March 14, 2016. Addresses
lettuce. Dow AgroSciences, LLC pesticide manufacturer. The following for mail and hand delivery of objections
requested this tolerance under the list of North American Industrial and hearing requests are provided in 40
Federal Food, Drug, and Cosmetic Act Classification System (NAICS) codes is CFR 178.25(b).
(FFDCA). not intended to be exhaustive, but rather In addition to filing an objection or
DATES: This regulation is effective provides a guide to help readers hearing request with the Hearing Clerk
January 13, 2016. Objections and determine whether this document as described in 40 CFR part 178, please
requests for hearings must be received applies to them. Potentially affected submit a copy of the filing (excluding
on or before March 14, 2016, and must entities may include: any Confidential Business Information
be filed in accordance with the • Crop production (NAICS code 111). (CBI)) for inclusion in the public docket.
instructions provided in 40 CFR part Information not marked confidential
• Animal production (NAICS code
178 (see also Unit I.C. of the pursuant to 40 CFR part 2 may be
112).
SUPPLEMENTARY INFORMATION). disclosed publicly by EPA without prior
• Food manufacturing (NAICS code notice. Submit the non-CBI copy of your
ADDRESSES: The docket for this action,
identified by docket identification (ID) 311). objection or hearing request, identified
number EPA–HQ–OPP–2014–0680, is • Pesticide manufacturing (NAICS by docket ID number EPA–HQ–OPP–
available at http://www.regulations.gov code 32532). 2014–0680, by one of the following
or at the Office of Pesticide Programs B. How can I get electronic access to methods:
Regulatory Public Docket (OPP Docket) other related information? • Federal eRulemaking Portal: http://
in the Environmental Protection Agency www.regulations.gov. Follow the online
Docket Center (EPA/DC), West William You may access a frequently updated instructions for submitting comments.
Jefferson Clinton Bldg., Rm. 3334, 1301 electronic version of EPA’s tolerance Do not submit electronically any
Constitution Ave. NW., Washington, DC regulations at 40 CFR part 180 through information you consider to be CBI or
asabaliauskas on DSK5VPTVN1PROD with RULES
20460–0001. The Public Reading Room the Government Printing Office’s e-CFR other information whose disclosure is
is open from 8:30 a.m. to 4:30 p.m., site at http://www.ecfr.gov/cgi-bin/text- restricted by statute.
Monday through Friday, excluding legal idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ • Mail: OPP Docket, Environmental
holidays. The telephone number for the 40tab_02.tpl. To access the OCSPP test Protection Agency Docket Center (EPA/
Public Reading Room is (202) 566–1744, guidelines referenced in this document DC), (28221T), 1200 Pennsylvania Ave.
and the telephone number for the OPP electronically, please go to http:// NW., Washington, DC 20460–0001.
Docket is (703) 305–5805. Please review www.epa.gov/test-guidelines-pesticides- • Hand Delivery: To make special
the visitor instructions and additional and-toxic-substances. arrangements for hand delivery or
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![Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations 1531
and it is recognized as an international or tribal governments, on the Parts per
Commodity
food safety standards-setting relationship between the national million
organization in trade agreements to government and the States or tribal
which the United States is a party. EPA governments, or on the distribution of
may establish a tolerance that is power and responsibilities among the * * * * *
different from a Codex MRL; however, various levels of government or between Lettuce, leaf .......................... 1.0
FFDCA section 408(b)(4) requires that the Federal Government and Indian
EPA explain the reasons for departing tribes. Thus, the Agency has determined
from the Codex level. The Codex has not that Executive Order 13132, entitled * * * * *
established any MRLs for propyzamide. ‘‘Federalism’’ (64 FR 43255, August 10,
V. Conclusion 1999) and Executive Order 13175, * * * * *
entitled ‘‘Consultation and Coordination [FR Doc. 2016–00534 Filed 1–12–16; 8:45 am]
Therefore, tolerances are established with Indian Tribal Governments’’ (65 FR BILLING CODE 6560–50–P
for residues of propyzamide 67249, November 9, 2000) do not apply
(pronamide), 3,5-dichloro-N-(1,1- to this action. In addition, this action
dimethyl-2-propynyl)benzamide, in or does not impose any enforceable duty or GENERAL SERVICES
on lettuce, leaf at 1.0 ppm. contain any unfunded mandate as ADMINISTRATION
VI. Statutory and Executive Order described under Title II of the Unfunded
Reviews Mandates Reform Act (UMRA) (2 U.S.C. 48 CFR Parts 501, 504, 509, 519, 522,
1501 et seq.). 536, 537, 552, and 570
This action establishes a tolerance
under FFDCA section 408(d) in This action does not involve any [GSAR–TA–01; Docket No. 2015–0016;
response to a petition submitted to the technical standards that would require Sequence No. 1]
Agency. The Office of Management and Agency consideration of voluntary
Budget (OMB) has exempted these types consensus standards pursuant to section General Services Administration
of actions from review under Executive 12(d) of the National Technology Acquisition Regulation (GSAR);
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act Technical Amendments
Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note). AGENCY: Office of Acquisition Policy,
October 4, 1993). Because this action General Services Administration (GSA).
VII. Congressional Review Act
has been exempted from review under ACTION: Final rule.
Executive Order 12866, this action is Pursuant to the Congressional Review
not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will SUMMARY: General Services
entitled ‘‘Actions Concerning submit a report containing this rule and Administration (GSA) is amending the
Regulations That Significantly Affect other required information to the U.S. General Services Administration
Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of Acquisition Regulation (GSAR) to make
FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller editorial changes. This technical
Order 13045, entitled ‘‘Protection of General of the United States prior to amendment includes updating
Children from Environmental Health publication of the rule in the Federal references and links, as well as deleting
Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major repetitive information that is covered
April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2). elsewhere within the General Services
contain any information collections Administration Acquisition Manual
subject to OMB approval under the List of Subjects in 40 CFR Part 180 (GSAM). Changes incorporate both
Paperwork Reduction Act (PRA) (44 internal acquisition guidance, and the
Environmental protection,
U.S.C. 3501 et seq.), nor does it require regulatory acquisition policies.
Administrative practice and procedure,
any special considerations under DATES: Effective: January 13, 2016.
Agricultural commodities, Pesticides
Executive Order 12898, entitled
and pests, Reporting and recordkeeping FOR FURTHER INFORMATION CONTACT: Ms.
‘‘Federal Actions to Address
requirements. Leah Price, Procurement Analyst, by
Environmental Justice in Minority
Populations and Low-Income Dated: December 31, 2015. phone at 703–605–2558, or email at
Populations’’ (59 FR 7629, February 16, Susan Lewis,
leah.price@gsa.gov for clarification of
1994). content. For information pertaining to
Director, Registration Division, Office of
Since tolerances and exemptions that the status or publication schedules,
Pesticide Programs.
are established on the basis of a petition contact the Regulatory Secretariat
under FFDCA section 408(d), such as Therefore, 40 CFR chapter I is Division at 202–501–4755. Please cite
the tolerance in this final rule, do not amended as follows: GSAR–TA–01; Technical Amendments.
require the issuance of a proposed rule, SUPPLEMENTARY INFORMATION: GSA is
the requirements of the Regulatory PART 180—[AMENDED] amending the GSAR to make editorial
Flexibility Act (RFA) (5 U.S.C. 601 et changes throughout the GSAM. There
seq.), do not apply. ■ 1. The authority citation for part 180 are no significant content changes
This action directly regulates growers, continues to read as follows: resulting from this technical
food processors, food handlers, and food Authority: 21 U.S.C. 321(q), 346a and 371. amendment.
asabaliauskas on DSK5VPTVN1PROD with RULES
retailers, not States or tribes, nor does Outdated references and links have
this action alter the relationships or ■ 2. In § 180.317, add alphabetically been updated. Throughout multiple
distribution of power and ‘‘Lettuce, leaf’’ to the table in paragraph GSAM parts, the Central Contractor
responsibilities established by Congress (a) to read as follows: Registration (CCR) and the Excluded
in the preemption provisions of FFDCA Parties List System (EPLS) have been
§ 180.317 Propyzamide; tolerances for changed to System for Award
section 408(n)(4). As such, the Agency
residues.
has determined that this action will not Management (SAM). This follows
have a substantial direct effect on States (a) * * * similar Federal Acquisition Regulation
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Document Created: 2016-01-13 01:01:01
Document Modified: 2016-01-13 01:01:01
| 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 January 13, 2016. Objections and requests for hearings must be received on or before March 14, 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 1526 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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