Propamocarb; Pesticide Tolerance, 9519-9523 [2017-02479]

Download as PDF Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations stationary source monitoring and reporting requirements of section 110(a)(2)(F). We will address these requirements in a separate action. [FR Doc. 2017–02530 Filed 2–6–17; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2016–0083; FRL–9957–68] Propamocarb; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a tolerance for residues of propamocarb in or on potato. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 7, 2017. Objections and requests for hearings must be received on or before April 10, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2016–0083, 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: 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: RDFRNotices@ epa.gov. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with RULES SUMMARY: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural VerDate Sep<11>2014 18:06 Feb 06, 2017 Jkt 241001 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/textidx?&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–2016–0083 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 10, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2016–0083, 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. PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 9519 • 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 October 27, 2016 (81 FR 74753) (FRL–9954–27), 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 5F8430) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.499 be amended by increasing the tolerance for residues of the fungicide propamocarb hydrochloride, in or on potato from 0.06 to 0.30 parts per million (ppm). That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received concerning this action for propamocarb 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 E:\FR\FM\07FER1.SGM 07FER1 9520 Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations 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 propamocarb-HCl including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with propamocarb-HCl 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. Propamocarb-HCl is a List C carbamate fungicide with specific activity against numerous Oomycete species, which cause foliar diseases and seedling, seed, root, foot, and stem rot in various edible and ornamental crops. Consistent with other carbamates, propamocarb-HCl’s database showed evidence of neurotoxicity in rats, though it does not inhibit cholinesterase. Neurotoxic effects include decreased motor activity following acute exposure and vacuolization of the choroid plexus (ventricles of the brain which produce cerebral spinal fluid) following subchronic and chronic durations. Other effects observed are indicative of toxicity to the digestive and GI tracts in dogs (chronic erosive gastritis, vacuolization of the salivary gland and stomach), and the eye in dogs and rats (hyporeflectability of the fundus, retinal degeneration, and vacuolization of the retinal gland). In all species, decreases in body weights, body-weight gains, and food consumption were observed following subchronic and chronic exposure. Available immunotoxicity data does not indicate an immunotoxic effect from exposure to propamocarb. Effects in the route-specific dermal and inhalation studies were primarily portal-of-entry effects. Dermal exposure caused dermal irritation in rats and rabbits at relatively high doses (>500 milligram/kilogram/day (mg/kg/day)). Inhalation exposure caused labored breathing and the appearance of red material around the nose. Systemic effects were observed following inhalation exposure at similar doses that caused portal-of-entry effects and included kidney cysts and changes in hematological parameters. Effects were observed in fetuses and offspring in the database at the same doses that elicited less severe effects in parental animals. In the developmental rat study, fetal effects included increased death, increased incidences of minor skeletal anomalies, increased incidences of small fetus, inter-atrial septal defects, and hemorrhage in the ears, upper GI tract, and nasopharynx/ sinuses. Maternal effects consisted of decreased absolute body-weights, decreased food consumption, postimplantation loss, and mortality. In the rat two-generation reproduction study, offspring effects consisted of deaths, decreased weights, and decreased viability and lactation indices and litter size. Parental effects were consistent with those previously described for adults in the hazard database. Reproductive effects consisted of increased vacuolization and decreased weight of the epididymides, decreased sperm counts and motility, and abnormal sperm morphology. Propamocarb-HCl was categorized as having low acute toxicity via the oral, dermal, and inhalation routes (Toxicity Categories III–IV). It is not a dermal irritant or a dermal sensitizer. It is considered a slight eye irritant. EPA classified propamocarb-HCl as ‘‘not likely to be carcinogenic to humans’’ by all routes of exposure based upon lack of evidence of carcinogenicity in rats and mice. Specific information on the studies received and the nature of the adverse effects caused by propamocarb-HCl as well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in document, ‘‘Propamocarb Hydrochloride (propamocarb-HCl): Human Health Assessment for Registration Review and a Petition for Increasing the Permanent Tolerance for Residues in/on Potato’’ at pp. 16–18 in docket ID number EPA– HQ–OPP–2016–0083. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of toxicological endpoints for propamocarb-HCl used for humanhealth risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPAMOCARB FOR USE IN HUMAN HEALTH RISK ASSESSMENT mstockstill on DSK3G9T082PROD with RULES Exposure/scenario Acute dietary (Females 13–50 years of age). VerDate Sep<11>2014 18:06 Feb 06, 2017 Point of departure and uncertainty/ safety factors NOAEL = 150 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x Jkt 241001 PO 00000 RfD, PAD, LOC for risk assessment Study and toxicological effects Acute RfD = 1.5 mg/ kg/day. aPAD = 1.5 mg/kg/ day. Developmental Toxicity Study-Rabbit LOAEL = 300 mg/kg/day based on post-implantation loss. Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\07FER1.SGM 07FER1 Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations 9521 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPAMOCARB FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued Exposure/scenario Acute dietary (General population including infants and children). Chronic dietary (All populations) Cancer (Oral, dermal, inhalation). Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects NOAEL = 200 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x NOAEL = 12 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Acute RfD = 2 mg/ kg/day. aPAD = 2 mg/kg/day Acute Neurotoxicity Screening Battery—Rat LOAEL = 2,000 mg/kg/day based on decreased motor activity. Chronic RfD = 0.12 mg/kg/day. cPAD = 0.12 mg/kg/ day. Carcinogenicity Study—Mouse LOAEL = 95 mg/kg/day based on decreased absolute body-weights in females. Classification: ‘‘not likely to be carcinogenic to humans’’ based on the absence of treatment-related tumors in two adequate rodent carcinogenicity studies. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). mstockstill on DSK3G9T082PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to propamocarb, EPA considered exposure under the petitioned-for tolerances as well as all existing propamocarb tolerances in 40 CFR 180.499. EPA assessed dietary exposures from propamocarb 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 propamocarb. 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 used tolerance-level residues and assumed 100% crop treated (PCT) for all commodities. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003–2008 NHANES/ WWEIA. As to residue levels in food, EPA used tolerance-level residues and assumed 100 PCT for all commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that propamocarb does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did VerDate Sep<11>2014 18:06 Feb 06, 2017 Jkt 241001 not use anticipated residue and/or PCT information in the dietary assessment for propamocarb. 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 propamocarb in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of propamocarb. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/ oppefed1/models/water/index.htm. The revised estimated drinking water concentrations (EDWCs) are those modeled for surface waters based on current labels and newly submitted fate and transport data for the registration review of propamocarb-HCl. All currently labeled uses were assessed including the potato tolerance increase described in this action. Surface water values were obtained from FLnurserySTD_V2 model for the acute value, and NJnurserySTD_V2 model for the chronic values representing foliar application to ornamentals in nurseries. Ground Water acute and chronic values were obtained from FLCITRUS_STD.SCN GW scenario. The EDWCs of propamocarb for acute exposures are 4,860 parts per billion (ppb) for surface water, and 73 ppb for ground water. The EDWCs of propamocarb for chronic exposure for non-cancer assessments are 385 ppb for surface water, and 70 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 4,860 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 385 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 nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Propamocarb is registered for use on golf course turf, which may result in dermal post-application exposures. Although potential dermal postapplication exposures were previously assessed (K. Lowe, 05/15/2013, D377624), EPA no longer considers the effects found in the dermal study to be adverse and therefore, no longer identifies a dermal hazard. As a result, there is no need to conduct a quantitative residential exposure assessment. 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 propamocarb to share a common mechanism of toxicity with any other substances, and propamocarb does not appear to produce a toxic metabolite produced by other substances. Although a carbamate, propamocarb-HCl is not an E:\FR\FM\07FER1.SGM 07FER1 9522 Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES N-methyl carbamate and does not cause cholinesterase inhibition. Thus, it was not included in the N-methyl carbamate cumulative risk assessment. For the purposes of this tolerance action, therefore, EPA has assumed that propamocarb does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There is no evidence of increased quantitative pre- or post-natal susceptibility following exposure to propamocarb-HCl. There is evidence of increased qualitative susceptibility in the database; however, concern for these effects is low because: (1) The effects are well characterized, (2) clear NOAELs were established, (3) the endpoints selected are protective of these effects, and (4) the effects were seen in the presence of maternal/parental toxicity. 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 propamocarb is complete. ii. Although there was evidence of neurotoxicity (decreased motor activity and vacuolization of the choroid plexus) in several studies following propamocarb-HCl exposure, including the ACN and SCN studies; there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity because the neurotoxicity effects are well-characterized with clear NOAEL/ VerDate Sep<11>2014 18:06 Feb 06, 2017 Jkt 241001 LOAEL values and the selected endpoints are protective of the observed effects. iii. Although there is evidence of increased qualitative susceptibility from exposure to propamocarb, there is no need to retain the 10X FQPA SF because: (1) The effects are well characterized; (2) clear NOAELs were established; (3) the endpoints selected are protective of these effects; and (4) the effects were seen in the presence of maternal/parental toxicity. 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 propamocarb in drinking water. These assessments will not underestimate the exposure and risks posed by propamocarb. 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 propamocarb will occupy 21% of the aPAD for females (13–49 years old) and 42% of the aPAD for infants (<1 year 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 propamocarb from food and water will utilize 26% of the cPAD for children (3–5 years old) the population group receiving the greatest exposure. There are no chronic or long-term residential exposures from uses of propamocarb. 3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no short-term or intermediateterm adverse effect was identified, PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 propamocarb is not expected to pose a short-term or intermediate-term risk. IV. Other Considerations A. Analytical Enforcement Methodology A gas chromatography/nitrogenphosphorus detection (GC/NPD) method is available for the enforcement of residues of propamocarb in plant commodities. This method has undergone a successful independent laboratory validation (ILV) and petition method validation (PMV), and is currently listed in the Pesticide Analytical Manual (PAM) Vol. II. An adequate liquid chromatography with tandem mass spectrometry (LC/MS/MS) for the enforcement of residues of propamocarb and its metabolites in livestock commodities has been submitted to the Agency. This method has undergone successful ILVs and a PMV. The results of a Food and Drug Administration (FDA) multiresidue testing study indicate that propamocarb and its metabolites are not recovered by any of the protocols. The recoveries of propamocarb with the QuEChERS multiresidue method are marginally adequate (68–69%; http://www.crlpesticides.eu/library/docs/fv/CRLFV_ Multiresidue_methods.pdf). 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 established a MRL for propamocarb in or on potato at 0.30 ppm. This MRL is the same as the tolerance established for propamocarb in the United States. V. Conclusion Therefore, a tolerance is established for residues of propamocarb in or on potato at 0.30 ppm. E:\FR\FM\07FER1.SGM 07FER1 mstockstill on DSK3G9T082PROD with RULES Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations 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 VerDate Sep<11>2014 18:06 Feb 06, 2017 Jkt 241001 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). ENVIRONMENTAL PROTECTION AGENCY VII. Congressional Review Act 9523 SUMMARY: Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 6, 2017. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.499, revise the entry for ‘‘Potato’’ in the table in paragraph (a) to read as follows: ■ § 180.499 Propamocarb; tolerances for residues. (a) * * * Parts per million Commodity * * * * * * * * * * * * 0.30 * * [FR Doc. 2017–02479 Filed 2–6–17; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 [EPA–HQ–OPP–2016–0594; FRL–9958–07] 2,4–D; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a tolerance for residues of 2,4–D in or on cotton, gin byproducts and amends the existing tolerance on cotton, undelinted seed. Dow AgroSciences requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 7, 2017. Objections and requests for hearings must be received on or before April 10, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2016–0594, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information * Potato ................................... 40 CFR Part 180 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 E:\FR\FM\07FER1.SGM 07FER1

Agencies

[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Rules and Regulations]
[Pages 9519-9523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02479]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0083; FRL-9957-68]


Propamocarb; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
propamocarb in or on potato. Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 7, 2017. Objections and 
requests for hearings must be received on or before April 10, 2017, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0083, 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: 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: RDFRNotices@epa.gov.

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-2016-0083 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 10, 2017. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0083, 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 October 27, 2016 (81 FR 74753) (FRL-
9954-27), 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 
5F8430) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.499 be amended by increasing the tolerance for residues of the 
fungicide propamocarb hydrochloride, in or on potato from 0.06 to 0.30 
parts per million (ppm). That document referenced a summary of the 
petition prepared by Bayer CropScience, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received concerning this action for propamocarb 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

[[Page 9520]]

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 
propamocarb-HCl including exposure resulting from the tolerances 
established by this action. EPA's assessment of exposures and risks 
associated with propamocarb-HCl 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.
    Propamocarb-HCl is a List C carbamate fungicide with specific 
activity against numerous Oomycete species, which cause foliar diseases 
and seedling, seed, root, foot, and stem rot in various edible and 
ornamental crops.
    Consistent with other carbamates, propamocarb-HCl's database showed 
evidence of neurotoxicity in rats, though it does not inhibit 
cholinesterase. Neurotoxic effects include decreased motor activity 
following acute exposure and vacuolization of the choroid plexus 
(ventricles of the brain which produce cerebral spinal fluid) following 
subchronic and chronic durations. Other effects observed are indicative 
of toxicity to the digestive and GI tracts in dogs (chronic erosive 
gastritis, vacuolization of the salivary gland and stomach), and the 
eye in dogs and rats (hyporeflectability of the fundus, retinal 
degeneration, and vacuolization of the retinal gland). In all species, 
decreases in body weights, body-weight gains, and food consumption were 
observed following subchronic and chronic exposure. Available 
immunotoxicity data does not indicate an immunotoxic effect from 
exposure to propamocarb.
    Effects in the route-specific dermal and inhalation studies were 
primarily portal-of-entry effects. Dermal exposure caused dermal 
irritation in rats and rabbits at relatively high doses (>500 
milligram/kilogram/day (mg/kg/day)). Inhalation exposure caused labored 
breathing and the appearance of red material around the nose. Systemic 
effects were observed following inhalation exposure at similar doses 
that caused portal-of-entry effects and included kidney cysts and 
changes in hematological parameters.
    Effects were observed in fetuses and offspring in the database at 
the same doses that elicited less severe effects in parental animals. 
In the developmental rat study, fetal effects included increased death, 
increased incidences of minor skeletal anomalies, increased incidences 
of small fetus, inter-atrial septal defects, and hemorrhage in the 
ears, upper GI tract, and nasopharynx/sinuses. Maternal effects 
consisted of decreased absolute body-weights, decreased food 
consumption, post-implantation loss, and mortality. In the rat two-
generation reproduction study, offspring effects consisted of deaths, 
decreased weights, and decreased viability and lactation indices and 
litter size. Parental effects were consistent with those previously 
described for adults in the hazard database. Reproductive effects 
consisted of increased vacuolization and decreased weight of the 
epididymides, decreased sperm counts and motility, and abnormal sperm 
morphology.
    Propamocarb-HCl was categorized as having low acute toxicity via 
the oral, dermal, and inhalation routes (Toxicity Categories III-IV). 
It is not a dermal irritant or a dermal sensitizer. It is considered a 
slight eye irritant.
    EPA classified propamocarb-HCl as ``not likely to be carcinogenic 
to humans'' by all routes of exposure based upon lack of evidence of 
carcinogenicity in rats and mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by propamocarb-HCl 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, ``Propamocarb Hydrochloride 
(propamocarb-HCl): Human Health Assessment for Registration Review and 
a Petition for Increasing the Permanent Tolerance for Residues in/on 
Potato'' at pp. 16-18 in docket ID number EPA-HQ-OPP-2016-0083.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of toxicological endpoints for propamocarb-HCl used for 
human-health risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Propamocarb 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 (Females 13-50       NOAEL = 150 mg/kg/    Acute RfD = 1.5 mg/  Developmental Toxicity Study-
 years of age).                     day.                  kg/day.              Rabbit LOAEL = 300 mg/kg/day
                                   UFA = 10x...........  aPAD = 1.5 mg/kg/     based on post-implantation loss.
                                   UFH = 10x...........   day.
                                   FQPA SF = 1x........

[[Page 9521]]

 
Acute dietary (General population  NOAEL = 200 mg/kg/    Acute RfD = 2 mg/kg/ Acute Neurotoxicity Screening
 including infants and children).   day.                  day.                 Battery--Rat LOAEL = 2,000 mg/kg/
                                   UFA = 10x...........  aPAD = 2 mg/kg/day.   day based on decreased motor
                                   UFH = 10x...........                        activity.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  NOAEL = 12 mg/kg/day  Chronic RfD = 0.12   Carcinogenicity Study--Mouse LOAEL
                                   UFA = 10x...........   mg/kg/day.           = 95 mg/kg/day based on decreased
                                   UFH = 10x...........  cPAD = 0.12 mg/kg/    absolute body-weights in females.
                                   FQPA SF = 1x........   day.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``not likely to be carcinogenic to humans'' based on the
                                    absence of treatment-related tumors in two adequate rodent carcinogenicity
                                    studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to propamocarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing propamocarb tolerances in 40 CFR 
180.499. EPA assessed dietary exposures from propamocarb 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 propamocarb. 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 used tolerance-level residues and assumed 100% crop treated 
(PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level 
residues and assumed 100 PCT for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that propamocarb does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for propamocarb. 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 propamocarb in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of propamocarb. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The revised estimated drinking water concentrations (EDWCs) are 
those modeled for surface waters based on current labels and newly 
submitted fate and transport data for the registration review of 
propamocarb-HCl. All currently labeled uses were assessed including the 
potato tolerance increase described in this action.
    Surface water values were obtained from FLnurserySTD_V2 model for 
the acute value, and NJnurserySTD_V2 model for the chronic values 
representing foliar application to ornamentals in nurseries. Ground 
Water acute and chronic values were obtained from FLCITRUS_STD.SCN GW 
scenario.
    The EDWCs of propamocarb for acute exposures are 4,860 parts per 
billion (ppb) for surface water, and 73 ppb for ground water. The EDWCs 
of propamocarb for chronic exposure for non-cancer assessments are 385 
ppb for surface water, and 70 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 4,860 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 385 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). Propamocarb is 
registered for use on golf course turf, which may result in dermal 
post-application exposures. Although potential dermal post-application 
exposures were previously assessed (K. Lowe, 05/15/2013, D377624), EPA 
no longer considers the effects found in the dermal study to be adverse 
and therefore, no longer identifies a dermal hazard. As a result, there 
is no need to conduct a quantitative residential exposure assessment.
    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 
propamocarb to share a common mechanism of toxicity with any other 
substances, and propamocarb does not appear to produce a toxic 
metabolite produced by other substances. Although a carbamate, 
propamocarb-HCl is not an

[[Page 9522]]

N-methyl carbamate and does not cause cholinesterase inhibition. Thus, 
it was not included in the N-methyl carbamate cumulative risk 
assessment. For the purposes of this tolerance action, therefore, EPA 
has assumed that propamocarb does not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's Web site 
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased quantitative pre- or post-natal susceptibility following 
exposure to propamocarb-HCl. There is evidence of increased qualitative 
susceptibility in the database; however, concern for these effects is 
low because: (1) The effects are well characterized, (2) clear NOAELs 
were established, (3) the endpoints selected are protective of these 
effects, and (4) the effects were seen in the presence of maternal/
parental toxicity.
    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 propamocarb is complete.
    ii. Although there was evidence of neurotoxicity (decreased motor 
activity and vacuolization of the choroid plexus) in several studies 
following propamocarb-HCl exposure, including the ACN and SCN studies; 
there is no need for a developmental neurotoxicity study or additional 
uncertainty factors (UFs) to account for neurotoxicity because the 
neurotoxicity effects are well-characterized with clear NOAEL/LOAEL 
values and the selected endpoints are protective of the observed 
effects.
    iii. Although there is evidence of increased qualitative 
susceptibility from exposure to propamocarb, there is no need to retain 
the 10X FQPA SF because: (1) The effects are well characterized; (2) 
clear NOAELs were established; (3) the endpoints selected are 
protective of these effects; and (4) the effects were seen in the 
presence of maternal/parental toxicity.
    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 propamocarb in drinking water. These assessments 
will not underestimate the exposure and risks posed by propamocarb.

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 propamocarb will occupy 21% of the aPAD for females (13-49 years 
old) and 42% of the aPAD for infants (<1 year 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 
propamocarb from food and water will utilize 26% of the cPAD for 
children (3-5 years old) the population group receiving the greatest 
exposure. There are no chronic or long-term residential exposures from 
uses of propamocarb.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Because no 
short-term or intermediate-term adverse effect was identified, 
propamocarb is not expected to pose a short-term or intermediate-term 
risk.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A gas chromatography/nitrogen-phosphorus detection (GC/NPD) method 
is available for the enforcement of residues of propamocarb in plant 
commodities. This method has undergone a successful independent 
laboratory validation (ILV) and petition method validation (PMV), and 
is currently listed in the Pesticide Analytical Manual (PAM) Vol. II. 
An adequate liquid chromatography with tandem mass spectrometry (LC/MS/
MS) for the enforcement of residues of propamocarb and its metabolites 
in livestock commodities has been submitted to the Agency. This method 
has undergone successful ILVs and a PMV. The results of a Food and Drug 
Administration (FDA) multiresidue testing study indicate that 
propamocarb and its metabolites are not recovered by any of the 
protocols. The recoveries of propamocarb with the QuEChERS multiresidue 
method are marginally adequate (68-69%; http://www.crl-pesticides.eu/library/docs/fv/CRLFV_Multiresidue_methods.pdf).

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 established a MRL for propamocarb in or on potato at 
0.30 ppm. This MRL is the same as the tolerance established for 
propamocarb in the United States.

V. Conclusion

    Therefore, a tolerance is established for residues of propamocarb 
in or on potato at 0.30 ppm.

[[Page 9523]]

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: January 6, 2017.
Daniel J. Rosenblatt,
Acting 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.  180.499, revise the entry for ``Potato'' in the table in 
paragraph (a) to read as follows:


Sec.  180.499  Propamocarb; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Potato..................................................            0.30
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-02479 Filed 2-6-17; 8:45 am]
 BILLING CODE 6560-50-P