80 FR 68772 - Acetamiprid; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 215 (November 6, 2015)
Federal Register Volume 80, Issue 215 (November 6, 2015)
| Page Range | 68772-68778 | |
| FR Document | 2015-28356 |
[Federal Register Volume 80, Number 215 (Friday, November 6, 2015)] [Rules and Regulations] [Pages 68772-68778] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-28356] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0740; FRL-9936-12] Acetamiprid; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation revises existing tolerances with regional restrictions for residues of acetamiprid in or on clover, forage and clover, hay. Interregional Research Project Number 4 (IR-4) requested this tolerance action under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 6, 2015. Objections and requests for hearings must be received on or before January 5, 2016, and must [[Page 68773]] 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-2014-0740, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0740 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 January 5, 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-2014-0740, 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, 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 February 11, 2015 (80 FR 7559) (FRL- 9921-94), 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 4E8307) by IR-4, IR-4 Project Headquarters, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR 180.578 be amended by revising (increasing) tolerances for residues of the insecticide, acetamiprid (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'- cyano-N-methylethanimidamide, including its metabolites and degradates, in or on clover, forage from 0.10 to 0.3 parts per million (ppm) and clover, hay from 0.01 to 1.5 ppm. That document referenced a summary of the petition prepared by Nisso America Incorporated, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has modified the tolerance for clover, hay from what was requested. The reason for this change is explained in Unit IV.D. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . . '' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for acetamiprid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acetamiprid 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 [[Page 68774]] concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Acetamiprid is moderately toxic in acute lethality studies via the oral route of exposure and is minimally toxic via the dermal and inhalation routes of exposure. It is not an eye or skin irritant, nor is it a dermal sensitizer. Acetamiprid does not appear to have specific target organ toxicity. Generalized toxicity was observed as decreases in body weight, body weight gain, food consumption and food efficiency in all species tested. Generalized liver effects were also observed in mice and rats (hepatocellular vacuolation in rats and hepatocellular hypertrophy in mice and rats); the effects were considered to be adaptive. Other effects observed in the oral studies include amyloidosis of multiple organs in the mouse oncogenicity study, tremors in high dose females in the mouse subchronic study, and microconcretions in the kidney papilla and mammary hyperplasia in the rat chronic/oncogenicity study. No effects were observed in a dermal toxicity study in rabbits. In the rat developmental study, fetal shortening of the 13th rib was observed in fetuses at the same dose level that produced maternal effects (reduced body weight and body weight gain and increased liver weights). In the developmental rabbit study, no developmental effects were observed in fetuses at doses that reduced maternal body weight and food consumption. In the reproduction study, decreased body weight, body weight gain, and food consumption were observed in parental animals while significant reductions in pup weights were seen in the offspring in both generations. Also observed were reductions in litter size, and viability and weaning indices among F 2 offspring as well as significant delays in the age to attain vaginal opening and preputial separation. In the developmental neurotoxicity study, parental effects were limited to decreased body weight and body weight gains, while the offspring effects noted were decreased body weights and body weight gains, decreased pre-weaning survival, and decreased maximum auditory startle response. In the acute neurotoxicity study, male and female rats displayed decreased motor activity, tremors, walking and posture abnormalities, dilated pupils, coldness to the touch and decreased grip strength and foot splay at the highest dose tested (HDT). There were clinical signs (decreases auditory startle, tremors) noted in rats and mice in the developmental neurotoxicity (DNT) and subchronic mouse studies. However, no neurotoxic effects were seen in the subchronic neurotoxicity study in rats. No neuropathology was observed in the toxicology studies. In immunotoxicity studies performed in both sexes of rats and mice, no effects on the immune system were observed up to the highest dose, although significant reductions in body weight and body weight gain were noted at that dose. Based on acceptable carcinogenicity studies in rats and mice, EPA has determined that acetamiprid is ``not likely to be carcinogenic to humans.'' The classification is based on (1) the absence of an increase in the incidence of tumors in a mouse carcinogenicity study; and (2) in a rat chronic/carcinogenicity study, the absence of a dose-response and the lack of a statistically significant increase in the mammary adenocarcinoma incidence by pair-wise comparison of the mid- and high- dose groups with the controls. There was no clear evidence of a mutagenic effect. Acetamiprid tested positive as a clastogen in an in vitro study but not in an in vivo study. Specific information on the studies received and the nature of the adverse effects caused by acetamiprid 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, ``Subject: Acetamiprid. Human Health Risk Assessment. . . . .for Use of the Insecticide on Clover. . . . .Interval (Regional Registration)'' dated September 2, 2015 at pp. 42 in docket ID number EPA-HQ-OPP-2014-0740. 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 the toxicological endpoints for acetamiprid used for human risk assessment is discussed in Unit III of the final rule published in the Federal Register of June 19, 2013 (78 FR 36671) (FRL- 9391-2). However, in this tolerance rule, an additional new use is considered spot-on treatments for dogs. This newly proposed spot-on dog treatment to control fleas, ticks, and mosquitoes has potential for long-term exposure in residential indoor settings; therefore, the Agency selected additional endpoints and POD for the following exposure/scenarios: (1) Long-term (>6 months) incidental oral (hand-to- mouth in children) and (2) Long-term (>6 months) dermal. The endpoints/ PODs selected were the same for both scenarios, based on effects observed in a rat chronic toxicity/oncogenicity study. In the study, at the LOAEL of 17.5 milligram/kilogram/day (mg/kg/day), decreased body weight and body weight gains were noted in females and hepatocellular vacuolation were noted in males. The NOAEL in the study is 7.1 mg/kg/ day. The level of concern (LOC) is 100, based on an interspecies uncertainty factor of 10X, an intra-species uncertainty factor of 10X, and an Food Quality Protection Act (FQPA) safety factor of 1X. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acetamiprid, EPA considered exposure under the petitioned- for tolerances as well as all existing acetamiprid tolerances in 40 CFR 180.578. EPA assessed dietary exposures from acetamiprid 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 acetamiprid. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake [[Page 68775]] Database (DEEM-FCID), Version 3.16. This software uses 2003-2008 food consumption data from the US Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues in the assessment. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used DEEM-FCID, Version 3.16 and food consumption data from the 2003-2008 USDA NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and tolerance-level residues in the assessment. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that acetamiprid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for acetamiprid. Tolerance-level residues and 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 acetamiprid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of acetamiprid. 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. EPA used the Food Quality Protection Act Index Reservoir Screening Tool (FIRST) and the Provisional Cranberry Model to generate surface water Estimated Drinking Water Concentrations (EDWCs) for use in the human health dietary risk assessment, while the Pesticide Root Zone Model for Groundwater (PRZM-GW) was used to generate groundwater EDWCs. The EDWCs of acetamiprid for acute exposures are 88.3 parts per billion (ppb) for surface water and 49.7 ppb for ground water. For chronic exposures for non-cancer assessments are estimated to be 32.2 ppb for surface water and 45.0 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 88.3 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 45 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). Acetamiprid is currently registered for the following uses that could result in residential exposures: Controlling a wide variety of indoor and outdoor insect pests using insecticide traps, crack and crevice treatments, soil treatments, and sprays. There is also a proposal to register acetamiprid for use by homeowners and commercial applicators as a monthly topical spot-on product for dogs only (not cats) to provide continuous protection against fleas, ticks, and mosquitoes. Residential exposure from proposed dog spot-on product is anticipated to result in dermal exposures for adult handlers. In addition, residential post-application dermal exposures are expected for adults and children 1 to 2 years old, and incidental oral exposures for children 1 to 2 years old. Inhalation exposure from the use of the spot-on product is considered negligible. Therefore, only dermal and incidental oral exposure were assessed for the proposed product. Residential post-application exposures are expected to be short- (1 to 30 days), intermediate- (1 to 6 months) for the indoor treatments, and long-term (greater than 6 months) in duration from pet spot-on products. Residential handler exposure is assumed to be short-term due to the intermittent nature of homeowner spot-on applications (once- monthly treatment). EPA assessed all these uses and conducted an aggregate residential exposure using the following assumptions: Residential handler exposures: The Agency used short-term and intermediate-term dermal and inhalation exposure estimates to adult applicators from applications to mattresses, cracks and crevices in the aggregate risk assessment. Post-application exposures: The Agency used short-term and intermediate-term dermal and inhalation exposure estimates to adults and children 1 to 2 years old from indoor applications (mattress treatment and crack and crevice treatments) and long-term dermal exposure estimates to adults and children 1 to 2 years old from contact with spot-on treated pets. In addition, the Agency used short-term and intermediate-term hand-to-mouth exposure estimates to children 1-2 years old from indoor applications and long-term hand-to-mouth exposure estimates from contact with spot-on treated pets. EPA combines risk values resulting from separate routes of exposure when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population, and if the hazard associated with the PODs is similar across routes. Residential post-application inhalation exposure is expected to be negligible from the proposed spot-on product; therefore, a quantitative assessment was not performed. For children 1 to 2 years old, post-application dermal and incidental oral (hand-to-mouth) exposures were combined for short-, intermediate-, and long-term durations. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at: http://www.epa.gov/pesticides/science/residential-exposure-sop.html. 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 acetamiprid to share a common mechanism of toxicity with any other substances, and acetamiprid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acetamiprid 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 [[Page 68776]] and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The pre- and post-natal toxicity databases for acetamiprid include developmental toxicity studies in the rat and rabbit, developmental neurotoxicity (DNT) study in rats and a 2-generation reproduction toxicity study in rats. There was no evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses following in utero exposure to acetamiprid in the developmental toxicity studies. In the DNT and 2-generation reproduction studies there was no evidence of quantitative increased susceptibility observed. However, there was evidence of increased qualitative susceptibility of rat pups seen in the studies. In the DNT study in rats, although both maternal and offspring effects were seen at the same dose level, offspring animals were more severely affected. Decreased pre-weaning survival, and decreased maximum auditory startle response were observed in the presence of limited maternal toxicity (body weight effects). In the 2-generation reproduction study, effects observed were a decrease in mean body weight, body weight gain, and food consumption in the parental animals, and significant reductions in body weights in pups (both generations). Also, reduction in litter size and viability and weaning indices were seen among F2 offspring, as well as significant delays in the age to attain vaginal opening and preputial separation. These offspring adverse effects were more severe than the parental effects. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings: i. The toxicology database for acetamiprid is complete. ii. Although there was evidence of increased qualitative susceptibility of the young in the DNT and 2-generation reproduction studies, there are clear NOAELs identified for the effects observed in the toxicity studies. Also, there was no evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses in the developmental toxicity studies. iii. Acetamiprid produced signs of neurotoxicity in the high dose groups in the acute and developmental neurotoxicity studies in rats and the subchronic toxicity study in mice. However, no neurotoxic findings were reported in the subchronic neurotoxicity study in rats. Additionally, there are clear NOAELs identified for the effects observed in the toxicity studies. The doses and endpoints selected for risk assessment are protective and account for all toxicological effects observed in the database, including neurotoxicity. iv. EPA has used conservative assumptions in the exposure (food, drinking water, and residential) assessment, including the use of 100 PCT assumptions, tolerance-level residue values, and upper-bound estimates of potential exposure through drinking water. In addition, the residential exposure assessment was conducted such that residential exposure and risk will not be underestimated. The aggregate exposure and risk estimates considered are expected to over-estimate the actual exposure and risk anticipated, based on the current and proposed use patterns; no risk estimates of concern were identified. 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 acetamiprid will occupy 67% of the aPAD for children 1-2 years old, the population subgroup receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions discussed in this unit for chronic exposure, EPA has concluded that chronic exposure to acetamiprid from food and water will utilize 61% of the cPAD for children 1-2 years old, the population subgroup receiving the greatest exposure. Based on the explanation in Unit III.C.3., adult aggregate exposures reflect background exposure from food and water, plus long- term post-application dermal exposure from contact with dogs following spot-on treatment. For children 1-2 years old, long-term aggregate assessment reflects post-application dermal and hand-to-mouth (incidental) exposures from contact with spot-on treated dogs. The chronic dietary exposure and post-application pet spot-on residential exposure were aggregated and compared to the long-term POD. Adult and children long-term aggregate MOEs were 570 and 100, respectively, are >=100, and indicate that risk estimates are not of concern. The chronic dietary exposure estimates are highly conservative, assuming tolerance- level residues and 100 PCT for all commodities. Therefore, EPA also considers the aggregate MOEs to be conservative estimates. 3. Short- and Intermediate-term risk. Short-term and intermediate aggregate exposure take into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acetamiprid is currently registered for uses that could result in short- and intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate- term residential exposures to acetamiprid. Toxicological endpoints and POD for assessing short- and intermediate-term risks associated with exposure to acetamiprid are identical. Therefore, separate assessments are not being conducted for these durations. Using the exposure assumptions described in this unit for short- and intermediate-term exposures which represent the combined short- and intermediate-term food, water, and residential exposures aggregate. Additionally, for adults, reflect dermal and inhalation exposures from applications to mattresses, cracks and crevices, and for children 1-2 years old short- and intermediate- term aggregate assessment reflects dermal, inhalation, and hand-to-mouth exposures from post-application exposures following indoor applications. EPA concluded the combined short- and intermediate-term food, water, and residential exposures result in aggregate MOEs of 300 for adults and 110 for children. Both short- and intermediate- term aggregate MOEs are >=100, and indicate that risks are not of concern. The chronic dietary exposure estimates are highly conservative, assuming tolerance-level residues and 100 PCT for all commodities. Therefore, EPA also considers the aggregate MOEs to be conservative estimates. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two [[Page 68777]] adequate rodent carcinogenicity studies, acetamiprid is classified as ``not likely to be carcinogenic to human'' and not expected to pose a cancer risk to humans. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to acetamiprid residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodologies are available to enforce the tolerance expression including; (1) gas chromatography with electron capture detection (GC/ECD) and (2) high-performance liquid chromotography (HPLC) with tandem mass spectrometric detection liquid chromotography/mass spectrometry/mass spectrometry (LC/MS/MS). The 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, 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 MRLs for acetamiprid in or on clover, forage or clover, hay. C. Response to Comments One comment expressed concern generally for pesticide residues remaining on harvested food crops and potential human health concerns. The commenter further states that ``it is the responsibility of our government to protect American consumers for being harmed by the food they eat and that this action is a step in the right direction for establishing a safer, healthier food system . . . .'' The Agency agrees with these comments. D. Revisions to Petitioned-For Tolerances Available and relevant field trial data support a clover tolerance of 2.0 ppm, instead of the proposed tolerance of 1.5 ppm, in clover hay. The petitioner used residues in clover hay from all field trials which included pre-harvest intervals (PHIs) ranging from 27 to 63 days to calculate the proposed 1.5 ppm tolerance level. Since the proposed labeling stipulates a PHI of 30 days, EPA utilized only those residue data for clover hay collected at PHIs of 27-32 days as the input dataset for the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedure, which yielded a clover hay tolerance level at 2.0 ppm. In clover forage, the recommended tolerance level includes an additional significant figure (0.30 ppm rather than 0.3 ppm). This is in order to avoid the situation where rounding of a residue result to the level of precision of the tolerance expression would be considered non-violative (such as 0.34 ppm being rounded to 0.3 ppm). V. Conclusion Therefore, revised tolerances with regional restrictions are established for residues of the insecticide acetamiprid, (1E)-N-[(6- chloro-3-pyridinyl)methyl]-N--cyano-N-methylethanimidamide, including its metabolites and degradates, in or on clover, forage at 0.30 ppm and clover, hay at 2.0 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). [[Page 68778]] List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: October 29, 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. 180.578, revise the tolerance for commodities in the table in paragraph (c) to read as follows: Sec. 180.578 Acetamiprid; tolerances for residues. * * * * * (c) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Clover, forage.......................................... 0.30 Clover, hay............................................. 2.0 ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-28356 Filed 11-5-15; 8:45 am] BILLING CODE 6560-50-P
![68772 Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations
State EPA
Rule No. Rule title effective Effective Final rule citation/date Comments
date date
(11) XI ......... Reports and Revisions ....... 1/22/1972 6/30/1972 37 FR 10842, 5/31/72.
(12) XII ........ Visibility Protection Class I 9/6/1988 3/17/1989 54 FR 6912, 2/15/89.
(13) XIII ....... Sweetwater PM10 Attain- 1/25/1979 8/1/1979 44 FR 38473, 7/02/79.
ment Plan.
(14) XIV ....... Stack Height Good Engi- 12/9/1988 4/16/1989 54 FR 11186, 3/17/89.
neering Practice.
(15) XV ........ Small Business Assistance 11/30/1993 8/19/1994 59 FR 31548, 6/20/94.
Program.
(16) XVI ....... City of Sheridan—PM10 Air 10/30/1990 7/25/1994 59 FR 32360, 6/23/94.
Quality Control and Main-
tenance Plan.
(17) XVII ...... PSD Implementation for 11/20/1990 6/23/1991 56 FR 23811, 5/24/91.
NOx.
(18) XVIII ..... Interstate Transport, Wyo- 4/15/2008 7/7/2008 73 FR 26019, 5/08/08.
ming Interstate Transport
SIP satisfying the require-
ment of Section
110(a)(2)(D)(i) of the CAA
for the 1997 8-hour
ozone and PM2.5 stand-
ards.
(19) XIX ....... Powder River Basin PM10 12/22/1993 10/11/1995 60 FR 47290, 9/12/95.
Memorandum of Agree-
ment.
(20) XX ........ Addressing Regional Haze 1/7/2011 1/11/2013 77 FR 73926, 12/12/12.
Visibility Protection For
The Mandatory Federal
Class I Areas Required
Under 40 CFR 51.309.
(21) XXI ....... Infrastructure SIP for Sec- 3/26/2008 12/6/2013 78 FR 73445, 12/06/13.
tion 110(a)(2)—1997
PM2.5 NAAQS.
(22) XXII ...... Infrastructure SIP for Sec- 8/19/2011 9/9/2015 80 FR 47857, 8/10/2015.
tion 110(a)(2)—2006
PM2.5 NAAQS.
(23) XXIII ..... Infrastructure SIP for Sec- 12/10/2009 8/24/2011 76 FR 44265, 7/25/11.
tion 110(a)(2)—1997
Ozone NAAQ.
(24) XXIV ..... Air Quality Control Regions 1/22/1972 6/30/1972 37 FR 10842, 5/31/72.
and Emissions Inventory.
(25) XXV ...... Wyoming State Implemen- 1/12/2011 3/3/2014 79 FR 5032, 1/30/14 ................... Excluding portions of the
tation Plan for Regional following: Chapters 6.4,
Haze for 309(g). 6.5.7, 6.5.8, and 7.5. EPA
disapproved (1) the NOX
BART determinations for
(a) Laramie River Units
1–3, (b) Dave Johnston
Unit 3, and (c) Wyodak
Unit 1; (2) the State’s
monitoring, record-
keeping, and reporting re-
quirements for BART
units; and (3) the State’s
reasonable progress
goals.
[FR Doc. 2015–27902 Filed 11–5–15; 8:45 am] ENVIRONMENTAL PROTECTION SUMMARY: This regulation revises
BILLING CODE 6560–50–P AGENCY existing tolerances with regional
restrictions for residues of acetamiprid
40 CFR Part 180 in or on clover, forage and clover, hay.
Interregional Research Project Number 4
[EPA–HQ–OPP–2014–0740; FRL–9936–12] (IR–4) requested this tolerance action
mstockstill on DSK4VPTVN1PROD with RULES
under the Federal Food, Drug, and
Acetamiprid; Pesticide Tolerances Cosmetic Act (FFDCA).
AGENCY: Environmental Protection DATES: This regulation is effective
Agency (EPA). November 6, 2015. Objections and
requests for hearings must be received
ACTION: Final rule.
on or before January 5, 2016, and must
VerDate Sep<11>2014 18:15 Nov 05, 2015 Jkt 238001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\06NOR1.SGM 06NOR1](https://thefederalregister.org/doc/80_FR_68987/page/1.svg)
![Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 68773
be filed in accordance with the C. How can I file an objection or hearing (increasing) tolerances for residues of
instructions provided in 40 CFR part request? the insecticide, acetamiprid (1E)-N-[(6-
178 (see also Unit I.C. of the Under FFDCA section 408(g), 21 chloro-3-pyridinyl)methyl]-N'-cyano-N-
SUPPLEMENTARY INFORMATION). U.S.C. 346a, any person may file an methylethanimidamide, including its
objection to any aspect of this regulation metabolites and degradates, in or on
ADDRESSES: The docket for this action, clover, forage from 0.10 to 0.3 parts per
identified by docket identification (ID) and may also request a hearing on those
objections. You must file your objection million (ppm) and clover, hay from 0.01
number EPA–HQ–OPP–2014–0740, is to 1.5 ppm. That document referenced
available at http://www.regulations.gov or request a hearing on this regulation
a summary of the petition prepared by
or at the Office of Pesticide Programs in accordance with the instructions
Nisso America Incorporated, the
Regulatory Public Docket (OPP Docket) provided in 40 CFR part 178. To ensure
registrant, which is available in the
in the Environmental Protection Agency proper receipt by EPA, you must
docket, http://www.regulations.gov. A
Docket Center (EPA/DC), West William identify docket ID number EPA–HQ–
comment was received on the notice of
Jefferson Clinton Bldg., Rm. 3334, 1301 OPP–2014–0740 in the subject line on
filing. EPA’s response to this comment
Constitution Ave. NW., Washington, DC the first page of your submission. All
is discussed in Unit IV.C.
20460–0001. The Public Reading Room objections and requests for a hearing Based upon review of the data
is open from 8:30 a.m. to 4:30 p.m., must be in writing, and must be supporting the petition, EPA has
Monday through Friday, excluding legal received by the Hearing Clerk on or modified the tolerance for clover, hay
holidays. The telephone number for the before January 5, 2016. Addresses for from what was requested. The reason for
Public Reading Room is (202) 566–1744, mail and hand delivery of objections this change is explained in Unit IV.D.
and the telephone number for the OPP and hearing requests are provided in 40
CFR 178.25(b). III. Aggregate Risk Assessment and
Docket is (703) 305–5805. Please review
In addition to filing an objection or Determination of Safety
the visitor instructions and additional
information about the docket available hearing request with the Hearing Clerk Section 408(b)(2)(A)(i) of FFDCA
at http://www.epa.gov/dockets. as described in 40 CFR part 178, please allows EPA to establish a tolerance (the
submit a copy of the filing (excluding legal limit for a pesticide chemical
FOR FURTHER INFORMATION CONTACT: any Confidential Business Information residue in or on a food) only if EPA
Susan Lewis, Registration Division (CBI)) for inclusion in the public docket. determines that the tolerance is ‘‘safe.’’
(7505P), Office of Pesticide Programs, Information not marked confidential Section 408(b)(2)(A)(ii) of FFDCA
Environmental Protection Agency, 1200 pursuant to 40 CFR part 2 may be defines ‘‘safe’’ to mean that ‘‘there is a
Pennsylvania Ave. NW., Washington, disclosed publicly by EPA without prior reasonable certainty that no harm will
DC 20460–0001; main telephone notice. Submit the non-CBI copy of your result from aggregate exposure to the
number: (703) 305–7090; email address: objection or hearing request, identified pesticide chemical residue, including
RDFRNotices@epa.gov. by docket ID number EPA–HQ–OPP– all anticipated dietary exposures and all
SUPPLEMENTARY INFORMATION:
2014–0740, by one of the following other exposures for which there is
methods: reliable information.’’ This includes
I. General Information • Federal eRulemaking Portal: http:// exposure through drinking water and in
www.regulations.gov. Follow the online residential settings, but does not include
A. Does this action apply to me? instructions for submitting comments. occupational exposure. Section
You may be potentially affected by Do not submit electronically any 408(b)(2)(C) of FFDCA requires EPA to
this action if you are an agricultural information you consider to be CBI or give special consideration to exposure
producer, food manufacturer, or other information whose disclosure is of infants and children to the pesticide
pesticide manufacturer. The following restricted by statute. chemical residue in establishing a
list of North American Industrial • Mail: OPP Docket, EPA/DC, tolerance and to ‘‘ensure that there is a
Classification System (NAICS) codes is (28221T), 1200 Pennsylvania Ave. NW., reasonable certainty that no harm will
not intended to be exhaustive, but rather Washington, DC 20460–0001. result to infants and children from
provides a guide to help readers • Hand Delivery: To make special aggregate exposure to the pesticide
determine whether this document arrangements for hand delivery or chemical residue . . . . ’’
applies to them. Potentially affected delivery of boxed information, please Consistent with FFDCA section
entities may include: follow the instructions at http:// 408(b)(2)(D), and the factors specified in
www.epa.gov/dockets/contacts.html. FFDCA section 408(b)(2)(D), EPA has
• Crop production (NAICS code 111). Additional instructions on commenting reviewed the available scientific data
• Animal production (NAICS code or visiting the docket, along with more and other relevant information in
112). information about dockets generally, is support of this action. EPA has
• Food manufacturing (NAICS code available at http://www.epa.gov/ sufficient data to assess the hazards of
311). dockets. and to make a determination on
aggregate exposure for acetamiprid
• Pesticide manufacturing (NAICS II. Summary of Petitioned-For
Tolerance including exposure resulting from the
code 32532).
tolerances established by this action.
B. How can I get electronic access to In the Federal Register of February EPA’s assessment of exposures and risks
other related information? 11, 2015 (80 FR 7559) (FRL–9921–94), associated with acetamiprid follows.
EPA issued a document pursuant to
mstockstill on DSK4VPTVN1PROD with RULES
You may access a frequently updated FFDCA section 408(d)(3), 21 U.S.C. A. Toxicological Profile
electronic version of EPA’s tolerance 346a(d)(3), announcing the filing of a EPA has evaluated the available
regulations at 40 CFR part 180 through pesticide petition (PP 4E8307) by IR–4, toxicity data and considered its validity,
the Government Printing Office’s e-CFR IR–4 Project Headquarters, 500 College completeness, and reliability as well as
site at http://www.ecfr.gov/cgi-bin/text- Road East, Suite 201 W., Princeton, NJ the relationship of the results of the
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 08540. The petition requested that 40 studies to human risk. EPA has also
40tab_02.tpl. CFR 180.578 be amended by revising considered available information
VerDate Sep<11>2014 16:19 Nov 05, 2015 Jkt 238001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\06NOR1.SGM 06NOR1](https://thefederalregister.org/doc/80_FR_68987/page/2.svg)
![Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 68777
adequate rodent carcinogenicity studies, protect American consumers for being contain any information collections
acetamiprid is classified as ‘‘not likely harmed by the food they eat and that subject to OMB approval under the
to be carcinogenic to human’’ and not this action is a step in the right direction Paperwork Reduction Act (PRA) (44
expected to pose a cancer risk to for establishing a safer, healthier food U.S.C. 3501 et seq.), nor does it require
humans. system . . . .’’ The Agency agrees with any special considerations under
5. Determination of safety. Based on these comments. Executive Order 12898, entitled
these risk assessments, EPA concludes D. Revisions to Petitioned-For ‘‘Federal Actions to Address
that there is a reasonable certainty that Tolerances Environmental Justice in Minority
no harm will result to the general Populations and Low-Income
population, or to infants and children Available and relevant field trial data Populations’’ (59 FR 7629, February 16,
from aggregate exposure to acetamiprid support a clover tolerance of 2.0 ppm, 1994).
residues. instead of the proposed tolerance of 1.5 Since tolerances and exemptions that
ppm, in clover hay. The petitioner used are established on the basis of a petition
IV. Other Considerations residues in clover hay from all field under FFDCA section 408(d), such as
A. Analytical Enforcement Methodology trials which included pre-harvest the tolerance in this final rule, do not
intervals (PHIs) ranging from 27 to 63 require the issuance of a proposed rule,
Adequate enforcement methodologies days to calculate the proposed 1.5 ppm
are available to enforce the tolerance the requirements of the Regulatory
tolerance level. Since the proposed Flexibility Act (RFA) (5 U.S.C. 601 et
expression including; (1) gas labeling stipulates a PHI of 30 days, EPA
chromatography with electron capture seq.), do not apply.
utilized only those residue data for
detection (GC/ECD) and (2) high- This action directly regulates growers,
clover hay collected at PHIs of 27–32
performance liquid chromotography food processors, food handlers, and food
days as the input dataset for the
(HPLC) with tandem mass spectrometric retailers, not States or tribes, nor does
Organization for Economic Cooperation
detection liquid chromotography/mass this action alter the relationships or
and Development (OECD) tolerance
spectrometry/mass spectrometry (LC/ distribution of power and
calculation procedure, which yielded a
MS/MS). responsibilities established by Congress
clover hay tolerance level at 2.0 ppm.
The methods may be requested from: In clover forage, the recommended in the preemption provisions of FFDCA
Chief, Analytical Chemistry Branch, tolerance level includes an additional section 408(n)(4). As such, the Agency
Environmental Science Center, 701 significant figure (0.30 ppm rather than has determined that this action will not
Mapes Rd., Ft. Meade, MD 20755–5350; 0.3 ppm). This is in order to avoid the have a substantial direct effect on States
telephone number: (410) 305–2905; situation where rounding of a residue or tribal governments, on the
email address: residuemethods@ result to the level of precision of the relationship between the national
epa.gov. tolerance expression would be government and the States or tribal
considered non-violative (such as 0.34 governments, or on the distribution of
B. International Residue Limits power and responsibilities among the
ppm being rounded to 0.3 ppm).
In making its tolerance decisions, EPA various levels of government or between
seeks to harmonize U.S. tolerances with V. Conclusion the Federal Government and Indian
international standards whenever Therefore, revised tolerances with tribes. Thus, the Agency has determined
possible, consistent with U.S. food regional restrictions are established for that Executive Order 13132, entitled
safety standards and agricultural residues of the insecticide acetamiprid, ‘‘Federalism’’ (64 FR 43255, August 10,
practices. EPA considers the (1E)–N–[(6–chloro–3– 1999) and Executive Order 13175,
international maximum residue limits pyridinyl)methyl]–N±-cyano–N- entitled ‘‘Consultation and Coordination
(MRLs) established by the Codex methylethanimidamide, including its with Indian Tribal Governments’’ (65 FR
Alimentarius Commission (Codex), as metabolites and degradates, in or on 67249, November 9, 2000) do not apply
required by FFDCA section 408(b)(4). clover, forage at 0.30 ppm and clover, to this action. In addition, this action
The Codex Alimentarius is a joint hay at 2.0 ppm. does not impose any enforceable duty or
United Nations Food and Agriculture contain any unfunded mandate as
Organization/World Health VI. Statutory and Executive Order described under Title II of the Unfunded
Organization food standards program, Reviews Mandates Reform Act (UMRA) (2 U.S.C.
and it is recognized as an international This action establishes tolerances 1501 et seq.).
food safety standards-setting under FFDCA section 408(d) in This action does not involve any
organization in trade agreements to response to a petition submitted to the technical standards that would require
which the United States is a party. EPA Agency. The Office of Management and Agency consideration of voluntary
may establish a tolerance that is Budget (OMB) has exempted these types consensus standards pursuant to section
different from a Codex MRL; however, of actions from review under Executive 12(d) of the National Technology
FFDCA section 408(b)(4) requires that Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
EPA explain the reasons for departing Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
from the Codex level. October 4, 1993). Because this action
VII. Congressional Review Act
The Codex has not established MRLs has been exempted from review under
for acetamiprid in or on clover, forage Executive Order 12866, this action is Pursuant to the Congressional Review
or clover, hay. not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will
entitled ‘‘Actions Concerning submit a report containing this rule and
mstockstill on DSK4VPTVN1PROD with RULES
C. Response to Comments Regulations That Significantly Affect other required information to the U.S.
One comment expressed concern Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of
generally for pesticide residues FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller
remaining on harvested food crops and Order 13045, entitled ‘‘Protection of General of the United States prior to
potential human health concerns. The Children from Environmental Health publication of the rule in the Federal
commenter further states that ‘‘it is the Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major
responsibility of our government to April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2).
VerDate Sep<11>2014 16:19 Nov 05, 2015 Jkt 238001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\06NOR1.SGM 06NOR1](https://thefederalregister.org/doc/80_FR_68987/page/6.svg)
![68778 Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations
List of Subjects in 40 CFR Part 180 Review, NASA conducted a DEPARTMENT OF COMMERCE
Environmental protection, comprehensive review of its regulations
and published two final rules in the National Oceanic and Atmospheric
Administrative practice and procedure,
Federal Register. The final rule Administration
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping published on March 12, 2015, (80 FR
12935) requires the following editorial 50 CFR Part 665
requirements.
Dated: October 29, 2015.
changes: [Docket No. 150615523–5973–03]
Susan Lewis, • Renumber section 1817.7300 as
RIN 0648–XD998
Director, Registration Division, Office of 1817.7000 and section 1817.7302 as
Pesticide Programs. 1817.7002. The final rule published on Pacific Island Pelagic Fisheries; 2015
March 12, 2015, redesignated subpart U.S. Territorial Longline Bigeye Tuna
Therefore, 40 CFR chapter I is
1817.73 as 1817.70, but failed to address Catch Limits for Guam
amended as follows:
its subsections.
AGENCY: National Marine Fisheries
PART 180—[AMENDED] • Correct the clause date at section Service (NMFS), National Oceanic and
1852.215–81. Atmospheric Administration (NOAA),
■ 1. The authority citation for part 180
continues to read as follows: List of Subject in 48 CFR Parts 1817 and Commerce.
1852 ACTION: Final specifications.
Authority: 21 U.S.C. 321(q), 346a and 371.
■ 2. In § 180.578, revise the tolerance for Government procurement. SUMMARY: In this final rule, NMFS
commodities in the table in paragraph specifies a 2015 limit of 2,000 metric
Manuel Quinones, tons (mt) of longline-caught bigeye tuna
(c) to read as follows:
NASA FAR Supplement Manager. for Guam. NMFS will allow the territory
§ 180.578 Acetamiprid; tolerances for to allocate up to 1,000 mt each year to
residues. Accordingly, 48 CFR parts 1817 and
U.S. longline fishing vessels in a
* * * * * 1852 are amended as follows: specified fishing agreement that meets
(c) * * * established criteria. As an
PART 1817—SPECIAL CONTRACTING
accountability measure, NMFS will
Parts per METHODS
Commodity monitor, attribute, and restrict (if
million
necessary) catches of longline-caught
■ 1. The authority citation for part 1817 bigeye tuna, including catches made
Clover, forage ....................... 0.30
is revised to read as follows: under a specified fishing agreement.
Clover, hay ........................... 2.0
Authority: 51 U.S.C. 20113(a) and 48 CFR These catch limits and accountability
* * * * * chapter 1. measures support the long-term
[FR Doc. 2015–28356 Filed 11–5–15; 8:45 am] sustainability of fishery resources of the
BILLING CODE 6560–50–P Subpart 1817–70 [Amended] U.S. Pacific Islands.
DATES: The final specifications are
1817.7300 and 1817.7302 [Redesignated
as 1817.7000 and 1817.7002] effective November 6, 2015, through
NATIONAL AERONAUTICS AND December 31, 2015. The deadline to
SPACE ADMINISTRATION ■ 2. Amend subpart 1817.70 by submit a specified fishing agreement
redesignating section 1817.7300 as pursuant to 50 CFR 665.819(b)(3) for
48 CFR Parts 1817 and 1852 1817.7000 and section 1817.7302 as review is December 7, 2015.
NASA Federal Acquisition Regulation 1817.7002. ADDRESSES: Copies of the fishery
Supplement ecosystem plans are available from the
PART 1852—SOLICITATION Western Pacific Fishery Management
AGENCY: National Aeronautics and PROVISIONS AND CONTRACT Council (Council), 1164 Bishop St.,
Space Administration. CLAUSES Suite 1400, Honolulu, HI 96813, tel
ACTION: Technical amendments. 808–522–8220, fax 808–522–8226, or
■ 3. The authority citation for part 1852 www.wpcouncil.org.
SUMMARY: NASA is making technical continues to read as follows: Copies of the environmental
amendments to the NASA FAR assessment (EA) and finding of no
Authority: 51 U.S.C. 20113(a) and 48 CFR
Supplement (NFS) to provide needed significant impact for this action,
chapter 1.
editorial changes. identified by NOAA–NMFS–2015–0077,
DATES: Effective: November 6, 2015. 1852.215–81 [Amended] are available from www.regulations.gov,
FOR FURTHER INFORMATION CONTACT: or from Michael D. Tosatto, Regional
Manuel Quinones, NASA, Office of ■ 4. Amend section 1852.215–81 by Administrator, NMFS Pacific Islands
Procurement, Contract and Grant Policy removing ‘‘FEB 1998’’ and adding ‘‘APR Region (PIR), 1845 Wasp Blvd., Bldg.
Division, via email at 2015’’ in its place. 176, Honolulu, HI 96818.
manuel.quinones@nasa.gov, or [FR Doc. 2015–28309 Filed 11–5–15; 8:45 am] FOR FURTHER INFORMATION CONTACT:
telephone (202) 358–2143. BILLING CODE 7510–13–P Jarad Makaiau, NMFS PIRO Sustainable
mstockstill on DSK4VPTVN1PROD with RULES
SUPPLEMENTARY INFORMATION: Fisheries, 808–725–5176.
SUPPLEMENTARY INFORMATION: NMFS is
I. Background specifying a catch limit of 2,000 mt of
As part of NASA’s retrospective longline-caught bigeye tuna for Guam in
review of existing regulations pursuant 2015. NMFS is also authorizing the
to section 6 of Executive Order 13563, territory to allocate up to 1,000 mt of its
Improving Regulation and Regulatory 2,000 mt bigeye tuna limit to U.S.
VerDate Sep<11>2014 17:42 Nov 05, 2015 Jkt 238001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\06NOR1.SGM 06NOR1](https://thefederalregister.org/doc/80_FR_68987/page/7.svg)
Document Created: 2015-12-14 15:09:15
Document Modified: 2015-12-14 15:09:15
| 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 November 6, 2015. Objections and requests for hearings must be received on or before January 5, 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 | 80 FR 68772 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR