83 FR 26369 - Acequinocyl; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 110 (June 7, 2018)
Federal Register Volume 83, Issue 110 (June 7, 2018)
| Page Range | 26369-26374 | |
| FR Document | 2018-12297 |
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)] [Rules and Regulations] [Pages 26369-26374] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12297] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0376; FRL-9978-20] Acequinocyl; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of acequinocyl in or on guava and the tropical and subtropical, small fruit, inedible peel, subgroup 24A. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective June 7, 2018. Objections and requests for hearings must be received on or before August 6, 2018, 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-2017-0376, 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 [[Page 26370]] 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-2017-0376 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 August 6, 2018. 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-2017-0376, 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 23, 2017 (82 FR 49020) (FRL- 9967-37), 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 7E8579) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide acequinocyl, 2- (acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its metabolite, 2- dodecyl-3-hydroxy-1,4-naphthoquinone (acequinocyl-OH), expressed as acequinocyl equivalents in or on guava at 0.9 ppm and the tropical and subtropical, small fruit, inedible peel, subgroup 24A at 2 ppm. That document referenced a summary of the petition prepared by Arysta LifeScience, the registrant, which is available in the docket, http://www.regulations.gov. A comment expressing concern about the effects of wind turbines on bats was received on the notice of filing, but it is not relevant to this action. EPA is establishing the requested tolerances with additional significant figures in conformity with Agency policy. 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 acequinocyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acequinocyl follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The target organs of acequinocyl are the liver (hepatocyte vacuolization, brown pigmented cells and perivascular inflammatory cells in liver) and hematopoietic system (hemorrhage, increased clotting factor times and increased platelet counts). There was no evidence of neurotoxicity or immunotoxicity. There was no evidence of carcinogenic potential in either the rat or mouse and there was no concern for genotoxicity or mutagenicity. In rats and rabbits, there was no evidence of increased quantitative or qualitative fetal susceptibility. For both species, maternal effects (clinical signs and gross necropsy findings) were observed at similar or lower doses than those producing fetal effects. In rabbits, there were increased incidences of late resorptions at the highest dose tested. Since it is unknown whether resorptions occurred from toxicity to maternal animals or the fetuses, the resorptions are considered maternal and developmental adverse effects. In the rat [[Page 26371]] two-generation reproduction toxicity study, there was increased quantitative offspring susceptibility. Offspring effects consisted of hemorrhagic effects, swollen body parts (head and extremities), protruding eyes, clinical signs (bloody encrusted nose, cold to touch, red urine, blue colored eyes and extremities, paleness), delays in pupil development, and increased mortality occurring mainly after weaning. The increased incidences of hemorrhagic effects post-weaning indicate toxicity to the hematopoietic system. While there were no parental effects up to the highest dose tested, hematological effects (changes in partial and activated partial thromboplastin times) were observed in adult animals in other studies at the same dose causing the offspring effects, but were not measured in the two-generation reproduction toxicity study. As a result, using a weight-of-evidence approach that considers the findings from the two-generation reproduction toxicity study in context of the full toxicological database, parental toxicity would be anticipated at the same doses as offspring effects if additional evaluations had been performed, particularly hematological measurements. There were no effects on reproductive parameters. Specific information on the studies received and the nature of the adverse effects caused by acequinocyl 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 the document titled ``Acequinocyl. Human Health Risk Assessment to Support the Petition for Tolerance for Residues in/ on Guava and Tropical and Subtropical, Small Fruit, Inedible Peel, Subgroup 24A'' on page numbers 29-31 in docket ID number EPA-HQ-OPP- 2017-0376. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for acequinocyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of January 18, 2017 (82 FR 5409) (FRL-9956-85). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acequinocyl, EPA considered exposure under the petitioned- for tolerances as well as all existing acequinocyl tolerances in 40 CFR 180.599. EPA assessed dietary exposures from acequinocyl 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 acequinocyl. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all proposed and registered uses. 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 assumed tolerance-level residues and 100 PCT for all proposed and registered uses. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that acequinocyl 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 or PCT information in the dietary assessment for acequinocyl. 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 acequinocyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of acequinocyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), Provisional Cranberry Model, and Screening Concentration in Ground Water (SCI-GROW) Model, the estimated drinking water concentrations (EDWCs) of acequinocyl for acute exposures are estimated to be 6.69 parts per billion (ppb) for surface water and 3.6 x 10-3 ppb for ground water, and for chronic exposures are estimated to be 6.69 ppb for surface water and 3.6 x 10-3 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both the acute and chronic dietary risk assessments, the water concentration value of 6.69 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). Acequinocyl is currently registered for the following uses that could result in residential exposures: Use on ornamentals for landscapes, gardens, and trees. EPA assessed residential exposure using the following assumptions: Residential handler exposures are not expected since all registered acequinocyl product labels with residential use sites (e.g., ornamentals for landscapes, gardens, and trees) require that handlers wear specific clothing (e.g., long-sleeve shirt/long pants) and/or use personal protective equipment (PPE). As a result, a residential handler assessment was not conducted. [[Page 26372]] Only short-term post-application dermal exposure is anticipated for the registered residential uses. The quantitative exposure/risk assessment for residential post-application exposures assessed dermal exposures to adults for activities associated with gardening, dermal exposures to children (6 to <11 years old) for activities associated with playing in and around gardens and gardening, dermal exposures to adults associated with handling trees and retail plants, and dermal exposures to children (6 to <11 years old) for activities associated with playing in and around trees and retail plants. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found acequinocyl to share a common mechanism of toxicity with any other substances, and acequinocyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acequinocyl 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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There is no evidence of an increased quantitative or qualitative fetal susceptibility in rats or rabbits. In isolation, there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study; however, the concern is low since: i. The effects in pups are well characterized with a clear NOAEL and ii. The effects are protected for by the selected endpoints. Therefore, there are no residual uncertainties for pre-/post-natal toxicity. Additionally, hematological parameters were not measured for the parental animals in the two-generation reproductive study; however, hematological effects were observed in adult animals in other oral rat studies at the same doses eliciting offspring effects. Therefore, considering the offspring findings in the two-generation reproductive toxicity study in context with the full toxicological database, there is no concern for offspring susceptibility since parental toxicity would be anticipated at the same dose as offspring 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 toxicity database for acequinocyl is complete.?> ii. There is no indication that acequinocyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence of an increased quantitative or qualitative fetal susceptibility in rats or rabbits, but in isolation there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study. However, the concern is low for the reasons outlined above in section III.D.2. 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 acequinocyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by acequinocyl. 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 acequinocyl will occupy 71% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to acequinocyl from food and water will utilize 71% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of acequinocyl is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acequinocyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to acequinocyl. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1140 for adults and 910 for children 6-11 years old. Because EPA's level of concern for acequinocyl is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). [[Page 26373]] An intermediate-term adverse effect was identified; however, acequinocyl is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for acequinocyl. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, acequinocyl is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to acequinocyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (two high-performance liquid chromatography methods with tandem mass-spectroscopy detection (HPLC/ MS/MS) for determining residues in/on fruit and nut commodities (Morse Methods Meth-133, Revision #4 and Meth-135, Revision #3)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established any MRLs for acequinocyl on the crops cited in this document.?> V. Conclusion Therefore, tolerances are established for residues of acequinocyl, including its metabolites and degradates, in or on guava at 0.90 ppm and the tropical and subtropical, small fruit, inedible peel, subgroup 24A 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), nor is it considered a regulatory action under Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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: May 25, 2018. Michael Goodis, 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. 180.599, add alphabetically the entries ``Guava'' and ``Tropical and subtropical, small fruit, inedible peel, [[Page 26374]] subgroup 24A'' to the table in paragraph (a) to read as follows: Sec. 180.599 Acequinocyl; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Guava....................................................... 0.90 * * * * * Tropical and subtropical, small fruit, inedible peel, 2.0 subgroup 24A............................................... * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2018-12297 Filed 6-6-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations 26369
Paperwork Reduction Act of 1995 (44 supporting this determination is on-scene representative may be
U.S.C. 3501–3520). available in the docket where indicated contacted via VHF Channel 16 or at
under ADDRESSES. (716) 843–9322. Vessel operators given
D. Federalism and Indian Tribal
permission to enter or operate in the
Governments G. Protest Activities
safety zone must comply with all
A rule has implications for federalism The Coast Guard respects the First directions given to them by the COTP or
under Executive Order 13132, Amendment rights of protesters. his on-scene representative.
Federalism, if it has a substantial direct Protesters are asked to contact the
Dated: June 4, 2018.
effect on the States, on the relationship person listed in the FOR FURTHER
between the national government and Joseph S. Dufresne,
INFORMATION CONTACT section to
the States, or on the distribution of coordinate protest activities so that your Captain, U.S. Coast Guard, Captain of the
power and responsibilities among the Port Buffalo.
message can be received without
various levels of government. We have jeopardizing the safety or security of [FR Doc. 2018–12301 Filed 6–6–18; 8:45 am]
analyzed this rule under that Order and people, places or vessels. BILLING CODE 9110–04–P
have determined that it is consistent
with the fundamental federalism List of Subjects in 33 CFR Part 165
principles and preemption requirements Harbors, Marine safety, Navigation ENVIRONMENTAL PROTECTION
described in Executive Order 13132. (water), Reporting and record keeping AGENCY
Also, this rule does not have tribal requirements, Security measures,
implications under Executive Order Waterways. 40 CFR Part 180
13175, Consultation and Coordination For the reasons discussed in the [EPA–HQ–OPP–2017–0376; FRL–9978–20]
with Indian Tribal Governments, preamble, the Coast Guard amends 33
because it does not have a substantial CFR part 165 as follows: Acequinocyl; Pesticide Tolerances
direct effect on one or more Indian
tribes, on the relationship between the PART 165—REGULATED NAVIGATION AGENCY: Environmental Protection
Federal Government and Indian tribes, AREAS AND LIMITED ACCESS AREAS Agency (EPA).
or on the distribution of power and ACTION: Final rule.
responsibilities between the Federal ■ 1. The authority citation for part 165
Government and Indian tribes. If you continues to read as follows: SUMMARY: This regulation establishes
believe this rule has implications for Authority: 33 U.S.C. 1231; 50 U.S.C. 191; tolerances for residues of acequinocyl in
federalism or Indian tribes, please 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; or on guava and the tropical and
contact the person listed in the FOR Department of Homeland Security Delegation subtropical, small fruit, inedible peel,
FURTHER INFORMATION CONTACT section. No. 0170.1. subgroup 24A. Interregional Research
Project Number 4 (IR–4) requested these
E. Unfunded Mandates Reform Act ■ 2. Add § 165.T09–0242 to read as
tolerances under the Federal Food,
follows:
The Unfunded Mandates Reform Act Drug, and Cosmetic Act (FFDCA).
of 1995 (2 U.S.C. 1531–1538) requires § 165.T09–0242 Safety Zone; Blazing DATES: This regulation is effective June
Federal agencies to assess the effects of Paddles 2018 SUP Race; Cuyahoga River, 7, 2018. Objections and requests for
their discretionary regulatory actions. In Cleveland, OH. hearings must be received on or before
particular, the Act addresses actions (a) Location. The safety zone will August 6, 2018, and must be filed in
that may result in the expenditure by a encompass all waters of the Cuyahoga accordance with the instructions
State, local, or tribal government, in the River in Cleveland OH, beginning at provided in 40 CFR part 178 (see also
aggregate, or by the private sector of position 41°29′36″ N and 081°42′13″ W Unit I.C. of the SUPPLEMENTARY
$100,000,000 (adjusted for inflation) or to the turnaround point at position INFORMATION).
more in any one year. Though this rule 41°28′52″ N and 081°40′33″ (NAD 83).
will not result in such an expenditure, (b) Enforcement period. This rule will ADDRESSES: The docket for this action,
we do discuss the effects of this rule be enforced from 8:30 a.m. through identified by docket identification (ID)
elsewhere in this preamble. 11:30 a.m. on June 23, 2018. number EPA–HQ–OPP–2017–0376, is
(c) Regulations. (1) In accordance with available at http://www.regulations.gov
F. Environment or at the Office of Pesticide Programs
the general regulations in § 165.23, entry
We have analyzed this rule under into, transiting, or anchoring within this Regulatory Public Docket (OPP Docket)
Department of Homeland Security safety zone is prohibited unless in the Environmental Protection Agency
Management Directive 023–01 and authorized by the Captain of the Port Docket Center (EPA/DC), West William
Commandant Instruction M16475.lD, Buffalo (COTP) or his designated on- Jefferson Clinton Bldg., Rm. 3334, 1301
which guide the Coast Guard in scene representative. Constitution Ave. NW, Washington, DC
complying with the National (2) This safety zone is closed to all 20460–0001. The Public Reading Room
Environmental Policy Act of 1969 (42 vessel traffic, except as may be is open from 8:30 a.m. to 4:30 p.m.,
U.S.C. 4321–4370f), and have permitted by the COTP or his Monday through Friday, excluding legal
determined that this action is one of a designated on-scene representative. holidays. The telephone number for the
category of actions that do not (3) The ‘‘on-scene representative’’ of Public Reading Room is (202) 566–1744,
individually or cumulatively have a the COTP is any Coast Guard and the telephone number for the OPP
significant effect on the human commissioned, warrant or petty officer Docket is (703) 305–5805. Please review
sradovich on DSK3GMQ082PROD with RULES
environment. This rule involves who has been designated by the COTP the visitor instructions and additional
establishment of a safety zone. It is to act on his behalf. information about the docket available
categorically excluded from further (4) Vessel operators desiring to enter at http://www.epa.gov/dockets.
review under paragraph L60(a) of or operate within the safety zone must FOR FURTHER INFORMATION CONTACT:
Appendix A, Table 1 of DHS Instruction contact the COTP Buffalo or his on- Michael Goodis, Registration Division
Manual 023–01–001–01, Rev. 01. A scene representative to obtain (7505P), Office of Pesticide Programs,
Record of Environmental Consideration permission to do so. The COTP or his Environmental Protection Agency, 1200
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![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations 26373
An intermediate-term adverse effect food safety standards-setting distribution of power and
was identified; however, acequinocyl is organization in trade agreements to responsibilities established by Congress
not registered for any use patterns that which the United States is a party. EPA in the preemption provisions of FFDCA
would result in intermediate-term may establish a tolerance that is section 408(n)(4). As such, the Agency
residential exposure. Intermediate-term different from a Codex MRL; however, has determined that this action will not
risk is assessed based on intermediate- FFDCA section 408(b)(4) requires that have a substantial direct effect on States
term residential exposure plus chronic EPA explain the reasons for departing or tribal governments, on the
dietary exposure. Because there is no from the Codex level. relationship between the national
intermediate-term residential exposure The Codex has not established any government and the States or tribal
and chronic dietary exposure has MRLs for acequinocyl on the crops cited governments, or on the distribution of
already been assessed under the in this document. power and responsibilities among the
appropriately protective cPAD (which is V. Conclusion various levels of government or between
at least as protective as the POD used to the Federal Government and Indian
assess intermediate-term risk), no Therefore, tolerances are established tribes. Thus, the Agency has determined
further assessment of intermediate-term for residues of acequinocyl, including that Executive Order 13132, entitled
risk is necessary, and EPA relies on the its metabolites and degradates, in or on ‘‘Federalism’’ (64 FR 43255, August 10,
chronic dietary risk assessment for guava at 0.90 ppm and the tropical and 1999) and Executive Order 13175,
evaluating intermediate-term risk for subtropical, small fruit, inedible peel, entitled ‘‘Consultation and Coordination
acequinocyl. subgroup 24A at 2.0 ppm. with Indian Tribal Governments’’ (65 FR
5. Aggregate cancer risk for U.S. VI. Statutory and Executive Order 67249, November 9, 2000) do not apply
population. Based on the lack of Reviews to this action. In addition, this action
evidence of carcinogenicity in two This action establishes tolerances does not impose any enforceable duty or
adequate rodent carcinogenicity studies, under FFDCA section 408(d) in contain any unfunded mandate as
acequinocyl is not expected to pose a response to a petition submitted to the described under Title II of the Unfunded
cancer risk to humans. Agency. The Office of Management and Mandates Reform Act (UMRA) (2 U.S.C.
6. Determination of safety. Based on Budget (OMB) has exempted these types 1501 et seq.).
these risk assessments, EPA concludes of actions from review under Executive This action does not involve any
that there is a reasonable certainty that Order 12866, entitled ‘‘Regulatory technical standards that would require
no harm will result to the general Planning and Review’’ (58 FR 51735, Agency consideration of voluntary
population, or to infants and children October 4, 1993). Because this action consensus standards pursuant to section
from aggregate exposure to acequinocyl has been exempted from review under 12(d) of the National Technology
residues. Executive Order 12866, this action is Transfer and Advancement Act
not subject to Executive Order 13211, (NTTAA) (15 U.S.C. 272 note).
IV. Other Considerations
entitled ‘‘Actions Concerning VII. Congressional Review Act
A. Analytical Enforcement Methodology Regulations That Significantly Affect
Adequate enforcement methodology Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review
(two high-performance liquid FR 28355, May 22, 2001) or Executive Act (5 U.S.C. 801 et seq.), EPA will
chromatography methods with tandem Order 13045, entitled ‘‘Protection of submit a report containing this rule and
mass-spectroscopy detection (HPLC/ Children from Environmental Health other required information to the U.S.
MS/MS) for determining residues in/on Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of
fruit and nut commodities (Morse April 23, 1997), nor is it considered a Representatives, and the Comptroller
Methods Meth-133, Revision #4 and regulatory action under Executive Order General of the United States prior to
Meth-135, Revision #3)) is available to 13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal
enforce the tolerance expression. and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major
The method may be requested from: FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2).
Chief, Analytical Chemistry Branch, does not contain any information List of Subjects in 40 CFR Part 180
Environmental Science Center, 701 collections subject to OMB approval
Environmental protection,
Mapes Rd., Ft. Meade, MD 20755–5350; under the Paperwork Reduction Act
Administrative practice and procedure,
telephone number: (410) 305–2905; (PRA) (44 U.S.C. 3501 et seq.), nor does
Agricultural commodities, Pesticides
email address: residuemethods@ it require any special considerations
and pests, Reporting and recordkeeping
epa.gov. under Executive Order 12898, entitled
requirements.
‘‘Federal Actions to Address
B. International Residue Limits Dated: May 25, 2018.
Environmental Justice in Minority
In making its tolerance decisions, EPA Populations and Low-Income Michael Goodis,
seeks to harmonize U.S. tolerances with Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
international standards whenever 1994). Pesticide Programs.
possible, consistent with U.S. food Since tolerances and exemptions that Therefore, 40 CFR chapter I is
safety standards and agricultural are established on the basis of a petition amended as follows:
practices. EPA considers the under FFDCA section 408(d), such as
international maximum residue limits the tolerance in this final rule, do not PART 180—[AMENDED]
(MRLs) established by the Codex require the issuance of a proposed rule,
sradovich on DSK3GMQ082PROD with RULES
Alimentarius Commission (Codex), as the requirements of the Regulatory ■ 1. The authority citation for part 180
required by FFDCA section 408(b)(4). Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
The Codex Alimentarius is a joint seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
United Nations Food and Agriculture This action directly regulates growers,
Organization/World Health food processors, food handlers, and food ■ 2. In § 180.599, add alphabetically the
Organization food standards program, retailers, not States or tribes, nor does entries ‘‘Guava’’ and ‘‘Tropical and
and it is recognized as an international this action alter the relationships or subtropical, small fruit, inedible peel,
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![26374 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations
subgroup 24A’’ to the table in paragraph May 17, 2018, the following correction 20590, phone (202) 366–4325, email
(a) to read as follows: is made: MCPSD@dot.gov.
SUPPLEMENTARY INFORMATION:
§ 180.599 Acequinocyl; tolerances for § 373.103 [Corrected]
residues. I. Public Participation
■ 1. On page 22873, in the third column,
(a) * * * in amendment 10a., the instruction Viewing Comments and Documents
‘‘Withdraw the amendments to
Parts per § 373.103 published April 16, 2018, at To view comments, as well as
Commodity million documents mentioned in this preamble
83 FR 16224’’ is withdrawn.
as being available in the docket, go to
Issued under the authority delegated in 49 www.regulations.gov and insert the
* * * * * CFR 1.87 on: May 30, 2018.
Guava ......................................... 0.90 docket number, ‘‘FMCSA–2017–0360’’
Larry W. Minor, in the ‘‘Keyword’’ box and click
* * * * * Associate Administrator for Policy. ‘‘Search.’’ Next, click the ‘‘Open Docket
Tropical and subtropical, small [FR Doc. 2018–12032 Filed 6–6–18; 8:45 am] Folder’’ button and choose the
fruit, inedible peel, subgroup BILLING CODE 4910–EX–P document to review. If you do not have
24A .......................................... 2.0 access to the internet, you may view the
docket online by visiting the Docket
* * * * * DEPARTMENT OF TRANSPORTATION Management Facility in Room W12–140
on the ground floor of the DOT West
* * * * * Federal Motor Carrier Safety Building, 1200 New Jersey Avenue SE,
[FR Doc. 2018–12297 Filed 6–6–18; 8:45 am] Administration Washington, DC 20590, between 9 a.m.
BILLING CODE 6560–50–P
and 5 p.m., e.t., Monday through Friday,
49 CFR Part 395 except Federal holidays.
[Docket No. FMCSA–2017–0360] II. Legal Basis
DEPARTMENT OF TRANSPORTATION
Hours of Service of Drivers of The National Highway System
Federal Motor Carrier Safety Commercial Motor Vehicles; Designation Act of 1995, Public Law
Administration Regulatory Guidance Concerning the 104–59, sec. 345, 109 Stat. 568. 613
Transportation of Agricultural (Nov. 28, 1995) (the Act), provided the
49 CFR Part 373 Commodities initial exception for drivers transporting
agricultural commodities or farm
RIN 2126–AC06 AGENCY: Federal Motor Carrier Safety supplies for agricultural purposes. The
Administration (FMCSA), DOT Act limited the exception to a 100 air-
General Technical, Organizational, ACTION: Announcement of regulatory mile radius from the source of the
Conforming, and Correcting guidance commodities or distribution point for
Amendments to the Federal Motor the farm supplies and during the
Carrier Safety Regulations; Correction SUMMARY: FMCSA announces regulatory
planting and harvesting seasons as
guidance to clarify the applicability of
AGENCY: Federal Motor Carrier Safety determined by the applicable State.
the ‘‘Agricultural commodity’’
Administration (FMCSA), DOT. The Safe, Accountable, Flexible,
exception in the ‘‘Hours of Service
Efficient Transportation Act: A Legacy
ACTION: Final rule; correction. (HOS) of Drivers’’ regulations. This
for Users (SAFETEA–LU) revised this
regulatory guidance clarifies the
SUMMARY: FMCSA corrects the technical provision, redesignated it as new
exception with regard to: drivers
corrections final rule published on May section 229 of Title II of the Motor
operating unladen vehicles traveling
17, 2018, that amended FMCSA Carrier Safety Improvement Act of 1999,
either to pick up an agricultural
regulations to make minor changes to and defined the terms ‘‘agricultural
commodity or returning from a delivery
correct inadvertent errors and commodity’’ and ‘‘farm supplies for
point; drivers engaged in trips beyond
omissions, remove or update obsolete agricultural purposes.’’ Public Law 109–
150 air-miles from the source of the
references, ensure conformity with 59, sections 4115 and 4130, 119 Stat.
agricultural commodity; determining
Office of the Federal Register style 1144, 1726, 1743 (Aug. 10, 2005). These
the ‘‘source’’ of agricultural
guidelines, and improve the clarity and terms are now defined in 49 CFR 395.2.
commodities under the exemptions; and
consistency of certain regulatory Most recently, the statute was
how the exception applies when
provisions. This document corrects an amended by section 32101(d) of the
agricultural commodities are loaded at
amendatory instruction. Moving Ahead for Progress in the 21st
multiple sources during a trip. This
DATES: Effective June 18, 2018.
Century Act (MAP–21), Public Law
regulatory guidance is issued to ensure
112–141, 126 Stat. 405, 778 (July 6,
FOR FURTHER INFORMATION CONTACT: Mr. consistent understanding and
2012). This provision revised the
David Miller, Federal Motor Carrier application of the exception by motor
description of the exception’s scope and
Safety Administration, Regulatory carriers and State officials enforcing
extended the applicable distance from
Development Division, 1200 New Jersey HOS rules identical to or compatible
100 air-miles to 150 air-miles from the
Avenue SE, Washington, DC 20590– with FMCSA’s requirements.
source.
0001, by telephone at (202) 366–5370 or DATES: This guidance is applicable on
sradovich on DSK3GMQ082PROD with RULES
via email at david.miller@dot.gov. Office June 7, 2018 and expires June 7, 2023. III. Background
hours are from 9 a.m. to 5 p.m. e.t., FOR FURTHER INFORMATION CONTACT: Mr. The focus of today’s guidance is
Monday through Friday, except Federal Thomas Yager, Chief, Driver and Carrier limited to the application of the 150 air-
holidays. Operations Division, Federal Motor mile exception for the transportation of
SUPPLEMENTARY INFORMATION: In FR Doc. Carrier Safety Administration, U.S. ‘‘agricultural commodities,’’ 49 CFR
2018–10437, appearing on page 22873 Department of Transportation, 1200 395.1(k)(1). It does not address ‘‘farm
in the Federal Register of Thursday, New Jersey Avenue SE, Washington, DC supplies for agricultural purposes’’
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Document Created: 2018-06-07 00:50:54
Document Modified: 2018-06-07 00:50:54
| 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 June 7, 2018. Objections and requests for hearings must be received on or before August 6, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: | |
| FR Citation | 83 FR 26369 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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