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美国修订溴虫腈在罗勒、韭菜、黄瓜中的农药残留限量

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放大字体  缩小字体 2020-02-19 08:44:47  来源:美国环境保护署  浏览次数:1051
核心提示:美国环境保护署制定溴虫腈在罗勒、韭菜、黄瓜中的农药残留限量分别为80 ppm、20 ppm、0.5ppm;修订“蔬菜、水果、组8-10”的分类,且农药残留限量为2ppm。
发布单位
美国环境保护署
美国环境保护署
发布文号 85 FR 8468
发布日期 2020-02-14 生效日期 2020-02-14
有效性状态 废止日期 暂无
属性 法规 专业属性 限量相关
备注 美国环境保护署制定溴虫腈在罗勒、韭菜、黄瓜中的农药残留限量分别为80 ppm、20 ppm、0.5ppm;修订“蔬菜、水果、组8-10”的分类,且农药残留限量为2ppm。
 

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of chlorfenapyr in or on basil, fresh leaves; chive, fresh leaves; and cucumber and increases the established tolerance on vegetable, fruiting, group 8-10. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective February 14, 2020. Objections and requests for hearings must be received on or before April 14, 2020, 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-2018-0783, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/?dockets.

FOR FURTHER INFORMATION CONTACT:

Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

 

I. General Information

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 Publishing 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-2018-0783 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 14, 2020. 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-2018-0783, 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/Start Printed Page 8469DC), (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 March 18, 2019 (84 FR 9737) (FRL-9989-71), 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 8E8717) by IR-4 Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.513 be amended by establishing tolerances for residues of the insecticide chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1 H-pyrrole-3-carbonitrile, in or on Basil, fresh leaves at 80 parts per million (ppm); Chive, fresh leaves at 20 ppm; Cucumber at 0.5 ppm; and Vegetable, fruiting, group 8-10 at 2.0 ppm. Upon establishment of the above tolerance, the petitioner requested removal of the existing tolerance on Vegetable, fruiting, group 8-10 at 1.0 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

based upon review of the data supporting the petition and pursuant to its authority in section 408(d)(4)(A)(i), EPA is establishing the requested tolerances and one tolerance at a different level than requested. The reason for this change is explained in Unit IV.C.

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 chlorfenapyr including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with chlorfenapyr 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.

Chlorfenapyr has moderate acute toxicity via the oral route of exposure and low acute toxicity via the dermal and inhalation routes of exposure. It is a mild eye irritant, but it is not a dermal irritant or sensitizer. Chlorfenapyr targets the central nervous system (CNS), inducing neurohistological changes (spongiform myelinopathy of the brain and spinal cord and vacuolization of the brain, spinal cord, and optic nerve) from subchronic and chronic dietary administration in mice and rats. In addition to neuropathology, rats also exhibited neurobehavioral changes on the day of dosing in the acute neurotoxicity study. Decreased motor activity was observed in the acute neurotoxicity study as well as in offspring in the developmental neurotoxicity (DNT) study. Several rat studies also noted effects in the liver (increased organ weights and tumors) at similar doses or above those where CNS effects were seen. The liver was identified in metabolism studies as the single organ to have the highest recovery of administered dose.

There was evidence of increased quantitative susceptibility to offspring in the database as a result of chlorfenapyr exposure. In the 2-generation reproduction study, decreased pup weights were seen at a lower dose than parental toxicity (decreased body-weight). In the DNT study, offspring toxicity (decreased motor activity and increased pup deaths on postnatal days 1-4) was seen in the absence of maternal toxicity. Additional effects on the CNS (vacuolation of white matter in the brain and decreased hippocampus size) were also observed in offspring at a higher dose in this study. There was no evidence of increased susceptibility to offspring in the developmental toxicity studies. In both the rat and rabbit developmental toxicity studies, although no maternal or developmental effects were noted up to the highest doses tested (HDT), maternal observations are limited in these developmental studies. Consequently, the data from the DNT are considered more robust for assessing the effects of chlorfenapyr on the nervous system.

Chlorfenapyr has a relatively high octanol-water partition coefficient and due to its lipophilic nature has been shown to accumulate in milk in a dietary cow study. Additionally, in the rat metabolism study, chlorfenapyr was found to accumulate in the fat tissue, such that females exhibited greater accumulation than males. This observation suggests chlorfenapyr is capable of accumulating in breast milk and leading to the early pup deaths seen in the reproduction toxicity and DNT studies through lactation.

Furthermore, the lack of toxicity in the rat and rabbit developmental studies suggests that the early pup deaths in the reproduction toxicity and DNT studies is the result of postnatal exposure through lactation.

EPA has concluded that a nonlinear approach using the chronic RfD for assessing cancer risk is appropriate for chlorfenapyr. For more information about this conclusion, see section 4.5.3 in the document entitled “SUBJECT: Chlorfenapyr. Human Health Risk Assessment for the Proposed New Uses on Greenhouse-Grown Basil, Chive, Cucumber, and Small Tomatoes,” in docket ID number EPA-HQ-OPP-2018-0783.

Specific information on the studies received and the nature of the adverse effects caused by chlorfenapyr 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 entitled “SUBJECT: Chlorfenapyr. Human Health Risk Assessment for the Proposed New Uses on Greenhouse-Grown Basil, Chive, Cucumber, and Small Tomatoes,” at pages 24-28 in Start Printed Page 8470docket ID number EPA-HQ-OPP-2018-0783.

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 chlorfenapyr used for human risk assessment is discussed in Unit III of the final rule published in the Federal Register of January 26, 2018 (83 FR 3605) (FRL-9970-88).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to chlorfenapyr, EPA considered exposure under the petitioned-for tolerances as well as all existing chlorfenapyr tolerances in 40 CFR 180.513. EPA assessed dietary exposures from chlorfenapyr 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 chlorfenapyr. In estimating acute dietary exposure, EPA used the Dietary Exposure evaluation Model—Food Consumption Intake Database (DEEM-FCID), Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003-2008. As to residue levels in food, EPA's acute unrefined analysis used tolerance-level residues and 100% crop-treated (PCT). DEEM processing factors were set to 1 for all commodities except tomato and peppers. EPA 2018 default processing factors were used in the acute dietary analyses for tomato and pepper processed raw agricultural commodities (RACs) to account for potential imports of foreign agricultural use of chlorfenapyr.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the DEEM-FCID, Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003-2008. As to residue levels in food, EPA's chronic analysis was unrefined and used tolerance-level residues and 100 PCT. DEEM processing factors were set to 1 for all commodities except tomato and peppers. EPA 2018 default processing factors were used in the chronic dietary analyses for tomato and pepper processed RACs to account for potential imports of foreign agricultural use of chlorfenapyr.

iii. Cancer. As indicated in Unit III.A., EPA has concluded that a nonlinear approach using the chronic RfD for assessing cancer risk is appropriate for chlorfenapyr; therefore, a separate quantitative cancer risk assessment is not required.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for chlorfenapyr. Tolerance level residues for proposed and established uses and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. Contamination of drinking water from chlorfenapyr is not expected to occur since none of the registered uses (which are all indoor uses) would result in residues in drinking water. Therefore, a dietary exposure assessment for chlorfenapyr in drinking water is unnecessary.

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).

Chlorfenapyr is currently registered for the following uses that could result in residential exposures: Crack/crevice/spot treatment on indoor and outdoor residential sites (including as a bed bug treatment). There are no residential uses associated with the petitioned-for new uses; therefore, an updated residential exposure assessment was not necessary for the proposed uses. The most conservative residential exposure scenarios were selected for use in the aggregate risk assessment. EPA combined post-application dermal and inhalation exposure from indoor applications (surfaces and mattresses) to control bed bugs to assess risks to adults and post-application dermal, inhalation, and hand-to-mouth exposures from indoor applications (surfaces and mattresses) to control bed bugs to assess risks to children 1 to <2 years old. The residential exposures are short- and intermediate-term for incidental oral, dermal and inhalation. No long-term exposures is expected.

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 chlorfenapyr to share a common mechanism of toxicity with any other substances, and chlorfenapyr does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that chlorfenapyr 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 Start Printed Page 8471case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. Although DNT studies show evidence of neurotoxicity/neuropathology and reproduction studies show susceptibility/sensitivity to offspring, the effects are well-characterized with clearly established NOAEL/LOAEL values and selected endpoints are protective for the observed effects.

3. Conclusion. EPA determined that the FQPA SF should be reduced to 1X for all exposure scenarios. That decision is based on the following findings:

i. The toxicity database for chlorfenapyr is complete.

ii. Although the central nervous system is the primary target for chlorfenapyr and neurotoxic effects were observed across studies, concern is low since the selected PODs are protective of observed neurotoxic effects.

iii. Although there is evidence of increased quantitative susceptibility in available DNT and reproduction studies, concern is low since the offspring effects are well-characterized with clearly established NOAEL/LOAEL values and the endpoints selected for risk assessment are protective of observed offspring effects.

iv. There are no residual uncertainties identified in the exposure databases. The dietary analysis assumed tolerance-level residues, EPA's 2018 default processing factors (except for tomatoes and peppers), and 100 PCT. The dietary analysis did not include exposure from drinking water as contamination of drinking water with chlorfenapyr as the result of all registered uses, including greenhouses or food/feed handling uses, is not expected to occur. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by chlorfenapyr.

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 chlorfenapyr will occupy 75% of the aPAD (at the 95th percentile of exposure) for children 3 to 5 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 chlorfenapyr from food and water will utilize 19% of the cPAD for children 3 to 5 years old, the population group receiving the greatest exposure. There are no chronic drinking water or residential exposure scenarios, therefore, the chronic aggregate risk is equivalent to the chronic dietary risk which is below the Agency's LOC.

3. Short- and intermediate-term risks. Short- and intermediate-term aggregate risk assessments were conducted since there is potential for short- and intermediate-term post-application exposures from previously registered uses of chlorfenapyr in residential settings. Short-term residential exposure estimates were aggregated with the average dietary exposure to provide a worst-case estimate of short-term aggregate risk for adults and children 1 to 2 years old (considered protective for children of all ages). Short-term aggregate MOEs are protective of intermediate-term exposure durations since the same endpoints and PODs were selected for both durations. Resulting short-term aggregate MOEs for adults at 660 and 120 for children (1 to 2 years old) are not of concern.

4. Aggregate cancer risk for U.S. population. As discussed in Unit III, the Agency has determined that quantification of risk using a non-linear approach (i.e., using a cRfD) adequately accounts for all chronic toxicity, including carcinogenicity that could result from exposure to chlorfenapyr. Since there are no chronic risks of concern, the Agency concludes that aggregate exposure to chlorfenapyr will not pose a cancer risk.

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 chlorfenapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The plant analytical enforcement method is designated as M2427, a gas chromatography/electron-capture detection (GC/ECD) method with a limit of quantitation (LOQ) of 0.05 ppm. The method has been subjected to a successful independent laboratory validation (ILV) as well as an acceptable radio validation using samples obtained from lettuce and tomato metabolism studies. EPA has concluded that method M2427 is adequate for data collection and tolerance enforcement purposes.

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: residuemethods@epa.gov.

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.

There are no Codex maximum residue limits (MRLs) for residues of chlorfenapyr in/on the proposed commodities.

C. Revisions to Petitioned-For Tolerances

EPA revised the proposed tolerances for residues of chlorfenapyr on vegetable, fruiting, group 8-10 based on current OECD rounding classes. There is no need to remove the existing tolerance for vegetable, fruiting, group 8-10 at 1.0 ppm; rather EPA is simply amending the existing tolerance as requested.Start Printed Page 8472

V. Conclusion

Therefore, tolerances are established for residues of the insecticide chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1 H-pyrrole-3-carbonitrile, in or on Basil, fresh leaves at 80 ppm; Chive, fresh leaves at 20 ppm; and Cucumber at 0.5 ppm; and Vegetable, fruiting, group 8-10 at 2 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

  • Environmental protection
  • Administrative practice and procedure
  • Agricultural commodities
  • Pesticides and pests
  • Reporting and recordkeeping requirements

Dated: January 24, 2020.

Michael Goodis,

Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED]

1.The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

2.In § 180.513, amend the table in paragraph (a)(1) as follows:

a.Add alphabetically the entries for “Basil, fresh leaves”; “Chive, fresh leaves”; and “Cucumber”; and

b.Revise the entry for “Vegetable, fruiting, group 8-10”.

The additions and revision read as follows:

§ 180.513
Chlorfenapyr; tolerances for residues.

(a) * * *

(1) * * *

Commodity Parts per million
Basil, fresh leaves 80
Chive, fresh leaves 20
Cucumber 0.5
 
*    *    *    *    *
Vegetable, fruiting, group 8-10 2
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