美國修訂溴蟲腈在羅勒、韭菜、黃瓜中的農(nóng)藥殘留限量

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.

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.

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.

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.

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.

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

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.

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).

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).