Flonicamid; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of flonicamid in or on multiple commodities which are identified and discussed later in this document. In addition, this regulation revokes the established tolerance for vegetable, fruiting, group 8-10 that is superseded by this action. Interregional Research Project Number 4 (IR-4) and ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective May 11, 2017. Objections and requests for hearings must be received on or before July 10, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0013, is available at http://www.regulations.govor 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 L. Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/​cgi-bin/​text-idx?​&​c=​ecfr&​tpl=​/​ecfrbrowse/​Title40/​40tab_​02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0013 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 July 10, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0013, 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 athttp://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/​dockets.

II. Summary of Petitioned-For Tolerance

In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-02); August 12, 2016 (81 FR 53379) (FRL-9949-53) and December 9, 2016 (81 FR 89036) (FRL-9953-69), EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs) by IR-4 (PP 5E8428); and ISK Biosciences (PP 5F8416 and 6F8443), respectively. These petitions request that 40 CFR 180.613 be amended by establishing tolerances for residues of the insecticide flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM (4-trifluoromethylnicotinamide), and TFNG, N-(4-trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on several commodities as follows. Pesticide petition 5E8428 submitted by IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W., Princeton, NJ 08540 requests to increase the existing tolerance on Vegetables, fruiting, group 8-10 from 0.4 ppm to 1.50 ppm. Pesticide petitions 5F8416 and 6F8443 submitted by ISK Biosciences Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077 request tolerances on tea at 40 ppm and fruit, citrus group 10-10 at 1.5 ppm, respectively. All supporting documents for this final rule, which bundles the three above-referenced petitions for purposes of this final rule, are found in docket ID EPA-HQ-OPP-2016-0013.

Summaries of the petitions prepared by IR4 and the registrant, ISK Biosciences Corporation, are available in the following dockets athttp://www.regulations.gov: PP 5E8428 in Start Printed Page 21942Docket: EPA-HQ-OPP-2016-0013; PP 5F8416 in Docket: EPA-HQ-OPP-2011-0985; and PP 6F8443 in EPA-HQ-OPP-2015-0561. Comments were received on the notices of filings. EPA's responses to the comments are discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the tolerance level for certain crops and corrected commodity definitions to be consistent with current EPA policies. The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for flonicamid, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flonicamid follows.

A. Toxicological Profile

EPA has evaluated the available toxicity database 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.

Flonicamid and its metabolites of concern, TFNA, TFNA-AM, TFNG, TFNG-AM, and TFNA-OH, demonstrated low toxicity in acute oral toxicity studies. Fonicamid showed no systemic toxicity in a 28-day dermal study at the limit dose.

Feeding studies in rats and dogs show the kidney and liver are the target organs for flonicamid toxicity. In repeat-dose subchronic and chronic oral toxicity studies, the consistently observed adverse effect in rats and mice were kidney toxicity (i.e., hyaline deposition and nephritis); in dogs, vomiting and increased percentage of reticulocytes (an indicator for potential anemia).

There is no evidence that flonicamid results in increased susceptibility (qualitative or quantitative) in utero in rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. In the rat prenatal developmental toxicity study, maternal toxicity consisted of kidney toxicity (i.e.,nephritis) in the absence of developmental toxicity at the highest-dose tested (HDT); in the rabbit, maternal toxicity consisted of decreased food consumption in the absence of developmental toxicity at the HDT. In the rat reproduction and fertility effects study, parental toxicity (i.e., kidney hyaline deposition and luteinizing hormone level increases) occurred at doses much lower than doses causing offspring effects (i.e., decreased body weight and delayed sexual maturation).

There are no concerns for flonicamid neurotoxicity. In the acute neurotoxicity study in rats, signs of toxicity such as decreased motor activity, tremors, impaired gait, and impaired respiration were observed at lethal dose levels (1000 mg/kg). In the subchronic neurotoxicity study, decreased body weight, food consumption, foot splay, and motor activity were observed in males at doses greater than 67 mg/kg/day, and in females at 722 mg/kg/day. In the immunotoxicity study in mice, there were no indications of increased immunotoxic potential in the T-cell dependent antibody response (TDAR) assay at the limit dose.

Mutagenicity studies were negative for flonicamid and its metabolites of concern. Treatment-related lung tumors were observed in CD-1 mice. This tumor type, however, is associated with species and strain sensitivity and is not directly correlated with cancer risks in humans. Nasal cavity tumors in male Wistar rats were linked to incisor inflammation. Nasolacrimal duct tumor findings for females were confounded by the lack of a dose-response, and the biological significance of these tumors is questionable. The determination of carcinogenicity potential for flonicamid was based on the weight of the evidence approach and resulted in the classification of “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.” The Agency determined that quantification of risk using a non-linear approach (i.e., using a chronic reference dose (cRfD)) adequately accounts for all chronic toxicity, including carcinogenicity that could result from exposure to flonicamid.

Specific information on the studies received and the nature of the adverse effects caused by flonicamid 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 athttp://www.regulations.gov in document “Subject: Flonicamid. Human Health Risk Assessment for New Uses on Legume Vegetables, Subgroups 6A, 6B, and 6C; Add Directions for use on Greenhouse Grown Peppers and Increase the Tolerance for Residues on Fruiting Vegetables, Group 8-10; New Use on Citrus Fruits, Group 10-10; and a Tolerance without U.S. Registration for residues in/on Dried Tea” at page 28 in docket ID number EPA-HQ-OPP-2016-0013.

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://Start Printed Page 21943www2.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for flonicamid used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of November 14, 2012 (77 FR 67771) (FRL-9368-7).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flonicamid, EPA considered exposure under the petitioned-for tolerances as well as all existing flonicamid tolerances in 40 CFR 180.613. EPA assessed dietary exposures from flonicamid 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. No such effects were identified in the toxicological studies for flonicamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model—Food Commodity Intake Database (DEEM-FCIDTM), Version 3.16, which incorporates 2003-2008 food consumption information from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA used an unrefined chronic dietary assessment conducted assuming 100 percent crop treated (PCT) estimates, tolerance-level residues for all commodities, and empirical or Dietary Exposure Evaluation Model—Food Commodity Intake Database (DEEM-FCIDTM) default processing factors. The processing factor was set to 1.0 for potato granules/flakes, tomato paste and tomato puree; for all other processed commodities DEEM default processing factors were used.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to flonicamid. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for flonicamid. Tolerance level residues and/or 100% CT 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 flonicamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of flonicamid. 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.

The drinking water assessment was conducted using both a parent only exposure, and a total toxic residue approach, which considers the parent compound and its major degradates of concern. Total toxic residues include 4-trifluoromethylnicotinic acid (TFNA), 4-trifluoromethylnictinamide (TFNA-AM), 6-hydro-4-trifluoromethylnicotinic acid (TFNA-OH), N-(4-trifluoromethylnicotinoyl)glycine (TFNG), and N-(4-trifluoromethylnicotinoyl)glycinamide (TFNG-AM).

Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of flonicamid for chronic exposures for non-cancer assessments are estimated to be 0.94 parts per billion (ppb) for surface water and 9.92 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 9.92 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). Flonicamid is not registered for any specific use patterns that would result in residential exposure.

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 flonicamid to share a common mechanism of toxicity with any other substances, and flonicamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flonicamid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://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 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. The prenatal and postnatal toxicity database for flonicamid includes prenatal developmental toxicity studies in rats and rabbits and a multigeneration reproduction toxicity study in rats. There is no evidence that flonicamid results in increased susceptibility (qualitative or quantitative) in utero in rats or rabbits in the prenatal developmental studies or in young rats in the multi-generation reproduction study. No developmental effects were seen in rabbits. In the multi-generation reproduction study, developmental delays in the offspring (decreased body weights, delayed sexual maturation) were seen only in the presence of parental toxicity (kidney and blood effects). Also, there are clear NOAELs and LOAELs for all effects. The degree of concern for prenatal and/or post-natal susceptibility is, therefore, low due to the lack of evidence of qualitative and quantitative susceptibility.Start Printed Page 21944

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, except where assessing risks from inhalation exposure as discussed below. Those decisions are based on the following findings:

i. The toxicity database for flonicamid is essentially complete, except for an outstanding subchronic 28-day inhalation study. In the absence of a subchronic inhalation study, EPA has retained a 10X FQPA SF to assess risks from inhalation exposure, although at present, residential inhalation exposure is not expected from existing or pending uses of flonicamid.

ii. There is no evidence that flonicamid is a neurotoxic chemical. As discussed in Unit III.A., EPA has concluded that the clinical signs observed from available acute and subchronic neurotoxicity studies were not the result of a neurotoxic mechanism. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that flonicamid results in increased susceptibility in utero in rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment was based on 100 PCT, tolerance-level residues and where applicable, default processing factors. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to flonicamid in drinking water. These assessments will not underestimate the exposure and risks posed by flonicamid.

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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, flonicamid is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flonicamid from food and water will utilize 59% of the cPAD for children 1-2 years old the population group receiving the greatest exposure. There are no residential uses for flonicamid.

3. Short- and intermediate-term risks. Short- and intermediate-term aggregate exposures take into account short- and intermediate-term residential exposures plus chronic exposure to food and water (considered to be a background exposure level). Flonicamid is not registered for any use patterns that would result in short- and intermediate-term residential exposures.

4. Aggregate cancer risk for U.S. population. Based on the information referenced in Unit III.A., EPA has concluded that the cPAD is protective of possible cancer effects from flonicamid, and as evidenced in Unit III.E.2, aggregate exposure to flonicamid is below the cPAD.

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 flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (FMC Method No. P-3561M, a liquid chromatography with tandem mass spectrometry (LC/MS/MS) method) is available to enforce the tolerance expression for flonicamid and its metabolites in or on plant commodities.

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.

The Codex has not established MRLs for flonicamid.

C. Response to Comments

1. Anonymous comments: One comment each on petitions, 5E8428 and 5F8416, was received. Both comments claim that flonicamid is a “toxic pesticide” and residues at any level in food commodities including tea (leaves) should not be allowed and requested that EPA deny setting tolerances for the petition-for new uses of flonicamid. One comment stated that the proposed flonicamid use would add to about 25,000 toxic chemicals currently in the environment and combine to create even more toxic chemical residues in food and drinking water further increasing harmful effects to humans and environment.

Agency response: The Agency understands the commenters' concerns and recognizes that some individuals believe that pesticides should be banned completely. However, under the existing legal framework provided by FFDCA section 408, EPA is authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute.

When new or amended tolerances are requested for the presence of the residues of a pesticide and its toxicologically significant metabolite(s) in food or feed, the Agency, as is required by FFDCA section 408, estimates the risk of the potential exposure to these residues by performing an aggregate risk assessment. Such a risk assessment integrates the individual assessments that are conducted for food, drinking water, and residential exposures. Additionally, the Agency, as is further required by FFDCA Section 408, considers available information concerning what are termed the cumulative toxicological effects of the residues of that pesticide and of other substances having a common mechanism of toxicity with it. The Agency has concluded after this assessment that there is a reasonable certainty that no harm will result from Start Printed Page 21945exposure to the residues of interest. Therefore, the proposed tolerance(s) are found to be acceptable.

2. Comment: A comment on petition 6F8443 stressed the importance of the Agency's use of concise and reliable analytical methods to identify and quantify chemical residues of flonicamid and various fungicides in order to draw accurate and definitive scientific conclusions regarding their effects on the environment.

Agency response: An available, accurate and concise EPA approved analytical method is a prerequisite for EPA pesticide registration and critical to the Agency's ability to identify, monitor and enforce pesticides residues, including metabolites and degradates of concern, that may exist in trace amounts in plants, animals and the environment. Unit IV.A. of this document identifies the specific analytical method used by the Agency in enforcing appropriate flonicamid use as well as how additional information can be obtained on the method.

D. Revisions to Petitioned-For Tolerances

Although the petitioner requested that the vegetable, fruiting group 8-10 tolerances be increased from 0.4 ppm to 1.5 ppm, data submitted did not support an increase in tolerances for the entire subgroup. The submitted data (which examined residues on greenhouse peppers only) only support an increase for the commodities in subgroup 8-10B. Therefore, EPA is maintaining the existing tolerance level for crops in subgroup 8-10A and revising the tolerance level for crops in subgroup 8-10B. Using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures and available field trial data (average) residues, EPA is establishing a tolerance for Pepper/Eggplant subgroup 8-10B at 3.0 ppm, instead of at 1.5 ppm as requested.

V. Conclusion

Therefore, tolerances are established for residues of flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM (4-trifluoromethylnicotinamide), and TFNG, N-(4-trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on Fruit, citrus, group 10-10 at 1.5 ppm; Pepper/Eggplant, subgroup 8-10B at 3.0 ppm; Tea at 40 ppm; and Tomato subgroup 8-10A at 0.4 ppm. In addition, EPA is revoking the existing tolerance for Vegetable, fruiting, group 8-10 because it is superseded by the new tolerances for subgroups 8-10A and 8-10B.

VI. Statutory and Executive Order Reviews

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

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

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

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 § 180.613:

i.Remove “Vegetable, fruiting, group 8-10” from the table in paragraph (a).

ii. Add alphabetically the following commodities to the table in paragraph (a): “Fruit, citrus, group 10-10”; “Pepper/Eggplant, subgroup 8-10B”; and “Tomato subgroup 8-10A”.

iii. Add “Tea” to the table in paragraph (a) and add footnote 1.

The additions to the table in paragraph (a) read as follows: