Source: https://www.federalregister.gov/documents/2019/04/08/2019-06690/flonicamid-pesticide-tolerances
Timestamp: 2020-02-24 14:20:36
Document Index: 58104735

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 2', 'art 180', '§\u2009180', '§\u2009180']

Federal Register :: Flonicamid; Pesticide Tolerances
Flonicamid; Pesticide Tolerances
A Rule by the Environmental Protection Agency on 04/08/2019
This regulation is effective April 8, 2019. Objections and requests for hearings must be received on or before June 7, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
84 FR 13805
13805-13809 (5 pages)
EPA-HQ-OPP-2018-0273
FRL-9990-52
2019-06690
https://www.federalregister.gov/d/2019-06690 https://www.federalregister.gov/d/2019-06690
This PDF is the current document as it appeared on Public Inspection on 04/05/2019 at 8:45 am.
Start Preamble Start Printed Page 13805
This regulation establishes a crop group tolerance for residues of flonicamid in or on the commodities in sunflower subgroup 20B. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2018-0273, 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.
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-2018-0273 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 June 7, 2019. 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-2018-0273, by one of the following methods:
In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-31), 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 8E8667) by Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requests to establish a tolerance in 40 CFR part 180 for residues of the insecticide flonicamid, including its metabolites and degradates, determined by measuring only the sum of flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM (4-trifluoromethylnicotinamide), and TFNG N-(4-trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on the commodities in sunflower subgroup 20B at 0.70 parts per million (ppm). That document referenced a summary of the petition prepared by ISK Bioscience 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.
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 Start Printed Page 13806occupational 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.
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 demonstrated low toxicity in acute oral toxicity studies. Flonicamid 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).
Further detail of the toxicological profile for flonicamid is discussed in Unit III.A. of the final rule published in the Federal Register of July 23, 2018 (83 FR 34775) (FRL-9977-82).
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 at http://www.regulations.gov in document, “SUBJECT: Flonicamid. Human Health Risk Assessment for the Establishment of Permanent Tolerances in or on Sunflower Subgroup 20B” at pages 18-19 in docket ID number EPA-HQ-OPP-2018-0273.
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 July 23, 2018 (83 FR 34775) (FRL-9977-82).
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 food consumption data from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The chronic dietary (food and drinking water) exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID), Version 3.16. As to residue levels in food, an unrefined chronic dietary exposure assessment was conducted for all proposed and established food uses of flonicamid. Tolerance-level residues were combined with 100 percent crop treated (PCT) estimates. Separate tolerances established for potato granules/flakes, tomato paste, and tomato puree were based on processing studies (processing factor set to 1.0 for these commodities) and DEEM default processing factors were used for the other processed commodities.
iii. Cancer. Flonicamid has been determined to have suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential. The Agency has determined that quantification of risk using a non-linear approach (i.e., using a chronic reference dose) adequately accounts for all chronic toxicity, including carcinogenicity that could result from exposure to flonicamid. Therefore, the chronic reference dose is considered protective for carcinogenic effects.
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 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 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 a total toxic residue approach, which considers the parent compound and its major degradates of concern.
Based on the Pesticide Root Zone Model Ground Water (PRZM GW), version 1.0, the estimated drinking water concentration (EDWC) of Start Printed Page 13807flonicamid for chronic exposure for non-cancer assessment is estimated to be 9.92 parts per billion (ppb) for ground water. The EDWC for surface water chronic exposure, derived using the Pesticide in Water Calculator (PWC version 1.52), is 0.94 ppb.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 9.92 ppb was used to assess the contribution to drinking water.
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.
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 website at http://www2.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​cumulative-assessment-risk-pesticides.
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.
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 indication that flonicamid is a neurotoxic chemical. As discussed in Unit III.A. of the final rule published in the Federal Register of July 23, 2018 (83 FR 34775) (FRL-9977-82), 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 in utero 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.
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 64% 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, Start Printed Page 13808aggregate exposure to flonicamid is below the cPAD. As a result, EPA concludes that there is not an aggregate cancer risk from exposures to flonicamid.
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.
Adequate enforcement methodology is available to enforce the tolerance expression. FMC Method No. P-3561M, a liquid chromatography-tandem mass spectrometry (LC/MS/MS) method, is an acceptable enforcement method for flonicamid and its metabolites in plant commodities. The method determines residues of flonicamid and its metabolites TFNA-AM, TFNA, and TFNG. The method has been sufficiently validated in five diverse crops. The limit of quantitation (LOQ) is 0.01 ppm. The limit of detection (LOD) can be estimated as one-third the LOQ.
There are no Codex maximum residue limits (MRLs) for flonicamid and its metabolites in/on sunflower subgroup 20B.
Therefore, tolerances are established for residues of flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM (4-trifluoromethylnicotinamide), and TFNG, N-(4-trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on sunflower subgroup 20B at 0.70 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).
Dated: March 26, 2019.
2. In § 180.613, add alphabetically the entry “Sunflower subgroup 20B” to the table in paragraph (a)(1) to read as follows:
§ 180.613
Flonicamid; tolerances for residues.
(1) * * * Start Printed Page 13809
Sunflower subgroup 20B 0.70
[FR Doc. 2019-06690 Filed 4-5-19; 8:45 am]