Source: https://www.federalregister.gov/documents/2016/06/01/2016-12722/fluensulfone-pesticide-tolerances
Timestamp: 2019-08-23 15:22:36
Document Index: 35385708

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

This regulation is June 1, 2016. Objections and requests for hearings must be received on or before August 1, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
34896-34902 (7 pages)
EPA-HQ-OPP-2015-0569
FRL-9946-07
Fluensulfone. Acute and Chronic Aggregate Dietary (Food and...
Fluensulfone. Petition from ADAMA and IR-4 for Registration of...
Fluensulfone – Aggregate Human Health Risk Assessment...
Fluensulfone: Drinking Water Exposure Assessment for Proposed...
https://www.federalregister.gov/d/2016-12722 https://www.federalregister.gov/d/2016-12722
This regulation establishes tolerances for residues of fluensulfone in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) and Makhteshim Agan of North America, Inc (d/b/a ADAMA) 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-2015-0569, 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-2015-0569 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 August 1, 2016. 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-2015-0569, by one of the following methods:
In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-9935-29), 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 5E8384) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of fluensulfone equivalents (i.e., the sum of thiazole sulfonic acid (TSA) and butene sulfonic acid (BSA) expressed as total fluensulfone equivalents) in or on the raw agricultural commodity vegetable, tuberous and corm, subgroup 1C at 0.6 ppm. That document referenced a summary of the petition prepared by Makhteshim Agan of North America, Inc., the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing, however it related to the chemical propenicol, not fluensulfone.
In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-86), 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 5F8351) by Makhteshim Agan of North America, Inc. (d/b/a ADAMA), 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of nematicide fluensulfone, including its metabolites and degradates, in or on berry, low growing, subgroup 13-07G at 0.30 ppm; head and stem Brassica subgroup 5A at 1.3 ppm; leafy Brassica greens subgroup 5B at 13 ppm; leafy vegetables, group 4, except Brassica vegetables at 2.6 ppm; leaves of root and tuber vegetables, group 2 at 20 ppm; radish, oriental at 0.50 ppm; and root vegetables, subgroup Start Printed Page 348971B, except sugar beet and oriental radish at 3.3 ppm. In addition, the petition requested to amend 40 CFR 180.680 to revise the existing tolerance expression in the introductory paragraph (a) to read “Tolerances are established for residues of the nematicide fluensulfone, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only 3,4,4-trifluoro-but-3-ene-1-sulfonic acid.” That document referenced a summary of the petition prepared by Makhteshim Agan of North America, Inc., the registrant, which is available in the docket, EPA-HQ-OPP-2015-0478 at http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has modified the levels at which tolerances are being established for most commodities. The reasons for these changes are explained in Unit IV.D.
The most sensitive endpoints for assessing safety of aggregate exposures to fluensulfone under the FFDCA are the increased pup-loss effects for acute dietary exposure; and body weight, hematological and clinical chemistry changes for chronic dietary as well as short/intermediate term dermal exposures.
Decreased locomotor activity in females, and decreased spontaneous activity, decreased rearing, and impaired righting response in both sexes were observed in the acute neurotoxicity study at the lowest dose tested. No other evidence for neurotoxicity was observed in the other studies in the toxicity database, including a subchronic neurotoxicity study. The doses and endpoints chosen for risk assessment are all protective of the effects seen in the acute neurotoxicity study. A developmental neurotoxicity study is not required.
Specific information on the studies received and the nature of the adverse effects caused by fluensulfone as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Fluensulfone—Aggregate Human Health Risk Assessment Addressing Label Amendments, Changes to the Residue Definition, and New Uses on Multiple Crops” on page 43 in docket ID number EPA-HQ-OPP-2015-0569.
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 Start Printed Page 34898complete 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 fluensulfone used for human risk assessment is shown in Table 1 of this unit.
Table 1—Summary of Toxicological Doses and Endpoints for Fluensulfone for Use in Human Health Risk Assessment
Acute dietary (All populations, including infants and children and females 13-49 years of age) NOAEL = 16.2 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1x Acute RfD = 0.16 mg/kg/day aPAD = 0.16 mg/kg/day 2-generation reproduction—rat offspring. LOAEL = 122.0 mg/kg/day based on an increase in pup loss between PND 1 and 4 in the F1 and F2 offspring with the majority of deaths occurring on day 2.
Chronic dietary (All populations) NOAEL= 9.6 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.10 mg/kg/day cPAD = 0.10 mg/kg/day 2-year toxicity/carcinogenicity-rat. LOAEL = 57.7 mg/kg/day based on decreased body weight in males, and hematology changes, clinical chemistry changes and histopathological effects in the lung and esophagus of both sexes.
Incidental oral short-term (1 to 30 days) NOAEL= 9.6 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE = 100 2-year toxicity/carcinogenicity-rat. LOAEL = 57.7 mg/kg/day based on decreased body weight in males, and hematology changes, clinical chemistry changes and histopathological effects in the lung and esophagus of both sexes.
Dermal short-term (1 to 30 days) Oral study NOAEL = 9.6 mg/kg/day (dermal absorption factor = 9.5%) UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE = 100 2-year toxicity/carcinogenicity-rat. LOAEL = 57.7 mg/kg/day based on decreased body weight in males, and hematology changes, clinical chemistry changes and histopathological effects in the lung and esophagus of both sexes.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluensulfone, EPA considered exposure under the petitioned-for tolerances as well as all existing fluensulfone tolerances in 40 CFR 180.680. Parent fluensulfone occurs at residue levels well below those of the BSA metabolite, the residue defined for the enforcement of tolerances. As previously noted, the BSA metabolite is not of toxicological concern. Since tolerances do not include fluensulfone itself, EPA has used the Organization for Economic Cooperation and Development (OECD) maximum residue limit (MRL) calculation procedures to derive tolerance-equivalent residue levels for fluensulfone. For foods where the level of fluensulfone is expected to be below the limit of quantification (LOQ), 0.01 ppm, the Agency has assumed that residues occur at the LOQ. For foods with quantifiable levels of fluensulfone, EPA has assumed that residues occur at the tolerance-equivalent level. EPA assessed dietary exposures from fluensulfone in food as follows:
Such effects were identified for fluensulfone. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the United States 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, the acute dietary risk assumed tolerance-equivalent residues and 100 percent crop treated (PCT).
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 fluensulfone. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for fluensulfone. Tolerance-equivalent level residues and 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fluensulfone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluensulfone. 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. Start Printed Page 34899
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) for acute exposures are estimated to be 11.8 parts per billion (ppb) for surface water and 77.6 ppb for ground water and for chronic exposures are estimated to be 0.173 ppb for surface water and 52.5 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 77.6 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 52.5 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). Fluensulfone is currently registered for the following uses that could result in residential exposures: Turf/lawns. EPA assessed residential exposure using the following assumptions: For residential handlers, a quantitative exposure/risk assessment was not developed because the product is not intended to be applied by homeowners. For adult residential post-application exposure, the Agency evaluated dermal post-application exposure only to outdoor turf/lawn applications (high contact activities). The Agency also evaluated residential post-application exposure for children via dermal and hand-to-mouth routes of exposure, resulting from treated outdoor turf/lawn applications (high contact activities).
EPA has not found fluensulfone to share a common mechanism of toxicity with any other substances, and fluensulfone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluensulfone 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.
2. Prenatal and postnatal sensitivity. No evidence of quantitative or qualitative susceptibility was seen in developmental toxicity studies in rats and rabbits. Fetal effects in those studies occurred in the presence of maternal toxicity and were not considered more severe than the maternal effects. However, there was evidence of increased qualitative, but not quantitative, susceptibility of pups in the 2-generation reproduction study in rats. Maternal effects observed in that study were decreased body weight and body weight gain; at the same dose, effects in offspring were decreased pup weights, decreased spleen weight, and increased pup loss (PND 1-4).
Although there is evidence of increased qualitative susceptibility in the 2-generation reproduction study in rats, there are no residual uncertainties with regard to pre- and post-natal toxicity following in utero exposure to rats or rabbits and pre- and post-natal exposures to rats. Considering the overall toxicity profile, the clear NOAEL for the pup effects observed in the 2-generation reproduction study, and that the doses selected for risk assessment are protective of all effects in the toxicity database including the offspring effects, the degree of concern for the susceptibility is low.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluensulfone will occupy 9.3% of the aPAD for all infants less than 1 year old, the population group receiving the greatest exposure.Start Printed Page 34900
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluensulfone from food and water will utilize 3.9% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluensulfone is not expected.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 5,700 for adults and 3,000 for children 1-2 years old. Because EPA's level of concern for fluensulfone is a MOE of 100 or below, these MOEs are not of concern.
Adequate enforcement methodology (acetonitrile/water (1:1, v/v) extraction and analysis by reverse-phase high-performance liquid chromatography-mass spectrometry (HPLC-MS/MS)) is available to enforce the tolerance expression.
The Codex has not established any MRLs for fluensulfone for the commodities covered by this document.
Three comments were submitted in response to the March 16, 2016 Notice of Filing. Two of them opposed the petition generally due to there being too many toxic chemicals being used in America without citing any specific human health concerns about fluensulfone itself. The Agency understands the commenters' concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.
The second comment was from the Center for Food Safety and primarily concerned about Agency compliance with any relevant obligations under the Endangered Species Act. This comment is not relevant to the Agency's evaluation of safety of the fluensulfone tolerances; section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment.
Most of the petitioned-for tolerance levels differ from those being established by the Agency. In the cases of the tolerances proposed by ADAMA, it is not clear to the Agency how the tolerance levels proposed in the March 16, 2016 Notice of Filing (Federal Register 2016-05952) were derived. EPA's tolerance levels are based on residues of BSA only, without any conversion to fluensulfone equivalents. The Agency used the OECD MRL procedures to derive the levels being established in today's action. For crop groups, and per EPA's current policy, tolerance levels for each representative commodity were calculated separately, and then the maximum value within each crop group was selected as the tolerance level. For root vegetables except sugar beet (Subgroup 1B), the tolerance level is based on data from radish root (including Oriental radish root). Although a separate listing for Oriental radish was requested, EPA is not establishing a separate tolerance level since that crop is a member of crop subgroup 1B. For leaves of root and tuber vegetables (Crop Group 2), EPA is establishing a tolerance for residues in/on the leaves of root and tuber vegetable, except sugar beet because the petitioned-for uses do not include a use on sugar beet; the tolerance is based on data from radish tops (including Oriental radish tops). The tolerance for residues in/on leafy vegetables except Brassica vegetables (Group 4) is based on data from leaf lettuce and spinach, assessed separately. For head and stem Brassica (Subgroup 5A), the tolerance is Start Printed Page 34901based on data from cabbage. For Brassica leafy greens (Subgroup 5B), data from mustard greens, komatsuna (Japanese mustard spinach), and mizuna (Japanese mustard) were combined to derive the tolerance level. All of EPA's tolerance levels are expressed to provide sufficient precision for enforcement purposes, and this may include the addition of trailing zeros (e.g., 0.30 ppm rather than 0.3 ppm).
In the case of the tolerance proposed by IR-4, the petitioned-for tolerance is based on the sum of residues of BSA and TSA, expressed as fluensulfone, rather than on residues of BSA only, which is how the tolerance expression currently describes measurement of residues for compliance purposes. Basing enforcement on BSA alone provides a suitable marker of use, simplifies residue analysis, and avoids enforcement complications that may result from the potential for TSA to carry over in treated soil from one year to the next. Furthermore, IR-4 did not propose tolerances for residues of fluensulfone in processed potato commodities. The submitted potato processing study indicates that during processing, residues of BSA in chips and in granules/flakes are likely to concentrate to levels greater than in tubers. Therefore, EPA is establishing separate tolerances to cover residues in those commodities.
Therefore, tolerances are established for residues of fluensulfone in or on berry, low growing, subgroup 13-07G at 0.30 ppm; Brassica, head and stem, subgroup 5A at 1.50 ppm; Brassica, leafy greens, subgroup 5B at 9.0 ppm; potato, chips at 0.60 ppm; potato, granules/flakes at 0.80 ppm; vegetables, leafy, except Brassica, group 4 at 2.0 ppm; vegetable, leaves of root and tuber, group 2, except sugar beet at 30 ppm; vegetables, root, except sugar beet, subgroup 1B at 3.0 ppm; and vegetables, tuberous and corm, subgroup 1C at 0.50 ppm. Also, the time-limited Section 18 tolerance for “carrot” is removed since it is now covered by the permanent tolerance for “vegetables, root, except sugar beet, subgroup 1B.” And lastly, the tolerance expression is changed as requested by the petitioner.
2. Section 180.680 is revised to read as follows:
(a) General. Tolerances are established for residues of the nematicide fluensulfone, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only 3,4,4-trifluoro-but-3-ene-1-sulfonic acid.
Berry, low growing, subgroup 13-07G 0.30
Brassica, head and stem, subgroup 5A 1.50
Potato, chips 0.60
Potato, granules/flakes 0.80
Vegetables, leafy, except Brassica, group 4 2.0
Vegetables, leaves of root and tuber, group 2, except sugar beet 30
Vegetables, root, except sugar beet, subgroup 1B 3.0
Vegetables, tuberous and corm, subgroup 1C 0.50
[FR Doc. 2016-12722 Filed 5-31-16; 8:45 am]