Final Rule.
SUMMARY
This regulation establishes tolerances for residues of oxathiapiprolin in or on multiple commodities that are identified and discussed later in this document. E.I. du Pont de Nemours and Company (“Dupont”) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
TABLE OF CONTENTS
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DATES:
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
B. How can I get electronic access to other related information?
C. How can I file an objection or hearing request?
II. Summary of Petitioned-for Tolerance
III. Aggregate Risk Assessment and Determination of Safety
A. Toxicological Profile
B. Toxicological Points of Departure/Levels of Concern
C. Exposure Assessment
D. Safety Factor for Infants and Children
E. Aggregate Risks and Determination of Safety
IV. Other Considerations
A. Analytical Enforcement Methodology
B. International Residue Limits
C. Response to Comments
D. Revisions to Petitioned-for Tolerances
V. Conclusion
VI. Statutory and Executive Order Reviews
VII. Congressional Review Act
List of Subjects in 40 CFR Part 180
PART 180—[AMENDED]
DATES:
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This regulation is effective September 4, 2015. Objections and requests for hearings must be received on or before November 3, 2015, 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:
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The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0114, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
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Susan Lewis, 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:
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I. General Information
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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-2014-0114 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 November 3, 2015. 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 (excludingany 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-2014-0114, 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 at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerance
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In the Federal Register of May 23, 2014 (79 FR 29729) (FRL-9910-29), 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 3F8220) by Dupont, 1007 Market Street, Wilmington, DE 19898. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide oxathiapiprolin, 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl] ethanone, in or on the following commodities: Brassica (cole) leafy vegetables, head and stem brassica crop subgroup 5A at 1.5 ppm; bulb vegetables, onion, bulb, crop subgroup 3-07A at 0.04 ppm; bulb vegetables, onion, green crop subgroup 3-07B at 2 ppm; cucurbit vegetables, crop group 9 at 0.2 ppm; fruiting vegetables crop group 8-10 at 0.2 ppm; grape (import tolerance) at 0.9 ppm; ginseng root at 0.4 ppm; leafy greens crop subgroup 4A at 15 ppm; peas, edible podded at 1 ppm; peas, succulent, shelled at 0.05 ppm; and vegetable, root and tuber vegetables, tuberous corm vegetable crop subgroup 1C at 0.01 ppm. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.
Additionally, in the Federal Register of July 17, 2015 (80 FR 42462) (FRL-9923-13), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing a correction to the filing of a pesticide petition (PP 3F8220) by Dupont. This document corrects the petition announced in the May 23, 2014 Federal Register by adding the omitted entry for dried fruit vegetable at 0.9 ppm. No FFDCA-related comments were received on this notice of filing.
Based upon review of the data supporting the petition, EPA has revised the tolerance levels of some commodities and corrected several commodity definitions. The reasons for these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
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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 oxathiapiprolin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with oxathiapiprolin follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
In the toxicity studies for oxathiapiprolin, no treatment-related effects were seen at doses up to the limit dose. No treatment-related effects were seen in subchronic or chronic oral toxicity (rats, mice, or dogs), dermal toxicity, neurotoxicity, or immunotoxicity studies. Additionally, there was no evidence of carcinogenicity in cancer studies with rats or mice. No treatment-related effects were seen in maternal or fetal animals in rat or rabbit developmental toxicity studies. Treatment-related effects were observed in offspring animals in rat reproduction studies (decreased body weight and delayed preputial separation); however, the effects were only observed at doses above the limit dose (1,227 milligram/kilogram/day (mg/kg/day)). Such high doses are not relevant for human health risk. No other treatment-related effects were observed in oral or dermal studies with oxathiapiprolin. The lack of observed toxicity is consistent with the low to moderate oral absorption and lack of bioaccumulation reported in the rat metabolism studies. In acute lethality studies, exposure to oxathiapiprolin resulted in low toxicity via the oral, dermal, and inhalation routes of exposure. Oxathiapiprolin was not a dermal or eye irritant, or a skin sensitizer.
Specific information on the studies received and the nature of the adverse effects caused by oxathiapiprolin 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, “Oxathiapiprolin—New Active Ingredient Human Health Risk Assessment of Uses on Turf, Ornamentals, and a Number of Crops” in docket ID number EPA-HQ-OPP-2014-0114.
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 thedose at which the NOAEL and the LOAEL are identified. 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
The majority of the toxicity studies for oxathiapiprolin did not demonstrate treatment-related effects, with the exception of the reproduction study. The effects in the reproduction study were minimal and seen at doses (above the limit dose) not relevant for human exposure. There were no adverse acute or chronic effects identified for any population groups (including infants and children). Therefore, due to the limited toxicity in the oxathiapiprolin toxicological database, toxicity endpoints and points of departure were not selected for oxathiapiprolin exposure scenarios and a quantitative risk assessment was not conducted.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to oxathiapiprolin, EPA considered exposure under the petitioned-for tolerances. There is likely to be dietary exposure to oxathiapiprolin from its use as a pesticide on food. Should exposure occur, however, minimal to no risk is expected for the general population, including infants and children, due to the low toxicity of oxathiapiprolin.
2. Dietary exposure from drinking water. Exposure to oxathiapiprolin via drinking water from the proposed uses is expected to be minimal due to rapid foliar uptake and limited quantities available in spray drift. No adverse effects were observed in the submitted toxicological studies for oxathiapiprolin regardless of the route of exposure.
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).
Oxathiapiprolin is not proposed or registered for any specific use pattern that would result in residential handler exposure. However, some of the uses could involve commercial application in areas where residential post-application activities could occur (i.e., individuals playing on treated golf courses, commercial landscapes or treated ornamentals purchased at a retail location). Since no adverse effects were observed for oxathiapiprolin in the submitted toxicological studies (regardless of the route of exposure), quantitative residential handler or post-application exposure assessments are not needed.
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 oxathiapiprolin to share a common mechanism of toxicity with any other substances, and oxathiapiprolin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that oxathiapiprolin 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://www.epa.gov/pesticides/cumulative.
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 Food Quality Protection Act Safety Factor (FQPA 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. No evidence of increased quantitative or qualitative susceptibility was seen in developmental toxicity studies in rats and rabbits. No treatment related effects were seen in maternal or fetal animals in the studies. However, there was evidence of increased quantitative susceptibility in reproduction studies in rats at doses above the limit dose. Decreased pup weight and delayed sexual maturation (preputial separation) were seen in the studies in the absence of maternal toxicity.
3. Conclusion. As part of its qualitative assessment, EPA evaluated the available toxicity and exposure data on oxathiapiprolin and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA considers the toxicity database to be complete and has identified no residual uncertainty with regard to prenatal and postnatal toxicity or exposure. No hazard was identified based on the available studies; therefore, EPA concludes that there are no threshold effects of concern to infants, children, or adults from oxathiapiprolin. As a result, EPA concludes that no additional margin of exposure (safety) is necessary.
E. Aggregate Risks and Determination of Safety
Taking into account the available data for oxathiapiprolin, EPA has concluded that given the lack of toxicity of this substance, no risks of concern are expected. Therefore, 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 oxathiapiprolin.
IV. Other Considerations
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A. Analytical Enforcement Methodology
Method 30422 (Supplement No. 1) was developed for plant commodities, and Method 31138 was developed for livestock commodities. Residues of oxathiapiprolin and associated metabolites are extracted from crop or livestock commodity samples using a solution of formic acid, water and acetonitrile, and diluted with acetonitrile and water. Both methods use liquid chromotography with tandem mass spectrometry (LC/MS/MS), specifically reverse-phase liquid chromatography (LC), and detection by electrospray tandem mass spectrometry (MS/MS).
The FDA multi-residue methods are not suitable for detection and enforcement of oxathiapiprolin residues or associated metabolites. However, the European Multiresidue Method (DFG Method S19) and the QuEChERS Multiresidue Method have shown success in some matrices.
Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression. 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 a MRL for oxathiapiprolin.
C. Response to Comments
One comment was received in response to the notice of filing of Dupont's application. The commenter objected to the increase of chemical residues generally and expressed concerns about the carcinogenic effects of chemicals on humans, particularly children. The Agency understands the commenter's concerns regarding toxic chemicals, their potential effects on humans, and population subgroups such as children. Pursuant to its authority under the FFDCA, and as discussed further in this preamble, EPA conducted a comprehensive assessment of oxathiapiprolin, including its potential for carcinogenicity. Based on its assessment of the available data, the Agency has concluded that there is a reasonable certainty that no harm will result from aggregate exposure to residues of oxathiapiprolin.
D. Revisions to Petitioned-for Tolerances
For grape, green onion, cucurbit vegetables, and edible podded pea, EPA has added an additional significant figure (such as 1.0 ppm rather than 1 ppm) to conform to EPA's convention for establishing enforceable tolerances. Thus, the tolerance for grape was revised to 0.70, for green onion to 2.0, for cucurbit vegetables to 0.20, and for edible-podded pea to 1.0. This is in order to avoid the situation where rounding of a residue result to the level of precision of the tolerance expression would be considered non-violative (such as 1.4 ppm being rounded to 1 ppm).
In the case of crop group 8-10, Fruiting Vegetables, the petitioned-for-tolerance was based on the exclusion of a tomato field trial from the tolerance calculation. If this trial is excluded, all representative commodities (bell pepper, non-bell pepper, and tomato) support a crop group tolerance of 0.20 ppm. However, EPA has concluded that this trial cannot be excluded from the tolerance derivation because there were insufficient data to support this trial as an outlier. Including those data in the tolerance calculation for crop group 8-10, EPA is establishing a tolerance for crop group 8-10 at 0.50 ppm and a tolerance for dried tomatoes at 3.0 ppm. EPA is not issuing a crop group 8-10 tolerance for dried versions of all commodities in that crop group, as EPA's current regulations do not permit the Agency to establish crop group processed commodity tolerances. Moreover, the available data do not support establishing separate individual tolerances for dried versions of the other commodities in crop group 8-10.
In the case of ginseng, Dupont submitted four field trials at the good agricultural practice (GAP) proposed use rate and two field trials at approximately two times the GAP. Based on a review of the data and consultation with the global partners, EPA has concluded that using the 1× data is more appropriate for setting the tolerance, and is establishing a tolerance at 0.15 ppm based on that data.
The Agency also corrected the commodity definitions for the following commodities: Bulb vegetables, onion, bulb, crop subgroup 3-07A, to onion, bulb, subgroup 3-07A; bulb vegetables, onion, green crop subgroup 3-07B to onion, green, subgroup 3-07B; brassica (cole) leafy vegetables, head and stem brassica crop subgroup 5A to brassica, head and stem, subgroup 5A; cucurbit vegetables, crop group 9 to vegetable, cucurbit, group 9; fruiting vegetables crop group 8-10 to vegetable, fruiting, group 8-10; ginseng root to ginseng; leafy vegetables (except brassica vegetables), leafy greens crop subgroup 4A to leafy greens, subgroup 4A; peas, edible podded to pea, edible-podded; peas, succulent, shelled to pea, succulent shelled; and vegetable, root and tuber vegetables, tuberous corm vegetable crop subgroup 1C, to vegetable, tuberous and corm, subgroup 1C.
The registrant did not petition for rotational crop tolerances. However, EPA has concluded that for future MRL harmonization purposes, it is appropriate to set a value of 0.10 ppm for inadvertent residues in all other food commodities/feed commodities (other than those covered by a tolerance as a result of use on growing crops).
V. Conclusion
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Therefore, tolerances are established for residues of oxathiapiprolin, 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl] ethanone, in or on the following commodities: Brassica, head and stem, subgroup 5A at 1.5 ppm; ginseng at 0.15 ppm; grape at 0.70 ppm; leafy greens subgroup 4A at 15 ppm; onion, bulb, crop subgroup 3-07A at 0.04 ppm; onion, green, crop subgroup 3-07B at 2.0 ppm; peas, edible podded at 1.0 ppm; peas, succulent, shelled at 0.05 ppm; tomato, dried at 3.0 ppm; vegetable, cucurbit, crop group 9 at 0.20 ppm; vegetables, fruiting, crop group 8-10 at 0.50 ppm; and vegetable, tuberous and corm, crop subgroup 1C at 0.01 ppm.
In addition, inadvertent tolerances are established residues of oxathiapiprolin on all other food commodities/feed commodities (other than those covered by a tolerance as a result of use on growing crops) at 0.10 ppm.
