Aluminum tris (O-ethylphosphonate); Pesticide Tolerances
Federal Register, Volume 83 Issue 55 (Wednesday, March 21, 2018)
Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)
Rules and Regulations
Pages 12260-12265
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-05642
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2016-0639; FRL-9974-63
Aluminum tris (O-ethylphosphonate); Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends a tolerance for residues of aluminum tris (O-ethylphosphonate) in or on Fruit, citrus, group 10. Fosetyl-al is the common name for aluminum tris (O-ethylphosphonate). Tessenderlo Kerley, Inc requested the amended tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 21, 2018. Objections and requests for hearings must be received on or before May 21, 2018, 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-2016-0639, 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: Michael Goodis, 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: email protected.
SUPPLEMENTARY INFORMATION:
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General Information
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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).
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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.
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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-2016-0639 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 May 21, 2018. 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-2016-0639, 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.
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Summary of Petitioned-For Tolerance
In the Federal Register of July 26, 2017 (82 FR 34664) (FRL-9963-
50), 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 6F8517) by Tessenderlo Kerley, Inc, 2255 N. 44th St., Suite 300, Phoenix, AZ 85008. The petition requested that 40 CFR 180.415 be modified by amending tolerances for residues of the fungicide aluminum tris (O-ethylphosphonate), in or on fruit, citrus, group 10 from 5.0 parts per million (ppm) to 9.0 ppm. That document referenced a summary of the petition prepared by Tessenderlo Kerley, Inc, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received on this notice of filing.
Because EPA does not issue group tolerances for groups that have been updated or superseded, the petitioner submitted a revised petition, clarifying that its request was to establish tolerances for residues of the fungicide aluminum tris (O-ethylphosphonate) in or on the updated crop group fruit, citrus, group 10-10 at 9.0 ppm. EPA published notice of this revised petition in the Federal Register on December 19, 2017 (82 FR 60167) (FRL-9971-11). That document referenced a summary of this updated petition, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.
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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 aluminum tris (O-
ethylphosphonate) including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with aluminum tris (O-ethylphosphonate) follows.
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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.
The major target organs following repeated oral exposure to fosetyl-Al are the reproductive system in the dog (testicular degeneration: Spermatocytic and/or spermatidic giant cells in the lumen of the seminiferous tubules) and the urinary system in the rat (histopathological changes in the kidney, impairment of calcium/
phosphorus metabolism, calculi and hyperplasia in the urinary tract, bladder tumors).
The prenatal developmental studies in rabbits and rats and the 3-
generation reproduction study in rats showed no indication of increased susceptibility following in utero and/or postnatal exposure to fosetyl-
Al. Developmental toxicity was not observed in the rat at the limit dose or in the rabbit at the highest dose tested (500 mg/kg/day). Reproductive toxicity was not observed
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at the limit dose, and offspring toxicity (decreased pup body weight at 600 mg/kg/day) was observed at the same dose as maternal toxicity (decreased body weight gain and urinary tract changes). The toxicology database for fosetyl-Al does not show any evidence of neurotoxicity.
Fosetyl-Al is classified as not likely to be carcinogenic to humans since it was negative for carcinogenicity except at extremely high doses (>limit dose) in rats and mice, and it did not show any genotoxic potential. Fosetyl-Al is not acutely toxic via the oral, dermal, and inhalation routes, is not a skin irritant or dermal sensitizer, but is a severe eye irritant.
Specific information on the studies received and the nature of the adverse effects caused by aluminum tris (O-ethylphosphonate) 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 Fosetyl-Aluminum (Fosetyl-AI): Human Health Risk Assessment in Support of the Amended Registration for the Proposed 0-day Pre-Harvest Interval (PHI) for Citrus Fruit Group 10-10 at pages 9-14 in docket ID number EPA-HQ-OPP-2016-0639.
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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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for aluminum tris (O-
ethylphosphonate) used for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Aluminum tris (O-ethylphosphonate) for Use in Human
Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (All populations).. No appropriate endpoint was identified. There were no adverse effects
observed in oral toxicity studies that could be attributed to a single-dose
exposure.
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Chronic dietary (All populations) NOAEL = 250mg/kg/day Chronic RfD = 2.5 Chronic oral toxicity (dog).
UFA = 10x........... mg/kg/day. LOAEL = 500 mg/kg/day based on an
UFH = 10x........... cPAD = 2.5 mg/kg/ increased incidence of testicular
FQPA SF = 1x........ day. degeneration (spermatocytic and/
or spermatidic giant cells in the
lumen of the seminiferous
tubules).
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Incidental oral (Short- and NOAEL = 300 mg/kg/ Residential LOC for 3-generation reproduction (rat).
intermediate-term). day. MOE
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