Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of isofetamid in or on multiple commodities which are identified and discussed later in this document. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). The regulation also removes the existing time-limited tolerances for residues on “bushberry subgroup 13–07B” and “caneberry subgroup 13–07A” because they are no longer needed as a result of this action.
This regulation is effective June 14, 2017. Objections and requests for hearings must be received on or before August 14, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2016–0263, is available at
Michael L. 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:
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).
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
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–2016–0263 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 August 14, 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–2016–0263, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about
In the
Based upon review of the data supporting the petition, EPA has revised some of the proposed tolerances; determined that tolerances for residues in livestock commodities are not required; and corrected some of the commodity definitions. The reason for these changes are explained in Unit IV.D.
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 isofetamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with isofetamid follows.
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 toxicology database is complete for isofetamid. In repeated dose studies, the liver was the primary target organ in the rat, mouse, and dog, as indicated by increased liver weights, changes in the clinical chemistry values, and liver hypertrophy. A second target organ was the thyroid in the rat and dog, as indicated by changes in thyroid weights and histopathology. Adrenal weight changes were observed in the subchronic rat and dog studies. In the rat and dog, the dose levels where toxicity was observed were similar or higher in the chronic studies compared with the respective subchronic studies, showing an absence of progression of liver toxicity with time. There was no evidence of carcinogenicity in the rat or mouse cancer studies; the mutagenicity battery was negative. There are no genotoxicity, neurotoxicity, or immunotoxicity concerns observed in the available toxicity studies. Developmental toxicity was not observed in the rat or rabbit, and offspring effects such as decreased body weight were seen only in the presence of parental toxicity in the multi-generation rat study. Isofetamid is classified as “Not Likely to be Carcinogenic to Humans” based on the absence of increased tumor incidence in acceptable/guideline carcinogenicity studies in rats and mice. Isofetamid is not acutely toxic; it is classified as Toxicity Category III for acute oral and dermal exposure, and Toxicity Category IV for inhalation exposure. Furthermore, it is not irritating to the eye or skin, and it is not a dermal sensitizer.
Specific information on the studies received and the nature of the adverse effects caused by isofetamid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are can be found at
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
A summary of the toxicological endpoints for isofetamid used for human risk assessment is discussed in Unit III.B. of the final rule published in the
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Based on the Pesticide Flooded Application Model and the Pesticide Root Zone Model Ground Water (PRZM GW) the estimated drinking water concentrations (EDWCs) of isofetamid for chronic exposures for non-cancer assessments are estimated to be 110 parts per billion (ppb) for surface water and 43 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 110 ppb was used to assess the contribution from drinking water.
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Isofetamid is currently registered for the following uses that could result in residential exposures: Turfgrass including golf courses, residential lawns, and recreational turfgrass. It is currently under review for registering use on ornamental plants. The proposed ornamental use is not intended for homeowner use and therefore a quantitative residential handler assessment was not conducted. Additionally, post-application exposures for adults and children are expected to be negligible. However, the existing turf use may result in short- and intermediate-term exposures. Residential exposure may occur by the dermal and incidental oral routes of exposures following the application of isofetamid on residential turf. However, since dermal hazard has not been identified for isofetamid, the only exposure scenario quantitatively assessed is for post-application incidental oral (for children 1 to <2 years old). These exposures have been assessed with current policies, which include the Agency's 2012 Residential Standard Operating Procedures (
Even though a previous risk assessment identified residential handler risk estimates for use in aggregate assessment, based on current policy and that isofetamid products are intended for sale/use to/by professional applicators, residential handler exposure assessments for turf are no longer applicable to the isofetamid aggregate risk assessment. Therefore, the aggregate assessment for this action only includes a risk contribution from residential post-application incidental oral exposure for children 1 to <2 years old.
There is the potential for post-application exposure for individuals as a result of being in an environment that has been previously treated with isofetamid such as residential ornamental lawns. Since dermal hazard has not been identified for isofetamid, a quantitative assessment for dermal exposure is not necessary and the only exposure scenarios quantitatively assessed are for children 1 to <2 years old who may experience short-term incidental oral exposure to isofetamid from treated turf. Intermediate-term incidental oral post-application exposures are possible (
The post-application incidental oral MOE values were calculated based on the scenario of liquid application of isofetamid to turf. Post-application risk estimates for all incidental oral scenarios are not of concern (MOEs range from 5,900 to 4,000,000). The incidental oral scenarios (
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EPA has not found isofetamid to share a common mechanism of toxicity with any other substances, and isofetamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isofetamid 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
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i. The toxicity database for isofetamid is complete.
ii. There is no indication that isofetamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that isofetamid results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to isofetamid in drinking water. EPA used similarly conservative assumptions to assess post application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by isofetamid.
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.
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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 an aggregate MOE of 1,600 for children (1–2 years old). Because EPA's level of concern for isofetamid is a MOE of 100 or below, this MOE is not of concern.
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Adequate enforcement methodology liquid chromatography with tandem mass spectrometry (LC–MS/MS) method is available to enforce the tolerance expression. Multiresidue methods testing data have been submitted for isofetamid and GPTC. The data indicate that multiresidue methods are not suitable for analysis of isofetamid and GPTC, so the multiresidue methods cannot serve as enforcement methods. The multiresidue data have been forwarded to the Food and Drug Administration (FDA).
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 isofetamid. There are no Canadian, Codex, or Mexican maximum residue limits (MRLs) for isofetamid in/on the commodities included in this petition.
All tolerance levels are based upon the Organization for Economic Co-operation and Development's (OECD) tolerance calculation procedures. Thus, the tolerance levels established in this notice for isofetamid in/on bushberry, subgroup 13–07B; cherry, subgroup 12–12A; plum, prune, dried; dried shelled pea and bean, except soybean, subgroup 6C; and succulent shelled pea and bean, subgroup 6B are lower than those requested by the petitioner. The tolerance levels established in this notice for caneberry, subgroup 13–07A and fruit, small vine climbing, except grape, subgroup 13–07E are higher than those requested by the petitioner based on the OECD calculation procedures.
Additionally, the Agency has determined that tolerances requested for residues in livestock commodities are not required. These tolerances fall under 40 CFR 180.6(a)(3) regarding secondary residues in livestock commodities,
The following commodity definitions have been corrected: Bushberry subgroup 13–07B; fruit, small vine climbing, except grape, subgroup 13–07E; pea and bean, dried shelled, except soybean, subgroup 6C; and pea and bean, succulent shelled, subgroup 6B.
Therefore, tolerances are established for residues of isofetamid, in or on apple, wet pomace, at 2.0 parts per million (ppm); bushberry subgroup 13–07B at 5.0 ppm; caneberry subgroup 13–07A at 4.0 ppm; cherry subgroup 12–12A at 4.0 ppm; fruit, pome, group 11–10 at 0.60 ppm; fruit, small vine climbing, except grape, subgroup 13–07E at 10.0 ppm; pea and bean, dried shelled, except soybean, subgroup 6C, at 0.040 ppm; pea and bean, succulent shelled, subgroup 6B, at 0.030 ppm; peach subgroup 12–12B at 3.0 ppm; plum, prune, dried at 1.50 ppm; plum subgroup 12–12C at 0.80 ppm; and vegetable, legume, edible podded, subgroup 6A at 1.50 ppm. Additionally, the existing time-limited tolerances are being removed for both Caneberry subgroup 13–07A at 4.0 ppm, and for Bushberry subgroup 13–07B at 5.0 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). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
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
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
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).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions and revision read as follows:
(a) * * *
(b)