Environmental Protection Agency (EPA).
Final rule.
This regulation establishes a tolerance for residues of thiencarbazone-methyl in or on wheat forage. Bayer CropScience requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective June 22, 2018. Objections and requests for hearings must be received on or before August 21, 2018, 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–2017–0448, 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
• 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–2017–0448 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 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–2017–0448, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
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 thiencarbazone-methyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with thiencarbazone-methyl 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.
Thiencarbazone-methyl has low acute toxicity via the oral, dermal, and inhalation routes of exposure. Thiencarbazone-methyl is not an eye nor a skin irritant and it is not a skin sensitizer.
The most toxicologically significant effect of thiencarbazone-methyl occurs in the urothelial system including the kidney, bladder, and urinary tract. Across species, the dog is more sensitive than the rat or the mouse. Common effects observed throughout the database included sulfonamide crystals in the urine, eosinophilic urolithiasis (kidney, ureter and bladder stones), pelvic dilation, thickening of the kidney, bladder, or ureter, collecting duct hyperplasia, urothelial hyperplasia, submucosal inflammatory cell infiltration, bladder hemorrhage, inflammation, and ulceration.
There is no evidence of susceptibility in the thiencarbazone-methyl database. Offspring effects occurred at the same doses as those which caused maternal toxicity. In rats, maternal toxicity was indicated by decreased body and placenta weight and yellowish sediment in the urinary bladder. Developmental toxicity was indicated by delayed ossification of several locations. In rabbits, maternal toxicity consisted of decreased body weight, deaths, reduced food consumption and sediment in the kidney and urinary bladder. Developmental toxicity consisted of more runt fetuses and lower body weight in female offspring. There were no effects on reproductive parameters in either males or females in a reproductive study in rats. Systemically, there were effects on the urothelial system at the high dose in the parents and decreases in body weight in females
There is no evidence of immunotoxicity, neurotoxicity, or mutagenicity in the thiencarbazone-methyl database. There were no treatment-related increases in neoplasia in the rat carcinogenicity study. In mice, calculi in the urothelial system as well as transitional cell epithelium tumors in the urinary bladder (1 male/3 females) and in the prostatic urethra (1 male) were observed at the highest dose tested (599 mg/kg/day in males and 758 mg/kg/day in females). Since the neoplasia occurred only in the high dose group, thiencarbazone-methyl was classified as “not likely to be a carcinogen to humans at doses that do not cause urothelial cytotoxicity.” The formation of the tumors is considered to be related to the secondary effects of the urothelial toxicity (irritation) and regenerative proliferation associated with the formation of urinary tract crystals/calculi.
Specific information on the studies received and the nature of the adverse effects caused by thiencarbazone-methyl 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
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
A summary of the toxicological endpoints for thiencarbazone-methyl used for human risk assessment is shown in Table 1 of this unit.
1.
i.
No such effects were identified in the toxicological studies for thiencarbazone-methyl; therefore, a quantitative acute dietary exposure assessment is unnecessary.
ii.
iii.
iv.
2.
Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI–GROW) models, the estimated drinking water concentrations (EDWCs) of thiencarbazone-methyl for chronic exposures for non-cancer assessments are estimated to be 0.36 ppb for surface water and 0.00079 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 of value 0.36 ppb was used to assess the contribution to drinking water.
3.
• Residential handler exposure is expected to be short-term in duration. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. There is a potential for inhalation and dermal exposure for adult handlers.
• Post-application exposure is expected to be short-term in nature. There is a potential for dermal exposure to adults and children and incidental oral exposure to children ages 1 <2 years old through contact with treated areas after treatment.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found thiencarbazone-methyl to share a common mechanism of toxicity with any other substances, and thiencarbazone-methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that thiencarbazone-methyl 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
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3.
i. The toxicity database for thiencarbazone-methyl is considered complete. There are available developmental studies in rats and rabbits, a reproductions study in rats, and acute and subchronic neurotoxicity battery studies. The requirement for a subchronic inhalation study was waived because thiencarbazone-methyl has low volatility, low acute inhalation toxicity and the use of a POD from an oral study to estimate inhalation exposures results in MOEs that are >100 times higher than the MOEs of concern.
ii. There is no indication that thiencarbazone-methyl 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 thiencarbazone-methyl 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% CT and
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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2.
3.
Thiencarbazone-methyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to thiencarbazone-methyl. 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 9,200 to adults, 140,000 for children 11–16 years old, 13,000 for children 6–11 years old, and 7,500 for children 1–2 years old. Because EPA's level of concern for thiencarbazone-methyl is a MOE of 100 or below, these MOEs are not of concern.
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Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression.
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 thiencarbazone-methyl.
Therefore, the tolerance is amended for residues of thiencarbazone-methyl, methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H–1,2,4-triazol-1-yl)carbonyl] amino]sulfonyl]-5-methyl-3-thiophenecarboxylate, in or on wheat forage at 0.15 ppm. In addition, EPA is revising the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of thiencarbazone-methyl not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression. EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.
This action amends a tolerance 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 subject to 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
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
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 and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The revisions read as follows:
(a)(1)
(2) Tolerances are established for residues of thiencarbazone-methyl, 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 the sum of thiencarbazone-methyl [methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1
(d)