[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Rules and Regulations]
[Pages 29028-29033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13453]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0448; FRL-9978-50]


Thiencarbazone-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: 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).

DATES: 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 SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0448, 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 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: 
<a href="/cdn-cgi/l/email-protection#15475153475b7a617c767066557065743b727a63"><span class="__cf_email__" data-cfemail="9bc9dfddc9d5f4eff2f8fee8dbfeebfab5fcf4ed">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

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

[[Page 29029]]

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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-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:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> 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

    In the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-
27), 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 
7F8583) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that the existing wheat, forage 
tolerance in 40 CFR 180.645 for residues of the herbicide 
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, be amended from 0.10 parts per million (ppm) to 
0.15 ppm. That document referenced a summary of the petition prepared 
by Bayer CropScience, the registrant, which is available in the docket, 
http://www.regulations.gov. No comments related to this tolerance 
action were received on the notice of filing.

III. 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 thiencarbazone-methyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with thiencarbazone-
methyl 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.
    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

[[Page 29030]]

toward the end of lactation. There was also evidence of reduced 
absolute and relative liver weight in males in the high dose F1 group. 
The pups also demonstrated evidence of urothelial effects as indicated 
by the presence of stones in the kidneys and urinary bladder in a few 
F2 weanlings at the highest dose tested.
    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 http://www.regulations.gov in document, Thiencarbazone-methyl Human Health 
Risk Assessment, at pages 39-42 in docket ID number EPA-HQ-OPP-2017-
0448.

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 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for thiencarbazone-methyl 
used for human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Thiencarbazone-Methyl for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  No selection because no indication of significant toxicity following a single
                                                                        dose.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 117 mg/kg/day  Chronic RfD = 1.17   Dog chronic feeding.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 117 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 1.17 mg/kg/    urothelial effects.
                                   FQPA SF = 1x........   day..
----------------------------------------------------------------------------------------------------------------
Oral short-term (adult and         NOAEL= 159 mg/kg/day  Residential MOE =    Dog subchronic study.
 incidental oral for children) (1  UFA = 10x...........   100.                LOAEL = 335 mg/kg/day in males and
 to 30 days).                      UFH = 10x...........                        351 mg/kg/day in females based on
                                   FQPA SF = 1x........                        urothelial effects.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  NOAEL = 159 mg/kg/    Residential MOE =    Dog subchronic study.
                                    day.                  100.                LOAEL = 335 mg/kg/day in males and
                                   DAF = 100%..........                        351 mg/kh/day in females based on
                                   UFA = 10x...........                        urothelial effects.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     NOAEL= 159 mg/kg/day  Residential MOE =    Dog subchronic study.
 days).                            UFA = 10x...........   100.                LOAEL = 335 mg/kg/day in males and
                                   UFH = 10x...........                        351 mg/kg/day in females based on
                                   FQPA SF = 1x........                        urothelial effects.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classification ``not likely to be carcinogenic to humans at doses that do not
                                    cause urothelium cytotoxicity.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies). DAF= dermal absorption factor.


[[Page 29031]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to thiencarbazone-methyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing thiencarbazone-methyl 
tolerances in 40 CFR 180.180.645. EPA assessed dietary exposures from 
thiencarbazone-methyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
thiencarbazone-methyl; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the dietary model Dietary Exposure Evaluation 
Model-Food Commodity Intake Database (DEEM-FCID). The modeled exposure 
estimates for the chronic assessment are based on tolerance level 
residues and assume 100% of the crops are treated.
    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 thiencarbazone-methyl because the chronic reference dose 
is protective of any cancer or pre-cancerous effect observed in 
carcinogenicity studies. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for thiencarbazone-methyl. Tolerance-level residues 
and/or 100% CT 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 thiencarbazone-methyl in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of thiencarbazone-methyl. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    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. 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). Thiencarbazone-methyl 
is currently registered for the following uses that could result in 
residential exposures: Application to residential turfgrass and 
ornamentals. EPA assessed residential exposure using the following 
assumptions:
    <bullet> 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.
    <bullet> 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 http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 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 
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 FQPA Safety 
Factor (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. There is no evidence of 
increased qualitative or quantitative susceptibility in the young. 
Offspring effects occurred at the same doses as those which caused 
maternal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    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 in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and

[[Page 29032]]

tolerance-level residues. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to thiencarbazone-methyl in drinking water. EPA used similarly 
conservative assumptions to assess postapplication exposure of children 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by thiencarbazone-
methyl.

E. Aggregate Risks and Determination of Safety

    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.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
thiencarbazone-methyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
thiencarbazone-methyl from food and water will utilize less than 1% of 
the cPAD for children 1-2 years old, the population group receiving the 
greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    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.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term adverse effect was identified, 
thiencarbazone-methyl is not expected to pose a intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. As explained in 
section III.A., thiencarbazone-methyl is considered ``not likely to be 
carcinogenic to humans at doses that do not cause urothelial 
cytotoxicity.'' Because the Agency is regulating exposure to 
thiencarbazone-methyl to ensure that the U.S. population will not be 
exposed to levels that cause urothelial cytotoxicity, EPA concludes 
that thiencarbazone-methyl will not pose an aggregate cancer risk.
    6. Determination of safety. Based on these risk assessments, 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 thiencarbazone-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC/MS/MS) is available to enforce 
the tolerance expression.

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 thiencarbazone-methyl.

V. Conclusion

    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.

VI. Statutory and Executive Order Reviews

    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 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    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

[[Page 29033]]

require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
    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 et seq.).
    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).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 1, 2018.
Daniel J. Rosenblatt,
Deputy Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


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2. In Sec.  180.645,
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a. Revise paragraph (a)(1) introductory text;
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b. Revise the entry for ``wheat, forage'' in the table in paragraph 
(a)(1);
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c. Revise paragraph (a)(2) introductory text; and
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d. Revise paragraph (d) introductory text.
    The revisions read as follows:


Sec.  180.645  Thiencarbazone-methyl; tolerances for residues.

    (a)(1) General. Tolerances are established for residues of the 
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 only 
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 the following food and feed commodities.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Wheat, forage...........................................            0.15
 
                                * * * * *
------------------------------------------------------------------------

    (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-1H-1,2,4-triazol-1-yl)-carbonyl]amino]sulfonyl]-5-methyl-3-
thiophenecarboxylate] and its metabolite BYH 18636-MMT [5-methoxy-4-
methyl-2,4-dihydro-3H-1,2,4-triazol-3-one], calculated as the 
stoichiometric equivalent of thiencarbazone-methyl, in or on the 
following food commodities of animal origin:
* * * * *
    (d) Indirect or inadvertent residues. 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-1H-1,2,4-triazol-1-yl)-
carbonyl]amino]sulfonyl]-5-methyl-3-thiophenecarboxylate] and its 
metabolite BYH 18636-MMT-glucoside [2-hexopyranosyl-5-methoxy-4-methyl-
2,4-dihydro-3H-1,2,4-triazol-3-one], calculated as the stoichiometric 
equivalent of thiencarbazone-methyl, in or on the following food 
commodities:
* * * * *
[FR Doc. 2018-13453 Filed 6-21-18; 8:45 am]
 BILLING CODE 6560-50-P


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