29028 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

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 5, 2018. 

Michael Goodis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.470, 

■ i. Add alphabetically the entries 

‘‘Alfalfa, forage’’; ‘‘Alfalfa, hay’’; ‘‘Cattle, 

fat’’; ‘‘Cattle, kidney’’; ‘‘Cattle, meat’’; 

‘‘Cattle, meat byproducts, except 

kidney’’; ‘‘Goat, fat’’; ‘‘Goat, kidney’’; 

‘‘Goat, meat’’; ‘‘Goat, meat byproducts, 

except kidney’’; ‘‘Hog, kidney’’; ‘‘Horse, 

fat’’; ‘‘Horse, kidney’’; ‘‘Horse, meat’’; 

‘‘Horse, meat byproducts, except 

kidney’’; ‘‘Milk’’; ‘‘Sheep, fat’’; ‘‘Sheep, 

kidney’’; ‘‘Sheep, meat‘‘; ‘‘Sheep, meat 

byproducts, except kidney’’; to the table 

in paragraph (a) and 

■ ii. Revise the commodities ‘‘Animal 

feed, nongrass, group 18, except alfalfa, 

forage’’, and ‘‘Animal feed, nongrass, 

group 18, except alfalfa, hay’’ in the 

table in paragraph (d). 

The additions and revisions read as 

follows: 

§ 180.470 Acetochlor; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Alfalfa, forage ....................... 8.0 

Alfalfa, hay ............................ 20 

* * * * * 

Cattle, fat .............................. 0.02 

Cattle, kidney ........................ 0.03 

Cattle, meat .......................... 0.02 

Cattle, meat byproducts, except kidney ........................ 0.02 

* * * * * 

Goat, fat ................................ 0.02 

Goat, kidney ......................... 0.03 

Goat, meat ............................ 0.02 

Goat, meat byproducts, except kidney ........................ 0.02 

Hog, kidney ........................... 0.02 

Horse, fat .............................. 0.02 

Horse, kidney ........................ 0.03 

Horse, meat .......................... 0.02 

Horse, meat byproducts, except kidney ........................ 0.02 

Milk ....................................... 0.02 

* * * * * 

Sheep, fat ............................. 0.02 

Sheep, kidney ....................... 0.03 

Sheep, meat ......................... 0.02 

Sheep, meat byproducts, except kidney ........................ 0.02 

* * * * * 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

Animal feed, nongrass, group 

18, except alfalfa, forage .. 1.3 

Animal feed, nongrass, group 

18, except alfalfa, hay ....... 3.5 

* * * * * 

[FR Doc. 2018–13459 Filed 6–21–18; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

SUMMARY: This regulation establishes a 

tolerance for residues of thiencarbazonemethyl 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: 

RDFRNotices@epa.gov. 

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 


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Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 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: 

• 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/textidx?&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: 

• 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 

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 thiencarbazonemethyl 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 


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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 thiencarbazonemethyl 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-adverseeffect-level (NOAEL) and the lowestobserved-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

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

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.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 1.17 

mg/kg/day.

cPAD = 1.17 mg/kg/ 

day. 

Dog chronic feeding. 

LOAEL = 117 mg/kg/day based on urothelial effects. 

Oral short-term (adult and incidental oral for children) (1 to 

30 days).

NOAEL= 159 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential MOE = 

100.

Dog subchronic study. 

LOAEL = 335 mg/kg/day in males and 351 mg/kg/day in females based on urothelial effects. 

Dermal short-term (1 to 30 

days).

NOAEL = 159 mg/ 

kg/day.

DAF = 100% 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential MOE = 

100.

Dog subchronic study. 

LOAEL = 335 mg/kg/day in males and 351 mg/kh/day in females based on urothelial effects. 

Inhalation short-term (1 to 30 

days).

NOAEL= 159 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential MOE = 

100.

Dog subchronic study. 

LOAEL = 335 mg/kg/day in males and 351 mg/kg/day in females based on 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. 


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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 thiencarbazonemethyl; 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 precancerous 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. Tolerancelevel 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 thiencarbazonemethyl. 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 nonoccupational, 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: 

• 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 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 thiencarbazonemethyl 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 


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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, thiencarbazonemethyl 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, thiencarbazonemethyl 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-methyl3-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 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.645, 

■ a. Revise paragraph (a)(1) introductory 

text; 

■ b. Revise the entry for ‘‘wheat, forage’’ 

in the table in paragraph (a)(1); 

■ c. Revise paragraph (a)(2) introductory 

text; and 

■ d. Revise paragraph (d) introductory 

text. 

The revisions read as follows: 

§ 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 thiencarbazonemethyl [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. 

Commodity Parts per 

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-3H1,2,4-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-1H1,2,4-triazol-1-yl)- 

carbonyl]amino]sulfonyl]-5-methyl-3- 

thiophenecarboxylate] and its 

metabolite BYH 18636–MMT-glucoside 

[2-hexopyranosyl-5-methoxy-4-methyl2,4-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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0167; FRL–9977–94] 

Benzovindiflupyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: In response to a petition filed 

by Syngenta Crop Protection, LLC under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), this regulation establishes 

tolerances for residues of 

benzovindiflupyr in or on bluegrass, 

forage at 0.15 parts per million (ppm), 

bluegrass, hay at 7.0 ppm, bluegrass, 

straw at 6.0 ppm, bromegrass, forage at 

0.15 ppm, bromegrass, hay at 7.0 ppm, 

bromegrass, straw at 6.0 ppm, fescue, 

forage at 0.15 ppm, fescue, hay at 7.0 

ppm, fescue, straw at 6.0 ppm, 

orchardgrass, forage at 0.15 ppm, 

orchardgrass, hay at 7.0 ppm, 

orchardgrass, straw at 6.0 ppm, and 

ryegrass, forage at 0.15 ppm, ryegrass, 

hay at 7.0 ppm, and ryegrass, straw at 

6.0 ppm. 

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–2017–0167, 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., 


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