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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29034 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Michael Goodis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

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 

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–2017–0167 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– 

2017–0167, 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 July 26, 

2017 (82 FR 34664) (FRL–9963–50), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 6F8542) by 

Syngenta Crop Protection, LLC, P.O. 

Box 18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.686 

be amended by establishing tolerances 

for residues of the fungicide 

benzovindiflupyr (N-[9- 

(dichloromethylene)-1,2,3,4-tetrahydro1,4-methanonaphthalen-5-yl]-3- 

(difluoromethyl)-1-methyl-1H-pyrazole4-carboxamide), in or on grasses grown 

for seed, forage at .15 parts per million 

(ppm); grasses grown for seed, hay at 7 

ppm; and grasses grown for seed, straw 

at 6 ppm. That document referenced a 

summary of the petition prepared by 

Syngenta Crop Protection, LLC, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

Although one commenter requested that 

this petition be denied, no basis or 

information was provided to support a 

denial of this petition. 

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 benzovindiflupyr 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with benzovindiflupyr 

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. 

The rat is the most sensitive species 

tested, and the target organs of 

benzovindiflupyr are the liver, thyroid, 

and kidneys in rats. Hepatotoxicity was 

manifested as changes in liver weights, 

liver hypertrophy, and decreased 

triglycerides. The kidney effects were 

tubular cell pigment deposits, changes 

in the tubular basophilia, and increased 

urea. Enlargement and focal c-cell 

hyperplasia of the thyroid were 

observed. An increased incidence of cell 

hypertrophy in the pituitary pars 

distalis was noted in the F1 generation 

males and females in the 2-generation 


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reproductive toxicity rat study. Mouse 

studies revealed distended large 

intestines, soft feces and hyperplasia of 

the colon and caecum. Indications of 

general malaise including decreased 

body weight and food consumption, 

decreased activity, decreased grip 

strength, piloerection, decreased 

response to stimulus, hunched posture, 

gait changes and/or ataxia were reported 

in the rat and mouse studies. In several 

studies, females tended to be more 

sensitive than males, and effects were 

generally seen at lower doses with 

gavage dosing than with dietary dosing. 

There are no concerns for 

developmental or reproductive toxicity 

following benzovindiflupyr exposure. 

Decreased fetal weight and ossification 

in the rat developmental toxicity studies 

occurred at maternally toxic doses. 

There were no maternal or fetal adverse 

effects in the rabbit developmental 

study. In rat reproduction studies, 

offspring effects (decreased body 

weight, liver and pituitary effects) 

occurred at doses higher than those 

causing parental effects, thus there was 

no quantitative increase in sensitivity in 

rat pups. There were no single-dose 

developmental effects identified in the 

developmental toxicity studies in rats or 

rabbits. Although decreases in growing 

follicle counts were noted in the 2- 

generation reproduction toxicity study, 

this effect did not result in reduced 

fertility in the rat. Furthermore, the 

antral follicle counts at a later stage in 

development were not decreased, so the 

decreased growing follicle count effect 

is not considered adverse. 

No evidence of specific neurotoxicity 

was observed in the acute oral (gavage) 

and sub-chronic oral (dietary) 

neurotoxicity (ACN and SCN) studies in 

rats, conducted on the benzovindiflupyr 

technical product. Although 

benzovindiflupyr caused decreased 

activity and decreased grip strength in 

the neurotoxicity studies, there was no 

supportive neuro-histopathology in any 

study to indicate a specific neurotoxic 

effect. 

The mouse immunotoxicity study was 

negative by the T-cell Dependent 

Antigen Response (TDAR) assay in the 

mouse. 

No systemic effects were noted at the 

limit dose of 1000 mg/kg/day in the 28- 

day dermal rat study. 

The Agency classified 

benzovindiflupyr as showing 

‘‘Suggestive Evidence of Carcinogenic 

Potential’’ based on the presence of 

granular cell tumors of the brain in male 

rats only at the highest dose tested. The 

Agency concluded that a non-genotoxic 

mode of action for thyroid tumors 

observed in male rats has been 

established as a result of upregulation of 

uridine diphosphate 

glucuronyltransferase (UDPGT), 

increased clearance of T3 and T4 

hormones, and increased TSH levels, 

resulting in increased thyroid cell 

proliferation, which progress to form 

thyroid tumors. There was no evidence 

of carcinogenicity in female rats or in 

male or female mice. In addition, there 

is no concern for mutagenicity. The 

Agency has determined that using a 

non-linear approach (i.e., RfD; reference 

dose) will adequately account for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to benzovindiflupyr. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by benzovindiflupyr as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled Benzovindiflupyr. Human Health 

Risk Assessment for the Proposed Use 

on Grasses Grown for Seeds on pages 

30–36 in docket ID number EPA–HQ– 

OPP–2017–0167. 

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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for benzovindiflupyr used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of November 14, 

2017 (82 FR 52669) (FRL–9967–33). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to benzovindiflupyr, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing benzovindiflupyr tolerances in 

40 CFR 180.686. EPA assessed dietary 

exposures from benzovindiflupyr 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. 

Such effects were identified for 

benzovindiflupyr. In estimating acute 

dietary exposure, EPA used 2003–2008 

food consumption information from the 

U.S. Department of Agriculture’s 

(USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA assumed 100 

percent crop treated (PCT) and 

tolerance-level residues. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used 2003–2008 food consumption 

data from the USDA’s NHANES/ 

WWEIA. As to residue levels in food, 

EPA assumed 100 PCT and tolerancelevel residues. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a non-linear approach 

(i.e., RfD) adequately accounts for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to benzovindiflupyr. A 

separate cancer assessment was not 

performed. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

benzovindiflupyr. Tolerance level 

residues and/or 100 PCT 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 benzovindiflupyr in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

benzovindiflupyr. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 


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29036 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

can be found at http://www2.epa.gov/ 

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 

Based on the Surface Water 

Concentration Calculator (SWCC) model 

and the Pesticide Root Zone Model 

Ground Water (PRZM–GW) model, the 

estimated drinking water concentrations 

(EDWCs) of benzovindiflupyr for acute 

exposures are estimated to be 8.41 parts 

per billion (ppb) for surface water and 

0.14 ppb for ground water and for 

chronic exposures for non-cancer 

assessments are estimated to be 5.41 

ppb for surface water and 0.14 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 8.41 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 5.41 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). 

Benzovindiflupyr is currently 

registered for the following uses that 

could result in residential exposures: 

Turf and ornamentals. EPA assessed 

residential exposure using the following 

assumptions: The residential uses of 

benzovindiflupyr will result in shortterm residential handler and postapplication exposure in residential 

settings. Only residential handler 

inhalation and post-application 

incidental oral exposure scenarios have 

been quantitatively assessed since no 

dermal hazard was identified. 

Residential handler short-term 

inhalation MOEs are well above the 

LOC of 100 for all scenarios assessed 

and are not of concern (inhalation MOEs 

are ≥180,000). Residential postapplication (incidental oral) MOEs for 

children ranged from 8,000 to 3,600,000 

on the day of application, using default 

input values, and are not of concern. 

The residential scenarios for the 

benzovindiflupyr aggregate assessments 

are as follows: Adults: Inhalation 

exposures from treating ornamentals 

with a manually pressurized hand-wand 

or backpack sprayer; children 1 to <2 

years old: Post-application hand-tomouth exposures from treated turf. 

These scenarios resulted in the highest 

residential exposures and are 

considered protective of other exposure 

scenarios. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

standard-operating-proceduresresidential-pesticide. 

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 benzovindiflupyr 

to share a common mechanism of 

toxicity with any other substances, and 

benzovindiflupyr does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that benzovindiflupyr 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:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

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 was no evidence of quantitative 

or qualitative susceptibility in fetuses or 

offspring in the rat and rabbit 

developmental studies or in the 2- 

generation rat reproduction study. 

Benzovindiflupyr produced effects in 

rat fetuses (i.e., decreased fetal weight 

and ossification) in developmental 

toxicity studies at maternally toxic 

doses. In the rabbit developmental 

study, there were no adverse effects in 

either the does or the fetuses at the 

highest dose tested. In reproduction 

studies, offspring effects occurred at 

doses higher than those causing parental 

effects; thus, there was no quantitative 

increase in sensitivity in rat pups. The 

LOAELs and NOAELs for the rat 

developmental and rat reproduction 

studies were clearly defined. 

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 

benzovindiflupyr is complete. 

ii. There is no indication that 

benzovindiflupyr is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

benzovindiflupyr 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 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

benzovindiflupyr in drinking water. 

EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by benzovindiflupyr. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate food and 

water 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

benzovindiflupyr will occupy 43% of 

the aPAD for children 1–2 years old, the 


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Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 29037 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

benzovindiflupyr from food and water 

will utilize 19% of the cPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of benzovindiflupyr is not 

expected. 

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). Benzovindiflupyr 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 benzovindiflupyr. 

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 2100 for adults and 510 for 

children. Because EPA’s LOC for 

benzovindiflupyr is an 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). 

An intermediate-term adverse effect 

was identified; however, 

benzovindiflupyr is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for benzovindiflupyr. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., EPA considers the chronic 

aggregate risk assessment to be 

protective of any aggregate cancer risk. 

Based on the results of the chronic risk 

assessment, which accounts for all 

chronic toxicity, including 

carcinogenicity, EPA does not expect 

any cancer risk to the U.S. population 

from aggregate exposure to 

benzovindiflupyr. 

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 

benzovindiflupyr residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate analytical method is 

available to enforce the proposed 

tolerances for benzovindiflupyr in the 

specified grass commodities. A Quick, 

Easy, Cheap, Effective, Rugged, and Safe 

(QuEChERS) multi-residue method 

(EN15662:2009) was developed for the 

determination of residues of 

benzovindiflupyr via liquid 

chromatography-mass spectrometry/ 

mass spectrometry (LC–MS/MS) 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

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 benzovindiflupyr. 

C. Revisions to Petitioned-For 

Tolerances 

The registrant petitioned for the use of 

benzovindiflupyr in or on grasses grown 

for seed, forage at 0.15 parts per million 

(ppm), grasses grown for seed, hay at 7 

ppm and grasses grown for seed, straw 

at 6 ppm. The Agency has not 

established a crop group for ‘‘grasses 

grown for seed’’ or otherwise defined 

what commodities are included in the 

category of ‘‘grasses grown for seed’’. 

The closest group tolerance to the 

commodity category requested is a crop 

group tolerance on grasses (i.e., ‘‘grass, 

forage, fodder and hay, group 17’’), 

although this group includes all grasses, 

whether grown for seed or not. 

Sufficient representative commodity 

residue data were not submitted to 

support establishing a crop group 17 

tolerances; therefore, the Agency is 

establishing tolerances for the 

individual grasses for which residue 

data were submitted: Bluegrass, 

bromegrass, fescue, orchardgrass, and 

ryegrass. 

V. Conclusion 

Therefore, tolerances are established 

for residues of benzovindiflupyr, 

including its metabolites and 

degradates, in or on bluegrass, forage at 

0.15 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. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001); Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997); or 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 


daltland on DSKBBV9HB2PROD with RULES
29038 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

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 

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 § 180.686, add alphabetically the 

commodities: ‘‘Bluegrass, forage’’; 

‘‘Bluegrass, hay’’; ‘‘Bluegrass, straw’’; 

‘‘Bromegrass, forage’’; ‘‘Bromegrass, 

hay’’; ‘‘Bromegrass, straw’’; ‘‘Fescue, 

forage’’; ‘‘Fescue, hay’’; ‘‘Fescue, straw’’; 

‘‘Orchardgrass, forage’’; ‘‘Orchardgrass, 

hay’’; ‘‘Orchardgrass, straw’’; ‘‘Ryegrass, 

forage’’; ‘‘Ryegrass, hay’’; and ‘‘Ryegrass, 

straw’’ to the table in paragraph (a) to 

read as follows: 

§ 180.686 Benzovindiflupyr; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Bluegrass, forage ....................... 0.15 

Bluegrass, hay ............................ 7.0 

Bluegrass, straw ......................... 6.0 

Bromegrass, forage .................... 0.15 

Bromegrass, hay ........................ 7.0 

Bromegrass, straw ...................... 6.0 

* * * * * 

Fescue, forage ............................ 0.15 

Fescue, hay ................................ 7.0 

Fescue, straw ............................. 6.0 

* * * * * 

Orchardgrass, forage .................. 0.15 

Orchardgrass, hay ...................... 7.0 

Orchardgrass, straw ................... 6.0 

* * * * * 

Ryegrass, forage ........................ 0.15 

Ryegrass, hay ............................. 7.0 

Ryegrass, straw .......................... 6.0 

* * * * * 

[FR Doc. 2018–13454 Filed 6–21–18; 8:45 am] 

BILLING CODE 6560–50–P 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Parts 1802 

RIN 2700–AE46 

NASA Federal Acquisition Regulation 

Supplement: Removal of Definitions 

(NFS Case 2018–N017) 

AGENCY: National Aeronautics and 

Space Administration. 

ACTION: Direct final rule. 

SUMMARY: NASA is issuing a final rule 

to amend the NASA Federal Acquisition 

Regulation (FAR) Supplement (NFS) to 

remove definitions which affect only the 

internal Agency administrative 

procedures and have no cost or 

administrative impact on contractors or 

prospective contractors. 

DATES: This final rule is effective August 

21, 2018. Comments due on or before 

July 23, 2018. If adverse comments are 

received, NASA will publish a timely 

withdrawal of the rule in the Federal 

Register. 

ADDRESSES: Submit comments 

identified by NFS Case 2018–N017, 

using any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

searching for ‘‘NFS Case 2018–N017’’. 

Select the link ‘‘Comment Now’’ that 

corresponds with ‘‘NFS Case 2018– 

N017’’. Follow the instructions 

provided on the screen. Please include 

your name, company name (if any), and 

‘‘NFS Case 2018–N017’’ on any 

uploaded files.’’ 

• Email: geoffrey.s.sage@nasa.gov. 

Include ‘‘NFS Case 2018–N017’’ in the 

subject line of the message. 

FOR FURTHER INFORMATION CONTACT: 

Geoffrey S. Sage, NASA Headquarters, 

Office of Procurement, Contract and 

Grant Policy Division, Suite 5K32, 300 

E Street SW, Washington, DC 20456– 

0001. Telephone 202–358–2420. 

SUPPLEMENTARY INFORMATION: 

I. Background 

NFS part 1802, Definitions of Words 

and Terms, contains the following 

definitions that affect only the internal 

Agency administrative procedures and 

have no cost or administrative impact 

on contractors or prospective 

contractors: Administrator, Contracting 

activity, Head of the agency or agency 

head, Head of the contracting activity 

(HCA), NASA Acquisition internet 

Service (NAIS), Procurement officer, 

and Senior Procurement Executive. 

Pursuant to Executive Order 13563, 

Improving Regulation and Regulatory 


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