Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52669 

includes owners or operators of title V 

sources prior to receiving a title V 

operating permit from CT DEEP, as well 

as sources not subject to the title V 

operating permit program. Therefore, 

after December 14, 2017, such owners or 

operators of a demo/reno activity in 

Connecticut subject to the Asbestos 

NESHAP must submit Asbestos 

NESHAP notifications required under 

Section 61.145(b) to the following 

address: Asbestos Demo/Reno 

Notifications, U.S. EPA Region 1, 5 Post 

Office Square, Mail Code: OES05–4, 

Boston, MA 02109–3912. The EPA 

believes the effective date of this 

notification provides sufficient time for 

affected sources that are not subject to 

the title V operating permit program, or 

are subject to the program but have not 

obtained a title V operating permit, to 

notify the EPA of future demo/reno 

activity in accordance with the Asbestos 

NESHAP. As noted throughout this 

document, the requirement to notify the 

EPA does not apply to sources that have 

obtained a title V operating permit 

under CT DEEP’s title V operating 

permit program, already, or that obtain 

a title V operating permit in the future. 

Any source that has received a title V 

operating permit from CT DEEP will 

continue to submit demo/reno 

notifications to the State of Connecticut. 

III. Do I still need to comply with the 

State of Connecticut regulations? 

Nothing in this notification or CT 

DEEP’s voluntary, partial withdrawal 

changes any source’s obligation to 

comply with state or local laws. All 

sources subject to such laws must still 

comply with the state and local 

regulations. The Connecticut 

Department of Public Health 

implements an asbestos program under 

the Regulations of Connecticut State 

Agencies. Sources that are subject to the 

Asbestos NESHAP must also comply 

with the Connecticut Department of 

Public Health’s asbestos program 

regulations. This includes potentially 

duplicative notification requirements 

for owners or operators of demo/reno 

activity subject to the Asbestos 

NESHAP, as well as the Connecticut 

Department of Public Health’s asbestos 

program. Owners or operators of 

affected sources should continue to 

work with their state or local agencies 

to ensure any applicable requirements 

are being met. More information on the 

Connecticut Department of Public Heath 

asbestos program can be accessed online 

at www.ct.gov/dph/asbestos. 

IV. EPA Action 

Based on CT DEEP’s voluntary and 

partial withdrawal relating to 

implementation and enforcement of the 

Asbestos NESHAP, the EPA is issuing 

this notification. As noted above, the CT 

DEEP will retain its delegation to 

implement and enforce the Asbestos 

NESHAP for sources that have obtained 

a title V operating permit from CT 

DEEP, or for sources that receive a title 

V operating permit in the future (once 

the permit is issued). CT DEEP will 

continue to assure compliance with all 

applicable CAA Section 112 

requirements for all sources that have 

title V operating permits or obtain title 

V operating permits after the date of this 

action. The delegation withdrawal is 

effective on December 14, 2017. 

List of Subjects in 40 CFR Part 61 

Environmental protection, Air 

pollution control, Asbestos, Hazardous 

substances, Reporting and 

recordkeeping requirements. 

Authority: This action is issued under the 

authority of section 112 of the Clean Air Act, 

as amended, 42 U.S.C. 7412. 

Dated: October 25, 2017. 

Deborah A. Szaro, 

Acting Regional Administrator, EPA-New 

England. 

[FR Doc. 2017–24638 Filed 11–13–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2016–0448; FRL–9967–33] 

Benzovindiflupyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

benzovindiflupyr in or on the bulb 

onion subgroup 3–07A, the green onion 

subgroup 3–07B, and increases an 

existing tolerance on sugarcane. 

Interregional Research Project Number 4 

(IR–4) and Syngenta Crop Protection 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

November 14, 2017. Objections and 

requests for hearings must be received 

on or before January 16, 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–2016–0448, 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 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 


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52670 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2016–0448 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 January 16, 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– 

2016–0448, 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 October 18, 

2016 (81 FR 71668) (FRL–9952–19), 

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 6E8483) by IR–4, 

Rutgers, The State University of New 

Jersey, 500 College Road East, Suite 

201–W, Princeton, NJ 08540. 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 onion, bulb, 

subgroup 3–07A at 0.02 parts per 

million (ppm), and onion, green, 

subgroup 3–07B at 0.4 ppm. 

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 6F8499) by 

Syngenta Crop Protection, LLC, P.O. 

Box 18300, Greensboro, NC 27419. The 

petition requested to establish a 

tolerance in 40 CFR part 180 for 

residues of the fungicide 

benzovindiflupyr in or on Sugarcane, 

cane, at 0.3 ppm. 

The documents referenced summaries 

of the petitions prepared by Syngenta 

Crop Protection, LLC, the registrant, 

which are available in the dockets EPA– 

HQ–OPP–2016–0448 and EPA–HQ– 

OPP–2016–0752 at http://

www.regulations.gov. There were no 

comments received in response to either 

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 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. 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 

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 


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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 1,000 milligrams/kilogram/ 

day (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 Onion, Bulb Subgroup 3–07A; Onion, 

Green, Subgroup 3–07B; and 

Sugarcane’’ on pages 32–38 in docket ID 

number EPA–HQ–OPP–2016–0448. 

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://

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 October 2, 2015 

(80 FR 59627) (FRL–9933–03). 

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 nonlinear RfD 

approach adequately accounts for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to benzovindiflupyr; therefore, 

a separate dietary cancer risk 

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 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 

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 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 the 

acute dietary risk assessment, the water 

concentration value of 8.41 ppb was 

used to assess the contribution to 

drinking water. For the 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: For handlers, exposure is 

expected as a result of application to 

turf and ornamentals. Post-application 

exposure is also expected as a result of 

being in an environment that has been 

previously treated with 

benzovindiflupyr. Both handler and 


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post-application exposure is short-term 

in duration; there are no intermediateor long term-exposures expected from 

the residential uses of benzovindiflupyr. 

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 post-application 

(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 (LOC = 

100). 

The residential scenarios used for the 

benzovindiflupyr aggregate assessments 

were as follows: Adults: Inhalation 

exposures from treating ornamentals 

with a manually pressurized handwand 

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 Web site 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 the doses 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 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 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 

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 level of 

concern for benzovindiflupyr is a MOE 


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Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52673 

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. 

As there is no chronic risk of concern, 

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 plant 

and livestock 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 any 

MRLs for benzovindiflupyr. 

V. Conclusion 

Therefore, tolerances are established 

for residues of benzovindiflupyr, 

including its metabolites and 

degradates, in or on onion, bulb, 

subgroup 3–07A at 0.02 ppm; onion, 

green, subgroup 3–07B at 0.40 ppm; and 

the existing ‘‘sugarcane, cane’’ tolerance 

is increased from 0.04 ppm to 0.30 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) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 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 

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: October 12, 2017. 

Michael L. Goodis, 

Director Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 


jstallworth on DSKBBY8HB2PROD with RULES
52674 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 

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, amend the table in 

paragraph (a) by: 

■ i. Adding alphabetically the 

commodities ‘‘Onion, bulb, subgroup 3– 

07A’’, ‘‘Onion, green, subgroup 3–07B’’, 

and 

■ ii. Revising the commodity 

‘‘Sugarcane, cane’’. 

The additions and revisions read as 

follows: 

§ 180.686 Benzovindiflupyr; tolerances for 

residues. 

(a) * * * 

Commodity 

Parts 

per 

million 

* * * * * 

Onion, bulb, subgroup 3–07A ...... 0.02 

Onion, green, subgroup 3–07B .... 0.40 

* * * * * 

Sugarcane, cane .......................... 0.30 

* * * * * 

* * * * * 

[FR Doc. 2017–24109 Filed 11–13–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 372 

[EPA–HQ–OPPT–2017–0197; FRL–9968–26] 

RIN 2070–AK32 

Community Right-to-Know; Adopting 

2017 North American Industry 

Classification System (NAICS) Codes 

for Toxics Release Inventory (TRI) 

Reporting; Withdrawal 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule; withdrawal. 

SUMMARY: In the Federal Register of 

August 17, 2017, EPA published both a 

direct final rule and a proposed rule to 

update the list of NAICS codes subject 

to reporting under the TRI to reflect the 

Office of Management and Budget 

(OMB) 2017 NAICS code revision. As 

noted in the direct final rule, if EPA 

received relevant adverse comment on 

the proposed update, the Agency would 

publish a timely withdrawal of the 

direct final rule in the Federal Register 

informing the public that the direct final 

action will not take effect. The Agency 

did receive a relevant adverse comment 

on the proposed update, and is therefore 

withdrawing the direct final rule and 

will instead proceed with a final rule 

based on the proposed rule after 

considering all public comments. 

DATES: Effective November 14, 2017 the 

direct final rule published in the 

Federal Register of August 17, 2017 (82 

FR 39038) (FRL–9964–77) is withdrawn. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: 

Stephanie Griffin, Toxics Release 

Inventory Program Division (7410M), 

Office of Pollution Prevention and 

Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–1463; email address: 

griffin.stephanie@epa.gov. 

For general information contact: The 

Emergency Planning and Community 

Right-to-Know Information Center; 

telephone number: (800) 424–9346, TDD 

(800) 553–7672; Web site: https://

www.epa.gov/home/epa-hotlines. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

A list of potentially affected entities is 

provided in the Federal Register of 

August 17, 2017. If you have questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

II. What rule is being withdrawn? 

In the August 17, 2017 Federal 

Register, EPA published both a direct 

final rule (see 82 FR 39038) and a 

proposed rule (see 82 FR 39101) 

pursuant to sections 313(g)(1) and 328 

of the Emergency Planning and 

Community Right-to-Know Act (EPCRA) 

for the purpose of updating the list of 

NAICS codes subject to TRI reporting 

under EPCRA section 313 to include 

OMB’s revised 2017 NAICS codes. The 

action would have also modified the list 

of relevant exceptions and limitations to 

the covered NAICS codes included in 

the CFR for TRI reporting purposes. 

Since the direct final rule and 

proposed rule’s publication, EPA 

received a public comment supporting 

the overall update, but noting that the 

direct final rule inadvertently omitted 

one of the covered NAICS codes 

updated by OMB. As a result of this 

omission, EPA is withdrawing the direct 

final rule published in the Federal 

Register on August 17, 2017, and will 

instead proceed with a final rule based 

on the proposed rule after considering 

(and responding to) all public comments 

received. 

III. How do I access the docket? 

To access the docket, please go to 

http://www.regulations.gov and follow 

the online instructions using the docket 

identification (ID) number EPA–HQ– 

OPPT–2017–0197. Additional 

information about the Docket Facility is 

also provided under ADDRESSES in the 

August 17, 2017 Federal Register 

document. If you have questions, 

consult the technical person listed 

under FOR FURTHER INFORMATION

CONTACT. 

IV. Good Cause Finding 

EPA finds that there is ‘‘good cause’’ 

under the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)(3)(B)) to 

withdraw the direct final rule discussed 

in this document without prior notice 

and comment. Alongside the direct final 

rule, EPA published an identical 

proposed rule and gave notice in the 

Federal Register that the direct final 

rule would be withdrawn if the Agency 

received adverse comment. 

For this document, notice and 

comment is impracticable and 

unnecessary because EPA is under a 

time limit to publish this withdrawal 

before the direct final rule is to take 

effect to limit confusion among Federal 

agencies and the regulated community. 

As such, EPA has determined that this 

document is not subject to the 30-day 

delay of effective date generally 

required by 5 U.S.C. 553(d). This 

withdrawal must become effective prior 

to the effective date of the direct final 

rule being withdrawn. 

V. Statutory and Executive Order 

Reviews 

This document withdraws regulatory 

requirements that have not gone into 

effect. As such, the Agency has 

determined that this withdrawal will 

not have any adverse impacts, economic 

or otherwise. The statutory and 

Executive Order review requirements 

applicable to the direct final rule being 

withdrawn were discussed in the 

August 17, 2017 Federal Register 

document. Those review requirements 

do not apply to this action because it is 

a withdrawal and does not contain any 

new or amended requirements. 

VI. Congressional Review Act (CRA) 

Pursuant to the CRA (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). Section 808 of the CRA allows 


jstallworth on DSKBBY8HB2PROD with RULES