48000 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 

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: September 6, 2017. 

Richard P. Keigwin, Jr., 

Acting Director, 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. Add § 180.109 to subpart C to read 

as follows: 

§ 180.109 Fenpicoxamid; Tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of fenpicoxamid 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels for fenpicoxamid is to 

be determined by measuring only 

fenpicoxamid ([[4-methoxy-2- 

[[[(3S,7R,8R,9S)-9-methyl-8-(2-methyl-1- 

oxopropoxy)-2,6-dioxo-7- 

(phenylmethyl)-1,5-dioxonan-3- 

yl]amino]carbonyl]-3- 

pyridinyl]oxy]methyl 2- 

methylpropanoate) in or on the 

commodity. 

Commodity Parts per 

million 

Banana* ................................ 0.15 

Wheat, grain* ........................ 0.60 

Rye, grain* ............................ 0.60 

*There are no U.S. registrations for use of 

fenpicoxamid on this commodity. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2017–22357 Filed 10–13–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2016–0142; FRL–9966–13] 

Triflumezopyrim; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

triflumezopyrim in or on rice, grain and 

rice, hulls. E.I. Dupont de Nemours and 

Company requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 16, 2017. Objections and 

requests for hearings must be received 

on or before December 15, 2017, 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–2016–0142, 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 

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. To access the OCSPP test 


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guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2016–0142 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 December 15, 2017. 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– 

2016–0142, 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 April 25, 

2016 (81 FR 24044) (FRL–9944–86), 

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 6E8448) by E.I. 

Dupont de Nemours and Company, 974 

Centre Road, Wilmington, DE 19805. 

The petition requested that 40 CFR part 

180 be amended by establishing 

tolerances for residues of the insecticide 

triflumezopyrim (2,4-dioxo-1-(5- 

pyrimidinylmethyl)-3-[3- 

(trifluoromethyl)phenyl]-2H-pyrido[1,2- 

a]pyrimidinium inner salt), in or on 

rice, grain at 0.20 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by E.I. 

Dupont de Nemours and Company, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance for rice, grain to 0.40 ppm 

based on the OECD tolerance 

calculation procedure. Additionally, 

EPA is requiring a tolerance for rice, 

hull at 1.0 ppm. The reason for these 

changes are explained in Unit IV.D. 

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 triflumezopyrim 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with triflumezopyrim 

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 most common 

adverse effect observed across the 

triflumezopyrim toxicological database 

was a decrease in absolute bodyweight 

in dogs and rats in both sexes following 

subchronic and chronic exposures. No 

additional non-cancer effects relevant 

for human health risk assessment were 

noted in the subchronic rat and dog oral 

toxicity studies. No effects were seen in 

the mice and rabbit studies, including 

the dermal toxicity study. 

Chronic exposures in rats resulted in 

an increased incidence of bile duct 

hyperplasia in the presence of decreases 

in absolute bodyweight (∼70 milligrams/ 

kilogram/day (mg/kg/day)). Additional 

lesions were seen in the liver, testes, 

and uterus at a higher dose (∼400 mg/ 

kg/day). The rat combined chronic/ 

carcinogenicity study showed an 

increase in uterine and liver tumors at 

a dose of ∼400 mg/kg/day, which is 

considered excessive for evaluating 

carcinogenic potential. The remaining 

doses were not considered excessive 

and did not show treatment-related 

tumors in either sex. Liver tumors in 

male mice during the mouse 

carcinogenicity study were considered 

treatment-related. The proposed mode 

of action (constitutive androstane 

receptor (CAR)-mediated proliferation) 

for the liver tumors in male mice was 

adequately supported by mechanistic 

data that clearly identified the sequence 

of events, dose-response concordance 

and temporal relationship for this tumor 

type. Triflumezopyrim is classified as 

‘‘not likely to be carcinogenic to humans 

at dose levels that do not cause a 

significant induction in CYP2B 

activity.’’ Based on the mechanistic 

studies provided, significant induction 

in CYP2B only occurred at 7,000 ppm 

(727 mg/kg/day in male mice); the 

chronic reference dose used for the 

Agency’s safety assessment is based on 

a no observed adverse effect level of 17 

mg/kg/day. As a result, the Agency 

concludes that the chronic reference 

dose will be protective of potential 

carcinogenicity, which can be assessed 

through a non-linear approach. There is 

no mutagenicity concern based on the 

results from the in vitro and in vivo 

genetic toxicity studies. 


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Evidence of increased quantitative 

susceptibility in the rat developmental 

toxicity study was observed in the form 

of incomplete ossification of the parietal 

skull in the fetuses of dams treated with 

a relatively high dose (200 mg/kg/day) 

in the absence of any maternal toxicity. 

There was no evidence of susceptibility 

in the rat reproduction toxicity or rabbit 

developmental toxicity study. 

Possible signs of neurotoxicity were 

observed in the acute neurotoxicity 

(ACN) in rats as well as in the 28-day 

subchronic oral toxicity study in dogs. 

An overall decrease in motor activity 

was observed in the ACN study on the 

day of dosing. Animals also showed 

slight decreases in body temperature 

and number of rearing movements, as 

well as increases in the incidence of 

high posture, at a dose 4x higher than 

what elicited the decrease in motor 

activity. The 28-day subchronic oral 

toxicity study in dogs showed 

neurobehavioral signs such as slight 

impairment of forelimb and/or hindlimb 

strength and effects on pupil 

constriction. However, the 

neurobehavioral signs were not seen in 

studies of longer duration in dogs. 

Although evidence of neurotoxicity 

was seen in the ACN study in rats and 

28-day oral toxicity study in dogs, 

concern is low since: (1) Effects are 

well-characterized with clearly 

established NOAEL/LOAEL values; (2) 

no additional neurotoxic effects were 

seen in the toxicological database 

including the subchronic neurotoxicity 

study (SCN); (3) there were no 

corroborating neuropathological 

findings; (4) the neurobehavioral signs 

in the dog were not observed in studies 

of longer durations in dogs; and (5) the 

selected endpoints for risk assessment 

are protective of these effects. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by Triflumezopyrim 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 document 

Triflumezopyrim: Human Health Risk 

Assessment to Establish Tolerances for 

Rice Without U.S. Registration at page 

21 in docket ID number EPA–HQ–OPP– 

2016–0142. 

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 https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks/guidancehuman-health-risk-assessmentspesticides. 

A summary of the toxicological 

endpoints for Triflumezopyrim used for 

human risk assessment is shown in the 

Table below. 

SUMMARY TABLE OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLUMEZOPYRIM 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) .. NOAEL = 100 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

aPAD = 1.0 mg/kg/ 

day.

Acute neurotoxicity study (rats). LOAEL = 500 mg/kg/day 

based on decreased motor activity on day of dosing. 

Chronic dietary (All populations) NOAEL = 17 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cPAD = 0.17 mg/kg/ 

day.

Combined chronic/carcinogenicity study (rats). LOAEL = 71/74 

(M/F) mg/kg/day based on decreased absolute bodyweights 

in females and increased incidence of bile duct hyperplasia 

in males. 

Cancer (Oral, dermal, inhalation).Not likely to be carcinogenic to humans at dose levels that do not cause a significant induction in CYP2B activity. Quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. 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). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use 

of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to triflumezopyrim, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from triflumezopyrim 

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 

triflumezopyrim. In estimating acute 

dietary exposure, EPA used food 


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consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat In America (NHANES/WWEIA). As 

to residue levels in food, EPA used an 

unrefined dietary analysis and 

incorporated tolerance-level residues 

and assumed 100% of all rice was 

treated. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat In America 

(NHANES/WWEIA). As to residue levels 

in food, EPA used an unrefined dietary 

analysis and incorporated tolerancelevel residues and assumed 100% of all 

rice was treated. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that triflumezopyrim is not 

likely to cause cancer to humans at dose 

levels that do not cause a significant 

increase in CYP2B activity. 

Additionally, there is no chronic risk 

from exposure to triflumezopyrim and 

the chronic reference dose is protective 

of potential carcinogenicity. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for triflumezopyrim. Tolerance-level 

residues and/or 100% CT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. Because there are no domestic 

registrations for triflumezopyrim in the 

United States, dietary exposure (acute 

and chronic) from imported 

commodities is the only source of 

exposure assessed. Residues from 

imported commodities are not expected 

to reach drinking water sources. 

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). 

Triflumezopyrim is not registered for 

any specific use patterns that would 

result in residential exposure. 

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 triflumezopyrim to 

share a common mechanism of toxicity 

with any other substances, and 

triflumezopyrim does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that triflumezopyrim 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:// 

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 was no evidence of increased 

susceptibility in the rabbit 

developmental or the rat reproduction 

toxicity studies; however, there was 

evidence of increased quantitative 

susceptibility in the rat developmental 

study in rats where an increased 

incidence of incomplete ossification of 

the parietal skull was seen in the 

absence of maternal toxicity. Concern is 

low since: (1) The effect is wellcharacterized with clearly established 

NOAEL/LOAEL values; and (2) the 

selected endpoints for this chemical are 

protective of these effects. 

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 for assessing risks 

for all populations. That decision is 

based on the following findings: 

i. The toxicity database for 

triflumezopyrim is complete. 

ii. Although there is evidence of 

neurotoxicity in the ACN study in rats 

and 28-day oral toxicity study in dogs 

for triflumezopyrim, the concern is low 

since: (1) The effects are wellcharacterized with clearly established 

NOAEL/LOAEL values; (2) no 

additional neurotoxic effects were seen 

in the toxicological database including 

the SCN; (3) there were no corroborating 

neuropathological findings; (4) the 

neurobehavioral signs in the dog were 

not observed in studies of longer 

durations in dogs; and (5) the selected 

endpoints for this chemical are 

protective of these effects. As a result, 

there is no need to require a 

developmental neurotoxicity study or 

retain the 10X to account for potential 

neurotoxic effects. 

iii. Although there was evidence of 

increased quantitative susceptibility in 

the rat developmental toxicity study 

where incomplete ossification of the 

parietal skull in the fetuses of dams 

treated with a relatively high dose (200 

mg/kg/day) was observed in the absence 

of any maternal toxicity, concern is low 

since: (1) The effect is wellcharacterized with clearly established 

NOAEL/LOAEL values and (2) the 

selected endpoints for this chemical are 

protective of these effects. There was no 

evidence of increased susceptibility in 

the rabbit developmental or the rat 

reproduction toxicity studies. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on considering 

that 100% of all rice was treated and 

using tolerance-level residues. Since the 

metabolites were found at insignificant 

levels in the metabolism studies, 

triflumezopyrim is considered the only 

residue of concern. These assessments 

will not underestimate the exposure and 

risks posed by triflumezopyrim. 

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 

triflumezopyrim will occupy <1% of the 

aPAD for all infants <1 year old, the 

population group receiving the greatest 

exposure. 


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2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

triflumezopyrim from food will utilize 

<1% of the cPAD for all infants <1 year 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for triflumezopyrim. 

3. Short-term and Intermediate-term 

risk. Triflumezopyrim is not registered 

for any use patterns that would result in 

short-term or intermediate-term 

residential exposure. Because there are 

no residential uses for triflumezopyrim, 

as a result, aggregate risk estimates for 

short- and intermediate-term exposure 

are equivalent to the chronic dietary risk 

estimates and are not of concern. 

4. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A., 

EPA has determined that 

triflumezopyrim is not likely to be 

carcinogenic to humans at doses that do 

not cause a significant induction in 

CYP2B activity. Because there is no 

chronic risk from exposure to 

triflumezopyrim and the chronic 

reference dose is protective of potential 

carcinogenicity, triflumezopyrim is not 

expected to pose a cancer risk. 

5. 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 

triflumezopyrim residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(DuPont Liquid chromatography Mass 

spectrometry/mass spectrometry (LC/ 

MS/MS) methods 36348 and 45170) is 

available to enforce the tolerance 

expression. 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 triflumezopyrim. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is establishing a tolerance for 

rice, grain at 0.40 ppm, rather than at 

0.20 ppm as requested, in addition to 

establishing a tolerance for rice, hulls of 

1.0 ppm. The rice grain tolerance is 

based on the OECD tolerance 

calculation procedure with the inputted 

residues adjusted proportionally to 

reflect the maximum application rate. 

The raw agricultural commodity of 

‘‘rice, grain’’ consists of the rice kernel, 

as well as the rice hull. The rice hull is 

considered a processed commodity for 

rice, and where residues concentrate in 

processed commodities, a higher 

tolerance to cover those residues is 

warranted. Because the available data 

indicates a higher level of residues on 

the rice hull, EPA is establishing a 

separate tolerance to cover those 

residues. 

V. Conclusion 

Therefore, tolerances are established 

for residues of triflumezopyrim, (2,4- 

dioco-1-(5-pyrimidinylmethyl)-3-[3- 

(trifluoromethyl)phenyl]-2H-pyrido[1,2- 

a]pyrimidinium inner salt), in or on 

rice, grain at 0.40 and rice, hulls at 1.0 

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) 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). 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 48005 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 7, 2017. 

Richard P. Keigwin, Jr., 

Director, 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. Add § 180.107 to subpart C to read 

as follows: 

§ 180.107 Triflumezopyrim; tolerance for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide triflumezopyrim, including 

its metabolites and degradates, in or on 

the following food commodities in the 

table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

triflumezopyrim (2,4-dioxo-1-(5- 

pyrimidinylmethyl)-3-[3- 

(trifluoromethyl)phenyl]-2H-pyrido[1,2- 

a] pyrimidinium inner salt) in or on the 

commodity. 

Commodity Parts per 

million 

Rice, grain * .......................... 0.40 

Rice, hulls * ........................... 1.0 

* There are no U.S. registrations for the use 

of triflumezopyrim on these commodities. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2017–22356 Filed 10–13–17; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 90 

[PS Docket No. 16–269, FCC 17–75] 

Procedures for Commission Review of 

State Opt-Out Request From the 

FirstNet Radio Access Network 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of six months, 

the information collection associated 

with the Commission’s Procedures for 

Commission Review of State Opt-Out 

Request from the FirstNet Radio Access 

Network, Report and Order (Report and 

Order)’s rules and procedures for 

administering the state opt-out process 

as provided under the Middle Class Tax 

Relief and Job Creation Act of 2012, as 

well delineating the specific standards 

by which the Commission will evaluate 

state opt-out applications. This 

document is consistent with the Report 

and Order, which stated that the 

Commission would publish a document 

in the Federal Register announcing the 

effective date of those rules. 

DATES: The amendments to 47 CFR 

90.532(b) and (c) published at 82 FR 

46690, October 6, 2017, are effective 

November 6, 2017. 

FOR FURTHER INFORMATION CONTACT: For 

additional information about the 

information collection, contact Nicole 

Ongele, FCC, at (202) 418–2991 or via 

email PRA@fcc.gov and to 

Nicole.Ongele@fcc.gov. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on October 6, 

2017, OMB approved this information 

collection under the emergency 

processing of the Paperwork Reduction 

Act (PRA), 5 CFR 1320.13, for a period 

of six months, the information 

collection requirements relating to the 

State opt-out rules contained in the 

Commission’s Report and Order, FCC 

17–75, published at 82 FR 46690, 

October 6, 2017. The OMB Control 

Number is 3060–1245. The Commission 

publishes this document as an 

announcement of the effective date of 

the rules. If you have any comments on 

the burden estimates listed below, or 

how the Commission can improve the 

collections and reduce any burdens 

caused thereby, please contact Nicole 

Ongele, Federal Communications 

Commission, Room 1–A620, 445 12th 

Street SW., Washington, DC 20554. 

Please include the OMB Control 

Number, 3060–1245, in your 

correspondence. The Commission will 

also accept your comments via email at 

PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received final OMB approval on October 

6, 2017, for the information collection 

requirements contained in the 

modifications to the Commission’s rules 

in 47 CFR 90.532. Under 5 CFR part 

1320, an agency may not conduct or 

sponsor a collection of information 

unless it displays a current, valid OMB 

Control Number. 

No person shall be subject to any 

penalty for failing to comply with a 

collection of information subject to the 

Paperwork Reduction Act that does not 

display a current, valid OMB Control 

Number. The OMB Control Number is 

3060–1245. 

The foregoing notice is required by 

the Paperwork Reduction Act of 1995, 

Public Law 104–13, October 1, 1995, 

and 44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control Number: 3060–1245. 

OMB Approval Date: October 6, 2017. 

OMB Expiration Date: April 30, 2018. 

Title: Procedures for Commission 

Review of State Opt-Out Request from 

the FirstNet Radio Access Network. 

Form Number: N/A. 

Respondents: State, local or tribal 

governments. 

Number of Respondents and 

Responses: 55 respondents; 110 

responses. 

Estimated Time per Response: 0.25 

hours per initial notification. 

Frequency of Response: One-time 

reporting requirement. 

Obligation to Respond: Required to 

obtain or retain benefits. Statutory 

authority for requiring licensees to 

submit this information enter into the 

written agreements is contained in the 

Middle Class Tax Relief and Job 

Creation Act of 2012, Public Law 112 

96, 126 Stat. 156 §§ 6001–6303, 6413 

(codified at 47 U.S.C. 1401–1443, 1457). 

Total Annual Burden: 26,414 hours. 

Total Annual Cost: No cost. 

Nature and Extent of Confidentiality: 

Alternative state plans are very likely to 

contain proprietary information as well 

as information whose disclosure could 

compromise network security. Parties 

may therefore seek confidential 

treatment of any filing under our Part 0 

rules, including the use of a protective 

order process to allow other those 

granted party status to the restricted 

proceeding access to the information on 

a confidential basis. 

Privacy Act: No impact(s). 

Needs and Uses: The purpose of 

requiring this collection is to comply 


jstallworth on DSKBBY8HB2PROD with RULES