Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 29017 

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). 

XI. 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 8, 2018. 

Michael Goodis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.960, alphabetically add the 

following polymer to the table to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

*******

Oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy) methylethoxy]methylether] 

ether, minimum number average molecular weight (in amu), 1400 daltons.

CAS Reg. No. 2112825–11–1. 

* * * * * * * 

[FR Doc. 2018–13457 Filed 6–21–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0156; FRL–9976–21] 

Tolfenpyrad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tolfenpyrad in 

or on multiple commodities which are 

identified and discussed later in this 

document. Nichino America, Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective June 

22, 2018. Objections and requests for 

hearings must be received on or before 

August 21, 2018, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2017–0156, 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. 


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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–2017–0156 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– 

2017–0156, 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 June 8, 2017 

(82 FR 26641) (FRL–9961–14), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of pesticide 

petitions (PP 7F8544 and PP 7F8543) by 

Nichino America, Inc., 4550 New 

Linden Hill Road, Suite 501, 

Wilmington, DE 19808–2951. The 

petitions requested that 40 CFR 180.675 

be amended by establishing tolerances 

for residues of the insecticide 

tolfenpyrad, 4-chloro-3-ethyl-1-methylN-[4-(p-tolyloxy)benzyl]pyrazole-5- 

carboxamide, in or on Brassica head and 

stem vegetable group (crop group 5–16) 

at 5.0 parts per million (ppm) (PP 

7F8544); Brassica leafy greens subgroup 

(4–16B) at 40 ppm (PP 7F8544); 

Vegetables, cucurbit, group 9 at 0.7 ppm 

(PP 7F8544); Vegetables, fruiting, group 

8–10 at 0.7 ppm (PP 7F8544); Fruit, 

pome, group 11–10 at 0.7 ppm (PP 

7F8544); and Apple, wet pomace at 2.5 

ppm (PP 7F8544). The petitions also 

requested that established tolerances be 

amended for residues of tolfenpyrad in 

or on Fruit, citrus, group 10–10 at 0.9 

ppm (PP 7F8544; PP 7F8543); Citrus, 

dried pulp at 3.0 ppm (PP 7F8544; PP 

7F8543); and Citrus, oil at 28.0 ppm (PP 

7F8544; PP 7F8543). That document 

referenced a summary of the petition 

prepared by Nichino America, Inc., the 

registrant, which is available in the 

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

There were no comments received in 

response to the notices of filing. 

Consistent with the authority in section 

408(d)(4)(A)(i), EPA is establishing 

tolerances that vary from what the 

petitioner sought. The reasons for these 

changes are explained in Unit IV.C. 

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 tolfenpyrad 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with tolfenpyrad 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. 

A variety of toxic effects were noted 

in the toxicology database for 

tolfenpyrad. However, the most 

consistent finding across species and 

studies was decreased body weight and/ 

or body weight gain, which were 

observed in adults of all species (rat, 

mice, rabbit, and dog) in the majority of 

the subchronic oral and dermal toxicity 

studies, and all chronic toxicity studies. 

The rat is the species most sensitive 

to body weight changes, with effects 

observed at much lower doses than in 

other species. In rats, significant 

decreases in body weight and body 

weight gain were observed in 


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subchronic oral and acute and 

subchronic neurotoxicity studies. 

Decreases in body weight and body 

weight gain were also seen in chronic 

rat studies but at lower doses than 

observed in the other rat studies. 

Although seen at lower doses, the body 

weight decrements noted in the chronic 

study were not as pronounced as seen 

after subchronic exposure or in the 

neurotoxicity studies. Decreases in body 

weight and body weight gain were also 

observed in reproduction, 

developmental toxicity, and 

developmental immunotoxicity studies 

at doses comparable to the chronic 

study. Significant decreases in body 

weight and body weight gain were seen 

in both mice and dogs after subchronic 

exposure; these effects were also noted 

in rabbits in a developmental toxicity 

study. Chronic exposure resulted in 

body weight and body weight gain 

decreases in mice and dogs at lower 

doses for longer duration studies. 

The body weight changes observed in 

the database were most often seen in the 

presence of decreased food 

consumption and in some studies, 

additional toxicity including liver/ 

kidney effects and clinical signs. 

Increased liver and kidney weights, 

liver and kidney hypertrophy, hyaline 

droplets in the kidney, and color change 

in the kidney were seen after subchronic 

exposure in rats. Chronic exposure 

resulted in similar effects along with 

color changes in the liver and liver 

histopathology at slightly lower doses 

than in the subchronic studies. Other 

effects noted in rats were effects on the 

harderian gland and lymph nodes. In 

dogs, both changes in liver and kidney 

histopathology, along with testicular 

atrophy and clinical signs (emaciation, 

decreased movement, and staggering 

gait) were seen in short-term studies. 

Long-term exposure resulted in 

histopathological changes in the liver, 

along with increased liver enzymes. No 

treatment-related effects were noted in 

the liver or kidney in mice. However, 

rough coats, hunched posture, ataxia, 

and hypoactivity were seen in 

subchronic studies. 

Moribundity and/or mortality were 

noted in at least one study in all tested 

species at ≥3 milligrams/kilogram/day 

(mg/kg/day). Moribundity and mortality 

were noted in two dams in a rat 

reproduction study. Mortality was also 

noted in one dam in a rabbit 

developmental toxicity study, as well as 

in two rats from an inhalation toxicity 

study (range-finding only). In mice and 

dogs, mortality was observed in both 

subchronic and chronic toxicity studies. 

In all cases, these effects were observed 

only after repeat-dose exposures, and 

the current points of departure (PODs) 

for the relevant exposure durations are 

protective of the observed mortality. 

There is no evidence of increased 

quantitative or qualitative susceptibility 

in the guideline rat and rabbit 

developmental studies, or the rat 

reproduction study. Although several 

adverse effects were noted in young 

animals in these studies, the effects 

were observed in the presence of 

significant maternal toxicity (significant 

body weight changes and/or 

moribundity/mortality). In a nonguideline rat developmental 

immunotoxicity (DIT) study, decreased 

survival, body weight, body weight gain, 

increased blackish abdominal cavity, 

and dark green abnormal intestinal 

contents were observed in offspring 

animals at 3 mg/kg/day. At the same 

dose, decreased body weight (up to 

10%), body weight gain (up to 36%) and 

food consumption were seen in 

maternal animals. This is consistent 

with the other developmental toxicity 

studies in the database, in which 

offspring toxicity is observed at the 

same dose as significant maternal 

toxicity. There was no evidence of 

immunotoxicity observed in the study. 

No evidence of neurotoxicity was 

observed in acute and subchronic 

neurotoxicity studies for tolfenpyrad. 

Although hunched posture, ataxia, and 

hypoactivity were seen in mice in a 28- 

day toxicity study, these effects were 

not seen in a 90-day study or after 

chronic exposure. In dogs, decreased 

spontaneous movement and staggering 

gait were observed after 13 weeks. In 

rats, decreased motor activity and prone 

position (lying face down) prior to death 

were noted in a reproduction study. 

Overall, the effects noted in the database 

were agonal effects mainly seen at high 

doses, not associated with 

neuropathology, and not noted in longterm studies. The effects observed are 

consistent with the mode of action for 

tolfenpyrad (mitochondrial inhibitor) 

and are not considered evidence of 

neurotoxicity. 

No evidence of carcinogenicity was 

observed in cancer studies with mice 

and rats. Therefore, in accordance with 

EPA’s Final Guidelines for Carcinogen 

Risk Assessment (March 2005), 

tolfenpyrad is classified as ‘‘not likely to 

be carcinogenic to humans.’’ Specific 

information on the studies received and 

the nature of the adverse effects caused 

by tolfenpyrad as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http://

www.regulations.gov in document 

‘‘Tolfenpyrad—Aggregate Human 

Health Risk Assessment of Proposed 

New Uses on Multiple Commodities’’ at 

pages 11–15 in docket ID number EPA– 

HQ–OPP–2017–0156. 

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 tolfenpyrad used for 

human risk assessment is shown in 

Table 1 of this unit. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TOLFENPYRAD 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 (General population including infants and 

children).

NOAEL = 10 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 0.1 mg/ 

kg/day.

aPAD = 0.1 mg/kg/ 

day. 

Acute Neurotoxicity Study in rats. 

LOAEL = 20 mg/kg/day based on decreased bodyweight, bodyweight gain and food consumption. 

Chronic dietary (All populations) NOAEL= 0.6 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.006 

mg/kg/day.

cPAD = 0.006 mg/ 

kg/day. 

Combined Chronic/Carcinogenicity Study in rats. 

LOAEL = 1.5 mg/kg/day based on decreased bodyweight, 

bodyweight gain, and food consumption of females, gross 

changes in the harderian glands of males, and 

histopathological changes in the liver, kidney and mesenteric 

lymph nodes of females and the kidney of males. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of significant tumor increases 

in two adequate rodent carcinogenicity studies. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members 

of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to tolfenpyrad, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing tolfenpyrad tolerances in 40 

CFR 180.675. EPA assessed dietary 

exposures from tolfenpyrad 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 tolfenpyrad. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

2003–2008 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 assumes 100 percent crop 

treatment (PCT) and tolerance-level 

residues with minor refinements 

including a factor to account for the 

reduction in residues when wrapper 

leaves are removed from head lettuce 

and cabbage, as well as empirical 

processing factors for tomato juice, 

paste, and puree, cottonseed oil, citrus 

juice, and grape juice (which was 

translated broadly to other juices for 

which empirical data were not 

available). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the 2003–2008 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 assumes 100 PCT and average 

residue levels from crop field trials as 

well as minor refinements listed above 

for acute exposure. Although partially 

refined, the chronic exposure estimates 

still retain a high level of conservatism 

due to the source and scope of the 

refinements, and are likely to 

overestimate the actual chronic dietary 

risk. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that tolfenpyrad does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residues and percent 

crop treated. Although EPA did not use 

any percent crop treated estimates for 

this action, the Agency relied on average 

residue information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such Data Call-Ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for tolfenpyrad in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of tolfenpyrad. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

tolfenpyrad for acute exposures are 

estimated to be 26.9 parts per billion 

(ppb) for surface water and 11.0 ppb for 

ground water, for chronic exposures for 

non-cancer assessments are estimated to 

be 12.2 ppb for surface water and 11.0 

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 26.9 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 12.2 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 


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(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Tolfenpyrad 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 tolfenpyrad to 

share a common mechanism of toxicity 

with any other substances, and 

tolfenpyrad does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that tolfenpyrad 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. 

Although evidence is noted for 

qualitative susceptibility in the young in 

the developmental immunotoxicity 

study (DIT) in rats, there is low concern 

and there are no residual uncertainties 

regarding increased quantitative or 

qualitative prenatal and/or postnatal 

susceptibility for tolfenpyrad. When the 

DIT study is considered along with the 

reproduction study, the offspring 

toxicity in the DIT study was observed 

at the same dose as comparable 

maternal toxicity (moribundity/ 

mortality) in the reproduction study. 

Therefore, EPA does not consider the 

isolated incident in the DIT a true 

indicator of qualitative susceptibility. 

Additionally, the effects observed in the 

DIT study are well-characterized, a clear 

NOAEL was identified, and the 

endpoints chosen for risk assessment 

are protective of potential offspring 

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. That decision is 

based on the following findings: 

i. The toxicity database for 

tolfenpyrad is complete. 

ii. There is no indication that 

tolfenpyrad is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is some evidence 

that tolfenpyrad may result in increased 

susceptibility, the concern for 

developmental or reproductive effects is 

low for the reasons contained in Unit 

III.D.2., and thus, a 10X FQPA safety 

factor is not necessary to protect infants 

and children. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues for the acute 

dietary exposure and average residue 

levels from crop field trials for the 

chronic dietary exposure. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to tolfenpyrad 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by tolfenpyrad. 

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 margin 

of exposure (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 

tolfenpyrad will occupy 54% of the 

aPAD for children 1–2 years of age, 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 tolfenpyrad 

from food and water will utilize 68% of 

the cPAD for children 1–2 years of age, 

the population group receiving the 

greatest exposure. There are no 

residential uses for tolfenpyrad. 

3. Short- and Intermediate-term risk. 

Short- and intermediated-term aggregate 

exposures take into account short- and 

intermediate-term residential exposures 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, tolfenpyrad is not 

registered for any use patterns that 

would result in short- or intermediateterm residential exposures. Short- and 

intermediate-term risks are assessed 

based on short- and intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there are no 

short- or intermediate-term residential 

exposures 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 short- and intermediate-term 

risk), no further assessment of shortand intermediate-term risk is necessary, 

and EPA relies on the chronic dietary 

risk assessment for evaluating short- and 

intermediate-term risk for tolfenpyrad. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

tolfenpyrad is not expected to pose a 

cancer risk to humans. 

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 tolfenpyrad 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies, 

utilizing high-performance liquid 

chromatography with tandem mass 

spectrometric detection (LC/MS/MS), 

are available for enforcement of 

tolfenpyrad residue tolerances in/on 

plant commodities (Morse Laboratories 

Analytical Method #Meth-183, Revision 

#2). For livestock, a method described 

in PTRL West Study No. 1841W is 

available. The livestock method 

adequately determines residues of 

tolfenpyrad and its metabolites, PT–CA, 


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29022 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

OH–PT–CA, and PCA in milk, bovine 

meat, kidney, liver and fat. Residues are 

determined by LC/MS/MS analysis. 

These methods are adequate for 

enforcement and 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 tolfenpyrad in commodities in 

this action. 

C. Revisions to Petitioned-For 

Tolerances 

EPA’s tolerance levels are expressed 

to provide sufficient precision for 

enforcement purposes, and this may 

include the addition of trailing zeros 

(such as 0.30 ppm rather than 0.3 ppm). 

This is done to avoid the situation 

where rounding of an observed violative 

residue to the level of precision of the 

tolerance expression would result in a 

residue considered non-violative (such 

as 0.34 ppm being rounded to 0.3 ppm). 

EPA added additional zeros for fruiting 

vegetables group 8–10 and cucurbit 

vegetables group 9. EPA is establishing 

tolerances for residues in or on fruit, 

citrus, group 10–10 at 0.80 ppm instead 

of 0.9 ppm; citrus, oil at 30 ppm instead 

of 28.0 ppm; and citrus, dried pulp at 

4.0 ppm instead of 3.0 ppm, based on 

the previously reviewed orange 

processing study, and the newly 

submitted lemon field trial residues as 

the input dataset for the Organization 

for Economic Cooperation and 

Development (OECD) MRL calculation 

procedure. In addition, the tolerances in 

fruits, pome, group 11–10 and apple wet 

pomace are based on the petitioner’s 

revision of the proposed maximum 

annual use rate on pome fruits, from 

0.42 lb ai per acre (lb ai/A) to 0.57 lb 

ai/A. 

D. International Trade Considerations 

In this rule, EPA is reducing the 

existing tolerances for citrus 

commodities as follows: Fruit, citrus, 

group 10–10 from 1.5 ppm to 0.80 ppm; 

citrus, dried pulp from 8.0 ppm to 4.0 

ppm; and citrus, oil from 70 ppm to 30 

ppm. The Agency is reducing these 

tolerances because these reductions 

requested by the petitioner are 

supported by available data. This 

reduction in tolerance levels is not 

discriminatory; the same food safety 

standard contained in the FFDCA 

applies equally to domestically 

produced and imported foods. 

In accordance with the World Trade 

Organization’s (WTO) Sanitary and 

Phytosanitary Measures (SPS) 

Agreement, EPA will notify the WTO of 

its tolerance revision. In addition, the 

SPS Agreement requires that Members 

provide a ‘‘reasonable interval’’ between 

the publication of a regulation subject to 

the Agreement and its entry into force 

in order to allow time for producers in 

exporting Member countries to adapt to 

the new requirement. At this time, EPA 

is establishing an expiration date for the 

existing tolerances to allow those 

tolerances remain in effect for a period 

of six months after the effective date of 

this final rule, in order to address this 

requirement. Prior to the expiration 

date, residues of tolfenpyrad up to the 

existing tolerance levels will be 

permitted; after the expiration date, 

residues will need to comply with the 

reduced tolerance levels. 

V. Conclusion 

Therefore, tolerances are established 

for residues of tolfenpyrad, 4-chloro-3- 

ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5- 

carboxamide, in or on Vegetable, 

Brassica, head and stem, group 5–16 at 

5.0 parts per million (ppm); Brassica, 

leafy greens, subgroup 4–16B at 40 ppm; 

Vegetable, cucurbit, group 9 at 0.70 

ppm; Vegetable, fruiting, group 8–10 at 

0.70 ppm; Fruit, pome, group 11–10 at 

1.0 ppm; and Apple, wet pomace at 3.0 

ppm. Furthermore, established 

tolerances are amended for residues of 

tolfenpyrad in or on Fruit, citrus, group 

10–10 from 1.5 ppm to 0.80 ppm; Citrus, 

dried pulp from 8.0 ppm to 4.0 ppm; 

and Citrus, oil from 70 ppm to 30 ppm. 

Finally, the tolerances for ‘‘Vegetable, 

fruiting, group 8–10’’ at 0.70 ppm and 

‘‘Watermelon’’ at 0.70 ppm in paragraph 

(b), which cover residues resulting from 

the section 18 emergency exemptions, 

are removed as it is superseded by the 

tolerances established for group 9 in this 

action. 

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 

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, 


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Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 29023 

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 8, 2018. 

Michael Goodis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.675: 

■ a. Revise the table in paragraph (a)(1); 

and 

■ b. Remove the entries for ‘‘Vegetable, 

fruiting, group 8–10’’ and 

‘‘Watermelon’’ in the table in paragraph 

(b). 

The revision reads as follows: 

§ 180.675 Tolfenpyrad; tolerance for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Almond hulls ............................... 6.0 

Apple, wet pomace ..................... 3.0 

Brassica, leafy greens, subgroup 

4–16B ...................................... 40 

Commodity Parts per 

million 

Citrus, dried pulp 1 ...................... 8.0 

Citrus, dried pulp ........................ 4.0 

Citrus, oil 1 .................................. 70.0 

Citrus, oil ..................................... 30 

Cotton, gin byproducts ............... 15.0 

Cotton, undelinted seed ............. 0.70 

Fruit, citrus, group 10–10 1 ......... 1.5 

Fruit, citrus, group 10–10 ........... 0.80 

Fruit, pome, group 11–10 ........... 1.0 

Fruit, stone, group 12–12 ........... 2.0 

Grape .......................................... 2.0 

Grape, raisin ............................... 6.0 

Nuts, tree, group 14–12 ............. 0.05 

Persimmon .................................. 2.0 

Plum, prune ................................ 3.0 

Pomegranate .............................. 2.0 

Potato ......................................... 0.01 

Tea .............................................. 30.0 

Vegetable, Brassica, head and 

stem, group 5–16 .................... 5.0 

Vegetable, cucurbit, group 9 ...... 0.70 

Vegetable, fruiting, group 8–10 .. 0.70 

Vegetable, leafy, except Brassica, group 4 ........................... 30.0 

1This tolerance expires on December 24, 

2018. 

* * * * * 

[FR Doc. 2018–13456 Filed 6–21–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0235; FRL–9976–41] 

Acetochlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acetochlor in 

or on alfalfa and related animal 

commodities which are identified and 

discussed later in this document. 

Monsanto Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

22, 2018. Objections and requests for 

hearings must be received on or before 

August 21, 2018, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2017–0235, 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. 

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–2017–0235 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 


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