65546 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 6, 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 § 180.546: 

■ i. Remove the entry ‘‘Kiwifruit’’ from 

the table in paragraph (a). 

■ ii. Add alphabetically the entries 

‘‘Cacao, dried bean’’; ‘‘Fruit, small, vine 

climbing, except grape, subgroup 13– 

07E’’; ‘‘Wasabi, stem’’; and ‘‘Wasabi, 

tops’’ to the table in paragraph (a). 

The additions read as follows: 

§ 180.546 Mefenoxam; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*****

Cacao, dried bean .................... 0.20 

*****

Fruit, small, vine climbing, except grape, subgroup 13–07E 0.10 

*****

Wasabi, stem ............................ 3.0 

Wasabi, tops ............................. 6.0 

* * * * * 

[FR Doc. 2018–27764 Filed 12–20–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0587; FRL–9987–34] 

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. Interregional Research 

Project No. 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 21, 2018. Objections and 

requests for hearings must be received 

on or before February 19, 2019 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–2017–0587, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Michael Goodis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to https://

www.epa.gov/aboutepa/about-officechemical-safety-and-pollutionprevention-ocspp. 

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–2017–0587 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 

February 19, 2019. 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– 

2017–0587, 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 https://

www.epa.gov/dockets/where-sendcomments-epa-dockets. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 


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II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of January 26, 

2018 (83 FR 3658) (FRL–9971–46), 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 7E8613) by IR–4, Rutgers, 

The State University of New Jersey, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.675 be 

amended by establishing tolerances for 

residues of the insecticide tolfenpyrad, 

4-chloro-3-ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5- 

carboxamide), in or on Arugula at 30.0 

parts per million (ppm); Avocado at 1.5 

ppm; Berry, low growing, subgroup 13– 

07G, except Cranberry and Blueberry, 

lowbush at 3.0 ppm; Bushberry, 

subgroup 13–07B at 7.0 ppm; Caneberry, 

subgroup 13–07A at 7.0 ppm; Celtuce at 

30.0 ppm; Cottonseed, subgroup 20C at 

0.70 ppm; Florence fennel at 30.0 ppm; 

Fruit, small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 2.0 ppm; 

Garden cress at 30.0 ppm; Leaf petiole 

vegetable, subgroup 22B at 30.0 ppm; 

Leafy greens, subgroup 4–16A at 30.0 

ppm; Onion, bulb, subgroup 3–07A at 

0.09 ppm; Onion, green, subgroup 3– 

07B at 10.0 ppm; Upland cress at 30.0 

ppm; Vegetable, fruiting, group 8–10 at 

1.0 ppm; and Vegetable, tuberous and 

corm, subgroup 1C at 0.01 ppm. 

The petitioner also requested that the 

following established tolerances be 

removed upon establishment of the 

petitioned-for tolerances: Cotton, 

undelinted seed at 0.70 ppm; Grape at 

2.0 ppm; Potato at 0.01 ppm; and 

Vegetable, leafy, except Brassica, group 

4 at 30.0 ppm. 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. 

Although a comment was submitted to 

the docket for the notice of filing, the 

issue raised is outside the scope of this 

rulemaking. 

Based upon review of the data 

supporting the petition, EPA is 

establishing the petitioned-for 

tolerances with some variations 

consistent with its authority in FFDCA 

section 408(d)(4)(A). The reasons for 

these variations 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 findings across species and 

studies were effects on bodyweight and 

bodyweight 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. 

Further detail of the toxicological 

profile for tolfenpyrad is discussed in 

Unit III.A. of the final rule published in 

the Federal Register of June 22, 2018 

(83 FR 29017) (FRL–9976–21). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by tolfenpyrad as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Tolfenpyrad-Aggregate Human Health 

Risk Assessment for Section 3 New Use 

Requests and Crop Group Tolerance 

Conversions’’ on page 31 in docket ID 

number EPA–HQ–OPP–2017–0587. 

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. 

A summary of the toxicological 

endpoints for tolfenpyrad used for 

human risk assessment is discussed in 

Unit III B. of the final rule published in 

the Federal Register of June 22, 2018 

(83 FR 29020) (FRL–9976–21). 

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 the Dietary 


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Exposure Evaluation Model DEEM– 

FCIDTM (Ver. 3.16). This model uses 

food consumption data from the 2003– 

2008 United States Department of 

Agriculture’s (USDA) National Health 

and Nutrition Examination Survey, 

What We Eat in America (NHANES/ 

WWEIA). As to residue levels in food, 

EPA used tolerance-level residues for all 

foods and assumed 100% crop treated 

(PCT) for all current and proposed 

crops. The assessment was refined with 

the application of empirical processing 

factors where available. Where 

empirical processing factors were not 

available or were not translated, default 

processing factors were used. 

Additional refinements include a factor 

to account for the reduction in residues 

when wrapper leaves are removed (head 

lettuce, radicchio, cabbage, Chinese 

Napa cabbage, and Brussels sprouts). 

Empirical processing factors were 

available for processed commodities of 

apple, orange, cottonseed, grape, plum, 

potato and tomato, and were translated 

to other processed commodities where 

appropriate. Where empirical 

processing factors were not available or 

were not translated, default processing 

factors were used. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the DEEM– 

FCIDTM (Ver. 3.16). This model uses 

food consumption data from the 2003– 

2008 USDA’s NHANES/WWEIA. As to 

residue levels in food, EPA assumed 

100% PCT and average residue levels 

from crop field trials as well as the 

refinements described above for the 

acute assessment. 

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 residue and percent 

crop treated (PCT) information. 

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 CallIns 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 

https://www.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. 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 

value of 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 

(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. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

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 https:// 

www.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 there is evidence of increased 

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 pre- 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) was observed 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 


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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. While there was evidence of 

qualitative susceptibility in one study, 

the Agency’s concern for the 

susceptibility is low because it was not 

observed in other studies with 

tolfenpyrad; offspring effects 

consistently occurred at or above the 

dose associated with significant 

maternal toxicity; there was a clear 

NOAEL/LOAEL; and endpoints and 

doses selected for risk assessment are 

protective of the susceptibility. 

iv. There are no residual uncertainties 

with regard to the exposure assessment. 

The acute dietary exposure assessment 

is based on high-end health protective 

residue levels (that account for parent 

and metabolites of concern), processing 

factors, and percent crop treated 

assumptions (100%). The chronic 

dietary assessment incorporates some 

refinement in that average residue 

values were used. For both the acute 

and chronic dietary exposure, actual 

exposures to tolfenpyrad will likely be 

lower than the estimated exposures. 

Furthermore, conservative, upper-bound 

assumptions were used to estimate 

exposure through drinking water, such 

that these exposures have not been 

underestimated. No residential 

exposures are expected. 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 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 63% 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 97% 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 intermediate-term aggregate 

exposures take into account short- and 

intermediate-term residential exposures 

plus chronic exposures to food and 

water (considered to be background 

exposure levels). 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 method with tandem 

mass spectrometry detection (LC/MS/ 

MS) is 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, 

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 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 established an MRL for 

tolfenpyrad on potato at 0.01 ppm. Due 

to crop group conversions, the 

established potato tolerance will be 

covered by Vegetable, tuberous and 

corm, subgroup 1C. Therefore, the 

Codex MRL for potato is harmonized 

with the U.S. tolerance for Vegetable, 

tuberous and corm, subgroup 1C at 0.01 

ppm. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioner requested tolerances 

for residues of tolfenpyrad and cited the 

International Union of Pure and 

Applied Chemistry (IUPAC) name for 

the chemical. The residue definition for 

tolfenpyrad tolerances currently 

established under 40 CFR 180.675 

complies with the Agency’s Guidance 

on Tolerance Expressions, except that 

the IUPAC chemical name is listed 

rather than the Chemical Abstracts 

Service (CAS) chemical name. The 

Agency’s practice is to use the CAS 

name; therefore, the tolerance 

expression is being revised. This change 

also results in harmonization of the 

chemical name expression with that 

used by the Pest Management 

Regulatory Agency (PMRA). 


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EPA reviewed the current residue 

data and tolerance conversion proposals 

and is establishing some the proposed 

tolerance levels for residues of 

tolfenpyrad in accordance with the 

Agency’s rounding practice. In addition, 

using the highest overall average residue 

level from the greenhouse tomato 

decline trial (at a post-harvest interval 

(PHI) of 5 days instead of a PHI of 1 

day), the Agency is establishing a 

tolerance for Vegetable, fruiting, group 

8–10 at 1.5 ppm instead of 1.0 ppm. 

While the petitioner requested 

individual tolerances for arugula, 

garden cress, and upland cress, 

individual tolerances are not necessary 

since these commodities are included in 

Brassica, leafy greens, subgroup 4–16B. 

Finally, the Agency is establishing a 

tolerance for the requested commodity 

Florence fennel as a tolerance for 

Fennel, Florence, fresh leaves and stalk 

to conform to the Agency’s preferred 

vocabulary for this commodity. 

V. Conclusion 

Therefore, tolerances are established 

for residues of tolfenpyrad, (4-chloro-3- 

ethyl-1-methyl-N-[[4-(4- 

methylphenoxy)phenyl]methyl]-1Hpyrazole-5-carboxamide), including its 

metabolites and degradates, in or on 

Avocado at 1.5 ppm; Berry, low 

growing, subgroup 13–07G, except 

cranberry and lowbush blueberry at 3.0 

ppm; Bushberry subgroup 13–07B at 7.0 

ppm; Caneberry subgroup 13–07A at 7.0 

ppm; Celtuce at 30 ppm; Cottonseed 

subgroup 20C at 0.70 ppm; Fennel, 

Florence, fresh leaves and stalk at 30 

ppm; Fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F at 2.0 

ppm; Leaf petiole vegetable subgroup 

22B at 30 ppm; Leafy greens subgroup 

4–16A at 30 ppm; Onion, bulb, 

subgroup 3–07A at 0.09 ppm; Onion, 

green, subgroup 3–07B at 10 ppm; 

Vegetable, fruiting, group 8–10 at 1.5 

ppm; and Vegetable, tuberous and corm, 

subgroup 1C at 0.01 ppm. In addition, 

EPA is removing the following 

tolerances from paragraph (a) as they are 

superseded by the new tolerances being 

established in this rulemaking Cotton, 

undelinted seed at 0.70 ppm; Grape at 

2.0 ppm; Potato at 0.01 ppm; and 

Vegetable, leafy except Brassica, group 

4 at 30.0 ppm. EPA is also removing the 

time-limited tolerance for onion, dry 

bulb at 0.09 ppm in § 180.675(b) as it is 

no longer needed with the 

establishment of a new permanent 

tolerance for onion, bulb subgroup 3– 

07A in paragraph (a)(1). 

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), nor is it considered a 

regulatory action under 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 tolerances 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: December 10, 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 introductory text of 

paragraph (a)(1); 

■ b. In the table to paragraph (a)(1): 

■ i. Add alphabetically the entries 

‘‘Avocado’’; ‘‘Berry, low growing, 

subgroup 13–07G, except cranberry and 

lowbush blueberry’’; ‘‘Bushberry, 

subgroup 13–07B’’; ‘‘Caneberry, 

subgroup 13–07A’’; ‘‘Celtuce’’; 

‘‘Cottonseed, subgroup 20C’’; ‘‘Fennel, 

Florence, fresh leaves and stalk’’; ‘‘Fruit, 

small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F’’; ‘‘Leaf 

petiole vegetable subgroup 22B’’; ‘‘Leafy 

greens, subgroup 4–16A’’; ‘‘Onion, bulb, 

subgroup 3–07A’’; ‘‘Onion, green, 

subgroup 3–07B’’; and ‘‘Vegetable, 

tuberous and corm, subgroup 1C’’; 

■ ii. Revise the entry for ‘‘Vegetable, 

fruiting, group 8–10’’; 

■ iii. Remove the entries ‘‘Cotton, 

undelinted seed’’; ‘‘Grape’’; ‘‘Potato’’; 


amozie on DSK3GDR082PROD with RULES
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65551 

and ‘‘Vegetable, leafy except Brassica, 

group 4’’; 

■ c. Revise the introductory text of 

paragraph (a)(2); 

■ d. Revise paragraph (b). 

The additions and revisions read as 

follows: 

§ 180.675 Tolfenpyrad; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide tolfenpyrad, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only tolfenpyrad (4-chloro-3- 

ethyl-1-methyl-N-[[4-(4- 

methylphenoxy)phenyl]methyl]-1Hpyrazole-5-carboxamide) in or on the 

commodity. 

Commodity Parts per 

million 

*******

Avocado ............................................................................................................................................................................................... 1.5 

Berry, low growing, subgroup 13–07G, except cranberry and lowbush blueberry ............................................................................. 3.0 

*******

Bushberry, subgroup 13–07B .............................................................................................................................................................. 7.0 

Caneberry, subgroup 13–07A ............................................................................................................................................................. 7.0 

Celtuce ................................................................................................................................................................................................. 30 

*******

Cottonseed, subgroup 20C .................................................................................................................................................................. 0.70 

Fennel, Florence, fresh leaves and stalk ............................................................................................................................................ 30 

*******

Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................................................................................................. 2.0 

*******

Leaf petiole vegetable subgroup 22B .................................................................................................................................................. 30 

Leafy greens, subgroup 4–16A ........................................................................................................................................................... 30 

*******

Onion, bulb, subgroup 3–07A .............................................................................................................................................................. 0.09 

Onion, green, subgroup 3–07B ........................................................................................................................................................... 10 

*******

Vegetable, fruiting, group 8–10 ........................................................................................................................................................... 1.5 

Vegetable, tuberous and corm, subgroup 1C ..................................................................................................................................... 0.01 

(2) Tolerances are established for 

residues of the insecticide tolfenpyrad, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified below is to 

be determined by measuring only the 

sum of tolfenpyrad, 4-chloro-3-ethyl-1- 

methyl-N-[[4-(4- 

methylphenoxy)phenyl]methyl]-1Hpyrazole-5-carboxamide, and its 

metabolite 4-[4-[(4-chloro-3-ethyl-1- 

methylpyrazol-5-yl)carbonylaminomethyl]phenoxy]-benzoic acid, 

calculated as the stoichiometric 

equivalent of tolfenpyrad. 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2018–27605 Filed 12–20–18; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 73 and 74 

[MB Docket Nos. 18–4, 17–105; FCC 18– 

145] 

Filing of Contracts 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

eliminates a paper filing requirement for 

broadcast station contracts and 

documents and instead requires that 

these same documents are either 

uploaded or listed in the online public 

file within 30 days. 

DATES: Effective Date: January 22, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Clark, Industry Analysis 

Division, Media Bureau, FCC, (202) 

418–2609. For additional information 

concerning the information collection 

requirements contained in the Report 

and Order, contact Cathy Williams at 

(202) 418–2918, or via the internet at 

PRA@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order, FCC 18–145, in MB Docket 

Nos. 18–4 and 17–105, adopted and 

released on October 23, 2018. The 

complete text of this document is 

available electronically via the search 

function on the FCC’s Electronic 

Document Management System 

(EDOCS) web page at https://

apps.fcc.gov/edocs_public/ (https://

apps.fcc.gov/edocs_public/). The 

complete document is available for 

inspection and copying in the FCC 

Reference Information Center, 445 12th 

Street SW, Room CY–A257, 

Washington, DC 20554 (for hours of 

operation, see https://www.fcc.gov/ 

general/fcc-reference-informationcenter). To request materials in 

accessible formats for people with 

disabilities (Braille, large print, 

electronic files, audio format), send an 

email to fcc504@fcc.gov (mail to: 

fcc504@fcc.gov) or call the FCC’s 

Consumer and Governmental Affairs 

Bureau at (202) 418–0530 (voice), (202) 

418–0432 (TTY). 


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