Federal Register / Vol. 79, No. 6 / Thursday, January 9, 2014 / Rules and Regulations 1599 

Subpart SS—Texas 

■ 2. In § 52.2270, the second table in 

paragraph (e) entitled ‘‘EPA Approved 

Nonregulatory Provisions and QuasiRegulatory Measures in the Texas SIP’’ 

is amended by revising the entry for 

‘‘Approval of the Speed Limits Local 

Initiative Measure in the DFW nine 

county area.’’ 

The revision reads as follows: 

§ 52.2270 Identification of plan. 

* * * * * 

(e) * * * 

EPA APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE TEXAS SIP 

Name of SIP provision Applicable geographic or 

nonattainment area 

State 

submittal/ 

effective date 

EPA approval date Comments 

*******

Approval of the Speed Limits 

Local Initiative Measure in the 

DFW nine county area. Affected counties are Dallas, 

Tarrant, Collin, Denton, Parker, 

Johnson, Ellis, Kaufman, 

Rockwall.

Dallas-Fort Worth ........................ 9/16/2010 1/9/2014 [Insert FR page 

number where document begins].

Recategorized as a Transportation Control Measure. 

* * * * * * * 

[FR Doc. 2014–00047 Filed 1–8–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0909; FRL–9904–70] 

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 

January 9, 2014. Objections and requests 

for hearings must be received on or 

before March 10, 2014, 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–2012–0909, 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), EPA West 

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: Lois 

Rossi, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 305–0001; 

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 http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0909 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 March 10, 2014. 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– 

2012–0909, 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 


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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.htm. 

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 May 02, 

2012 (77 FR 25954) (FRL–9346–1), 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 0F7791) by Nichino 

America, Inc., 4550 New Linden Hill 

Rd., Suite 501, Wilmington, DE 19808. 

The petition requested that 40 CFR 180 

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 head lettuce at 5 

ppm; leaf lettuce at 30 ppm; leaf 

petioles, subgroup 4B at 12.5 ppm; 

spinach at 24 ppm; Brassica, head and 

stem, subgroup 5A at 3.6 ppm; Brassica, 

leafy, subgroup 5B at 44 ppm; vegetable, 

fruiting group 8 at 0.6 ppm; potatoes at 

0.04 ppm; nut, tree group 14 (including 

pistachio) at 0.04 ppm; almond, hulls at 

5.0 ppm; fruit, pome, group 11 at 0.6 

ppm; apple, wet pomace at 5.0 ppm; 

vegetable, cucurbit, group 9 at 0.8 ppm; 

fruit, stone, group 12 at 3.0 ppm; 

pomegranates at 3.0 ppm; persimmons 

at 3.0 ppm; citrus, group 10 at 1.0 ppm; 

citrus, pulp, dried at 2.0 ppm; citrus, oil 

at 16.0 ppm; grapes at 2.0 ppm; raisins 

at 5 ppm; cotton, undelinted seed at 0.6 

ppm; cotton, gin byproducts at 9.0 ppm; 

tea at 20 ppm; milk at 0.03 ppm; cattle, 

fat, at 0.01 ppm; goat, fat at 0.01 ppm; 

horse, fat at 0.01 ppm; sheep, fat at 0.01 

ppm; cattle, kidney at 0.3 ppm; goat, 

kidney at 0.3 ppm; horse, kidney at 0.3 

ppm; sheep, kidney at 0.3 ppm; cattle, 

liver at 0.7 ppm; goat, liver at 0.7 ppm; 

horse, liver at 0.7 ppm; sheep, liver at 

0.7 ppm; cattle, meat at 0.02 ppm; goat, 

meat at 0.02 ppm; horse, meat at 0.02 

ppm, and sheep, meat at 0.02 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. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

nearly all of the proposed tolerances. 

The reasons for these changes are 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. Tolfenpyrad is a 

broad-spectrum pyrazole insecticide 

that is proposed for use to control 

thrips, aphids and scales through the 

egg, larval, nymph, and adult stages. 

The toxicity database for tolfenpyrad is 

complete. Tolfenpyrad is acutely toxic 

by oral route, but has low acute 

inhalation and dermal toxicity. It is also 

not irritating to the eye and skin and is 

not a skin sensitizer. 

Toxicological testing indicates that 

tolfenpyrad is not neurotoxic or 

immunotoxic and it is classified as ‘‘not 

likely to be carcinogenic to humans.’’ 

However, the most consistent finding 

across species and studies was effects 

on body weight and body weight gain. 

Decreases in body weight and/or body 

weight gain 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 

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. Body weight changes observed in 

other species were similar in magnitude 

to those in rats, but were observed at 

higher doses. 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. The severity of body 

weight changes increased with dose in 

mice while body weight effects in dogs 

were seen only at the highest dose 

tested. 

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 


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harderian gland and lymph nodes. In 

dogs, both 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 

histopathology in the liver only, 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. Missing ears and ear 

lesions (scabs, sores, ulceration, and 

inflammation) were seen in a chronic 

toxicity study. The ear lesions observed 

were likely self inflicted since the mice 

in the study were individually caged. 

No explanation was given to why the 

lesions occurred and the toxicological 

significance of this finding is unclear. 

Moribundity and/or mortality were 

noted in at least one study in all species 

at ≥ 3 milligrams/kilogram/day (mg/kg/ 

day). Moribundity and mortality were 

noted in two dams in a rat reproduction 

study, and mortality was noted in one 

dam in a rabbit developmental toxicity 

study. Mortality was also observed in 

two animals in an inhalation toxicity 

study (range-finding only). In mice and 

dogs, mortality was observed in both 

subchronic and chronic toxicity studies. 

In all cases, effects were observed in the 

presence of body weight changes and 

the points of departure (POD) 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, a potential 

increase in qualitative susceptibility 

was seen. In the 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. 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. Human Health Risk 

Assessment’’ in docket ID number EPA– 

HQ–OPP–2012–0909. 

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://

www.epa.gov/pesticides/factsheets/

riskassess.htm. A summary of the 

toxicological endpoints for tolfenpyrad 

used for human risk assessment is 

shown in Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TOLFENPYRAD FOR USE IN DIETARY HUMAN

HEALTH RISK ASSESSMENTS

Exposure/scenario Point of departure Uncertainty/FQPA 

safety factors 

RfD, PAD, level of 

concern for risk 

assessment 

Study and toxicological effects 

Acute Dietary (General Population, 

including Infants 

and Children).

NOAEL = 10 mg/

kg/day.

UFA = 10 × ...........

UFH = 10 × 

FQPA 

SF = 1× 

Acute RfD = 0.1 

mg/kg/day.

aPAD = 0.1 mg/kg/

day 

LOAEL = 20 mg/kg/day from an acute neurotoxicity study 

in rats, based on decreased body weight, body weight 

gain and food consumption 

Chronic Dietary (All 

Populations).

NOAEL = 0.6 mg/

kg/day.

UFA = 10 × ...........

UFH = 10 × 

FQPA SF = 1× 

Chronic RfD = 

0.006 mg/kg/day.

cPAD = 0.006 mg/

kg/day 

LOAEL = 1.5 mg/kg/day from a combined chronic/carcinogenicity in rats, based on decreased body weight, 

body weight 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 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TOLFENPYRAD FOR USE IN DIETARY HUMAN

HEALTH RISK ASSESSMENTS—Continued 

Exposure/scenario Point of departure Uncertainty/FQPA 

safety factors 

RfD, PAD, level of 

concern for risk 

assessment 

Study and toxicological effects 

Cancer ................... Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. 

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. 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 U.S. 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA assumed 

100 percent crop treated (PCT) and 

tolerance-level residues. 

ii. Chronic exposure. The chronic 

assessment is significantly refined. 

Inputs to the chronic assessment 

include average residue levels from crop 

field trials; use of projected PCT 

estimates for foods that were shown to 

have a high contribution to the overall 

dietary exposure (as discussed in Unit 

III.C.1.iv.) and assumptions of 100 PCT 

for the rest of the commodities; liberal 

translation of juice processing factors; 

and reduction of residues from removal 

of head lettuce and cabbage wrapper 

leaves. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that there was no evidence of 

carcinogenicity in cancer studies with 

mice and rats. Therefore, a cancer 

exposure assessment was not 

conducted. 

iv. Anticipated residue and PCT 

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. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency estimated the PCT for 

new uses as follows: 40% for oranges; 

65% for table grapes; and 50% for 

spinach. 

EPA estimates PCT for new uses for 

tolfenpyrad based on the PCT of the 

dominant pesticide (i.e., the one with 

the greatest PCT) on that site over the 

three most recent years of available data. 

Comparisons are only made among 

pesticides of the same pesticide types 

(i.e., the dominant insecticide on the 

use site is selected for comparison with 

a new insecticide). The PCTs included 

in the analysis may be for the same 

pesticide or for different pesticides 

since the same or different pesticides 

may dominate for each year. Typically, 

EPA uses USDA/NASS as the source for 

raw PCT data because it is publicly 

available and does not have to be 

calculated from available data sources. 

When a specific use site is not surveyed 

by USDA/NASS, EPA uses proprietary 

data and calculates the estimated PCT. 

The estimated PCT for new uses, 

based on the average PCT of the market 

leader, is appropriate for use in the 

chronic dietary risk assessment. This 

method of estimating a PCT for a new 

use of a registered pesticide or a new 

pesticide produces a high-end estimate 

that is unlikely, in most cases, to be 

exceeded during the initial 5 years of 

actual use. The predominant factors that 

bear on whether the estimated PCT for 

new uses could be exceeded are (1) the 

extent of pest pressure on the crops in 

question; (2) the pest spectrum of the 

new pesticide in comparison with the 

market leaders as well as whether the 

market leaders are well-established for 

this use; and (3) resistance concerns 

with the market leaders. 


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All information currently available 

has been considered for tolfenpyrad, 

and it is the opinion of the Agency that 

it is unlikely that actual PCT for 

tolfenpyrad will exceed the estimated 

PCT for new uses during the next 5 

years. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which novaluron may be applied in a 

particular area. 

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://www.epa.gov/oppefed1/models/

water/index.htm. 

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 26.9 

parts per billion (ppb) in surface water 

and 11 ppb for ground water; for 

chronic exposures, 12.2 ppb in surface 

water and 11 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration of value 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 

(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 Web site at 

http://www.epa.gov/pesticides/

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Although there seems to be 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 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 

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 PCT assumptions (100%). 

The chronic dietary assessment 

incorporates significant refinement in 

that average residue values were used 

and projected PCT estimates were used 

for a few crops, the estimates are below 

the level of concern for all population 

subgroups because conservative 

assumptions, including the highly 

unlikely scenario that 100% of the 

planted acreage would be treated. 

Furthermore, conservative, upper-bound 

assumptions were used to determine 

exposure through drinking water, such 

that these exposures have not been 

underestimated. There are no residential 

exposure scenarios at this time. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 


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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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. For the acute assessment, the 

dietary risk for the U.S. population is 

estimated to be 62% of the aPAD. 

Children 3–5 years old are the highestexposed population subgroup, with an 

estimated exposure at the 95th 

percentile of 0.076 mg/kg/day, which 

corresponds to 76% of the aPAD. 

Typically EPA has concerns when 

estimated exposures exceed 100% of the 

acute or chronic population-adjusted 

dose (aPAD or cPAD). Acute dietary risk 

estimates are below EPA’s level of 

concern for all population subgroups. 

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 69% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of topramezone is not 

expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

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 exposure. Because there 

is no short- or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short- and 

intermediate-term risk), no further 

assessment of short- or intermediateterm 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 

are available in Pesticide Analytical 

Manual II (PAM II) for citrus and 

processed fractions (Method I), ginned 

cottonseed (Method IA), and bovine 

tissues and milk (Method II). 

Additionally, Method M–073 and M– 

936–95–2 have been validated by the 

Agency and submitted for inclusion in 

PAM II as enforcement methods. These 

five methods are adequate for 

enforcement of the tolerances on plants 

and livestock. Method M–073 and M– 

936–95–2 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 MRLs 

for tolfenpyrad. 

C. Revisions to Petitioned-For 

Tolerances 

Nearly all of the commodity 

definitions for the petitioned-for 

tolerances are inconsistent with the 

current Agency definitions and must be 

revised. For head lettuce, spinach, and 

celery subgroup 4B leaf petioles, EPA 

has concluded that a group tolerance of 

30 ppm for vegetable, leafy, except 

Brassica, group 4 is appropriate. For all 

remaining crops (except prune, grape, 

milk, and cattle, goat, horse, and sheep 

fat), EPA revised the tolerance values 

based on residue data and the use of the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. 

The submitted data for processed 

commodities are adequate and sufficient 

for the assessing and establishing 

tolerances associated with the proposed 

registration. EPA cannot determine the 

cause of the differences in the proposed 

tolerances for citrus dried pulp and oil, 

and raisin. 

EPA is establishing tolerances for 

meat and meat byproducts that differ 

from the requested livestock tolerances 

due to differences between the dietary 

burden calculation generated by the 

petitioner and that generated by the 

Agency. 

Finally, as EPA explained in its latest 

crop group rulemaking (77 FR 50617, 

August 22, 2012) (FRL–9354–3), EPA 

will attempt to conform petitions 

seeking tolerances for crop groups to the 

newer established crop groups, rather 

than establish new tolerances under the 

pre-existing crop groups, as part of its 

effort to eventually convert tolerances 

for any pre-existing crop group to 

tolerances with coverage under the 

revised crop group. Therefore, although 

the petitioner requested tolerances for 

crop groups 8 (fruiting vegetables), 10 

(citrus fruit), 11 (pome fruit), 12 (stone 

fruit), and 14 (tree nuts), EPA evaluated 

and is establishing tolerances for crop 

groups 8–10 (fruiting vegetables), 10–10 

(citrus fruit), 11–10 (pome fruit), 12–12 

(stone fruit), and 14–12 (tree nuts). 

V. Conclusion 

Therefore, tolerances are established 

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

ethyl-1–methyl-N-[4-(p-tolyloxy) 

benzyl] pyrazole-5-carboxamide in or on 

almond, hulls at 6.0 ppm; citrus, dried 

pulp at 8.0 ppm; citrus, oil at 70 ppm; 

cotton, undelinted seed at 0.70 ppm; 

cotton, gin byproducts at 15 ppm; fruit, 

citrus, group 10–10 at 1.5 ppm; fruit, 

stone, group 12–12 at 2.0 ppm; grape at 

2.0 ppm; grape, raisin at 6.0 ppm; nut, 

tree, group 14–12 at 0.05 ppm; 

persimmon at 2.0 ppm; plum, prune at 

3.0 ppm; pomegranate at 2.0 ppm; 

potato at 0.01 ppm; tea at 30 ppm; 

vegetable, leafy, except Brassica, group 

4 at 30 ppm; milk at 0.03. ppm; cattle, 

fat at 0.01 ppm; cattle, meat at 0.01 

ppm; cattle, meat byproducts at 0.35 

ppm; goat, fat at 0.01 ppm; goat, meat 

at 0.01 ppm; goat, meat byproducts at 

0.35 ppm; horse, fat at 0.01 ppm; horse, 


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meat at 0.01 ppm; horse, meat by 

products at 0.35 ppm; sheep, fat at 0.01 

ppm; sheep, meat at 0.01 ppm; and 

sheep, meat byproducts at 0.35 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(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 23, 2013. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Add § 180.675 to subpart C to 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-(ptolyloxy)benzyl]pyrazole-5- 

carboxamide. 

Commodity Parts per million 

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

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

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

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

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

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

Fruits, citrus, group 10–10 ......................................................................................................................................... 1.5 

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

(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-(ptolyloxy)benzyl]pyrazole-5- 

carboxamide, and its metabolite 4-[4-[(4- 

chloro-3-ethyl-1-methylpyrazol-5- 

yl)carbonylamino-methyl]phenoxy]- 

benzoic acid, calculated as the 


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stoichiometric equivalent of 

tolfenpyrad. 

Commodity Parts per million 

Cattle, fat ................................................................................................................................................................... 0.01 

Cattle, meat ............................................................................................................................................................... 0.01 

Cattle, meat byproducts ............................................................................................................................................. 0.35 

Goat, fat ..................................................................................................................................................................... 0.01 

Goat, meat ................................................................................................................................................................. 0.01 

Goat, meat byproducts .............................................................................................................................................. 0.35 

Horse, fat ................................................................................................................................................................... 0.01 

Horse, meat ............................................................................................................................................................... 0.01 

Horse, meat byproducts ............................................................................................................................................ 0.35 

Milk ............................................................................................................................................................................. 0.03 

Sheep, fat .................................................................................................................................................................. 0.01 

Sheep, meat .............................................................................................................................................................. 0.01 

Sheep, meat byproducts ............................................................................................................................................ 0.35 

(b) Section 18 emergency exemptions. 

[Reserved]. 

(c) Tolerances with regional 

registration. [Reserved]. 

(d) Indirect or inadvertent residues. 

[Reserved]. 

[FR Doc. 2014–00163 Filed 1–8–14; 8:45 am] 

BILLING CODE 6560–50–P 


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