54620 Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0712; FRL–9915–47] 

Sulfentrazone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of sulfentrazone 

in or on apple. The Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

September 12, 2014. Objections and 

requests for hearings must be received 

on or before November 12, 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–2013–0712, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0712 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 November 12, 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– 

2013–0712, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of December 

30, 2013 (78 FR 79359) (FRL–9903–69), 

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 3E8202) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.498 be 

amended by establishing tolerances for 

residues of the herbicide sulfentrazone, 

(N-[2,4-dichloro-5-[4-(difluoromethyl)- 

4,5-dihydro-3-methyl-5-oxo-1H-1,2,4- 

triazol-1- 

yl]phenyl]methanesulfonamide), and its 

metabolite HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone, in or on 

apple at 0.15 parts per million (ppm). 

That document referenced a summary of 

the petition prepared on behalf of IR–4 

by FMC Corporation, the registrant, 

which is available in the docket, 

http://www.regulations.gov. Comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

determined that it is appropriate to 

establish the tolerance in or on apple for 

the combined residues of the free and 

conjugated forms of the herbicide 

sulfentrazone, and its metabolites HMS 

(N-(2,4-dichloro-5-(4-(difluoromethyl)- 

4,5-dihydro-3-hydroxymethyl-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone. The reason 

for this decision is discussed 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 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations 54621 

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 sulfentrazone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with sulfentrazone 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. 

Subchronic and chronic toxicity 

studies in rats, mice, and dogs identified 

the hematopoietic system as the target of 

sulfentrazone. Sulfentrazone inhibits 

the enzyme protoporphyrinogen oxidase 

(PPO) in target plants, and the results of 

subchronic and chronic toxicity studies 

in mammalian systems are consistent 

with PPO inhibition. Disruption of 

heme biosynthesis was indicated by 

signs of anemia, and decreases in 

hematocrit (Hct), hemoglobin (HGB), 

and mean corpuscular volume (MCV) in 

mice, rats, and dogs at comparable dose 

levels from short- through long-term 

exposures without a significant increase 

in severity. 

Sulfentrazone caused developmental 

effects when administered via the oral 

(rats and rabbits) and dermal (rat only) 

routes of exposure. Developmental 

effects in rats and rabbits consisted of 

reductions in the number of 

implantations in rats, and increases in 

early resorptions and reduction in live 

fetuses per litter in rats and rabbits. 

Surviving rat fetuses exhibited reduced/ 

delayed skeletal ossifications, and 

decreased fetal body weights. 

Developmental effects in rats were seen 

in the absence of maternal toxicity. In 

contrast with the rat studies, 

developmental effects in rabbits were 

observed at a maternally toxic dose, 

where clinical signs of toxicity included 

hematuria (red blood cells in urine), 

abortions, and decreased body-weight 

gains. In the 2-generation reproductive 

toxicity study in rats, developmental 

effects included an increased duration 

of gestation, reduced prenatal viability 

(fetal and litter), reduced litter size, and 

an increased number of stillborn pups. 

Pup body-weight deficits, along with 

reduced pup and litter postnatal 

survival, were also observed. All of the 

offspring effects were reported in the 

presence of mild maternal toxicity 

(decreased body weight and bodyweight gain, particularly in F1 females). 

No systemic toxicity was seen via the 

dermal route up to the limit dose in a 

28-day dermal toxicity study in adult 

non-pregnant rabbits. In a dermal 

developmental study in rats, there was 

an increased quantitative fetal 

susceptibility. While no maternal effects 

were observed up to the highest dose 

tested, fetal effects were observed at this 

dose, and consisted of decreased body 

weights, increased incidences of fetal 

variations, hypoplastic or wavy ribs, 

incompletely ossified lumbar vertebral 

arches, incompletely ossified ischia or 

pubis, and a reduced number of thoracic 

vertebral and rib ossification sites. 

In the 26-day inhalation toxicity 

study, effects that were considered 

treatment related and adverse effects 

occurred only at the highest 

concentration tested. Systemic effects at 

this concentration consisted of 

significant reductions in red blood cell 

(RBC) parameters including RBC count, 

HGB concentrations, Hct, MCV, mean 

corpuscular HGB (MCH), and/or 

reticulocytes in both sexes. Portal-ofentry effects in this study consisted of 

an increased incidence of minimal nasal 

respiratory epithelial hyperplasia in 

both sexes as well as minimal laryngeal 

epithelial attenuation in all test material 

exposure groups. The effects on 

hematological parameters were 

reversible after 28 days of recovery, 

while the nasal injury persisted. 

In an acute neurotoxicity (ACN) study 

in rats, effects consisted of an increased 

incidence of clinical signs of toxicity 

(staggered gait, splayed hind limbs, and 

abdominal gripping), changes in 

functional-observation battery (FOB) 

parameters, and decreased motor 

activity at a high dose level. Complete 

recovery was observed by day 14, and 

there was no evidence of 

neuropathology. In a rat subchronic 

neurotoxicity (SCN) study, clinical signs 

of toxicity, increased motor activity, 

and/or decreased body weights, bodyweight gain, and food consumption 

were also observed with no evidence of 

neuropathology. A published, nonguideline developmental toxicity study 

in the rat did not conclusively 

demonstrate developmental 

neurotoxicity and contained several 

shortcomings that limit its use for 

regulatory purposes, including the lack 

of a no-observed-adverse-effect-level 

(NOAEL) (DeCastro VL, Destefani CR, 

Diniz C, Poli P., 2007, Evaluation of 

neurodevelopmental effects on rats 

exposed prenatally to sulfentrazone. 

Neurotoxicology 28(6):1249–59). The 

reported effects involving measures of 

physical and reflex development are 

likely secondary effects reflective of the 

poor general state of the offspring as 

reported in the rat 2-generation 

reproductive toxicity study at similar 

dose levels but with a well-defined 

NOAEL. 

In the 28-day rat immunotoxicity 

study, there were no effects on the 

immune system and systemic effects 

consisted of reduced body weight, and 

increased absolute and relative spleen 

weights at the highest dose tested. 

Carcinogenicity studies in rats and mice 

showed no evidence of increased 

incidence of tumor formation due to 

treatment with sulfentrazone, and the 

EPA has classified sulfentrazone as not 

likely to be carcinogenic to humans. The 

available mutagenicity studies indicate 

that sulfentrazone is weakly clastogenic 

in the in vitro mouse lymphoma assay 

in the absence of S9 activation. There is 

no evidence that sulfentrazone is 

mutagenic in bacterial cells or 

clastogenic in male or female mice in 

vivo. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by sulfentrazone as well 

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

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Sulfentrazone—Preliminary HumanHealth Risk Assessment for Registration 

Review and the Risk Assessment for the 

Section 3 Registration Request for a New 

Use on Apples’’ at pp. 44–49 in docket 

ID number EPA–HQ–OPP–2013–0712. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

mstockstill on DSK4VPTVN1PROD with RULES

54622 Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations 

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 the NOAEL and the 

LOAEL are identified. 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 sulfentrazone used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk 

assessment 

Study and toxicological effects 

Acute dietary (Females 13–49 

years of age).

NOAEL = 14 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.14 

mg/kg/day.

aPAD = 0.14 mg/kg/

day.

2-generation Reproductive Toxicity Study—Rat 

Offspring Toxicity LOAEL = 33 (M) and 40 (F) mg/kg/day 

based on reduced prenatal viability (fetal & litter), reduced litter size, increased number of stillborn pups, reduced pup 

and litter postnatal survival, and decreased pup body weights 

throughout lactation. 

Acute dietary (General population including infants and 

children).

NOAEL = 250 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 2.5 mg/

kg/day.

aPAD = 2.5 mg/kg/

day.

Acute Neurotoxicity (ACN) Study—Rat 

LOAEL = 750 mg/kg/day based on increased incidence of clinical signs and FOB parameters and decreased motor activity. 

Chronic dietary (All populations) NOAEL = 14 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.14 

mg/kg/day.

cPAD = 0.14 mg/kg/

day.

2-generation Reproductive Toxicity Study—Rat 

Offspring Toxicity LOAEL = 33 (M) and 40 (F) mg/kg/day 

based on reduced prenatal viability (fetal & litter), reduced litter size, increased number of stillborn pups, reduced pup 

and litter postnatal survival, and decreased pup body weights 

throughout lactation. 

Incidental oral short- (1 to 30 

days) and intermediate-term 

(1–6 months).

NOAEL = 14 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-Generation Reproductive Toxicity Study—Rat 

Offspring LOAEL = 33 mg/kg/day based on decreased pup 

body weights and reduced postnatal survival in both generations. 

Dermal short-term (1 to 30 

days).

Dermal study 

NOAEL = 100 mg/

kg/day.

UFA = 10 x 

UFH = 10 x 

FQPA SF = 1x 

LOC for MOE = 100 Dermal Developmental Study—Rat 

LOAEL = 250 mg/kg/day based on decreased fetal body 

weight; increased incidences of fetal skeletal variations: hypoplastic or wavy ribs, incompletely ossified lumbar vertebral 

arches, and incompletely ossified ischia or pubes; and reduced number of thoracic vertebral and rib ossification sites. 

Short-term (1–30 days) inhalation.Portal-of-entry 

NOAEL = 0.256 

mg/L, HEC = 

0.054 mg/L, HED 

= 1.55.

mg/kg/day UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 30 .. Portal-of-entry LOAEL = 1.71 mg/L based on an increased incidence of minimal nasal respiratory epithelial hyperplasia in 

male and female rats. 

Cancer (Oral, dermal, inhalation).Sulfentrazone is classified as not likely to be carcinogenic to humans 

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

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). HEC = human-equivalent concentration. HED = human-equivalent dose. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sulfentrazone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing sulfentrazone tolerances in 40 

CFR 180.498. EPA assessed dietary 

exposures from sulfentrazone 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 sulfentrazone, and EPA performed 

separate acute risk assessments for 

females 13 to 49 years old and for the 

general population, including infants 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations 54623 

and children, based on different 

endpoints and acute population 

adjusted doses (aPADs). In estimating 

acute dietary exposures, EPA used the 

Dietary Exposure Evaluation Model, 

Food Consumption Intake Database 

(DEEM–FCID, ver. 3.16), which 

incorporates consumption data from 

United States Department of Agriculture 

(USDA) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA; 2003– 

2008). As to residue levels in food, EPA 

assumed tolerance-level residues, 100 

percent crop treated (PCT), and DEEM 

(ver. 7.81) default processing factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used DEEM–FCID, ver. 3.16, which 

incorporated consumption data from the 

USDA’s NHANES/WWEIA; 2003–2008. 

As to residue levels in food, EPA 

assumed tolerance-level residues, 100 

PCT, and DEEM (ver. 7.81) default 

processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that sulfentrazone 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 PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for sulfentrazone. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for sulfentrazone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

sulfentrazone. 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 Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of 

sulfentrazone for acute exposures are 

estimated to be 37.3 parts per billion 

(ppb) for surface water and 134 ppb for 

ground water; and for chronic exposures 

for non-cancer assessments are 

estimated to be 5.3 ppb for surface water 

and 98 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 134 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 98 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). 

Sulfentrazone is currently registered for 

the following uses that could result in 

residential exposures: Residential home 

lawns/turf and recreational turf, such as 

golf courses. EPA assessed residential 

exposures using the following 

assumptions: Adults were assessed for 

potential short-term dermal and 

inhalation handler exposures from 

applying sulfentrazone to residential 

turf/home lawns and for short-term 

postapplication dermal exposure from 

contact with treated residential and 

recreational turf. 

Children, ages 11 < 16 years old and 

6 < 11 years old, were assessed for 

postapplication dermal exposure from 

contact with treated residential and 

recreational turf (home lawns and golf 

courses). Children, ages 1 < 2 years old, 

were assessed for postapplication shortterm dermal and incidental oral 

exposures (hand-to-mouth, object-tomouth, and episodic ingestion of 

granules), as well as short- and 

intermediate-term incidental oral soil 

ingestion scenarios from contact with 

residential turf/home lawns. 

The recommended adult residential 

exposure scenario for use in the 

aggregate assessment reflects short-term 

dermal exposure from applications to 

turf via backpack sprayer. The 

recommended residential exposure 

scenario for use in the combined shortand intermediate-term aggregate 

assessment for children ages 1 < 2 years 

old reflects dermal and hand-to-mouth 

exposures from postapplication 

exposure to turf applications. This 

combination should be considered a 

protective estimate of children’s 

exposure to pesticides used on turf 

since the incidental oral scenarios are 

considered inter-related, likely 

occurring interspersed amongst each 

other across time; therefore, combining 

these scenarios would be overlyconservative because of the conservative 

nature of each individual assessment. In 

addition, the only potential 

intermediate-term exposure is 

postapplication soil ingestion which is 

significantly less than short-term handto-mouth exposure. Further, this 

scenario is considered protective of 

potential post-application exposures to 

children, ages 6 < 11 and 11 < 16 years 

old, as children 1–2 years old represent 

the population subgroup for children 

with the greatest exposure, and is 

therefore considered protective of other 

children population subgroups. 

Chronic exposures are not expected 

and were not assessed. Finally, 

residential handler and/or 

postapplication inhalation risk 

estimates were not combined with 

dermal or oral risk estimates in the 

aggregate risk assessment since the 

toxicological effects in the inhalation 

toxicological study were portal-of-entry 

and were different from those seen in 

the dermal and oral toxicological 

studies. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

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 sulfentrazone to share a common 

mechanism of toxicity with any other 

substances, and sulfentrazone does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

sulfentrazone 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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

mstockstill on DSK4VPTVN1PROD with RULES

54624 Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is evidence of increased 

quantitative susceptibility following in 

utero exposure in the oral and dermal 

rat developmental toxicity studies. 

Developmental effects, including 

decreased fetal body weights and 

reduced/delayed skeletal ossifications, 

were observed at doses that were not 

maternally toxic. In the 2-generation 

reproduction study in rats, offspring 

effects such as decreased body weights 

and decreased litter survival were 

observed at a slightly maternally toxic 

dose (slightly decreased body weight 

gain), indicating possible slightly 

increased qualitative susceptibility. 

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 

sulfentrazone is complete. 

ii. In the ACN and SCN studies, 

observed effects included changes in 

motor activity and FOB parameters, 

clinical signs, and body-weight 

decrements. There is low concern for 

neurotoxicity since: 

1. Effects were seen at relatively high 

doses; 

2. Effects occurred in the absence of 

neuropathology; 

3. There is no evidence of 

neurotoxicity in other available studies 

in the toxicity database; 

4. Effects are well-characterized with 

clearly established NOAEL/LOAEL 

values; and 

5. The selected PODs are protective of 

these effects. 

iii. There was evidence for increased 

quantitative susceptibility following 

oral and dermal exposures in the 

developmental toxicity studies in rats. 

Although developmental toxicity was 

observed at lower doses than maternal 

toxicity in both studies in the rat, the 

concern is low based on the following 

considerations: 

1. The toxicology database for 

assessing pre- and postnatal 

susceptibility is complete; 

2. There are clear NOAELs and 

LOAELs for the developmental effects 

observed via both the oral and dermal 

routes; 

3. The PODs used for assessing 

dietary and dermal exposure risks are 

based on developmental and/or 

offspring toxicity; 

4. The portal-of-entry effects seen in 

the 26-day inhalation study are 

protective of the developmental toxicity; 

and 

5. There are no residual uncertainties 

for pre- and/or postnatal toxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to sulfentrazone 

in drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by sulfentrazone. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to sulfentrazone 

will occupy 6.7% of the aPAD for 

females 13–49 years old, and 1.1% of 

the aPAD for all infants less than 1 year 

old, the population group receiving the 

greatest exposure for all populations 

other than females 13–49 years old. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to sulfentrazone 

from food and water will utilize 7.1% 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 sulfentrazone is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Sulfentrazone is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to sulfentrazone. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 480 for adults. 

Because EPA’s level of concern for 

sulfentrazone is a MOE of 100 or below, 

this MOE is not of concern. 

4. Short- and intermediate-term risk. 

Combined short- and intermediate-term 

aggregate exposures take into account 

short- and intermediate-term residential 

exposures plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

Sulfentrazone is currently registered for 

uses that could result in short- and 

intermediate-term residential exposures, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures to sulfentrazone. 

Using the exposure assumptions 

described in this unit for combined 

short- and intermediate-term exposures, 

EPA has concluded that the combined 

short- and intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 260 for children 

1–2 years old, the population subgroup 

for children with the greatest exposure. 

Because EPA’s level of concern for 

sulfentrazone is a MOE of 100 or below, 

this MOEs are not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

chemical name is not expected to pose 

a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

sulfentrazone residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

gas chromatography (GC), is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations 54625 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for sulfentrazone. 

C. Response to Comments 

EPA received one comment to the 

Notice of Filing that made a general 

objection to the presence of any 

sulfentrazone residues on apple or any 

other crop. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned on 

agricultural crops. However, the existing 

legal framework provided by section 

408 of the FFDCA states that tolerances 

may be set when persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. This citizen’s comment appears 

to be directed at the underlying statute 

and not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. The Agency has 

concluded after this assessment, that 

there is a reasonable certainty that no 

harm will result from aggregate human 

exposure to sulfentrazone. 

D. Revisions to Petitioned-For 

Tolerances 

EPA was petitioned to establish a 

tolerance in or on apple for residues of 

sulfentrazone and its metabolite HMS; 

however, upon review of the data 

supporting the petition, the Agency has 

determined that the apple tolerance 

should be established on the combined 

residues of the free and conjugated 

forms of sulfentrazone, including its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone. EPA 

previously reviewed metabolism data 

and determined that the residues of 

concern are the parent compound, 

sulfentrazone, and the metabolites HMS 

and DMS (free and conjugated) in all 

crops except soybean seed, where the 

residues of concern are sulfentrazone 

and the metabolite HMS. Samples of 

raw agricultural and processed 

commodities from the apple studies 

were analyzed for residues of 

sulfentrazone and its metabolites DMS 

and HMS, and EPA is establishing an 

apple tolerance based upon those 

analyses. 

V. Conclusion 

Therefore, tolerances are established 

for residues of sulfentrazone, (N-[2,4- 

dichloro-5-[4-(difluoromethyl)-4,5- 

dihydro-3-methyl-5-oxo-1H-1,2,4- 

triazol-1- 

yl]phenyl]methanesulfonamide), and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone, in or on 

apple at 0.15 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 

mstockstill on DSK4VPTVN1PROD with RULES

54626 Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Rules and Regulations 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 4, 2014. 

Lois Rossi, 

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. In § 180.498, add alphabetically the 

following commodity to the table in 

paragraph (a)(2) to read as follows: 

§ 180.498 Sulfentrazone; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

Apple ..................................... 0.15 

* * * * * 

* * * * * 

[FR Doc. 2014–21807 Filed 9–11–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

48 CFR Parts 1201 and 1202 

[Docket No. OST–2014–0119] 

RIN 2105–AE34 

Organization and Delegation of Powers 

and Duties in the Transportation 

Acquisition Regulation 

AGENCY: Office of the Secretary (OST), 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This rule amends the 

Transportation Acquisition Regulation 

(TAR) to reflect the elevation of the 

Research and Innovative Technology 

Administration into the Office of the 

Secretary, creating the Office of the 

Assistant Secretary for Research and 

Technology. The amendment to TAR 

allows the Assistant Secretary for 

Research and Technology to have the 

same authority as the former Research 

and Innovative Technology 

Administrator. The change provides the 

Office of the Assistant Secretary for 

Research and Technology (formerly the 

Research and Innovative Technology 

Administration) the same authority as 

an Operating Administration, and 

provides the Assistant Secretary for 

Research and Technology to have the 

same authority as a Head of an 

Operating Administration. 

DATES: This rule is effective September 

12, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Lenita Ahmadi, Office of the Senior 

Procurement Executive, M–61, 1200 

New Jersey Ave. SE., Washington, DC 

20950, (202) 366–4974. 

SUPPLEMENTARY INFORMATION: This final 

rule reflects changes made in Public 

Law 113–76, Division L, Title I— 

Department of Transportation, which 

states, ‘‘Notwithstanding section 102 of 

title 49 and section 5315 of title 5, 

United States Code, there shall be an 

Assistant Secretary for Research and 

Technology within the Office of the 

Secretary, appointed by the President 

with the advice and consent of the 

Senate, to lead such office: Provided 

further, that any reference in law, 

regulation, judicial proceedings, or 

elsewhere to the Research and 

Innovative Technology Administration 

shall be deemed to be a reference to the 

Office of the Assistant Secretary for 

Research and Technology of the 

Department of Transportation.’’ 

Accordingly, the Transportation 

Acquisition Regulation (TAR) has been 

revised to update references of the 

Research and Innovative Technology 

Administration to references of the 

Assistant Secretary for Research and 

Technology. This rule also provides for 

the Assistant Secretary for Research and 

Technology to have the same authority 

under TAR as the former Research and 

Innovative Technology Administrator. 

A. Background 

The U.S. Department of 

Transportation (DOT) has determined 

that changes to TAR are necessary to 

implement and align it with the 

Consolidated Appropriations Act, 2014. 

These changes are necessary in order to 

update references to the Research and 

Innovative Technology Administration 

(RITA) by replacing them with 

references to the Office of the Assistant 

Secretary for Research and Technology 

(OST–R). The changes are also 

necessary to ensure that the Assistant 

Secretary of OST–R continues to 

exercise the same authority under TAR 

as the Administrator of the former RITA. 

B. Public Participation 

This final rule does not impose new 

substantive requirements. It simply 

updates the CFR to reflect changes made 

by other law and represent the current 

organizational posture of the 

Department with regard to the Office of 

the Assistant Secretary for Research and 

Technology. The final rule is ministerial 

in nature and relates only to 

Departmental management, procedure, 

and practice. Therefore, the Department 

has determined that notice and 

comment are unnecessary and that the 

rule is exempt from prior notice and 

comment requirements under 5 U.S.C. 

553(b)(3)(A). This rule will not have a 

substantive impact on the public, as it 

is purely organizational. Therefore, the 

Department finds that there is good 

cause under 5 U.S.C. 553(d)(3) to make 

this rule effective less than 30 days after 

publication in the Federal Register. 

C. Regulatory Analysis and Notices 

1. Executive Order 12866 (Regulatory 

Planning and Review), Executive Order 

13563 (Improving Regulation and 

Regulatory Review), and DOT 

Regulatory Policies and Procedures 

The DOT has considered the impact 

of this rulemaking action under 

Executive Orders 12866 and 13563 

(January 18, 2011, ‘‘Improving 

Regulation and Regulatory Review’’), 

and the DOT’s regulatory policies and 

procedures (44 FR 11034; February 26, 

1979). The Department has determined 

that this rule is not a significant 

regulatory action, and therefore, was not 

subject to review by the Office of 

Management and Budget under 

Executive Order 12866. There are no 

costs associated with this rule. The rule 

updates references to RITA to reflect its 

elevation into the Office of the Secretary 

as OST–R. 

2. Executive Order 13132 (Federalism) 

The Department has analyzed this 

final rule under the principals and 

criteria contained in Executive Order 

13132, dated August 4, 1999, and it has 

been determined that it does not have a 

substantial direct effect on, or sufficient 

federalism implications for, the States, 

nor would it limit the policymaking 

discretion of the States. Therefore, the 

preparation of a Federalism Assessment 

is not necessary. 

3. Regulatory Flexibility Act 

Because no notice of proposed 

rulemaking is required for this rule 

under the Administrative Procedure 

Act, 5 U.S.C. 553, the provisions of the 

Regulatory Flexibility Act (Pub. L. 96– 

354, 5 U.S.C. 601–612) do not apply. 

Even so, DOT has evaluated the effects 

of these changes on small entities and 

does not believe that this rule would 

impose any costs on small entities as it 

merely revises and clarifies TAR. 

Therefore, I hereby certify that this final 

rule does not have a significant 

mstockstill on DSK4VPTVN1PROD with RULES