Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Rules and Regulations 28843 

Pesticide chemical CAS Reg. No. Limits 

Heptyl alcohol ............................................ 111–70–6 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Hexanal ..................................................... 66–25–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Hexanoic acid ............................................ 142–62–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

n-Hexanol .................................................. 111–27–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

(Z)-3-Hexenol ............................................ 928–96–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

(Z)-3-Hexenol acetate ............................... 3681–71–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Hexyl acetate ............................................ 142–92–7 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Lauric acid ................................................. 143–07–7 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Lauric aldehyde ......................................... 112–54–9 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Lauryl alcohol ............................................ 112–53–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

d-Limonene ............................................... 5989–27–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Methyl-a-ionone ........................................ 127–42–4 When ready for use, the end-use concentration is not to exceed 100 ppm.

3-Methyl-2-butenyl acetate ........................ 1191–16–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

2-Methylundecanal .................................... 110–41–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Myristaldehyde .......................................... 124–25–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Myristic acid .............................................. 544–63–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Neryl acetate ............................................. 141–12–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Nonanal ..................................................... 124–19–6 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Nonanoic acid ........................................... 112–05–0 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Nonyl alcohol ............................................. 143–08–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Octanal ...................................................... 124–13–0 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Octanoic acid ............................................ 124–07–2 When ready for use, the end-use concentration is not to exceed 100 ppm. 

1-Octanol ................................................... 111–87–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Palmitic acid .............................................. 57–10–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Propionic acid ............................................ 79–09–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Stearic acid. .............................................. 57–11–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

2-Tridecanal .............................................. 7774–82–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

3,5,5-Trimethylhexanal .............................. 5435–64–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Undecanal ................................................. 112–44–7 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Undecyl alcohol ......................................... 112–42–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Valeraldehyde ........................................... 110–62–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Valeric acid ................................................ 109–52–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

* * * * * 

[FR Doc. 2015–11959 Filed 5–19–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0340; FRL–9926–62] 

Trinexapac-ethyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of trinexapacethyl in or on multiple commodities 

which are identified and discussed later 

in this document. Syngenta Crop 

protection LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

20, 2015. Objections and requests for 

hearings must be received on or before 

July 20, 2015, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

mstockstill on DSK4VPTVN1PROD with RULES

28844 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Rules and Regulations 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0340, 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: 

Susan Lewis, 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 Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&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–2014–0340 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 July 20, 2015. 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– 

2014–0340, 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 August 1, 

2014 (79 FR 44731) (FRL–9911–67), 

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 4F8254) by 

Syngenta Crop Protection, LLC, P.O. 

Box 18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.662 

be amended by establishing tolerances 

for residues of the plant growth 

regulator trinexapac-ethyl, (4- 

(cyclopropyl-a-hydroxy-methylene)-3,5- 

dioxo-cyclohexanecarboxylic acid ethyl 

ester), and its primary metabolite CGA– 

179500 in or on rice, bran at 1.5 parts 

per million (ppm); rice, grain at 0.4 

ppm; rice, straw at 0.07 ppm; rice, wild, 

grain at 0.4 ppm; rye, bran at 2.5 ppm; 

rye, grain at 2.0 ppm; rye, hay at 0.8 

ppm; and rye, straw at 0.4 ppm. That 

document referenced a summary of the 

petition prepared by Syngenta Crop 

Protection LLC, 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 

modified the proposed tolerances on rye 

commodities to rye, bran at 6.0 ppm; 

rye, grain at 4.0 ppm; rye, hay at 1.5 

ppm; and rye, straw at 0.9 ppm. The 

reason for these changes are explained 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for trinexapac-ethyl 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with trinexapac-ethyl 

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 

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Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Rules and Regulations 28845 

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. 

Trinexapac-ethyl exhibits low acute 

toxicity as shown in the standard acute 

toxicity battery as well as in the acute 

neurotoxicity study in rats with no 

systemic or neurotoxic effects up to the 

limit dose. The dog appears to be the 

most sensitive species while no 

systemic adverse effects were seen in 

rats, rabbits, or mice up to the limit dose 

(1,000 milligram/kilogram/day (mg/kg/

day)) following subchronic or chronic 

oral exposure. In the dogs; however, 

decreased body weight gain and food 

consumption, diffuse thymic atrophy, 

and changes in the epithelial cells of the 

renal tubules were seen in the 90-day 

dog study at 516/582 mg/kg/day (males/ 

females). Following chronic exposure, 

dose-related neuropathology of the brain 

characterized as focal bilateral 

vacuolation of the dorsal medial 

hippocampus and/or lateral midbrain 

was seen at ≥365/357 mg/kg/day in male 

and female dogs, respectively. The 

lesions remained confined to the 

supporting cells in the central nervous 

system and did not progress to more 

advanced or more extensive damage of 

the nervous tissue. These lesions were 

not associated with other 

neuropathological findings or overt 

neurological signs, so their biological 

significance is unknown. Similar lesions 

were not observed in the rat or mouse 

following subchronic or chronic dietary 

exposure, and there was no other 

evidence in any other species tested to 

indicate a neurotoxicity potential. 

Furthermore, the brain lesions observed 

in the chronic dog study are not likely 

to develop from a short-term exposure 

and were not observed in either the rat 

or mouse short-term studies. In support 

of these findings, no evidence of 

neurotoxicity in the acute or subchronic 

rat neurotoxicity studies was found. 

In the rat and rabbit developmental 

toxicity studies, there is evidence of 

increased qualitative and quantitative 

susceptibility in the rat (increased 

incidence of asymmetrical sternebrae at 

the limit dose) and rabbit (decreased 

number of live fetuses/litter and 

increased post-implantation loss and 

early resorption at 360 mg/kg/day) in 

the absence of maternal toxicity. 

Qualitative sensitivity was observed in 

the 2-generation reproduction study but 

only in excess of the limit dose (1,212 

mg/kg/day). The decreased pup survival 

when analyzed with sexes combined, 

resulted in statistical significance (5– 

7%); this finding was not significant 

when the data were analyzed separately. 

Further evaluation of the individual 

litters suggested that one or two litters 

were the cause of the reduced pup 

survival at the highest dose tested. 

Reproductive toxicity was not observed 

up to the limit dose. There was also no 

indication of immunotoxicity in mice 

up to the limit dose. 

Data from the combined chronic 

toxicity/carcinogenicity study in the rat 

did not demonstrate an increase in any 

tumor type that would be relevant to 

humans. The observation of squamous 

cell carcinomas in the non-glandular 

portion of the stomach of two males at 

806 mg/kg/day does not provide 

reasonable evidence of a possible 

deleterious effect of trinexapac-ethyl on 

the pharynx and/or esophagus (nonglandular areas) of the human. This is 

because trinexapac-ethyl would not be 

in contact with human tissues for a 

significant period of time compared to 

the length of time it was in contact with 

the non-glandular portion of the rat 

stomach. Follicular adenocarcinomas of 

the thyroid were significantly increased 

in males (5%) at 806 mg/kg/day but this 

value was within the historical control 

range. In the mouse, there was no 

evidence of carcinogenicity. The 

mutagenicity database is complete, with 

no evidence of mutagenicity. The cancer 

classification for trinexapac-ethyl is 

‘‘Not Likely to be Carcinogenic to 

Humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by trinexapac-ethyl as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Trinexapac-ethyl: Human Health Risk 

Assessment to Support New Uses on 

Rice and Rye’’ on page 34 in docket ID 

number EPA–HQ–OPP–2014–0340. 

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 trinexapac-ethyl used for 

human risk assessment is discussed in 

Unit III B. of the final rule published in 

the Federal Register of March 2, 2012 

(77 FR 12742) (FRL–9337–9). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to trinexapac-ethyl, EPA 

considered exposure under the 

petitioned-for tolerances (as revised in 

this regulation) as well as all existing 

trinexapac-ethyl tolerances in 40 CFR 

180.662. EPA assessed dietary 

exposures from trinexapac-ethyl 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 trinexapac-ethyl. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA assumed 

that residues are present in all 

commodities at the tolerance level and 

that 100% of all commodities with 

trinexapac-ethyl tolerances are treated. 

The acute dietary exposure was only 

estimated for females 13 to 49 years old 

based on an in utero effect (decrease in 

mean number of fetuses/litter and an 

increase in post-implantation loss) 

identified in the rabbit developmental 

study. An endpoint of concern was not 

identified for the general U.S. 

population; however, the acute dietary 

assessment will ensure protection of 

women that may become pregnant. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

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28846 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Rules and Regulations 

from the USDA 2003–2008 (NHANES/

WWEIA). As to residue levels in food, 

EPA assumed that residues are present 

in all commodities at the tolerance level 

and that 100% of all commodities with 

trinexapac-ethyl tolerances are treated. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that trinexapac-ethyl does 

not pose a cancer risk to humans. 

Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for trinexapac-ethyl. 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 trinexapac-ethyl in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

trinexapac-ethyl. 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 Tier 1 Rice Model and 

Pesticide Root Zone Model Ground 

Water (PRZM GW), the estimated 

drinking water concentrations (EDWCs) 

of trinexapac-ethyl for acute exposures 

are estimated to be 31.68 parts per 

billion (ppb) for surface water and 0.116 

ppb for ground water. The EDWCs of 

trinexapac-ethyl for chronic exposures 

for non-cancer assessments are 

estimated to be 31.68 ppb for surface 

water and 0.054 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 31.68 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 31.68 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). 

Trinexapac-ethyl is currently registered 

for the following uses that could result 

in residential exposures: Residential 

lawns, athletic fields, parks, and golf 

courses. EPA assessed residential 

exposure using the following 

assumptions: That homeowner handlers 

wear shorts, short-sleeved shirts, socks, 

and shoes, and that they complete all 

tasks associated with the use of a 

pesticide product including mixing/

loading, if needed, as well as the 

application. Residential handler 

exposure scenarios for both dermal and 

inhalation are considered to be shortterm only, due to the infrequent use 

patterns associated with homeowner 

products. 

EPA uses the term ‘‘post-application’’ 

to describe exposure to individuals that 

occur as a result of being in an 

environment that has been previously 

treated with a pesticide. Trinexapacethyl can be used in many areas that can 

be frequented by the general population 

including residential areas (e.g., home 

lawns, recreational turf). As a result, 

individuals can be exposed by entering 

these areas if they have been previously 

treated. Therefore, short-and 

intermediate-term dermal postapplication exposures and risks were 

also assessed for trinexapac-ethyl. There 

is the potential for dermal and 

incidental oral exposure to children; 

however, since there is no toxicological 

endpoint of concern for that route, a 

quantitative assessment was not 

conducted. 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 trinexapac-ethyl to share a 

common mechanism of toxicity with 

any other substances, and trinexapacethyl does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that trinexapac-ethyl 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 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Evidence of increased qualitative and/or 

quantitative susceptibility of the 

offspring was seen only at high doses in 

the developmental rat and rabbit 

studies, and in the rat reproduction 

study. Developmental toxicity in the rat 

was only observed at the limit dose 

(increased incidence of asymmetrical 

sternebrae at 1,000 mg/kg) in the 

absence of maternal toxicity. In the 

rabbit, no maternal toxicity was 

demonstrated at the highest dose tested 

(360 mg/kg/day), but there was a 

decrease in the mean number of fetuses/ 

litter and an increase in postimplantation loss and early resorptions 

at this dose level. 

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 trinexapacethyl is complete. 

ii. There is no indication that 

trinexapac-ethyl is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional Uncertainty Factor’s to 

account for neurotoxicity. 

iii. Although, there is evidence of 

susceptibility in the rat and rabbit 

developmental studies and qualitative 

susceptibility in the 2-generation rat 

reproduction study, these effects only 

occurred at the highest doses tested for 

each study, and there were clearly 

identified NOAELs/LOAELs for the 

rabbit developmental study, the rat 

developmental study and for the 

reproduction study for each fetal/

offspring effect. Therefore, there are no 

residual concerns with respect to 

developmental and reproductive effects. 

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Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Rules and Regulations 28847 

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 trinexapacethyl 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 trinexapac-ethyl. 

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. Therefore, acute aggregate risk is 

equivalent to the acute dietary risk as 

discussed in Unit III.C.1.i. All risk 

estimates are below EPA’s level of 

concern. The acute dietary exposure 

estimate for females 13 to 49 years old 

will only utilize 2% of the aPAD, which 

is well below the Agency’s level of 

concern (100% of the aPAD). 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to trinexapacethyl from food and water will utilize 

6% of the cPAD for children 1 to 2 years 

old, the population group receiving the 

greatest exposure. 

3. Short- and intermediate-term risk: 

Short- and immediate-term aggregate 

exposure take into account short-term 

and intermediate-term residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

Trinexapac-ethyl is currently registered 

for uses that could result in short- and 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term and intermediate-term 

residential exposures to trinexapacethyl. The short- and intermediate-term 

toxicological endpoints for trinexapacethyl are the same for each route of 

exposure. Therefore, for residential 

exposure scenarios, only short-term 

exposures were assessed, and are 

considered to be protective of 

intermediate-term exposure and risk. 

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 aggregate 

MOEs of 4500 for children 11–16 years 

old and 230 for adult females. Because 

EPA’s level of concern for trinexapacethyl is a MOE of 100 or below, these 

MOEs are not of concern. 

4. 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. 

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 trinexapacethyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Method GRM020.01A, which utilizes 

high performance liquid 

chromatography with triple-quadrupole 

mass spectrometry (LC–MS/MS) is 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for trinexapac-ethyl. 

C. Revisions to Petitioned-For 

Tolerances 

EPA revised the petitioned-for 

tolerances on rye which were 

determined by extrapolating from 

residue data on barley. EPA concurs 

with translating from the existing cereal 

grains, however, from a residue 

perspective, rye is more similar to wheat 

than to barley. Since the tolerances for 

wheat commodities are higher than the 

tolerances for barley commodities, EPA 

has revised the tolerances for rye to be 

consistent with the wheat tolerances. 

The use of the higher wheat tolerances 

also represents a more conservative 

(protective) approach for assessing risk 

from total residues. 

V. Conclusion 

Therefore, tolerances are established 

for residues of trinexapac-ethyl, (4- 

(cyclopropyl-a-hydroxy-methylene)-3,5- 

dioxo-cyclohexanecarboxylic acid ethyl 

ester), and the associated metabolite 

trinexapac, (4- 

(cyclopropylhydroxymethylene)-3,5- 

dioxocyclohexanecarboxylic acid), 

calculated as the stoichiometric 

equivalent of trinexapac-ethyl, in or on 

rice, bran at 1.5 ppm; rice, grain at 0.4 

ppm; rice, straw at 0.07 ppm; rice, wild, 

grain at 0.4 ppm; rye, bran at 6.0 ppm; 

rye, grain at 4.0 ppm; rye, hay at 1.5 

ppm; and rye, straw at 0.9 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

mstockstill on DSK4VPTVN1PROD with RULES

28848 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Rules and Regulations 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 8, 2015. 

G. Jeffery Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.662, is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.662 Trinexapac-ethyl; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Rice, bran ................................. 1.5 

Rice, grain ................................ 0.4 

Rice, straw ................................ 0.07 

Rice, wild, grain ........................ 0.4 

Rye, bran .................................. 6.0 

Rye, grain ................................. 4.0 

Rye, hay ................................... 1.5 

Rye, straw ................................. 0.9 

* * * * * 

* * * * * 

[FR Doc. 2015–11972 Filed 5–19–15; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 15–88; RM–11747; DA 

15–584] 

Television Broadcasting Services; 

Bend, Oregon 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Commission has before it 

a Notice of Proposed Rulemaking issued 

in response to a petition for rulemaking 

filed by TDS Broadcasting LLC (‘‘TDS’’), 

the licensee of KOHD, channel 51, 

Bend, Oregon, requesting the 

substitution of channel 18 for channel 

51 at Bend. TDS filed comments 

reaffirming its interest in the proposed 

channel substitution and stated that if 

the proposal is granted, it will promptly 

file an application for the facilities 

specified in its rulemaking petition and 

construct the station. TDS also reiterates 

that the grant of the petition would 

serve the public interest because its 

operation on channel 18 would 

eliminate potential interference to and 

from wireless operations in the Lower 

700 MHZ A Block located adjacent to 

channel 51 in Portland, Oregon market, 

permitting the wireless licensee to 

expand service to additional consumers 

sooner than would otherwise be 

possible. 

DATES: This rule is effective May 20, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Bernstein, Joyce.Bernstein@

fcc.gov, Media Bureau, (202) 418–1647. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MB Docket No. 15–88, 

adopted May 14, 2015, and released 

May 14, 2015. The full text of this 

document is available for public 

inspection and copying during normal 

business hours in the FCC’s Reference 

Information Center at Portals II, CY– 

A257, 445 12th Street SW., Washington, 

DC 20554. This document will also be 

available via ECFS (http://

fjallfoss.fcc.gov/ecfs/). To request 

materials in accessible formats for 

people with disabilities (braille, large 

print, electronic files, audio format), 

send an email to fcc504@fcc.gov or call 

the Consumer & Governmental Affairs 

Bureau at 202–418–0530 (voice), 202– 

418–0432 (tty). 

This document does not contain 

information collection requirements 

subject to the Paperwork Reduction Act 

of 1995, Public Law 104–13. In addition, 

therefore, it does not contain any 

information collection burden ‘‘for 

small business concerns with fewer than 

25 employees,’’ pursuant to the Small 

Business Paperwork Relief Act of 2002, 

Public Law 107–198, see 44 U.S.C. 

3506(c)(4). Provisions of the Regulatory 

Flexibility Act of 1980 do not apply to 

this proceeding. 

The Commission will send a copy of 

this Report and Order in a report to be 

sent to Congress and the Government 

Accountability Office pursuant to the 

Congressional review Act, see 5 U.S.C. 

801(a)(1)(A). 

List of Subjects in 47 CFR Part 73 

Television. 

Federal Communications Commission. 

Barbara A. Kreisman, 

Chief, Video Division, Media Bureau. 

Final Rule 

For the reasons discussed in the 

preamble, the Federal Communications 

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