12740 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 

Commodity Parts per 

million 

Cattle, meat byproducts ......... 0 .04 

Citrus, dried pulp .................... 0 .60 

Coffee, bean, green 1 ............. 0 .05 

Corn, field, forage ................... 0 .10 

Corn, field, stover ................... 0 .05 

Corn, pop, forage ................... 0 .10 

Corn, pop, stover .................... 0 .05 

Corn, sweet, forage ................ 0 .10 

Corn, sweet, kernel plus cob 

with husks removed ............ 0 .02 

Corn, sweet, stover ................ 0 .05 

Cotton, gin byproducts ........... 1 .5 

Cotton, undelinted seed ......... 0 .10 

Crambe, seed ......................... 0 .02 

Cranberry ................................ 0 .02 

Flax, seed ............................... 0 .02 

Food commodities and feed 

commodities (other than 

those covered by a higher 

tolerance as a result of use 

on growing crops) in food/ 

feed handling establishments .................................. 0 .02 

Fruit, citrus, group 10 ............. 0 .40 

Fruit, pome, group 11 ............. 0 .2 

Fruit, small, vine climbing, 

subgroup 13–07F, except 

fuzzy kiwifruit ....................... 0 .20 

Fruit, stone, group 12 ............. 0 .5 

Goat, meat .............................. 0 .02 

Goat, meat byproducts ........... 0 .04 

Grain, aspirated fractions ....... 2 .0 

Grain, cereal, group 15, except barley .......................... 0 .02 

Grape, raisin ........................... 0 .30 

Hog, meat ............................... 0 .02 

Hog, meat byproducts ............ 0 .02 

Hop, dried cones .................... 0 .10 

Horse, meat ............................ 0 .02 

Horse, meat byproducts ......... 0 .04 

Mango ..................................... 0 .40 

Milk ......................................... 0 .02 

Millet, pearl, forage ................. 0 .02 

Millet, pearl, stover ................. 0 .02 

Millet, proso, forage ................ 0 .02 

Millet, proso, stover ................ 0 .02 

Millet, proso, straw ................. 0 .02 

Oat, forage .............................. 0 .50 

Oat, hay .................................. 0 .02 

Oat, straw ............................... 0 .02 

Peanut .................................... 0 .05 

Peanut, hay ............................ 0 .25 

Peanut, meal .......................... 0 .15 

Peppermint, tops .................... 1 .5 

Pistachio ................................. 0 .02 

Potato ..................................... 0 .25 

Radish, tops ............................ 0 .80 

Rapeseed, seed ..................... 0 .02 

Rye, forage ............................. 0 .50 

Rye, straw ............................... 0 .02 

Sapodilla ................................. 0 .40 

Sapote, black .......................... 0 .40 

Sapote, mamey ...................... 0 .40 

Sheep, meat ........................... 0 .02 

Sheep, meat byproducts ........ 0 .04 

Sorghum, forage ..................... 0 .02 

Sorghum, grain, stover ........... 0 .02 

Soybean, hulls ........................ 0 .08 

Spearmint, tops ...................... 1 .5 

Star apple ............................... 0 .40 

Sunflower ................................ 0 .02 

Tomato, paste ......................... 0 .80 

Vegetable, cucurbit, group 9 .. 0 .2 

Commodity Parts per 

million 

Vegetable, fruiting, group 8 .... 0 .25 

Vegetable, leafy, except brassica, group 4 ....................... 4 .0 

Vegetable, legume, group 6 ... 0 .02 

Vegetable, root, subgroup 1A 0 .05 

Vegetable, tuberous and 

corm, except potato, subgroup 1D ............................. 0 .02 

Wheat, forage ......................... 0 .50 

Wheat, hay ............................. 0 .02 

Wheat, straw ........................... 0 .02 

1There are no U.S. registrations as of September 17, 2003. 

* * * * * 

[FR Doc. 2012–4983 Filed 3–1–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0524; FRL–9337–9] 

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, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 2, 2012. Objections and requests 

for hearings must be received on or 

before May 1, 2012, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0524. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; email address: 

benbow.bethany@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. To access the 

OCSPP test guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 


rmajette on DSK2TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 12741 

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–2010–0524 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 May 1, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0524, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 4, 

2010, (75 FR 46925) (FRL–8834–9), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of two 

pesticide petitions (PP 0F7719 and 

0F7720) by Syngenta Crop Protection, 

Inc., P.O. Box 18300, Greensboro, NC 

27419. Petition 0F7719 requested that 

40 CFR part 180 be amended by 

establishing tolerances for residues of 

the plant growth regulator, trinexapacethyl and its primary metabolite CGA– 

179500, in or on grass, forage, grown for 

seed at 1.60 parts per million (ppm); 

grass, hay, grown for seed at 3.5 ppm; 

grass, seed screenings, grown for seed at 

45.0 ppm; grass, straw, grown for seed 

at 12 ppm; cattle (fat, meat, meat 

byproducts) at 0.05 ppm; goat (fat, meat, 

meat byproducts) at 0.05 ppm; horse 

(fat, meat, meat byproducts) at 0.05 ppm 

and sheep (fat, meat, meat byproducts) 

at 0.05 ppm. Petition 0F7720 requested 

that 40 CFR part 180 be amended by 

establishing tolerances for residues in or 

on barley, grain at 1.6 ppm; barley, hay 

at 0.7 ppm; barley, straw at 0.35 ppm; 

cattle, kidney at 0.05 ppm; hog, kidney 

at 0.05 ppm; oat, forage at 1.0 ppm; oat, 

grain at 4.1 ppm; oat, hay at 1.3 ppm; 

oat, straw at 0.7 ppm; sugarcane, cane 

at 0.8 ppm; wheat, forage at 1.0 ppm; 

wheat, grain at 4.1 ppm; wheat, hay at 

1.3 ppm and wheat, straw at 0.7 ppm. 

That notice referenced a summary of 

the petitions prepared by Syngenta Crop 

Protection, Inc., the registrant, which is 

available in the docket, http:// 

www.regulations.gov. 

Based upon review of the data 

supporting the petition, EPA has revised 

most of the proposed tolerance levels, 

added tolerances for hog fat and meat, 

and deleted the proposed tolerance for 

cattle kidney. The reasons for these 

changes are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * * ’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 

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. 

The acute toxicity of trinexapac-ethyl 

is low via the oral, eye, dermal, or 

inhalation routes of exposure, and it is 

not a dermal sensitizer. 

In adult animals (rats, rabbits, mice, 

dogs), no systemic adverse effects are 

seen below the limit dose following 

subchronic or chronic oral exposure 

with the exception of dogs. The 90-day 

subchronic dog study showed decreased 

body weight gain and food 

consumption, diffuse thymic atrophy, 

and changes in the epithelial cells of the 

renal tubules at 516/582 milligrams/ 

kilogram/day (mg/kg/day) (males/ 

females). Following chronic exposure, 

dose-related neuropathology of the brain 

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. They 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 

acute, 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 were not 

observed in the sub-chronic dog study 

up to 890 mg/kg/day and are thus not 

likely to develop from a short-term 

exposure. 

Evidence of increased qualitative and 

quantitative susceptibility to offspring 

exists at or above the limit dose of the 

developmental and reproduction 

studies. Developmental toxicity was 

observed in the rat (increased incidence 

of asymmetrical sternebrae) and rabbit 

(decreased number of live fetuses/litter 

and increased post-implantation loss) at 

the highest dose tested, with no 

evidence of maternal toxicity observed 

in either species. In the rat reproduction 

study, reproductive toxicity was not 

observed, but decreased pup survival 


rmajette on DSK2TPTVN1PROD with PROPOSALS
12742 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 

and decreased pup body weight/bodyweight gain during lactation were 

observed above the limit dose with only 

reduced body weight and food 

consumption observed in the parental 

animals (>1,200 mg/kg/day). 

Trinexapac-ethyl is classified as ‘‘Not 

likely to be carcinogenic to humans.’’ 

The combined chronic toxicity/ 

carcinogenicity study in the rat did not 

demonstrate an increase in any tumor 

type that would be relevant to humans. 

In the mouse, there was no evidence of 

carcinogenicity. The mutagenicity 

database is also complete, with no 

evidence of mutagenicity. 

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 and the lowest-observed-adverseeffect-level from the toxicity studies can 

be found at http://www.regulations.gov 

in the document, ‘‘Trinexapac-ethyl: 

Human Health Risk Assessment for the 

Section 3 Registration Action on Cereal 

Grains, Sugarcane, and Grasses Grown 

for Seed’’ p. 48 in docket ID number 

EPA–HQ–OPP–2010–0524. 

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 (LOC) 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 (U/SF) 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 nonthreshold 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 shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRINEXAPAC-ETHYL 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 = 60 mg/ 

kg/day. 

UFA = 10×. 

UFH = 10×. 

FQPA SF = 1×. 

Acute RfD = 0.6 

mg/kg/day.

aPAD = 0.6 mg/kg/ 

day.

Developmental rabbit study. 

LOAEL = 360 mg/kg/day, based on a decrease in mean 

number of fetuses/litter and an increase in post-implantation loss. 

Acute dietary (General population including infants and children).No appropriate endpoint for the general population including infants and children 

Chronic dietary (All populations) ............ NOAEL = 31.6 mg/ 

kg/day. 

UFA = 10×. 

UFH = 10×. 

FQPA SF = 1×. 

Chronic RfD = 0.32 

mg/kg/day.

cPAD = 0.32 mg/ 

kg/day.

Chronic oral toxicity study—dog. 

LOAEL = 357 mg/kg/day, based on elevated serum cholesterol values in females, mucoid feces in females and 

bloody feces in both sexes, and minimal, focal 

vacuolation of the dorsal medial hippocampus and/or 

lateral midbrain in both sexes. 

Incidental oral (short and intermediateterm).No appropriate endpoint for the incidental oral scenario for children 

Dermal & Inhalation (short- and intermediate-term-adults only).Dermal (or oral) 

study NOAEL = 

60 mg/kg/day 

(dermal absorption rate = 

77.5%. 

UFA = 10×. 

UFH = 10×. 

FQPA SF = 1×. 

Residential ............

LOC for MOE = 

100.

Occupational 

LOC for MOE = 

100.

Developmental rabbit study. 

LOAEL = 360 mg/kg, based on a decrease in mean number of fetuses/litter and an increase in post-implantation 

loss. 

Cancer (Oral, dermal, inhalation) ........... Classification: ‘‘Not likely to be Carcinogenic to Humans’’ 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. Mg/kg/day—milligrams per day. 

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. There are no 

tolerances currently established for 

trinexapac-ethyl. 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 


rmajette on DSK2TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 12743 

occurring as a result of a 1-day or single 

exposure. In estimating acute dietary 

exposure, EPA used food consumption 

information from the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA assumed 

that residues are present in all 

commodities at the tolerance level and 

that 100% of commodities with 

tolerances are treated with trinexapacethyl. Dietary Exposure Evaluation 

Model (DEEMTM) 7.81 default 

concentration factors were used to 

estimate residues of trinexapac-ethyl in 

processed commodities. 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 is 

protective of women that may become 

pregnant. 

ii. Chronic exposure. In estimating 

chronic dietary exposure, EPA used 

food consumption information from the 

USDA 1994–1996 and 1998 CSFII. As to 

residue levels in food, EPA assumed 

that residues are present in all 

commodities at the tolerance level and 

that 100% of commodities with 

tolerances are treated with trinexapacethyl. DEEMTM 7.81 default 

concentration factors were used to 

estimate residues of trinexapac-ethyl in 

processed commodities. 

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 was not conducted. 

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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

trinexapac-ethyl for acute exposures are 

estimated to be 12.61 parts per billion 

(ppb) for surface water and 0.009 ppb 

for ground water. Chronic exposures for 

non-cancer assessments are estimated to 

be 1.56 ppb for surface water and 0.009 

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 of value of 12.61 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 1.56 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 with the 

assumption 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-term dermal 

post-application exposures and risks 

were also assessed for trinexapac-ethyl. 

There is the potential for incidental oral 

exposure; 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 

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 susceptibility to 

offspring exists at or above the limit 

dose of the developmental and 

reproduction studies. Developmental 

toxicity was observed in the rat 

(increased incidence of asymmetrical 

sternebrae) and rabbit (decreased 

number of live fetuses/litter and 

increased post-implantation loss) at the 

highest dose tested, with no evidence of 

maternal toxicity observed in either 

species. In the rat reproduction study, 

reproductive toxicity was not observed, 

but decreased pup survival and 

decreased pup body weight/bodyweight gain during lactation were 

observed above the limit dose with only 

reduced body weight and food 

consumption observed in the parental 

animals (>1,200 mg/kg/day). 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 


rmajette on DSK2TPTVN1PROD with PROPOSALS
12744 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 

were reduced to 1×. That decision is 

based on the following findings: 

i. The toxicology database for 

trinexapac-ethyl is largely complete, 

with the exception of a subchronic 

neurotoxicity study, which is a new 

data requirement under 40 CFR part 158 

for registration of a pesticide (food and 

non-food uses OPPTS 870.6200b). 

Though dose-related neuropathology of 

the brain was observed in the dog, EPA 

has concluded that there is no need for 

a developmental neurotoxicity (DNT) 

study or additional UFs to account for 

neurotoxicity for the following reasons: 

• These effects in the dog study were 

observed only at high doses (>357 mg/ 

kg/day) and with chronic exposure, and 

no associated neurological signs or other 

neuropathology were observed. 

Furthermore, the lesions remained 

confined to the supporting cells in the 

central nervous system (CNS) and did 

not progress to more advanced or more 

extensive damage of the nervous tissue. 

There are clear NOAELs/LOAELs for 

this effect; in which the NOAEL dose is 

10-fold lower than the LOAEL dose at 

which neuropathology is observed, and 

is therefore sufficiently protective. 

Furthermore, similar lesions were not 

observed in the rat or mouse following 

subchronic or chronic dietary exposure, 

and there was no other evidence in any 

species tested to indicate a 

neurotoxicity potential. 

• Results of the acute neurotoxicity 

study show no indications of 

neurotoxicy at the highest dose. 

Although subchronic inhalation data 

on trinexapac-ethyl are not available 

and an oral study was selected for 

inhalation risk assessment, the selected 

points of departure are considered 

adequately protective for all exposed 

populations. Therefore, an additional 

10x database UF was not retained for 

lack of inhalation toxicity data and 

these data are not being required. 

ii. Although there is evidence of 

susceptibility in the rat and rabbit 

developmental studies and in the rat 

reproduction study, EPA’s concern for 

these effects is low, and there are no 

residual uncertainties since the effects 

only occurred at the highest doses tested 

(360–1,200 mg/kg/day), for each study, 

and there were clearly identified 

NOAELs (60–593 mg/kg/day) for each 

fetal/offspring effect. 

iii. There are no residual uncertainties 

in the exposure database. Because the 

acute and chronic dietary exposure 

estimates were based on several 

conservative assumptions (100% of 

crops treated with residues present at 

tolerance levels, default processing 

factors and screening level drinking 

water estimates), EPA is confident that 

the dietary exposure assessments do not 

underestimate risk to the general U.S. 

population and various population 

subgroups. Similarly, EPA does not 

believe that the non-dietary residential 

exposures are underestimated because 

they are based on the conservative 

assumptions of EPA’s Draft Standard 

Operating Procedures (SOPs) for 

Residential Exposure Assessments 

(December 1997), and updates 

contained in the Science Advisory 

Council Policy 12 (February 2001) as 

well as the uses specified in the 

proposed labels. 

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 aPAD and 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. Acute aggregate risk 

takes into account exposure to residues 

in food and drinking water alone. 

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. Based on the 

residential use patterns for trinexapacethyl, chronic residential exposure to 

residues is not expected. 

3. Short- and intermediate-term risk. 

Since the short- and intermediate-term 

toxicological endpoints for trinexapacethyl are the same for each route of 

exposure, only short-term exposures 

were assessed. 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 (considered to be a 

background exposure level) with adult 

post-application dermal exposure 

estimates for trinexapac-ethyl. 

Using the exposure assumptions 

described in this unit, EPA has 

concluded the combined food, water, 

and adult post-application dermal 

exposures result in aggregate MOEs of 

761 for liquid products and 601 for 

granular products. Because EPA’s level 

of concern for trinexapac-ethyl 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, 

trinexapac-ethyl 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 U.N. 

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. 

There are no established or proposed 

Codex, Canadian, or Mexican MRLs for 

trinexapac-ethyl in or on any food or 

feed crops. 


rmajette on DSK2TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 12745 

C. Response to Comments 

An anonymous citizen objected to the 

presence of any pesticide residues on 

food. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

FFDCA contemplates that tolerances 

greater than zero 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. 

D. Revisions to Petitioned-For 

Tolerances 

Many of the proposed tolerances are 

different from the tolerances being set 

by EPA. EPA is setting different levels 

than were proposed based on EPA’s 

analysis of the field trial data using the 

Organization for Economic Cooperation 

and Development tolerance calculation 

procedures. Also, the Agency calculated 

dietary burden differently by using the 

highest residue measured in trials 

instead of the proposed tolerance level 

residues. Table 2.2.3, ‘‘Tolerance 

Summary for Trinexapac-ethyl’’ 

summarizes these differences on page 8 

of the document, ‘‘Trinexapac-ethyl: 

Human Health Risk Assessment for the 

Section 3 Registration Action on Cereal 

Grains, Sugarcane, and Grasses Grown 

for Seed’’ which is located in docket ID 

number EPA–HQ–OPP–2010–0524. 

V. Conclusion 

Therefore, tolerances are established 

for residues of trinexapac-ethyl, 

including its metabolites and 

degradates, as set forth in the regulatory 

text. Compliance with the tolerance 

levels is to be determined by measuring 

both trinexapac-ethyl, ethyl 4- 

(cyclopropylhydroxymethylene)-3,5- 

dioxocyclohexanecarboxylate and the 

associated metabolite trinexpac, 4- 

(cyclopropylhydroxymethylene)-3,5- 

dioxocyclohexanecarboxylic acid, 

calculated as the stoichiometric 

equivalent of trinexapac-ethyl. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: February 16, 2012. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.662 is added to subpart 

C to read as follows: 

§ 180.662 Trinexapac-ethyl; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the plant 

growth inhibitor, trinexapac-ethyl, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring both 

trinexapac-ethyl, ethyl 4- 

(cyclopropylhydroxymethylene)-3,5- 

dioxocyclohexanecarboxylate and the 

associated metabolite, trinexpac, 4- 

(cyclopropylhydroxymethylene)-3,5- 

dioxocyclohexanecarboxylic acid, 

calculated as the stoichiometric 

equivalent of trinexapac-ethyl, in or on 

the commodity. 

Commodity Parts per 

million 

Barley, grain ........................... 2 .0 

Barley, hay .............................. 0 .8 

Barley, straw ........................... 0 .4 

Cattle, fat ................................ 0 .02 

Cattle, meat ............................ 0 .02 

Cattle, meat byproducts ......... 0 .04 

Goat, fat .................................. 0 .02 


rmajette on DSK2TPTVN1PROD with PROPOSALS
12746 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 

Commodity Parts per 

million 

Goat, meat .............................. 0 .02 

Goat, meat byproducts ........... 0 .04 

Grass, forage .......................... 1 .5 

Grass, hay .............................. 4 .0 

Grass, seed screenings .......... 40 .0 

Grass, straw ........................... 10 .0 

Hog, fat ................................... 0 .02 

Hog, kidney ............................. 0 .03 

Hog, meat ............................... 0 .02 

Horse, fat ................................ 0 .02 

Horse, meat ............................ 0 .02 

Horse, meat byproducts ......... 0 .04 

Oat, forage .............................. 1 .0 

Oat, grain ................................ 4 .0 

Oat, hay .................................. 1 .5 

Oat, straw ............................... 0 .9 

Sheep, fat ............................... 0 .02 

Sheep, meat ........................... 0 .02 

Sheep, meat byproducts ........ 0 .04 

Sugarcane, cane .................... 0 .8 

Wheat, forage ......................... 1 .5 

Wheat, grain ........................... 4 .0 

Wheat, hay ............................. 1 .5 

Commodity Parts per 

million 

Wheat, middlings .................... 6 .5 

Wheat, straw ........................... 0 .9 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–4984 Filed 3–1–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

[Docket ID FEMA–2011–0002; Internal 

Agency Docket No. FEMA–B–1237] 

Changes in Flood Elevation 

Determinations 

Correction 

In rule document 2012–488 appearing 

on pages 1887–1889 in the issue of 

Thursday, January 12, 2012, make the 

following corrections: In the table 

appearing on pages 1888–1889, the 

column titled ‘‘Chief executive officer of 

community’’ is corrected to appear as 

set forth below. 

§ 65.4 [Corrected] 

State and county Location and 

case No. 

Date and name of newspaper where notice was 

published 

Chief executive officer of 

community 

Effective date of 

modification 

Community 

No. 

Delaware: 

Kent ............. Town of Camden 

(10–03– 

0303P).

February 18, 2011; February 25, 2011; The 

Delaware State News.

The Honorable Richard E. Maly, 

Mayor, Town of Camden, 1783 

Friends Way, Camden, DE 

19934.

June 27, 2011 ........... 100003 

Kent ............. Unincorporated 

areas of Kent 

County (10– 

03–0303P).

February 18, 2011; February 25, 2011; The 

Delaware State News.

The Honorable P. Brooks Banta, 

President, Kent County Levy 

Court, Administrative Complex, 

555 South Bay Road, Room 

243, Dover, DE 19901.

June 27, 2011 ........... 100001 

Puerto Rico: 

Puerto Rico.

Commonwealth 

of Puerto Rico 

(10–02– 

1752P).

October 13, 2011; October 20, 2011; El Nuevo 

Dia.

The Honorable Rube ́n FloresMarza ́n, Chairperson, Puerto 

Rico Planning Board, Roberto 

Sanchez Vilella Governmental 

Center, North Building, 16th 

Floor, De Diego Avenue International Baldorioty de Castro 

Avenue, San Juan, PR 00940.

October 6, 2011 ........ 720000 

Texas: 

Bexar ........... City of San Antonio (11–06– 

0604P).

November 4, 2011; November 11, 2011; The 

San Antonio ExpressNews.

The Honorable Julia ́n Castro, 

Mayor, City of San Antonio, 100 

Military Plaza, San Antonio, TX 

78205.

March 12, 2012 ......... 480045 

Bexar ........... Unincorporated 

areas of Bexar 

County (11– 

06–3419P).

November 16, 2011; November 23, 2011; The 

Daily Commercial Recorder.

The Honorable Nelson W. Wolff, 

Bexar County Judge, 101 West 

Nueva Street, 10th Floor, San 

Antonio, TX 78205.

March 22, 2012 ......... 480035 

Denton ......... Town of Flower 

Mound (11– 

06–2301P).

October 25, 2011; November 1, 2011; The 

Denton Record-Chronicle.

The Honorable Melissa D. Northern, Mayor, Town of Flower 

Mound, 2121 Cross Timbers 

Road, Flower Mound, TX 75028.

February 29, 2012 ..... 480777 

Denton ......... Unincorporated 

areas of Denton County 

(11–06– 

1910P).

October 28, 2011; November 4, 2011; The 

Denton Record-Chronicle.

The Honorable Mary Horn, Denton 

County Judge, 110 West Hickory Street, 2nd Floor, Denton, 

TX 76201.

October 21, 2011 ...... 480774 

Grimes ......... Unincorporated 

areas of 

Grimes County 

(11–06– 

2364P).

November 9, 2011; November 16, 2011; The 

Navasota Examiner.

The Honorable Betty Shiflett, 

Grimes County Judge, Grimes 

County Courthouse, 100 Main 

Street, Anderson, TX 77830.

May 2, 2012 .............. 481173 


rmajette on DSK2TPTVN1PROD with PROPOSALS