46816 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations 

EPA-APPROVED MISSOURI NONREGULATORY SIP PROVISIONS—Continued 

Name of nonregulatory SIP 

provision 

Applicable geographic or nonattainment area 

State submittal date EPA approval date Explanation 

(60) Section 128 Declaration: 

Missouri Air Conservation 

Commission Representation 

and Conflicts of Interest Provisions; Missouri Revised 

Statutes (RSMo) RSMo 

105.450, RSMo 105.452, 

RSMo 105.454, RSMo 

105.462, RSMo 105.463, 

RSMo 105.466, RSMo 

105.472, and RSMo 

643.040.2.

Statewide ................ 8/08/12 .................... 6/21/13; 78 FR 

37457 

[EPA–R07–OAR–2013–0208; FRL– 

9825–7]. 

(61) Section 110(a)(2) Infrastructure Requirements for 

the 2008 Pb NAAQS.

Statewide ................ 12/20/11 .................. 8/19/14, 79 FR 

48994 

[EPA–R07–OAR–2014–0290; FRL– 

9915–28-Region 7] This action addresses the following CAA elements: 

110(a)(2)(A), (B), (C), (D), (E), (F), (G), 

(H), (J), (K), (L), and (M). 

(62) Implementation Plan for the 

2008 Lead NAAQS.

City of 

Herculaneum, MO.

4/18/13 .................... 10/20/14, 79 FR 

62574 

[EPA–R07–OAR–2014–0448; FRL– 

9918–18-Region-7] 

[FR Doc. 2015–19092 Filed 8–5–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0441; FRL–9930–99] 

Fluazifop-P-Butyl; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends a 

tolerance for residues of fluazifop-Pbutyl in or on sweet potato, roots. 

Syngenta Crop Protection requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 6, 2015. Objections and requests 

for hearings must be received on or 

before October 5, 2015, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0441, 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 Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0441 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 October 5, 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– 

2014–0441, 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 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations 46817 

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 September 

5, 2014 (79 FR 53009) (FRL–9914–98), 

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 4F8262) by 

Syngenta Crop Protection, P.O. Box 

18300, Greensboro, NC 27419–8300. 

The petition requested that 40 CFR 

180.411 be amended by amending the 

established tolerance for residues of the 

herbicide fluazifop-P-butyl in or on 

sweet potato, roots from 0.05 parts per 

million (ppm) to 1.5 ppm. That 

document referenced a summary of the 

petition prepared by Syngenta, the 

registrant, which is available in the 

docket, http://www.regulations.gov. No 

FFDCA-related comments were received 

on the notice of filing. 

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 fluazifop-P-butyl 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluazifop-P-butyl 

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. 

Fluazifop-P-butyl is the R enantiomer 

of fluazifop-butyl [(R,S)-2-(4-((5- 

(trifluoromethyl)-2- 

pyridinyl)oxy)phenoxy)propanoic acid, 

butyl ester]. The toxicology database for 

fluazifop-P-butyl consists of studies 

conducted using fluazifop-butyl 

(racemic mixture) and its enriched Risomer, fluazifop-P-butyl. Comparison 

studies have shown similar toxicities 

from both compounds. Metabolism 

studies have been conducted in the rat 

with fluazifop-butyl, and absorption, 

excretion, and confirmatory metabolism 

studies in the dog with fluazifop-butyl, 

and hamster with fluazifop-P-butyl. 

Comparative metabolism studies in the 

rat show that both fluazifop-P-butyl and 

fluazifop-butyl mixed isomers are 

rapidly hydrolyzed to fluazifop acid and 

the [S] enantiomer is rapidly converted 

to the [R] enantiomer in the blood, 

yielding similar toxicities. In vivo, the Sisomer quickly converts to the R-isomer. 

Oral dog and female rat studies show 

similar results, while male rats show 

greater toxicity. Fluazifop-butyl is 

rapidly absorbed through the gut after 

oral dosing and the ester linkage is 

hydrolyzed to produce the fluazifop 

acid in the blood. No parent fluazifopester was detected in plasma at any 

time. Male rats show similar fluazifop 

acid excretion to the female, but 

excretion is slower, because fluazifop is 

excreted in the bile and results in a 

higher percentage in the feces. 

The liver and kidney are its target 

organs expressed for the most part as 

liver toxicity in the presence of 

peroxisome proliferation and 

exacerbation of age-related kidney 

toxicity. These data are reasonably 

consistent among the rat with fluazifopbutyl and fluazifop-P-butyl, dog with 

fluazifop-butyl, and hamster with 

fluazifop-P-butyl. Fluazifop-P-butyl 

shows similar toxicity by both the 

inhalation and oral routes. 

Although the liver and kidney were 

the organs most consistently affected, 

other findings were used as endpoints 

for selection of the points of departure. 

A rat developmental study exhibiting 

diaphragmatic hernia effects was used 

as the basis to select the acute dietary 

endpoint for females 13–49 years of age. 

The short-term incidental oral and 

children’s dermal endpoints were 

selected based upon a maternal body 

weight gain decrement exhibited in the 

developmental toxicity studies 

performed on rats. The chronic dietary 

(all populations), intermediate-term 

dermal and inhalation, as well as the 

intermediate-term incidental oral 

endpoints, were selected from the 2- 

generation reproduction study in rats. 

This study was significant in exhibiting 

decreased testes and epididymal 

weights in males, along with decreased 

uterine and pituitary weights in females. 

In regard to the short-term dermal for 

adults and inhalation endpoints used in 

this assessment, the developmental 

toxicity studies performed on rats were 

used as the basis for endpoint selection. 

These studies were notable in exhibiting 

decreased fetal weights, as well as 

hydroureter and delayed ossification 

effects. An additional endpoint was 

chosen that was specific for short-term 

dermal exposure to children, as a 

developmental effect is generally 

protective of pregnant women and 

fetuses. In this case, the maternal 

toxicity (body weight gain decrement) 

was chosen to be protective of children. 

Indications of possible neurotoxicity 

were observed in the acute 

neurotoxicity study, including clinical 

signs indicative of toxicity (reduced 

activity, decreased rearing, hunched 

posture and/or piloerection), decreased 

body temperature, and decreased motor 

activity (total distance and number of 

rearings). No signs of neurotoxicity were 

observed in the subchronic 

neurotoxicity test at doses up to 70 mg/ 

kg/day in males and 328 mg/kg/day in 

females. There was no observed 

immunotoxicity resulting from 

fluazifop-P-butyl exposure in the 

submitted study. There was no 

carcinogenicity observed in acceptable 

studies in the rat with fluazifop-butyl or 

in the hamster for fluazifop-P-butyl. The 

hamster was selected for cancer study, 

because liver peroxisome proliferation 

more closely resembled what was found 

for human liver cells. There was no 

mutagenicity observed for fluazifopbutyl or fluazifop-P-butyl. 

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46818 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations 

In a dermal absorption and 

pharmacokinetic study in humans, most 

of the applied dose appeared to be in 

the stratum corneum and easily 

removed (the unrecovered test material 

was speculated to be in the outer layers 

of the skin). Peak plasma levels were 

shown to occur 24 to 31 hours after 

application in these men. The one halflife for excretion was about 18 hours. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluazifop-P-butyl 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 

‘‘Fluazifop-P-Butyl. Human-Health Risk 

Assessment for Sweet Potato Label 

Amendment and Resulting Tolerance 

Increase.’’ at pages 28–36 in docket ID 

number EPA–HQ–OPP–2014–0441. 

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 fluazifop-P-butyl used for 

human risk assessment is shown in 

Table 1 of this unit. 

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 = 50 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.50 

mg/kg/day.

MRIDs: 00088857, 92067047, 00088858, 92067048, Rat developmental. 

Developmental LOAEL = 200 mg/kg/day based on diaphragmatic hernia. 

Acute dietary (General population including infants and 

children).

.................................. .................................. An appropriate endpoint for the general population attributable 

to a single dose was not identified in the available studies. 

Chronic dietary (All populations) NOAEL = 0.74 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = cPAD 

= 0.0074 mg/kg/

day.

MRIDs: 00088859, 92067050, Rat reproduction study; reproductive 

LOAEL = 5.8 mg/kg/day based on decreased testes and 

epididymal weights. 

Incidental oral short-term (1 to 

30 days).

NOAEL = 100 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

MRIDs: 46082913, 46158401, Rat developmental study; maternal 

LOAEL = 300 mg/kg/day based on maternal body weight gain 

decrement during GD 7–16. 

Dermal short-term (1 to 30 

days: Children).

NOAEL = 100 mg/

kg/day.

DAF= 9% (low exposure) or 2% (high 

exposure). 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

MRIDs: 46082913, 46158401, Rat developmental study; maternal. 

LOAEL = 300 mg/kg/day based on maternal body weight gain 

decrement during GD 7–16. 

Dermal short-term (1 to 30 

days: Adults).

NOAEL = 2.0 mg/kg/

day.

DAF = 9% (low exposure) or 2% 

(high exposure). 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

MRIDs: 46082903, 46082013, Rat developmental study; Developmental 

LOAEL = 5.0 mg/kg/day based on fetal weight decrement, 

hydroureter, and delayed ossification. 

Inhalation short-term (1 to 30 

days).

Inhalation (or oral) 

study NOAEL = 

2.0 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

MRIDs: 46082903, 46082013, Rat developmental study; Developmental 

LOAEL = 5.0 mg/kg/day based on fetal weight decrement, 

hydroureter, and delayed ossification. 

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Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations 46819 

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (Oral, dermal, inhalation).Not likely to be carcinogenic to humans. 

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

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

potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = 

use of a short-term study for long-term risk assessment. UFDB = to account for the absence of key data (i.e., lack of a critical study). FQPA SF = 

FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of 

concern. N/A = not applicable. DAF = dermal absorption factor. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluazifop-P-butyl, EPA 

considered exposure under the 

petitioned-for tolerance as well as all 

existing fluazifop-P-butyl tolerances in 

40 CFR 180.411. EPA assessed dietary 

exposures from fluazifop-P-butyl 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 fluazifop-P-butyl. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Survey/What We Eat in 

America (NHANES/WWEIA) database. 

The acute dietary analysis was 

conducted using 100% crop treated 

assumptions and tolerance-level 

residues, adjusted as appropriate using 

factors from the metabolism studies, to 

account for residues of concern not 

measured by the analytical method. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 2003– 

2008 NHANES/WWEIA database. As to 

residue levels in food, the chronic 

dietary analysis was conducted 

assuming mean residue levels from crop 

field trials with a ratio adjustment for 

additional metabolites of concern, 

average percent crop treated estimates, 

and experimentally-determined 

processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluazifop-P-butyl 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. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

FFDCA section 408(b)(2)(F), EPA may 

require registrants to submit data on 

PCT. 

The Agency estimated the PCT for 

existing uses as follows: For the acute 

dietary analysis, 100 PCT was assumed 

for all crops. The following average 

percent crop treated estimates were 

used in the chronic dietary risk 

assessments for the following crops that 

are currently registered for fluazifop-Pbutyl: Apricots, 2.5%; asparagus, 2.5%; 

carrots, 15%; cherries, 1%; cotton, 1%; 

dry beans/peas. 1%; garlic, 10%; 

grapefruit, 15%; grapes, 2.5%; 

nectarines, 1%; onions, 10%; oranges, 

2.5%; peaches, 2.5%; peanuts, 1%; 

pecans, 1%; peppers, 2.5%; plums, 

2.5%; potatoes, 1%; prunes, 2.5%; 

soybeans, 2.5%; and sugar beets, 1%; 

100 PCT was assumed for sweet 

potatoes and all other registered crops 

not listed above. 

To determine PCT values, EPA uses 

available data from United States 

Department of Agriculture/National 

Agricultural Statistics Service (USDA/ 

NASS), proprietary market surveys, and 

the National Pesticide Use Database for 

each chemical/crop combination from 

the most recent 6–7 years. EPA uses an 

average PCT for chronic dietary risk 

analysis. The average PCT figure for 

each existing use is derived by 

combining available public and private 

market survey data for that use, 

averaging across all observations, and 

rounding to the nearest 5%, except for 

those situations in which the average 

PCT is less than one. In those cases, 1% 

is used as the average PCT and 2.5% is 

used as the maximum PCT. EPA uses a 

maximum PCT for acute dietary risk 

analysis. The maximum PCT figure is 

the highest observed maximum value 

reported within the recent 6 years of 

available public and private market 

survey data for the existing use and 

rounded up to the nearest multiple of 

5%. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

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46820 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which fluazifop-P-butyl may be applied 

in a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluazifop-P-butyl in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fluazifop-P-butyl. 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. 

Estimated drinking water 

concentrations (EDWCs) in ground 

water were modeled using Tier I 

SCIGROW (version 2.3) and surface 

water EDWCs were modeled using Tier 

II PRZM (Pesticide Root Zone Model) 

and EXAMS (Exposure Analysis 

Modeling System). Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. For the acute dietary 

risk assessment, the surface water 

concentration value of 33.4 ppb was 

used to assess the contribution from 

drinking water. For the chronic dietary 

risk assessment, the surface water 

concentration value of 6.6 ppb was used 

to assess the contribution from 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). 

Fluazifop-P-butyl is currently 

registered for the following uses that 

could result in residential exposures: 

Non-agricultural outdoor buildings, 

building foundations, curbs, driveways, 

fencerows, non-agricultural areas 

(wildlife refuge), non-crop areas, 

ornamentals (lawns, flowering shrubs, 

flowering plants, gardens, ground 

covers, plants, trees, turf, and woody 

shrubs), patios, pathways, rights-of-way, 

sidewalks, and storage yards. EPA 

assessed residential exposure using the 

following assumptions. For handlers, 

there is a potential for short-term 

inhalation and dermal exposure. 

Residential handler exposure scenarios 

include handwand, hose and sprayer, 

backpack, sprinkler can, and RTU hose 

end sprayer. 

There is also the potential for shortterm post-application exposure for 

dermal exposure to all groups: Adult 

and child (1 to <2 years) turf-high 

contact; adult and youth (11–16 years) 

mowing; adult, child (6 to <11 years) 

and youth (11–16 years) golfing; adult 

and child (6 to <11 years) garden. Two 

separate dermal absorption values were 

used: 9% is used for assessing dermal 

exposures while golfing or mowing a 

lawn, since these are representative of 

low exposure activities (i.e., the Agency 

assumes that 9% of dermal exposures 

will be absorbed), whereas 2% is used 

for assessing dermal exposures from 

high-contact lawn activities, since these 

are representative of high-exposure 

activities (i.e., the Agency assumes that 

2% of dermal exposures will be 

absorbed). In addition, there is potential 

for short-term post-application 

incidental oral exposure for children (1 

to <2 years). Chemical-specific 

dislodgeable foliar residue (DFR) data 

are available and were used for the 

residential post application exposure 

assessment for gardens. Since Turf 

Transferable Residue (TTR) data are not 

available for fluazifop-P-butyl, default 

TTR values were used for the residential 

post application exposure assessment 

for turf. Given the conservatisms 

associated with default TTR values and 

the potential compounding nature of 

conservatisms in the turf assessment, 

EPA is able to rely upon the calculated 

exposure estimates with confidence that 

exposure is not being underestimated. 

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 fluazifop-P-butyl to share a 

common mechanism of toxicity with 

any other substances, and fluazifop-Pbutyl does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fluazifop-P-butyl 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 (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. 

No increased offspring sensitivity over 

parent was seen in the rabbit pre-natal 

developmental studies or the rat postnatal reproduction study, and no 

evidence of neurotoxicity was observed. 

Several rat developmental toxicity 

studies conducted on both fluazifopbutyl and fluazifop-P-butyl indicate 

fetal effects (ranging from delayed 

ossification, fetal weight decrements, 

increased incidence of small fetuses, 

cervical arches and centrum in fetuses 

and litters at levels from 5 to 20 mg/kg/ 

day to diaphragmatic hernia at 200 mg/ 

kg/day) in the absence of maternal 

toxicity. 

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 assessing 

potential prenatal and postnatal toxicity 

of fluazifop-P-butyl to infants and 

children is complete. 

ii. As there is limited indication of 

developmental neurotoxicity resulting 

from exposure to fluazifop-P-butyl with 

the current data sets, there is no need 

for a developmental neurotoxicity 

study. There were no developmental or 

central nervous system malformations 

seen in any of the developmental 

toxicity studies with rats or rabbits and 

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Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations 46821 

no evidence of neurotoxicity or 

neuropathology in adult animals in the 

available studies. The toxicological 

significance of the marginal increases in 

brain weights at high doses is unknown 

in the absence of corroborative 

histopathological lesions. EPA therefore 

concludes that there is not a concern for 

developmental neurotoxicity resulting 

from exposure to fluazifop-butyl or 

fluazifop-P-butyl. 

iii. While there was quantitative 

evidence of increased susceptibility in 

the fetuses of rats exposed in utero to 

fluazifop-butyl and fluazifop-P-butyl, 

EPA concludes that there is no residual 

uncertainty for prenatal or postnatal 

toxicity that would warrant an 

additional 10X safety factor. The 

available studies clearly identify welldefined NOAELs and LOAELs that are 

consistent across the five developmental 

rat toxicity studies. In addition, the 

Agency has selected, based on these 

studies, a developmental endpoint of 

concern (diaphragmatic hernia) for 

assessing acute dietary risk. As this 

endpoint is relevant to single exposures, 

the acute risk assessment based on this 

endpoint will be protective of any fetal 

effects resulting from a single exposure. 

Further, the Agency has selected, based 

these studies, a developmental endpoint 

of concern (delayed ossifications) for 

repeat exposure scenarios, which will 

be protective of any developmental 

effects in those scenarios. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

There is an adequate toxicity database 

for fluazifop-P-butyl and exposure data 

are complete. The dietary and 

residential assessments are based on 

reliable data and will not underestimate 

exposure/risk. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fluazifop-P-butyl in 

drinking water. EPA used similarly 

conservative assumptions to assess post 

application exposure of children as well 

as incidental oral exposure of toddlers. 

Although EPA has required additional 

data on transferable residues from 

treated turf for fluazifop-P-butyl, EPA is 

confident that it has not underestimated 

turf exposure due to the 

conservativeness of the default turf 

transfer value and conservative 

assumptions in the short-term turf 

assessment procedures (e.g., assuming 

residues do not degrade over the thirty 

day assessment period and assuming 

high-end activities on turf for every day 

of the assessment period). The 

additional data on transferable turf 

residues have been required in case 

refinement of exposure assessments is 

needed in the future and to further 

EPA’s general understanding of the 

availability of turf transferable pesticide 

residues. These assessments will not 

underestimate the exposure and risks 

posed by fluazifop-P-butyl. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fluazifop will occupy 14% of the aPAD 

for females 13–49 years old, the only 

relevant population subgroup for the 

acute dietary endpoint. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluazifop-Pbutyl from food and water will utilize 

64% of the cPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

fluazifop-P-butyl is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Fluazifop-P-butyl is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to Fluazifop-P-butyl. 

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 210 for adults and 3100 for 

children. Because EPA’s level of 

concern for fluazifop-P-butyl is a MOE 

of 100 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, fluazifop-Pbutyl is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for fluazifop-P-butyl. 

5. Aggregate cancer risk for U.S. 

population. Fluazifop-P-butyl has been 

classified as ‘‘Not likely to be 

carcinogenic to humans’’; therefore, 

EPA concludes that fluazifop-P-butyl 

will not pose a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fluazifop-Pbutyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(High Performance Liquid 

Chromatography/Ultra-Violet 

Spectrometry (HPLC/UV)) is available to 

enforce the tolerance expression. The 

method is available in Pesticide 

Analytical Methods (PAM), Volume II: 

Method I for animal tissues and milk 

and Method II for crops. The stated 

detection limits are 0.02–0.05 ppm for 

crops, 0.01 ppm for milk, and 0.02 ppm 

for animal tissues. Improved 

enforcement methods based on liquid 

chromatography and tandem mass 

spectroscopy, LC/MS/MS, are available 

as Method GRM044.01A and Method 

GRM044.02A. Both of these methods 

have been validated at 0.01 ppm on a 

wide variety of crop matrices. 

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). 

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46822 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Rules and Regulations 

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 fluazifop-P-butyl. 

V. Conclusion 

Therefore, the tolerance is amended 

for residues of fluazifop-P-butyl in or on 

sweet potato, roots from 0.05 ppm to 1.5 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This action amends a tolerance under 

FFDCA section 408(d) in response to a 

petition submitted to the Agency. The 

Office of Management and Budget 

(OMB) has exempted these types of 

actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this 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 

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: July 23, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.411, revise the commodity 

‘‘Sweet potato, roots’’ in the table in 

paragraph (a) to read as follows: 

§ 180.411 Fluazifop-P-butyl; tolerances for 

residues. 

(a) * * * 

Commodity 

Parts 

per 

million 

* * * * * 

Sweet potato, roots ........................ 1.5 

* * * * * 

[FR Doc. 2015–18825 Filed 8–5–15; 8:45 am] 

BILLING CODE 6560–50–P 

CHEMICAL SAFETY AND HAZARD 

INVESTIGATION BOARD 

40 CFR Part 1600 

Organization and Functions of the 

Chemical Safety and Hazard 

Investigation Board 

AGENCY: Chemical Safety and Hazard 

Investigation Board. 

ACTION: Final rule. 

SUMMARY: This rule amends the quorum 

and voting regulations of the Chemical 

Safety and Hazard Investigation Board 

(CSB). The amendments add a 

requirement for the Chairperson to place 

notation votes that have been 

calendared for discussion at a Board 

Meeting to the agenda of a public 

meeting within 90 days of the 

calendared notation vote. The rule also 

adds a requirement for the Chairperson 

to conduct a minimum of four public 

meetings per year in Washington, DC. 

DATES: Effective August 6, 2015. 

SUPPLEMENTARY INFORMATION: This final 

rule will promote increased 

transparency and accountability for 

Board activities. It aligns with the Open 

Government principles of transparency, 

participation, and collaboration, as 

outlined in the Memorandum on 

Transparency and Open Government 

(74 FFR 4685, Jan. 26, 2009). 

The Board conducts most votes 

through a process of notation voting. In 

notation voting, Board Members may 

vote to approve, disapprove, or calendar 

a notation item for discussion at a 

public meeting. In recent years, notation 

items have been calendared but then not 

placed on the agenda for discussion at 

a public meeting of the Board. The 

addition of language to 40 CFR 

1600.5(b) will ensure that calendaring is 

used in the way it was intended. It will 

require the consideration of calendared 

notation votes at a public meeting 

within 90 days of the calendaring 

action. Prior to the adoption of this 

amendment to the rule, calendaring 

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