10670 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 

Organism 

Methodology category Method 1 Citation 1

Total 

coliforms 

........................................ E*Colite® Test 2 .....................................................

........................................ Readycult® Test 2 ..................................................

........................................ modified Colitag® Test 2 ........................................

* * * * * * * 

1The procedures must be done in accordance with the documents listed in paragraph (c) of this section. For Standard Methods, either editions, 20th (1998) or 21st (2005), may be used. For the Standard Methods Online, the year in which each method was approved by the Standard 

Methods Committee is designated by the last two digits following the hyphen in the method number. The methods listed are the only online 

versions that may be used. For vendor methods, the date of the method listed in paragraph (c) of this section is the date/version of the approved 

method. The methods listed are the only versions that may be used for compliance with this rule. Laboratories should be careful to use only the 

approved versions of the methods, as product package inserts may not be the same as the approved versions of the methods. 2 Incorporated by reference. See paragraph (c) of this section. 

3 Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system conducts at least 25 parallel tests between lactose broth and lauryl tryptose broth using the water normally tested, and if the findings from this comparison demonstrate that the falsepositive rate and false-negative rate for total coliforms, using lactose broth, is less than 10 percent. 4All filtration series must begin with membrane filtration equipment that has been sterilized by autoclaving. Exposure of filtration equipment to 

UV light is not adequate to ensure sterilization. Subsequent to the initial autoclaving, exposure of the filtration equipment to UV light may be used 

to sanitize the funnels between filtrations within a filtration series. Alternatively, membrane filtration equipment that is pre-sterilized by the manufacturer (i.e., disposable funnel units) may be used. 5 Multiple-tube and multi-well enumerative formats for this method are approved for use in presence-absence determination under this regulation. 6 Colisure® results may be read after an incubation time of 24 hours. 7A multiple tube enumerative format, as described in Standard Methods for the Examination of Water and Wastewater 9221, is approved for 

this method for use in presence-absence determination under this regulation. 

* * * * * 

§ 141.855 [Amended] 

■ 4. Section 141.855 is amended by 

adding a reserved paragraph (d)(2). 

§ 141.861 [Amended] 

■ 5. In § 141.861, paragraph (b)(1) is 

amended by removing ‘‘§ 141.858’’ and 

adding in its place ‘‘§ 141.859’’. 

PART 142—NATIONAL PRIMARY 

DRINKING WATER REGULATIONS 

■ 6. The authority citation for part 142 

continues to read as follows: 

Authority: 42 U.S.C. 300f, 300g–1, 300g– 

2, 300g–3, 300g–4, 300g–5, 300g–6, 300j–4, 

300j–9, and 300j–11. 

■ 7. Section 142.16 is amended by 

revising paragraphs (q)(2) introductory 

text and (q)(2)(ii) to read as follows: 

§ 142.16 Special primacy requirements. 

* * * * * 

(q) * * * 

(2) The State’s application for primacy 

for subpart Y must include a written 

description for each provision included 

in paragraphs (q)(2)(i) through (ix) of 

this section. 

* * * * * 

(ii) Reduced Monitoring Criteria—An 

indication of whether the State will 

adopt the reduced monitoring 

provisions of 40 CFR part 141, subpart 

Y. If the State adopts the reduced 

monitoring provisions, it must describe 

the specific types or categories of water 

systems that will be covered by reduced 

monitoring and whether the State will 

use all or a reduced set of the criteria 

specified in §§ 141.854(h)(2) and 

141.855(d)(1)(iii) of this chapter. For 

each of the reduced monitoring criteria, 

the State must describe how the 

criterion will be evaluated to determine 

when systems qualify. 

* * * * * 

[FR Doc. 2014–04173 Filed 2–25–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0638; FRL–9906–70] 

Fluxapyroxad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluxapyroxad 

in or on multiple commodities which 

are identified and discussed later in this 

document. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 26, 2014. Objections and 

requests for hearings must be received 

on or before April 28, 2014, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0638, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 10671 

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. If OCSPP test guidelines 

are cited, insert the following: To access 

the OCSPP test guidelines referenced in 

this document electronically, please go 

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

‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0638 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 April 28, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0638, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of December 

19, 2012 (77 FR 75082) (FRL–9372–6), 

January 16, 2013 (78 FR 3377) (FRL– 

9375–4), and July 19, 2013 (78 FR 

43115) (FRL–9392–9), EPA issued 

notices pursuant to FFDCA section 

408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petitions (PP 2F8053, PP 2F8058 and PP 

3F8161 by BASF Corporation, 26 Davis 

Drive, Research Triangle Park, NC 

27709. The petitions requested that 40 

CFR 180.666 be amended by 

establishing tolerances for residues of 

the fungicide fluxapyroxad, 3- 

(difluoromethyl)-1-methyl-N-(3′,4′,5′- 

trifluoro[1,1′-biphenyl]-2-yl)-1Hpyrazole-4-carboxamide, in or on 

almond at 0.05 parts per million (ppm); 

almond, hulls at 4.0 ppm; berry, low 

growing, subgroup 13–07G at 4.0 ppm; 

bushberry, subgroup 13–07B at 6.0 ppm; 

caneberry, subgroup 13–07A at 6.0 ppm; 

fruit, small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 2.0 ppm; 

grapes at 2.0 ppm; grapes, raisin at 5.7 

ppm; pecans at 0.05 ppm; rice, bran at 

8.5 ppm; rice, grain at 5.0 ppm; rice, 

hulls strawberry at 4.0 ppm; sugarcane, 

cane at 3.0 ppm; vegetable, brassica 

leafy, group 5 at 3.0 ppm; vegetable, 

bulb, group 3–07 at 0.8 ppm; vegetable, 

cucurbit, group 9 at 0.4 ppm; vegetable, 

leafy, except brassica, group 4 at 15.0 

ppm; vegetable, root, except sugar beet, 

subgroup 1B at 0.7 ppm (PP 2F8053); 

nongrass animal feeds, group 18 at 0.5 

ppm; mint at 0.05 ppm (PP 2F8058); and 

by amending the tolerance for fruit, 

stone, group 12 from 2.0 ppm to 3.0 

ppm (PP 3F8161). The documents 

referenced summaries of the petitions 

prepared by BASF Corporation, the 

registrant, which are available in 

dockets EPA–HQ–OPP–2012–0638 (PP 

2F8053), EPA–HQ–OPP–2012–0924 (PP 

2F8058), and EPA–HQ–OPP–2013–0477 

(PP 3F8161), http://

www.regulations.gov. 

Based on EPA’s review of the data 

supporting the petitions, BASF 

Corporation revised their petition PP 

2F8053 by proposing tolerances for fishfreshwater finfish; fish-shelfish, 

crustacean; and hog, meat byproducts; 

and by decreasing, increasing, or 

deleting previously proposed tolerances 

for various commodities, as follows: 

Almond at 0.02 parts per million (ppm); 

almond, hulls at 4.0 ppm; berry, low 

growing, subgroup 13–07G at 4.0 ppm; 

bushberry, subgroup 13–07B at 7.0 ppm; 

caneberry, subgroup 13–07A at 5.0 ppm; 

fish-freshwater finfish at 0.01 ppm; fishshellfish, crustacean at 0.01 ppm; fruit, 

small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 2.0 ppm; 

grape, raisin at 5.7 ppm; hog, meat 

byproducts at 0.01 ppm; pecan at 0.06 

ppm; rice, bran at 8.5 ppm; rice, grain 

at 5.0 ppm; rice, hulls at 15.0 ppm; 

sugarcane, cane at 3.0 ppm; vegetable, 

brassica leafy, group 5 at 4.0 ppm; 

vegetable, bulb, group 3–07 at 1.5 ppm; 

vegetable, cucurbit, group 9 at 0.5 ppm; 

vegetable, leafy, except brassica, group 4 

at 30.0 ppm; vegetable, root, except 

sugarbeet, subgroup 1B at 0.9 ppm. EPA 

issued a notice announcing the filing of 

the revised petition in the Federal 

Register of November 27, 2013 (78 FR 

70906) (FRL–9902–87). That document 

referenced a summary of the revised 

petition prepared by BASF, which is 

available in docket EPA–HQ–OPP– 

2012–0638. 

Three comments were received on the 

notices of filing. EPA’s response to the 

comments is discussed in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

mstockstill on DSK4VPTVN1PROD with RULES

10672 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 

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 fluxapyroxad 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluxapyroxad 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. 

Fluxapyroxad is of low acute toxicity 

by the oral, dermal and inhalation 

routes, is not irritating to the eyes and 

skin, and is not a dermal sensitizer. The 

primary target organ for fluxapyroxad 

exposure via the oral route is the liver 

with secondary toxicity in the thyroid 

for rats only. Liver toxicity was 

observed in rats, mice, and dogs, with 

rats as the most sensitive species for all 

durations of exposure. In rats, adaptive 

effects of hepatocellular hypertrophy 

and increased liver weights and changes 

in liver enzyme activities were first 

observed. As the dose or duration of 

exposure to fluxapyroxad increased, 

clinical chemistry changes related to 

liver function also occurred, followed 

by hepatocellular necrosis, neoplastic 

changes in the liver, and tumors. 

Thyroid effects were observed only in 

rats. These effects were secondary to 

changes in liver enzyme regulation, 

which increased metabolism of thyroid 

hormone, resulting in changes in 

thyroid hormones, thyroid follicular 

hypertrophy and hyperplasia, and 

thyroid tumor formation. Tumors were 

not observed in species other than rats 

or in organs other than the liver and 

thyroid. 

Fluxapyroxad is classified as ‘‘Not 

likely to be Carcinogenic to Humans’’ 

based on convincing evidence that 

carcinogenic effects are not likely below 

a defined dose range. There is no 

mutagenicity concern from in vivo or in 

vitro assays. The hypothesized mode of 

action (i.e., a non-genotoxic) for 

treatment related tumors (i.e., the liver 

and thyroid) was supported by a full 

panel of in vitro and in vivo studies that 

showed no evidence of genotoxicity, 

together with mechanistic studies in the 

liver and thyroid of rats that satisfied 

stringent criteria for establishing 

tumorgenic modes of action. The studies 

clearly identified the sequence of key 

events, dose-response concordance and 

temporal relationship to the tumor 

types. The Agency has determined that 

the chronic population adjusted dose 

(PAD) will adequately account for all 

chronic effects, including 

carcinogenicity that could result from 

exposure to fluxapyroxad because the 

points of departure (POD) for the 

chronic population adjusted dose 

(cPAD) is based on the most sensitive 

endpoint, liver effects. Effects in the 

liver preceded liver tumors and the 

effects observed in the thyroid (in rats 

only) were believed to be secondary to 

the liver effects. 

No evidence of neurotoxicity was 

observed in response to repeated 

administration of fluxapyroxad. An 

acute neurotoxicity study showed 

decreased rearing and motor activity. 

This occurred on the day of dosing only 

and in the absence of histopathological 

effects or alterations in brain weights. 

This indicated that any neurotoxic 

effects of fluxapyroxad are likely to be 

transient and reversible due to 

alterations in neuropharmacology and 

not from neuronal damage. There were 

no neurotoxic effects observed in the 

subchronic dietary toxicity study. No 

evidence of reproductive toxicity was 

observed. Developmental effects 

observed in both rats and mice (thyroid 

follicular hypertrophy and hyperplasia 

in rats and decreased defecation, food 

consumption, body weight/body weight 

gain, and increased litter loss in rabbits) 

occurred at the same doses as those that 

caused adverse effects in maternal 

animals, indicating no quantitative 

susceptibility. Since the maternal 

toxicities of thyroid hormone 

perturbation in rats and systemic 

toxicity in rabbits likely contributed to 

the observed developmental effects 

there is low concern for qualitative 

susceptibility. An immunotoxicity study 

in mice showed no evidence of 

immunotoxic effects from fluxapyroxad. 

Subchronic oral toxicity studies in 

rats, developmental toxicity studies in 

rabbits, and in vitro and in vivo 

genotoxicity studies were performed for 

fluxapyroxad metabolites F700F001, 

M700F002, and M700F048. Like 

fluxapyroxad, no genotoxic effects were 

observed for any of these metabolites. 

All three metabolites displayed lower 

subchronic toxicity via the oral route 

than fluxapyroxad, with evidence of 

non-specific toxicity (decreased body 

weight) observed only for M700F0048 at 

the limit dose. Only M700F0048 

exhibited developmental toxicity at 

doses similar to those that caused 

developmental effects in rabbits with 

fluxapyroxad treatment. However, these 

effects (abortions and resorptions) were 

of a different nature than for 

fluxapyroxad (paw hyperflexion) and 

are considered secondary to maternal 

toxicity. The Agency considers these 

studies sufficient for hazard 

identification and characterization and 

concludes that these metabolites do not 

have hazards that exceed those of 

fluxapyroxad in nature, severity, or 

potency. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluxapyroxad as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Human Health Risk Assessment for 

Use of Fluxapyroxad on Numerous 

Crops’’ at pp. 52 in docket ID number 

EPA–HQ–OPP–2012–0638. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological POD and levels of concern 

to use in evaluating the risk posed by 

human exposure to the pesticide. For 

hazards that have a threshold below 

which there is no appreciable risk, the 

toxicological POD is used as the basis 

for derivation of reference values for 

risk assessment. PODs are developed 

based on a careful analysis of the doses 

in each toxicological study to determine 

the dose at which the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a 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 fluxapyroxad used for 

human risk assessment is shown in 

Table 1 of this unit. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 10673 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUXAPYROXAD 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 (General population including infants and children, and females 13–49 years 

of age).

NOAEL = 125 mg/kg/day .......

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

Acute RfD = 1.25 mg/kg/day.

aPAD = 1.25 mg/kg/day. 

Acute neurotoxicity study in 

rats. 

LOAEL = 500 mg/kg/day 

based on decreased motor 

activity and decreased 

rearing. 

Chronic dietary (All populations) ...................... NOAEL = 2.1 mg/kg/day ........

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

Chronic RfD = 0.021 mg/kg/

day..

cPAD = 0.021 mg/kg/day. 

Chronic toxicity/carcinogenicity study in rats. 

LOAEL = 11 mg/kg/day based 

on non-neoplastic changes 

in the liver (foci, masses). 

Incidental oral short-term (1 to 30 days) .......... NOAEL = 9 mg/kg/day ...........

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

LOC for MOE = 100 ............... 28-day oral toxicity study in 

rats. 

LOAEL = 176 mg/kg/day 

based on changes in thyroid hormones and thyroid 

follicular hypertrophy/

hyperplasia. 

Dermal short- and intermediate-term (1 day to 

6 months).

No hazard identified 28-day dermal toxicity study in 

rats. 

LOAEL = Not observed. 

Inhalation short-term (1 to 30 days) ................. NOAEL= 9 mg/kg/day ............

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

LOC for MOE = 100 ............... 28-day oral toxicity study in 

rats. 

LOAEL = 176 mg/kg/day 

based on changes in thyroid hormones and thyroid 

follicular hypertrophy/

hyperplasia. 

Inhalation intermediate-term (1 to 6 months) ... Inhalation (or oral) study 

NOAEL = 7.3 mg/kg/day.

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

LOC for MOE = 100 ............... 90-day dietary study in rats. 

LOAEL = 35.1 mg/kg/day 

based on thyroid follicular 

hypertrophy/hyperplasia. 

Cancer (Oral, dermal, inhalation) ..................... Classification: Not likely to be carcinogenic to humans at doses sufficient to induce liver and/or 

thyroid tumors. Quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity. 

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

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

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

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluxapyroxad, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fluxapyroxad tolerances in 40 

CFR 180.666. EPA assessed dietary 

exposures from fluxapyroxad 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 fluxapyroxad. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA used 

tolerance level residues adjusted 

upward to account for metabolites of 

concern not included in the tolerance 

expression, 100 percent crop treated 

(PCT) assumptions, and dietary 

exposure evaluation model (DEEM) 

default and empirical processing factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 2003– 

2008 NHANES/WWEIA. As to residue 

levels in food, a moderately refined 

chronic dietary exposure analysis was 

performed. An assumption of 100 PCT 

and DEEM default and empirical 

processing factors were used for the 

chronic dietary analysis. Combined 

average field trial residues for parent 

and highest average field trial residues 

for metabolites of concern were used for 

all plant commodities. For livestock 

commodities tolerance level residues 

adjusted upward to account for 

metabolites of concern not included in 

the tolerance expression were used. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to fluxapyroxad. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii., 

chronic exposure. 

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 

mstockstill on DSK4VPTVN1PROD with RULES

10674 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 

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. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluxapyroxad in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fluxapyroxad. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the Tier 1 Rice Model and 

the Pesticide Root Zone Model Ground 

Water (PRZM GW), the estimated 

drinking water concentrations (EDWCs) 

of fluxapyroxad for acute exposures are 

estimated to be 127 parts per billion 

(ppb) for surface water and 203 ppb for 

ground water. The EDWCs for chronic 

exposures for non-cancer assessments 

are estimated to be 127 ppb for surface 

water and 184 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 203 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 184 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). 

Fluxapyroxad is registered for the 

following uses that could result in 

residential exposures: residential turf. 

EPA assessed residential exposure using 

the following assumptions: Residential 

handler exposures are expected to be 

short-term (1 to 30 days) via either the 

dermal or inhalation routes of 

exposures. Intermediate-term exposures 

are not likely because of the intermittent 

nature of applications by homeowners. 

Since no dermal hazard was identified 

for fluxapyroxad, MOEs were calculated 

for the inhalation route of exposure 

only. 

Both adults and children may be 

exposed to fluxapyroxad residues from 

contact with treated lawns. Adult 

postapplication exposures were not 

quantitatively assessed since no dermal 

hazard was identified for fluxapyroxad 

and inhalation exposures are typically 

negligible in outdoor settings. The 

exposure assessment for children 

included incidental oral exposure 

resulting from transfer of residues from 

the hands or objects to the mouth, and 

from incidental ingestion of soil. Post 

application hand-to-mouth and objectto-mouth exposures are expected to be 

short-term (1 to 30 days) in duration due 

to the intermittent nature of 

applications in residential 

environments. 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 fluxapyroxad to 

share a common mechanism of toxicity 

with any other substances, and 

fluxapyroxad does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that fluxapyroxad 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 (10×) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10×, 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 evidence of quantitative 

susceptibility was observed in a 

reproductive and developmental 

toxicity study in rats or in 

developmental toxicity studies in rats 

and rabbits. Developmental toxicity data 

in rats showed decreased body weight 

and body weight gain in the offspring at 

the same dose levels that caused thyroid 

follicular hypertrophy/hyperplasia in 

parental animals. Effects in rabbits were 

limited to paw hyperflexion, a 

malformation that is not considered to 

result from a single exposure and that 

usually reverses as the animal matures. 

Developmental effects observed in both 

rats and rabbits occurred at the same 

doses as those that caused adverse 

effects in maternal animals, indicating 

no quantitative susceptibility. The 

Agency has low concern for 

developmental toxicity because the 

observed effects were of low severity, 

were likely secondary to maternal 

toxicity, and demonstrated clear 

NOAELs. Further, the NOAELs for these 

effects were at dose levels higher than 

the points of departure selected for risk 

assessment for repeat-exposure 

scenarios. Therefore, based on the 

available data and the selection of risk 

assessment endpoints that are protective 

of developmental effects, there are no 

residual uncertainties with regard to 

pre- and/or postnatal 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 1×. That decision is 

based on the following findings: 

i. The toxicity database for 

fluxapyroxad is complete. Although no 

subchronic inhalation data is available 

EPA has waived that data requirement 

based on, among other things, its 

conclusion that even if an additional 

10× safety factor was applied, inhalation 

exposure would not raise a risk of 

concern. 

ii. There is no indication that 

fluxapyroxad is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. Neither the acute or the 

subchronic neurotoxicity studies 

indicated specific neurotoxicity 

responses to fluxapyroxad. Because 

fluxapyroxad can disrupt thyroid 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 10675 

hormone levels, the Agency considered 

the potential for fluxapyroxad to cause 

developmental neurotoxicity as a result 

of thyroid hormone disruption, which is 

more sensitive endpoint than the 

endpoints used in a developmental 

neurotoxicity study. Based on its 

evaluation of thyroid hormone data 

submitted for fluxapyroxad and the 

ontogeny of thyroid hormone 

metabolism, the Agency has determined 

that adverse thyroid hormone 

disruptions in the young are unlikely to 

occur at dose levels as low as the points 

of departure chosen for risk assessment. 

The Agency has low concern for 

neurotoxic effects of fluxapyroxad at 

any life stage. 

iii. Based on the developmental and 

reproductive toxicity studies discussed 

in Unit III.D.2., there are no residual 

uncertainties with regard to prenatal 

and/or postnatal toxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues or field trial 

residue data. The dietary risk 

assessment is based on reliable data, is 

conservative and will not underestimate 

dietary exposure to fluxapyroxad. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to fluxapyroxad in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by fluxapyroxad. 

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 

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 

fluxapyroxad will occupy 12% of the 

aPAD for children 3–5 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluxapyroxad 

from food and water will utilize 64% of 

the cPAD for infants (< 1year 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 fluxapyroxad 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). Fluxapyroxad 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 fluxapyroxad. 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 320 for 

adults and 560 for children. Because 

EPA’s level of concern for fluxapyroxad 

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, fluxapyroxad is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm 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 intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

fluxapyroxad. 

5. Aggregate cancer risk for U.S. 

population. EPA classified fluxapyroxad 

as ‘‘Not likely to be Carcinogenic to 

Humans’’ based on convincing evidence 

that carcinogenic effects are not likely 

below a defined dose range. The Agency 

has determined that the quantification 

of risk using the cPAD for fluxapyroxad 

will adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

fluxapyroxad. The POD for the cPAD is 

based on the most sensitive endpoint, 

liver effects. Effects in the liver 

preceded liver tumors and the effects 

observed in the thyroid (in rats only) 

were believed to be secondary to the 

liver effects. As noted above, chronic 

exposure to fluxapyroxad from food and 

water will utilize 64% of the cPAD for 

infants (< 1year old) the population 

group receiving the greatest exposure. 

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 fluxapyroxad 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

A Liquid Chromatography-Mass 

Spectrometer/Mass Spectrometer (LC/

MS/MS) method is available as an 

enforcement method. This method uses 

reversed-phase High Pressure Liquid 

Chromatography (HPLC) with gradient 

elution, and includes 2 ion transitions 

to be monitored for the parent 

fluxapyroxad. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established MRLs 

for fluxapyroxad on the commodities 

subject in this notice. 

C. Response to Comments 

Three anonymous public comments 

were received opposing establishment 

mstockstill on DSK4VPTVN1PROD with RULES

10676 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 

of the requested tolerances. The first 

commenter alleges that there is already 

too much toxicity from pesticide 

chemicals in the U.S. and EPA should 

not allow more pesticide residues on 

food. The second commenter claims that 

a data gap exists for maximum residues 

of fluxapyroxad in wheat and for 

accumulation of fluxapyroxad residues 

in soil and argues that EPA should 

require testing of pesticides when 

combined with other pesticides. The 

third anonymous commenter states that 

the U.S. should no longer allow the 

importation of pet foods from China. 

The Department of Utility, City of 

Sacramento, California submitted a 

comment on the application by BASF to 

register fluxapyroxad for use on rice 

under the Federal Insecticide, 

Fungicide, and Rodenticide Act, 7 

U.S.C. 136 et seq. Several issues in that 

comment pertain to EPA’s risk 

assessment for the fluxapyroxad 

tolerance petition. The Department of 

Utility expresses concern with the 

potential human health effects of 

breakdown products (metabolites, 

degradates, transformations products) 

that occur both prior and subsequent to 

water treatment, the effects of water 

treatment on the removal of 

fluxapyroxad residues, and the potential 

synergistic effects from exposure to 

multiple rice pesticides in drinking 

water. 

The anonymous commenters either 

raise irrelevant or non-specific issues, 

make unsubstantiated claims, or are 

mistaken in their allegations. General 

claims regarding the toxicity of other 

pesticides and objections to the import 

of pet food from China do not raise 

safety concerns regarding EPA’s 

assessment of the risk from aggregate 

exposure to fluxapyroxad. With regard 

to potential cumulative effects from the 

interaction of fluxapyroxad with other 

substances, EPA has addressed this 

issue in Unit III. C. 4., above. Finally, 

the commenter who claims there are 

data gaps is mistaken. The Agency 

determined that the available residue 

chemistry data for fluxapyroxad are 

sufficient to support the established 

tolerances for registered wheat uses. No 

data gaps were identified for wheat 

commodities or for rotational crop 

commodities. Additionally, the 

fluxapyroxad product label statements 

restrict crop rotation to commodities 

listed on the label. 

The remaining comments raised by 

Sacramento’s Department of Utility 

express concerns with EPA’s 

examination of breakdown products 

from fluxapyroxad, and fluxapyroxad 

residue removal through water 

treatment in a drinking water plant. EPA 

possesses a full complement of standard 

metabolism and environmental fate 

studies on fluxapyroxad, as specified 

under 40 CFR 158.1300 and 158.1410. 

These include hydrolysis (OCSPP 

Guideline 835.2120), aqueous 

photolysis (OCSPP Guideline 835.2240), 

aerobic soil metabolism, and aerobic 

aquatic metabolism studies (OCSPP 

Guidelines 835.4100/4200 and 

835.4300/4400). While these studies 

provide general information on the fate 

of fluxapyroxad and its metabolites in 

the environment, they do not directly 

address the chemicals’ fate during 

drinking water treatment, and were 

therefore used only for qualitative 

characterization of such effects. The 

studies show that fluxapyroxad is stable 

to hydrolysis and aquatic degradation, 

therefore the chemical is not expected to 

degrade during drinking water 

treatment, and/or subsequent delivery of 

treated water to the consumer’s tap. 

Because fluxapyroxad is moderately to 

slightly mobile in soils, treatment 

methods such as sedimentation, 

flocculation, and activated carbon 

filtration are expected to have some 

effect at removing fluxapyroxad. 

Available studies also show that 

fluxapyroxad does not degrade via 

photolysis, therefore where ultraviolet 

light is used as a means of disinfection, 

enhanced degradation of fluxapyroxad 

is not expected to occur. The chemical 

structure of fluxapyroxad does not 

appear to include any moieties where 

oxidation due to water chlorination 

could result in the formation of an 

obviously more-toxic transformation 

product, such as an oxon. EPA 

possesses toxicity data on various 

fluxapyroxad metabolites and 

degradates. The data indicate that none 

of these metabolites are more toxic than 

parent fluxapyroxad, and they were 

therefore not considered as separate 

entities in dietary or drinking water risk 

assessments. In conclusion, based upon 

the available information, EPA believes 

that it has adequately taken drinking 

water treatment into account in 

addressing potential human health risks 

from fluxapyroxad. EPA does not 

routinely require data on the effects of 

water treatment processes on pesticides. 

Rather, in assessing risks, EPA generally 

employs (as it did with fluxapyroxad) 

estimates of pesticide concentrations in 

source (untreated) water as a surrogate 

for concentrations in consumed water. 

This approach is inherently 

conservative, and is therefore expected 

to be protective of public health. 

D. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petitions, petition PP 

2F8058 was revised by decreasing the 

proposed tolerances for nongrass animal 

feeds, group 18 from 0.5 to 0.30 ppm; 

and mint from 0.05 to 0.01 ppm. In 

addition, the Agency is amending the 

existing tolerance for grain, cereal, 

group 15, by adding ‘‘except rice’’ to the 

commodity definition. In lieu of the 

proposed tolerances for almonds and 

pecans, and since these are the 

representative commodities for the tree 

nut crop group, the Agency is 

establishing a tolerance for the tree nut 

crop group 14–12 at 0.06 ppm. 

The Agency concluded that based on 

the residue data these changes are 

required to support the proposed uses. 

The Agency analyzed the field trial data 

for the respective commodities using the 

Organization for Economic Cooperation 

and Development tolerance calculation 

procedures to determine the appropriate 

tolerances. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluxapyroxad, 3- 

(difluoromethyl)-1-methyl-N-(3′,4′,5′- 

trifluoro[1,1′-biphenyl]-2-yl)-1Hpyrazole-4-carboxamide, as requested in 

the revised petitions. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 10677 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 14, 2014. 

Lois Rossi, 

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 § 180.666: 

■ a. Revise the following commodities 

in the table in paragraph (a): ‘‘Grain, 

cereal, group 15, (except corn, field, 

grain; except corn, pop, grain; except 

corn, kernels plus cobs with husks 

removed; except wheat)’’ and ‘‘Fruit, 

stone, group 12.’’ 

■ b. Add alphabetically 21 commodities 

to the table in paragraph (a). 

■ c. Revise paragraph (d). 

The revisions and additions read as 

follows: 

§ 180.666 Fluxapyroxad; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

Almond, hulls ......................................................................................................................................................................................... 4 .0 

* * * * * * * 

Berry, low growing, subgroup 13–07G .................................................................................................................................................. 4 .0 

Bushberry, subgroup 13–07B ................................................................................................................................................................ 7 .0 

Caneberry, subgroup 13–07A ............................................................................................................................................................... 5 .0 

*******

Fish-freshwater finfish ............................................................................................................................................................................ 0 .01 

Fish-shellfish, crustacean ...................................................................................................................................................................... 0 .01 

*******

Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................................................................................................... 2 .0 

*******

Fruit, stone, group 12–12 ...................................................................................................................................................................... 3 .0 

*******

Grain, cereal, group 15, (except corn, field, grain; except corn, pop, grain; except corn, kernels plus cobs with husks removed; 

except rice; except wheat .................................................................................................................................................................. 3 .0 

*******

Grape, raisin .......................................................................................................................................................................................... 5 .7 

Hog, meat byproducts ........................................................................................................................................................................... 0 .01 

*******

Nut, tree, group 14–12 .......................................................................................................................................................................... 0 .06 

*******

Rice, bran .............................................................................................................................................................................................. 8 .5 

Rice, grain .............................................................................................................................................................................................. 5 .0 

Rice, hulls .............................................................................................................................................................................................. 15 .0 

*******

Sugarcane, cane .................................................................................................................................................................................... 3 .0 

mstockstill on DSK4VPTVN1PROD with RULES

10678 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Rules and Regulations 

Commodity Parts per 

million 

*******

Vegetable, brassica leafy, group 5 ........................................................................................................................................................ 4 .0 

Vegetable, bulb, group 3–07 ................................................................................................................................................................. 1 .5 

Vegetable, cucurbit, group 9 ................................................................................................................................................................. 0 .50 

* * * * * * * 

Vegetable, leafy, except brassica, group 4 ........................................................................................................................................... 30 

* * * * * * * 

Vegetable, root, except sugarbeet, subgroup 1B .................................................................................................................................. 0 .90 

*******

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

combined indirect or inadvertent 

residues of the fungicide fluxapyroxad, 

including its metabolites and 

degradates, in or on the commodities 

listed in the table below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only fluxapyroxad, 3-(difluoromethyl)- 

1-methyl-N-(3′,4′,5′-trifluoro[1,1′- 

biphenyl]-2-yl)-1H-pyrazole-4- 

carboxamide in or on the commodity. 

Commodity Parts per 

million 

Nongrass animal feeds, 

group18 ............................... 0 .30 

Peppermint, tops .................... 0 .01 

Spearmint, tops ...................... 0 .01 

[FR Doc. 2014–04164 Filed 2–25–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0093; FRL–9906–17] 

N-(n-octyl)-2-pyrrolidone; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of N-(n-octyl)-2- 

pyrrolidone (CAS Reg. No. 2687–94–7) 

when used as an inert ingredient 

(solvent) in formulations of pyraflufenethyl herbicide at a maximum 

concentration of 20% weight. Wagner 

Regulatory Associates on behalf of 

Nichino America, Inc. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of N-(noctyl)-2-pyrrolidone. 

DATES: This regulation is effective 

February 26, 2014. Objections and 

requests for hearings must be received 

on or before April 28, 2014, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0093, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0093 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 April 28, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

mstockstill on DSK4VPTVN1PROD with RULES