Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 27019 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart N—Idaho 

■ 2. In § 52.670, the table in paragraph 

(e) is amended by adding an entry at the 

end of the table for ‘‘Interstate Transport 

Requirements for the 2010 NO2

NAAQS’’ to read as follows: 

§ 52.670 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED IDAHO NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES

Name of SIP provision Applicable geographic or 

non-attainment area 

State 

submittal date EPA Approval date Comments 

*******

Interstate Transport Requirements for the 2010 NO2

NAAQS.

State-wide ............................ 12/24/2015 5/5/2016 [Insert Federal 

Register citation].

This action addresses the following CAA elements: 

110(a)(2)(D)(i)(I). 

* * * * * 

[FR Doc. 2016–10452 Filed 5–4–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0324; FRL–9945–48] 

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 May 

5, 2016. Objections and requests for 

hearings must be received on or before 

July 5, 2016, 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–2015–0324, 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. 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–2015–0324 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 5, 2016. 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– 

2015–0324, 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 


ehiers on DSK5VPTVN1PROD with RULES
27020 Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 

follow the instructions at http://

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

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-for Tolerance 

In the Federal Register of August 26, 

2015 (80 FR 51759) (FRL–9931–74), 

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 5F8344) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR 180.666 be 

amended by establishing tolerances for 

residues of the fungicide fluxapyroxad, 

in or on citrus, dried pulp at 2.7 parts 

per million (ppm); citrus oil at 19 ppm; 

fruit, citrus group 10–10 at 1.0 ppm; 

grass forage, fodder and hay group 17 at 

30 ppm; non-grass animal feed, group 

18 at 30 ppm; and poultry, fat at 0.005 

ppm. The petition also requested that 

the existing tolerance for residues of 

fluxapyroxad on egg be amended from 

0.002 ppm to 0.01 ppm and that the 

tolerance for inadvertent residues of 

fluxapyroxad on nongrass animal feeds, 

group 18 at 0.3 ppm be removed upon 

establishment of the superceding group 

18 tolerance. That document referenced 

a summary of the petition prepared by 

BASF Corporation, the registrant, which 

is available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

recommended tolerances for poultry 

meat, poultry meat byproduct, and milk 

fat for which there were no established 

tolerances previously due to low dietary 

burden and falling under category 3 of 

CFR 180.6(a). The reason for these 

changes are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.* * *’’ 

Consistent with 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 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 

tumorigenic 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 


ehiers on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 27021 

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 Fluxaproxad on Citrus Crop 

Group 10–10, Grass Crop Group 17, and 

Non-Grass Crop Group 18.’’ on pp. 56 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 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. 

Summary of the toxicological 

endpoints for used for human risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUXAPYROXAD FOR USE IN DIETARY, RESIDENTIAL

AND NON-OCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS

Exposure/scenario Point of 

departure 

Uncertainty/FQPA 

safety 

factors 

RfD, PAD, level 

of concern 

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 = 10x 

UFH = 10x 

FQPA SF = 1x 

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 (both sexes) and decreased rearing (males 

only). 

Chronic Dietary (All Populations).NOAEL = 2.1 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

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 

(1–30 days).

NOAEL = 7.3mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC 

for MOE = 100.

90-day dietary study in rats. 

MIRD 47923567. 

LOAEL = 35.1 mg/kg/day based on thyroid follicular 

hypertrophy/hyperplasia. 

Dermal Short- and Intermediate-Term.No hazard identified. 

Inhalation, Short-Term (1– 

30 days) and Intermediate-term (1–6 

months).

NOAEL = 7.3 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC 

for MOE = 100.

90-day dietary study in rats. 

MIRD 47923567. 

LOAEL = 35.1 mg/kg/day based on thyroid follicular 

hypertrophy/hyperplasia. 

Cancer (oral, dermal, inhalation).Classification: Not likely to be carcinogenic to humans below a defined dose range. 

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). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOA = mode of action. 


ehiers on DSK5VPTVN1PROD with RULES
27022 Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 

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 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance-level 

residues adjusted to account for the 

metabolites of concern (M700F008, and 

M700F010 (milk only)) and 100 percent 

crop treated (PCT) assumptions were 

used. DEEM default and empirical 

processing factors were used to modify 

the tolerance values. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 CSFII. As to 

residue levels in food, a moderately 

refined chronic dietary exposure 

analysis was performed for the general 

U.S. population and various population 

subgroups. Combined average residue 

for parent and highest residue for 

metabolite M700F008 and 100 PCT 

assumptions were used. For livestock 

commodities tolerance-level residues 

adjusted to account for the metabolites 

of concern (M700F008, M700F010) were 

used. An assumption of 100 PCT was 

also used for the chronic dietary 

analysis. DEEM default and empirical 

processing factors were used to modify 

the tolerance values. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluxapyroxad 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. 

The Agency did not use PCT 

information in the dietary assessment 

for fluxapyroxad; 100 PCT was assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for 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 Pesticide Root Zone 

Model Ground Water (PRZM GW), the 

estimated drinking water concentrations 

(EDWCs) of fluxapyroxad for acute 

exposures are 127 ppb parts per billion 

(ppb) for surface water and 203 ppb for 

ground water. The EDWCs for chronic 

exposures for non-cancer assessments 

are 127 ppb for surface water and 188 

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 

value of 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). 

There are no residential exposure 

associated with the proposed uses in 

this action; however, there are existing 

turf uses that were previously assessed 

for fluxapyroxad. Although the Agency 

had conducted a residential exposure 

assessment for previous fluxapyroxad 

actions, the Agency completed an 

updated turf assessment to reflecting an 

update in the single maximum 

application rate from 2.47 pounds active 

ingredient/gallon (lb ai/gallon) to 0.005 

lb ai/gallon. The present assessment 

assumed the following exposure 

scenarios: 

• Residential handler: The Agency 

assessed inhalation exposures to adults 

from applications only because 

fluxapyroxad does not pose a dermal 

risk. Residential handler exposure is 

expected to be short-term in duration. 

Intermediate-term exposures are not 

likely because of the intermittent nature 

of applications by homeowners. 

• Post-application exposures: Dermal 

exposures were not assessed because 

there is no identified systemic dermal 

hazard for fluxapyroxad. Postapplication inhalation exposure while 

engaged in activities on or around 

previously treated turf is generally not 

quantitatively assessed. The 

combination of low vapor pressure for 

chemicals typically used as active 

ingredients in outdoor residential 

pesticide products and dilution in 

outdoor air is likely to result in minimal 

inhalation exposure. Incidental oral 

exposure for children is anticipated. 

The quantitative oral exposure/risk 

assessment for residential postapplication exposures is based on the 

incidental oral scenario for children 

1<2. 

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 


ehiers on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 27023 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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 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 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

fluxapyroxad is complete. 

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. Although an acute 

neurotoxicity study showed decreased 

rearing and motor activity, this occurred 

on the day of dosing only 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. 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 residue database is adequate. The 

dietary risk assessment is conservative 

and will not underestimate dietary 

exposure to fluxapyroxad. There are 

residential uses proposed for 

fluxapyroxad and the assessment will 

not underestimate residential exposure 

via handler for adults and incidental 

oral for children. 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 post 

application exposure of children as well 

as incidental oral exposure of toddlers. 

There are residential uses proposed for 

fluxapyroxad and the assessment will 

not underestimate residential exposure 

via handler for adults and incidental 

oral for children. 

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 

fluxapyroxad will occupy 12% of the 

aPAD for children 1–2 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 66% of 

the cPAD for infants (< 1 year old). 

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 1139 for 

adults and 431 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. As discussed in Unit III.A., 

EPA has 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. Because the Agency has 

determined fluxapyroxad will not cause 

a chronic risk, the Agency concludes 

that fluxapyroxad will not pose a cancer 

risk for the U.S. population. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 


ehiers on DSK5VPTVN1PROD with RULES
27024 Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 

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 

There are suitable residue analytical 

methods available for enforcement of 

fluxapyroxad tolerances (BASF Methods 

L0137/01 for plants and L0140/02 for 

animal matrices) which have been 

radio-validated and have underwent 

successful validation by an independent 

laboratory. These are liquid 

chromatography with tandem mass 

spectrometry (LC/MS/MS) methods and 

monitor two ion transitions. The Limit 

of Quantitation (LOQ) for BASF method 

L0137/01 is 0.01 ppm for various 

matrices. The LOQ for BASF method 

L0140/02 is 0.01 ppm for liver and 

muscle, and 0.001 ppm for milk and 

eggs. 

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. 

There are no Codex MRLs for citrus or 

grass and non-grass animal feed at 

present. US and Codex use different 

dietary burden evaluations and 

calculations which result in US 

tolerances for residues in ruminant meat 

byproduct, milk, and milk fat generally 

much lower than corresponding Codex 

MRLs. 

C. Revisions to Petitioned-for Tolerances 

EPA is establishing tolerances for 

milk fat and poultry meat, and meat 

byproduct that the applicant did not 

request. There have been no established 

tolerances for poultry tissues because 

residues were not expected to be found 

in those tissues due to the low dietary 

burden; i.e., category 3 of 40 CFR 

180.6(a) applied for those poultry 

matrices previously. However, because 

of expectation of higher residues on the 

feed items associated with the proposed 

uses (mainly grass and non-grass), the 

livestock dietary burdens have 

increased, and residues are now 

expected to be transferred to poultry 

tissues. Consequently, the Agency is 

establishing poultry tolerances. 

Similarly, due to the higher livestock 

dietary burdens, EPA is establishing a 

new tolerance for residues in milk fat, 

and increasing current tolerances on 

milk, ruminant fat and meat byproduct 

(to include fat and meat byproduct of 

cattle, goat, horse and sheep). EPA is 

also establishing higher tolerances than 

what the applicant proposed for grass 

(group 17), citrus oil, dried pulp, and 

poultry fat. The difference in the group 

17 grass tolerance is due to the fact that 

EPA is using residues from 0-day 

postharvest interval (PHI) from grass 

samples (instead of 14-day PHI used by 

the applicant). With regard to citrus oil, 

the difference between the petitionedfor and established tolerance is due to 

the use of the highest average field trial 

(HAFT) data by EPA (instead of median 

used by the applicant), times processing 

factor. Dried pulp tolerance difference is 

due to EPA rounding of the calculated 

tolerance. Lastly, the difference in the 

tolerance in poultry fat is due to 

recalculating dietary burden for 

livestock, taking into account residues 

on feed commodities from (0-day PHI) 

grass, alfalfa and clover which resulted 

in higher than previously calculated 

dietary burdens and therefore higher 

tolerances. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluxapyroxad, in or on 

cattle, fat at 0.06 ppm; cattle, meat 

byproduct at 0.04 ppm; citrus, dried 

pulp at 3.0 ppm; citrus, oil at 40 ppm; 

fruit, citrus, group 10–10 at 1.0 ppm; 

goat, fat at 0.06 ppm; goat, meat 

byproduct at 0.04 ppm; grass, forage, 

fodder, and hay, group 17 at 40 ppm; 

horse, fat at 0.06 ppm; horse, meat 

byproduct at 0.04 ppm; milk at 0.01 

ppm; milk, fat at 0.15 ppm; non-grass 

animal feeds, group 18 at 30 ppm; 

poultry, fat, poultry, meat and meat 

byproduct, each at 0.01 ppm; sheep, fat 

at 0.06 ppm; and sheep, meat byproduct 

at 0.04 ppm. Finally, the Agency is 

removing the tolerance for inadvertent 

residues of fluxapyroxad on non-grass 

animal feeds, group 18 contained in 

paragraph (d) of section 180.666, as it is 

subsumed by the tolerance for non-grass 

animal feeds, group 18 being established 

in paragraph (a) of the same section. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

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 


ehiers on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 27025 

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: April 26, 2016. 

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 § 180.666, amend the table in 

paragraph (a) as follows: 

■ i. Add alphabetically the entries 

‘‘Citrus, dried pulp’’, ‘‘Citrus, oil’’, 

‘‘Fruit, citrus, group 10–10’’, ‘‘Grass 

forage, fodder and hay, group 17’’, 

‘‘Milk, fat’’, ‘‘Non-grass animal feed, 

group 18’’, ‘‘Poultry, fat’’, ‘‘Poultry, 

meat’’ and ‘‘Poultry, meat byproduct’’. 

■ ii. Revise the following entries 

‘‘Cattle, fat’’, ‘‘Cattle, meat byproduct’’, 

‘‘Egg’’, ‘‘Goat, fat’’, ‘‘Goat, meat 

byproduct’’, ‘‘Horse, fat’’, ‘‘Horse, meat 

byproduct’’, ‘‘Milk’’, ‘‘Sheep, fat,’’ and 

‘‘Sheep, meat byproduct’’. 

■ iii. Remove from the table in 

paragraph (d) the entry ‘‘non-grass 

animal feeds, group 18’’. 

The amendments read as follows: 

§ 180.666 Fluxapyroxad; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, fat .............................. 0.06 

* * * * * 

Cattle, meat byproduct ......... 0.04 

Citrus, dried pulp .................. 3.0 

Citrus, oil ............................... 40 

* * * * * 

Egg ....................................... 0.01 

Fruit, citrus, group 10–10 ..... 1.0 

* * * * * 

Grass, forage, fodder and 

hay, group 17 .................... 40 

Goat, fat ................................ 0.06 

* * * * * 

Goat, meat byproduct ........... 0.04 

* * * * * 

Horse, fat .............................. 0.06 

* * * * * 

Horse, meat byproduct ......... 0.04 

Milk ....................................... 0.01 

Milk, fat ................................. 0.15 

Non-grass animal feed, 

group 18 ............................ 30 

* * * * * 

Poultry, fat ............................ 0.01 

Poultry, meat ........................ 0.01 

Poultry, meat byproduct ....... 0.01 

* * * * * 

Sheep, fat ............................. 0.06 

* * * * * 

Sheep, meat byproduct ........ 0.04 

* * * * * 

* * * * * 

[FR Doc. 2016–10581 Filed 5–4–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0213; FRL–9945–58] 

Butanedioic Acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, Disodium 

Salts; 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 butanedioic 

acid, 2-sulfo-, C-C9-11-isoalkyl esters, 

C10-rich, disodium salts (CAS Reg. No. 

815583–91–6) when used as an inert 

ingredient (surfactant) in pesticides 

applied to growing crops and raw 

agricultural commodities after harvest 

under 40 CFR 180.910 limited to 

maximum concentration of 10% by 

weight in pesticide formulations. Keller 

and Heckman LLP on behalf of Cytec 

Industries, 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 butanedioic acid, 

2-sulfo-, C-C9-11-isoalkyl esters, C10- 

rich, disodium salts. 

DATES: This regulation is effective May 

5, 2016. Objections and requests for 

hearings must be received on or before 

July 5, 2016, 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–2015–0213, 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 


ehiers on DSK5VPTVN1PROD with RULES