28270 Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 2, 2012. 

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 § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Acetone (Cas Reg. No. 67–64–1) ................................................................................................. ...................................... solvent or cosolvent. 

*******

[FR Doc. 2012–11623 Filed 5–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0421; FRL–9346–7] 

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 

14, 2012. Objections and requests for 

hearings must be received on or before 

July 13, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0421. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Olga 

Odiott, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9369; email address: 

odiott.olga@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

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

Title40/40tab_02.tpl. To access the 

OCSPP test guidelines referenced in this 

document electronically, please go 

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–2010–0421 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 13, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 


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In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0421, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of June 23, 

2010 (75 FR 35803) (FRL–8831–3), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 0F7709) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709–3528. The 

petition requested that 40 CFR part 180 

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)-1H-pyrazole-4- 

carboxamide, in or on multiple 

commodities. That notice 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 on EPA’s review 

of the data supporting the petition, 

BASF Company revised their petition 

(PP 0F7709) by: 

1. Proposing tolerances for corn, pop, 

grain; corn, sweet kernels plus cobs 

with husks removed; and wheat, grain; 

2. Decreasing or increasing the 

proposed tolerances for various 

commodities; 

3. Deleting the proposed tolerance for 

vegetable, root, subgroup 1A and 

proposing a tolerance for beet, sugar; 

and 

4. Proposing a tolerance for oilseeds, 

group 20. 

The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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 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. 

In accordance with the EPA’s Final 

Guidelines for Carcinogen Risk 

Assessment (March, 2005), 

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: 

• No treatment-related tumors were 

seen in male or female mice when tested 

at doses that were adequate to assess 

carcinogenicity (including the Limit 

Dose); 

• Treatment-related liver tumors were 

seen in male rats at doses ≥250 parts per 

million (ppm) (11 milligrams/kilogram/ 

day (mg/kg/day)) and in female rats at 

doses ≥1,500 ppm (82 mg/kg/day); 

• Treatment-related thyroid follicular 

cell tumors were seen in male rats only 

at doses ≥1,500 ppm (68 mg/kg/day); 

• There is no mutagenicity concern 

from in vivo or in vitro assays; 

• The hypothesized mode of action 

(i.e., a non-genotoxic) for each tumor 

type (i.e., the liver and thyroid) was 

supported by adequate studies that 

clearly identified the sequence of key 

events, dose-response concordance and 

temporal relationship to the tumor 

types. The mode of action met the 

criteria established by the Agency. 

The Agency has determined that the 

chronic population adjusted dose 

(cPAD) will adequately account for all 

chronic effects, including 

carcinogenicity, that could result from 

exposure to fluxapyroxad. 

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. 


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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 

‘‘Fluxapyroxad: Human Health Risk 

Assessment for Use of New Active 

Ingredient on Cereal Grains, Legume 

Vegetables (Succulent and Dry), Oil 

Seed Crops (Canola and Sunflower), 

Peanuts, Pome Fruit, Stone Fruit, Root 

and Tuber Vegetables (Potatoes and 

Sugar Beets), Fruiting Vegetables, and 

Cotton,’’ at page 39 in docket ID number 

EPA–HQ–OPP–2010–0421–0005. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for fluxapyroxad used for 

human risk assessment is shown in the 

following Table. 

TABLE—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 = 10x 

UFH = 10x 

FQPA SF = 1x 

aRfD = 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 

cRfD = 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) 

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. EPA assessed 

dietary exposures from fluxapyroxad in 

food as follows: 


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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 U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, tolerance level residues 

adjusted to account for metabolites of 

concern, 100 percent crop treated (PCT) 

assumptions, and Dietary Exposure 

Evaluation Model (DEEM) default and 

empirical processing factors were used. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. 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. Highest average field trial 

(HAFT) residues for parent plus 

metabolite were used for all plant 

commodities. For livestock 

commodities, tolerance level residues 

adjusted to account for metabolites of 

concern were used. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or nonlinear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. 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. EPA did 

not use anticipated residue or PCT 

information in the acute dietary 

assessment for fluxapyroxad. Tolerance 

level residues and 100 PCT information 

were assumed for all food commodities. 

For the chronic dietary assessment 

tolerance level residues and 100 PCT 

information were assumed for livestock 

commodities. HAFT residues for parent 

plus metabolite were used for all plant 

commodities. 

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. 

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 First Index Reservoir 

Screening Tool (FIRST), and the 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of fluxapyroxad for acute 

exposures are estimated to be 14.1 parts 

per billion (ppb) for surface water and 

0.087 ppb for ground water. For chronic 

exposures the EDWCs are estimated to 

be 6.7 ppb for surface water and 0.087 

ppb for ground water. Modeled 

estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

EDWCs of 14.1 ppb for surface water 

and 0.087 ppb for ground water were 

used for the acute and the chronic 

dietary assessments, respectively. 

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 not registered for any 

specific use patterns that would result 

in residential exposure. 

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 (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 


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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 

prenatal 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. Neither the acute or the 

subchronic neurotoxicity studies 

indicated specific neurotoxicity 

responses to fluxapyroxad. Because 

fluxapyroxad can disrupt thyroid 

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. 

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 

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 6% 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 48% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for fluxapyroxad. 

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 not 

registered for any use patterns that 

would result in short-term residential 

exposure and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD. 

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). 

Fluxapyroxad is not registered for any 

use patterns that would result in 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD. 

5. Aggregate cancer risk for U.S. 

population. In accordance with the 

EPA’s Final Guidelines for Carcinogen 

Risk Assessment (March 2005), 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. 

As noted above, chronic exposure to 

fluxapyroxad from food and water will 

utilize 48% of the cPAD for children 1– 

2 years 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 and the 

metabolites M700F008 and M700F048, 

so the method also serves as the 

confirmatory method. 

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. 


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Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 28275 

C. Revisions to Petitioned-For 

Tolerances 

Based on EPA’s review, BASF 

Company revised their petition (PP 

0F7709) by: 

1. Proposing tolerances for corn, pop, 

grain; corn, sweet kernels plus cobs 

with husks removed; and wheat, grain. 

Tolerances for these commodities were 

originally proposed as part of the 

respective crop group tolerances, but the 

Agency determined that separate 

tolerances are needed because of 

differences between the needed 

tolerances and the proposed crop group 

tolerances. 

2. Decreasing or increasing the 

proposed tolerances for various 

commodities. 

3. Deleting the proposed tolerance for 

vegetable, root, subgroup 1A and 

proposing a tolerance for beet, sugar. 

The submitted data are not sufficient to 

support a tolerance for the proposed 

subgroup 1A, but it supports a tolerance 

for beet, sugar. 

4. Deleting tolerances that the Agency 

determined are not needed and/or are 

covered by other proposed tolerances. 

5. Proposing a tolerance for oilseeds, 

group 20. The registrant had proposed 

tolerances for all the representative 

commodities for crop group 20 and the 

submitted data supports establishment 

of the group tolerance. 

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 petition. 

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 

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) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 2, 2012. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Add § 180.666 to subpart C to read 

as follows: 

§ 180.666 Fluxapyroxad; tolerances for 

residues. 

(a) General. Tolerances are 

established for 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)-1Hpyrazole-4-carboxamide in or on the 

commodity. 

Commodity Parts per 

million 

Apple, wet pomace ................... 2 .0 

Beet, sugar ............................... 0 .1 

Beet, sugar, dried pulp ............. 0 .1 

Beet, sugar, tops ...................... 7 .0 

Cattle, fat .................................. 0 .05 

Cattle, meat .............................. 0 .01 

Cattle, meat byproducts ........... 0 .03 

Corn, field, grain ....................... 0 .01 

Corn, oil .................................... 0 .03 

Corn, pop, grain ........................ 0 .01 

Corn, sweet, kernels plus cobs 

with husks removed .............. 0 .15 

Cotton, gin byproducts ............. 0 .01 

Cotton, undelinted seed ........... 0 .01 

Egg ........................................... 0 .002 

Fruit, pome, group 11 ............... 0 .8 

Fruit, stone, group 12 ............... 2 .0 

Goat, fat .................................... 0 .05 


emcdonald on DSK29S0YB1PROD with RULES
28276 Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations 

Commodity Parts per 

million 

Goat, meat ................................ 0 .01 

Goat, meat byproducts ............. 0 .03 

Grain, aspirated fractions ......... 20 .0 

Grain, cereal, group 15, (except 

corn, field, grain; except 

corn, pop, grain; except corn, 

kernels plus cobs with husks 

removed; except wheat) ....... 3 .0 

Grain, cereal, forage, fodder 

and straw, group 16 .............. 20 

Horse, fat .................................. 0 .05 

Horse, meat .............................. 0 .01 

Horse, meat byproducts ........... 0 .03 

Milk ........................................... 0 .005 

Oilseeds, group 20 ................... 0 .9 

Pea and bean, dried shelled 

except soybean, subgroup 

6C .......................................... 0 .4 

Pea and bean, succulent 

shelled, subgroup 6B ............ 0 .5 

Peanut ...................................... 0 .01 

Peanut, refined oil .................... 0 .02 

Plum, prune .............................. 3 .0 

Potato, wet peel ........................ 0 .1 

Rice, bran ................................. 4 .5 

Rice, hulls ................................. 8 .0 

Sheep, fat ................................. 0 .05 

Sheep, meat ............................. 0 .01 

Sheep, meat byproducts .......... 0 .03 

Soybean, hulls .......................... 0 .3 

Soybean, seed .......................... 0 .15 

Vegetable, foliage of legume, 

group 7 .................................. 30 

Vegetables, fruiting, group 8 .... 0 .7 

Vegetable, legume, edible podded, subgroup 6A ................. 2 .0 

Vegetable, tuberous and corm, 

subgroup 1C ......................... 0 .02 

Wheat, bran .............................. 0 .6 

Wheat, grain ............................. 0 .3 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–11602 Filed 5–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0425; FRL–9341–8] 

Penflufen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of penflufen in or 

on multiple commodities which are 

identified and discussed later in this 

document. Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

14, 2012. Objections and requests for 

hearings must be received on or before 

July 13, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0425. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Marianne Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8043; email address: 

lewis.marianne@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

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

Title40/40tab_02.tpl. To access the 

OCSPP test guidelines referenced in this 

document electronically, please go 

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–2010–0425 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 13, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0425, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 


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