10968 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Rules and Regulations 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 9, 2012. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.655 is added to read as 

follows: 

§ 180.655 Flazasulfuron; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of flazasulfuron, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

flazasulfuron (N-[[(4,6-dimethoxy-2- 

pyrimidinyl)amino]carbonyl]-3- 

(trifluoromethyl)-2- 

pyridinesulfonamide). 

Commodity Parts per 

million 

Fruit, citrus, group 10–10 ........... 0.01 

Grape .......................................... 0.01 

Sugarcane .................................. 0.01 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–4332 Filed 2–23–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0364; FRL–9336–9] 

Fluopyram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluopyram in 

or on multiple commodities which are 

identified and discussed later in this 

document. Bayer Crop Science 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 24, 2012. Objections and 

requests for hearings must be received 

on or before April 24, 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–2009–0364. 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: Lisa 

Jones, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 308–9424; 

email address: jones.lisa@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 

harmonized 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–2009–0364 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 24, 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–2009–0364, 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 


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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 January 6, 

2010 (75 FR 864) (FRL–8801–5), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 8F7358 and 

8F7463) by Bayer Crop Science, 2.T.W. 

Alexander Drive, Research Triangle 

Park, NC 27709. 

Petition 8F7358 requested that 40 CFR 

part 180 be amended by establishing 

tolerances on residues of the fungicide, 

fluopyram, N-[2-[3-chloro-5- 

(trifluoromethyl)-2-pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates in or on 

the following commodities: Grape at 2.0 

parts per million (ppm); strawberry at 

2.0 ppm; and tomato at 1.0 ppm. A 

subsequent petition 8F7463 requested 

that 40 CFR part 180 be amended by 

establishing additional tolerances on 

residues of the fungicide, fluopyram, N- 

[2-[3-chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates in or on 

the following commodities: Alfalfa, 

forage at 0.25 ppm; alfalfa, hay at 0.80 

ppm; almond, hulls at 8.0 ppm; apple, 

wet pomace at 2.5 ppm; artichoke at 2.0 

ppm; banana at 1.0 ppm; beet, sugar, 

roots at 0.10 ppm; berry, low growing, 

subgroup 13–07G at 2.0 ppm; Brassica, 

head and stem, subgroup 5A at 3.0 ppm; 

Brassica, leafy greens, subgroup 5B at 35 

ppm; bushberries, subgroup 13–07B at 

10 ppm; caneberries, subgroup 13–07A 

at 5.0 ppm; citrus, oil at 10 ppm; corn, 

sweet, kernel plus cob with husk 

removed at 0.10 ppm; cotton, gin 

byproducts at 0.05 ppm; cotton, 

undelinted seed at 0.10 ppm; fruit, 

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

group 11 at 1.0 ppm; fruit, small, vine, 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 2.0 ppm; fruit, 

stone, group 12 at 2.0 ppm; grain, cereal, 

forage, fodder and straw, group 16, 

except rice, forage at 8.0 ppm; grain, 

cereal, forage, fodder and straw, group 

16, except rice, hay, straw and stover at 

14 ppm; grain, cereal, forage, fodder and 

straw, group 16, except rice, aspirated 

fractions at 50 ppm; grain, cereal, group 

15, except rice and sweet corn at 3.0 

ppm; grape, raisin at 3.5 ppm; grass, 

forage, fodder and hay, group 17, forage 

at 80 ppm; grass, forage, fodder and hay, 

group 17, hay at 30 ppm; herbs, 

subgroup 19A, fresh at 50 ppm; herbs, 

subgroup 19A, dried at 260 ppm; hop, 

dried cones at 100 ppm; nut, tree, group 

(including pistachio) 14 at 0.05 ppm; 

okra at 8.0 ppm; oilseed, group 20, 

except cotton at 5.0 ppm; onion, bulb, 

subgroup 3–07A at 0.30 ppm; onion, 

green, subgroup 3–07B at 20 ppm; 

peanut at 0.05 ppm; peanut, hay at 50 

ppm, pepper, non-bell at 8.0 ppm; 

potato, processed potato waste at 0.15 

ppm; soybean, aspirated fractions at 70 

ppm; soybean, forage at 8.0 ppm; 

soybean, hay at 30 ppm; soybean, hulls 

at 0.40 ppm; soybean, seed at 0.30 ppm; 

spices, except black pepper, subgroup 

19B at 100 ppm; vegetable, cucurbit, 

group 9 at 1.0 ppm; vegetable, foliage of 

legume, except soybean, subgroup 7A, 

forage at 30 ppm; vegetable, foliage of 

legume, except soybean, subgroup 7A, 

hay at 75 ppm; vegetable, foliage of 

legume, except soybean, subgroup 7A, 

vines at 16 ppm; vegetable, fruiting, 

except non-bell pepper, group 8 at 1.0 

ppm; vegetable, leafy, except Brassica, 

group 4 at 35 ppm; vegetable, leaves of 

root and tuber, group 2 at 30 ppm; 

vegetable, legume, edible podded, 

subgroup 6A at 2.0 ppm; vegetable, 

legume, succulent shelled, subgroup 6B 

at 0.20 ppm; vegetable, pea and bean, 

dried shelled (except soybean), 

subgroup 6C at 0.50 ppm; vegetable, 

root and tuber, except sugar beet, 

subgroup 1B at 0.50 ppm; and vegetable, 

tuberous and corm, subgroup 1C at 0.05 

ppm. 

This petition (8F7463) also requested 

that 40 CFR part 180 be amended by 

establishing tolerances on residues of 

the fungicide, fluopyram, N-[2-[3- 

chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates, in or on 

the following commodities: Cattle, fat at 

0.10 ppm; cattle, meat at 0.10 ppm; 

cattle, meat byproducts, except liver at 

0.10 ppm; cattle, liver at 1.2 ppm; eggs 

at 0.1 ppm; goat, fat at 0.10 ppm; goat, 

meat at 0.10 ppm; goat, meat 

byproducts, except liver at 0.10 ppm; 

goat, liver at 1.2 ppm; hog, fat at 0.01 

ppm; hog, meat at 0.01 ppm; hog, meat 

byproducts, except liver at 0.01 ppm; 

hog, liver at 0.15 ppm; horse, fat at 0.10 

ppm; horse, meat at 0.10 ppm; horse, 

meat byproducts, except liver at 0.10 

ppm; horse, liver at 1.2 ppm, milk at 1.2 

ppm; poultry, fat at 0.05 ppm; poultry, 

meat at 0.03 ppm; poultry, meat 

byproducts at 0.20 ppm; sheep, fat at 

0.10 ppm; sheep, meat at 0.10 ppm; 

sheep, meat byproducts, except liver at 

0.10 ppm; and sheep, liver at 1.2 ppm. 

That notice referenced a summary of 

the petitions prepared by Bayer Crop 

Science, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. 

One comment was received from a 

private citizen who opposed the 

manufacturing and selling of this 

product due to the lack of available bee 

information. This comment is 

considered irrelevant because the safety 

standard for approving tolerances under 

section 408 of the FFDCA is directed 

solely at the safety of the pesticide 

residues in food to the food consumer 

and does not permit consideration of 

environmental effects on bees. 

Based upon review of the data 

supporting the petitions, EPA has 

revised tolerance levels. Subsequently, 

the petitions have been further modified 

per Bayer Crop Science’s request to 

withdraw a majority of the primary 

crops initially proposed for this action, 

and expanded the original rotatable 

crops of alfalfa and cotton to include 

canola, soybean, and cereals grains 

except rice, December 8, 2011 (76 FR 

76676) (FRL–9328–8). The reason for 

these changes is explained in Unit 

IV.D.START. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

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

of FFDCA, and the factors specified in 

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


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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 fluopyram 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluopyram 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. 

Decreased body weight and liver 

effects were the common and frequent 

findings in the fluopyram subchronic 

and chronic oral toxicity studies in rats, 

mice, and dogs, and they appeared to be 

the most sensitive effects. Liver effects 

were characterized by increased liver 

weight, hepatocellular hypertrophy, 

hepatocellular vacuolation, increased 

mitosis and hepatocellular necrosis. In 

the carcinogenicity study, increased 

liver tumors were also observed in 

female rats. Liver effects in rodents were 

seen at lower dose levels than those in 

the dogs. Thyroid effects were found at 

dose levels similar to those that 

produced liver effects in rats and mice; 

these effects consisted of follicular cell 

hypertrophy, increased thyroid weight 

and hyperplasia at dose levels greater 

than or equal to 100 milligrams/ 

kilogram/day (mg/kg/day). Changes in 

thyroid hormone levels were also seen 

in a subchronic toxicity study. In male 

mice, there was an increased incidence 

of thyroid adenomas. 

Fluopyram is classified as ‘‘Likely to 

be Carcinogenic to Humans’’ and a unit 

risk, Q1*, of 1.55 × 10¥2 (mg/kg/day)¥1

was used for the linear low dose 

extrapolation of cancer risk based on 

liver tumors in female rats; thyroid 

tumors were also observed in male 

mice. Fluopyram is not genotoxic or 

mutagenic. 

Fluopyram is not a developmental 

toxicant, nor did it adversely affect 

reproductive parameters. No evidence of 

qualitative or quantitative susceptibility 

was observed in developmental studies 

in rats and rabbits or in a 

multigeneration study in rats. 

In an acute neurotoxicity study, 

transient decreased motor activity was 

seen only on the day of treatment, but 

no other findings demonstrating 

neurotoxicity were observed. In 

addition, no neurotoxicity was observed 

in the subchronic neurotoxicity study in 

the presence of other systemic adverse 

effects. Fluopyram did not produce 

treatment-related effects on the immune 

system. 

Fluopyram has low acute toxicity via 

the oral, dermal and inhalation routes of 

exposure. Fluopyram is not a skin or eye 

irritant or sensitizer under the 

conditions of the murine lymph node 

assay. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluopyram 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 the document 

‘‘Fluopyram: Human Health Risk 

Assessment for Proposed Uses on 

Apples, Bananas (Import only), Cherries 

(Sweet and Tart), Dried Beans, Peanuts, 

Potatoes, Strawberries, Sugar Beets, Tree 

Nuts, Watermelon, and Wine Grapes’’ 

beginning at Appendix A, pages 41–47 

in docket ID number EPA–HQ–OPP– 

2009–0364. 

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. 

The details for selecting toxicity 

endpoints and points of departure for 

various exposure scenarios can be found 

at http://www.regulations.gov in the 

document ‘‘Fluopyram: Human Health 

Risk Assessment for Proposed Uses on 

Apples, Bananas (Import only), Cherries 

(Sweet and Tart), Dried Beans, Peanuts, 

Potatoes, Strawberries, Sugar Beets, Tree 

Nuts, Watermelon, and Wine Grapes’’ in 

Appendix A on pages 47–66 in docket 

ID number EPA–HQ–OPP–2009–0364. 

A summary of the toxicological 

endpoints for fluopyram used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOPYRAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

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).

NOAEL= 50 mg/kg/day ..... UFA= 10X ..........................

UFH=10X 

FQPA SF=1X 

aRfD = 0.50 mg/kg/day .....

aPAD = 0.50 mg/kg/day 

Acute Neurotoxicity Study 

in Rats. 

The LOAEL of 100 mg/kg 

in females is based on 

decreased motor and locomotor activity in females. 

The LOAEL in males was 

125 mg/kg/day. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOPYRAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario Point of departure Uncertainty/ 

FQPA safety factors 

RfD, PAD, Level of concern for risk assessment Study and toxicological 

effects 

Acute Dietary (Females 

13–49 years of age).

An endpoint attributable to a single dose exposure has not been identified for this subpopulation. 

Chronic Dietary (All Populations).NOAEL= 1.2 mg/kg/day .... UFA= 10X ..........................

UFH= 

10X 

FQPA SF=1X 

cRfD = 0.012 mg/kg/day ...

cPAD = 0.012 mg/kg/day 

Combined Chronic/Carcinogenicity in Rats. 

The LOAEL of 6.0 mg/kg/ 

day is based on follicular 

cell hypertrophy in the 

thyroid, and increased 

liver weight with gross 

pathological and 

histopathological findings. 

Cancer (oral, dermal, inhalation).Based on the liver tumor in female rats, EPA classified fluopyram as a ‘‘Likely to be Carcinogenic to Human’’ and 

recommended the use of linear low dose extrapolation model for risk assessment using a unit risk, Q1* = 1.55 × 

10¥2 (mg/kg/day)¥1. 

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 (a = acute, c = chronic). mg/kg/day = milligrams/kilogram/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluopyram, EPA considered 

exposure under the petitioned-for 

tolerances. EPA assessed dietary 

exposures from fluopyram 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 fluopyram. 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). The acute dietary 

analysis included tolerance residue 

levels, 100% crop treated assumption 

and processing factors (empirical and 

default). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. The chronic dietary analysis 

included average residue levels from 

crop field trials, 100% crop treated 

assumption, and processing factors 

(empirical and default). 

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. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

non-linear 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 fluopyram should be 

classified as ‘‘Likely to be Carcinogenic 

to Humans’’ and a linear approach has 

been used to quantify cancer risk. The 

cancer dietary analysis included average 

residue levels from crop field trials, 

processing factors (empirical and 

default, commercial and household), 

and percent crop treated (PCT) 

estimates. 

iv. Anticipated residue and PCT 

information. EPA used tolerance level 

residues and assumed 100% crop 

treated in the acute dietary assessment 

for fluopyram. For the chronic dietary 

assessment, EPA used average residues 

from field trials and 100% CT 

information. The cancer dietary risk 

assessment used average residues from 

field trials and projected percent crop 

treated estimates based on processing 

factors. 

Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

new uses as follows: 


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Almonds: 33%; apples: 40%; barley: 

22%; dry beans: 7%; cherry: 49%; 

cotton: 7%; grapes: 79%; oats: 23%; 

peanuts: 67%; potatoes: 64%; rapeseed: 

73%; rye: 63%; sorghum: 12%; 

soybeans: 1%; strawberries: 71%; sugar 

beets: 48%; watermelon: 54%; and 

wheat: 1%. 

EPA’s estimate of the percent crop 

treated for the new uses of fluopyram 

represents the upper bound of use 

expected during the pesticide’s initial 5 

years of registration; that is, the percent 

crop treated for fluopyram is a threshold 

of use that EPA is reasonably certain 

will not be exceeded for this registered 

use site. The percent crop treated for use 

in the chronic dietary assessment is 

calculated as the average percent crop 

treated of the market leader or leaders 

(i.e., the pesticides with the greatest 

percent crop treated) on that crop over 

the 3 most recent years of available data. 

The percent crop treated for use in the 

acute dietary assessment is the 

maximum observed percent crop treated 

over the same period. Comparisons are 

only made among pesticides of the same 

pesticide types (e .g., the market leader 

for fungicides on the use crop is 

selected for comparison with a new 

fungicide). The market leader included 

in the estimation may not be the same 

for each year since different pesticides 

may dominate at different times. 

To calculate these percent crop 

treated values, EPA used recent data 

from the National Agricultural Statistics 

Service (NASS) 2002–2006, and recent 

proprietary data (2006–2010). The 

estimates for the primary crops are 

based on the market leader approach 

involving several registered fungicides, 

and the estimates for the rotational 

crops are based on acres of wheat, corn, 

sorghum, barley, oats, rye, millet, 

soybeans, canola, cotton, and alfalfa 

grown relative to the total acreage of dry 

beans and potatoes treated with 

fluopyram. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which fluopyram may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluopyram in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fluopyram. 

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. 

Environmental fate studies indicate 

that the parent fluopyram is stable 

under environmental conditions. 

Reported half-lives range from 89 days 

in field and aqueous photolysis studies 

to >1,000 days in aerobic/anaerobic 

water/sediment systems. Fluopyram is 

mobile in soil and can therefore, be 

expected to occur in surface water 

runoff and/or in ground water leachate. 

Upper-bound ground water estimates 

were derived using the Tier I Screening 

Concentration in Ground Water (SCI– 

GROW) model. Surface water estimates 

were partially refined by incorporating 

a foliar degradation rate into the Tier II 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/ 

EXAMS) model. The foliar decay rate 

was calculated from field trial studies in 

which residues were determined at 

various intervals following foliar 

application; no rain or irrigation 

occurring during the study period. All 

other inputs reflect high-end 

assumptions regarding application rates 

and percent cropped area (PCA) in the 

watershed. 

Based on the Tier II PRZM/EXAMS 

and SCI–GROW models the estimated 

drinking water concentrations (EDWCs) 

of fluopyram for acute exposures are 13 

parts per billion (ppb) for surface water 

and 0.32 ppb for ground water. The 

EDWCs of fluopyram for chronic 

exposures for non-cancer assessments 

are estimated to be 4.9 ppb for surface 

water and 0.32 ppb for ground water 

and the EDWCs of fluopyram chronic 

exposures for cancer assessments are 

estimated to be 3.5 ppb for surface water 

and 0.32 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 13 ppb (1 in 10 year 

annual peak) based on a maximum 

application rate of 0.446 lb ai/A/season 

(cucumber) was used to access the 

contribution to drinking water. For 

chronic dietary risk assessment, the 

water concentration of value 4.9 ppb 

(1 in 10 year annual mean) based on a 

maximum application rate of 0.356 lb 

active ingredient/Acre (a.i./A)/season 

(potato) was used to access the 

contribution to drinking water. For 

cancer dietary risk assessment, the 

water concentration of value 3.5 ppb 

(1 in 30 year annual mean) based on a 

maximum application rate of 0.356 lb 

a.i./A/season (potato) was used to access 

the contribution of 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). 

Fluopyram 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 fluopyram to share a common 

mechanism of toxicity with any other 

substances, and fluopyram does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

fluopyram 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 


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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. 

The available developmental toxicity 

studies in rats and rabbits and the multigeneration reproduction in rats 

demonstrate no evidence of increased 

susceptibility in the developing or 

young animals which were exposed 

during prenatal or postnatal periods. 

Decreased fetal body weight was 

observed at levels equal to or greater 

than the maternal LOAEL in both rat 

and rabbit developmental studies. 

Likewise, body weight effects were seen 

in offspring at levels equal to the 

parental LOAEL in the rat 2-generation 

reproductive toxicity study. 

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 fluopyram 

is complete and includes the 

immunotoxicity study and neurotoxicity 

screening battery. 

ii. The fluopyram toxicology database 

did not demonstrate evidence of 

neurotoxicity. Although transient 

decreases in motor and locomotor 

activities in the acute neurotoxicity 

study on the day of treatment and 

limited use of hind-limbs and reduced 

motor activity in the rat chronic/ 

carcinogenicity study were seen, there 

were no other associated 

neurobehavioral or histopathology 

changes found in other studies in the 

fluopyram toxicity database. The effects 

seen in the chronic/carcinogenicity 

study were in the presence of increased 

mortality and morbidity such as general 

pallor and appearance. Therefore, the 

reduced motor activity and limited use 

of hind-limbs seen in these two studies 

were judged to be the consequence of 

the systemic effects and not direct 

neurotoxicity. There is no indication 

that fluopyram is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

fluopyram results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the multi-generation 

reproduction study. 

iv. There are no residual uncertainties 

in the exposure database. Although 

extended field rotational crop studies 

are required as a condition of 

registration, the rotational crop 

tolerances used in the dietary risk 

assessment are not expected to 

underestimate exposure because they 

are based on crop residue results from 

direct foliar treatment as opposed to 

residues taken up by plants through 

roots from treated soil. The acute dietary 

exposure assessment was performed 

using tolerance level residues for all 

crops whereas the chronic dietary 

assessment included average field trial 

residue levels for all crops. Both acute 

and chronic assessments assumed 100% 

crop treated and incorporated empirical 

or default processing factors. The 

dietary exposure assessment also 

assumed that all drinking water will 

contain fluopyram at the highest EDWC 

levels modeled by the Agency for 

ground or surface water. Residential 

exposures are not expected. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to fluopyram in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by fluopyram. 

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 

fluopyram will occupy 8.8% of the 

aPAD for children 1 to 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 fluopyram from 

food and water will utilize 13% of the 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for fluopyram. 

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). Because no short-term 

adverse effect was identified; fluopyram 

is not expected to pose a short-term risk. 

A short-term adverse effect was 

identified; however, fluopyram is not 

registered for any use patterns that 

would result in short-term residential 

exposure. Short-term risk is assessed 

based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-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 short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 

fluopyram. 

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). 

Because no intermediate-term effect was 

identified, fluopyram is not expected to 

pose an intermediate-term risk. An 

intermediate-term adverse effect was 

identified; however, fluopyram 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 short-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 

fluopyram. 

5. Aggregate cancer risk for U.S. 

population. Using the exposure 

assumptions described in this unit for 

the cancer risk assessment, EPA has 

concluded that exposure to fluopyram 

from food and water will result in a 

lifetime cancer risk of 2.9 × 10¥6 for the 

general U.S. population. EPA generally 

considers cancer risks in the range of 

1 in 1 million (1 × 10¥6) or less to be 

negligible. The precision which can be 

assumed for cancer risk estimates is best 

described by rounding to the nearest 

integral order of magnitude on the log 

scale; for example, risks falling between 


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3 × 10¥7 and 3 × 10¥6 are expressed as 

risks in the range of 10¥6. Considering 

the precision with which cancer hazard 

can be estimated, the conservativeness 

of low-dose linear extrapolation, and the 

rounding procedure described above, 

cancer risk should generally not be 

assumed to exceed the benchmark level 

of concern of the range of 10¥6 until the 

calculated risk exceeds approximately 

3 × 10¥6. This is particularly the case 

where some conservatism is maintained 

in the exposure assessment. 

Although the fluopyram exposure risk 

assessment is refined, it retains some 

conservatism due, among other things, 

to the use of field trial data to estimate 

residues in food and the use of high-end 

assumptions to estimate residues in 

water. Accordingly, EPA has concluded 

the cancer risk from aggregate exposure 

to fluopyram falls within the range of 

1 × 10¥6 and is thus negligible. 

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 fluopyram 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The German multiresidue method 

DFG Method S 19, a gas 

chromatography with mass selective 

detection (GC/MSD) method, has been 

proposed for the enforcement of 

tolerances for fluopyram residues in or 

on crop commodities, and a high 

performance liquid chromatography 

method with tandem mass spectrometry 

detection (HPLC/MS/MS), Method 

01079, has been proposed for the 

enforcement of tolerances for residues of 

fluopyram and its metabolite, AE 

C656948-benzamide, in livestock 

commodities. The validated limit of 

quantitation (LOQ) is 0.01 ppm for each 

analyte in each matrix. The proposed 

enforcement method for plant 

commodities (DFG Method S19) and 

livestock commodities (Method 01079) 

are deemed adequate as enforcement 

methods. Adequate HPLC/MS/MS 

methods were used for data collection 

for crop and livestock commodities. The 

FDA multiresidue methods of PAM Vol. 

I are suitable for the determination of 

fluopyram in non-fatty matrices (using 

Section 302), but are not suitable for 

detection of AE C656948-benzamide 

residues. The method may be requested 

from: Chief, Analytical Chemistry 

Branch, Environmental Science Center, 

701 Mapes Rd., Ft. Meade, MD 20755– 

5350; telephone number: (410) 305– 

2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

Codex Maximum Residue Limits 

(CXLs) have been established for grape 

at 2 ppm and dried grapes (raisins) at 5 

ppm; milk at 0.07 ppm; mammalian 

meat at 0.1 ppm, and edible offal 

mammalian (meat byproducts) at 0.7 

ppm. For the purpose of international 

harmonization, EPA is establishing U.S. 

tolerances for wine grape at 2.0 ppm 

(raised from 1.4 ppm); milk at 0.07 ppm 

(raised from 0.06 ppm); and hog meat 

byproducts at 0.70 ppm (raised from 

0.45 ppm). 

The Codex MRL for grapes is based on 

field trials conducted in Europe, and is 

calculated by rounding up of the 

statistically determined 1.3 ppm to 2 

ppm. A U.S. tolerance for dried grapes 

(raisins) is not needed as the tolerance 

request is for wine-type grapes only, 

which are not converted to raisins. 

Harmonization of recommended U.S. 

tolerances for meat and meat byproducts 

(other than hog) with Codex MRLs 

cannot be achieved. The Codex MRL for 

livestock is calculated on the basis of 

the diets listed in Annex 6 of the 2009 

JMPR Report (OECD Feedstuffs Derived 

from Field Crops) and the use of a 

reasonable worst case diet/feed 

approach (RWCF). The dietary burden 

was calculated using only grape pomace 

residue and 20% contribution to the 

Australian dairy and beef cattle diets. 

The U.S. tolerance was based on 

guidance ‘‘Revisions of Feedstuffs in 

(Table 1) OPPTS Test Guideline 

860.1000’’ and ‘‘Guidance on 

Constructing Maximum Reasonably 

Balanced Diets (MRBD)’’. Based on the 

U.S. livestock diets (which does not 

include grape pomace) and the cattle 

feeding study, the meat byproduct 

(cattle, goat horse, sheep) tolerances 

need to be set at 1.1 ppm, a higher level 

than the 0.7 Codex MRL for edible offal. 

Similarly, the U.S. meat tolerances for 

these animals need to be set higher than 

the Codex MRL (0.15 versus 0.1 ppm). 

C. Revisions to Petitioned-For 

Tolerances 

Because the Agency’s preliminary risk 

assessment of fluopyram determined 

that aggregate exposure to fluopyram 

potentially exceeded safe levels, the 

petitioner withdrew tolerance proposals 

and registration requests for the 

following crops: Crop Group 1B Root 

vegetable; 1C Tuberous and corm 

vegetable (except potatoes and 

sugarbeet); Crop Group 2 Leaves of root 

and tuberous vegetables, Crop 

subgroups 3–07A and B Bulb vegetables; 

Crop Group 4 Leafy vegetables; Crop 

Group 5 Brassica; Crop Group 6A Edible 

legumes; Crop Group 6B Succulent 

beans and peas; Crop Group 6C (part) 

Dried peas and some dried beans, 

(except soybeans); Crop Group 7 Foliage 

of legume vegetables; Crop Group 8 

Fruiting vegetables; Crop Group 10 

Citrus; Crop Group 11 Pome fruit 

(except apple); Crop subgroups 13–07A 

and B Caneberries and Bushberries; 

Crop subgroup 13–07F Vine fruit 

(except wine grapes); Crop subgroup 

13–07G Low growing berries (except 

strawberry); Crop Group 15 Cereal 

Grains (except for rotational purposes); 

Crop Group16 Forage Cereals (except for 

rotational purposes); Crop Group17 

Grasses grown for forage or seed; Crop 

Group18 Non grass animal feeds; Crop 

Group19 Herbs and Spices; Crop Group 

20 Oilseeds (except canola); Hops; 

Globe artichoke; Christmas Trees; Turf; 

and Ornamentals. 

The petitioner subsequently, 

submitted a revised registration 

specifying uses only on the following 

crops: Apple; banana (no U.S. 

registration); bean, dry; beet, sugar, root; 

cherry (sweet and tart); grape, wine; nut 

tree crop group 14; peanut; pistachio; 

potatoes; strawberry; and watermelon. 

Based on the available field trial data, 

and NAFTA tolerance calculation 

procedures, the Agency recommended 

appropriate tolerance levels for 

individual commodities as opposed to 

levels proposed for crop groups. 

However, although the petitioner 

proposed a tolerance for ‘‘nut, tree, 

group 14 (including pistachio)’’ at 0.05 

ppm, EPA determined that separate 

tolerances must be established for the 

tree nut crop group and pistachio 

because pistachio is not at this time 

included in crop group 14. The 

available data indicate that 0.05 ppm is 

an appropriate level for these tolerances. 


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The petitioner has proposed 

tolerances for combined residues of 

fluopyram and AE C656948-benzamide 

in egg; milk; the fat, meat, and meat 

byproducts of poultry; and the fat, liver, 

meat, and meat byproducts (except 

liver) of cattle, goat, hog, horse, and 

sheep. The estimated livestock dietary 

burden and available feeding study data 

indicate that most of the proposed 

tolerances for livestock commodities are 

too low. In addition, EPA no longer 

establishes separate tolerances for liver 

(it is accounted for in the meat 

byproducts of livestock animals). Based 

on the NAFTA calculator, the Agency 

recommended higher tolerances. 

The revised registration permits crop 

rotation to alfalfa, cotton, canola, cereal 

grains (except rice), and soybean with 

certain restrictions. However, extensive 

field rotational crop data for these crops 

are not available. In the absence of 

sufficient rotational crop data, highly 

conservative target crop residue data 

were used for setting tolerance for 

rotational crops. The preference was to 

select an intermediate level between the 

confined accumulation/limited field 

rotational crop data and primary crop 

data for the target rotated crops so as to 

discourage potential misuse (i.e., direct 

foliar application) and provide adequate 

maximum residue levels for legal uses 

according to label instructions. Thus, 

pending extensive field rotational crop 

data, EPA recommends interim 

rotational crop tolerances be set at half 

of the calculated primary crop 

tolerances with a PBI of 30 days. 

In addition, the Agency determined 

tolerances were not required for the 

following petitioned commodities: Beet, 

sugar, tops; corn, sweet, kernel plus cob 

with husk removed; grain, cereal, forage, 

fodder and straw, group 16, except rice, 

aspirated fractions; and soybean hulls, 

thus, these tolerances have been 

removed. Tolerances were not needed 

for the following reasons: the tolerance 

for the commodity corn, sweet, kernel 

plus cob with husk removed is covered 

under grain, cereal, group 15, except 

rice; Bayer withdrew their requests for 

tolerances for grain, cereal, forage, 

fodder and straw, group 16, except rice; 

aspirated fractions and soybean, hulls; 

and the sugar beet top tolerance was 

withdrawn because sugar beet tops are 

no longer considered a major livestock 

commodity. 

Moreover, EPA is revising certain 

crop definitions (as proposed) for the 

following: almond, hulls; beet, sugar, 

roots; eggs; grain, cereal, group 15, 

except rice and sweet corn. The correct 

commodity terminology are almond, 

hull; beet, sugar, root; egg; and grain, 

cereal, group 15, except rice, 

respectively. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluopyram, in or on 

multiple commodities as shown in the 

codified text below. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 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. Section 180.661 is added to subpart 

C to read as follows: 

§ 180.661 Fluopyram; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

Fluopyram, N-[2-[3-chloro-5- 

(trifluoromethyl)-2-pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates in or on 

the commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 


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10976 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Rules and Regulations 

determined by measuring only 

fluopyram in or on the commodity. 

Commodity Parts 

per million 

Almond, hull .............................. 8 .0 

Apple ......................................... 0 .30 

Apple, wet pomace ................... 0 .60 

Banana 1 ................................... 1 .0 

Bean, dry .................................. 0 .09 

Beet, sugar, root ....................... 0 .04 

Cherry ....................................... 0 .60 

Grape, wine .............................. 2 .0 

Nut, tree, group 14 ................... 0 .05 

Peanut ...................................... 0 .02 

Pistachio ................................... 0 .05 

Potato ....................................... 0 .02 

Potato, processed potato waste 0 .08 

Strawberry ................................ 1 .5 

Watermelon .............................. 1 .0 

1There are no U.S. registrations. 

(2) Tolerances are established for 

residues of the fungicide fluopyram, N- 

[2-[3-chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates. 

Compliance with the tolerance levels 

specified in the table below is to be 

determined by measuring only the sum 

of fluopyram and its metabolite, 2- 

(trifluoromethyl)benzamide, calculated 

as the stoichiometric equivalent of 

fluopyram, in or on the commodity. 

Commodity Parts per 

million 

Cattle, fat .................................. 0 .11 

Cattle, meat .............................. 0 .15 

Cattle, meat byproducts ........... 1 .1 

Egg ........................................... 0 .25 

Goat, fat .................................... 0 .11 

Goat, meat ................................ 0 .15 

Goat, meat byproducts ............. 1 .1 

Hog, fat ..................................... 0 .05 

Hog, meat ................................. 0 .05 

Hog, meat byproducts .............. 0 .70 

Horse, fat .................................. 0 .11 

Horse, meat .............................. 0 .15 

Horse, meat byproducts ........... 1 .1 

Milk ........................................... 0 .07 

Poultry, fat ................................ 0 .20 

Poultry, meat ............................ 0 .15 

Poultry, meat byproducts .......... 0 .60 

Sheep, fat ................................. 0 .11 

Sheep, meat ............................. 0 .15 

Sheep, meat byproducts .......... 1 .1 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. It 

is recommended that tolerances be 

established for indirect or inadvertent 

residues of fungicide fluopyram, N-[2- 

[3-chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates, in or on 

the commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

fluopyram in or on the commodity. 

Commodity Parts per 

million 

Alfalfa, forage ........................... 0 .45 

Alfalfa, hay ................................ 1 .1 

Canola, seed ............................ 1 .8 

Cotton, gin byproducts ............. 0 .05 

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

Grain, cereal, forage, fodder 

and straw, group 16, except 

rice; forage ............................ 4 .0 

Grain, cereal, forage, fodder 

and straw, group 16, except 

rice; hay, straw and stover ... 7 .0 

Grain, cereal, group 15, except 

rice ........................................ 1 .5 

Soybean, forage ....................... 4 .0 

Soybean, hay ............................ 15 

Soybean, seed .......................... 0 .10 

[FR Doc. 2012–4321 Filed 2–23–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Part 252 

Defense Federal Acquisition 

Regulation Supplement; Technical 

Amendment 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD is making technical 

amendments to the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to provide needed editorial 

changes. 

DATES: Effective Date: February 24, 

2012. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Ynette Shelkin, Defense Acquisition 

Regulations System, OUSD (AT&L) 

DPAP (DARS), Room 3B855, 3060 

Defense Pentagon, Washington, DC 

20301–3060. Telephone 703–602–8384; 

facsimile 703–602–7887. 

SUPPLEMENTARY INFORMATION: This final 

rule amends the DFARS as follows: 

Æ 252.212–7001 Revises the clause 

date and makes conforming changes to 

the dates of the DFARS clauses 

referenced in paragraphs (b)(20) and 

(c)(2) of the clause. 

Æ 252.227–7013 Revises the clause 

date and corrects paragraph numbers 

referenced in paragraphs (b)(2)(i)(A), 

(b)(4), and (b)(6) of the clause. 

Æ 252.227–7014 Revises the clause 

date and corrects paragraph numbers 

referenced in paragraphs (b)(4)(i) and 

(b)(6) of the clause. 

List of Subjects in 48 CFR Part 252 

Government procurement. 

Ynette R. Shelkin, 

Editor, Defense Acquisition Regulations 

System. 

Therefore, 48 CFR part 252 is 

amended as follows: 

PART 252—SOLICITATION 

PROVISIONS AND CONTRACT 

CLAUSES 

■ 1. The authority citation for 48 CFR 

part 252 continues to read as follows: 

Authority: 41 U.S.C. 1303 and 48 CFR 

chapter 1. 

252.212–7001 [Amended] 

■ 2. Section 252.212–7001 is amended 

by removing the clause date 

‘‘(JANUARY 2012)’’ and adding ‘‘(FEB 

2012)’’ in its place, in paragraph (b)(20), 

removing ‘‘(SEP 2011)’’ and adding 

‘‘(FEB 2012)’’ in its place, and in 

paragraph (c)(2), removing ‘‘(SEP 2011)’’ 

and adding ‘‘(FEB 2012)’’ in its place. 

252.227–7013 [Amended] 

■ 3. Section 252.227–7013 is amended 

by removing the clause date ‘‘(SEP 

2011)’’ and adding ‘‘(FEB 2012)’’ in its 

place, in paragraph (b)(2)(i)(A), 

removing ‘‘as provided in paragraphs 

(b)(ii) and (b)(iv) through (b)(ix) of this 

clause’’ and adding ‘‘as provided in 

paragraphs (b)(1)(ii) and (b)(1)(iv) 

through (b)(1)(ix) of this clause’’ in its 

place, in paragraph (b)(4), removing 

‘‘enumerated in paragraph (a)(13) of this 

clause’’ and adding ‘‘enumerated in 

paragraph (a)(14) of this clause’’ in its 

place, and in paragraph (b)(6), removing 

‘‘in accordance with paragraph (a)(13)’’ 

and adding ‘‘in accordance with 

paragraph (a)(14)’’ in its place. 

252.227–7014 [Amended] 

■ 4. Section 252.227–7014 is amended 

by removing the clause date ‘‘(MAR 

2011)’’ and adding ‘‘(FEB 2012)’’ in its 

place, in paragraph (b)(4)(i), removing 

‘‘enumerated in paragraph (a)(14) of this 

clause or lesser rights in computer 

software documentation than are 

enumerated in paragraph (a)(13)’’ and 

adding ‘‘enumerated in paragraph 

(a)(15) of this clause or lesser rights in 

computer software documentation than 

are enumerated in paragraph (a)(14)’’ in 

its place, and in paragraph (b)(6), 

removing ‘‘made in accordance with 

paragraph (a)(14)’’ and adding ‘‘made in 


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