Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 14291 

the Federal Government and Indian 

tribes. Thus, EPA 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 

EPA 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). 

XI. 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 29, 2012. 

Keith A. Matthews, 

Director, Biopesticides and Pollution 

Prevention 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. Section 180.1206 is amended by 

revising paragraph (b) to read as follows: 

§ 180.1206 Aspergillus flavus AF36; 

exemption from the requirement of a 

tolerance. 

* * * * * 

(b) An exemption from the 

requirement of a tolerance is established 

for residues of Aspergillus flavus AF36 

in or on pistachio when applied as an 

antifungal agent and used in accordance 

with good agricultural practices. 

* * * * * 

[FR Doc. 2012–5769 Filed 3–8–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0349; FRL–9335–7] 

Penthiopyrad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of penthiopyrad 

in or on multiple commodities which 

are identified and discussed later in this 

document. Mitsui Chemical Agro, Inc. 

c/o Landis International Inc. requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 9, 2012. Objections and requests 

for hearings must be received on or 

before May 8, 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–2010–0349. 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: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8050; email address: 

maignan.tawanda@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–2010–0349 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 


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received by the Hearing Clerk on or 

before May 8, 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–2010–0349, 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 

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 

Tolerances 

In the Federal Register of October 27, 

2010 (75 FR 66092) (FRL–8848–3), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 9F7661) by Mitsui 

Chemical Agro, Inc. c/o Landis 

International Inc., P.O. Box 5126 

Valdosta, GA 31603–5126. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide penthiopyrad, 

(RS)-N-[2-(1,3-dimethylbutyl)-3- 

thienyl]-1-methyl-3-(trifluoromethyl)- 

1H-pyrazole-4-carboxamide, in or on 

fruit, pome, group 11 at 0.4 parts per 

million (ppm); apple, wet pomace at 1.0 

ppm; fruit, stone, group 12 at 4.0 ppm; 

low growing berry, subgroup 13–07G at 

3.0 ppm; vegetable, bulb, group 3 at 4.0 

ppm; vegetable, brassica head and stem, 

subgroup 5A at 8.0 ppm; vegetable, 

brassica leafy, subgroup 5B at 45 ppm; 

vegetable, fruiting, group 8 at 2.5 ppm; 

tomato, paste at 5.0 ppm; vegetable, 

cucurbit, group 9 at 1.0 ppm; vegetable, 

leafy, except brassica, group 4 at 20 

ppm; vegetable, root, subgroup 1A at 2.5 

ppm; vegetable, tuberous and corm, 

subgroup 1C at 0.06 ppm; vegetables, 

leaves of root and tuber, group 2 at 55 

ppm; vegetable, edible-podded legume, 

subgroup 6A at 2.5 ppm; vegetable, 

succulent, shelled peas and beans, 

subgroup 6B at 0.4 ppm; vegetable, pea 

and bean, dried shelled, except soybean, 

subgroup 6C at 0.3 ppm; soybean, seed 

at 0.3 ppm; soybean, hulls at 1.0 ppm; 

peanut, nutmeat at 0.04 ppm; grain, 

cereal (except corn, millet, sorghum) at 

0.2 ppm; corn, field, sweet, pop at 0.01 

ppm; corn, refined oil at 0.03 ppm; 

cereal grain, millet at 0.9 ppm; cereal 

grain, sorghum at 0.9 ppm; nut, tree, 

group 14 (including pistachios) at 0.05 

ppm; almond, hulls at 6.0 ppm; canola 

at 1.0 ppm; sunflower at 0.8 ppm; 

cotton, seed at 0.35 ppm; cotton, gin 

byproducts at 10 ppm; alfalfa, forage at 

10 ppm; alfalfa, hay at 25 ppm; foliage 

of legume vegetables, group 7, hay at 80 

ppm; foliage of legume vegetables, 

group 7, vines/forage at 30 ppm; peanut, 

hay at 50 ppm; grain, cereal, group 16, 

hay at 90 ppm; grain, cereal, group 16, 

forage at 25 ppm; grain, cereal, group 

16, straw at 2 ppm; grain, cereal, stover 

at 11 ppm and establishing tolerances 

for residues of penthiopyrad, (RS)-N-[2- 

(1,3-dimethylbutyl)-3-thienyl]-1-methyl3-(trifluoromethyl)-pyrazole-4- 

carboxamide and its major metabolite 

PAM (1-methyl-3-trifluoromethyl-1Hpyrazole-4-carboxamide) in animal 

commodities hog, meat at 0.01 ppm; 

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

ppm; hog, kidney at 0.01 ppm; hog, 

meat byproducts at 0.01 ppm; cattle, 

meat at 0.05 ppm; cattle, fat at 0.05 

ppm; cattle, liver at 0.2 ppm; cattle, 

kidney at 0.1 ppm; cattle, meat 

byproducts at 0.2 ppm; sheep, meat at 

0.01 ppm; sheep, fat at 0.02 ppm; sheep, 

liver at 0.05 ppm; sheep, kidney at 0.02 

ppm; sheep, meat byproducts at 0.05 

ppm; milk at 0.05 ppm; milk, fat at 0.01 

ppm; poultry, meat at 0.01 ppm; 

poultry, fat at 0.01 ppm; poultry, liver 

at 0.01 ppm; poultry, meat byproducts 

at 0.01 ppm; poultry, eggs at 0.01 ppm. 

That notice referenced a summary of the 

petition prepared by Mitsui Chemical 

Agro, Inc. c/o Landis International, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

several of the proposed tolerance levels. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 penthiopyrad 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with penthiopyrad 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. 

For penthiopyrad, the liver and 

thyroid are the target organs. In toxicity 

studies, short-term oral exposure 

resulted in liver alterations in rats and 

mice at similar doses, and in dogs at 

higher doses. Short-term exposure also 

resulted in thyroid changes in mice and 

rats. Other effects observed were body 

weight changes and hematological 

alterations in rats and dogs, along with 

gallbladder effects in dogs. Short-term 

dermal exposure did not result in 

dermal irritation or systemic effects up 

to the limit dose tested. 

Long-term exposure in rats resulted in 

liver effects; adrenal, ovarian, and 


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thyroid hypertrophy; and thyroid 

tumors. In mice, chronic exposure led to 

liver and thyroid effects and liver 

tumors. In dogs, effects noted (liver, 

gallbladder, and adrenal glands) were 

similar to those seen in subchronic dog 

studies, with the addition of more 

progressive gallbladder effects. 

No evidence of increased quantitative 

or qualitative susceptibility was 

observed in developmental toxicity 

studies in rats or rabbits or in a 

reproduction toxicity study in rats. 

However, increased quantitative 

susceptibility was seen in a 

developmental neurotoxicity (DNT) 

study in rats. In the DNT, decreased 

body weight, increased motor activity, 

and tremors were seen in offspring 

animals in the absence of maternal 

toxicity. 

Clinical signs (hunched posture, 

unsteady gait, reduced body 

temperature, and increased landing 

foots play) were observed in the acute 

neurotoxicity study in rats. However, no 

clinical signs were observed in the 

subchronic neurotoxicity study in rats. 

In the immunotoxicity study in mice, 

decreased plaque forming ability was 

observed at the limit dose. However, in 

the immunotoxicity study in rats, no 

evidence of immunotoxicity was 

observed up to the highest dose tested. 

Penthiopyrad has been classified as 

having ‘‘suggestive evidence of 

carcinogenicity.’’ Although liver tumors 

were seen in a cancer study in the 

mouse, the tumors were only observed 

at high doses and only noted in one sex 

and one species. The no-observedadverse-effect-level (NOAEL) (27 

milligrams/kilogram/day (mg/kg)) used 

for establishing the chronic reference 

dose is approximately 10-fold lower 

than the lowest dose (200 mg/kg/day) 

that induced liver tumors in mice. 

Based on these factors, including the 

fact that the only tumors seen were liver 

tumors in mice, the Agency has 

determined that the quantification of 

risk using a non-linear approach will 

adequately account for all chronic 

toxicity, including carcinogenicity that 

could result from exposure to 

penthiopyrad. The EPA received a 

number of studies for penthiopyrad 

metabolites, including subchronic oral, 

mutagenicity studies, etc.; however, 

none of these studies indicated that 

metabolites were more toxic than the 

parent. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by penthiopyrad as well 

as the NOAEL and can be found at 

http://www.regulations.gov in the 

document ‘‘Penthiopyrad. Human 

Health Risk Assessment for the Section 

3 Registration Action on Numerous 

Agricultural Crops, Turfgrass, and 

Ornamentals,’’ starting on page 23 in 

docket ID number EPA–HQ–OPP–2010– 

0349. 

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 penthiopyrad used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PENTHIOPYRAD 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 (All populations) .. NOAEL = 125 mg/kg/day .........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.25 mg/kg/day ....

aPAD = 1.25 mg/kg/day 

Acute Neurotoxicity in Rats LOAEL = 500 

mg/kg/day based on transient functional 

alterations (e.g., hunched posture, unsteady gait, reduced body temperature, 

and increased landing foot splay) and 

decreased motor activity at the estimated time-to-peak-effect (4 hours) on 

the day of administration. 

Chronic dietary (All populations) NOAEL = 27 mg/kg/day ........... Chronic RfD = 0.27 mg/kg/day Co-critical studies. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cPAD = 0.27 mg/kg/day Chronic Toxicity/Carcinogenicity in Rats 

LOAEL = 83 mg/kg/day, based on decreased body weight gain and adrenal 

effects in females and hepatic periportal 

fatty degeneration in males. 

Chronic Toxicity in Rats 

LOAEL = 100 mg/kg/day, based on altered plasma chemistry profile, increased liver weight and alterations in 

the adrenal and thyroid glands. 

Incidental Oral short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

NOAEL = 27 mg/kg/day ...........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100.

28–Day Oral Toxicity in Dogs LOAEL = 

80 mg/kg/day, based on mucosal 

edema in the gall bladder. 


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

ASSESSMENT—Continued 

Exposure/Scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Children’s Dermal short-term (1 

to 30 days) and intermediateterm (1 to 6 months).

NOAEL = 100 mg/kg/day (dermal absorption factor = 40%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 

100.

Postnatal Developmental Neurotoxicity in 

Rats 

LOAEL = 250 mg/kg/day, based on decreased body weight (8%) in offspring 

animals seen in the absence of maternal toxicity. 

Adult Dermal short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

NOAEL = 75 mg/kg/day (dermal absorption factor = 40%.

UFA = 10x 

UFH = 10x 

Residential LOC for MOE = 

100.

Developmental in Rabbits 

LOAEL = 225 mg/kg/day, based on abortion. 

Inhalation short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Inhalation (or oral) study ..........

NOAEL = 27 mg/kg/day (inhalation absorption factor = 

100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ................. 28–Day Oral Toxicity in Dogs LOAEL = 

80 mg/kg/day, based on mucosal 

edema in the gall bladder. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Suggestive Evidence of Carcinogenicity’’ based on liver tumors in male mice. The dose and 

non-cancer endpoint selected for chronic dietary exposure (cRfD) are protective of potential cancer effects. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. milligrams/kilograms/day = mg/kg/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to penthiopyrad, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from penthiopyrad 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 

penthiopyrad. 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 Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance-level 

residues, 100% crop treated 

assumptions for all commodities, and 

both default and empirical processing 

factors. 

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, EPA 

used tolerance-level residues, 100% 

crop treated assumptions for all 

commodities, and both default and 

empirical processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

determined that quantification using a 

linear low dose approach was not 

required, and the chronic dose and 

endpoint are considered to be protective 

of cancer effects. Thus, no separate 

exposure assessment was performed in 

assessing cancer risk. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for penthiopyrad in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

penthiopyrad. 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), provisional 

Tier 1 Cranberry and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

penthiopyrad for acute exposures are 

estimated to be 289 parts per billion 

(ppb) for surface water and ≤98 ppb for 

groundwater. For chronic exposures are 

estimated to be 222 ppb for surface 

water and ≤98 ppb for groundwater. The 

surface water estimates were used for 

both the acute and chronic (non-cancer/ 

cancer) assessments because they were 

higher than the groundwater estimates. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

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). 

Penthiopyrad is currently registered 

for the following use that could result in 

residential exposures: Turfgrass. EPA 

assessed residential exposure using the 

following assumptions: 

No chemical-specific unit exposure 

data were provided in support of this 

submission; therefore, the Occupational 

Pesticide Handler Unit Exposure 

Surrogate Reference Table (June 2011) 

and the Outdoor Residential Exposure 

Task Force (OREFT) study unit 

exposures were used to estimate handler 

exposures. These unit exposures were 

based on residential handlers wearing 

short pants, short-sleeved shirt, and no 

gloves. 

Postapplication scenarios include 

children (1 to 3 years old) playing on 

treated turf, adults performing yard 

work on treated turf, and adults playing 

golf on treated turf. The postapplication 

scenarios resulting from commercial 

and residential applications were 

assessed using default assumptions and 

transfer coefficients from the EPA Draft 

SOPs for Residential Exposure 

Assessments, 2000. As the short- and 

intermediate-term dermal endpoints are 

the same for each route of exposure, 

only short-term dermal exposures were 

assessed for adults and children. EPA 

estimates short-term dermal 

postapplication exposure based on 

day-0 residues, that is, the residue 


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present on the day of application. Using 

day-0 residues to assess intermediateterm exposure does not take into 

account dissipation of residues over 

time and, thus, results in a conservative 

estimate. Therefore, the short-term 

dermal postapplication exposure 

assessment represents the worst case 

scenario and is protective of 

intermediate-term dermal exposure. 

Additionally, oral non-dietary ingestion 

exposures were assessed for children 

(i.e., soil ingestion, and hand-/object-tomouth). Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found penthiopyrad to 

share a common mechanism of toxicity 

with any other substances, and 

penthiopyrad does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that penthiopyrad 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. 

There is no evidence of increased 

quantitative or qualitative susceptibility 

in developmental toxicity studies on 

rats/rabbits or in a reproduction toxicity 

study on rats. However, there is 

evidence of increased susceptibility 

following prenatal/or postnatal 

exposure in preliminary and definitive 

DNT studies on rats. Effects include 

decreased body weight, increased motor 

activity, and tremors (definitive), as well 

as mortality (preliminary). 

Although increased susceptibility was 

seen in the DNT studies, the EPA 

concluded that there is a low concern 

and no residual uncertainties for 

prenatal and/or postnatal toxicity effects 

of penthiopyrad because: 

• The pup body weight changes noted 

in the definitive and preliminary DNT 

studies were observed in other 

developmental/reproduction studies at 

similar doses. Additionally, the body 

weight changes in these studies 

occurred in the presence of significant 

maternal toxicity and there was no 

evidence of increased susceptibility. 

Although clinical signs (tremors and 

increased motor activity) were noted in 

offspring animals in the DNT study, the 

neurotoxic potential of penthiopyrad 

has been adequately characterized in the 

available neurotoxicity studies. In the 

preliminary DNT study, mortality was 

observed in the offspring animals at the 

limit dose. However, this finding is 

attributed to the poor condition (body 

weight loss, under activity, pallor) of the 

offspring animals in this dose group. 

• Clear NOAELs have been identified 

for all offspring effects and the risk 

assessments are based on the most 

sensitive endpoints. Therefore, the 

NOAELs selected for risk assessment are 

protective of potential developmental 

and offspring effects. 

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 

penthiopyrad is complete. 

ii. There is no concern for 

neurotoxicity after exposure to 

penthiopyrad. A complete neurotoxicity 

battery is available for penthiopyrad. 

This includes acute neurotoxicity, 

subchronic neurotoxicity, and DNT 

studies in rats. As a result, the 

neurotoxic potential of penthiopyrad is 

well characterized and no additional 

data are needed 

iii. There is no residual concern 

regarding increased quantitative or 

qualitative prenatal and/or postnatal 

susceptibility for the reasons explained 

in Unit III.D.2. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% crop 

treated and tolerance-level residues. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to penthiopyrad in drinking water. EPA 

used similarly conservative assumptions 

to assess residential exposures, 

including those of adults applying 

penthiopyrad and postapplication 

exposures of adults and children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by penthiopyrad. 

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 

penthiopyrad will occupy 7% of the 

aPAD for the general U.S. population 

and 11% of the aPAD for children 1 to 

2 years old (the population group 

receiving the greatest exposure). Since 

acute aggregate risk results from 

exposure to residues in food and water 

alone, the acute aggregate risks are not 

of concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to penthiopyrad 

from food and water will utilize 11% of 

the cPAD for the general U.S. 

population and 19% of the cPAD for 

children 1 to 2 years old (the population 

group receiving the greatest exposure). 

Since there are no residential scenarios 

that result in long-term exposure to 

penthiopyrad, the chronic aggregate 

risks are equivalent to the chronic 

dietary risks and are not of concern. 

3. Short-/intermediate-term risk. 

Short-/intermediate-term aggregate 

exposure takes into account short-/ 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). The short-/ 


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14296 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 

intermediate-term toxicological 

endpoints for penthiopyrad are the same 

for each route of exposure. Therefore, 

for residential exposure scenarios, only 

short-term exposures were assessed, and 

are protective of intermediate-term 

exposure and risk. Penthiopyrad is 

proposed for registration for uses that 

could result in short-/intermediate-term 

residential exposures, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short -term residential 

exposures to penthiopyrad. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short-term food, water, and 

residential exposures result in adult 

aggregate estimated MOEs of 580 for 

males and females. Furthermore, 

although there is the potential for 

exposure to children resulting from two 

different routes (i.e. dermal and oral 

exposure), the toxicological effects from 

the dermal and oral routes of exposure 

are different. As a result, a combined 

residential exposure assessment was not 

conducted for children. The short-term 

aggregate risk assessment for children 

resulted in estimated MOEs of 500 for 

dermal and 410 for oral exposure. 

Because EPA’s level of concern for 

penthiopyrad is a MOE of 100 or below, 

these MOEs are not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the relevant 

cancer studies EPA has concluded that 

the pesticide poses no greater than a 

negligible cancer risk and the chronic 

dietary risk assessment is protective of 

cancer effects and, therefore, cancer risk 

resulting from exposure to penthiopyrad 

is not of concern. 

5. 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 

penthiopyrad residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate liquid chromatography 

methods with tandem mass 

spectrometry (LC/MS/MS) are available 

to enforce the tolerance expressions for 

penthiopyrad in plant (Method CEMR 

3727 also known as Method CEM 3399– 

001) and livestock (Methods LDA0082 

and LDA0083) matrices. 

The methods 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. 

The Codex has not established MRLs 

for the new active ingredient 

penthiopyrad. 

C. Revisions to Petitioned-For 

Tolerances 

The EPA has revised several of the 

proposed tolerance levels. The major 

reason for the modifications is that the 

petitioner determined the proposed 

tolerances using the tolerance 

calculation procedure utilized by 

countries in the North American Free 

Trade Agreement but EPA conducted a 

joint review of this chemical with the 

United Kingdom and utilized a similar, 

but slightly different tolerance 

calculation procedure followed by the 

Organization for Economic Co-operation 

and Development. 

V. Conclusion 

Therefore, tolerances are established 

for residues of penthiopyrad, N-[2-(1,3- 

dimethylbutyl)-3-thienyl]-1-methyl-3- 

(trifluoromethyl)-1H-pyrazole-4- 

carboxamide, in or on plant and 

livestock commodities as indicated 

below. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, such as 

the tolerances 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 


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Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 14297 

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 24, 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 § 180.658 to subpart C to read 

as follows: 

§ 180.658 Penthiopyrad; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of 

penthiopyrad, 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 penthiopyrad (N-[2-(1,3- 

dimethylbutyl)-3-thienyl]-1-methyl-3- 

(trifluoromethyl)-1H-pyrazole-4- 

carboxamide). 

Commodity Parts per 

million 

Alfalfa, forage ............................. 7.0 

Alfalfa, hay .................................. 20 

Almond, hulls .............................. 6.0 

Apple, wet pomace ..................... 1.5 

Barley, grain ............................... 0.15 

Barley, hay .................................. 80 

Barley, milled byproducts ........... 0.90 

Barley, straw ............................... 1.0 

Beet, sugar, dried pulp ............... 1.5 

Beet, sugar, roots ....................... 0.5 

Berry, low growing, subgroup 

13–07G ................................... 3.0 

Brassica, head and stem, subgroup 5A ................................. 5.0 

Brassica, leafy greens, subgroup 

5B ............................................ 50 

Buckwheat, grain ........................ 0.15 

Canola ........................................ 1.5 

Commodity Parts per 

million 

Corn, field, forage ....................... 40 

Corn, field, grain ......................... 0.01 

Corn, field, refined oil ................. 0.05 

Corn, field, stover ....................... 15 

Corn, pop, grain .......................... 0.01 

Corn, sweet, kernel plus cob 

with husks removed ................ 0.01 

Cotton, seed ............................... 1.5 

Cotton, gin byproducts ............... 15 

Fruit, pome, group 11–10 ........... 0.50 

Fruit, stone, group 12 ................. 4.0 

Grain, aspirated fractions ........... 30 

Millet, spp. .................................. 0.80 

Nut, tree, group 14 ..................... 0.06 

Oat, forage .................................. 40 

Oat, grain .................................... 0.15 

Oat, hay ...................................... 80 

Oat, straw ................................... 1.0 

Pea and bean, dried shelled, except soybean, subgroup 6C .... 0.40 

Peanut ........................................ 0.04 

Peanut, hay ................................ 30 

Peanut, refined oil ...................... 0.06 

Pistachio ..................................... 0.06 

Potato, processed potato waste 0.20 

Rye, forage ................................. 40 

Rye, grain ................................... 0.15 

Rye, straw ................................... 1.0 

Sorghum, forage ......................... 40 

Sorghum, grain, grain ................. 0.80 

Sorghum, stover ......................... 15 

Soybean, seed ............................ 0.40 

Sunflower, seed .......................... 1.5 

Teosinte, grain ............................ 0.15 

Tomato, paste ............................. 3.5 

Triticale, forage ........................... 40 

Triticale, grain ............................. 0.15 

Triticale, hay ............................... 80 

Triticale, straw ............................ 1.0 

Vegetable, bulb, group 3–07 ...... 3.0 

Vegetable, cucurbit, group 9 ...... 0.60 

Vegetable, foliage of legume, 

group 7, hay ............................ 200 

Vegetable, foliage of legume, 

group 7, vines/forage .............. 50 

Vegetable, fruiting, group 8–10 .. 3.0 

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

Vegetable, leaves of root and 

tuber, group 2 ......................... 50 

Vegetable, legume, edible podded, subgroup 6A ................... 4.0 

Vegetable, legume, succulent 

shelled, subgroup 6B .............. 0.40 

Vegetable, root, subgroup 1B, 

except sugar beet ................... 3.0 

Vegetable, tuber and corm, subgroup 1C ................................. 0.06 

Wheat, forage ............................. 40 

Wheat, grain ............................... 0.15 

Wheat, hay ................................. 80 

Wheat, milled byproducts ........... 0.30 

Wheat, straw ............................... 1.0 

(2) Tolerances are established for 

residues of penthiopyrad, 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 the sum of 

penthiopyrad (N-[2-(1,3-dimethylbutyl)- 

3-thienyl]-1-methyl-3-(trifluoromethyl)- 

1H-pyrazole-4-carboxamide) and its 

metabolite (1-methyl-3-trifluoromethyl1H-pyrazole-4-carboxamide), calculated 

as the stoichiometric equivalent of 

penthiopyrad, in or on the commodity. 

Commodity Parts per 

million 

Cattle, fat .................................... 0.03 

Cattle, meat ................................ 0.03 

Cattle, meat byproducts ............. 0.09 

Goat, fat ...................................... 0.03 

Goat, meat .................................. 0.03 

Goat, meat byproducts ............... 0.09 

Horse, fat .................................... 0.03 

Horse, meat ................................ 0.03 

Horse, meat byproducts ............. 0.09 

Milk ............................................. 0.02 

Sheep, fat ................................... 0.03 

Sheep, meat ............................... 0.03 

Sheep, meat byproducts ............ 0.09 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–5650 Filed 3–8–12; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 51 and 54 

[WC Docket Nos. 10–90, 07–135, 05–337, 

03–109; GN Docket No. 09–51; CC Docket 

Nos. 01–92, 96–45; WT Docket No. 10–208; 

DA 12–147] 

Connect America Fund; a National 

Broadband Plan for Our Future; 

Establishing Just and Reasonable 

Rates for Local Exchange Carriers; 

High-Cost Universal Service Support 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission clarifies 

certain rules. This document also 

modifies certain initial filing deadlines 

required to comply with the Paperwork 

Reduction Act requirements, and finds 

good cause to delete certain rules that 

are now obsolete. 

DATES: Effective April 9, 2012, except 

for §§ 54.313(a)(9), 54.313(f)(2), and 

54.1003(b), which contain information 

collection requirements that are not 

effective until approved by the Office of 

Management and Budget. The Federal 

Communications Commission will 

publish a document in the Federal 

Register announcing the effective date 

for those sections. 


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