Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Rules and Regulations 23891 

V. Conclusion 

Therefore, tolerances are established 

for residues of metiram (a mixture of 5.2 

parts by weight of ammoniates of 

[ethylenebis (dithiocarbamato)] zinc 

with 1 part by weight ethylenebis 

[dithiocarbamic acid] bimolecular and 

trimolecular cyclic anhydrosulfides and 

disulfides), including its metabolites 

and degradates, in or on banana at 3 

ppm and grape, wine at 5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Pursuant to the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that this action will not have 

significant negative economic impact on 

a substantial number of small entities. 

Establishing a pesticide tolerance or an 

exemption from the requirement of a 

pesticide tolerance is, in effect, the 

removal of a regulatory restriction on 

pesticide residues in food and thus such 

an action will not have any negative 

economic impact on any entities, 

including small entities. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 20, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.217 is amended by 

revising the section heading and 

paragraph (a) to read as follows: 

§ 180.217 Metiram; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of a metiram (a 

mixture of 5.2 parts by weight of 

ammoniates of [ethylenebis 

(dithiocarbamato)] zinc with 1 part by 

weight ethylenebis [dithiocarbamic 

acid] bimolecular and trimolecular 

cyclic anhydrosulfides and disulfides), 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in this 

paragraph is to be determined by 

measuring only those metiram residues 

convertible to and expressed in terms of 

the degradate carbon disulfide. 

Commodity Parts per 

million 

Apple ............................................. 0.5 

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

Banana 1 ....................................... 3 

Grape, wine 1 ................................ 5 

Potato ........................................... 0.2 

1There are no U.S. registrations on bananas and grape, wine as of April 29, 2011. 

* * * * * 

[FR Doc. 2011–10333 Filed 4–28–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0266; FRL–8869–5] 

Pyrasulfotole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes or 

revises tolerances for residues of 

pyrasulfotole in or on grain sorghum, 

grass, and livestock commodities. Bayer 

CropScience LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

29, 2011. Objections and requests for 

hearings must be received on or before 

June 28, 2011, 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–2010–0266. 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, 


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23892 Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Rules and Regulations 

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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 

1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–5218; e-mail 

address: stanton.susan@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://www.gpoaccess.gov/ecfr. 

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–2010–0266 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 June 28, 2011. 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–2010–0266, 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 Tolerance 

In the Federal Register of June 23, 

2010 (75 FR 35801) (FRL–8831–3), 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 9F7680) by Bayer 

CropScience LLC, 2 T. W. Alexander 

Drive, Research Triangle Park, NC 

27709. The petition requested that 

40 CFR part 180 be amended by 

establishing tolerances for residues of 

the herbicide pyrasulfotole, (5-hydroxy1,3-dimethyl-1H-pyrazol-4-yl)[2- 

(methylsulfonyl)-4- 

(trifluoromethyl)phenyl]methanone, in 

or on sorghum, grain at 0.8 parts per 

million (ppm); sorghum, forage at 1.2 

ppm; sorghum, stover at 0.35 ppm; 

grass, hay at 2.5 ppm; and grass, forage 

at 10 ppm. The petition also requested 

that established tolerances in 40 CFR 

180.631 for residues of pyrasulfotole on 

livestock commodities be increased to 

the following levels: Cattle, goat, hog, 

sheep, horse, meat at 0.04 ppm; cattle, 

goat, hog, sheep, horse, fat at 0.04 ppm; 

cattle, goat, hog, sheep, horse, meat 

byproducts, except liver at 2 ppm; and 

cattle, goat, hog, sheep, horse, liver at 

8 ppm. The petition requested that the 

new and revised tolerances be 

established for residues of pyrasulfotole, 

including its metabolites and 

degradates, but that compliance with 

the specified tolerance levels be 

determined by measuring only residues 

of pyrasulfotole, (5-hydroxy-1,3- 

dimethyl-1H-pyrazol-4-yl)-[2- 

(methylsulfonyl)-4-(trifluoromethyl)- 

phenyl]-methanone, and its desmethyl 

metabolite, (5–Hydroxy-3-methyl-1Hpyrazol-4-yl)-[2-(methylsulfonyl)-4- 

(trifluoromethyl)phenyl] methanone, 

calculated as the stoichiometric 

equivalent of pyrasulfotole, in or on the 

commodities. That notice referenced a 

summary of the petition prepared by 

Bayer CropScience LLC, 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 

the sorghum commodity terms and the 

proposed tolerances levels for sorghum, 

grass; and livestock commodities. 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 


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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 pyrasulfotole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyrasulfotole 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. 

Pyrasulfotole has low to moderate 

acute toxicity via the oral, dermal, and 

inhalation routes of exposure. It is not 

a dermal sensitizer or skin irritant but 

has been shown to be a moderate eye 

irritant. 

Chronic oral exposure of rats to 

pyrasulfotole resulted in extensive eye 

toxicity at almost all doses tested. Eye 

effects included corneal opacity, 

neovascularization of the cornea, 

inflammation of the cornea, regenerative 

corneal hyperplasia, corneal atrophy, 

and/or retinal atrophy. Ocular toxicity is 

believed to be an indirect result of 

tyrosinemia caused by inhibition of 

hepatic HPPD (4- 

hydroxyphenylpyruvate dioxygenase). 

In mice, ocular toxicity was not 

observed at any dose, thereby reflecting 

accepted differences in effects among 

rodent species for HPPD inhibitors. 

Long-term exposure of mice to 

pyrasulfotole did cause toxicity of the 

urinary system, including the kidney, 

urinary bladder, and ureters at the 

highest dose tested (HDT), as well as 

gallstone formation at all doses tested. 

Dogs treated with pyrasulfotole for 1 

year exhibited toxicity of the urinary 

system (kidneys and bladder) at mid 

and high doses, as well as cataracts at 

a very low incidence at the HDT. 

In the combined chronic/ 

carcinogenicity study in rats, two male 

rats had rare treatment-related corneal 

tumors at the HDT (104/140 milligrams/ 

kilograms/day (mg/kg/day), M/F)), a 

dose associated with widespread 

corneal inflammation, hyperplasia, 

metaplasia, neurovascularization and 

atrophy. In the mouse carcinogenicity 

study, treatment-related urinary bladder 

transitional cell tumors were seen in 

males and females only at the HDT 

(560/713 mg/kg/day, M/F). The 

evidence from animal data is suggestive 

of carcinogenicity, which raises a 

concern for carcinogenic effects but is 

judged not sufficient for quantification 

of cancer risk in humans. In the case of 

pyrasulfotole, cancer risk from dietary 

exposure is less of a concern based on 

the following weight of evidence 

considerations: 

• The incidence of ocular tumors was 

low (2/55), seen only at the high dose, 

and was associated with widespread 

corneal inflammation, hyperplasia, 

metaplasia, neurovascularization, and 

atrophy; 

• It is biologically plausible for 

corneal tumors to result from a 

nongenotoxic mode of action that is 

secondary to corneal inflammation and 

regenerative hyperplasia caused by 

tyrosine; 

• The urinary bladder tumors in mice 

were seen only at the high dose (onehalf of the Limit Dose), which was 

determined to be an excessive dose due 

to occurrence of death, bladder stones, 

and bladder hyperplasia; 

• Data from available toxicity studies 

showed dose and temporal concordance 

among putative key events for the 

biological plausibility for a 

nongenotoxic proliferative mechanism 

for the bladder tumors. This was 

evidenced by the concurrent presence of 

secondary inflammation and 

hyperplastic lesions in the urinary 

bladder induced by the urinary stones; 

• In both species tumors were 

observed only at the highest dose tested 

(i.e., lack of dose-response); 

• Pyrasulfotole and its benzoic 

metabolite, AE B197555, do not pose a 

mutagenic concern; and 

• The NOAEL of 1.0 mg/kg/day used 

for deriving the chronic RfD is 

approximately 100- to 500-fold lower 

than the doses that induced ocular 

tumors in rats (104 mg/kg/day) and 

urinary bladder tumors in mice (560 

mg/kg/day). 

Thus, for all these reasons, the 

Agency has determined that a nonlinear approach is adequate for 

assessing cancer risk and that the 

chronic PAD (0.01 mg/kg/day) will 

adequately account for all chronic 

effects, including carcinogenicity, likely 

to result from exposure to the 

pyrasulfotole. 

Signs of potential neurotoxicity were 

observed in the acute neurotoxicity 

study in rats (decreased locomotor 

activity on the day of treatment), as well 

as in the rat subchronic neurotoxicity 

study (urine staining in the high dose 

females during the Functional 

Observational Battery) and rat 

developmental neurotoxicity (DNT) 

study (decreased brain weights, learning 

deficits, and the changes in brain 

morphometry). 

In the prenatal developmental toxicity 

study in rats, an increased incidence of 

skeletal variations was observed in fetal 

offspring at the mid dose, as was 

decreased fetal body weight in male 

offspring. Both effects were observed in 

the presence of maternal toxicity 

(decreased body weight gain, enlarged 

placenta, clinical signs) at the same 

dose. In the DNT study in rats, ocular 

toxicity as well as several adverse 

developmental effects (delayed 

preputial separation, morphometric 

changes, and delays in learning/ 

memory) were observed at the mid dose. 

Ocular toxicity was also observed at this 

dose in maternal animals; an identical 

NOAEL was established in both dams 

and offspring. In the prenatal 

developmental toxicity study in rabbits, 

an increased incidence of skeletal 

variations was observed in fetal 

offspring at the mid dose. However, 

maternal toxicity (decreased body 

weight gain and food consumption) was 

observed only at the next highest dose 

tested. Therefore, increased quantitative 

susceptibility of offspring was observed 

in the rabbit developmental toxicity 

study, but not in the developmental 

toxicity or DNT studies in rats. 

In the 2-generation reproductive 

toxicity study in rats, ocular toxicity 

(keratitis, corneal opacity and/or corneal 

neovascularization), was observed at the 

mid and high doses in the adults and 

offspring of 2-generations. Thyroid 

(colloid alteration, pigment deposition) 

and kidney (tubular dilation) toxicity 

were observed in adult animals of each 

generation. Colloid alteration and 

pigment deposition were also observed 

in rats following short-term dermal and 

chronic oral exposure of rats, although 

they were attributed to aging in the 

latter case. At the highest dose tested, 

decreased viability and decreased body 

weight were observed in offspring of 

both generations. At the mid and/or 

high doses, delays in balanopreputial 

separation (males) and vaginal patency 

(females) were observed in firstgeneration offspring. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyrasulfotole as well 

as the NOAEL and the lowest-observedVerDate Mar<15>2010 16:27 Apr 28, 2011 Jkt 223001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\29APR1.SGM 29APR1

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23894 Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Rules and Regulations 

adverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Pyrasulfotole: Human-Health Risk 

Assessment for Proposed Section 3 Uses 

on Grain Sorghum and Grass Grown for 

Seed,’’ p. 30 in docket ID number EPA– 

HQ–OPP–2010–0266. 

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 pyrasulfotole used for 

human risk assessment is shown in the 

following Table: 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRASULFOTOLE 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 = 3.8 milligrams/kilograms/day (mg/kg/day).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.038 mg/kg/day ......

aPAD = 0.038 mg/kg/day 

Developmental neurotoxicity (rat; 

dietary). 

LOAEL = 37 mg/kg/day based on 

delayed preputial separation 

(males), decreased cerebrum 

length (PND 21 females), and 

decreased cerebellum height 

(PND 21 males). 

Chronic dietary (All populations) .... NOAEL= 1.0 mg/kg/day ................

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.01 mg/kg/day .....

cPAD = 0.01 mg/kg/day 

Combined chronic toxicity/carcinogenicity (rat; dietary). 

LOAEL = 10/14 mg/kg/day (M/F) 

based on corneal opacity, 

neovascularization of the cornea, inflammation of the cornea, regenerative corneal 

hyperplasia, corneal atrophy, 

and/or retinal atrophy (both 

sexes), and hepatocellular hypertrophy along with increased 

serum cholesterol (males). 

Cancer (Oral, dermal, inhalation) .. Classification: ‘‘Suggestive Evidence of Carcinogenic Potential’’ based on increased incidences of corneal 

tumors in male rats (oral carcinogenicity study) and urinary bladder tumors in male and female mice (oral 

carcinogenicity study). 

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

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account 

for the absence of data or other data deficiency. 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. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyrasulfotole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyrasulfotole tolerances in 40 

CFR 180.631. EPA assessed dietary 

exposures from pyrasulfotole 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 pyrasulfotole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

that residues are present in all 

commodities at the tolerance level and 

that 100% of commodities are treated 

with pyrasulfotole. Dietary Exposure 

Evaluation Model (DEEM) TM 7.81 

default concentration factors were used 

to estimate residues of pyrasulfotole in 

processed commodities. 

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 

assumed tolerance-level residues and 

100 percent crop treated (PCT) and used 

DEEMTM 7.81 default concentration 

factors to estimate residues of 

pyrasulfotole in processed commodities. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

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

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 


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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 a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to pyrasulfotole. Cancer risk 

was assessed using the same exposure 

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

chronic exposure. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyrasulfotole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyrasulfotole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

pyrasulfotole for acute exposures are 

estimated to be 6.9 parts per billion 

(ppb) for surface water and 2.4 ppb for 

ground water. For chronic exposures for 

non-cancer assessments the EDWCs are 

estimated to be 4.8 ppb for surface water 

and 2.4 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 6.9 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 4.8 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Pyrasulfotole 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.’’ 

Pyrasulfotole, mesotrione, 

isoxaflutole, and topramezone belong to 

a class of herbicides that inhibit the 

liver enzyme HPPD, which is involved 

in the catabolism (metabolic 

breakdown) of tyrosine (an amino acid 

derived from proteins in the diet). 

Inhibition of HPPD can result in 

elevated tyrosine levels in the blood, a 

condition called tyrosinemia. HPPDinhibiting herbicides have been found to 

cause a number of toxicities in 

laboratory animal studies including 

ocular, developmental, liver, and kidney 

effects. Of these toxicities, it is the 

ocular effect (corneal opacity) that is 

highly correlated with the elevated 

blood tyrosine levels. In fact, rats dosed 

with tyrosine alone show ocular 

opacities similar to those seen with 

HPPD inhibitors. Although the other 

toxicities may be associated with 

chemically-induced tyrosinemia, other 

mechanisms may also be involved. 

There are marked differences among 

species in the ocular toxicity associated 

with inhibition of HPPD. Ocular effects 

following treatment with HPPDinhibitor herbicides are seen in the rat 

but not in the mouse. Monkeys also 

seem to be recalcitrant to the ocular 

toxicity induced by HPPD inhibition. 

The explanation of this species-specific 

response in ocular opacity is related to 

the species differences in the clearance 

of tyrosine. A metabolic pathway exists 

to remove tyrosine from the blood that 

involves a liver enzyme called tyrosine 

aminotransferase (TAT). In contrast to 

rats where ocular toxicity is observed 

following exposure to HPPD-inhibiting 

herbicides, mice and humans are 

unlikely to achieve the levels of plasma 

tyrosine necessary to produce ocular 

opacities, because the activity of TAT in 

these species is much greater compared 

to rats. Thus, humans and mice have a 

highly effective metabolic process for 

handling excess tyrosine. 

HPPD inhibitors (e.g., nitisinone) are 

used as effective therapeutic agents to 

treat patients suffering from rare genetic 

diseases of tyrosine catabolism. 

Treatment starts in childhood but is 

often sustained throughout the patient’s 

lifetime. The human experience 

indicates that a therapeutic dose (1 mg/ 

kg/day dose) of nitisinone has an 

excellent safety record in infants, 

children, and adults and that serious 

adverse health outcomes have not been 

observed in a population followed for 

approximately a decade. Rarely, ocular 

effects are seen in patients with high 

plasma tyrosine levels; however, these 

effects are transient and can be readily 

reversed upon adherence to a restricted 

protein diet. This indicates that an 

HPPD inhibitor in and of itself cannot 

easily overwhelm the tyrosine-clearance 

mechanism in humans. 

Therefore, due to an efficient 

metabolic process to handle excess 

tyrosine, exposure to environmental 

residues of HPPD-inhibiting herbicides 

is unlikely to result in high blood levels 

of tyrosine and ocular toxicity in 

humans; and EPA has concluded that a 

cumulative risk assessment with other 

HPPD inhibitors is unnecessary. 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 

Food Quality Protection Act (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 prenatal and postnatal toxicity 

database for pyrasulfotole includes 

developmental toxicity studies in rats 

and rabbits, a DNT study in rats and a 

2-generation reproductive toxicity study 

in rats. As discussed in unit III.A, there 

was quantitative evidence of increased 

susceptibility of fetal offspring in the 

developmental toxicity study in rabbits. 

In this study, an increased incidence of 

skeletal variations was observed in fetal 

offspring at the mid dose; whereas 

maternal toxicity (decreased body 

weight gain and food consumption) was 

observed only at the next highest dose 

tested. 

The concern for increased 

susceptibility seen in the rabbit 

developmental toxicity study is low 

because a) there is well established 

developmental NOAEL in this study, b) 

the increased susceptibility was not 

seen in the rat developmental toxicity 

study, the DNT study in rats, or the 2- 

generation reproduction study in rats, 


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and c) the NOAEL of the study chosen 

for the chronic RfD (1 mg/kg/day) is 10- 

fold lower than the NOAEL observed in 

the rabbit developmental 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 

pyrasulfotole is largely complete, 

lacking only an immunotoxicity study. 

There is no evidence of potential 

immunotoxicity (such as effects on the 

spleen or thymus, or increased 

globulins) in the available toxicity 

studies for pyrasulfotole; and EPA is 

using critical studies for the chronic and 

acute RfDs that have the lowest NOAELs 

in the database for those exposure 

durations. Therefore, EPA does not 

believe that conducting a functional 

immunotoxicity study will result in a 

lower POD than that currently used for 

overall risk assessment, and a database 

uncertainty factor (UFDB) is not needed 

to account for lack of this study. 

ii. Although there were signs of 

neurotoxicity observed in the acute, 

subchronic and developmental 

neurotoxicity studies, EPA’s concern for 

these effects is low. The critical study 

(developmental neurotoxicity study in 

rats) chosen for the acute RfD has a 

well-defined NOAEL that is 54-fold 

lower than the dose at which effects 

(decreased locomotor activity on day 0) 

were seen in the acute neurotoxicity 

study. The critical study (chronic 

toxicity/carcinogenicity study in the rat) 

chosen for the chronic RfD also has a 

well-defined NOAEL that is 42- and 37- 

fold lower than the doses at which 

effects were observed in the subchronic 

and developmental neurotoxicity 

studies, respectively. Therefore, EPA 

does not believe that an additional 

uncertainty factor is needed to account 

for neurotoxicity. 

iii. Although there is evidence of 

increased quantitative susceptibility of 

in utero rabbits in the prenatal 

developmental toxicity study, the 

degree of concern for developmental 

effects is low, and EPA did not identify 

any residual uncertainties after 

establishing toxicity endpoints and 

traditional UFs to be used in the risk 

assessment of pyrasulfotole. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to pyrasulfotole 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by pyrasulfotole. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to pyrasulfotole 

will occupy 9% 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 pyrasulfotole 

from food and water will utilize 16% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for pyrasulfotole. 

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). A short-term adverse 

effect was identified; however, 

pyrasulfotole is not registered for any 

use patterns that would result in shortterm 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 pyrasulfotole. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term adverse effect was 

identified; however, pyrasulfotole is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

pyrasulfotole. 

5. Aggregate cancer risk for U.S. 

population. As explained in Unit III.A, 

risk assessments based on the endpoint 

selected for chronic risk assessment are 

considered to be protective of any 

potential carcinogenic risk from 

exposure to pyrasulfotole. Based on the 

results of the chronic risk assessment 

discussed above in Unit III.E.2, EPA 

concludes that pyrasulfotole is not 

expected to pose a cancer risk. 

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 pyrasulfotole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. Bayer Method AI–001–P04– 

02 (a high-performance liquid 

chromatography (HPLC)/mass 

spectrometry (MS)/MS method) is 

available to enforce pyrasulfotole 

tolerances in plants. Bayer Method AI– 

006–A08–01 (an HPLC–MS/MS method) 

is suitable as an enforcement method for 

livestock commodities. 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). 


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Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Rules and Regulations 23897 

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 a MRL 

for pyrasulfotole on grain sorghum, 

grass, or livestock commodities. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has revised the sorghum 

commodity terms and the tolerance 

levels for both sorghum and grass 

commodities. The sorghum commodity 

terms have been revised (from 

‘‘sorghum, grain;’’ sorghum, forage;’’ and 

sorghum, stover’’ to ‘‘sorghum, grain, 

grain;’’ ‘‘sorghum, grain, forage;’’ and 

‘‘sorghum, grain, stover’’) to agree with 

the accepted terminology in the 

Agency’s Food and Feed Vocabulary. 

The tolerance levels for sorghum and 

grass commodities have been revised as 

follows based on analysis of the field 

trial data using the Agency’s NAFTAharmonized tolerance/MRL calculator in 

accordance with the Guidance for 

Setting Pesticide Tolerances Based on 

Field Trial Data: Sorghum, grain, grain 

from 0.8 ppm to 0.70 ppm; sorghum, 

grain, forage from 1.2 ppm to 1.5 ppm; 

sorghum, grain, stover from 0.35 ppm to 

0.80 ppm; grass, forage from 10 ppm to 

25 ppm; and grass, hay from 2.5 ppm to 

3.5 ppm. 

Based on the results of the cattle 

feeding study and the calculated 

maximum reasonable dietary burden 

(MRDB) for cattle, EPA determined that 

the existing tolerance of 0.02 ppm in or 

on the meat of cattle, goat, horse, and 

sheep is adequate and need not be 

raised to 0.04 ppm, as proposed; but 

that tolerances should be established for 

residues of pyrasulfotole and its 

desmethyl metabolite in or on milk at 

0.03 ppm (no increase in the established 

tolerance of 0.01 ppm was proposed); fat 

of cattle, goat, horse and sheep at 0.03 

ppm (proposed at 0.04 ppm); liver of 

cattle, goat, horse, and sheep at 3.0 ppm 

(proposed at 8 ppm); and meat 

byproducts, except liver, of cattle, goat, 

horse, and sheep at 0.70 ppm (proposed 

at 2 ppm). 

Based upon a MRDB for hogs, there is 

no reasonable expectation of finding 

quantifiable residues of pyrasulfotole or 

its desmethyl metabolite in hog muscle 

and fat; thus, the current tolerances of 

0.02 ppm are adequate (proposed at 0.04 

ppm). There is a reasonable expectation 

of residues of pyrasulfotole and/or its 

desmethyl metabolite in hog liver and 

kidney, and EPA has determined that 

tolerances for these commodities should 

be set at the following levels: hog, meat 

byproducts, except liver at 0.05 ppm 

(proposed at 2 ppm); and hog, liver at 

0.30 ppm (proposed at 8 ppm). 

The petitioner did not propose 

changes to the existing poultry 

tolerances for pyrasulfotole; however, 

based on the results of the poultry 

metabolism study and the calculated 

MRDB for poultry, EPA has determined 

that the existing tolerance for residues 

of pyrasulfotole and its desmethyl 

metabolite in or on poultry, meat 

byproducts should be increased from 

0.02 ppm to 0.20 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyrasulfotole, including 

its metabolites and degradates as set 

forth in the regulatory text. 

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 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: April 21, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 


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23898 Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Rules and Regulations 

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 180.631 is amended by 

revising the introductory text and table 

in paragraph (a) to read as follows: 

§ 180.631 Pyrasulfotole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

pyrasulfotole, 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 pyrasulfotole 

((5-hydroxy-1,3-dimethyl-1H-pyrazol-4- 

yl)[2-(methylsulfonyl)-4- 

(trifluoromethyl)phenyl]methanone) 

and its desmethyl metabolite (5- 

hydroxy-3-methyl-1H-pyrazol-4-yl)[2- 

(methylsulfonyl)-4- 

(trifluoromethyl)phenyl]methanone), 

calculated as the stoichiometric 

equivalent of pyrasulfotole, in or on the 

commodities: 

Commodity Parts per 

million 

Aspirated grain fractions ........... 0 .40 

Barley, grain ............................. 0 .02 

Barley, hay ................................ 0 .30 

Barley, straw ............................. 0 .20 

Cattle, fat .................................. 0 .03 

Cattle, liver ................................ 3 .0 

Cattle, meat .............................. 0 .02 

Cattle, meat byproducts, except 

liver ........................................ 0 .70 

Eggs .......................................... 0 .02 

Goat, fat .................................... 0 .03 

Goat, liver ................................. 3 .0 

Goat, meat ................................ 0 .02 

Goat, meat byproducts, except 

liver ........................................ 0 .70 

Grass, forage ............................ 25 

Grass, hay ................................ 3 .5 

Hog, fat ..................................... 0 .02 

Hog, liver .................................. 0 .30 

Hog, meat ................................. 0 .02 

Hog, meat byproducts, except 

liver ........................................ 0 .05 

Horse, fat .................................. 0 .03 

Horse, liver ............................... 3 .0 

Horse, meat .............................. 0 .02 

Horse, meat byproducts, except 

liver ........................................ 0 .70 

Milk ........................................... 0 .03 

Oat, forage ................................ 0 .10 

Oat, grain .................................. 0 .08 

Oat, hay .................................... 0 .50 

Oat, straw ................................. 0 .20 

Poultry, fat ................................ 0 .02 

Poultry, meat ............................ 0 .02 

Poultry, meat byproducts .......... 0 .20 

Rye, forage ............................... 0 .20 

Rye, grain ................................. 0 .02 

Rye, straw ................................. 0 .20 

Sheep, fat ................................. 0 .03 

Sheep, liver ............................... 3 .0 

Commodity Parts per 

million 

Sheep, meat ............................. 0 .02 

Sheep, meat byproducts, except liver ................................ 0 .70 

Sorghum, grain, forage ............. 1 .5 

Sorghum, grain, grain ............... 0 .70 

Sorghum, grain, stover ............. 0 .80 

Wheat, forage ........................... 0 .20 

Wheat, grain ............................. 0 .02 

Wheat, hay ............................... 0 .80 

Wheat, straw ............................. 0 .20 

* * * * * 

[FR Doc. 2011–10435 Filed 4–28–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0267; FRL–8870–9] 

Mefenpyr-diethyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mefenpyrdiethyl in or on multiple commodities. 

Bayer CropScience LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation also moves established 

tolerances for canola and soybean 

commodities to correct an 

administrative error. 

DATES: This regulation is effective April 

29, 2011. Objections and requests for 

hearings must be received on or before 

June 28, 2011, 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–2010–0267. 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: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; e-mail address: 

benbow.bethany@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://www.gpoaccess.gov/ecfr. 

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– 


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