Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 13257 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.,) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 20, 2013. 

Lois Rossi, 

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. In § 180.659: 

■ a. Add alphabetically the following 

commodities to the table in paragraph 

(a)(2). 

■ b. Add a new paragraph (a)(3). 

The additions read as follows. 

§ 180.659 Pyroxasulfone; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Soybean, forage ......................... 1.0 

Soybean, hay .............................. 2.0 

(3) Tolerances are established for 

residues of the herbicide pyroxasulfone, 

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 pyroxasulfone, 3-[[[5- 

(difluoromethoxy)-1-methyl-3- 

(trifluoromethyl)-1H-pyrazol-4- 

yl]methyl]sulfonyl]-4,5-dihydro-5,5- 

dimethylisoxazole, and its metabolites, 

5-(difluoromethoxy)-1-methyl-3- 

(trifluoromethyl)-1H-pyrazol-4- 

carboxylic acid (M–3); [5- 

(difluoromethoxy)-3-(trifluoromethyl)- 

1H-pyrazol-4-yl]methanesulfonic acid 

(M–25); and 3-[1-carboxy-2-(5,5- 

dimethyl-4,5-dihydroisoxazol-3- 

ylthio)ethylamino]-3-oxopropanoic acid 

(M–28), calculated as the stoichiometric 

equivalent of pyroxasulfone, in or on 

the commodity. 

Commodity Parts per 

million 

Soybean, seed ............................ 0.06 

* * * * * 

[FR Doc. 2013–04559 Filed 2–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1002; FRL–9379–6] 

Pyraflufen-ethyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraflufenethyl in or on multiple commodities 

which are identified and discussed later 

in this document. Nichino America, Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 27, 2013. Objections and 

requests for hearings must be received 

on or before April 29, 2013, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–1002, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Bethany Benbow, Registration Division 


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(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; email 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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

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–2011–1002 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 29, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2011–1002, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at 

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

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of March 14, 

2012 (77 FR 15012) (FRL–9335–9), EPA 

issued a document pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1F7944) by Nichino 

America, Inc., 4550 New Linden Hill 

Road Suite 501, Wilmington, DE 19808. 

The petition requested that 40 CFR 

180.585 be amended by establishing 

tolerances for residues of the herbicide 

pyraflufen-ethyl, ethyl 2-[2-chloro-5-(4- 

chloro-5-difluoromethoxy)-1-methyl-1Hpyrazol-3-yl]-4-fluorophenoxy] acetate 

and its acid metabolite, E–1, 2-chloro-5- 

(4-chloro-5-difluoromethoxy-1-methyl1H-pyrazol-3-yl)-4-fluorophenoxyacetic 

acid, expressed in terms of the parent, 

in or on hop, dried cone at 0.01 parts 

per million (ppm); peanut at 0.01 ppm; 

peanut, hay at 0.07 ppm; peanut, meal 

at 0.01 ppm; and peanut, refined oil at 

0.01 ppm. That document referenced a 

summary of the petition prepared by 

Nichino America, Inc., 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 is 

establishing tolerances for peanut and 

peanut, hay but not establishing 

tolerances for hop, dried cone; peanut, 

meal; or peanut, refined oil. In addition, 

the current time-limited tolerances 

established for combined residues of 

pyraflufen-ethyl and metabolite E–1 in 

milk and the meat by-products of cattle, 

goat, horse, and sheep at 0.02 ppm are 

being revised to permanent tolerances 

for combined residues of pyraflufenethyl and metabolites E–1 and E–9 at 

0.03 ppm. Finally, permanent tolerances 

for combined residues of pyraflufenethyl and metabolites E–1 and E–9 are 

also being set for the fat and meat of 

cattle, goat, horse, and sheep at 0.03 

ppm. The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for pyraflufen-ethyl 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyraflufen-ethyl 

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. Pyraflufen-ethyl 

exhibits relatively low acute toxicity 

from oral, dermal, and inhalation 

exposure. It produces moderate eye 


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irritation and is not a dermal irritant or 

a dermal sensitizer. Following repeated 

short-term and chronic oral dosing, the 

liver, kidney, and hematopoietic system 

are the target organs for pyraflufen-ethyl 

in the rat and/or mouse. The rabbit 

appears to be the most sensitive species 

in the toxicity database with adverse 

effects, including mortality. Adverse 

effects were not noted in the dog 

following oral exposure or in the rat 

following dermal exposure. There was 

no evidence of increased susceptibility 

following pre-natal exposure to rats and 

rabbits in the developmental toxicity 

studies or following pre- and post-natal 

exposure to rats in the multi-generation 

reproduction study. Although not 

mutagenic in the mutagenicity battery or 

carcinogenic in the rat, pyraflufen-ethyl 

is classified as ‘‘Likely to be 

Carcinogenic to Humans’’ due to a 

compound-related increase in incidence 

of hepatocellular adenomas, 

carcinomas, and/or hepatoblastomas in 

male and female mice. A linear lowdose extrapolation approach is used to 

estimate human cancer risk (Q1*) based 

on combined hepatocellular adenomas, 

carcinomas, and/or hepatoblastomas 

seen in male mice. 

Since the last risk assessment, the 

neurotoxicity battery was reviewed and 

determined to be negative for both acute 

and subchronic neurotoxicity. 

Additionally, the Agency reviewed an 

immunotoxicity study that showed a 

decreased immune response (decreases 

of anti-sheep red blood cell (SRBC) 

antibody forming cell (AFC) response in 

male rats), only at a dose level 

approaching the limit dose. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyraflufen-ethyl as 

well as the no observed adverse effect 

levels (NOAELs) and the lowest 

observed adverse effect levels (LOAELs) 

from the toxicity studies can be found 

at http://www.regulations.gov in 

document Pyraflufen-ethyl—Human 

Health Risk Assessment for a Section 3 

Registration of New Food Uses on Hops 

and Peanuts at pages 44–48 in docket ID 

number EPA–HQ–OPP–2011–1002. 

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 pyraflufen-ethyl used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRAFLUFEN-ETHYL FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for risk assessment Study and toxicological effects 

Acute dietary (General population including infants and children).None An endpoint attributable to a single 

dose was not identified for 

pyraflufen-ethyl from the available 

data. 

Chronic dietary (All populations) ......... NOAEL = 20 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.20 mg/kg/day ...........

cPAD = 0.20 mg/kg/day. 

Mouse carcinogenicity study. 

LOAEL = 98 mg/kg/day based on liver 

toxicity. 

Incidental oral short-term (1 to 30 

days).

NOAEL = 20 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ............................ Developmental toxicity—rabbit. 

Maternal LOAEL = 60 mg/kg/day 

based on decreases in body weight 

and food consumption, gastrointestinal (GI) observations, and 

abortions. 

Dermal short-term (1 to 30 days); Dermal intermediate-term (1 to 6 

months).

None 28-day dermal toxicity—rats. 

No dermal or systemic toxicity was 

seen at the limit dose (1,000 mg/kg/ 

day). 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRAFLUFEN-ETHYL 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 

Inhalation short-term (1 to 30 days) 

and Intermediate and long term (1– 

6 months).

Inhalation (or oral) 

study NOAEL = 20 

mg/kg/day (inhalation absorption rate 

= 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 100 ......... Developmental toxicity-rabbit. 

LOAEL = 60 mg/kg/day based on decreases in body weight and food 

consumption, GI observations, and 

abortions. 

Cancer (Oral, dermal, inhalation) ........ Classification: ‘‘Likely to be Carcinogenic to Humans’’ by the oral route. Q1* = 3.32 × 10¥2 (mg/kg/ 

day)¥1

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyraflufen-ethyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyraflufen-ethyl tolerances in 

40 CFR 180.585. EPA assessed dietary 

exposures from pyraflufen-ethyl 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. No such effects were 

identified in the toxicological studies 

for pyraflufen-ethyl; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of 

Agriculture’s (USDA) National Health 

and Nutrition Examination Survey, 

What We Eat in America (NHANES/ 

WWEIA). As to residue levels in food, 

EPA incorporated all current and 

proposed tolerances for combined 

residues of pyraflufen-ethyl and 

metabolite E–1 in plants and residues of 

pyraflufen-ethyl, metabolite E–1 and 

metabolite E–9 in animals and assumed 

100% of crops were treated. The 

commodities of corn, wheat, soybeans, 

cottonseed, potatoes, pome fruit, stone 

fruit, pomegranates, olives, grapes, tree 

nuts, and pistachios were analyzed at 1⁄2

the combined levels of quantitation 

(LOQs) of the parent and metabolites for 

the residue values in the dietary 

assessment because the field trials 

showed that residues were lower than 

the LOQ. All other established and 

proposed commodities were analyzed 

using tolerance-level residues. Because 

the commodity-specific processing 

studies did not show pyraflufen-ethyl 

concentration after processing, the 

chronic dietary exposure assessment did 

not incorporate processing factors for 

the following commodities: Treated 

corn grain, soybean seeds, wheat grain, 

apples, and grapes. However, default 

processing factors were used for dry 

potatoes (6.5X), peanut butter (1.89X), 

dried beef (1.92X), and corn syrup 

(1.5X). An empirical processing factor of 

0.6X was used for cotton seed oil. The 

anticipated residue in meat, milk, fat, 

and meat byproducts was calculated to 

be 0.001 ppm. Chronic (non-cancer) 

dietary exposure from drinking water 

was determined based on a Tier 2 

(surface water) drinking water estimate 

provided by the Environmental Fate and 

Effects Division (EFED). The chronic 

(annual average) estimate for drinking 

water was incorporated directly into the 

dietary assessment for the combined 

residues of pyraflufen-ethyl and its 

metabolic products, E–1, E–2, and E–3, 

which are the major residues present in 

the supporting studies. 

iii. Cancer. Pyraflufen-ethyl is 

classified as ‘‘Likely to be Carcinogenic 

to Humans’’ by the oral route; therefore, 

a cancer dietary risk assessment was 

conducted. EPA determines whether 

quantitative cancer exposure and risk 

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

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the data summarized 

in Unit III.A., EPA has concluded that 

pyraflufen-ethyl should be classified as 

‘‘Likely to be Carcinogenic to Humans’’ 

and a linear approach has been used to 

quantify cancer risk. 

All exposure inputs for the cancer 

assessment were the same as for the 

chronic dietary exposure assessment, 

except the estimated drinking water 

concentrations (EDWC). A Tier 2 

drinking water (surface water) of a (30- 

year average) estimate for pyraflufenethyl and its metabolic products, E–1, 

E–2, and E–3, was incorporated directly 

into the dietary assessment to estimate 

chronic carcinogenic risk from drinking 

water containing pyraflufen-ethyl. 

iv. Anticipated residue information. 

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

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

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

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

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

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

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 


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2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyraflufen-ethyl in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyraflufen-ethyl. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

pyraflufen-ethyl acute exposures are 

estimated to be 0.640 parts per billion 

(ppb) for surface water and 0.0018 ppb 

for ground water. The estimated 

drinking water concentrations (EDWCs) 

of pyraflufen-ethyl for non-cancer 

chronic exposures are estimated to be 

0.295 ppb for surface water and 0.0018 

ppb for ground water. The EDWCs of 

pyraflufen-ethyl for chronic exposures 

for cancer assessments are estimated to 

be 0.268 ppb for surface water and 

0.0018 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 0.295 ppb 

was used to assess the contribution to 

drinking water. For cancer dietary risk 

assessment, the water concentration of 

value 0.268 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). 

Pyraflufen-ethyl is currently 

registered for the following uses that 

could result in residential exposures: 

Established ornamental turf lawns 

(residential, industrial, and 

institutional), parks, cemeteries, athletic 

fields, golf courses, sod farms, nurseries, 

ornamental plantings, and Christmas 

trees. EPA assessed residential handler 

exposure using the following 

assumptions: (1) Most residential uses 

will result in short-term (1–30 day) 

exposures, (2) residential handlers are 

assumed to be wearing short-sleeved 

shirts, short pants, shoes, and socks 

during pyraflufen-ethyl application, (3) 

various application methods may be 

used such as manually pressurized 

handwands, backpack sprayers, and 

hose-end sprayers. 

When determining the potential for 

residential post-application exposure, 

the Agency considers residues from leaf 

to skin/hand residue transfer, children’s 

hand-to-mouth transfer, and exposure 

time. Because exposure to treated 

gardens and turf could be expected 

within the same day, adult postapplication cancer exposure to treated 

trees and retail plants and turf were 

combined. The exposure assessment for 

treated plants is considered extremely 

conservative in that the plants are 

assumed to be treated the same day that 

residential post-application contact 

occurs, with no residue transfer between 

treatment and purchase of the plants. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/opp00001/ 

science/USEPA-OPP-HED_Residential

%20SOPs_Oct2012.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 pyraflufen-ethyl to share a 

common mechanism of toxicity with 

any other substances, and pyraflufenethyl does not appear to produce a toxic 

metabolite which is also produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pyraflufen-ethyl 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 

susceptibility of rat or rabbit fetuses 

following in utero exposure in the 

developmental studies with pyraflufenethyl. There is no evidence of increased 

susceptibility of young rats in the 

pyraflufen-ethyl reproduction study and 

there are no residual uncertainties for 

pre- and/or postnatal exposure. 

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 pyraflufenethyl is complete. 

ii. There is no indication that 

pyraflufen-ethyl is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

pyraflufen-ethyl results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% crop 

treated (CT) and tolerance-level residues 

for the proposed commodities, and 

residue inputs of 1⁄2 LOQ as refined 

estimates of the currently registered 

commodities. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to pyraflufen-ethyl in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of adults and 

children as well as incidental oral 

exposure of children. In addition, the 

residential exposure assessment is based 

on the updated 2012 Residential 

Standard Operating Procedures (SOPs) 

employing surrogate study data, 

including conservative exposure 

assumptions based on day 0 dermal/oral 

contact to turf and surfaces treated at 

the maximum application rate. These 

data are reliable and are not expected to 

underestimate risks to adults or 

children. The Residential SOPs are 

based upon reasonable ‘‘worst-case’’ 

assumptions and are not expected to 

underestimate risk. Although some of 

the residue values used in the dietary 

exposure assessment were refined, these 

assessments will not underestimate the 

exposure and risks posed by pyraflufenethyl. 


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13262 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 

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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, pyraflufen-ethyl is 

not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to pyraflufenethyl from food and water will utilize 

< 1% of the cPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

pyraflufen-ethyl is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Pyraflufen-ethyl is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to pyraflufen-ethyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined chronic dietary and shortterm residential exposures result in an 

adult (inhalation) non-cancer aggregate 

MOE of 290,000. The aggregate MOE for 

children 1–2 years old, including 

incidental oral exposures from treated 

turf, is 9,600. Because EPA’s level of 

concern for pyraflufen-ethyl is a MOE of 

100 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term adverse effect was 

identified; however, pyraflufen-ethyl 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 

pyraflufen-ethyl. 

5. Aggregate cancer risk for U.S. 

population. The aggregate cancer risk 

assessment for the general U.S. 

population considers exposure 

estimates from dietary consumption of 

pyraflufen-ethyl in food and drinking 

water and exposure through residential 

uses of pyraflufen-ethyl. Exposures from 

residential uses are based on the 

lifetime average daily dose and assume 

an exposure period of 2 days per year 

and 35 years of exposure over a 78 year 

lifetime. Average food and water 

exposure to pyraflufen-ethyl was used 

in the aggregate assessment. Estimated 

cancer risk for the general U.S. 

population includes infants and 

children; therefore, a children’s cancer 

risk estimate was not reported 

separately. The aggregate cancer risk 

estimate for pyraflufen-ethyl is 2.6 × 

10 ¥6. EPA generally considers cancer 

risks in the range of one in one million 

(1 × 10 ¥6) or less to be negligible. The 

precision that can be assumed for cancer 

risk estimates is best described by 

rounding to the nearest integral order of 

magnitude on the log scale; for example, 

risks falling between 3 × 10 ¥7 and 3 × 

10 ¥6 are expressed as risks in the range 

of 10¥6. Considering the precision with 

which cancer hazard can be estimated, 

the conservativeness of low-dose linear 

extrapolation, and the rounding 

procedure just described, cancer risk 

should generally not be assumed to 

exceed the benchmark level of concern 

of the range of 10 ¥6 until the calculated 

risk exceeds approximately 3 × 10 ¥6. 

This is particularly the case where some 

conservatism is maintained in the 

exposure assessment. Although the 

pyraflufen-ethyl exposure risk 

assessment is somewhat refined, it 

retains significant conservatism due, 

among other things, to the assumption 

that 100% of registered crops are treated 

in the dietary cancer assessment and 

100% dermal absorption was assumed 

in the residential exposure cancer 

assessment. Accordingly, EPA has 

concluded the cancer risk for all 

existing pyraflufen-ethyl uses and the 

uses associated with the tolerances 

established in this action falls within 

the range of 1 × 10 ¥6 to 3 × 10 ¥6 and 

is thus negligible. Therefore, the 

aggregate cancer risk estimate from 

pyraflufen-ethyl residues in food and 

drinking water is not of concern for the 

general U.S. population. 

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 pyraflufenethyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography-mass spectrometry 

(GC/MS)) is available to enforce the 

tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residue

methods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for pyraflufen-ethyl. 

C. Revisions to Petitioned-For 

Tolerances 

Based on a lack of adequate residue 

data, the Agency is not granting 

tolerances for hops at this time. As 

permitted under 40 CFR 180.8, the 

petitioner has withdrawn its request for 

hop, dried cone tolerances. 


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Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 13263 

In addition, the requested tolerances 

for peanut, meal and peanut, refined oil 

are not being granted since those 

residues will be covered by the 

proposed tolerance for peanut. Because 

peanut hay is fed to livestock and may 

affect residue levels, upon review of the 

data supporting the petitions, EPA 

determined that several livestock 

tolerances should be revised (from 

residues of the parent and metabolite E1 in milk and meat by-products of cattle, 

goat, horse, and sheep at 0.02 ppm to 

residues of the parent and metabolites 

E-1 and E-9 at 0.03 ppm) and several 

new livestock tolerances should be 

established (residues of the parent and 

metabolites E-1 and E-9 in the fat and 

meat of cattle, goat, horse and sheep at 

0.03 ppm). The Agency revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation. 

Finally, based on data submitted with 

this petition, EPA is removing the timelimitations for these tolerances. 

V. Conclusion 

Therefore, permanent tolerances are 

established for the combined residues of 

pyraflufen-ethyl, metabolite E-1, and 

metabolite E-9 in or on (cattle, goat, 

horse, sheep) fat, meat, and meat byproducts at 0.03 ppm; milk at 0.03 ppm; 

and new tolerances are established for 

the combined residues of pyraflufenethyl and metabolite E-1 in or on peanut 

at 0.01 ppm; and peanut, hay at 0.07 

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). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 20, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR part 180 is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.585, revise paragraph (a) to 

read as follows: 

§ 180.585 Pyraflufen-ethyl; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide, 

pyraflufen-ethyl, including its 

metabolites and degradates, in the 

commodities in the table below. 

Compliance with the plant commodity 

tolerance levels specified in the table is 

to be determined by measuring only the 

sum of the parent pyraflufen-ethyl, ethyl 

2-[2-chloro-5-(4-chloro-5- 

difluoromethoxy)-1-methyl-1H-pyrazol3-yl]-4-fluorophenoxy] acetate, and its 

acid metabolite, E–1, 2-chloro-5-(4- 

chloro-5-difluoromethoxy-1-methyl-1Hpyrazol-3-yl)-4-fluorophenoxyacetic 

acid, calculated as the stoichiometric 

equivalent of pyraflufen-ethyl in or on 

the commodity. Compliance with the 

livestock commodity tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of the parent pyraflufen-ethyl, ethyl 2- 

[2-chloro-5-(4-chloro-5- 

difluoromethoxy)-1-methyl-1H-pyrazol3-yl]-4-fluorophenoxy] acetate and its 

acid metabolites: E–1, 2-chloro-5-(4- 

chloro-5-difluoromethoxy-1-methyl-1Hpyrazol-3-yl)-4-fluorophenoxyacetic 

acid, and E–9, 2-chloro-5-(4-chloro-5- 

difluoromethoxy-1H-pyrazol-3-yl)-4- 

fluorophenoxyacetic acid, both 

calculated as the stoichiometric 

equivalent of pyraflufen-ethyl in or on 

the commodity. 

Commodity Parts per 

million 

Almond, hulls .............................. 0.02 

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

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

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

Corn, field, forage ....................... 0.01 

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

Corn, field, stover ....................... 0.01 

Cotton, gin byproducts ............... 1.5 

Cotton, undelinted seed ............. 0.04 

Fruit, pome, group 11–10 ........... 0.01 

Fruit, stone, group 12 ................. 0.01 

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


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13264 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 

Commodity Parts per 

million 

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

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

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

Grass, forage, group 17 ............. 1.0 

Grass, hay, group 17 .................. 1.4 

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

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

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

Milk ............................................. 0.03 

Nut, tree, group 14 ..................... 0.01 

Olive ............................................ 0.01 

Peanut ........................................ 0.01 

Peanut, hay ................................ 0.07 

Pistachio ..................................... 0.01 

Pomegranate .............................. 0.01 

Potato ......................................... 0.02 

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

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

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

Soybean, forage ......................... 0.05 

Soybean, hay .............................. 0.10 

Soybean, seed ............................ 0.01 

Wheat, forage ............................. 0.02 

Wheat, grain ............................... 0.01 

Wheat, hay ................................. 0.01 

Wheat, straw ............................... 0.01 

* * * * * 

[FR Doc. 2013–04555 Filed 2–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0302; FRL–9377–6] 

Acetochlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

inadvertent tolerances for residues of 

acetochlor in or on crop groups 15 and 

16 for cereal grains by dropping the 

exclusion for rice grain and straw. 

Monsanto Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 27, 2013. Objections and 

requests for hearings must be received 

on or before April 29, 2013 and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0302, is 

available at 

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

Office of Pesticide Programs Regulatory 

Public Docket (OPP Docket) in the 

Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Hope Johnson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5410; email address: 

johnson.hope@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

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–2012–0302 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 29, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0302, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 25, 

2012 (77 FR 43562) (FRL–9353–6), EPA 

issued a document pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 2F7996) by Monsanto 

Company, 1300 I St. NW., Suite 450 

East, Washington, DC 20005. The 

petition requested revisions to the 

current tolerances for residues of the 

herbicide acetochlor, 2-chloro-2′- 

methyl-6′-ethyl-Nethoxymethylacetanilide and its 

metabolites containing either the 2- 

ethyl-6-methylaniline (EMA) or the 2-(1- 

hydroxyethyl)-6-methyl-aniline (HEMA) 

moiety, at 40 CFR 180.470 for grain, 

cereal, group 15, except corn, grain 

sorghum, rice, and wheat, grain and 

grain, cereal, forage, fodder and straw, 

group 16, except corn, grain sorghum, 

rice and wheat, straw. 

Specifically the petition requested 

that crop groups 15 and 16 be amended 


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