72226 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

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: November 27, 2012. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.559, in paragraph (a), 

revise the introductory text; and in the 

table, revise the entry for ‘‘Wheat, grain’’ 

to read as follows: 

§ 180.559 Clodinafop-propargyl; 

tolerances for residues. 

(a) General. Tolerances are 

established for clodinafop-propargyl, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only clodinafop-propargyl 

[(2R)-2-[4-[(5-chloro-3-fluoro-2- 

pyridinyl)oxy]phenoxy]propanoic acid, 

2-propynyl ester] and its metabolite 

clodinafop [(2R)-2-[4-[(5-chloro-3- 

fluoro-2- 

pyridinyl)oxy]phenoxy]propanoic acid]. 

Commodity Parts per 

million 

*****

Wheat, grain ......................... 0.02 

*****

* * * * * 

[FR Doc. 2012–29248 Filed 12–4–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0458; FRL–9370–8] 

Picoxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of picoxystrobin 

in or on multiple commodities which 

are identified and discussed later in this 

document. E.I. du Pont de Nemours & 

Company requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 5, 2012. Objections and 

requests for hearings must be received 

on or before February 4, 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–2010–0458, 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: 

Grant Rowland, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0254; email address: 

rowland.grant@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 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 72227 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2010–0458 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 February 4, 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– 

2010–0458, 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 June 23, 

2010 (75 FR 35801) (FRL–8831–3), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 0F7722) by E.I. du Pont de 

Nemours & Company 1007 Market 

Street, Wilmington, DE 19898, proposed 

to establish tolerances in 40 CFR part 

180 for residues of the fungicide 

picoxystrobin, in or on the cereal grains 

crop group (crop group 15) except rice 

at 0.2 parts per million(ppm); the cereal 

forage and fodder crop group (crop 

group 16) except rice at 13.0 ppm; cereal 

grain aspirated grain fractions at 4.5 

ppm; cereal grain oil at 1.5 ppm; the dry 

legume vegetables crop subgroup (crop 

group 6, subgroup C) except soybean at 

0.1 ppm; the legume vegetable foliage 

crop group (crop group 7) at 18.0 ppm; 

soybean seed at 0.05 ppm; soybean 

forage at 0.8 ppm; soybean hay at 2.5 

ppm; soybean aspirated grain fractions 

at 3.2 ppm; soybean hulls at 10.0 ppm; 

soybean oil at 0.05 ppm; canola seed at 

0.05 ppm; meat and meat byproducts 

except liver of cattle, goat, hog, horse, 

and sheep at 0.01 ppm; fat of cattle, 

goat, hog, horse, and sheep at 0.05 ppm; 

liver of cattle, goat, hog, horse, and 

sheep at 0.8 ppm; meat, meat 

byproducts, fat, and eggs of poultry at 

0.01 ppm; milk at 0.01 ppm, and cream, 

at 0.03 ppm. That notice referenced a 

summary of the petition prepared by E.I. 

du Pont de Nemours & Company, 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 proposed tolerance levels for several 

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 

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 picoxystrobin, 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with picoxystrobin 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. 

The most consistently observed 

effects of picoxystrobin exposure across 

species, genders, and treatment 

durations were decreased body weight, 

body weight gain and food 

consumption, and diarrhea. The effects 

on body weight and food consumption 

were consistent with the commonly 

observed findings for compounds which 

disrupt mitochondria respiration system 

and the resulting disruption of energy 

production. Similar to some other 

strobilurins, picoxystrobin causes 

intestinal disturbance as indicated by 

increased incidence of diarrhea or 

duodenum mucosal thickening. These 

intestinal effects appeared to be related 

to the irritating action on the mucus 

membranes as demonstrated by the 

severe eye irritation effect seen in the 

primary eye irritation study on 

picoxystrobin. 

Picoxystrobin caused changes in 

behavioral effects in both the acute and 

subchronic neurotoxicity studies with 

no neuropathological findings. The 

effects observed with acute exposure 


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72228 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

were transient (i.e. lasted for a day) and 

consisted of low arousal and decreased 

motor activities in males and decreased 

rearing in females, and, with subchronic 

exposure, included decreased male 

forelimb grip and increased female 

hindlimb splay. In the absence of any 

neuropathological findings, the 

behavioral effects were attributed to 

general malaise (probably related to 

energy production perturbations) as 

evidenced by the associated decreased 

body weight and body weight gain. 

In the rat and rabbit developmental 

toxicity studies, developmental toxicity 

was expressed as skeletal variations at 

doses causing maternal toxicity (i.e. 

diarrhea, decreased body weight, body 

weight gain, food consumption, and 

clinical signs of toxicity). In the 

reproduction study, parental/systemic 

toxicity manifested as decreased body 

weight and body weight gain in both the 

parents and offspring; no reproductive 

toxicity was seen. 

Picoxystrobin induced a treatmentrelated increase in testicular interstitial 

cell benign tumors only in the high dose 

male rats. No tumors were seen in 

females; no treatment related-increase in 

any type of tumor incidence was seen in 

male and female mice at doses that were 

considered to be adequate for the 

assessment of carcinogenicity of 

picoxystrobin. There is no mutagenic 

concern. Based on these data, EPA has 

concluded that quantification of cancer 

risk based on a non-linear approach 

(i.e., reference dose (RfD) will 

adequately account for all chronic 

toxicity, including carcinogenicity, that 

which could result from exposure to 

picoxystrobin. Specific information on 

the studies received and the nature of 

the adverse effects caused by 

picoxystrobin as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in document, 

‘‘Picoxystrobin: Human Health Risk 

Assessment for Proposed Uses on 

Canola, Cereal Grains Except Rice, Dried 

Shelled Peas and Beans, and Soybeans.’’ 

at pages 17–22 in docket ID number 

EPA–HQ–OPP–2010–0458. 

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 

picoxystrobin used for human risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PICOXYSTROBIN 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 (Females 13–49 

years of age).

There were no appropriate toxicological effects attributable to a single exposure (dose) observed in available toxicity studies. Therefore, a dose and endpoint were not identified for this risk assessment. 

Acute dietary (General population 

including infants and children).

LOAEL = 200 mg/kg/day ..............

UFA = 10x .....................................

UFH = 10x .....................................

FQPA SF = 10x ............................

aRfD = 0.2 mg/kg/day ...................

aPAD = 0.2 mg/kg/day .................

Acute Neurotoxicity—Rat 

LOAEL = 200 mg/kg/day based 

on low arousal and decreased 

motor activities in males, decreased rearing in females, in 

addition to decreased bodyweight gain and food consumption in both sexes on Day 1. 

Chronic dietary (All populations) ... NOAEL= 4.6 mg/kg/day ................

UFA = 10x .....................................

UFH = 10x .....................................

FQPA SF = 1x ..............................

cRfD = 0.046 mg/kg/day ...............

cPAD = 0.046 mg/kg/day ..............

Chronic Toxicity—Dog 

LOAEL = 15.7 mg/kg/day based 

on decreased body weights, 

weight gains, and food consumption in both sexes. 

Cancer (Oral, dermal, inhalation) .. Classification: ‘‘Suggestive evidence of Carcinogenic Potential’’ based on tumors in one species and one 

sex: A treatment-related increase in testicular interstitial cell benign tumors in high dose male rats. Quantification of cancer is based on a non-linear (i.e. RfD) approach. 

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

milligram/kilogram/day. 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 picoxystrobin, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from picoxystrobin 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 


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occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

picoxystrobin. In estimating acute 

dietary exposure for the general 

population, including infants and 

children, EPA used food consumption 

information from the U.S. Department of 

Agriculture (USDA) National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). As 

to residue levels in food, EPA’s 

assumption of this dietary assessment 

included total highest field trial total 

residues (parent and metabolite) for all 

proposed crops. In addition, 100 percent 

crop treated (PCT) was assumed. Dietary 

Exposure Evaluation Model (DEEM) 

version 7.81 default processing factors 

were assumed except for where 

tolerances were established for 

processed commodities or when 

processing studies showed no 

concentration. A separate tolerance was 

set for wheat bran, wheat germ, barley 

bran and corn oil. Tolerance levels were 

used for livestock commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Continuing Survey of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used total highest average 

field trial total residues (parent and 

metabolite) for all proposed crops. In 

addition, 100 PCT was assumed. DEEM 

version 7.81 default processing factors 

were assumed except for where 

tolerances were established for 

processed commodities. Tolerance 

levels were used for livestock 

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 

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 is 

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 for picoxystrobin. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for picoxystrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

picoxystrobin. 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. 

The drinking water assessment used a 

total toxic residue approach to include 

parent and the major environmental 

degradates: Compound 2, Compound 3, 

Compound 7, and Compound 8. Based 

on the Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

and Screening Concentration in Ground 

Water models, the estimated drinking 

water concentrations of picoxystrobin 

for: 

• Acute exposures are estimated to be 

7.95 parts per billion (ppb) for surface 

water and 0.041 ppb for ground water. 

• Chronic exposures for non-cancer 

assessments are estimated to be 2.41 

ppb for surface water and 0.041 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 7.95 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 2.41 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). 

Picoxystrobin is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found picoxystrobin to 

share a common mechanism of toxicity 

with any other substances, and 

picoxystrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that picoxystrobin 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. 

The prenatal and postnatal toxicity 

studies include rat and rabbit prenatal 

development studies, in addition to 

reproduction and fertility effects studies 

in rats. No evidence of increased 

qualitative or quantitative 

susceptibility/sensitivity was seen in 

any of these studies. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA Safety 

factor were reduced to 1X for chronic 

dietary exposure. For acute dietary 

exposures for the general population, 

including infants and children where 

the acute neurotoxicity is study used as 

an endpoint for risk assessment, EPA is 


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72230 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

retaining a 10X FQPA safety factor. That 

decision is based on the following 

findings: 

i. Although all required toxicity 

studies for picoxystrobin have been 

submitted, the acute neurotoxicity study 

used for acute dietary risk assessment 

did not demonstrate a NOAEL, and a 

LOAEL was used as an endpoint. 

Therefore, the 10X FQPA safety factor 

was retained for use of a LOAEL to 

extrapolate a NOAEL. 

ii. There is no indication that 

picoxystrobin 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 

picoxystrobin 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 PCT, total 

highest field trial total residues for acute 

exposures, total highest average field 

trial total residues for chronic 

exposures, and tolerance levels for 

livestock commodities. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to picoxystrobin 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by picoxystrobin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

picoxystrobin will occupy 1.3% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to picoxystrobin 

from food and water will utilize 2.8% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for picoxystrobin. 

3. Short- and intermediate—term 

risks. Short- and intermediate— term 

risk aggregate exposures take into 

account residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Because no short-term 

or intermediate-term adverse effects 

were identified, picoxystrobin is not 

expected to pose a short- or 

intermediate— term risk. 

4. Aggregate cancer risk for U.S. 

population. The Agency considers the 

chronic aggregate risk assessment, 

making use of the cPAD, to be protective 

of any aggregate cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to 

picoxystrobin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

(a liquid chromatography tandem mass 

spectrometry method (LC/MS/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: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. No Codex MRLs 

have been established for picoxystrobin. 

C. Revisions to Petitioned-for Tolerances 

The Agency has revised several of the 

commodity definitions and modified the 

levels for which tolerances are being 

established as follows: Vegetable, 

legume, dried shelled, except soybean, 

(group 6C) at 0.1 ppm is revised to pea 

and bean, dried shelled, except soybean, 

subgroup 6C at 0.06 ppm; soybean 

forage at 0.08 ppm is revised to soybean, 

forage at 1.0 ppm; soybean hay at 2.5 

ppm is revised to soybean, hay at 3.0 

ppm; soybean hulls at 10 ppm is revised 

to soybean, hulls at 0.2 ppm; canola, 

seed at 0.05 ppm is revised to rapeseed 

subgroup 20A at 0.08 ppm; barley, grain 

which was proposed as crop group 15 

at 0.2 ppm is revised to barley, grain at 

0.3 ppm. Tolerance for soybeans oil was 

proposed at 0.8 ppm, but EPA has 

determined that a tolerance is not 

needed. These tolerances have been 

revised based on the use of the 

Organization for Economic Co-operation 

and development tolerance calculation 

procedure (OECD TCP). Further, EPA 

determined that the proposed tolerance 

for crop group 15 (grain, cereal, except 

rice), and crop subgroup 7A group/ 

subgroup (vegetable, foliage of legume) 

each be modified and established as 

follows: Grain, cereal, group 15, except 

rice and barley at 0.04 ppm; vegetable, 

foliage of legume, except soybean, 

subgroup 7A at 40.0 ppm. Crop group 

16 (grain, cereal, forage and fodder 

except rice) however, should each be 

broken up and established with 

individual tolerances. These tolerances 

are revised as follows: Grain, cereal, 

forage, fodder, and straw, group 16, 

straw at 2.0 ppm; grain, cereal, forage 

fodder, and straw, group 16, stover at 

10.0 ppm; grain, cereal, forage, fodder 

and straw group 16, hay at 5.0 ppm; 

grain, cereal forage, fodder, and straw, 

group 16, forage at 15.0 ppm; 

Based on the corn processing study, 

the proposed tolerance for cereal grain 

oil at 1.5 ppm is revised to corn, field, 

refined oil at 0.07 ppm. 

The proposed tolerance for cereal 

(wheat), aspirated grain fractions at 4.5 

ppm is being established as grain, 

aspirated grain fractions at 10 ppm; 

soybean, aspirated grain fractions at 3.2 

ppm is revised to grain, aspirated grain 

fractions at 10 ppm as well. 

Though not proposed, the Agency has 

determined it was appropriate to 

establish tolerances for wheat, bran at 

0.06 ppm; wheat, germ at 0.09 ppm; and 

barely, bran at 0.5 ppm. 

EPA also revised livestock tolerances 

as follows, based on the calculated 

dietary burden to account for the 

transfer of residues to livestock matrices 

(tissues and milk): Cattle, fat from 0.05 


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Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 72231 

ppm to 0.01 ppm; goat, fat from 0.05 

ppm to 0.01 ppm; hog, fat from 0.05 

ppm to 0.01 ppm. horse, fat from 0.5 

ppm to 0.01 ppm; sheep, fat from 0.05 

ppm to 0.01 ppm; horse, liver at 0.8 

ppm and horse, meat byproduct, except 

liver at 0.01 ppm were combined as 

horse, meat byproduct at 0.01 ppm. 

Sheep, liver at 0.8 ppm and sheep, meat 

byproducts, except liver at 0.01 ppm 

were combined as sheep, meat 

byproducts, at 0.01 ppm. Goat, liver at 

0.8 ppm and goat, meat byproducts, 

except liver at 0.01 ppm were combined 

as goat, meat byproducts at 0.01 ppm.; 

hog, liver at 0.8 ppm and hog, meat 

byproducts, except liver at 0.01 were 

combined as hog, meat byproducts at 

0.01 ppm. Cattle, liver at 0.8 ppm and 

cattle, meat byproduct, except liver at 

0.01 ppm were combined as cattle, meat 

byproducts at 0.01 ppm. Finally a 

tolerance was proposed on cream at 0.03 

ppm; however EPA has determined that 

no tolerance is needed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of picoxystrobin, methyl 

(aE)-a-(methoxymethylene)-2-[[[6- 

(trifluoromethyl)-2- 

pyridinyl]oxy]methyl]benzeneacetate in 

or on barley, bran at 0.5 ppm; barley, 

grain at 0.3 ppm; rapeseed subgroup 

20A at 0.08 ppm; cattle, fat at 0.01 ppm; 

cattle, meat at 0.01 ppm; cattle, meat 

byproducts, at 0.01 ppm; corn, field, 

refined oil at 0.07 ppm; goat, fat at 0.01 

ppm; goat, meat at 0.01 ppm; goat meat 

byproduct, at 0.01 ppm; grain, aspirated 

grain fractions at 10 ppm; grain, cereal, 

group 15, except rice and barely at 0.04 

ppm; grain, cereal, forage, fodder, and 

straw, group 16, hay at 5.0 ppm; grain, 

cereal, forage, fodder, and straw, group 

16, forage at 15 ppm; grain, cereal, 

forage, fodder, and straw group 16, 

stover at 10 ppm; grain, cereal, forage, 

fodder, and straw, group 16, straw at 2 

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

0.01 ppm; hog, meat byproducts, at 0.01 

ppm; horse, fat at 0.01 ppm; horse, meat 

at 0.01 ppm; horse, meat byproducts, at 

0.01 ppm; milk at 0.01 ppm; pea and 

bean, dried shelled, except soybean, 

subgroup 6C at 0.06 ppm; eggs at 0.01 

ppm; poultry, fat at 0.01 ppm; poultry, 

meat at 0.01 ppm; poultry, meat 

byproducts at 0.01 ppm; sheep, fat at 

0.01 ppm; sheep, meat at 0.01 ppm; 

sheep, meat byproducts, at 0.01 ppm; 

soybean, forage at 1 ppm; soybean, hay 

at 3 ppm; soybean, hulls at 0.2 ppm; 

soybean, seed at 0.05 ppm; vegetable, 

foliage of legume, except soybean, 

subgroup 7A at 40 ppm; wheat, bran at 

0.06 ppm; and wheat, germ at 0.09 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: November 26, 2012. 

Steven Bradbury, 

Director, Office of Pesticides Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Add § 180.669 to subpart C to read 

as follows: 

§ 180.669 Picoxystrobin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

picoxystrobin, including its metabolites 

and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only picoxystrobin, methyl (aE)-a- 

(methoxymethylene)-2-[[[6- 

(trifluoromethyl)-2- 

pyridinyl]oxy]methyl]benzeneacetate. 

Commodity Parts per 

million 

Barley, bran ............................ 0 .5 

Barley, grain ........................... 0 .3 

Cattle, fat ................................ 0 .01 

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

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

Corn, field, refined oil ............. 0 .07 

Eggs ........................................ 0 .01 

Goat, fat .................................. 0 .01 

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


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72232 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

Commodity Parts per 

million 

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

Grain, aspirated grain fractions ..................................... 10 

Grain, cereal, forage, fodder, 

and straw, group 16, forage 15 

Grain, cereal, forage, fodder, 

and straw, group 16, hay .... 5 

Grain, cereal, forage, fodder, 

and straw, group 16, stover 10 

Grain, cereal, forage, fodder, 

and straw, group 16, straw 2 

Grain, cereal, group 15, except rice and barley ............ 0 .04 

Hog, fat ................................... 0 .01 

Hog, meat ............................... 0 .01 

Hog, meat byproducts ............ 0 .01 

Horse, fat ................................ 0 .01 

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

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

Milk ......................................... 0 .01 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C ........................................ 0 .06 

Poultry, fat .............................. 0 .01 

Poultry, meat .......................... 0 .01 

Poultry, meat byproducts ........ 0 .01 

Rapeseed subgroup 20A ........ 0 .08 

Sheep, fat ............................... 0 .01 

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

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

Soybean, forage ..................... 1 

Soybean, hay .......................... 3 

Soybean, hulls ........................ 0 .2 

Soybean, seed ........................ 0 .05 

Vegetable, foliage of legume, 

except soybean, subgroup 

7A ........................................ 40 

Wheat, bran ............................ 0 .06 

Wheat, germ ........................... 0 .09 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–29250 Filed 12–4–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0743; FRL–9364–7] 

Dodine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dodine, (Ndodecyl guanidine acetate) in or on 

multiple commodities and also removes 

multiple, previously established 

tolerances which are identified and 

discussed later in this document. 

Agriphar S.A., c/o Ceres International 

LLC requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 5, 2012. Objections and 

requests for hearings must be received 

on or before February 4, 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–2011–0743, 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: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; email address: 

gibson.tamue@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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2011–0743 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 February 4, 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– 

2011–0743, 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 August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1F7872) by Agriphar S.A., 


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