Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 53039 

action, is indicating that it is more likely 

than not that the State has corrected the 

deficiency that started the sanctions 

clocks. Therefore, it is not in the public 

interest to initially impose sanctions or 

to keep applied sanctions in place when 

the State has most likely done all it can 

to correct the deficiency that triggered 

the sanctions clocks. Moreover, it would 

be impracticable to go through noticeand-comment rulemaking on a finding 

that the State has corrected the 

deficiency prior to the rulemaking 

approving the State’s submittal. 

Therefore, EPA believes that it is 

necessary to use the interim final 

rulemaking process to stay and defer 

sanctions while EPA completes its 

rulemaking process on the approvability 

of the State’s submittal. Moreover, with 

respect to the effective date of this 

action, EPA is invoking the good cause 

exception to the 30-day notice 

requirement of the APA because the 

purpose of this notice is to relieve a 

restriction (5 U.S.C. 553(d)(1)). 

III. Statutory and Executive Order 

Reviews 

This action stays and defers federal 

sanctions and imposes no additional 

requirements. 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is 

not a ‘‘significant regulatory action’’ and 

therefore is not subject to review by the 

Office of Management and Budget. 

This action is not subject to Executive 

Order 13211, ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) because it is 

not a significant regulatory action. 

The Administrator certifies that this 

action will not have a significant 

economic impact on a substantial 

number of small entities under the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.). 

This rule does not contain any 

unfunded mandate or significantly or 

uniquely affect small governments, as 

described in the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

This rule does not have tribal 

implications because it will not have a 

substantial direct effect on one or more 

Indian tribes, on the relationship 

between the federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

federal government and Indian tribes, as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

This action does not have federalism 

implications because it does not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). 

This rule is not subject to Executive 

Order 13045, ‘‘Protection of Children 

from Environmental Health Risks and 

Safety Risks’’ (62 FR 19885, April 23, 

1997), because it is not economically 

significant. 

The requirements of section 12(d) of 

the National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272) do not apply to this rule because 

it imposes no standards. 

This rule does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to Congress and the 

Comptroller General. However, section 

808 provides that any rule for which the 

issuing agency for good cause finds that 

notice and public procedure thereon are 

impracticable, unnecessary, or contrary 

to the public interest, shall take effect at 

such time as the agency promulgating 

the rule determines. 5 U.S.C. 808(2). 

EPA has made such a good cause 

finding, including the reasons therefore, 

and established an effective date of 

August 28, 2013. 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This rule is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by October 28, 2013. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this rule for the 

purpose of judicial review nor does it 

extend the time within which petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental 

regulations, Ozone, Particulate matter, 

Reporting and recordkeeping 

requirements. 

Dated: August 15, 2013. 

Jared Blumenfeld, 

Regional Administrator, Region 9. 

[FR Doc. 2013–21011 Filed 8–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0549; FRL–9395–5] 

Pyraclostrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraclostrobin 

in or on multiple commodities which 

are identified and discussed later in this 

document. This regulation additionally 

removes several permanent and timelimited tolerances that will be 

superseded by tolerances established by 

this action. Interregional Research 

Project Number 4 (IR–4) and BASF 

Corporation requested tolerances 

associated with pesticide petition (PP) 

numbers 2E8069 and 2F8038, 

respectively, under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 28, 2013. Objections and 

requests for hearings must be received 

on or before October 28, 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–2012–0549, 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: Lois 

Rossi, Registration Division (7505P), 


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53040 Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFNotices@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–2012–0549 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 October 28, 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– 

2012–0549, 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 

Tolerances 

In the Federal Register of January 16, 

2013 (78 FR 3377) (FRL–9375–4), 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 2E8069) by IR–4, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.582 be 

amended by establishing tolerances for 

residues of the fungicide pyraclostrobin, 

carbamic acid, [2-[[[1-(4-chlorophenyl)- 

1H-pyrazol-3- 

yl]oxy]methyl]phenyl]methoxy-, methyl 

ester and its metabolite methyl-N-[[[1- 

(4-chlorophenyl) pyrazol-3- 

yl]oxy]otolyl] carbamate (BF 500–3), 

expressed as the parent compound, in or 

on artichoke, globe at 3.0 parts per 

million (ppm); endive, belgium at 3.0 

ppm; and persimmon at 3.0 ppm. The 

petition additionally requested that EPA 

establish tolerances in or on vegetable, 

bulb, group 3–07 at 0.9 ppm; vegetable, 

fruiting, group 8–10 at 1.4 ppm; fruit, 

citrus, group 10–10 at 2.0 ppm; fruit, 

pome, group 11–10 at 1.5 ppm; oilseed, 

group 20 at 0.45 ppm; caneberry 

subgroup 13–07A at 4.0 ppm; bushberry 

subgroup 13–07B at 4.0 ppm; small 

fruit, vine climbing subgroup (except 

fuzzy kiwi) 13–07F at 2.0 ppm; and low 

growing berry subgroup 13–07G at 1.2 

ppm. Further, upon approval of these 

subgroup/crop group tolerances the 

petition also requested that the 

following existing tolerances be 

removed for berry, group 13 at 4.0 ppm; 

fruit, citrus, group 10 at 2.0 ppm; fruit, 

pome, group 11 at 1.5 ppm; grape at 2.0 

ppm; strawberry at 1.2 ppm; vegetable, 

bulb, group 3 at 0.9 ppm; vegetable, 

fruiting, group 8 at 1.4 ppm; borage, 

seed at 0.45 ppm; castor oil plant, seed 

at 0.45 ppm; chinese tallowtree, seed at 

0.45 ppm; crambe, seed at 0.45 ppm; 

cuphea, seed at 0.45 ppm; echium, seed 

at 0.45 ppm; euphorbia, seed at 0.45 

ppm; evening primrose, seed at 0.45 

ppm; flax seed at 0.45 ppm; gold of 

pleasure, seed at 0.45 ppm; hare’s ear 

mustard, seed at 0.45 ppm, jojoba, seed 

at 0.45 ppm; lesquerella, seed at 0.45 

ppm, lunaria, seed at 0.45 ppm; 

meadowfoam, seed at 0.45 ppm; 

milkweed, seed at 0.45 ppm; mustard, 

seed at 0.45 ppm; niger seed, seed at 

0.45 ppm; oil radish, seed at 0.45 ppm; 

poppy, seed at 0.45 ppm; rapeseed, seed 

at 0.45 ppm; rose hip, seed at 0.45 ppm; 

safflower, seed at 0.45 ppm; sesame, 

seed at 0.45 ppm; stokes aster, seed at 

0.45 ppm; sunflower, seed at 0.45 ppm; 

sweet rocket, seed at 0.45 ppm; 

tallowwood, seed at 0.45 ppm; tea oil 

plant, seed at 0.45 ppm; and ternonia, 

seed at 0.45 ppm. That document 

referenced a summary of the petition 

prepared on behalf of IR–4 by BASF 

Corporation, the registrant, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Additionally, in the Federal Register 

of August 22, 2012 (77 FR 50661) (FRL– 

9358–9), 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 2F8038) by 

BASF Corporation, 26 Davis Drive, P.O. 

Box 13528, Research Triangle Park, NC, 

27709–3528. The petition requested that 

40 CFR 180.582 be amended by 

establishing tolerances for residues of 

the fungicide pyraclostrobin, carbamic 

acid, expressed as the parent 

compound, in or on sugarcane, cane at 

0.2 ppm. No tolerances were proposed 

for the processed commodities refined 

sugar and molasses, as no concentration 

of pyraclostrobin residues are expected 

in these commodities. That document 

referenced a summary of the petition 

prepared by BASF Corporation, 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 level in or on 

endive, belgium. Further, the petitioner 

later requested to amend low growing 

berry subgroup 13–07G to exclude 

cranberry. The reasons for these changes 

are explained in Unit IV.C. 


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Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 53041 

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 pyraclostrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyraclostrobin 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. 

There are no concerns for 

reproductive susceptibility, 

neurotoxicity, mutagenicity, 

genotoxicity, or immunotoxicity. The 

most consistently observed effects 

resulting from pyraclostrobin exposure 

across species, genders, and treatment 

durations were diarrhea and decreased 

body weight, body weight gain, and 

food consumption. Pyraclostrobin also 

causes intestinal disturbances, 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 irritation seen in the 

primary eye irritation study. In the rat 

acute and subchronic neurotoxicity 

studies, neuropathology and behavior 

changes were not observed. 

In the rat developmental toxicity 

study, developmental toxicity including 

an increased incidence of dilated renal 

pelvis and cervical ribs occurred at a 

dose greater than the dose causing 

maternal toxicity (including decreased 

body weights and body weight gains 

and reduced food consumption and 

reduced food efficiency). The rabbit 

developmental toxicity study indicates 

qualitative evidence of increased 

developmental susceptibility based on 

increased resorptions per litter, 

increased post-implantation loss and 

dams with total resorptions, in the 

presence of maternal toxicity (reduced 

body weight gain, food consumption, 

and food efficiency). In a dose rangefinding one-generation reproduction 

study, systemic toxicity was manifested 

as decreased body weight and body 

weight gain in both the parents and 

offspring. The effects occurred at the 

same dose levels for both parental and 

the offspring, but the decrease in pup 

weight was more than that in the 

parental animals. However, the body 

weight effect was not found in the 

guideline 2-generation reproduction 

study in either parental or offspring 

animals at similar dose level. No 

reproductive toxicity was seen. 

Pyraclostrobin has been classified as 

not likely to be carcinogenic to humans 

based on the lack of treated related 

increase in tumor incidence in 

adequately conducted carcinogenicity 

studies in rats and mice. Pyraclostrobin 

did not cause mutagenicity or 

genotoxicity in the in vivo and in vitro 

assays, nor did it cause immunotoxicity 

in T-cell dependent antibody response 

assays in mice with preliminary review. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyraclostrobin as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at 

http://www.regulations.gov in 

document: ‘‘Pyraclostrobin—Human 

Health Risk Assessment for a Section 3 

Registration of New Uses on Sugarcane, 

Globe Artichoke, Belgium Endive, 

Persimmon, Greenhouse Grown Tomato 

Transplants for Home Consumer 

Market, and Residential Ornamentals, 

Landscape Gardens, Fruit Trees, and 

Nut Trees; Plus Crop Group Expansions/ 

Revisions for Bulb Vegetable Group 3– 

07, Fruiting Vegetable Group 8–10, 

Citrus Fruit Group 10–10, Pome Fruit 

Group 11–10, Berry Subgroups 13–07A, 

B, F, and G, and Oilseed Group 20’’ at 

pages 43–49 in docket ID number EPA– 

HQ–OPP–2012–0549. 

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 pyraclostrobin used for 

human risk assessment is shown in 

Table 1. of this unit. 


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53042 Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRACLOSTROBIN 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).

NOAEL = 5.0 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.05 

mg/kg/day.

aPAD = 0.05 mg/kg/

day 

Developmental toxicity—rabbit. LOAEL = 10.0 mg/kg/day 

based on developmental toxicity findings of increased resorptions. 

Acute dietary (General population including infants and 

children).

NOAEL = 300 mg/

kg/day.

UFA = 10 x 

UFH = 10 x 

FQPA SF = 1x 

Acute RfD = 3.0 mg/

kg/day.

aPAD = 3.0 mg/kg/

day 

Acute neurotoxicity—rat. LOAEL = 1000 mg/kg/day based on 

decreased body weight gain in males. 

Chronic dietary (All populations) NOAEL= 3.4 mg/kg/

day.

UFA = 10x 

UFH = 10 x 

FQPA SF = 1x 

Chronic RfD = 0.034 

mg/kg/day.

cPAD = 0.034 mg/

kg/day 

Carcinogenicity—rat. LOAEL = 9.2 mg/kg/day based on decreased body weight/body weight gain, kidney tubular casts 

and atrophy in both sexes; increased incidence of liver necrosis and erosion/ulceration of the glandular-stomach and 

fore-stomach in males. 

Incidental oral short-term (1 to 

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

NOAEL= 5.8 mg/kg/

day.

UFA = 10 x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Subchronic toxicity—dog. LOAEL = 12.9 mg/kg/day based on 

increased incidence of diarrhea, clinical chemistry changes, 

duodenum mucosal hypertrophy, and decreased body weight 

and food intake/efficiency. 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Oral study NOAEL = 

5.0 mg/kg/day 

(dermal absorption 

rate = 14%).

UFA = 10 x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental toxicity—rabbit. LOAEL = 10.0 mg/kg/day 

based on developmental toxicity findings of increased resorptions and maternal toxicity based on decreased body weight 

gain and decreased food intake/efficiency. 

Inhalation short-term .................

(1 to 30 days) and intermediate-term (1 to 6 months).

Inhalation study 

NOAEL = 0.23 

mg/kg/day.

UFA = 10 x 

UFH = 10 x 

FQPA SF = 1x 

LOC for MOE = 100 Inhalation toxicity—rat. LOAEL = 6.9 mg/kg/day (air concentration = 0.03 mg/L) based on duodenum mucosal hyperplasia 

and respiratory system findings including alveolar 

histiocytosis and olfactory atrophy/necrosis in nasal tissue. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘not likely to be carcinogenic to humans’’ based on the absence of significant tumor increases 

in two adequate rodent carcinogenicity studies. 

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 pyraclostrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyraclostrobin tolerances in 40 

CFR 180.582. EPA assessed dietary 

exposures from pyraclostrobin in food 

as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for pyraclostrobin. 

In estimating acute dietary exposure, 

EPA used Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCID) Version 3.16, which uses food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA) from 2003 

through 2008. As to residue levels in 

food, EPA used tolerance-level residues 

or highest field trial residues and 

empirical or default processing factors. 

Experimentally-derived processing 

factors were used for fruit juices, 

tomato, sugarcane, and wheat 

commodities. For all other processed 

commodities, DEEM default processing 

factors were assumed. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

EPA included tolerance-level or average 

field trial residues, average percent crop 

treated (PCT) estimates when available, 

and empirical processing factors. 

Experimentally-derived processing 

factors were used for fruit juices, 

tomato, sugar cane, and wheat 

commodities. For all other processed 

commodities, DEEM default processing 

factors were assumed. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that pyraclostrobin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Percent crop treated (PCT) 

information. Section 408(b)(2)(F) of 

FFDCA states that the Agency may use 

data on the actual percent of food 

treated for assessing chronic dietary risk 

only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 


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Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 53043 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

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

EPA may require registrants to submit 

data on PCT. 

The following average PCT estimates 

were used in the chronic dietary risk 

assessments for the crops that are 

currently registered for pyraclostrobin: 

almonds 40%; apples 15%; apricots 

25%; barley 10%; green beans 5%; 

blueberries 45%; broccoli 5%; cabbage 

10%; caneberries 50%; cantaloupes 

15%; carrots 35%; cauliflower 2.5%; 

celery 2.5%; cherries 50%; corn 10%; 

cotton 2.5%; cucumber 5%; dry beans/ 

peas 10%; garlic 15%; grapefruit 25%; 

grapes 30%; hazelnuts (filberts) 15%; 

lemons 2.5%; lettuce 5%; nectarines 

10%; onions 20%; oranges 5%; peaches 

20%; peanuts 25%; pears 15%; green 

peas 5%; pecans 2.5%; peppers 10%; 

pistachios 30%; plums/prunes 5%; 

potatoes 15%; pumpkins 20%; soybeans 

5%; spinach 5%; squash 15%; 

strawberries 65%; sugar beets 45%; 

sweet corn 5%; tangelos 15%; 

tangerines 10%; tomatoes 25%; walnuts 

1%; watermelons 30%; wheat 5%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

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

have been met. With respect to 

condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which pyraclostrobin may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyraclostrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyraclostrobin. 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 

pyraclostrobin for acute exposures are 

estimated to be 35.6 parts per billion 

(ppb) for surface water and 0.06 ppb for 

ground water. Chronic exposures for 

non-cancer assessments are estimated to 

be 2.3 ppb for surface water and 0.02 

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 35.6 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 2.3 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). 

Pyraclostrobin is currently registered for 

the following uses and additional 

proposed uses that could result in 

residential handler and postapplication 

exposures: Treated gardens, fruit or nut 

trees, tomato transplants, and turf. EPA 

assessed residential exposure using the 

following assumptions: Short-term adult 

handler exposures via the dermal and 

inhalation routes resulting from 

application of pyraclostrobin to gardens, 

trees, and turf. Short-term dermal 

postapplication exposures were 

assessed for adults, youth 11 to 16 years 

old, and children 6 to 11 years old. 

Short-term dermal and incidental oral 

exposures were assessed for children 1 

to < 2 years old. Based on the registered 

uses of pyraclostrobin on residential 

and golf course turf, intermediate-term 

postapplication exposures are possible. 

However, since the short- and 

intermediate-term endpoints and PODs 

for dermal and oral routes are the same, 

the short-term exposure and risk 

estimates are considered to be protective 

of potential intermediate-term exposure 

and risk. 

For the aggregate assessment, 

inhalation and dermal exposures were 

not aggregated together because the 

toxicity effect from the inhalation route 

of exposure was different than the effect 

from the dermal route of exposure. The 

scenarios with the highest residential 

exposures that were used in the shortterm aggregate assessment for 

pyraclostrobin are as follows: 

• Adult short-term aggregate 

assessment—Residential inhalation 

exposure from application 

pyraclostrobin to turf via manually 

pressurized hand wand or backpack 

sprayer; residential dermal 

postapplication exposure via activities 

on treated turf. 

• Youth (11–16 years old) short-term 

aggregate assessment—Residential 

dermal exposure from postapplication 

golfing on treated turf. 

• Children (6–11 years old) shortterm aggregate assessment—Residential 

dermal exposures from postapplication 

activities in treated gardens. 

• Children (1 < 2 years old) shortterm aggregate assessment—Residential 

dermal and hand-to-mouth exposures 

from postapplication exposure to treated 

turf. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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


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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 pyraclostrobin to 

share a common mechanism of toxicity 

with any other substances, and 

pyraclostrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pyraclostrobin 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 that pyraclostrobin 

results in increased susceptibility in rats 

or rabbits in the prenatal developmental 

studies or in young rats in the 2- 

generation reproduction study. 

Although there is qualitative evidence 

of increased susceptibility in the 

prenatal development study in rabbits, 

the Agency did not identify any residual 

uncertainties after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment of 

pyraclostrobin. The degree of concern 

for prenatal and/or postnatal toxicity is 

low. 

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 

pyraclostrobin is complete. 

ii. There is no indication that 

pyraclostrobin is a neurotoxic chemical. 

Effects seen in the acute and subchronic 

neurotoxicity studies in rats are 

considered to reflect perturbations in 

mitochondrial respiration leading to 

effects on energy production rather than 

signs of neurotoxicity; therefore, there is 

no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity 

iii. There is no evidence that 

pyraclostrobin results in increased 

susceptibility in rats in the prenatal 

developmental study or in young rats in 

the 2-generation reproduction study. 

The prenatal rabbit developmental 

toxicity study showed qualitative 

evidence of increased susceptibility to 

prenatal rabbits; however, this study 

was chosen for endpoint selection for 

the acute dietary (females 13–49) and 

short-term dermal exposure scenarios. 

This study has a clearly defined NOAEL 

of 5.0 mg/kg/day. EPA did not identify 

any residual uncertainties after 

establishing toxicity endpoints and 

traditional UFs to be used in the risk 

assessment of pyraclostrobin. The 

degree of concern for prenatal and/or 

postnatal toxicity is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary exposure assessments 

were performed assuming 100 PCT and 

tolerance-level or highest field trial 

residues. The chronic dietary exposure 

assessments were performed using 

average PCT estimates, when available, 

and tolerance-level or highest field trial 

residues. These data are reliable and are 

not expected to underestimate risks to 

adults or children. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

pyraclostrobin in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by pyraclostrobin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to pyraclostrobin 

will occupy 87% of the aPAD for 

females 13–49 years old; and 2.8% for 

children 1–2 years old, the population 

group receiving the greatest exposure for 

the general U.S. population, including 

infants and children. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to pyraclostrobin 

from food and water will utilize 27% 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 pyraclostrobin 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). Pyraclostrobin 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 pyraclostrobin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 120 for children 1–2 years old, 

360 for children 6–11 years old, 1,500 

for youth 11–16 years old, 760 for adult 

handlers, and 230 for adults from 

postapplication exposures. Because 

EPA’s level of concern for 

pyraclostrobin 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). 

Pyraclostrobin is currently registered for 

uses that could result in intermediateterm residential exposure; however, 

since the short- and intermediate-term 

endpoints and PODs for dermal and oral 

routes are the same, the short-term 

exposure and risk estimates are 

considered to be protective of potential 


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intermediate-term exposure and risk 

and an intermediate-term aggregate 

assessment was not performed. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

pyraclostrobin is not expected to pose a 

cancer risk to humans. 

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 

pyraclostrobin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Two adequate methods are available 

to enforce the tolerance expression for 

residues of pyraclostrobin and the 

metabolite BF 500–3 in or on plant 

commodities: A liquid chromatography 

with tandem mass spectrometry (LC/

MS/MS) method, BASF Method D9908; 

and a high-performance LC with 

ultraviolet detection (HPLC/UV) 

method, Method D9904. The methods 

may be found in the Pesticide Analytical 

Manual, Volume I. 

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 pyraclostrobin in or on sugarcane, 

endive, belgium, and persimmon. A 

Codex MRL has been established for 

pyraclostrobin in or on globe artichoke 

at 2.0 ppm. EPA has determined that the 

U.S. tolerance should be set at 3.0 ppm. 

The field trials comprising the data set 

used by Codex are from Europe, and 

these trials were conducted under an 

application rate and preharvest interval 

different from that on the U.S. trials. 

The U.S. tolerance is based on 

application of the Organization for 

Economic Cooperation and 

Development (OECD) tolerance 

calculation procedures to the validated 

field trial data, which shows that the 

U.S. tolerance for globe artichoke must 

be at 3.0 ppm to avoid violations for 

crops treated in accordance with the 

EPA approved label. These different 

tolerance levels may be due, in part, to 

the different residue definitions for 

pyraclostrobin for the U.S. tolerances 

and the Codex MRLs. Codex established 

MRLs for residues of pyraclostrobin 

only, and in the U.S. tolerances, are 

currently established for parent and its 

desmethoxy metabolite (methyl-N-[[[1- 

(4-chlorophenyl)-1H-pyrazol-3- 

yl]oxy]methyl] phenylcarbamate). 

Currently, pyraclostrobin has over 100 

tolerances for multiple commodities and 

crop groups. When this chemical goes 

through registration review the U.S. 

EPA will determine if it is possible to 

change the existing residue definition to 

align with Codex which would 

potentially allow for harmonization of 

MRL and tolerance levels. However, 

given the number of existing tolerances 

it is not appropriate to consider such a 

change for this petition only. Therefore, 

because the residue definitions are 

currently different and pyraclostrobin 

field trials in the U.S. show higher 

residue levels than Codex MRL levels, it 

is not possible to harmonize the U.S. 

tolerance for globe artichoke with the 

Codex MRL. Additionally, the following 

U.S. crop group tolerances established 

in this action could not be harmonized 

because of the difference in residue 

definitions between U.S. tolerances for 

pyraclostrobin and Codex MRLs. The 

crop group tolerances which could not 

be harmonized with Codex MRLs for 

commodities in these crop group 

tolerances include: The bulb vegetable 

group 3–07; the fruiting vegetables 

group 8–10; the pome fruit group 11–10; 

the caneberry subgroup 13–07A; the 

bushberry subgroup 13–07B; the small 

fruit vine climbing subgroup 13–07F; 

and the low growing berry subgroup 13– 

07G. The Codex has established an MRL 

for the Codex equivalent of the U.S. 

citrus fruit group 10–10 and for the 

oilseed group 20, but although the 

numerical levels for the U.S. and Codex 

crop groups are the same, the numerical 

values refer to different residues. 

C. Revisions to Petitioned-for Tolerances 

Based on the data submitted with the 

petition, EPA is revising the proposed 

tolerance in or on endive, belgium from 

3.0 ppm to 4.0 ppm. The Agency revised 

this tolerance level based on analysis of 

the residue field trial data using the 

OECD tolerance calculation procedures. 

EPA is additionally removing the timelimited tolerance in or on sugarcane, 

cane at 0.02 ppm as it will be 

superseded by the permanent tolerance 

at 0.2 ppm. Finally, EPA is removing the 

time-limited tolerance in or on 

sugarcane, molasses at 0.4 ppm, as the 

Agency has determined that no 

concentration of pyraclostrobin residues 

are expected in these commodities and 

the tolerance is therefore not necessary. 

The information regarding sugarcane, 

molasses was included in the August 

22, 2012 (77 FR 50661) notice of filing 

for PP number 2F8038. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyraclostrobin, carbamic 

acid, [2-[[[1-(4-chlorophenyl)-1Hpyrazol-3- 

yl]oxy]methyl]phenyl]methoxy-, methyl 

ester) and its desmethoxy metabolite 

(methyl N-[[[1-(4-chlorophenyl)-1Hpyrazol-3-yl]oxy]methyl]phenyl 

carbamate), calculated as the 

stoichiometric equivalent of 

pyraclostrobin in or on artichoke, globe 

at 3.0 ppm; endive, belgium at 4.0 ppm; 

persimmon at 3.0 ppm; sugarcane, cane 

at 0.20 ppm; vegetable, bulb, group 3– 

07 at 0.9 ppm; vegetable, fruiting, group 

8–10 at 1.4 ppm; fruit, citrus, group 10– 

10 at 2.0 ppm; fruit, pome, group 11–10 

at 1.5 ppm; oilseed group 20 at 0.45 

ppm; caneberry subgroup 13–07A at 4.0 

ppm; bushberry subgroup 13–07B at 4.0 

ppm; fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F at 2.0 

ppm; and berry, low growing, subgroup 

13–07G, except cranberry at 1.2 ppm. 

This regulation additionally removes 

established tolerances in or on 

vegetable, bulb, group 3; vegetable, 

fruiting, group 8; fruit, citrus, group 10; 

fruit, pome, group 11; cotton, 

undelinted seed; borage, seed; castor oil 

plant, seed; Chinese tallowtree, seed; 

crambe, seed; cuphea, seed; echium, 

seed; euphorbia, seed; evening 

primrose, seed; flax, seed; gold of 

pleasure, seed; hare’s ear mustard, seed; 

jojoba, seed; lesquerella, seed; lunaria, 

seed; meadowfoam, seed; milkweed, 

seed; mustard, seed; niger seed, seed; oil 

radish, seed; poppy, seed; rapeseed, 

seed; rose hip, seed; safflower, seed; 

sesame, seed; stokes aster, seed; 

sunflower, seed; sweet rocket, seed; 

tallowwood, seed; tea oil plant, seed; 

vernonia, seed; berry, group 13; grape; 

and strawberry. This regulation finally 

removes the time-limited tolerances in 

or on sugarcane, cane and sugarcane, 

molasses. 


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53046 Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 

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: August 14, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.582: 

■ a. Revise the table in paragraph (a)(1). 

■ b. Remove the commodities 

‘‘Sugarcane, cane’’ and ‘‘Sugarcane, 

molasses’’ in the table in paragraph (b). 

■ c. Revise the table in paragraph (b). 

The revisions read as follows: 

§ 180.582 Pyraclostrobin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per million 

Alfalfa, forage ..................... 10 

Alfalfa, hay .......................... 30 

Almond, hulls ...................... 7 .0 

Apple, wet pomace ............. 8 .0 

Artichoke, globe .................. 3 .0 

Avocado .............................. 0 .6 

Banana ............................... 0 .04 

Barley, grain ....................... 1 .4 

Barley, hay .......................... 25 

Barley, straw ....................... 6 .0 

Bean, succulent shelled ..... 0 .5 

Beet, sugar, dried pulp ....... 1 .0 

Beet, sugar, roots ............... 0 .2 

Beet, sugar, tops ................ 8 .0 

Commodity Parts per million 

Berry, low growing, subgroup 13–07G, except 

cranberry ......................... 1 .2 

Brassica, head and stem, 

subgroup 5A .................... 5 .0 

Brassica, leafy greens, subgroup 5B ......................... 16 .0 

Bushberry subgroup 13– 

07B .................................. 4 .0 

Caneberry subgroup 13– 

07A .................................. 4 .0 

Canistel ............................... 0 .6 

Citrus, dried pulp ................ 12 .5 

Citrus, oil ............................. 9 .0 

Coffee, green bean ............. 1 0 .3 

Corn, field, forage ............... 5 .0 

Corn, field, grain ................. 0 .1 

Corn, field, refined oil ......... 0 .2 

Corn, field, stover ............... 17 .0 

Corn, pop, grain .................. 0 .1 

Corn, pop, stover ................ 17 .0 

Corn, sweet, forage ............ 5 .0 

Corn, sweet, kernel plus 

cob with husks removed 0 .04 

Corn, sweet, stover ............ 23 .0 

Cotton, gin byproducts ....... 30 

Endive, belgium .................. 4 .0 

Fruit, citrus, group 10–10 ... 2 .0 

Fruit, pome, group 11–10 ... 1 .5 

Fruit, small vine climbing, 

except fuzzy kiwifruit, 

subgroup 13–07F ............ 2 .0 

Fruit, stone, group 12 ......... 2 .5 

Grain, aspirated fractions ... 2 .5 

Grape, raisin ....................... 7 .0 

Grass, forage ...................... 10 

Grass, hay .......................... 4 .5 

Grass, seed screenings ...... 27 

Grass, straw ....................... 14 

Hop, dried cones ................ 23 .0 

Mango ................................. 0 .6 

Nut, tree, group 14 ............. 0 .04 

Oat, grain ............................ 1 .2 

Oat, hay .............................. 18 

Oat, straw ........................... 15 

Oilseed group 20 ................ 0 .45 

Papaya ................................ 0 .6 

Pea, succulent .................... 0 .2 

Pea and bean, dried 

shelled, except soybean, 

subgroup 6C ................... 0 .5 

Peanut ................................ 0 .05 

Peanut, refined oil .............. 0 .1 

Peppermint, tops ................ 8 .0 

Persimmon .......................... 3 .0 

Pistachio ............................. 0 .7 

Radish, tops ........................ 16 

Rye, grain ........................... 0 .04 

Rye, straw ........................... 0 .5 

Sapodilla ............................. 0 .6 

Sapote, black ...................... 0 .6 

Sapote, mamey .................. 0 .6 

Sorghum, grain, forage ....... 5 .0 

Sorghum, grain, grain ......... 0 .60 

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

Soybean, forage ................. 11 

Soybean, hay ...................... 14 

Soybean, hulls .................... 0 .06 

Soybean, seed .................... 0 .04 

Spearmint, tops .................. 8 .0 

Star apple ........................... 0 .6 

Sugarcane, cane ................ 0 .20 

Vegetable, bulb, group 3– 

07 .................................... 0 .9 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 53047 

Commodity Parts per million 

Vegetable, cucurbit, group 

9 ...................................... 0 .5 

Vegetable, foliage of legume, except soybean, 

subgroup 7A .................... 25 .0 

Vegetable, fruiting, group 

8–10 ................................ 1 .4 

Vegetable, leafy, except 

brassica, group 4 ............ 29 .0 

Commodity Parts per million 

Vegetable, leaves of root 

and tuber, group 2, except sugar beet ............... 16 .0 

Vegetable, legume, edible 

podded, subgroup 6A ..... 0 .5 

Vegetable, root, except 

sugar beet, subgroup 1B 0 .4 

Vegetable, tuberous and 

corm, subgroup 1C ......... 0 .04 

Commodity Parts per million 

Vegetables, foliage of legume, group 7 ................... 25 

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

Wheat, hay ......................... 6 .0 

Wheat, straw ....................... 8 .5 

* * * * * 

(b) Section 18 emergency exemptions. 

* * * 

Commodity Parts per 

million 

Expiration/revocation date 

Endive, belgium ....................................................................................................................................................... 11.0 12/31/13 

* * * * * 

[FR Doc. 2013–20921 Filed 8–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0586; FRL–9393–8] 

Halosulfuron-methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of halosulfuronmethyl in or on artichoke and caneberry 

subgroup 13–07A. The Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 28, 2013. Objections and 

requests for hearings must be received 

on or before October 28, 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–2012–0586, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotice@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–2012–0586 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 October 28, 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– 

2012–0586, 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.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 


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