Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48907 

Commodity Parts per 

million 

*****

Cilantro, leaves ......................... 8 .0 

Coriander, seed ........................ 0 .13 

* * * * * 

[FR Doc. 2012–20034 Filed 8–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0395; FRL–9357–5] 

Fludioxonil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fludioxonil in 

or on multiple commodities which are 

identified and discussed later in this 

document, associated with pesticide 

petition (PP) 1E7853 and PP 1E7870. 

This regulation additionally revises 

several established tolerances, and 

removes several established permanent 

and time-limited tolerances. 

Interregional Research Project Number 4 

(IR–4) and Syngenta Crop Protection, 

LLC, requested the tolerances associated 

with PP 1E7853 and PP 1E7870, 

respectively, under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 15, 2012. Objections and 

requests for hearings must be received 

on or before October 15, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0395, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS 

code 112). 

• Food manufacturing (NAICS 

code 311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2011–0395 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 15, 2012. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0395, by one of 

the following methods: 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0395 by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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 July 20, 

2011 (76 FR 43231) (FRL–8880–1), 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 1E7853, by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.516 be 

amended by establishing tolerances for 

residues of the fungicide fludioxonil, (4- 

(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H 

-pyrrole-3-carbonitrile), in or on acerola 

at 5.0 parts per million (ppm); atemoya 

at 20 ppm; biriba at 20 ppm; cherimoya 

at 20 ppm; custard apple at 20 ppm; 

feijoa at 5.0 ppm; guava at 5.0 ppm; 

ilama at 20 ppm; jaboticaba at 5.0 ppm; 

passionfruit at 5.0 ppm; soursop at 20 

ppm; starfruit at 5.0 ppm; sugar apple at 


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20 ppm; wax jambu at 5.0 ppm; ginseng 

at 3.0 ppm; onion, bulb subgroup 3–07A 

at 0.2 ppm; onion, green subgroup 3– 

07B at 7.0 ppm; caneberry subgroup 13– 

07A at 5.0 ppm; bushberry subgroup 

13–07B at 2.0 ppm; fruit, small vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 1.0 ppm; berry, low 

growing, subgroup 13–07G, except 

cranberry at 2.0 ppm; vegetable, fruiting, 

group 8–10, except tomato at 0.7 ppm; 

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

fruit, pome, group 11–10 at 5.0 ppm; 

leafy greens subgroup 4A at 30 ppm; 

potato at 6.0 ppm; pineapple at 8.0 ppm; 

and dragon fruit at 1.0 ppm. 

That notice additionally requested to 

amend established tolerances of 

fludioxonil in or on avocado from 0.45 

ppm to 5.0 ppm; sapote, black from 0.45 

ppm to 5.0 ppm; canistel from 0.45 ppm 

to 5.0 ppm; sapote, mamey from 0.45 

ppm to 5.0 ppm; mango from 0.45 ppm 

to 5.0 ppm; papaya from 0.45 ppm to 5.0 

ppm; sapodilla from 0.45 ppm to 5.0 

ppm; star apple from 0.45 ppm to 5.0 

ppm; longan from 1.0 ppm to 20 ppm; 

lychee from 1.0 ppm to 20 ppm; pulasan 

from 1.0 ppm to 20 ppm; rambutan from 

1.0 ppm to 20 ppm; Spanish lime from 

1.0 ppm to 20 ppm; and tomato from 

0.50 ppm to 3.0 ppm. Upon approval of 

the aforementioned tolerances, the 

petition finally requested to amend 40 

CFR 180.516 by removing the 

established tolerances for residues of 

fludioxonil in or on the following raw 

agricultural commodities: Onion, bulb 

at 0.2 ppm; onion, green at 7.0 ppm; 

caneberry subgroup 13A at 5.0 ppm; 

bushberry subgroup 13B at 2.0 ppm; 

Juneberry at 2.0 ppm; lingonberry at 2.0 

ppm; salal at 2.0 ppm; grape at 1.0 ppm; 

strawberry at 2.0 ppm; vegetable, 

fruiting, group 8 at 0.01 ppm; tomatillo 

at 0.50 ppm; fruit, citrus, group 10 at 10 

ppm; fruit, pome, group 11 at 5.0 ppm; 

and leafy greens subgroup 4A, except 

spinach at 30 ppm. That notice 

referenced a summary of the petition 

prepared on behalf of IR–4 by Syngenta 

Crop Protection, LLC, the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

In the Federal Register of May 2, 2012 

(77 FR 25954) (FRL–9346–1), 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 1E7853) by IR–4, that 

requested that 40 CFR 180.516 be 

amended by establishing tolerances for 

residues of the fungicide fludioxonil, (4- 

(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H 

-pyrrole-3-carbonitrile), in or on the 

commodities requested in the Federal 

Register of July 20, 2011, with one 

change. This petition requested to 

establish a tolerance for residues of 

fludioxonil in or on vegetable, tuberous 

and corm, subgroup 1C at 6.0 ppm. This 

request superseded the previous request 

to establish a tolerance in or on potato 

at 6.0 ppm, as potato is the 

representative commodity of crop 

subgroup 1C. The May 2, 2012 petition 

additionally requested that EPA remove 

the established tolerance in or on 

vegetable, tuberous and corm, subgroup 

1D at 3.5 ppm, as the tolerance will be 

superseded by the vegetable, tuberous 

and corm, subgroup 1C tolerance. That 

notice referenced a summary of the 

petition prepared on behalf of IR–4 by 

Syngenta Crop Protection, LLC, the 

registrant, which is available in the 

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

comment was received to this notice of 

filing. EPA’s response to this comment 

is discussed in Unit IV.C. 

Additionally, in the Federal Register 

of April 4, 2012 (77 FR 20334) (FRL– 

9340–4), EPA issued a notice pursuant 

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

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

1E7870 by Syngenta Crop Protection, 

LLC, P.O. Box 18300, Greensboro, NC 

27409. The petition requested that 40 

CFR 180.516 be amended by 

establishing a tolerance for residues of 

the fungicide fludioxonil in or on leafy 

petioles subgroup 04B at 14 ppm. That 

notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, LLC, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. One comment was 

received to this notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petitions, EPA has 

revised the proposed tolerance levels 

and/or has revised the commodity 

definitions for several commodities. 

Additionally, EPA has removed several 

established tolerances and has 

determined that tolerances should be 

established in or on several livestock 

commodities. Finally, the Agency has 

revised the tolerance expression for all 

established commodities to be 

consistent with current Agency policy. 

The reasons for these changes are 

explained in Unit IV.D. 

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 fludioxonil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fludioxonil 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. 

Fludioxonil is of low acute toxicity 

and is not a dermal sensitizer. For 

subchronic and chronic toxicity, the 

primary effects in the mouse and rat 

were similar and included decreased 

body weight and food consumption 

associated with clinical pathological 

and histopathological effects in the liver 

and kidney. In the subchronic dog 

study, diarrhea was the most sensitive 

indicator of toxicity. In contrast, in the 

chronic toxicity study in dogs, 

decreased body-weight gain in females 

was the most sensitive indicator of 

toxicity. Liver toxicity was observed in 

both dog studies at higher doses. 

Fludioxonil is not developmentally 

toxic in rabbits. In a rat developmental 

toxicity study at the highest dose tested 

(HDT), fludioxonil caused an increase in 

fetal incidence and litter incidence of 

dilated renal pelvis in the presence of 

maternal toxicity. There was no 

quantitative or qualitative evidence of 

increased susceptibility to rats and 

rabbits following in utero exposure. 

There was also no quantitative or 


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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 48909 

qualitative evidence of increased 

susceptibility to rats following postnatal 

exposure and there was no evidence of 

immunotoxicity when tested up to 

including the limit dose. 

EPA determined that fludioxonil 

poses a negligible cancer risk. This 

conclusion was based on the fact that 

cancer studies with fludioxonil only 

showed marginal evidence of cancer in 

one sex of one species. There was no 

evidence of carcinogenicity in mice 

when tested up to the limited dose 

7,000 ppm. There was no evidence of 

carcinogenicity in male rats, but there 

was a statistically significant increase, 

both trend and pairwise, of combined 

hepatocellular tumors in female rats. 

The pairwise increase for combined 

tumors was significant at p = 0.03, 

which is not a strong indication of a 

positive effect. Further, statistical 

significance was only found when liver 

adenomas were combined with liver 

carcinomas. Finally, the increase in 

these tumors was within, but at the high 

end, of the historical controls. 

Fludioxonil was not mutagenic in the 

tests for gene mutations. However, 

based on the induction of polyploidy in 

the in vitro Chinese hamster ovary cell 

cytogenetic assay and the suggestive 

evidence of micronuclei induction in rat 

hepatocytes in vivo, additional 

mutagenicity testing was performed in 

three studies specifically designed to 

address the concerns regarding 

aneuploidy. The results of these assays 

were negative for aneuploidy activity. Specific information on the studies 

received and the nature of the adverse 

effects caused by fludioxonil 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: 

‘‘Fludioxonil. Tolerance Petitions for 

Residues in/on Ginseng, Leafy Petioles 

Crop Subgroup 4B, Pineapple (postharvest treatment), Tuberous and Corm 

Vegetable Subgroup 1C, Tropical Fruit 

(post-harvest treatment), Bulb Onion 

Subgroup 3–07A, Green Onion 

subgroup 3–07B, Caneberry Subgroup 

13–07A, Bushberry Subgroup 13–07B, 

Small Fruit Vine Climbing Subgroup 

13–07F (except fuzzy kiwifruit), LowGrowing Berry Subgroup 13–07G 

(except cranberry), Fruiting Vegetable 

Group 8–10 (except tomato), Citrus Fruit 

Group 10–10, Pome Fruit Group 11–10, 

Leafy Vegetable (except Brassica) 

Subgroup 04A, Dragon Fruit, and 

Tomato (post-harvest treatment). 

Human-Health Risk Assessment.’’ pp. 

40–42 in docket ID number EPA–HQ– 

OPP–2011–0395. 

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 fludioxonil 

used for human risk assessment is 

shown in the Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUDIOXONIL 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 = 100 mg/ 

kg/day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 1 mg/ 

kg/day.

aPAD = 1 mg/kg/ 

day 

Prenatal developmental toxicity in rats 

LOAEL = 1,000 mg/kg/day based on the increased incidence of fetuses and litters with dilated renal pelvis and 

dilated ureter in rat developmental study. 

Acute dietary (General population including infants and children).There were no appropriate toxicological effects attributable to a single exposure (dose) observed in 

available oral toxicity studies, including maternal toxicity in the developmental toxicity studies. Therefore, a dose and endpoint were not identified for this risk assessment. 

Chronic dietary (All populations) ............ NOAEL= 3.3 mg/ 

kg/day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 

0.033 mg/kg/day.

cPAD = 0.033 mg/ 

kg/day 

Chronic toxicity in dogs 

LOAEL = 35.5 mg/kg/day based on decreased weight gain 

in female dogs during weeks 1–52 of one-year dog 

feeding study. 


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48910 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Rules and Regulations 

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

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Incidental oral short-term (1 to 30 days) NOAEL= 10 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 

100.

Rabbit developmental study 

LOAEL = 100 mg/kg/day based on decreased weight gain 

during dosing period. 

Incidental oral intermediate-term (1 to 6 

months).

NOAEL= 3.3 mg/ 

kg/day.

UFA= 10X 

UFH= 10X 

FQPA SF = 1X 

LOC for MOE = 

100.

Chronic toxicity in dogs 

LOAEL = 35.5 mg/kg/day based on decreased weight gain 

in female dogs during weeks 1–52 of one-year dog 

feeding study. 

Inhalation short-term (1 to 30 days) ....... Inhalation (or oral) 

study NOAEL = 

10 mg/kg/day 

(inhalation absorption rate = 

100%).

UFA = 10X 

UFH = 10X 

FQPA SF = 10X 

LOC for MOE = 

1000.

Rabbit developmental study 

LOAEL = 100 mg/kg/day based on decreased weight gain 

during dosing period. 

Cancer (Oral, dermal, inhalation) ........... Poses no greater than a negligible cancer risk. 

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). UFDB = to account for the absence of data or other data deficiency. 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 fludioxonil, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fludioxonil tolerances in 40 CFR 

180.516. EPA assessed dietary 

exposures from fludioxonil 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 fludioxonil for females 13–49 years 

old (i.e., females of child-bearing age). 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed tolerance-level 

residues, 100 percent crop treated (PCT) 

estimates, and DEEMTM ver. 7.81 default 

processing factors. There were no 

appropriate toxicological effects 

attributable to a single exposure for the 

general population; therefore, these 

population subgroups were not 

included in this assessment. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed tolerance-level residues for 

most commodities, with the exception 

of the following commodities for which 

anticipated residues were used: Celery, 

pineapple, potato, spinach, apple, 

grapefruit, lemon, lime, orange, pear, 

tomato, head lettuce, leaf lettuce, fresh 

parsley, brassica leafy vegetables group 

5, grape, cherry, peach, and plum. The 

anticipated residues were estimated 

from field trial and processing study 

data for the chronic analysis. The 

chronic dietary exposure assessment 

also incorporated 100 PCT estimates 

and DEEMTM ver. 7.81 default 

processing factors, with the exception of 

citrus fruit juice (1X), apple juice (1X), 

grape juice (0.42X), raisin (1.65X), 

potato commodities (1X), and tomato 

commodities (1X), except dried tomato 

(14.3X). These processing factors are 

based upon crop-specific processing 

study data. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fludioxonil poses a 

negligible cancer risk to humans. 

Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue information. 

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

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

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

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

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

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

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 


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2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fludioxonil in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fludioxonil. 

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 

fludioxonil for surface water are 

expected to be 83.8 parts per billion 

(ppb) for acute exposures and 38.5 ppb 

for chronic exposures. The EDWCs of 

fludioxonil for ground water are 

expected to be 0.2 ppb for acute and 

chronic exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 83.8 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 38.5 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). 

Fludioxonil is currently registered for 

the following uses that could result in 

residential exposures: Parks, golf 

courses, athletic fields, residential 

lawns, ornamentals, and greenhouses. In 

addition to the conventional uses of 

fludioxonil in residential areas, there 

are also antimicrobial uses. However, 

residential turf uses of fludioxonil are 

expected to result in the highest 

potential exposure of all registered 

residential uses of fludioxonil and, 

therefore, were assessed. 

EPA assessed residential exposure 

using the following assumptions: Shortterm inhalation for residential handler 

exposure scenarios, including mixing/ 

loading/applying fludioxonil. 

Residential handler exposures were 

considered to be short-term only due to 

the infrequent use patterns associated 

with homeowner products. 

Additionally, EPA assessed potential 

short- and intermediate-term 

postapplication exposures to toddlers 

(children 1–2 years old) resulting from 

physical activities on turf. These 

included incidental oral exposures from 

hand-to-mouth, object-to-mouth, and 

incidental soil ingestion. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/ 

science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found fludioxonil to share a common 

mechanism of toxicity with any other 

substances, and fludioxonil does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

fludioxonil 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 fludioxonil toxicity database 

includes developmental toxicity studies 

in rats and rabbits and a 2-generation 

reproduction study in rats. In the rat 

developmental study, there was an 

increase in the number of fetuses and 

litters with dilated renal pelvis and 

dilated ureter at the limit dose (1,000 

mg/kg/day); maternal toxicity occurred 

at the same dose and was manifested as 

a reduction in corrected body-weight 

gain, indicating that there is no 

quantitative susceptibility for these fetal 

effects. In the rabbit developmental 

study, no developmental toxicity was 

seen up to the HDT. Maternal toxicity 

was demonstrated at that dose. In the 2- 

generation rat reproduction study, 

offspring toxicity was seen at the same 

dose that produced parental toxicity. 

The parental toxicity was manifested as 

increased clinical signs, decreased body 

weight, body weight gain and food 

consumption. Offspring toxicity was 

manifested as decreased weight gain in 

pups. Parental and offspring toxicity 

were comparable; therefore, it was 

concluded that there is no increased 

susceptibility in the 2-generation 

reproduction study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X for risks other than 

those related to inhalation exposure. 

EPA is retaining the 10X FQPA safety 

factor for risks from inhalation 

exposure. That decision is based on the 

following findings: 

i. The toxicity database for fludioxonil 

is complete except for a 90-day 

inhalation study. The point of departure 

for assessing risk from inhalation 

exposure is being extrapolated from an 

oral study. The uncertainty associated 

with this extrapolation requires the 

retention of the 10X FQPA SF for these 

exposures. 

ii. The only potential indicator of 

neurotoxicity in the fludioxonil toxicity 

database was convulsions noted in mice 

following handling at high doses. The 

convulsions were considered to be 

agonal in nature. Therefore, EPA has 

determined that there is no need for a 

developmental neurotoxicity study or 

an additional safety factor to account for 

neurotoxicity. 

iii. There is no evidence that 

fludioxonil results in increased 

susceptibility in in utero rabbits in the 

prenatal developmental study or in 

young rats in the 2-generation 

reproduction study. In the rat 

developmental toxicity study, fetal 

effects were noted at the limit dose in 

the presence of maternal toxicity. 

However, EPA determined that the 

degree of concern is low for the noted 

fetal effects because the effects were 

observed at the same doses as maternal 

effects, and there is a clear NOAEL 

established which was used in endpoint 

selection. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary assessment for 

females 13–49 years old was unrefined, 

assuming 100 PCT and tolerance-level 


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residues, and the chronic dietary 

exposure assessment assumed 100 PCT 

and used tolerance-level residues or 

made use of average residues derived 

from crop field trial studies. The 

chronic assessment also assumed DEEM 

default or other processing factors based 

on reliable processing data. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to fludioxonil in 

drinking water. EPA used similarly 

conservative assumptions to assess 

short- and intermediate-term 

postapplication exposure resulting from 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by fludioxonil. 

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 fludioxonil will 

occupy 16% of the aPAD for females 

13–49 years old, the population group 

identified as having a potential acute 

exposure to fludioxonil. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fludioxonil 

from food and water will utilize 68% of 

the cPAD for children 1 to 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 

fludioxonil 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). Fludioxonil 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 

fludioxonil. 

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 an 

aggregate MOE of 310 for children 1–2 

years old. Because EPA’s level of 

concern for fludioxonil is a MOE of 100 

or below, this MOE is not of concern. 

Because the short-term oral and 

inhalation risks were estimated using 

the same oral POD, these routes of 

exposure could be combined for the 

adult short-term exposure assessment. 

However, because the level of concern 

for oral and inhalation routes of 

exposure are not the same (an MOE of 

<100 defines the level of concern for 

incidental oral risk while inhalation risk 

is defined by an MOE of <1,000) an 

aggregate risk index (ARI) was required 

to estimate aggregate risk for adults. 

Only adults are assumed to be exposed 

to a combination of oral and inhalation 

exposures because inhalation exposures 

for fludioxonil may occur only as to 

those who apply the pesticide. EPA 

identifies ARIs at or below one as a risk 

estimate of concern. The short-term 

aggregate ARI exposure estimates to 

fludioxonil residues for adults are 9.5 

for the general population and 11 for 

adults 50 years and older. 

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). 

Fludioxonil is currently registered for 

uses that could result in intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to fludioxonil. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 105 for children 

1–2 years old. Because EPA’s level of 

concern for fludioxonil is a MOE of 100 

or below, this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fludioxonil poses a 

negligible cancer risk to humans. 

Therefore, fludioxonil 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 fludioxonil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate high-performance liquid 

chromatography/ultraviolet light 

detector (HPLC/UV) methods (Syngenta 

Methods AG–597 and AG–597B) are 

available for enforcing tolerances for 

residues of fludioxonil in or on plant 

commodities. An adequate liquid 

chromatography, tandem mass 

spectrometry (LC–MS/MS) method 

(Analytical Method GRM025.03A) is 

available for enforcing tolerances for 

residues of fludioxonil in or on 

livestock commodities. 

The methods may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

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. 

There are no Codex MRLs established 

for the following tolerances associated 

with these petitions: Ginseng; tropical 

fruit commodities; onion, green, 

subgroup 3–07B; leaf petioles crop 

subgroup 4B; and fat of cattle, goat, 

horse, and sheep. The following United 

States tolerances being established by 

this action are harmonized with 

comparable Codex MRLs: Caneberry 

subgroup 13–07A at 5.0 ppm; bushberry 

subgroup 13–07B at 2.0 ppm; and fruit, 

pome, group 11–10 at 5.0 ppm; onion, 

bulb, subgroup 3–07A at 0.50 ppm; 

fruit, small vine climbing, except fuzzy 


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kiwifruit, subgroup 13–07F at 2.0 ppm; 

and berry, low growing, subgroup 13– 

07G, except cranberry at 3.0 ppm. 

The following United States 

tolerances being established by this 

action cannot be harmonized with the 

comparable Codex MRL: Tomato; leafy 

greens subgroup 4A; vegetable, tuberous 

and corm, subgroup 1C; fruit, citrus, 

group 10–10; and fruit, pome, group 11– 

10. The residue data and use patterns in 

the United States for these commodities 

support a higher tolerance value than 

what is established by Codex. The 

Codex has proposed, though has not yet 

approved, MRLs on citrus fruits at 10 

ppm and pome fruits at 5.0 ppm that 

would result in harmonization with the 

United States for these commodities. 

Finally, EPA is establishing a 

tolerance on vegetable, fruiting, group 

8–10, except tomato that is not 

harmonized with Codex MRLs on 

eggplant at 0.3 ppm or sweet peppers at 

1 ppm, which are members of the 

fruiting vegetable crop group. The 

United States tolerance was established 

as the result of a joint review of residue 

field trial data with Canada’s Pest 

Management Regulatory Agency 

(PMRA). Based on the EPA and PMRA 

review of the data supporting the 

petition, the resulting tolerance for 

vegetable, fruiting, group 8–10, except 

tomato is 0.5 ppm. This tolerance 

cannot be harmonized with the Codex 

MRLs on eggplant at 0.3 ppm and sweet 

peppers at 1 ppm since the MRLs are 

established for two individual members 

of the fruiting vegetable crop group at 

different levels. 

C. Response to Comments 

EPA received one comment to the 

notice of filing for PP 1E7870, which 

requested additional information about 

the nature of the residue and the 

adverse effects noted from exposure to 

fludioxonil. A summary of information 

about the nature of the residue and the 

adverse effects from fludioxonil was 

available to the commenter in the 

docket at the time of the notice of filing. 

That information, as well as specific 

information on the nature of the residue, 

including physical and chemical 

characteristics, and the adverse effects 

caused by fludioxonil from the toxicity 

studies can be found in the supporting 

and related material at http:// 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2011–0395. 

Additionally, the Agency received 

one comment to the May 2, 2012 notice 

of filing for PP 1E7853. The commenter 

raised concerns about the proposal to 

increase an existing tolerance for 

fludioxonil 5–10 times the current level 

and further stated that EPA would need 

to amend the protocol and develop a 

completely new method. In response to 

these concerns, EPA notes that the 

appropriate residue field trial data to 

support the amended use pattern for a 

post-harvest use was submitted to the 

Agency. From the risk assessment for 

the action, which included review of the 

field trial data supporting petitioned-for 

tolerance amendments, EPA has 

determined that the tolerance levels to 

be established by the Agency are 

appropriate and safe. 

D. Revisions to Petitioned-For 

Tolerances 

Based on the data supporting the 

petitions, EPA revised the proposed 

tolerances on several commodities, as 

follows: Ginseng from 3.0 ppm to 4.0 

ppm; vegetable, fruiting, group 8–10, 

except tomato from 0.7 ppm to 0.50 

ppm; tomato from 3.0 ppm to 5.0 ppm; 

pineapple from 8.0 ppm to 20 ppm; and 

leaf petioles crop subgroup 4B from 14 

ppm to 15 ppm. Upon review of the data 

supporting the petitions, EPA also 

determined that several tolerances 

should be established on livestock 

commodities, as follows: Milk at 0.01 

ppm; cattle, goat, horse, and sheep meat 

at 0.01 ppm; meat byproducts of cattle, 

goat, horse, and sheep at 0.05 ppm; and 

fat of cattle, goat, horse, and sheep at 

0.05 ppm. The Agency revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. 

Additionally, EPA revised the onion, 

bulb, subgroup 3–07A from 0.20 ppm to 

0.50 ppm; fruit, small vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

from 1.0 ppm to 2.0 ppm; and berry, low 

growing, subgroup 13–07G, except 

cranberry from 2.0 ppm to 3.0 ppm, in 

order to align with the Codex MRLs 

associated with these tolerances. 

EPA also removed the established 

tolerance in or on vegetable, leafy, 

except brassica, group 4 at 0.01 ppm, as 

it will be superseded by tolerances on 

leafy greens subgroup 4A at 30 ppm and 

leaf petioles subgroup 4B at 15 ppm. 

Similarly, EPA removed the established 

tolerance on vegetable, bulb, group 3 at 

0.02 ppm, as the tolerance will be 

superseded by tolerances on bulb onion 

subgroup 3–07A at 0.50 ppm and green 

onion subgroup 3–07B at 7.0 ppm. In 

order to clarify the established 

vegetable, root and tuber, group 1 

tolerance at 0.02 ppm, the Agency 

revised the entry to beet, sugar at 0.02 

ppm. This change has been made 

because all other commodity members 

currently in crop group 1 will be 

superseded by tolerances in or on 

vegetable, root, except sugar beet, 

subgroup 1B at 0.75 ppm and vegetable, 

tuberous and corm, subgroup 1C at 6.0 

ppm. EPA also revised the proposed 

commodity definitions to reflect the 

correct designation for fruit, small, vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F and dragon fruit. 

Finally, the Agency has revised the 

tolerance expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

fludioxonil not specifically mentioned; 

and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fludioxonil, (4-(2,2- 

difluoro-1,3-benzodioxol-4-yl)-1 Hpyrrole-3-carbonitrile), in or on guava, 

feijoa, jaboticaba, wax jambu, starfruit, 

passionfruit, and acerola at 5.0 ppm; 

sugar apple, atemoya, custard apple, 

cherimoya, ilama, soursop and biriba at 

20 ppm; ginseng at 4.0 ppm; onion, 

bulb, subgroup 3–07A at 0.50 ppm; 

onion, green, subgroup 3–07B at 7.0 

ppm; caneberry subgroup 13–07A at 5.0 

ppm; bushberry subgroup 13–07B at 2.0 

ppm; fruit, small, vine climbing, 

subgroup 13–07F, except fuzzy kiwifruit 

at 2.0 ppm; berry, low growing, 

subgroup 13–07G, except cranberry at 

3.0 ppm; vegetable, fruiting, group 8–10, 

except tomato at 0.50 ppm; fruit, citrus, 

group 10–10 at 10 ppm; fruit, pome, 

group 11–10 at 5.0 ppm; leafy greens 

subgroup 4A at 30 ppm; vegetable, 

tuberous and corm, subgroup 1C at 6.0 

ppm; pineapple at 20; dragon fruit at 1.0 

ppm; and leaf petioles subgroup 4B at 

15 ppm. This regulation additionally 

amends established tolerances of 

fludioxonil in or on avocado, black 

sapote, canistel, mamey sapote, mango, 

papaya, sapodilla and star apple from 

0.45 ppm to 5.0 ppm; longan, lychee, 

pulasan, rambutan, and Spanish lime 

from 1.0 ppm to 20 ppm; and tomato 

from 0.50 ppm to 5.0 ppm. 

Tolerances are established for 

residues of fludioxonil, (4-(2,2-difluoro1,3-benzodioxol-4-yl)-1-H-pyrrole-3- 

carbonitrile), and its metabolites 

converted to 2,2-difluoro-1,3- 

benzodioxole-4-carboxylic acid, 

calculated as the stoichiometric 

equivalent of fludioxonil, in or on milk 

at 0.01 ppm; cattle, meat byproducts at 

0.05 ppm; cattle, meat at 0.01 ppm; 

cattle, fat at 0.05 ppm; goat, meat 

byproducts at 0.05 ppm; goat, meat at 

0.01 ppm; goat, fat at 0.05 ppm; horse, 

meat byproducts at 0.05 ppm; horse, 


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meat at 0.01 ppm; horse, fat at 0.05 

ppm; sheep, meat byproducts at 0.05 

ppm; sheep, meat at 0.01 ppm; and 

sheep, fat at 0.05 ppm. 

This regulation additionally removes 

established tolerances in or on onion, 

bulb; onion, green; caneberry subgroup 

13A; bushberry subgroup 13B; 

Juneberry; lingonberry; salal; grape; 

strawberry; vegetable, fruiting group 8; 

tomatillo; fruit, citrus, group 10; fruit, 

pome, group 11; leafy green subgroup 

4A, except spinach; vegetable, tuberous 

and corm, except potato, subgroup 1D; 

vegetable, leafy, except brassica, group 

4; and vegetable, bulb, group 3. This 

regulation also removes the time-limited 

tolerances in or on starfruit and 

pineapple. Finally, this regulation 

revises the established tolerance on 

vegetable, root and tuber, group 1 at 

0.02 ppm to beet, sugar at 0.02 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) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 3, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.516 is amended by 

revising paragraphs (a) and (b) to read 

as follows: 

§ 180.516 Fludioxonil; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

fludioxonil, 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 

fludioxonil, 4-(2,2-difluoro-1,3- 

benzodioxol-4-yl)-1-H-pyrrole-3- 

carbonitrile). 

Commodity Parts per 

million 

Acerola .......................................... 5 .0 

Animal feed, nongrass, group 18 0 .01 

Atemoya ........................................ 20 

Avocado ........................................ 5 .0 

Bean, dry ...................................... 0 .4 

Bean, succulent ............................ 0 .4 

Beet, sugar, roots ......................... 0 .02 

Berry, low growing, subgroup 13– 

07G, except cranberry .............. 3 .0 

Biriba ............................................. 20 

Brassica, head and stem, subgroup 5A ................................... 2 .0 

Brassica, leafy greens, subgroup 

5B .............................................. 10 

Bushberry subgroup 13–07B ........ 2 .0 

Caneberry subgroup 13–07A ....... 5 .0 

Canistel ......................................... 5 .0 

Cherimoya .................................... 20 

Citrus, oil ....................................... 500 

Cotton, gin byproducts ................. 0 .05 

Cotton, undelinted seed ............... 0 .05 

Custard apple ............................... 20 

Dragon fruit ................................... 1 .0 

Feijoa ............................................ 5 .0 

Flax, seed ..................................... 0 .05 

Fruit, citrus, group 10–10 ............. 10 

Fruit, pome, group 11–10 ............. 5 .0 

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F ............................................ 2 .0 

Fruit, stone, group 12 ................... 5 .0 

Ginseng ........................................ 4 .0 

Grain, cereal, group 15 ................ 0 .02 

Grain, cereal, forage, fodder, and 

straw, group 16 ......................... 0 .01 

Grass, forage, fodder and hay, 

group 17 .................................... 0 .01 

Guava ........................................... 5 .0 

Herb subgroup 19A, dried leaves 65 

Herb subgroup 19A, fresh leaves 10 

Ilama ............................................. 20 

Jaboticaba .................................... 5 .0 

Kiwifruit, fuzzy ............................... 20 

Leaf petioles subgroup 4B ........... 15 

Leafy greens subgroup 4A ........... 30 

Longan .......................................... 20 

Lychee .......................................... 20 

Mango ........................................... 5 .0 

Melon subgroup 9A ...................... 0 .03 

Onion, bulb, subgroup 3–07A ...... 0 .50 

Onion, green, subgroup 3–07B .... 7 .0 

Papaya .......................................... 5 .0 


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Commodity Parts per 

million 

Passionfruit ................................... 5 .0 

Peanut .......................................... 0 .01 

Peanut, hay .................................. 0 .01 

Pineapple ...................................... 20 

Pistachio ....................................... 0 .10 

Pomegranate ................................ 5 .0 

Pulasan ......................................... 20 

Rambutan ..................................... 20 

Rapeseed, forage ......................... 0 .01 

Rapeseed, seed ........................... 0 .01 

Safflower, seed ............................. 0 .01 

Sapodilla ....................................... 5 .0 

Sapote, black ................................ 5 .0 

Sapote, mamey ............................ 5 .0 

Soursop ........................................ 20 

Spanish lime ................................. 20 

Spice subgroup 19B ..................... 0 .02 

Star apple ..................................... 5 .0 

Starfruit ......................................... 5 .0 

Sugar apple .................................. 20 

Sunflower, seed ............................ 0 .01 

Tomato .......................................... 5 .0 

Turnip, greens .............................. 10 

Vegetable, cucurbit, group 9 ........ 0 .45 

Vegetable, foliage of legume, 

group 7 ...................................... 0 .01 

Vegetable, fruiting, group 8–10, 

except tomato ........................... 0 .50 

Vegetable, leaves of root and 

tuber, group 2 ........................... 30 

Vegetable, legume, group 6 ......... 0 .01 

Vegetable, root, except sugar 

beet, subgroup 1B .................... 0 .75 

Vegetable, tuberous and corm, 

subgroup 1C ............................. 6 .0 

Watercress .................................... 7 .0 

Wax jambu .................................... 5 .0 

Yam, true, tuber ............................ 8 .0 

(2) Tolerances are established for 

residues of the fungicide fludioxonil, 

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 the sum of fludioxonil, 

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1- 

H-pyrrole-3-carbonitrile), and its 

metabolites converted to 2,2-difluorol,3-benzodioxole-4-carboxylic acid, 

calculated as the stoichiometric 

equivalent of fludioxonil. 

Commodity Parts per 

million 

Cattle, fat .................................. 0.05 

Cattle, meat .............................. 0.01 

Cattle, meat byproducts ........... 0.05 

Goat, fat .................................... 0.05 

Goat, meat ................................ 0.01 

Goat, meat byproducts ............. 0.05 

Horse, fat .................................. 0.05 

Horse, meat .............................. 0.01 

Horse, meat byproducts ........... 0.05 

Milk ........................................... 0.01 

Sheep, fat ................................. 0.05 

Sheep, meat ............................. 0.01 

Sheep, meat byproducts .......... 0.05 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2012–19988 Filed 8–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 120109034–2171–01] 

RIN 0648–XC153 

Fisheries of the Northeastern United 

States; Northeast Multispecies 

Fishery; White Hake Trimester Total 

Allowable Catch Area Closure for the 

Common Pool Fishery 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS is closing the White 

Hake Trimester Total Allowable Catch 

(TAC) Area to all common pool vessels 

fishing with trawl gear, sink gillnet gear, 

or longline/hook gear for the remainder 

of Trimester 1, through August 31, 2012. 

This action is necessary to prevent the 

common pool fishery from exceeding its 

Trimester 1 TAC or its annual catch 

limit for white hake. This rule is 

expected to slow the catch rate of white 

hake in the common pool fishery for the 

remainder of Trimester 1. 

DATES: Effective August 15, 2012, 

through 2400 hours, August 31, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Heil, Fishery Policy Analyst, 978– 

281–9257, Fax 978–281–9135. 

SUPPLEMENTARY INFORMATION: 

Regulations governing the NE 

multispecies fishery are found at 50 CFR 

part 648, subpart F. Beginning in fishing 

year (FY) 2012, the common pool’s 

annual catch limit for each stock is 

apportioned into trimester total 

allowable catches (TACs). The 

regulations at § 648.82(n) require the 

Regional Administrator to close the 

Trimester TAC Area for a stock when 

available information supports a 

determination that 90 percent of the 

Trimester TAC is projected to be caught. 

The Trimester TAC Area for a stock will 

close to all common pool vessels fishing 

with gear capable of catching that stock 

for the remainder of the trimester. Any 

overages of a trimester TAC will be 

deducted from Trimester 3, and any 

overages of the common pool’s annual 

catch limit will be deducted from the 

common pool’s catch limit the following 

fishing year. Any uncaught portion of 

the Trimester 1 and Trimester 2 TAC 

will be carried over into the next 

trimester. Any uncaught portion of the 

common pool’s annual catch limit may 

not be carried over into the following 

fishing year. 

The FY 2012 common pool catch 

limit for white hake is 26 mt (57,320 lb). 

The Trimester 1 (May 1 through August 

31) TAC is 10 mt (22,046 lb). Based on 

the best available data which includes 

vessel trip reports (VTRs), dealer 

reported landings, and vessel 

monitoring system (VMS) information, 

NMFS projected that 90 percent of the 

Trimester 1 TAC for white hake had 

been harvested on August 4, 2012. 

Therefore, Effective August 15, 2012, 

the White Hake Trimester TAC Area is 

closed for the remainder of Trimester 1, 

through August 31, 2012, to all common 

pool vessels fishing with trawl gear, 

sink gillnet gear, and longline/hook 

gear. The White Hake Trimester TAC 

Area will reopen to common pool 

vessels fishing with trawl, sink gillnet, 

and longline/hook gear at the beginning 

of Trimester 2, at 0001 hours, September 

1, 2012. 

Classification 

This action is required by 50 CFR part 

648, and is exempt from review under 

Executive Order 12866. 

The Assistant Administrator for 

Fisheries, NOAA (AA), finds good cause 

pursuant to 5 U.S.C. 553(b)(B) to waive 

prior notice and the opportunity for 

public comment because it would be 

impracticable and contrary to the public 

interest. This action closes the White 

Hake Trimester TAC Area for common 

pool vessels fishing with trawl gear, 

sink gillnet gear, and longling/hook gear 

through August 31, 2012. The 

regulations at § 648.82 require this 

action to ensure that the common pool 

fishery does not exceed its catch limits 

for white hake in fishing year 2012. The 

catch data indicating that 90 percent of 

the Trimester 1 TAC for white hake has 

been caught only recently became 

available. If implementation of this 

closure is delayed to solicit prior public 

comment, the white hake Trimester 1 

TAC will be exceeded, thereby 

undermining the conservation 

objectives of the Fishery Management 

Plan. Any overage of the Trimester 1 

TAC must be deducted from the 

Trimester 3 TAC, and any overage of the 

total catch limit in FY 2012 must be 

deducted from the FY 2013 catch limit. 

This would have adverse economic 

consequences on common pool vessels. 

The AA further finds, pursuant to 5 


srobinson on DSK4SPTVN1PROD with RULES