26536 Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Rules and Regulations 

§ 180.1254 Aspergillus flavus NRRL 21882 

on peanut; exemption from requirement of 

a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Aspergillus flavus NRRL 21882 in or 

on peanut; peanut hay; peanut, meal; 

peanut, refined oil. 

■ 30. Section 180.1258 is revised to read 

as follows: 

§ 180.1258 Acetic acid; exemption from 

the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the biochemical pesticide acetic acid 

when used as a preservative on postharvest agricultural commodities 

intended for animal feed, including 

Alfalfa, seed; alfalfa, hay; barley, grain; 

bermudagrass, hay; bluegrass, hay; 

bromegrass, hay; clover, hay; corn, field, 

grain; corn, pop, grain; cowpea, hay; 

fescue, hay; lespedeza, hay; lupin; oat, 

grain; orchardgrass, hay; peanut, hay; 

timothy, hay; vetch, hay; and wheat, 

grain, or commodities described as grain 

or hay. 

■ 31. Section 180.1261 is revised to read 

as follows: 

§ 180.1261 Xanthomonas campestris pv. 

vesicatoria and Pseudomonas syringae pv. 

tomato specific Bacteriophages. 

An exemption from the requirement 

of a tolerance is established for residues 

of Xanthomonas campestris pv. 

vesicatoria and Pseudomonas syringae 

pv. tomato specific bacteriophages in or 

on pepper and tomato. 

■ 32. In § 180.1274, by revising the 

introductory text to read as follows: 

§ 180.1274 Tris (2-ethylhexyl) phosphate; 

exemption from the requirement of a 

tolerance. 

Tris (2-ethylhexyl) phosphate (TEHP, 

CAS Reg. No. 78–42–2) is exempt from 

the requirement of a tolerance for 

residues in grain, aspirated fractions; 

barley, grain, barley, hay, barley, straw; 

wheat, grain; wheat, forage; wheat, hay; 

wheat, straw when used under the 

following conditions: 

■ 33. Section 180.1276 is revised to read 

as follows: 

§ 180.1276 Tobacco mild green mosaic 

tobamovirus (TMGMV); temporary 

exemption from the requirement of a 

tolerance. 

A temporary exemption from the 

requirement of a tolerance is established 

for residues of tobacco mild green 

mosaic tobamovirus in or on all grass, 

forage and grass, hay. 

■ 34. Section 180.1279 is revised to read 

as follows: 

§ 180.1279 Zucchini yellow mosaic virus— 

weak strain; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance for residues of the ZYMV– 

WK strain in or on all raw cucurbit 

when applied/used in accordance with 

label directions. 

[FR Doc. E9–12694 Filed 6–2–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0312; FRL–8414–6] 

Triflumizole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

triflumizole and its metabolites 

containing the 4-chloro-2- 

trifluoromethylaniline (FA-1-1) moiety, 

calculated as the parent compound, in 

or on leafy greens subgroup 4A, except 

spinach; Brassica, head and stem, 

subgroup 5A; Brassica, leafy greens, 

subgroup 5B; cilantro leaves; Swiss 

chard; pineapple; papaya; black sapote; 

canistel; mamey sapote; mango; 

sapodilla; star apple; hops, dried cones; 

and turnip greens. Interregional 

Research Project Number 4 (IR-4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). This regulation also deletes 

the following time-limited tolerances, as 

permanent tolerances supersede them: 

Collards, kale and mustard greens, as 

residues on these commodities will be 

covered by the Brassica, leafy greens, 

subgroup 5B tolerance; broccoli, since 

residues will be covered by the Brassica, 

head and stem, subgroup 5A tolerance; 

dandelion leaves and parsley leaves, 

since residues will be covered by the 

leafy greens subgroup 4A tolerance; 

Swiss chard and turnip greens, as the 

time-limited tolerances will be 

superseded by permanent tolerances; 

and coriander leaves, as the cilantro 

leaves tolerance supersedes it and is the 

preferred commodity definition. 

DATES: This regulation is effective June 

3, 2009. Objections and requests for 

hearings must be received on or before 

August 3, 2009, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0312. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

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; e-mail 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. 


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Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Rules and Regulations 26537 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2007–0312 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before August 3, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2007–0312, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petitions for Tolerance 

In the Federal Register of June 27, 

2007 (72 FR 35237) (FRL–8133–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 7E7183) by IR-4, 

Rutgers, The State University of New 

Jersey, 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.476 be 

amended by establishing a tolerance for 

combined residues of the fungicide 

triflumizole, 1-(1-((4-chloro-2- 

(trifluoromethyl)phenyl)imino)-2- 

propoxyethyl)-1 H-imidazole, and its 

metabolites containing the 4-chloro-2- 

trifluoromethylaniline moiety, 

calculated as the parent compound, in 

or on Brassica, leafy greens, subgroup 

5B at 20.0 parts per million (ppm). That 

notice referenced a summary of the 

petition prepared on behalf of IR-4 by 

Chemtura USA Corporation, the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

In the Federal Register of February 6, 

2008 (73 FR 6964) (FRL–8350–9), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 7E7258 and 

7E7286) by IR-4. The petition requested 

that 40 CFR 180.476 be amended by 

establishing tolerances for combined 

residues of the fungicide triflumizole, 

and its metabolites containing the 4- 

chloro-2-trifluoromethylaniline moiety, 

calculated as the parent compound, in 

or on food commodities for PP 7E7258: 

Leafy greens subgroup 4A, except 

spinach, at 35 ppm; cilantro, leaves at 

35 ppm; Swiss chard at 18 ppm; 

pineapple at 4.0 ppm; papaya at 2.5 

ppm; sapote, black at 2.5 ppm; canistel 

at 2.5 ppm; sapote, mamey at 2.5 ppm; 

mango at 2.5 ppm; sapodilla at 2.5 ppm; 

star apple at 2.5 ppm; and hop, dried 

cones at 50.0 ppm; and for PP 7E7286: 

Brassica, head and stem, subgroup 5A at 

5.0 ppm. That notice referenced a 

summary of the petition prepared on 

behalf of IR-4 by Chemtura USA 

Corporation, the registrant, which is 

available to the public in the docket, 

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

no comments received in response to 

this notice of filing. 

In the Federal Register of May 16, 

2008 (73 FR 28461) (FRL–8361–6), EPA 

issued a notice pursuant to section 

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

346a(d)(3), announcing the amendment 

of pesticide petition (PP 7E7258) by IR4. The petition requested that 40 CFR 

180.476 be amended by additionally 

establishing a tolerance for combined 

residues of the fungicide triflumizole, 

and its metabolites containing the 4- 

chloro-2-trifluoromethylaniline moiety, 

calculated as the parent compound, in 

or on the food commodity turnip, greens 

at 40 ppm. That notice referenced a 

summary of the petition prepared on 

behalf of IR-4 by Chemtura USA 

Corporation, the registrant, which is 

available to the public in the docket, 

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

no comments received in response to 

this notice of filing. 

Based upon review of the data 

supporting these petitions, EPA has 

determined that some of the proposed 

tolerance levels should be increased and 

has also revised the tolerance 

expression. 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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for combined residues of 

triflumizole, and its metabolites 

containing the 4-chloro-2- 

trifluoromethylaniline moiety, 

calculated as the parent compound, on 

leafy greens subgroup 4A, except 

spinach at 35 parts per million (ppm); 

Brassica, head and stem, subgroup 5A at 

8.0 ppm; Brassica, leafy greens, 

subgroup 5B at 40.0 ppm; cilantro 


dwashington3 on PROD1PC60 with RULES
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leaves at 35 ppm; Swiss chard at 18 

ppm; pineapple at 4.0 ppm; papaya at 

2.5 ppm; black sapote at 2.5 ppm; 

canistel at 2.5 ppm; mamey sapote at 2.5 

ppm; mango at 2.5 ppm; sapodilla at 2.5 

ppm; star apple at 2.5 ppm; hop, dried 

cones at 50.0 ppm; and turnip greens at 

40 ppm. EPA’s assessment of exposures 

and risks associated with establishing 

tolerances 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. 

Triflumizole has low acute toxicity 

via the oral, dermal, and inhalation 

routes. It is a mild eye irritant and 

dermal sensitizer, but is not a dermal 

irritant. The primary target organ 

affected by triflumizole is the liver. 

Liver effects were seen in rat and mouse 

subchronic and chronic/carcinogenicity 

studies. Subchronic effects included 

increased absolute and relative liver 

weights, accumulation of fat droplets, 

and slight hepatocyte centrilobular 

swelling. With increased length of 

exposure, the types of microscopic 

lesions noted increased in number and 

severity. Chronic effects included 

hepatocyte fatty vacuolization; 

hepatocyte hypertrophy, focal 

inflammation, and necrosis; fatty 

degeneration; eosinophilic foci of 

hepatocyte alteration; hepatic nodules; 

bile duct hyperplasia; and hyaline 

degeneration/fibrosis of the bile duct. 

The dog was less sensitive to the effects 

of triflumizole. In the dog chronic study, 

effects included increased liver weights, 

increased serum alkaline phosphatase 

levels, and a macroscopic hepatic 

lobular pattern and granular texture. A 

very mild, macrocytic anemia was also 

noted and was most likely secondary to 

liver effects. 

A special microsomal enzyme 

induction study showed that 

triflumizole can induce hepatic 

microsomal enzymes when 

administered orally at high doses. 

Kidney weights were increased in the 

rat and mouse also, but the only 

pathology seen microscopically was in 

the rat chronic/carcinogenicity study in 

which cortical cysts were noted. Other 

organ effects were observed 

microscopically at the highest dose 

tested (HDT) in the chronic rat study, 

which mainly involved cystic or 

hyperplastic lesions in endocrine glands 

and/or lymph nodes. Body weight 

decrements were noted in the rat and/ 

or mouse subchronic, chronic and 

carcinogenicity studies and the 

developmental and reproduction 

studies. 

Long-term dietary administration of 

triflumizole did not result in an overall 

treatment-related increase in incidence 

of tumor formation in rats or mice. 

Based upon the lack of evidence of 

carcinogenicity in rats and mice, EPA 

classified triflumizole as ‘‘not likely to 

be carcinogenic to humans’’ by all 

routes of exposure. Further, triflumizole 

did not show evidence of mutagenicity 

in in vitro or in vivo studies. 

Signs of neurotoxicity were seen in 

the acute oral toxicity studies in the rat 

and mouse and an acute inhalation 

study in the rat. Neurotoxic signs were 

also observed in the acute neurotoxicity 

study based on functionalobservational-battery (FOB) findings 

(neuromuscular impairment) and 

decreased locomotor activity. By day 8 

of the observation period treated males 

and females were comparable to the 

controls. Although there was a 

statistically significant increase in 

hindlimb splay of low-dose females, this 

effect does not appear to be of great 

toxicological significance, since no 

other FOB effects were observed in lowdose females. No evidence of 

neurotoxicity was seen in the rat 

subchronic oral toxicity study or the 

mouse subchronic oral toxicity and 

carcinogenicity studies. 

In oral rat developmental studies, 

fetal effects (decreased numbers of 

viable fetuses, increased dead or 

resorbed fetuses, increased numbers of 

late resorptions, decreased fetal body 

weight and increased incidences of 

cervical ribs) were seen at the same 

doses where less severe maternal effects 

were noted (decreases in body weight 

gain and food consumption and 

increases in placental, spleen and liver 

weights). Fetal effects in the rabbit 

developmental study (decreased 24– 

hour survival, increased fetal and litter 

incidences of lumbar ribs and decreased 

placental weights) were noted at the 

same dose as maternal toxic effects 

(decreased food consumption, and 

decreased placental weights). In a multigeneration study in rats, offspring 

effects included decreased pup weights, 

survival indices, and litter sizes in both 

F3 litters, reduced litter size in the F1a 

litter, increased total-litter mortality in 

the F3a litter, and developmental effects 

in the F1b and F2b progeny. 

Reproductive toxicity, manifested as 

increased gestation length, was 

increased at the high dose. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by triflumizole 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 

‘‘Triflumizole: Second Amended 

Human Health Risk Assessment for 

Proposed Uses on Leafy Greens 

(Subgroup 4A) Except Spinach, Head 

and Stem Brassica (Subgroup 5A), 

Cilantro, Swiss Chard, Pineapple, 

Papaya, Black Sapote, Canistel, Mamey 

Sapote, Mango, Sapodilla, Star Apple, 

and Hops’’ pages 51–55 in docket ID 

number EPA–HQ–OPP–2007–0312. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 


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Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Rules and Regulations 26539 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

EPA identified an acute effect for the 

general population (neuromuscular 

impairment and decreased locomotor 

activity seen in the rat acute 

neurotoxicity study) and for females 13 

to 49 years old (decreased numbers of 

viable fetuses, increased dead or 

resorbed fetuses, increased numbers of 

late resorptions, decreased fetal body 

weight, and increased incidence of 

cervical ribs in the rat developmental 

toxicity study that are presumed to 

occur after a single exposure). The aPAD 

for the general population has been 

established at 0.25 milligrams/kilogram/ 

day (mg/kg/day); whereas, the aPAD for 

females 13 to 49 years old is lower (0.1 

mg/kg/day) due to the more sensitive 

endpoint on which it is based. 

In previous risk assessments for 

triflumizole, the chronic reference dose 

(cRfD) for the general population was 

derived from the NOAEL of 1.5 mg/kg/ 

day from the multi-generation rat 

reproduction study. However, the 

Registrant requested that the Agency 

consider historical control data in 

relation to the rat reproductive study. 

Based on evaluation of the historical 

control data it was determined that the 

NOAEL should be 3.5 mg/kg/day 

(previously classified as the LOAEL). 

The NOAEL of 3.5 mg/kg/day was based 

on decreased pup body weight, 

mortality, reduced litter size and 

increased incidence of hydroureter and 

space between the body wall and organs 

observed at 8.5 mg/kg/day (NOAEL= 3.5 

mg/kg/day). In addition, gestation 

length was increased in the dams of F1a, 

F2a, and F3a intervals at the LOAEL of 

8.5 mg/kg/day (NOAEL = 3.5 mg/kg/ 

day). 

Based on a re-evaluation of the 

toxicity database, it was determined that 

the most suitable endpoint for the 

derivation of a cRfD was a LOAEL of 3.5 

mg/kg/day (a NOAEL was not 

determined) identified in a chronic rat 

study and based on liver toxicity. The 

revised NOAEL of 3.5 mg/kg/day in the 

rat reproduction study would not be 

protective of potential liver toxicity 

associated with triflumizole. It was 

determined that the LOAEL of 3.5 mg/ 

kg/day from the Combined Chronic 

Toxicity/Carcinogenicity (based on liver 

effects) was protective with an 

additional safety factor. 

A summary of the toxicological 

endpoints for triflumizole used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Triflumizole: Second Amended 

Human Health Risk Assessment for 

Proposed Uses on Leafy Greens 

(Subgroup 4A) Except Spinach, Head 

and Stem Brassica (Subgroup 5A), 

Cilantro, Swiss Chard, Pineapple, 

Papaya, Black Sapote, Canistel, Mamey 

Sapote, Mango, Sapodilla, Star Apple, 

and Hops’’ pages 30-32 in docket ID 

number EPA–HQ–OPP–2007–0312. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to triflumizole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing triflumizole tolerances in 40 

CFR 180.476. EPA assessed dietary 

exposures from triflumizole 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. 

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 and 100 percent crop treated 

(PCT) for all existing and new uses of 

triflumizole. 

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 

used average field trial residues as 

anticipated residues (ARs) for apple, 

grape, pear, cherry, cucurbit, strawberry, 

leafy greens (subgroup 4A) except 

spinach, head and stem Brassica 

(subgroup 5A), cilantro, Swiss chard, 

pineapple, papaya, black sapote, 

canistel, mamey sapote, mango, 

sapodilla, star apple and hops. For all 

other commodities, the assessment used 

tolerance level residues. The EPA used 

PCT information for apples, 

cantaloupes, cherries, cucumbers, 

grapes, hazelnuts (filberts), honeydew 

melons, pears, pumpkins, squash, 

strawberries and watermelons. 100 PCT 

information was used for the remaining 

registered and proposed uses. 

iii. Cancer. Based on absence of 

significant tumor increases in two 

rodent carcinogenicity studies, EPA has 

classified triflumizole as ‘‘not likely to 

be carcinogenic to humans;’’ therefore, a 

quantitative exposure assessment to 

evaluate cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

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

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

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

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

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

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

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

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. 

• 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 Agency used PCT information for 

chronic assessments as follows: 

Apples 20%; Cantaloupe 10%; 

Cherries 15%; Cucumbers 5%; Grapes 

5%; Hazelnuts (Filberts) 15%; 

Honeydew melons 15%; Pears 40%; 

Pumpkin 5%; Squash 1%; Strawberry 

15%; and Watermelon 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 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 


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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 triflumizole 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 triflumizole in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of triflumizole. 

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) for surface 

water and Screening Concentration in 

Ground Water (SCI-GROW) models for 

ground water, the estimated drinking 

water concentrations (EDWCs) of 

triflumizole and its metabolites 

containing the 4-chloro-2- 

trifluoromethyl aniline moiety for 

surface water are estimated to be 37.4 

parts per billion (ppb) for acute 

exposures; 15.8 ppb for chronic 

exposures for non-cancer assessments. 

For ground water, the EDWCs for all of 

the above exposure scenarios are 

estimated to be 3.11 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 37 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 16 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). 

Triflumizole is currently registered for 

use on ornamental plants including 

trees, shrubs and vines in residential 

areas. Since residential applications of 

triflumizole are to be made by 

commercial applicators, residential 

handler exposures are not expected to 

occur. In addition, post-application 

exposures of adults and children from 

this use have been determined to be 

negligible. Therefore, a residential 

exposure assessment is not necessary for 

triflumizole and was not conducted. 

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 triflumizole to 

share a common mechanism of toxicity 

with any other substances, and 

triflumizole does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that triflumizole 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 website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

database for triflumizole includes 

prenatal developmental toxicity studies 

in rats and rabbits and a multigeneration reproduction toxicity study 

in rats. There is no evidence of 

increased quantitative or qualitative 

susceptibility of rabbit fetuses following 

in utero exposure to triflumizole. 

Although 24–hour fetal survival was 

reduced in this study, 24–hour fetal 

survival is more an indicator of fetal 

endurance after being removed from the 

womb rather than a measurement of 

treatment-related effects on fetal 

viability and, thus, is not appropriate to 

use to ascertain fetal susceptibility. In 

the multi-generation rat reproduction 

study, reproductive toxicity (increased 

gestation length and increased vaginal 

bleeding and dystocias) was increased at 

the high dose. However, these effects 

may be a result of endocrine effects on 

the reproductive system. Comparison of 

offspring toxicity to reproductive 

toxicity is more appropriate to evaluate 

susceptibility because the increased 

gestation length in the dams is a true 

parental effect and may affect the dam 

or the offspring; therefore, there is no 

increased susceptibility of offspring 

following prenatal and postnatal 

exposure in the rat reproduction study. 

There was evidence of increased 

qualitative susceptibility following in 

utero exposure of rats in a 

developmental study. Developmental 

toxicity resulted in decreased pup 

viability, increased dead or resorbed 

fetuses and an increased incidence of 

cervical ribs at doses that resulted in 

less severe maternal toxicity (decreases 

in body weight gain and food 

consumption and increases in placental, 

spleen and liver weights). There are no 

residual uncertainties for developmental 

toxicity, and the use of the 

developmental NOAEL and the 

endpoint for the acute reference dose 

(aRfD) for females 13-49 is considered 

protective of the prenatal toxicity 

following an acute dietary exposure. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 3X for all repeated 

exposure scenarios and 1X for single 


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exposure scenarios. That decision is 

based on the following findings. 

i. The toxicity database for 

triflumizole is complete except for 

immunotoxicity testing. Recent changes 

to 40 CFR part 158 make 

immunotoxicity testing (OPPTS 

Guideline 870.7800) required for 

pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. In the 

toxicity database for triflumizole, there 

was some indication of possible 

immunotoxicity in the form of nonneoplastic lesions, characterized as 

dilated cyctic sinuses in the thymic 

lymph node following dietary 

administration for 2 years. However, 

these lesions were seen only in male 

rats at the HDT and only at the 

termination of the study. This indicates 

that these lesions are non-specific, are 

due to the age of the rats, and thus are 

not attributable to frank 

immunotoxicity. There were no other 

corroborative changes, such as changes 

in the thymus weights, in this study or 

in the thymus and spleen in the other 

studies (i.e., subchronic and chronic 

studies in dogs). Moreover, triflumizole 

belongs to the imidazole class of 

compounds, which are not known to be 

immunotoxicants. Based on the 

considerations in this unit, the Agency 

does not believe that conducting the 

immunotoxicity study will result in a 

dose less than the point of departure 

already used in this risk assessment and 

an additional database uncertainty 

factor for potential immunotoxicity does 

not need to be applied. 

ii. There is no need for a 

developmental neurotoxicity (DNT) 

study or additional UFs to account for 

neurotoxicity based on the following 

considerations: 

Signs of neurotoxicity were observed 

in the acute neurotoxicity study based 

on FOB findings (neuromuscular 

impairment) and decreased locomotor 

activity. By day 8 of the observation 

period treated males and females were 

comparable to the controls. Although 

there was a statistically significant 

increase in hindlimb splay of low-dose 

females, this effect does not appear to be 

of great toxicological significance, as no 

other FOB effects were observed in lowdose females. In a combined subchronic 

oral toxicity/subchronic neurotoxicity 

study there was no evidence of 

neurotoxicity at any dose tested. 

Further, there were no signs of 

neurotoxicity and no indications of 

increased susceptibility of in utero rats 

or rabbits or offspring in the 

developmental and reproduction studies 

for triflumizole. There was evidence of 

qualitative toxicity in the rat 

developmental toxicity study, but only 

at doses that were maternally toxic. The 

evidence does not support the need for 

a developmental neurotoxicity study. 

This conclusion is supported by: 

• No neurotoxic signs noted in the rat 

subchronic study at any dose; 

• No neurotoxic signs in the adult or 

offspring in the developmental and 

reproduction studies; and 

• No neurotoxicity noted in any 

developmental toxicity study. 

iii. There is no evidence that 

triflumizole results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. Although there is 

evidence of increased qualitative 

susceptibility in the prenatal 

developmental study in rats, the Agency 

did not identify any residual 

uncertainties after establishing toxicity 

endpoints, traditional UFs for single 

exposure scenarios, and an additional 

3X SF for repeated exposures to 

triflumizole (to address concerns for the 

use of a LOAEL instead of a NOAEL to 

derive the cRfD. 

iv. The chronic POD is derived from 

the use of a LOAEL (based on liver 

toxicity; aseosinophilic foci in male rats 

and fatty vacuolation and inflammation 

and necrosis in female rats) established 

in the combined chronic toxicity/ 

carcinogenicity study in rats. Although 

use of a LOAEL as a POD raises 

uncertainty, here the uncertainty is 

relatively low indicating that a 3X 

FQPA safety factor will be adequate. 

That conclusion is based on the 

following weight of evidence 

considerations: 

• The most sensitive endpoint in the 

target organ (liver) for this class of 

compounds (imidazole fungicide) is 

used for assessing chronic risk; 

• There is low concern for the 

observed effects since the lesions did 

not progress into malignancy; 

• The response was marginal at the 

LOAEL; 

• The available data do not show this 

chemical to be a potent toxicant, as clear 

NOAELs were established following 

dietary administrations in all other 

studies, such as the 2–generation 

reproduction study in rat (3.5 mg/kg/ 

day); subchronic rat (15.3 mg/kg/day) 

and mouse (33.1 mg/kg/day) studies; 

chronic dog study (10 mg/kg/day); and 

mouse carcinogenicity (16.2 mg/kg/day) 

study; and 

• The extrapolated NOAEL of 1.2 mg/ 

kg/day is supported by a comparable 

NOAEL (2.5 mg/kg/day) used to derive 

the cRfD for a structurally-related 

chemical (Imazalil). 

Based on these weight-of-evidence 

considerations, EPA is confident that 

the 3X FQPA SF is adequate to address 

the concerns for the lack of a NOAEL in 

the rat combined chronic toxicity/ 

carcinogenicity study and that the cRfD 

would not underestimate dietary risk 

from chronic exposure to triflumizole. 

Specific information regarding the 

additional FQPA safety factor for 

chronic exposure to triflumizole can be 

found at http://www.regulations.gov in 

document ‘‘Triflumizole: A Short 

History of the Chronic Endpoint’’ in 

docket ID number EPA–HQ–OPP–2007– 

0312. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessments were performed based on 

100 PCT and tolerance-level residues. 

The chronic dietary food exposure 

assessment utilized tolerance-level 

residues or anticipated residues that are 

based on reliable field trial data. For 

several currently registered 

commodities, the chronic assessment 

also utilized PCT data that have a valid 

basis and are considered to be reliable. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to triflumizole in drinking water. At this 

time, residential exposure of infants and 

children is expected to be negligible 

from the use of triflumizole. These 

assessments will not underestimate the 

exposure and risks posed by 

triflumizole. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 


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exposure, EPA performed separate acute 

risk assessments for females 13 to 49 

years old and for the general population, 

including infants and children, based on 

different endpoints and aPADs. For 

females aged 13–49, acute dietary 

exposure to triflumizole from food and 

water will occupy 67% of the aPAD 

chosen for that population subgroup. 

For the general population and 

population subgroups other than 

females aged 13–49, acute dietary 

exposure to triflumizole is greatest for 

children 1-2 years old. That subgroup 

will occupy 40% of the applicable 

aPAD. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to triflumizole 

from food and water will utilize 44% 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 triflumizole is not expected. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Although triflumizole is registered for 

commercial use on ornamentals in 

residential areas, this use is not 

expected to result in significant shortterm or intermediate-term exposures of 

adults or children. Therefore, the shortterm and intermediate-term aggregate 

risk is the sum of the risk from exposure 

to triflumizole through food and water 

and will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the absence of 

significant tumor increases in two 

rodent carcinogenicity studies, 

triflumizole was classified as ‘‘not likely 

to be carcinogenic to humans,’’ and is 

not expected to pose a cancer risk to 

humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to triflumizole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate Gas Chromatography/ 

Nitrogen Phosphorus Detector (GC/NPD) 

method is available in Pesticide 

Analytical Methods (PAM) Vol. II 

(Method I, section 180.476) for 

determining the combined residues of 

triflumizole and its metabolites 

containing the FA-1-1 moiety in plant 

commodities. The method limit of 

quantitation (LOQ) is 0.5 ppm for plant 

commodities. 

B. International Residue Limits 

There are no Codex, Canadian or 

Mexican maximum residue limits 

(MRLs) established for residues of 

triflumizole in or on commodities 

associated with this petition. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA revised the 

proposed tolerances for the following 

commodities: Brassica, leafy greens, 

subgroup 5B from 20 ppm to 40 ppm; 

and Brassica, head and stem, subgroup 

5A from 5.0 ppm to 8.0 ppm. EPA 

revised the tolerance levels based on 

analysis of the residue field trial data 

using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance Italicize Guiidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data. EPA also revised the 

tolerance expression to clarify 1. That, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of triflumizole 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. This change 

was made to both the tolerance 

expressions for plant commodities and 

animal commodities because it makes 

no substantive change to the meaning of 

the tolerance but rather only clarifies 

the existing language. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of triflumizole, 1- 

(1-((4-chloro-2- 

(trifluoromethyl)phenyl)imino)-2- 

propoxyethyl)-1 H -imidazole, and its 

metabolites containing the 4-chloro-2- 

trifluoromethylaniline moiety, 

calculated as the parent compound, in 

or on leafy greens subgroup 4A, except 

spinach at 35 ppm; Brassica, head and 

stem, subgroup 5A at 8.0 ppm; Brassica, 

leafy greens, subgroup 5B at 40.0 ppm; 

cilantro, leaves at 35 ppm; Swiss chard 

at 18 ppm; pineapple at 4.0 ppm; 

papaya at 2.5 ppm; sapote, black at 2.5 

ppm; canistel at 2.5 ppm; sapote, 

mamey at 2.5 ppm; mango at 2.5 ppm; 

sapodilla at 2.5 ppm; star apple at 2.5 

ppm; hop, dried cones at 50.0 ppm; and 

turnip, greens at 40 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 


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Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Rules and Regulations 26543 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 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: May 22, 2009. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ Section 180.476 is amended by 

revising the introductory text for 

paragraph (a)(1); by alphabetically 

adding the following commodities to the 

table in paragraph (a)(1); by revising the 

introductory text for paragraph (a)(2); 

and by removing the entries for 

Broccoli; Collards; Coriander, leaves; 

Dandelion, leaves; Kale; Mustard, 

greens; Parsley, leaves; Swiss chard; and 

Turnip, greens from the table in 

paragraph (b) to read as follows: 

§ 180.476 Triflumizole; tolerances for 

residues 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

triflumizole, including its metabolites 

and degradates, in or on the 

commodities listed in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the parent compound 

triflumizole, 1-(1-((4-chloro-2- 

(trifluoromethyl)phenyl)imino)-2- 

propoxyethyl )-1 H -imidazole, and its 

metabolites containing the 4-chloro-2- 

trifluoromethylaniline moiety, 

calculated as stoichiometric equivalent 

of the parent compound. 

Commodity Parts per million 

*****

Brassica, head and stem, subgroup 5A .............................................................................................................................. 8.0 

Brassica, leafy greens, subgroup 5B .................................................................................................................................. 40 

Canistel ................................................................................................................................................................................ 2.5 

*****

Cilantro, leaves .................................................................................................................................................................... 35 

*****

Hop, dried cones ................................................................................................................................................................. 50 

Leafy greens subgroup 4A, except spinach ........................................................................................................................ 35 

Mango .................................................................................................................................................................................. 2.5 

Papaya ................................................................................................................................................................................. 2.5 

*****

Pineapple ............................................................................................................................................................................. 4.0 

Sapodilla .............................................................................................................................................................................. 2.5 

Sapote, black ....................................................................................................................................................................... 2.5 

Sapote, mamey .................................................................................................................................................................... 2.5 

Star apple ............................................................................................................................................................................ 2.5 

*****

Swiss chard ......................................................................................................................................................................... 18 

Turnip, greens ...................................................................................................................................................................... 40 

*****

(2) Tolerances are established for 

residues of the fungicide triflumizole, 

including its metabolites and 

degradates, in or on the commodities of 

animal origin listed in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the parent compound 

triflumizole, 1-(1-((4-chloro-2- 

(trifluoromethyl)phenyl)imino)-2- 

propoxyethyl )-1 H -imidazole, the 

metabolite 4-chloro-2-hydroxy-6- 

trifluoromethylaniline sulfate, and other 

metabolites containing the 4-chloro-2- 

trifluoromethylaniline moiety, 

calculated as the parent compound. 

* * * * * 

[FR Doc. E9–12949 Filed 6–2–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0158; FRL–8416–7] 

Aspergillus flavus AF36 on Pistachio; 

Extension of Temporary Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

temporary exemption from the 

requirement of a tolerance for residues 

of the Aspergillus flavus AF36 (A. flavus 

AF36) on pistachio when applied/used 


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