55300 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

Commodity Parts per million 

Banana ........................... 0.3 

Beet, sugar, dried pulp ... 1.0 

Beet, sugar, molasses .... 0.4 

Beet, sugar, roots ........... 0.3 

Beet, sugar, tops ............ 9.0 

Bushberry subgroup 13B 0.3 

Cattle, meat byproducts 0.05 

Citrus, dried pulp ............ 5.0 

Citrus, oil ......................... 40.0 

Cranberry ........................ 0.5 

Fruit, citrus, group 10 ..... 1.0 

Fruit, stone, group 12 ..... 1.0 

Goat, meat byproducts ... 0.05 

Grain, aspirated fractions 6.0 

Grape1 ............................ 1.0 

Horse, meat byproducts 0.05 

Peanut ............................ 0.1 

Pecan .............................. 0.05 

Sheep, meat byproducts 0.05 

Wheat, forage ................. 4.0 

Wheat, grain ................... 0.1 

Wheat, hay ..................... 8.0 

Wheat, straw ................... 8.0 

1There are no United States registrations for 

grape as of August 2006. 

* * * * * 

[FR Doc. 06–7957 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0347; FRL–8092–1] 

Propiconazole; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes or 

revises tolerances for combined residues 

of propiconazole and its metabolites 

containing the dichlorobenzoic acid 

(DCBA) moiety expressed as parent 

compound in or on various 

commodities; and inadvertent residues 

in or on alfalfa, forage and alfalfa, hay. 

Syngenta Crop Protection, Inc. and 

Interregional Research Project No. 4 (IR4), requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 22, 2006. Objections and 

requests for hearings must be received 

on or before November 21, 2006, 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–2006–0347. All documents in the 

docket are listed in the index for the 

docket. 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 Building), 

2777 S. Crystal Drive, Arlington, VA. 

The Docket Facility is open from 8:30 

a.m. to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Mary Waller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary@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: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides 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 Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket 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 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2006–0347 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 

on or before November 21, 2006. 

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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0347, 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 Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 


rwilkins on PROD1PC63 with RULES_1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55301 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of May 3, 2006 

(71 FR 26084) (FRL–8060–2), 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) 2F6371 and 

5F4498 by Syngenta Crop Protection, 

Inc., and PP 6E4788, 7E4860, and 

8E4931 by Interregional Research 

Project No. 4 (IR-4). The petitions 

requested that 40 CFR 180.434 be 

amended by establishing a tolerance for 

combined residues of the fungicide 

propiconazole, 1-[[2-(2,4- 

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl] methyl]-1H-1,2,4-triazole and its 

metabolites determined as 2,4- 

dichlorobenzoic acid and expressed as 

parent compound in or on leafy 

vegetables (Subgroup 4B) at 5.0 parts 

per million (ppm) (PP 6E4788); 

cranberry at 1.0 ppm (PP 7E4860); Mint 

at.3.0 ppm (PP 8E4931); and under PP 

2F6371, almond, hulls and onion, green 

at 8.0 ppm; berries (Group 13) and 

legume vegetables (Group 6) at 1.0 ppm; 

foliage of legume vegetables (Group 7)/ 

sorghum/soybean, forage and sugar beet, 

tops at 10.0 ppm; carrot, roots/ 

pistachios/nuts, tree (Group 14) at 0.2 

ppm; foliage of legume vegetable (Group 

7)/soybean, hay at 32.0 ppm; onion, dry 

bulb/corn, grain/sugar beet, roots at 0.3 

ppm; sorghum, grain/grain cereal group 

(except corn, rice, and sorghum), bran at 

2.5 ppm; sorghum, stover at 15.0 ppm; 

soybean, seed/grain, cereal group 

(except corn, rice, and sorghum), hay/ 

sugar beet, dried pulp at 2.0 ppm; 

strawberry at 1.5 ppm; grain, cereal 

group (except corn, rice, and sorghum) 

(Group 15), forage/sugar beet, molasses 

at 3.0 ppm; grain, cereal group (except 

corn, rice, and sorghum), straw at 13.0 

ppm; grain, cereal group (except corn, 

rice, and sorghum)/corn, oil at 0.5 ppm; 

rice, bran and hulls at 28.0 ppm; and 

aspirated grain fraction at 17.0 ppm. 

Further, the petition requested existing 

tolerances be amended for corn, forage 

at 4.0 ppm; corn, stover at 25.0 ppm; 

rice, grain at 7.0 ppm; and rice, straw at 

18.0 ppm. Additionally, PP 5F4498, 

requested inadvertent residues for 

alfalfa, forage and hay at 0.1 ppm. That 

notice included a summary of the 

petition prepared by Syngenta Crop 

Protection, Inc., the registrant. There 

were no comments received in response 

to the notice of filing. 

Upon completing review of the 

current propiconazole database, the 

Agency concluded that the appropriate 

tolerance levels for propiconazole 

residues in or on pending crops and 

livestock commodities should be 

established as follow: On grain, 

aspirated fractions at 30 ppm; almond, 

hulls at 7.0 ppm; barley, grain at 0.3 

ppm; barley, hay at 1.4 ppm; barley, 

straw at 10 ppm; barley, bran at 0.6 

ppm; cattle, fat at 0.05 ppm; cattle, meat 

at 0.05 ppm; cattle, meat byproducts, 

except liver and kidney at 0.05 ppm; 

leafy petioles, subgroup 4B at 5.0 ppm; 

Berry group 13 at 1.0 ppm; carrot, roots 

at 0.25 ppm; corn, field, forage at 12 

ppm; corn, sweet, forage at 6.0 ppm; 

corn, field, grain at 0.2 ppm; corn, pop, 

grain at 0.2 ppm; corn, field, stover at 

30 ppm; corn, pop, stover at 30 ppm; 

corn, sweet, stover at 30 ppm; goat, fat 

at 0.05 ppm; goat, meat at 0.05 ppm; 

goat, meat byproducts, except liver and 

kidney at 0.05 ppm; hog, kidney at 0.2 

ppm; hog, liver at 0.2 ppm; horse, fat at 

0.05 ppm; horse, meat at 0.05 ppm; 

horse, meat byproducts, except liver and 

kidney at 0.05 ppm; spearmint, tops at 

3.5 ppm; peppermint, tops at 3.5 ppm; 

oat, forage at 1.7 ppm; oat, grain at 0.3 

ppm; oat, hay at 1.4 ppm; oat, straw at 

10 ppm; onion, bulb at 0.2 ppm; onion, 

green at 9.0 ppm; pistachio at 0.1 ppm; 

rice, bran at 15 ppm; rice, grain at 7.0 

ppm; rice, hulls at 20 ppm; rice, straw 

at 18 ppm; rye, grain at 0.3 ppm; rye, 

forage at 1.7 ppm; rye, straw at 10 ppm; 

rye, bran at 0.6 ppm; sorghum, grain, 

forage at 12 ppm; sorghum, grain, grain 

at 3.5 ppm; sorghum, grain, stover at 15 

ppm; sheep, fat at 0.05 ppm; sheep, 

meat at 0.05 ppm; sheep, meat 

byproducts, except liver and kidney at 

0.05 ppm; soybean, forage at 11 ppm; 

soybean, hay at 30 ppm; soybean, seed 

at 2.0 ppm; strawberry at 1.3 ppm; beet, 

sugar, dried pulp at 1.0 ppm; beet, 

sugar, roots at 0.3 ppm; beet, sugar, tops 

at 10 ppm; beet, sugar, molasses at 1.5 

ppm; nut, tree, group 14 at 0.1 ppm; 

wheat, bran at 0.6 ppm; wheat, forage at 

1.7 ppm; wheat, grain at 0.3 ppm; 

wheat, hay at 1.4 ppm; wheat, straw at 

10 ppm; cranberry at 1.0 ppm; and 

inadvertent residues in or on alfalfa, 

forage at 0.1 ppm and alfalfa, hay at 0.1 

ppm. The Agency concluded that there 

are insufficient data to establish 

tolerances legume vegetables (Group 6); 

foliage of legume vegetables (Group 7); 

cereal group (except corn, rice, and 

sorghum) (Group 15). For additional 

information refer to 

www.regulations.gov Docket No. EPA–

HQ–OPP–2006–0347–0008. 

EPA is also deleting several 

established tolerances in 40 CFR 

180.434(a), (b), and (c) that are no longer 

needed as a result of this action. 

The revisions to 180.434(a) are as 

follows: 

• Delete celery at 5.0 ppm. Replaced 

with leafy petioles, subgroup 4B at 5.0 

ppm. 

• Delete pecans at 0.1 ppm. Replaced 

with nut, tree, group 14 at 0.1 ppm. 

The revisions to 180.434(b) are as 

follows: 

• Delete the time-limited tolerance for 

blueberry at 1.0 ppm. Replaced with 

Berry group 13 at 1.0 ppm, under 40 

CFR 180.434(a). 

• Delete the time-limited tolerance for 

cranberry; grain, aspirated fractions; 

sorghum, grain, grain; sorghum, grain, 

stover; soybean; soybean, forage; and 

soybean, hay. All are being replaced by 

permanent tolerances. 

• Delete time-limited tolerance for 

dry bean; dry bean forage; and dry bean 

hay since these tolerances have expired. 

The revisions to 180.434(c) are as 

follows: 

• Delete mint, tops (leaves and stems) 

at 0.3 ppm. Replaced with spearmint, 

tops at 3.5 ppm and peppermint, tops at 

3.5 ppm under 40 CFR 180.434(a). 

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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 


rwilkins on PROD1PC63 with RULES_1
55302 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for combined 

residues of propiconazole and its 

metabolites containing the 

dichlorobenzoic acid (DCBA) moiety 

expressed as parent compound on grain, 

aspirated fractions at 30 ppm; almond, 

hulls at 7.0 ppm; barley, grain at 0.3 

ppm; barley, hay at 1.4 ppm; barley, 

straw at 10 ppm; barley, bran at 0.6 

ppm; cattle, fat at 0.05 ppm; cattle, meat 

at 0.05 ppm; cattle, meat byproducts, 

except liver and kidney at 0.05 ppm; 

leafy petioles, subgroup 4B at 5.0 ppm; 

Berry group 13 at 1.0 ppm; carrot, roots 

at 0.25 ppm; corn, field, forage at 12 

ppm; corn, sweet, forage at 6.0 ppm; 

corn, field, grain at 0.2 ppm; corn, pop, 

grain at 0.2 ppm; corn, field, stover at 

30 ppm; corn, pop, stover at 30 ppm; 

corn, sweet, stover at 30 ppm; goat, fat 

at 0.05 ppm; goat, meat at 0.05 ppm; 

goat, meat byproducts, except liver and 

kidney at 0.05 ppm; hog, kidney at 0.2 

ppm; hog, liver at 0.2 ppm; horse, fat at 

0.05 ppm; horse, meat at 0.05 ppm; 

horse, meat byproducts, except liver and 

kidney at 0.05 ppm; spearmint, tops at 

3.5 ppm; peppermint, tops at 3.5 ppm; 

oat, forage at 1.7 ppm; oat, grain at 0.3 

ppm; oat, hay at 1.4 ppm; oat, straw at 

10 ppm; onion, bulb at 0.2 ppm; onion, 

green at 9.0 ppm; pistachio at 0.1 ppm; 

rice, bran at 15 ppm; rice, grain at 7.0 

ppm; rice, hulls at 20 ppm; rice, straw 

at 18 ppm; rye, grain at 0.3 ppm; rye, 

forage at 1.7 ppm; rye, straw at 10 ppm; 

rye, bran at 0.6 ppm; sorghum, grain, 

forage at 12 ppm; sorghum, grain, grain 

at 3.5 ppm; sorghum, grain, stover at 15 

ppm; sheep, fat at 0.05 ppm; sheep, 

meat at 0.05 ppm; sheep, meat 

byproducts, except liver and kidney at 

0.05 ppm; soybean, forage at 11 ppm; 

soybean, hay at 30 ppm; soybean, seed 

at 2.0 ppm; strawberry at 1.3 ppm; beet, 

sugar, dried pulp at 1.0 ppm; beet, 

sugar, roots at 0.3 ppm; beet, sugar, tops 

at 10 ppm; beet, sugar, molasses at 1.5 

ppm; nut, tree, group 14 at 0.1 ppm; 

wheat, bran at 0.6 ppm; wheat, forage at 

1.7 ppm; wheat, grain at 0.3 ppm; 

wheat, hay at 1.4 ppm; wheat, straw at 

10 ppm; cranberry at 1.0 ppm; and 

inadvertent residues in or on alfalfa, 

forage at 0.1 ppm and alfalfa, hay at 0.1 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

the tolerance 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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

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

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

can be found at www.regulations.gov 

Docket No. EPA–HQ–OPP–2006–0347–

0005; pages 35–42. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

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

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for propiconazole used for 

human risk assessment is discussed at 

www.regulations.gov Docket No. EPA–

HQ–OPP–2006–0347–0004; pages 23–

25. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.434) for the 

combined residues of propiconazole and 

its metabolites containing the 

dichlorobenzoic acid (DCBA) moiety 

expressed as parent compound, in or on 

a variety of raw agricultural 

commodities. Tolerances are also 

established for residues of 

propiconazole and its metabolites 

containing the dichlorobenzoic acid 

(DCBA) moiety expressed as parent 

compound in or on milk as well as fat, 

meat, kidney, liver and meat by 

products of cattle, goats, hogs, horse, 

and sheep. Some of these existing 

tolerances are being revised as a result 

of this action. Risk assessments were 

conducted by EPA to assess dietary 

exposures from propiconazole 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 conducting the acute dietary 

exposure assessment EPA used the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM-FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessments: Tolerance levels and one 

hundred percent of the crops were 

treated for all proposed new uses, 

revised uses, and existing uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM-FCIDTM, which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 nationwide CSFII, 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

Tolerance levels and 100% of the crops 

were treated for all proposed new uses, 

revised uses, and existing uses. 

iii. Cancer. Propiconazole has been 

classified as a group C (possible human 

carcinogen). The Agency concluded that 

the chronic risk assessment, making use 

of the chronic population adjusted dose 

(cPAD), is protective of any potential 

carcinogenic risk. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

propiconazole in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

propiconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55303 

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

oppefed1/models/water/index.htm. 

A registrant drinking water 

monitoring study showed very few 

detections among a total of 38 selected 

community water systems in 12 states. 

The Agency concluded that the 

sampling scheduling of this monitoring 

study is not rigorous enough to be used 

for water assessment. Since the 

monitoring studies did not provide good 

quality data, this drinking water 

assessment is based on the model 

predicted drinking water 

concentrations. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

concentration in Ground Water (SCIGROW) models, the estimated 

environmental concentrations (EECs) of 

propiconazole for acute exposures are 

estimated to be 55.8 parts per billion 

(ppb) for surface water and 0.64 ppb for 

ground water. The EECs for chronic 

exposures are estimated to be 21.6 ppb 

for surface water and 0.64 ppb for 

ground water. 

To estimate surface water for each 

specific use, the maximum allowable 

label rate was input into PRZM/EXAMS. 

The output concentrations were without 

percent cropped area (PCA) 

consideration. The final estimated 

drinking water concentrations were then 

adjusted with the proper PCA. Except 

the uses of soybean (0.41 ppb) and 

wheat (0.56 ppb), other uses assume the 

default PCA of 0.87 ppb. Among these 

modeling results, turf use gives the 

highest acute concentration of 55.78 ppb 

(Microgram/liter (μg/L)). For the chronic 

exposure, turf use has the highest 

concentration of 21.61 ppb (μg/L). 

The EECs in ground water were 

calculated using the Tier I SCI-GROW 

model. SCI-GROW is neither scenarionor crop-specific. The only input 

requirements are application rate, 

number of applications, Koc, and aerobic 

soil metabolism half-life. The higher 

estimated concentrations are associated 

with the higher rate. Turf use has the 

highest concentration of 0.64 μg/L (ppb). 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model (DEEMFCID(TM)). For acute dietary risk 

assessment, the peak water 

concentration value of 55.8 ppb was 

used to access the contribution to 

drinking water. For chronic dietary risk 

assessment, the annual average 

concentration of 21.6 ppb was used to 

access 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). 

Propiconazole is currently registered 

for use on the following residential nondietary sites: Ground covers; turf and 

ornamentals in lawns and golf courses; 

ornamentals trees (injection); shade 

trees (outdoor spray); herbaceous plants; 

ornamental woody shrubs and vines and 

antimicrobial uses in paint and wood 

protection treatment. The risk 

assessment was conducted using the 

following residential exposure 

assumptions: 

Homeowners can be exposed to 

propiconazole through dermal and 

inhalation routes while applying home 

use products. All risk calculations were 

conducted using the maximum turf 

application rate (1.8 lb ai/acre). The 

anticipated use patterns and current 

labeling indicate three major residential 

exposure scenarios based on the types of 

equipment and techniques that can 

potentially be used to make 

propiconazole applications. The 

quantitative exposure/risk assessment 

developed for residential handlers is 

based on these scenarios: 

• Mixer/Loader/applying liquids and 

wettable powder in water soluble 

packets via low pressure handwand. 

• Mixer/Loader/applying liquids and 

wettable powder in water soluble 

packets via hose-end sprayer. 

• Applying treated paint using airless 

sprayer and hose-end spray. 

Residential handler exposure 

scenarios are considered to be shortterm only due to the infrequent uses 

associated with homeowner products. 

The existing residential use patterns 

result in post application dermal 

exposures to adults, and dermal and 

oral exposures to infants and children. 

These exposure scenarios are 

considered short term only, due to the 

fact that: 

i. Post-application exposures were 

calculated using propiconazole as the 

parent compound; 

ii. Compound specific turf 

transferable residue (TTR) data indicate 

that at the Indiana, California, and 

Pennsylvania test sites, average total 

propiconazole residues declined to 

below the minimum quantifiable limit 

(MQL) by 14, 10 and 8 days after 

treatment, respectively. These 

dissipation rates, combined with label 

specific use rates and frequency of use 

specifications, reinforce the hand to 

mouth short-term exposure scenario; 

iii. For short term exposure to 

children 1–2 years old, the driving 

factors for this risk assessment are hand 

to mouth, object to mouth, and dermal 

exposure. Soil ingestion is insignificant 

(margin of exposure (MOE) >300,000) 

compared to these factors, indicating 

that the post application scenario 

should be short term only. Although 

both residential and antimicrobial uses 

result in incidental oral and dermal 

exposure to children, the highest 

incidental oral and dermal exposure 

scenarios are from residential use on 

turf, which were used in the short term 

aggregate risk assessment. 

In addition to using the EPA’s 

Standard Operational Procedure (SOP) 

for residential assessment, the study 

specific turf transferable residue (TTR) 

was used to estimate exposures. The 

EPA combined exposures resulting from 

separate post-application exposure 

scenarios when it is likely they can 

occur simultaneously based on the usepattern and the behavior associated with 

the exposed population. The 

assumptions used for each of the 

scenarios separately are considered to 

account for potential high levels of 

exposure (i.e., time spent outdoors, 

dislodgeable residues) therefore, 

combining all these activities together is 

considered a very high end estimate of 

exposure. Propiconazole is classified as 

a non-volatile chemical; therefore a 

residential inhalation post-application 

assessment was not assessed. 

The only residential use scenario that 

will result in potential intermediate 

term exposure to propiconazole is post 

application exposure to children from 

wood treatment (antimicrobial use) from 

incidental oral and dermal contact 

activities. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Propiconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between this pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same sequence of 

major biochemical events (EPA, 2002). 

In conazoles, however, a variable 

pattern of toxicological responses is 

found. Some are hepatotoxic and 

hepatocarcinogenic in mice. Some 


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55304 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

induce thyroid tumors in rats. Some 

induce developmental, reproductive, 

and neurological effects in rodents. 

Furthermore, the conazoles produce a 

diverse range of biochemical events 

including altered cholesterol levels, 

stress responses, and altered DNA 

methylation. It is not clearly understood 

whether these biochemical events are 

directly connected to their toxicological 

outcomes. Thus, there is currently no 

evidence to indicate that conazoles 

share common mechanisms of toxicity 

and EPA is not following a cumulative 

risk approach based on a common 

mechanism of toxicity for the conazoles. 

For information regarding EPA’s 

procedures for cumulating effects from 

substances found to have a common 

mechanism of toxicity, see EPA’s 

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

pesticides/cumulative. 

Propiconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole conjugates (triazole alanine and 

triazole acetic acid). To support existing 

tolerances and to establish new 

tolerances for triazole-derivative 

pesticides, including propiconazole, 

EPA conducted a human health risk 

assessment for exposure to 1,2,4- 

triazole, triazole alanine, and triazole 

acetic acid resulting from the use of all 

current and pending uses of any 

triazole-derived fungicide. The risk 

assessment is highly conservative, 

screening-level evaluation in terms of 

hazards associated with common 

metabolites (e.g., use of a maximum 

combination of uncertainty factors) and 

potential dietary and non-dietary 

exposures (i.e., high end estimates of 

both dietary and non-dietary exposures). 

In addition, the Agency retained the 

additional 10X FQPA safety factor for 

the protection of infants and children. 

The assessment includes evaluations of 

risks for various subgroups, including 

those comprised of infants and children. 

The Agency’s complete risk assessment 

is found in the propiconazole 

reregistration docket at 

www.regulations.gov, Docket ID number 

EPA–HQ–OPP–2005–0497–0013. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. In applying this provision, 

EPA either retains the default value of 

10X when reliable data do not support 

the choice of a different factor, or, if 

reliable data are available, EPA uses a 

different additional safety factor value 

based on the use of traditional 

uncertainty factors and/or special FQPA 

safety factors, as appropriate. 

2. Prenatal and postnatal sensitivity. 

There is low concern for pre- and/or 

postnatal toxicity resulting from 

exposure to propiconazole. In the 

developmental toxicity study in rats, the 

EPA considered the fetal effects 

observed in this study at a dose lower 

than that evoking maternal toxicity to be 

quantitative evidence of increased 

susceptibility of fetuses to in utero 

exposure to propiconazole. In the 

developmental toxicity study in rabbits, 

the Agency determined that neither 

quantitative nor qualitative evidence of 

increased susceptibility of fetuses to in 

utero exposure to propiconazole was 

observed in this study. In the 2–

generation reproduction study in rats, 

neither quantitative nor qualitative 

evidence of increased susceptibility of 

neonates (as compared to adults) to preand/or postnatal exposure to 

propiconazole was observed in the 

study. Since there is quantitative 

evidence of increased susceptibility of 

the young following exposure to 

propiconazole in the developmental rat 

study, the Agency performed a Degree of 

Concern Analysis to: 

i. Determine the LOC for the effects 

observed when considered in the 

context of all available toxicity data; and 

ii. Identify any residual uncertainties 

after establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the risk assessment of this chemical. 

If residual uncertainties are identified, 

then EPA examines whether these 

residual uncertainties can be addressed 

by a special FQPA safety factor and, if 

so, the size of the factor needed. In the 

developmental rat study, quantitative 

susceptibility was evidenced as 

increased incidence of rudimentary ribs, 

unossified sternebrae, as well as 

increased incidence of shortened and 

absent renal papillae and increased cleft 

palate at (90 mg/kg/day) a dose lower 

than that evoking maternal toxicity 

(severe clinical toxicity at 300 mg/kg/ 

day). Considering the overall toxicity 

profile and the doses and endpoints 

selected for risk assessment for 

propiconazole, the EPA characterized 

the degree of concern for the effects 

observed in this study as low, noting 

that there is a clear no observed adverse 

effect level (NOAEL) and wellcharacterized dose response for the 

developmental effects observed. No 

residual uncertainties were identified. 

The NOAEL for developmental effects 

in this study (30 mg/kg/day) is used as 

the basis for the acute Reference dose 

(aRfD) for the female 13–50 population 

subgroup as well as for short-term 

incidental oral, dermal and inhalation 

endpoints. For all other toxicity 

endpoints established for 

propiconazole, a NOAEL lower than this 

developmental NOAEL is used. 

3. Conclusion. There is a complete 

toxicity data base for propiconazole and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. There 

is low concern for pre- and/or postnatal 

toxicity resulting from exposure to 

propiconazole. In the developmental 

toxicity study in rats the fetal effects 

observed were seen at a dose lower than 

that evoking maternal toxicity. These 

effects were considered to be 

quantitative evidence of increased 

susceptibility of fetuses to in utero 

exposure to propiconazole. Therefore, as 

discussed above a Degree of Concern 

Analysis was conducted and the EPA 

concluded that the degree of concern for 

the effects observed in this study was 

low and no residual uncertainties were 

identified. EPA determined that the 10X 

SF to protect infants and children 

should be removed. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

propiconazole will occupy 6% of the 

acute Population Adjusted Dose (aPAD) 

for the U.S. population, 5% of the aPAD 

for females 13 years and older, 14% of 

the aPAD for all infants (<1 year old), 

the subpopulation at greatest exposure, 

and 13% of the aPAD for children 1–2 

years old. Therefore, EPA does not 

expect the aggregate exposure to exceed 

100% of the aPAD. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to propiconazole from 

food and water will utilize 6% of the 

chronic Population Adjusted Dose 

(cPAD) for the U.S. population, 14% of 

the cPAD for all infants (<1 year old), 

and 14% of the cPAD for children 1–2 

years old, the subpopulation at greatest 

exposure. Based the use pattern, chronic 

residential exposure to residues of 

propiconazole is not expected. 


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Therefore, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Propiconazole is currently registered 

for use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for propiconazole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, water and residential exposures 

aggregated result in aggregate MOEs for 

children 1–2 years old of 1,100 for hand 

to mouth activity on turf; 4,500 for 

object to mouth activity on turf; 330,000 

for soil ingestion; 210 for high contact 

turf activities; and 410 from the 

antimicrobial use of propiconazole in 

treated wood. The food, water and 

residential exposures aggregated for 

children 1–2 years old following postapplication of propiconazole result in 

an aggregate MOE of 160 for high 

contact activities. The corresponding 

aggregate MOE for adults following 

post-application exposure is 330. These 

aggregate MOEs do not exceed the 

Agency’s LOC for aggregate exposure to 

food, water and residential uses. 

Therefore, EPA does not expect shortterm aggregate exposure to exceed the 

Agency’s LOC. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Propiconazole is currently registered 

for use(s) that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic food 

and water and intermediate-term 

exposures for propiconazole. 

Using the exposure assumptions 

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

food, water and residential exposures 

aggregated result in an aggregate MOE of 

120 for combined exposures from 

incidental oral and dermal contact 

activities for children 1–2 years old. 

These aggregate MOEs do not exceed the 

Agency’s LOC for aggregate exposure to 

food, water and residential uses. 

Therefore, EPA does not expect 

intermediate-term aggregate exposure to 

exceed the Agency’s LOC. 

5. Aggregate cancer risk for U.S. 

population. The Agency considers the 

chronic aggregate risk assessment, 

making use of the cPAD, to be protective 

of any aggregate cancer risk. See Unit 

III.E.2. 

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, and to infants and children 

from aggregate exposure to 

propiconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(a gas chromatography (GC) method 

using electron capture detection 

(Method AG-454) is available to enforce 

the tolerance expression. The method 

may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

The Codex Alimentarius Commission 

has established several maximum 

residue limits (MRLs) for propiconazole 

in/on various raw agricultural 

commodities. The Codex MRLs are 

expressed in terms of propiconazole per 

se. In addition, both Canada and Mexico 

have established MRLs/tolerances on 

several commodities which also have 

U.S. tolerances. The U.S. tolerance 

expression includes all metabolites 

determined as 2,4-dichloro-benzoic 

acid. In conjunction with the 

reregistration process EPA intends to 

revise the expression to propiconazole 

per se. To the extent possible, for the 

present petitions, U.S. tolerances have 

been numerically harmonized with 

Codex, Canadian, and Mexican MRLs; 

however, differences in use patterns and 

the supporting residue data have 

precluded reducing many tolerances. A 

summary of Codex MRLs, Canadian 

MRLs, and Mexican tolerances and the 

corresponding U.S. tolerances for 

propiconazole is discussed at 

www.regulations.gov Docket No. EPA–

HQ–OPP–2006–0347–0004; pages 53–

54. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of propiconazole 

and its metabolites containing the 

dichlorobenzoic acid (DCBA) moiety 

expressed as parent compound in or on 

grain, aspirated fractions at 30 ppm; 

almond, hulls at 7.0 ppm; barley, grain 

at 0.3 ppm; barley, hay at 1.4 ppm; 

barley, straw at 10 ppm; barley, bran at 

0.6 ppm; cattle, fat at 0.05 ppm; cattle, 

meat at 0.05 ppm; cattle, meat 

byproducts, except liver and kidney at 

0.05 ppm; leafy petioles, subgroup 4B at 

5.0 ppm; Berry group 13 at 1.0 ppm; 

carrot, roots at 0.25 ppm; corn, field, 

forage at 12 ppm; corn, sweet, forage at 

6.0 ppm; corn, field, grain at 0.2 ppm; 

corn, pop, grain at 0.2 ppm; corn, field, 

stover at 30 ppm; corn, pop, stover at 30 

ppm; corn, sweet, stover at 30 ppm; 

goat, fat at 0.05 ppm; goat, meat at 0.05 

ppm; goat, meat byproducts, except 

liver and kidney at 0.05 ppm; hog, 

kidney at 0.2 ppm; hog, liver at 0.2 ppm; 

horse, fat at 0.05 ppm; horse, meat at 

0.05 ppm; horse, meat byproducts, 

except liver and kidney at 0.05 ppm; 

spearmint, tops at 3.5 ppm; peppermint, 

tops at 3.5 ppm; oat, forage at 1.7 ppm; 

oat, grain at 0.3 ppm; oat, hay at 1.4 

ppm; oat, straw at 10 ppm; onion, bulb 

at 0.2 ppm; onion, green at 9.0 ppm; 

pistachio at 0.1 ppm; rice, bran at 15 

ppm; rice, grain at 7.0 ppm; rice, hulls 

at 20 ppm; rice, straw at 18 ppm; rye, 

grain at 0.3 ppm; rye, forage at 1.7 ppm; 

rye, straw at 10 ppm; rye, bran at 0.6 

ppm; sorghum, grain, forage at 12 ppm; 

sorghum, grain, grain at 3.5 ppm; 

sorghum, grain, stover at 15 ppm; sheep, 

fat at 0.05 ppm; sheep, meat at 0.05 

ppm; sheep, meat byproducts, except 

liver and kidney at 0.05 ppm; soybean, 

forage at 11 ppm; soybean, hay at 30 

ppm; soybean, seed at 2.0 ppm; 

strawberry at 1.3 ppm; beet, sugar, dried 

pulp at 1.0 ppm; beet, sugar, roots at 0.3 

ppm; beet, sugar, tops at 10 ppm; beet, 

sugar, molasses at 1.5 ppm; nut, tree, 

group 14 at 0.1 ppm; wheat, bran at 0.6 

ppm; wheat, forage at 1.7 ppm; wheat, 

grain at 0.3 ppm; wheat, hay at 1.4 ppm; 

wheat, straw at 10 ppm; cranberry at 1.0 

ppm; and inadvertent residues in or on 

alfalfa, forage at 0.1 ppm and alfalfa, hay 

at 0.1 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or impose any 


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enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: September 12, 2006. 

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 180.434 is revised to read 

as follows: 

§ 180.434 Propiconazole; tolerances for 

residue. 

(a) General. Tolerances are 

established for the combined residues of 

the fungicide 1-[[2-(2,4-dichlorophenyl)- 

4-propyl-1,3-dioxolan-2-yl] methyl]-1H1,2,4-triazole and its metabolites 

determined as 2,4-dichlorobenzoic acid 

and expressed as parent compound in or 

on the following commodities: 

Commodity Parts per million 

Almond, hulls .................. 7.0 

Banana ........................... 0.2 

Barley, bran .................... 0.6 

Barley, grain ................... 0.3 

Barley, hay ...................... 1.4 

Barley, straw ................... 10 

Beet, sugar, dried pulp ... 1.0 

Beet, sugar, molasses .... 1.5 

Beet, sugar, roots ........... 0.3 

Beet, sugar, tops ............ 10 

Berry, group 13 ............... 1.0 

Carrot, roots .................... 0.25 

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

Cattle, kidney .................. 2.0 

Cattle, liver ...................... 2.0 

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

Cattle, meat byproducts, 

except liver and kidney 0.05 

Corn, field, forage ........... 12 

Corn, field, grain ............. 0.2 

Corn, field, stover ........... 30 

Corn, pop, grain .............. 0.2 

Corn, pop, stover ............ 30 

Corn, sweet, forage ........ 6.0 

Corn, sweet, kernel plus 

cob with husks removed ......................... 0.1 

Corn, sweet, stover ........ 30 

Fruit, stone, group 12 ..... 1.0 

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

Goat, kidney ................... 2.0 

Goat, liver ....................... 2.0 

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

Goat, meat byproducts, 

except liver and kidney 0.05 

Grain, aspirated fractions 30 

Grass, forage .................. 0.5 

Grass, hay ...................... 0.5 

Grass, straw ................... 40 

Hog, kidney ..................... 0.2 

Hog, liver ........................ 0.2 

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

Horse, kidney .................. 2.0 

Horse, liver ..................... 2.0 

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

Horse, meat byproducts, 

except liver and kidney 0.05 

Leaf petioles, subgroup 

4B ................................ 5.0 

Milk ................................. 0.05 

Mushroom ....................... 0.1 

Nut, tree, group 14 ......... 0.1 

Oat, forage ...................... 1.7 

Oat, grain ........................ 0.3 

Oat, hay .......................... 1.4 

Oat, straw ....................... 10 

Onion, bulb ..................... 0.2 

Onion, green ................... 9.0 

Peanut ............................ 0.2 

Peanut, hay .................... 20 

Peppermint, tops ............ 3.5 

Pineapple ........................ 0.1 


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Commodity Parts per million 

Pistachio ......................... 0.1 

Rice, bran ....................... 15 

Rice, grain ...................... 7.0 

Rice, hulls ....................... 20 

Rice, straw ...................... 18 

Rye, bran ........................ 0.6 

Rye, forage ..................... 1.7 

Rye, grain ....................... 0.3 

Rye, straw ....................... 10 

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

Sheep, kidney ................. 2.0 

Sheep, liver ..................... 2.0 

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

Sheep, meat byproducts, 

except liver and kidney 0.05 

Sorghum, grain, forage ... 12 

Sorghum, grain, grain ..... 3.5 

Sorghum, grain, stover ... 15 

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

Soybean, hay .................. 30 

Soybean, seed ................ 2.0 

Spearmint, tops .............. 3.5 

Strawberry ...................... 1.3 

Wheat, bran .................... 0.6 

Wheat, forage ................. 1.7 

Wheat, grain ................... 0.3 

Wheat, hay ..................... 1.4 

Wheat, straw ................... 10 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. A tolerance with regional 

registration, as defined in §180.1(m), is 

established for residues of 1-[[2-(2,4- 

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole and its 

metabolites determined as 2,4- 

dichlorobenzoic acid and expressed as 

parent compound, in or on the 

following commodities: 

Commodity Parts per million 

Cranberry ........................ 1.0 

Rice, wild ........................ 0.5 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

combined residues of the fungicide 1- 

[[2-(2,4-dichlorophenyl)-4-propyl-1,3- 

dioxolan-2-yl] methyl]-1H-1,2,4-triazole 

and its metabolites determined as 2,4- 

dichlorobenzoic acid and expressed as 

parent compound in or on the following 

commodities when present therein as a 

result of application of propiconazole to 

growing crops in paragraphs (a) and (c) 

of this section: 

Commodity Parts per million 

Alfalfa, forage ................. 0.1 

Alfalfa, hay ...................... 0.1 

[FR Doc. 06–8064 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0170; FRL–8092–2] 

Buprofezin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues or 

residues of buprofezin in or on almond 

hulls; cotton, gin byproducts: 

Cottonseed; and tomato. Nichino 

America, Inc., Linden Park Suite 501, 

4550 New Linden Hill Road, 

Wilmington, DE 19908 requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), as amended 

by the Food Quality Protection Act of 

1996 (FQPA). 

DATES: This regulation is effective 

September 22, 2006. Objections and 

requests for hearings must be received 

on or before November 21, 2006, 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–2006–0170. All documents in the 

docket are listed in the index for the 

docket. 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 Building), 

2777 S. Crystal Drive, Arlington, VA. 

The Docket Facility is open from 8:30 

a.m. to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Sweeney, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5063; e-mail address: 

sweeney.kevin@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: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers. 

This listing is not intended to be 

exhaustive, but rather provides 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 Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket 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 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 


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