12606 Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide, 

fenpropathrin, (alpha-cyano-3-phenoxybenzyl 2,2,3,3- 

tetramethylcyclopropanecarboxylate), in 

or on almond, hulls at 4.5 ppm; cherry, 

sweet at 5.0 ppm; cherry, tart at 5.0 

ppm; fruit, stone, crop group 12 (except 

cherry) at 1.4 ppm; nut, tree, crop group 

14 at 0.10 ppm; avocado at 1.0 ppm; 

black sapote at 1.0 ppm; canistel at 1.0 

ppm; maney sapote at 1.0 ppm; mango 

at 1.0 ppm; papaya at 1.0 ppm; sapodilla 

at 1.0 ppm; star apple at 1.0; caneberry, 

subgroup 13-07A at 12.0 ppm; olive at 

5.0 ppm; and pistachio at 0.10 ppm. In 

addition, the Agency is deleting a timelimited tolerance on currant at 15 ppm 

which had an expiration date of 12/31/ 

2008. 

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 

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: February 24, 2009. 

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. 466 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) and by removing the text in 

paragraph (b) and reserving the heading. 

§ 180.466 Fenpropathrin; tolerances for 

residues. 

* * * * * 

Commodity Parts per million 

Almond, hulls ........... 4.5 

Avocado ................... 1.0 

* * * * * 

Caneberry subgroup 

13-07A.

12 

Canistel .................... 1.0 

* * * * * 

Cherry, sweet .......... 5.0 

Cherry, tart .............. 5.0 

* * * * * 

Fruit, stone, crop 

group 12, except 

cherry.

1.4 

* * * * * 

Mango ...................... 1.0 

* * * * * 

Nut, tree, crop group 

14.

0.10 

Olive ........................ 5.0 

Papaya .................... 1.0 

* * * * * 

Pistachio .................. 0.10 

* * * * * 

Sapodilla .................. 1.0 

Sapote, black ........... 1.0 

Sapote, mamey ....... 1.0 

* * * * * 

Star apple ................ 1.0 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. E9–6412 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1202; FRL–8403–7] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

propiconazole in or on beet, garden, 

roots at 0.30 ppm; beet, garden, tops at 


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5.5 ppm; cilantro, leaves at 13 ppm; 

parsley, fresh leaves at 13 ppm; parsley, 

dried leaves at 35 ppm; pineapple at 4.5 

ppm; and pineapple, process residue at 

7.0 ppm. The Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 25, 2009. Objections and requests 

for hearings must be received on or 

before May 26, 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–2007–1202. 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I 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–2007–1202 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 May 26, 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–2007–1202, 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. Petition for Tolerance 

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 a 

pesticide petition (PP 7E7300) by the 

Interregional Research Project Number 4 

(IR-4), 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.343 be 

amended by establishing tolerances 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 food 

commodities beet, garden, roots at 0.6 

ppm; parsley, leaves at 13 ppm; parsley, 

dried leaves at 60 ppm; coriander, fresh 

at 13 ppm; vegetable, leaves of root and 

tuber, group 2 at 8.0 ppm; pineapple 

(post harvest) at 0.9 ppm; and turnip, 

roots at 0.2 ppm. That notice referenced 

a summary of the petition prepared by 

Syngenta Crop Protection, 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. 

Based upon review of the data 

supporting the petition, EPA has 

corrected commodity definition, 

revised, deleted and/or modified 

tolerances petitioned for as follows: 

• Revised the tolerance level (adjusted 

for 1x application rate) for beet, garden, 

roots from 0.6 to 0.30 ppm and 

established a tolerance for beet, garden, 

tops at 5.5 ppm, 

• Revised the tolerance level for 

parsley, dried from 60 to 35 ppm, 

• Revised the tolerance level for 

pineapple from 0.9 to 4.5 ppm, 

replacing existing pineapple tolerance 

of 0.1 ppm, and establish a tolerance for 

pineapple, process residue at 7.0 ppm, 

• Corrected the commodity name from 

‘‘coriander, fresh’’ to ‘‘cilantro, leaves’’. 


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At this time, the Agency is not making 

a decision on the proposed tolerance for 

vegetable, leaves of root and tuber, 

group 2 at 8.0 ppm, and the proposed 

tolerance for turnip, roots at 0.2 ppm. 

That aspect of the petition remains 

pending. 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 

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 food 

commodities: beet, garden, roots at 0.30 

ppm; beet, garden, tops at 5.5 ppm, 

cilantro, leaves at 13 ppm; parsley, fresh 

at 13 ppm; parsley, dried at 35 ppm; 

pineapple at 4.5 ppm; and pineapple, 

process residue at 7.0 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

Propiconazole has low to moderate 

toxicity in experimental animals by the 

oral, dermal and inhalation routes. It is 

moderately irritating to the eyes, and 

minimally irritating to the skin. It is a 

dermal sensitizer. Propiconazole is 

readily absorbed by the rat skin with 

40% absorption within 10 hours of 

dermal application. 

The primary target organ for 

propiconazole toxicity in animals is the 

liver. Increased liver weights were seen 

in mice after subchronic or chronic oral 

exposures to propiconazole at doses >50 

mg/kg/day. Liver lesions such as 

vacuolation of hepatocytes, ballooned 

liver cells, foci of enlarged hepatocytes, 

hypertrophy and necrosis are 

characteristic of propiconazole toxicity 

in rats and mice. Mice appear to be 

more susceptible to its toxicity than rats. 

Decreased body weight gain in 

experimental animals was seen in 

subchronic, chronic, developmental and 

reproductive studies. Dogs appeared to 

be more sensitive to the localized 

toxicity of propiconazole as manifested 

by stomach irritation at 6 mg/kg/day 

and above. 

In rabbits, developmental toxicity 

occurred at a higher dose than the 

maternal toxic dose, while in rats, 

developmental toxicity occurred at 

lower doses than maternal toxic doses. 

Increased incidences of rudimentary 

ribs occurred in rat and rabbit fetuses. 

Increased cleft palate malformations 

were noted in two studies in rats. In one 

published study in rats developmental 

effects (incomplete ossification of the 

skull, caudal vertebrae and digits, extra 

rib (14th rib) and missing sternebrae, 

malformations of the lung and kidneys) 

were reported at doses that were not 

maternally toxic. 

In the 2–generation reproduction 

study in rats, offspring toxicity occurred 

at a higher dose than the parental toxic 

dose suggesting lower susceptibility of 

the offspring to the toxic doses of 

propiconazole in this study. 

Propiconazole was negative for 

mutagenicity in the in vitro BALB/ C 

3T3 cell transformation assay, bacterial 

reverse mutation assay, Chinese hamster 

bone marrow chromosomal aberration 

assay, unscheduled DNA synthesis 

studies in human fibroblasts and 

primary rat hepatocytes, mitotic gene 

conversion assay and the dominant 

lethal assay in mice. Hepatocellular 

proliferation studies in mice suggest 

that propiconazole induces cell 

proliferation followed by treatmentrelated hypertrophy in a manner similar 

to the known hypertrophic agent 

phenobarbital. 

Propiconazole was carcinogenic to 

CD-1 male mice. Propiconazole was not 

carcinogenic to rats nor to female mice. 

The Agency classified propiconazole as 

Group C - possible human carcinogen 

and recommended that for the purpose 

of risk characterization the reference 

dose (RfD) approach be used for 

quantification of human risk. 

Propiconazole is not genotoxic and this 

fact, together with special mechanistic 

studies indicate that propiconazole is a 

threshold carcinogen. Propiconazole 

produced liver tumors in male mice 

only at a high dose that was toxic to the 

liver. At doses below the RfD liver 

toxicity is not expected, and therefore 

tumors are also not expected. 

EPA has evaluated the available 

toxicity data and considered their 

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 adverse 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 http:// 

www.regulations.gov in document: 

‘‘Propiconazole FQPA Human Health 

Risk Assessment for the Section 3 

Registrations on Garden Beets, Turnips, 

Parsley, Cilantro and Pineapple.’’ 

Petition No. 7E7300, dated September 

30, 2008, page 21 in Docket ID number: 

EPA–HQ–OPP–2007–1202–0003. 

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 the NOAEL in 

the toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, 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 


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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 

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

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for propiconazole used for 

human risk assessment can be found at 

http://www.regulations.gov in 

document: ‘‘Propiconazole FQPA 

Human Health Risk Assessment for the 

Section 3 Registrations on Garden Beets, 

Turnips, Parsley, Cilantro and 

Pineapple.’’ Petition No. 7E7300, dated 

September 30, 2008, page 21 in docket 

ID number EPA–HQ–OPP–2007–1202– 

0003. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to propiconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing propiconazole tolerances in (40 

CFR 180.434). EPA assessed 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 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 conducted acute dietary 

analysis for propiconazole using 

tolerance level residues and 100 percent 

crop treated (PCT) for all existing and 

proposed uses. 

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 

conducted chronic dietary analysis for 

propiconazole using tolerance level 

residues and 100 PCT for all existing 

and proposed uses. 

iii. Cancer. As explained in this Unit, 

the chronic RfD is protective of 

propiconazole’s cancer effects. For the 

purpose of assessing cancer risk under 

the chronic RfD, EPA used the same 

exposure estimates as discussed in Unit 

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

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for propiconazole. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for propiconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

propiconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

concentration in Ground Water (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. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model (DEEMFCIDTM). 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 the following uses that could result 

in residential exposures: Turf, 

ornamentals, and antimicrobial uses in 

wood preservation treatments and paint. 

No new residential uses are associated 

with the petitioned-for tolerances. 

However, adults, adolesescents and 

toddlers may be exposed to 

propiconazole from currently registered 

uses. EPA assessed residential exposure 

using the following 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; 

and 

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 


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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 nonvolatile 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. Propiconazole is used on 

many different types of wood including 

playground structures. EPA assessed the 

risk to children playing on 

propiconazole-treated structures using 

screening level assessment. 

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.’’ 

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 their 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. In conazoles, 

however, a variable pattern of 

toxicological responses is found. Some 

include hepatotoxic and 

hepatocarcinogenic in mice. Some 

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 and two triazole conjugates 

(triazolylalanine and triazolylacetic 

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, triazolylalanine, and 

triazolylacetic acid resulting from the 

use of all current and pending uses of 

any triazole-derived fungicide. The risk 

assessment is a 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 http:// 

www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497. Also, see document: 

‘‘Common Triazole Metabolites: 

Updated Aggregate Human Health Risk 

Assessment to Address Tolerance 

Petitions for Metconazole, 

Propiconazole, Prothioconazole, and 

Tetraconazole,’’ dated November 8, 

2008, Docket: EPA–HQ–OPP–2007– 

1202–0006. 

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 Agency concluded that there is low 

concern for pre- and/or postnatal 

toxicity resulting from exposure to 

propiconazole. In the developmental 

toxicity study in rabbits, the EPA 

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, EPA 

determined that neither quantitative nor 

qualitative evidence of increased 

susceptibility of neonates (as compared 

to adults) to pre- and/or postnatal 

exposure to propiconazole was observed 

in this study. In the developmental rat 

study, however, 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). nsidering 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. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

propiconazole is complete except for 

immunotoxicity testing. EPA began 

requiring functional immunotoxicity 

testing of all food and non-food use 

pesticides on December 26, 2007. Since 

this requirement went into effect after 

the tolerance petition was submitted, 


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these studies are not yet available for 

propiconazole. In the absence of specific 

immunotoxicity studies, EPA has 

evaluated the available propiconazole 

toxicity data to determine whether an 

additional database uncertainty factor is 

needed to account for potential 

immunotoxicity. There was no evidence 

of adverse effects on the organs of the 

immune system at the LOAEL in any 

study propiconazole. In addition, 

propiconazole does not belong to a class 

of chemicals (e.g., the organotins, heavy 

metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. Based on the 

considerations in this Unit, EPA does 

not believe that conducting a special 

series 870.7800 immunotoxicity study 

will result in a point of departure less 

than the NOAEL of 10.0 mg/kg/day used 

in calculation the cPAD for 

propiconazole, and therefore, an 

additional database uncertainty factor is 

not needed to account for potential 

immunotoxicity. 

ii. EPA also began requiring acute and 

subchronic neutotoxicity testing of all 

food and non-food use pesticides on 

December 26, 2007. An acute 

neurotoxicity study has been submitted 

to the Agency, but since the requirement 

for neurotoxicity testing went into effect 

after the tolerance petition was 

submitted, the subchronic neurotoxicity 

study is not yet available for 

propiconazole. In the absence of the 

subchronic neurotoxicity study, EPA 

has evaluated the available 

propiconazole toxicity data to determine 

whether an additional database 

uncertainty factor is needed to account 

for potential neurotoxicity after repeated 

exposures. With the exception of the 

developmental studies in the rat, there 

were no indications in any of the 

repeated dose studies that 

propiconazole is neurotoxic. In the 

developmental studies in the rat, there 

were some clinical signs of 

neurotoxicity at 300 mg/kg/day but not 

at lower doses. Based on the 

considerations in this Unit, EPA does 

not believe that conducting a series 

870.6200b subchronic neurotoxicity 

study will result in a point of departure 

less than the NOAEL of 10 mg/kg/day 

used in calculation the cPAD for 

propiconazole, and therefore, an 

additional database uncertainty factor is 

not needed to account for potential 

neurotoxicity from repeated exposures. 

There is no indication in the 

developmental and reproduction 

studies, nor in the acute neurotoxicity 

study that a developmental 

neurotoxicity study should be required. 

iii. There is no evidence that 

propiconazole results in increased 

susceptibility in in utero in rabbits in 

the rabbit prenatal developmental study 

or in young rats in the 2–generation 

reproduction study. Although 

quanititative susceptibility of the young 

was observed in the rat developmental 

study, there is low concern for the 

prenatal toxicity seen in this study for 

the reasons described in this Unit. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

Dietary food exposure assessments were 

performed based on 100 PCT and 

tolerance-level residues. The exposure 

databases (dietary food, drinking water, 

and residential) are complete and the 

risk assessment for each potential 

exposure scenario includes all 

metabolites and/or degradates of 

concern and does not underestimate the 

potential risk for infants and children. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to propiconazole in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by propiconazole. 

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. Short-, 

intermediate-, and chronic-term 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. 

Acute and chronic aggregate dietary 

(food and drinking water) exposure and 

risk assessments were conducted for 

parent propiconazole using the Dietary 

Exposure Evaluation Model DEEMFCIDTM, Version 2.03 which use food 

consumption data from the U.S. 

Department of Agriculture’s Continuing 

Surveys of Food Intakes by Individuals 

(CSFII) from 1994–1996 and 1998. This 

dietary assessment is for the parent 

propiconazole only. The common 

metabolites- triazole, triazolylalanine 

(TA), and triazolylacetic acid (TAA) are 

also residues of concern. Since these are 

common metabolites from several 

triazole pesticides, the risk assessment 

for triazoles was assessed separately. 

The updated risk assessment for triazole 

metabolites indicated that adding the 

new uses of propiconazole will not 

result in unacceptable risk to the 

triazole metabolites (see ‘‘Common 

Triazole Metabolites: Updated Aggregate 

Human Health Risk Assessment to 

Address Tolerance Petitions for 

Metconazole, Propiconazole, 

Prothioconazole, and Tetraconazole,’’ 

dated November 8, 2008, ID Docket 

Number: EPA–HQ–OPP–2007–1202– 

0006. 

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 

exposure, the acute dietary exposure 

from food and water to propiconazole 

will occupy 16% of the aPAD for all 

infants <1 year old the population group 

receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to propiconazole 

from food and water will utilize 17% 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 propiconazole is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Propiconazole is currently registered 

for uses that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to propiconazole. 

An aggregated risk to toddlers from 

exposures to residential turf use 

including: 

i. Hand-to-mouth activity, 

ii. Object to mouth activity, 

iii. Soil ingestion, and 

iv. Turf-general high-contact activities 

was evaluated and resulted in an 

aggregate MOE of 170 which is below 

the Agency’s level of concern (MOE of 

100 or less). 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential and antimicrobial exposures 

aggregated result in aggregate combined 

MOE of 160 resulting from all exposure 


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scenarios (oral and dermal). The highest 

incidental oral and dermal exposure 

scenarios are from residential use on 

turf, which were used in the short-term 

aggregate risk assessment. The shortterm aggregate risk does not exceed the 

Agency’s level of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Propiconazole is currently registered 

for uses that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure to propiconazole through food 

and water with intermediate-term 

exposures for propiconazole. 

Using the exposure assumptions 

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

the combined intermediate-term food, 

water, and residential exposures 

aggregated result in aggregate MOEs of 

120 (exposure to Children 1–2 years 

old), which is below the Agency’s level 

of concern (MOE of 100 or less). 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). 

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 the aggregate cancer risk. See Unit 

III.A. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to 

propiconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography (GC) method using 

flame ionization detection (Method AG354) 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; e-mail 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. In addition, both Canada 

and Mexico have established MRLs for 

propiconazole in/on various 

commodities. No Codex, Mexican, or 

Canadian MRLs have been established 

for any crop commodity associated with 

this petition. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of available data 

supporting the petition, EPA revised the 

tolerance levels, added or deleted 

tolerances, or otherwise modified the 

petition as proposed in the notice of 

filing, as follows: 

• Revised the tolerance level for beet, 

garden, roots from 0.6 to 0.30 ppm and 

established a tolerance for beet, garden, 

tops at 5.5 ppm, Adequate field trial 

residue data were submitted for garden 

beets at 1.5 times the proposed 

maximum treatment rate. Adjusting to 

the 1x rate, the Agency is setting a 0.30 

ppm tolerance on garden beet roots and 

a 5.5 ppm tolerance on garden beet tops. 

• Corrected the commodity name from 

‘‘coriander, fresh’’ to ‘‘cilantro, leaves’’ 

based on the Agency’s current crop 

naming guidelines, 

• Revised the tolerance level for 

parsley, dried from 60 to 35 ppm. 

Available processing data show that 

propiconazole residues concentrate in 

parsley, dried (processing factor of 5.5). 

The highest average field trial (HAFT) 

value from field studies is 6.3 ppm. 

Multiplying the processing factor by the 

HAFT value indicates that a tolerance 

level of 35 is needed. 

• Revised the proposed tolerance level 

for pineapple from 0.9 ppm to 4.5 ppm, 

replacing the existing pineapple 

tolerance of 0.1 ppm. The appropriate 

tolerance level for propiconzole in/on 

pineapple was calculated from HAFT 

values in a dataset of eighteen (18) 

samples from pineapple postharvest 

field trials using application rates 

within 25% of the maximum label use 

rate. These data indicate a 

propiconazole residue tolerance level 

for pineapple at 4.5 ppm is appropriate, 

and 

• Established a tolerance for 

pineapple, process residue at 7.0 ppm. 

Propiconazole residues in pineapple 

process residue concentrate with a 

processing factor of 1.7. Multiplying the 

processing factor for pineapple by the 

HAFT value (3.6 ppm) indicates that a 

tolerance level of 7.0 ppm is needed. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of propiconazole, 

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 food 

commodities: Beet, garden, roots at 0.30 

ppm; beet, garden, tops at 5.5 ppm; 

cilantro, leaves at 4.5 ppm; parsley, 

fresh at 13 ppm; parsley, dried at 35 

ppm; pineapple at 4.5 ppm; and 

pineapple, process residue at 7.0 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, 


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1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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: February 27, 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. 

■ 2. Section 180.434 is amended by 

revising the tolerance for pineapple and 

by alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§180.434 Propiconazole; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*****

Beet, garden, roots ................... 0.30 

Beet, garden, tops .................... 5.5 

*****

Cilantro, leaves ......................... 13 

*****

Parsley, fresh leaves ................ 13 

Parsley, dried leaves ................ 35 

*****

Pineapple .................................. 4.5 

Pineapple, process residue ...... 7.0 

* * * * * 

[FR Doc. E9–6273 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0081; FRL–8404–4] 

Thymol; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of thymol (as 

present in thyme oil) in or on food 

commodities when applied/used in/on 

public eating places, dairy processing 

equipment, and/or food processing 

equipment and utensils. Sensible Life 

Products submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of thymol. 

DATES: This regulation is effective 

March 25, 2009. Objections and requests 

for hearings must be received on or 

before May 26, 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–2007–0081. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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: 

Mark Hartman, Antimicrobials Division 

(7510P), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–0734; 

hartman.mark@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 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 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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions. If 

you have any questions regarding the 

applicability of this action to a 

particular entity, consult the person 


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