Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 27261 

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 (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995, 

Public Law 104–113, section 12(d) (15 

U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 3, 2011. 

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 180.649 is amended as 

follows: 

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

■ b. In the table in paragraph (a)(2), 

revise the entries for cattle, liver; cattle, 

meat byproducts, except liver; goat, 

liver; goat, meat byproducts, except 

liver; horse, liver; horse, meat 

byproducts, except liver; sheep, liver; 

and sheep, meat byproducts, except 

liver. 

The revised texts read as follows: 

§ 180.649 Saflufenacil; tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

Almond, hulls ............................ 0 .10 

Cotton, gin byproducts ............. 0 .45 

Cottonseed subgroup 20C ....... 0 .20 

Fruit, citrus, group 10 ............... 0 .03 

Fruit, pome, group 11 ............... 0 .03 

Fruit, stone, group 12 ............... 0 .03 

Grain, aspirated fractions ......... 10 

Grain, cereal, forage, fodder 

and straw group 16 ............... 0 .10 

Grain, cereal, group 15 ............ 0 .03 

Grape ........................................ 0 .03 

Nut, tree, group 14 ................... 0 .03 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C .......................................... 0 .30 

Pea and bean, succulent 

shelled, subgroup 6B ............ 0 .03 

Pea, hay ................................... 17 

Pistachio ................................... 0 .03 

Rapeseed subgroup 20A .......... 0 .45 

Sunflower subgroup 20B .......... 1 .0 

Soybean, hulls .......................... 0 .50 

Soybean, seed .......................... 0 .10 

Vegetable, foliage of legume, 

group 7 (except pea, hay) .... 0 .10 

Vegetable, legume, edible podded, subgroup 6A ................. 0 .03 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, liver ................................ 2 .5 

* * * * * 

Cattle, meat byproducts, except 

liver ........................................ 0 .05 

* * * * * 

Goat, liver ................................. 2 .5 

* * * * * 

Goat, meat byproducts, except 

liver ........................................ 0 .05 

* * * * * 

Horse, liver ............................... 2 .5 

* * * * * 

Horse, meat byproducts, except 

liver ........................................ 0 .05 

* * * * * 

Sheep, liver ............................... 2 .5 

* * * * * 

Sheep, meat byproducts, except liver ................................ 0 .05 

* * * * * 

* * * * * 

[FR Doc. 2011–11553 Filed 5–10–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–1009; FRL–8873–2] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of propiconazole 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project #4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). In 

addition, this action establishes a timelimited tolerance for residues of 

propiconazole in or on avocado, in 

response to the approval of a quarantine 

exemption under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) authorizing use to control 

the disease, laurel wilt (caused by 

Raffaelea lauricola) in the state of 

Florida. This regulation establishes a 

maximum permissible level of residues 

of propiconazole in this food 

commodity. The time-limited tolerance 

expires and is revoked on December 31, 

2013. 

DATES: This regulation is effective May 

11, 2011. Objections and requests for 

hearings must be received on or before 

July 11, 2011, 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–2009–1009. 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.), 


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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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–1009 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 11, 2011. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–1009, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of March 19, 

2010 (75 FR 13277) (FRL–8813–2), 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 9E7659) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.434 be 

amended by establishing tolerances for 

residues of the fungicide 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 

onion, bulb, subgroup 3–07A at 0.2 

parts per million (ppm); onion, green, 

subgroup 3–07B at 9.0 ppm; caneberry 

subgroup 13–07A at 1.0 ppm; bushberry 

subgroup 13–07B at 1.0 ppm; and low 

growing berry subgroup 13–07G, except 

cranberry at 1.3 ppm. The petition also 

proposed to amend the tolerances in 40 

CFR 180.434 by increasing the 

tolerances in or on peppermint, tops 

and spearmint, tops from 3.5 ppm to 10 

ppm; and by removing the tolerances for 

berry group 13 at 1.0 ppm; onion, bulb 

at 0.2 ppm; onion, green at 9.0 ppm and 

strawberry at 1.3 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta, the registrant, 

which is available in the docket, 

http://www.regulations.gov. Comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed in Unit IV.C. 

EPA is also establishing a timelimited tolerance for residues of 

propiconazole in or on avocado at 10 

ppm. This tolerance expires and is 

revoked on December 31, 2013. The 

Agency is establishing this time-limited 

tolerance in response to a quarantine 

exemption request under FIFRA section 

18 on behalf of the Florida Department 

of Agriculture and Consumer Services 

for emergency use of propiconazole to 

control the disease, laurel wilt, in 

avocado. 

According to the applicant, an 

emergency situation exists due to the 

introduction of laurel wilt, a disease 

affecting avocado trees caused by the 

pathogenic fungus Raffaelea lauricola. 

This fungus is vectored by the redbay 

ambrosia beetle, a newly introduced 

species, native to Asia, which has 

moved rapidly toward the avocado 

production area since its initial 

discovery in Georgia in 2002. Avocado 

tree death from laurel wilt has been 

documented and research has 

demonstrated that the redbay ambrosia 

beetle attacks healthy avocado trees 

from all 22 cultivars tested so far. 

Control of the vector, the redbay 

ambrosia beetle, is problematic since 

inoculation of a tree requires only 1 

beetle, the beetle is capable of flight to 

escape insecticide treatments, and the 

two currently registered insecticides 

will not provide the necessary yearround control due to limits in residual 

activity and number of applications 

allowed. Once a tree is infected with the 

disease, there is no cure and the tree 

will die. For these reasons, the applicant 

states that the potential impact of this 

disease on avocado growing and 

production could be devastating. The 

applicant states that the avocado 

producing areas are under severe threat 

from laurel wilt, and control through a 

suitable fungicide, such as the requested 

material, is essential to protecting 


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continued production of avocado in 

Florida as well as protecting other 

susceptible tree species in the U.S. EPA 

has authorized under FIFRA section 18 

the use of propiconazole on avocado in 

Florida. After having reviewed the 

submission, EPA concurs that 

emergency conditions exist for this 

state. 

As part of its assessment of the 

emergency exemption request, EPA 

assessed the potential risks presented by 

the residues of propiconazole in 

avocado, as discussed below. In doing 

so, EPA considered the safety standard 

in section 408(b)(2) of the FFDCA and 

EPA decided that the necessary timelimited tolerance under section 408(l)(6) 

of the FFDCA would be consistent with 

the safety standard and with FIFRA 

section 18. Consistent with the need to 

move quickly on the emergency 

exemption in order to address the 

urgent non-routine situation and to 

ensure that the resulting food is safe and 

lawful, EPA is issuing this time-limited 

tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of the 

FFDCA. Although, this time-limited 

tolerance expires and is revoked on 

December 31, 2013, under section 

408(l)(5) of the FFDCA, residues of the 

pesticide not in excess of the amount 

specified in the tolerance remaining in 

or on avocado after that date will not be 

unlawful provided the pesticide is 

applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

this time-limited tolerance at the time of 

application. EPA will take action to 

revoke this time-limited tolerance 

earlier if any experience with, scientific 

data, or other relevant information on 

this pesticide indicates that the residues 

are not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decision about whether propiconazole 

meets EPA’s registration requirements 

for use on avocado or whether a 

permanent tolerance for this use would 

be appropriate. Under this 

circumstance, EPA does not believe that 

the time-limited tolerance serves as a 

basis for registration of propiconazole 

by a State for special local needs under 

FIFRA section 24(c). Nor does the timelimited tolerance serve as the basis for 

any State other than Florida to use this 

pesticide on this crop under section 18 

of FIFRA without following all 

provisions of EPA’s regulations 

implementing FIFRA section 18 as 

identified in 40 CFR part 166. 

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 propiconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with propiconazole 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. 

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 

greater than 50 milligrams/kilograms/ 

day (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 

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 


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27264 Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 

toxicity is not expected, and therefore 

tumors are also not expected. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by propiconazole as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2009–1009 on 

pages 34–40 in the document titled 

‘‘Revised Propiconazole Human Health 

Risk Assessment for a Section 3 

Registration on Mint, Bulb Vegetables, 

Caneberry Subgroup 13–07A, Bushberry 

Subgroup 13–07B, and Low Growing 

Berry Subgroup 13–07G’’ 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for propiconazole used for 

human risk assessment is shown in the 

following Table: 

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

ASSESSMENT

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–50 years of age) .. NOAEL = 30 milligrams/kilograms/day 

(mg/kg/day).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD =0.3 mg/kg/ 

day.

aPAD = 0.3 mg/kg/day 

DNT Study—Rat. 

LOAEL = 90 mg/kg/day based on increased 

incidence of rudimentary ribs, un-ossified 

sternebrae, as well as increased incidence 

of shortened and absent renal papillae and 

increased cleft palate. 

Acute dietary (General population including infants and children).NOAEL = 30 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.3 mg/ 

kg/day.

aPAD = 0.3 mg/kg/day 

Acute neurotoxicity study Rat. 

LOAEL = 100 mg/kg/day based on clinical 

signs of toxicity (piloerection in one male, 

diarrhea in one female, tip toe gait in 3 females). 

Chronic dietary (All populations) ...................... NOAEL= 10 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.1 mg/ 

kg/day.

cPAD = 0.1 mg/kg/day 

24-month oncogenicity study on CD–1 mice. 

LOAEL = 50 mg/kg/day based on non-neoplastic liver effects (increased liver weight 

in males and increase in liver lesions: 

masses/raised areas/swellings/nodular 

areas mainly). 

Incidental Oral Exposure (Short-Term) and 

Dermal short-term (1 to 30 days).

Oral study ...................

NOAEL = 30 mg/kg/ 

day dermal absorption rate = 40% exposures.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ... Acute Neurotoxicity Study—Rats. 

LOAEL = 100 mg/kg/day based on clinical 

signs of toxicity (piloerection in one male, 

diarrhea in one female, tip toe gait in 3 females). 

Incidental Oral Exposure (Intermediate-Term) 

and Dermal intermediate-term (1 to 6 

months).

Oral study ...................

NOAEL= 10 mg/kg/ 

day dermal absorption rate = 40% for 

dermal exposures.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ... 24 Month Oncogenicity Study—Mice. 

LOAEL = 50 mg/kg/day based on non-neoplastic liver effects (increased liver weight 

in males and increase in liver lesions: 

masses/raised areas/swellings/nodular 

areas mainly). 

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

study.

NOAEL= 30 mg/kg/ 

day (inhalation absorption rate = 

100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ... Acute Neurotoxicity Study—Rats. 

LOAEL = 100 mg/kg/day based on clinical 

signs of toxicity (piloerection in one male, 

diarrhea in one female, tip toe gait in 3 females). 


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

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (Oral, dermal, inhalation) ..................... Classification: Group C, possible human carcinogen, RfD approach for risk characterization. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 

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. 

Such effects were identified for 

propiconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance levels 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 

used tolerance levels and 100 PCT for 

all existing and proposed uses. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to propiconazole. Cancer 

risk was assessed using 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 (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

propiconazole for acute exposures are 

estimated to be 55.78 parts per billion 

(ppb) for surface water and 0.64 ppb for 

ground water, for chronic exposures for 

non-cancer assessments are estimated to 

be 21.61 ppb for surface water and 0.64 

ppb for ground water and for chronic 

exposures for cancer assessments are 

estimated to be 13.24 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. For 

acute dietary risk assessment, the water 

concentration value of 55.8 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 21.6 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Propiconazole is currently registered for 

the following uses that could result in 

residential exposures: Turf, ornamentals 

and in paint. EPA assessed residential 

exposure using the following 

assumptions: Short-term risk to toddlers 

was assessed for incidental oral and 

dermal exposure. The highest incidental 

oral and dermal exposure scenarios are 

expected from residential use on turf. 

Short-term risk to adults was assessed 

for dermal and inhalation residential 

handler exposure as well as dermal 

exposure for residential postapplication. Adult handlers have some 

inhalation exposure however, based on 

the low vapor pressure of 

propiconazole, negligible post 

application inhalation exposure is 

anticipated to occur. The highest post 

application exposure from residential 

use on turf was used to assess risk to 

short term aggregate exposures. 

The only residential use scenario that 

will result in potential intermediateterm exposure to propiconazole is 

dermal and incidental oral post 

application exposure to children from 

wood treatment (antimicrobial use). 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

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, 


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27266 Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 

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 

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 Web 

site 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, U.S. 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 

Food Quality Protection Act (FQPA) 

safety factor (SF) 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 and an update to assess 

the addition of the commodities 

included in this action may be found in 

docket ID number EPA–HQ–OPP–2009– 

1009 in the documents titled ‘‘Common 

Triazole Metabolites: Updated Dietary 

(Food + Water) Exposure and Risk 

Assessment to Address The Section 3 

Request for Propiconazole on Mint, Bulb 

Vegetables Subgroups 3–07A and 3– 

07B, Caneberry Subgroup 13–07A, 

Bushberry Subgroup 13–07B, and Low 

growing Berry Subgroup 13–07G’’ and 

‘‘Common Triazole Metabolites: 

Updated Dietary (Food + Water) 

Exposure and Risk Assessment to 

Address The Section 18 Request for 

Propiconazole on Avocado in Florida.’’ 

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 SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There is low concern for prenatal and/ 

or postnatal toxicity resulting from 

exposure to propiconazole. In the 

developmental toxicity study in rats, 

fetal effects observed in this study at a 

dose lower than that evoking maternal 

toxicity are considered to be 

quantitative evidence of increased 

susceptibility of fetuses to in utero 

exposure to propiconazole. In the 

developmental toxicity study in rabbits, 

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 prenatal and/or postnatal 

exposure to propiconazole was observed 

in this study. There is no evidence of 

neuropathology or abnormalities in the 

development of the fetal nervous system 

from the available toxicity studies 

conducted with propiconazole. In the 

rat acute neurotoxicity study, there was 

evidence of mild neurobehavioral 

effects at 300 mg/kg, but no evidence of 

neuropathology from propiconazole 

administration. Since there was 

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 

and concluded that the degree of 

concern for the effects observed in this 

study was low and no residual 

uncertainties were identified, for the 

reasons explained in this Unit. 

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 the 

lack of immunotoxicity and subchronic 

neutotoxicity studies. 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 in any 

propiconazole study. 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 

Harmonized Guideline 870.7800 

immunotoxicity study will result in a 

POD less than the NOAEL of 10.0 mg/ 

kg/day used in calculating the cPAD for 

propiconazole, and therefore, an 

additional database uncertainty factor is 

not needed to account for potential 

immunotoxicity. 

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 

Harmonized Guideline 870.6200b 

subchronic neurotoxicity study will 

result in a POD less than the NOAEL of 

10 mg/kg/day used in calculating 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, or in the acute neurotoxicity 


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Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 27267 

study that a developmental 

neurotoxicity study should be required. 

ii. There is no evidence of 

neuropathology or abnormalities in the 

development of the fetal nervous system 

from the available toxicity studies 

conducted with propiconazole. In the 

rat acute neurotoxicity study, there was 

evidence of mild neurobehavioral 

effects at 300 mg/kg, but no evidence of 

neuropathology from propiconazole 

administration. 

iii. Although an apparent increased 

quantitative susceptibility was observed 

in fetuses and offspring based on 

minimal toxicity at high doses of 

administration, clear NOAELs and 

LOAELs have been identified for all 

effects of concern, and a clear doseresponse has been well defined. Since 

this increased susceptibility is occurring 

at high doses and a clear dose response 

has been well defined for all effects of 

concern, residual uncertainties or 

concerns for prenatal and/or postnatal 

toxicity are minimal. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. 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 dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute population 

adjusted dose (aPAD) and chronic PAD 

(cPAD). For linear cancer risks, EPA 

calculates the lifetime probability of 

acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

propiconazole will occupy 17% of the 

aPAD for children 1 to 2 years 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 18% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

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. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 160 for toddlers (children 1 to 

2 years old), between 120 and 4,400 for 

adults from handler activities, and 330 

for adults from post-application 

activities. Because EPA’s level of 

concern for propiconazole is a MOE of 

100 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

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 through food and water with 

intermediate-term residential exposures 

to 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 result 

in an aggregate MOE of 120 for toddlers 

(children 1 to 2 years old). Because 

EPA’s level of concern for 

propiconazole is a MOE of 100 or below, 

these MOEs are not of concern. 

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. 

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 

(HPLC/UV Method AG–671A) 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 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for propiconazole for any of the subject 

crops in this document. 

C. Response to Comments 

A comment was received from a 

private citizen objecting to 

establishment of tolerances stating that 

residues should be zero. The Agency 

has received similar comments from this 

commenter on numerous previous 

occasions. Refer to Federal Register 70 

FR 37686, June 30, 2005; 70 FR 1354, 

January 7, 2005; 69 FR 63096, October 

29, 2004 for the Agency’s response to 

these objections. 

V. Conclusion 

Therefore, tolerances are established 

for 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 as set forth in the 

regulatory text. In addition this 

regulation establishes a time-limited 

tolerance for residues of propiconazole 

in or on avocado at 10 ppm. 


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27268 Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations 

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, 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 (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 (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995, 

Public Law 104–113, section 12(d) (15 

U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 2, 2011. 

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. Amend § 180.434 as follows: 

■ i. In the table to paragraph (a), remove 

the entries for ‘‘berry group 13,’’ ‘‘onion, 

bulb,’’ ‘‘onion, green,’’ and ‘‘strawberry’’; 

revise the entries for ‘‘peppermint, tops’’ 

and ‘‘spearmint, tops’’, and add 

alphabetically entries for ‘‘bushberry, 

subgroup 13–07B,’’ ‘‘caneberry, 

subgroup 13–07A,’’ ‘‘low growing berry 

subgroup 13–07G, except cranberry,’’ 

‘‘onion, bulb subgroup 3–07A,’’ and 

‘‘onion, green, subgroup 3–07B.’’ 

■ ii. In the table to paragraph (b) add 

alphabetically and entry for ‘‘avocado.’’ 

The added and revised text reads as 

follows: 

§ 180.434 Propiconazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Bushberry, subgroup 13–07B ... 1 .0 

Caneberry, subgroup 13–07A .. 1 .0 

* * * * * 

Low growing berry subgroup 

13–07G, except cranberry .... 1 .3 

* * * * * 

Onion, bulb subgroup 3–07A ... 0 .2 

Onion, green, subgroup 3–07B 9 .0 

* * * * * 

Peppermint, tops ...................... 10 .0 

* * * * * 

Spearmint, tops ........................ 10 .0 

* * * * * 

(b) * * * 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Avocado ........ 10 12/31/13 

* * * * * 

* * * * * 

[FR Doc. 2011–11564 Filed 5–10–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0938; FRL–8872–6] 

Glyphosate; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation increases the 

established tolerance for residues of 

glyphosate in or on corn, field, forage. 

Monsanto Company requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

11, 2011. Objections and requests for 

hearings must be received on or before 

July 11, 2011, 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– 


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