Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Rules and Regulations 27419

2-[1-(ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the following raw agricultural

commodities:

Commodity Parts per

million

Endive ....................................... 2.0

[FR Doc. 95–12744 Filed 5–23–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 2F4154/R2136; FRL–4955–3]

RIN 2070–AB78

Fenbuconazole; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of the fungicide fenbuconazole,

alpha-[2-(4-chlorophenyl)ethyl]-alphaphenyl-3-(1H-1,2,4-triazole)-1-

propanenitrile, and its metabolites cis-5-

(4-chlorophenyl)dihydro-3-phenyl-3-

(1H-1,2,4-triazole-1-ylmethyl)-2-3Hfuranone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3Hfuranone, expressed as fenbuconazole,

in or on the raw agricultural commodity

bananas (whole fruit) at 0.3 ppm of

which not more than 0.05 ppm is

contained in the banana pulp. Rohm &

Haas Co. submitted petitions for this

regulation to establish a maximum

permissible level for residues of the

fungicide.

EFFECTIVE DATE: This regulation

becomes effective May 24, 1995..

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 2F4154/

R2136], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251. A copy of any

objections and hearing request filed

with the Hearing Clerk should be

identified by the document control

number and submitted to: Public

Response and Program Resources

Branch, Field Operations Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20450. In

person, bring copy of objections and

hearing request to: Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 2F4154/R2136].

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: James M. Stone, Acting Product

Manager (PM) 22, Registration Division,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location and telephone number:

Rm. 229, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, (703)- 305-

5540; e-mail:

stone.james@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of December 30, 1992

(57 FR 62334), which announced that

Rohm & Haas, Agricultural Chemicals,

Independence Mall West, Philadelphia,

PA 19105, had submitted a pesticide

petition (PP) 2F4154, to EPA requesting

that the Administrator, pursuant to

section 408(d) of the Federal Food, Drug

and Cosmetic Act (FFDCA), 21 U.S.C.

346a(d), amend 40 CFR part 180 by

establishing a regulation to permit

residues of fenbuconazole, alpha-[2-(4-

chlorophenyl)ethyl]-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile, and

its metabolites [5-(4-chlorophenyl)-

dihydro-3-phenyl-3-(methyl-1H-1,2,4-

triazole-1-yl)-2-3H-furanone] in or on

bananas (pulp) at 0.05 part per million

(ppm) and bananas (peel) at 0.3 ppm.

Subsequently, on June 29, 1994 (59 FR

33503), EPA announced that Rohm &

Haas had amended the petition to

propose amending 40 CFR part 180 by

establishing a regulation to permit

residues of fenbuconazole, alpha-(2-(4-

chlorophenyl)ethyl)-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile, and

its metabolites cis-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-4-ylmethyl)-2-3Hfuranone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3H-furanone

in or on bananas (whole fruit) at 0.3

ppm of which not more than 0.05 ppm

is contained in banana pulp.

There were no comments or requests

for referral to an advisory committee

received in response to these notices of

filing.

The scientific data submitted in the

petitions and all other relevant material

have been evaluated. The toxicology

data considered in support of the

tolerances include:

1. A rat acute oral study with an LD50

greater than 2 grams (g)/kilogram (kg).

2. A 13-week rat feeding study with

a no-observed-effect level (NOEL) of 20

ppm (1.3 milligrams(mg)/kg/day males

and 1.5 mg/kg/day females) and a

lowest-observed-effect level (LOEL) of

80 ppm (5.1 mg/kg/day males and 6.3

mg/kg/day females) based on

hepatotoxicity.

3. A 3-month mouse feeding study

with a NOEL of 20 ppm (3.8 mg/kg/day

males and 5.7 mg/kg/day females) and

a LOEL of 60 ppm (11.1 mg/kg/day

males and 17.6 mg/kg/day females)

based on hepatotoxicity.

4. A 3-month dog feeding study with

a NOEL of 100 ppm (3.3 mg/kg/day

males and 3.5 mg/kg/day females) and

LOEL of 400 ppm (13.3 mg/kg/day

males and 14.0 mg/kg/day females),

based hepatocellular hypertrophy.

5. A 21-day rat dermal study with a

NOEL greater than 1,000 mg/kg/day

(limit dose).

6. A 78-week dietary carcinogenicity

study in mice with a NOEL of 1.43 mg/

kg/day and a LOEL of 28.6 mg/kg/day

(males) and 92.9 mg/kg/day (females)

based on hepatocellular enlargement

and a greater incidence and severity of

hepatocellular vacuolation. There was

evidence of carcinogenicity based on the

occurrence of increased trend for

malignant liver tumors in males and an

increase in benign and malignant liver

tumors in females. The carcinogenic

effects observed are discussed below.

7. A 24-month rat chronic feeding/

carcinogenicity study with a NOEL of 80

ppm (3.03 mg/kg/day for males and 4.02

mg/kg/day for females) for systemic

effects and an LEL of 800 ppm (30.62

mg/kg/day for males and 43.07 mg/kg/

day for females) based on decreased in

body weights in females, and increased

liver weighs in females and males along

with hepatocellular enlargement and
27420 Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Rules and Regulations

vacuolization. There was also an

increase in thyroid weights with slight

increases in thyroid focal cystic

hyperplasia and follicular cell neoplasia

in both sexes. A LOEL was not

established for males. There was

evidence of carcinogenicity based on the

increased occurrence of thyroid

follicular cell benign and malignant

tumors in males. The carcinogenic

effects observed are discussed further

below.

8. A 24-month male rat chronic

feeding/carcinogenicity study with a

NOEL of less than 800 ppm (30.41 mg/

kg/day) and a LOEL is 800 ppm (30.41

mg/kg/day) based on increased liver

with centrilobular to midzonal

hepatocellular enlargement and

vacuolization, decreased body weight

gain, and increased thyroid weights.

There was evidence of carcinogenicity

based on the increased occurrence of

thyroid follicular cell benign and

malignant tumors. The carcinogenic

effects observed are discussed further

below.

9. A 1-year dog chronic feeding study

with a NOEL of 150 ppm (3.75 mg/kg/

day) and the LOEL, based on decreases

in body weight gain and increased liver

weight, of 1,200 ppm (30 mg/kg/day).

10. A two generation reproduction

study in rats with a parental NOEL of 4

mg/kg/day (80 ppm) and a LOEL of 40

mg/kg/day (800 ppm), based on

decreased body weight, decreased food

consumption, increased number of

dams not delivering viable or delivering

nonviable offspring, and increases in

adrenal and thyroid weights. The

reproductive NOEL is greater than 40

mg/kg/day (800 ppm) [(highest dose

tested (HDT)].

11. A developmental toxicity study in

rabbits with a maternal NOEL of 10 mg/

kg/day, and a developmental NOEL of

30 mg/kg/day, and a maternal LOEL of

30 mg/kg/day due to only 1/19 (5%) of

the pregnant does producing a viable

fetus, and no developmental LOEL

(greater than 30 mg/kg/day).

12. A developmental toxicity study in

rats with a maternal NOEL and

developmental NOEL of 30 mg/kg/day

and a LEL of 75 mg/kg/day due to

decrease in maternal body weight

compared to controls and increase in

early and late resorption with a decrease

in number of live fetuses per dam.

13. No evidence of gene mutation was

observed in a test for induction of gene

mutation at the HGPRT locus in Chinese

hamster ovary cells. No increase in the

number of cells with aberrations or

observations per cell were noted in an

in vivo cytogenetics assay using bone

marrow from treated rats. No increase in

unscheduled DNA synthesis in rat

primary hepatocyte study was observed.

14. A rat metabolism study showed

that radiolabeled fenbuconazole is

rapidly absorbed, distributed, and

excreted following oral administration

in rats. Biliary excretion data indicated

that systemic absorption of

fenbuconazole was high for all dosing

groups. The feces was the major route of

excretion. Tissue distribution and

bioaccumulation of fenbuconazole

appeared to be minimal.

The Health Effects Division

Carcinogenicity Peer Review Committee

has concluded that the available data

provide limited evidence of the

carcinogenicity of fenbuconazole in

mice and rats and has classified

fenbuconazole as a Group C (possible

human carcinogen with limited

evidence of carcinogenicity in animals)

in accordance with Agency guidelines,

published in the Federal Register in

1986 (51 FR 33992; Sept. 24, 1986) and

recommended that for the purpose of

risk characterization a low-dose

extrapolation model should be applied

to the experimental animal tumor data

for quantification for human risk (Q1*).

This decision was based on the

induction of thyroid follicular cell

adenomas and/or combined adenomascarcinomas in male rats in two studies,

both by pairwise comparison with

controls and by trend analysis. The

studies were combined for the purpose

of deriving the Q1*. The Q1* for

fenbuconazole based on a recalculation

with a 3/4’s power safety factor is 1.06

X 10-2 (mg/kg/day)-1 in human

equivalents.

Based on (1) the established pecan

and stone fruit group (except plums and

prunes) tolerances, (2) the limitation of

production of the only fenbuconazole

product registered under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) for use on stone fruit to

28,500 pounds of active ingredient per

year (calculated to be equivalent to

treating 12.8% of the total U.S acreage

of apricots, cherries, nectarines, and

peaches per year), and (3) the proposed

banana tolerances, the upper-bound

limit of the dietary carcinogenic risk is

calculated in the range of 1 incidence in

1 million (9 X 10-7).

Processing studies for bananas are not

required. Therefore, food/feed additive

tolerances are not needed in

conjunction with these uses.

Using the NOEL of 3.0 mg/kg/day

from the most sensitive species in the

rat chronic feeding study with a 100-

fold safety factor, the Reference Dose

(RfD) for systemic effects is 0.03 mg/kg/

day. The theoretical maximum residue

contribution (TMRC) from the

established and proposed tolerances is

0.000616 mg/kg/day and utilizes 2

percent of the RfD for the overall U.S.

population. For exposure of the most

highly exposed subgroups in the

population, non-nursing infants (less

than 1-year old), the TMRC is 0.00522

mg/kg/day and utilizes 17 percent of the

RfD.

The metabolism of fenbuconazole in

plants is adequately understood. Due to

the following chemistry data gap,

magnitude of the residue: Crop field

trials with unbagged bananas (two in

Hawaii and two in Puerto Rico) [GLN

171-4], EPA believes it is inappropriate

to establish permanent tolerances for the

uses of fenbuconazole at this time.

However, based on trials with bagged

bananas and one side-by-side trial with

bagged and unbagged bananas, EPA

believes that the existing data support

time-limited tolerances to December 31,

1998.

The nature of the residue in plants is

adequately understood for the purposes

of these time-limited tolerances. An

analytical method, gas-liquid

chromatography with a thermionicspecific detector with nitrogen

selectivity, is available for enforcement

purposes. The enforcement

methodology has been submitted to the

Food and Drug Administration for

publication in the Pesticide Analytical

Manual, Vol. II (PAM II). Because of the

long lead time for publication of the

method in PAM II, the analytical

methodology is being made available in

the interim to anyone interested in

pesticide enforcement when requested

from: Calvin Furlow, Public Response

and Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Rm. 1132, CM

#2, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202, (703)-305-5232.

There is no reasonable expectation

that secondary residues will occur in

milk, eggs, or meat of livestock and

poultry since there are no livestock feed

items associated with this action. The

pesticide is considered useful for the

purpose for which the tolerance is

sought. Based on the information and

data considered, the Agency has

determined that the time-limited

tolerance established by amending 40

CFR part 180 will protect the public

health. Therefore, the tolerances are

established as set forth below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

and/or request a hearing with the
Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Rules and Regulations 27421

Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fees provided by 40

CFR 180.33(i). If a hearing is requested,

the objections must include a statement

of the factual issue(s) on which a

hearing is requested, and the requestor’s

contentions on each such issue, and a

summary of the evidence relied upon by

the objection (40 CFR 178.27). A request

for a hearing will be granted if the

Administrator determines that the

material submitted shows the following:

there is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

A record has been established for this

rulemaking under docket number [PP

2F4154/R2136] (including objections

and hearing requests submitted

electronically as described below). A

public version of this record, including

printed, paper versions of electronic

comments, which does not include any

information claimed as CBI, is available

for inspection from 8 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Rm. 1132, Public Response and Program

Resources Branch, Field Operations

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Written objections and hearing

requests, identified by the document

control number [PP 2F4154/R2136],

may be submitted to the Hearing Clerk

(1900), Environmental Protection

Agency, Rm. 3708, 401 M St., SW.,

Washington, DC 20460.

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk can be sent directly to EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk must be submitted as an ASCII file

avoiding the use of special characters

and any form of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any objections and hearing

requests received electronically into

printed, paper form as they are received

and will place the paper copies in the

official rulemaking record which will

also include all objections and hearing

requests submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to all the requirements of the

Executive Order (i.e., Regulatory Impact

Analysis, review by the Office of

Management and Budget (OMB)). Under

section 3(f), the order defines

‘‘significant’’ as those actions likely to

lead to a rule (1) having an annual effect

on the economy of $100 million or

more, or adversely and materially

affecting a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local or tribal governments or

communities (also known as

‘‘economically significant’’); (2) creating

serious inconsistency or otherwise

interfering with an action taken or

planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

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 10, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

b. In § 180.480, by amending

paragraph (a) in the table therein by

adding and alphabetically inserting the

raw agricultural commodity bananas, to

read as follows:

§ 180.480 Fenbuconazole; tolerances for

residues.

(a) * * *

Commodity Parts per million

Bananas (whole fruit) 0.3 (of which not

more than 0.05

ppm is contained in

the banana pulp).

* * * * *

* * * * *

[FR Doc. 95–12743 Filed 5–23–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4E4359/R2127; FRL–4936–3]

RIN 2070–AB78

Paraquat; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes

tolerances for residues of the desiccant,

defoliant, and herbicide paraquat in or

on the raw agricultural commodities

lentils, lentil forage, and lentil hay. The

Interregional Research Project No. 4 (IR4) requested this regulation to establish

the maximum permissible levels for

residues of paraquat in or on the

commodities, and EPA has found that

paraquat is useful and safe for the

requested tolerances.

EFFECTIVE DATE: This regulation

becomes effective May 24, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 4E4359/

R2127], may be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees