Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63945

tribal governments in the aggregate, or

to the private sector, will not be or

exceed $100 million. Thus, today’s rule

is not subject to the requirements of

Section 202 and 205 of the Act. Because

the rule contains no regulatory

requirements that might significantly or

uniquely affect small governments, it

also is not subject to the requirements

of Section 203 of the Act. Small

governments are subject to the same

requirements as other entities whose

duties result from this rule and they

have the same ability as other entities to

retain and pump out treated sewage or

discharge outside of the designated

zones.

List of Subjects in 40 CFR Part 140

Environmental protection, Sewage

disposal, Vessels.

Dated: December 5, 1995.

Jeanne M. Fox,

Regional Administrator.

For the reasons set out in the

preamble, 40 CFR Part 140 is amended

as follows:

PART 140—[AMENDED]

1. The authority citation for Part 140

continues to read as follows:

Authority: Sec. 312, as added Oct. 18,

1972, Pub. L. 92–500, Sec. 2, 86 Stat. 871.

Interpret or apply Sec. 312(b)(1), 33 U.S.C.

1322(b)(1).

2. In § 140.4 paragraph (b)(1) is

amended by designating the

undesignated text after the colon as

paragraph (b)(1)(i) and by adding

paragraph (b)(1)(ii) to read as follows:

§ 140.4 Complete prohibition.

* * * * *

(b) * * *

(1) * * *

(ii) Two portions of the Hudson River

in New York State, the first is bounded

by an east-west line through the most

northern confluence of the Mohawk

River which will be designated by the

Troy-Waterford Bridge (126th Street

Bridge) on the south and Lock 2 on the

north, and the second of which is

bounded on the north by the southern

end of Houghtaling Island and on the

south by a line between the Village of

Roseton on the western shore and Low

Point on the eastern shore in the

vicinity of Chelsea, as described in

Items 2 and 3 of 6 NYCRR Part 858.4.

[FR Doc. 95–30406 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP 3F4222/R2192; FRL–4989–4]

RIN 2070–AB78

Tebuconazole; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes

tolerances for residues of the fungicide

tebuconazole (alpha-[2-(4-

chlorophenyl)ethyl]-alpha-(1,1-

dimethylethyl)-1H-1,2,4-triazole-1-

ethanol) in or on the raw agricultural

commodities cherries at 4.0 parts per

million (ppm) and peaches (includes

nectarines) at 1.0 ppm. Miles, Inc. (now

Bayer Corp.) submitted a petition

pursuant to the Federal Food, Drug and

Cosmetic Act (FFDCA) for the regulation

to establish these maximum permissible

levels for residues of the fungicide.

EFFECTIVE DATE: The effective date of

this rule is November 22, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 3F4222/

R2192], 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, OPP

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

Pittsburgh, PA 15251. A copy of any

objections and hearing requests 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

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

person, bring copy of objections and

hearing requests to Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

A copy of any 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 document number [PP 3F4222/

R2192]. No Confidential Business

Information (CBI) should be submitted

through e-mail. 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: Connie B. Welch, Product

Manager (PM) 21, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 227, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA 22202, (703)-

305-6226; e-mail:

welch.connie@.epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of August 17, 1995 (60

FR 42885), which announced that Miles,

Inc., Agricultural Division (formerly

Mobay Corp., Agricultural Chemicals

Division, now Bayer Corp.), P.O. Box

4913, Kansas City, MO 64120-0013, had

submitted pesticide petition (PP)

3F4222 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), establish a tolerance for

residues of the fungicide tebuconazole

(alpha-(4-chlorophenyl)ethyl]-alpha-

(1,1-dimethylethyl)-1H-1,2,4-triazole-1-

ethanol) in or on the raw agricultural

commodities cherries at 4.0 parts per

million (ppm) and peaches (includes

nectarines per 40 CFR 180.1(h)) at 1.0

ppm.

There were no comments received in

response to the notice of filing. The

scientific data submitted in the petition

and other relevant material have been

evaluated. The toxicological data

considered in support of the tolerance

include:

1. A 90-day rat feeding study with a

no-observed-effect level (NOEL) of 34.8

milligrams per kilogram of body weight

per day (mg/kg bw/day) (400 ppm) and

a lowest-effect-level (LEL) of 171.7 mg/

kg bw/day (1,600 ppm) in males, based

on decreased body weight gains and

histological changes in the adrenals. For

females, the NOEL was 10.8 mg/kg bw/

day (100 ppm) and the LEL was 46.5

mg/kg bw/day (400 ppm) based on

decreased body weights, decreased body

weight gains, and histological changes

in the adrenals.

2. A 90-day dog-feeding study with a

NOEL of 200 ppm (73.7 mg/kg bw/day

in males and 73.4 mg/kg bw/day in

females) and an LEL of 1,000 ppm

(368.3 mg/kg bw/day in males and 351.8

mg/kg bw/day in females). The LEL was
63946 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

based on decreases in mean body

weights, body weight gains, and food

consumption, and an increase in liver

N-demethylase activity.

3. A 1-year dog feeding study with a

NOEL of 1 mg/kg bw/day (40 ppm) and

an LEL of 5 mg/kg bw/day (200 ppm),

based on lenticular and corneal opacity

and hepatic toxicity in either sex (the

current Reference Dose was determined

based on this study). A subsequent 1-

year dog feeding study, using lower

doses to further define the NOEL for

tebuconazole, defines a systemic LOEL

of 150 ppm (based on adrenal effects in

both sexes) and a systemic NOEL of 100

ppm.

4. A 2-year rat chronic feeding study

defined, a NOEL of 7.4 mg/kg bw/day

(100 ppm), and an LEL of 22.8 mg/kg

bw/day (300 ppm) based on body

weight depression, decreased

hemoglobin, hematocrit, MCV and

MCHC, and increased liver microsomal

enzymes in females. Tebuconazole was

not oncogenic at the dose levels tested

(0, 100, 300, and 1,000 ppm).

5. A rat oral developmental toxicity

study with a maternal NOEL of 30 mg/

kg bw/day and an LEL of 60 mg/kg bw/

day based on elevation of absolute and

relative liver weights. For

developmental toxicity, a NOEL of 30

mg/kg bw/day and an LEL of 60 mg/kg

bw/day was determined, based on

delayed ossification of thoracic, cervical

and sacral vertebrae, sternum, fore and

hind limbs and increase in

supernumerary ribs.

6. A rabbit oral developmental

toxicity study with a maternal NOEL of

30 mg/kg bw/day and an LEL of 100 mg/

kg bw/day based on depression of body

weight gains and food consumption. A

developmental NOEL of 30 mg/kg bw/

day and an LEL of 100 mg/kg bw/day

were based on increased postimplantation losses, from both early and

late resorptions and frank

malformations in eight fetuses of five

litters.

7. A mouse oral developmental

toxicity study with a maternal NOEL of

10 mg/kg bw/day and an LEL of 20 mg/

kg bw/day based on a supplementary

study indicating reduction in hematocrit

and histological changes in liver. A

developmental NOEL of 10 mg/kg bw/

day and an LEL of 30 mg/kg bw/day

based on dose-dependent increases in

runts/dam at 30 and 100 mg/kg bw/day.

8. A mouse dermal developmental

toxicity study with a maternal NOEL of

30 mg/kg bw/day and an LEL of 60 mg/

kg bw/day based on a supplementary

study indicating increased liver

microsomal enzymes and histological

changes in liver. The NOEL for

developmental toxicity in the dermal

study in the mouse is 1,000 mg/kg bw/

day, the highest dose tested (HDT).

9. A two-generation rat reproduction

study with a dietary maternal NOEL of

15 mg/kg bw/day (300 ppm) and an LEL

of 50 mg/kg bw/day (1,000 ppm) based

on depressed body weights, increased

spleen hemosiderosis, and decreased

liver and kidney weights. A

reproductive NOEL of 15 mg/kg bw/day

(300 ppm) and an LEL of 50 mg/kg bw/

day (1,000 ppm) were based on neonatal

birth weight depression.

10. An Ames mutagenesis study in

Salmonella that showed no

mutagenicity with or without metabolic

activation.

11. A micronucleus mutagenesis assay

study in mice that showed no

genotoxicity.

12. A sister chromatid exchange

mutagenesis study using CHO cells that

was negative at dose levels 4 to 30 ug/

mL without activation or 15 to 120 ug/

mL with activation.

13. An unscheduled DNA synthesis

(UDS) study that was negative for UDS

in rat hepatocytes.

Additionally, a mouse oncogenicity

study at dietary levels of 0, 20, 60, and

80 ppm for 21 months did not reveal

any oncogenic effect for tebuconazole at

any dose tested. Because the maximumtolerated-dose (MTD) was not reached

in this study, the study was classified as

supplementary. A followup mouse

study at higher doses (0, 500, and 1,500

ppm in the diet), with an MTD at 500

ppm, revealed statistically significant

incidences of hepatocellular adenomas

and carcinomas in males and

carcinomas in females. The initial and

followup studies, together with

supplementary data submitted by Miles,

Inc., were classified as core minimum.

The Office of Pesticide Programs’

Health Effects Division’s

Carcinogenicity Peer Review Committee

(CPRC) has classified tebuconazole as a

Group C carcinogen (possible human

carcinogen). This classification is based

on the Agency’s ‘‘Guidelines for

Carcinogen Risk Assessment’’ published

in the Federal Register of September 24,

1986 (51 FR 33992). The Agency has

chosen to use the reference dose

calculations to estimate human dietary

risk from tebuconazole residues. The

decision supporting classification of

tebuconazole as a possible carcinogen

(Group C) rather than a probable

carcinogen (Group B) was primarily

based on the statistically significant

increase in the incidence of

hepatocellular adenomas, carcinomas,

and combined adenomas/carcinomas in

both sexes of NMRI mice both by

positive trend and pairwise comparison

at the HDT, and the structural

correlation with at least six other related

triazole pesticides that produce liver

tumors.

The Reference Dose (RfD) is

established at 0.01 mg/kg of body

weight (bwt)/day, based on a noobserved-effect level (NOEL) of 1.00 mg/

kg bwt/day and an uncertainty factor of

100. The NOEL is based on a 1-year dogfeeding study that demonstrated

lenticular and corneal opacity and

hepatic toxicity as an endpoint effect. A

chronic exposure analysis was

performed using tolerance level residues

and 100 percent crop-treated

information to estimate the Theoretical

Maximum Residue Contribution

(TMRC) for the general population and

22 subgroups.

The Theoretical Maximum Residue

Contribution (TMRC) from the

published uses is estimated at 0.000008

mg/kg bwt/day and utilizes 0.075% of

the RfD for the general population of the

lower 48 States. The proposed use on

peaches, cherries, and necatrines

contributes 0.000377 mg/kg bwt/day

(3.8% of the RfD) which raises the

TMRC to 0.000385 mg/kg bwt/day or

3.9% of the RfD.

The TMRC for the most highly

exposed subgroup, nonnursing infants

(less than 1-year old) is 0.000003 mg/kg

bwt/day which represents 0.03% of the

RfD. The proposed use on peaches,

cherries, and nectarines for nonnursing

infants (less than 1-year old) raises the

TMRC to 0.002525 or 25.3% of the RfD.

The nature of the residue in cherries,

peaches, and nectarines is adequately

understood. An adequate analytical

method using gas chromatography is

available for enforcement purposes.

The enforcement methodology has

been submitted to the Food and Drug

Administration for publication in the

Pesticide Analytical Manual, Volume 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.
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63947

There are currently no actions

pending against the continued

registration of this chemical.

Based on the information and data

considered, the Agency has determined

that the tolerances 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

to the regulation and may also request

a hearing on those objections.

Objections and hearing requests must be

filed with the 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 fee prescribed 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, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (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 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).

EPA has established a record for this

rulemaking under docket number [PP

3F4222/R2192] (including comments

and data 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, except legal

holidays. The public record is located in

Room 1132 of the 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.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments 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 all comments 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

comments 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, EPA

must judge whether a rule is ‘‘major’’

and therefore requires a Regulatory

Impact Analysis. This rule was

submitted to the Office of Management

and Budget (OMB) for review as

required by Executive Order 12866.

Under the Regulatory Flexibility Act

(5 U.S.C. 605(b)), EPA 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).

OMB has approved the information

collection requirements contained in

this rule under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3501 et seq.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 22, 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.

2. In § 180.474, by amending the table

therein by adding and alphabetically

inserting new entries for cherries and

peaches (includes nectarines), to read as

follows:

§ 180.474 Tebuconazle (alpha-[2-(4-

chlorophenyl)-ethyl]-alpha-(1,1-

dimethylethyl)-1H-1,2,4-triazole); tolerances

for residues.

* * * * *

Commodity Parts per

million

* * * * *

Cherries .................................... 4.0

* * * * *

Peaches (includes necatrines) . 1.0

* * * * *

[FR Doc. 95–29986 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 5E4540/R2186; FRL–4985–7]

RIN 2070–AB78

α-Alkyl(C21-C71)-ω-Hydroxypoly

(Oxyethylene); Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document exempts αalkyl(C21-C71)-ω-hydroxypoly

(oxyethylene) from the requirement of a

tolerance when used at levels not to

exceed 10% as a wetting agent or

granule coating in pesticide

formulations. Petrolite Corp. requested

this regulation under the Federal Food,

Drug and Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation

becomes effective December 13, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 5E4540/

R2186], may be submitted to: Hearing

Clerk (1900), Environmental Protection

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

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

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

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

person, bring copy of objections and

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