Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Proposed Rules 18533

may be delivered to Room 1313 at the

same address between 8:00 a.m. and

3:00 p.m., Monday through Friday,

except Federal holidays. The telephone

number is (504) 589–2965.

FOR FURTHER INFORMATION CONTACT: Mr.

Phil Johnson, Bridge Administration

Branch, at the address given above,

telephone (504) 589–2965.

SUPPLEMENTARY INFORMATION:

Request for Comments

Interested parties are invited to

participate in the proposed rulemaking

by submitting written views, comments,

or arguments. Persons submitting

comments should include their names

and addresses, identify the bridge and

give reasons for concurrence with or any

recommended change in this proposal.

Persons desiring acknowledgment that

their comments have been received

should enclose a stamped, selfaddressed postcard or envelope.

The Coast Guard plans no public

hearing. Persons may request a public

hearing by writing to the Eighth Coast

Guard District at the address under

ADDRESSES. The request should include

reasons why a hearing would be

beneficial. If it is determined that the

opportunity for oral presentations will

aid this rulemaking, the Coast Guard

will hold a public hearing at a time and

place announced by a later notice in the

Federal Register.

The Commander, Eighth Coast Guard

District, will evaluate all

communications received and

determine a course of final action on

this proposal. The proposed regulation

may be changed in the light of

comments received.

Background and Purpose

The Iberville Parish School Board has

requested the regulation because a new,

staggered starting time has been

implemented for the schools in the

Parish. The extension of the morning

and afternoon closure for the LA 77

bridge will assist school buses in

transporting the students to and from

their classes in a timely manner. The

new proposed regulation would allow

for the free flow of vehicular traffic,

while still serving the reasonable needs

of navigational interests.

Discussion of Proposed Rules

The LA 77 bridge is a pontoon bridge.

Navigational clearances provided by the

bridge are 2.0 feet vertical above mean

high water in the closed to navigation

position and unlimited vertical

clearance in the open to navigation

position. Horizontal clearance is 125.0

feet. Navigation on the waterway

consists of tugs with tows, commercial

fishing vessels, occasional small oil

field work boats and recreational craft.

Data obtained from the Louisiana

Department of Transportation and

Development show that, during a six

month period ending late in August

1995, the number of vessels that passed

the bridge during the proposed

extended half-hour closure (7:30 a.m. to

8:00 a.m., Monday through Friday)

totaled 242. This breaks down to about

1.3 vessels per day during this half-hour

period. Since this count includes

vessels that were waiting because of the

already in effect one and one-half hour

closure, 1.3 vessels are a very minimal

amount of traffic being detained. The

Coast Guard feels that this request for a

one-half hour extension is reasonable.

Regulatory Evaluation

This proposal is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential cost

and benefits under section 6(a)(3) of that

order. It has not been reviewed by the

Office of Management and Budget under

that order. It is not significant under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040; February 26, 1979).

The Coast Guard expects the

economic impact of this proposal to be

so minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

must consider whether this proposal, if

adopted, will have a significant

economic impact on a substantial

number of small entities. ‘‘Small

entities’’ may include (1) small

businesses and not-for-profit

organizations that are independently

owned and operated and are not

dominant in their fields and (2)

governmental jurisdictions with

populations of less than 50,000.

Since the proposed rule also

considers the needs of local commercial

fishing vessels, the economic impact is

expected to be minimal. Therefore, the

Coast Guard certifies under 5 U.S.C.

605(b) that this proposal, if adopted,

will not have a significant economic

impact on a substantial number of small

entities. If, however, you think that your

business or organization qualifies as a

small entity and that this rule will have

a significant economic impact on your

business or organization, please submit

a comment (see ADDRESSES) explaining

why you think it qualifies and in what

way and to what degree this rule will

economically effect it.

Collection of Information

This proposal contains no collectionof-information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.).

Federalism Implications

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612, and it has been determined that

the proposed rulemaking does not have

sufficient federalism implications to

warrant the preparation of a Federalism

Assessment.

Environment

The Coast Guard considered the

environmental impact of this proposal

and concluded that under paragraph

2.B.2. of Commandant Instruction

M16475.1B, this proposal is

categorically excluded from further

environmental documentation. A

‘‘Categorical Exclusion Determination’’

is available in the docket for inspection

or copying where indicated under

ADDRESSES.

List of Subjects in 33 CFR Part 117

Bridges.

For the reasons set out in the

preamble, the Coast Guard proposes to

amend Part 117 of Title 33, Code of

Federal Regulations, as follows:

PART 117—DRAWBRIDGE

OPERATION REGULATIONS

1. The authority citation for Part 117

continues to read as follows:

Authority: 33 U.S.C. 499; 49 CFR 1.46; 33

CFR 1.05–1(g).

2. In section 117.478, paragraph (b) is

revised to read as follows:

§ 117.478 Lower Grand River.

* * * * *

(b) The draw of the LA 77 bridge, mile

47.0 (Alternate Route) at Grosse Tete,

shall open on signal; except that, from

about August 15 to about June 5 (the

school year), the draw need not be

opened from 6 a.m. to 8 a.m. and from

2:30 p.m. to 4:30 p.m., Monday through

Friday except Federal holidays. The

draw shall open on signal at any time

for an emergency aboard a vessel.

* * * * *

Dated: February 14, 1996.

R.C. North,

Rear Admiral, U.S. Coast Guard, Commander,

Eighth Coast Guard District.

[FR Doc. 96–10083 Filed 4–25–96; 8:45 am]

BILLING CODE 4910–14–M
18534 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[PP 5E4434/P–651; FRL–5363–3]

RIN 2070–AB18

Aluminum Tris (O-ethylphosphonate);

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

time-limited tolerance for residues of

the fungicide aluminum tris (Oethylphosphonate) (also referred to in

this document as fosetyl-Al) in or on the

raw agricultural commodity blueberry.

The proposed regulation to establish a

maximum permissible level for residues

of the fungicide was requested in a

petition submitted by the Interregional

Research Project No. 4 (IR-4). The timelimited tolerance for blueberry would

expire on December 31, 1998.

DATES: Comments, identified by the

document control number [PP 5E4434/

P–651], must be received on or before

May 28, 1996.

ADDRESSES: By mail, submit written

comments 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

comments to: Rm. 1132 CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202. Comments and data may also be

submitted to OPP by sending electronic

mail (e-mail) to: oppdocket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comments and data will

also be accepted on disks in

WordPerfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number [PP 5E4434/P–651].

Electronic comments on this proposed

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found in the

‘‘SUPPLEMENTARY INFORMATION’’

section of this document.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’.

CBI should not be submitted through email. Information marked as CBI will

not be disclosed except in accordance

with procedures set forth in 40 CFR part

2. A copy of the comment that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the Virginia

address given above, from 8 a.m. to 4:30

p.m., Monday through Friday, excluding

legal holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt L. Jamerson, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Sixth Floor, Crystal Station #1,

2800 Jefferson Davis Highway,

Arlington, VA 22202, (703) 308-8783; email:jamerson.hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

5E4434 to EPA on behalf of the

Agricultural Experiment Stations of

Maine, Michigan, New Jersey, North

Carolina, and Oregon. This petition

requests that the Administrator,

pursuant to section 408(e) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(e), amend 40 CFR

180.415 by establishing a time-limited

tolerance for residues of the fungicide

fosetyl-Al [aluminum tris (Oethylphosphonate)], in or on the raw

agricultural commodity blueberry at 40

parts per million (ppm). The petitioner

requested that the tolerance expire on

December 31, 1998, to allow IR-4

sufficient time to develop additional

magnitude of residue data in support of

a permanent tolerance for blueberries.

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerance include:

(1) A 2–year feeding study in dogs fed

diets containing 0, 10,000, 20,000, or

40,000 ppm with a no-observed-effect

level (NOEL) of 10,000 ppm (250

milligrams (mg)/kilogram (kg)/day). The

lowest-observed-effect level (LOEL) was

20,000 ppm (500 mg/kg/day) based on a

slight degeneration of the testes.

(2) A 2–year feeding/carcinogenicity

study in rat fed diets containing 0,

2,000, 8,000, or 40,000/30,000 ppm with

a systemic NOEL of 8,000 ppm (400 mg/

kg/day). The 40,000 ppm dose was

reduced to 30,000 ppm after the first

two weeks of the study due to the

occurrence of red urine and staining of

the abdominal fur in male and female

rats dosed at 40,000 ppm. Systemic

effects (urinary tract stone formation

and epithelial irritation) were observed

at the high dose level. The study also

demonstrated a significantly elevated

incidence of urinary bladder tumors

(adenomas and carcinomas combined)

at the highest dose tested. The tumors

were mainly seen in surviving males at

the time of terminal sacrifice.

The registrant submitted additional

information regarding the relationship

between the induction of urinary

bladder tumors and the presence of

urinary bladder stones in rats, which

indicates that the extremely high dose

level (40,0000/30,000 ppm) fed to rats

produces urinary tract toxicity that

precedes and seems to lead to the

carcinogenic response in rats.

(3) A 2–year feeding/carcinogenicity

study in mice fed diets containing 0,

2,500, 10,000, or 20,000/30,000 ppm.

The 20,000 ppm dose was increased to

30,000 ppm during week 19 of the

study. The NOEL for systemic effects is

established at 20,000/30,000 ppm

(3,000/4,500 mg/kg/day) based on

hematological effects. There were no

carcinogenic effects observed under the

conditions of this study.

(4) A three-generation reproduction

study in rats fed diets containing 0,

6,000, 12,000 or 24,000 ppm with a

NOEL for reproductive effects of 6,000

ppm (300 mg/kg/day). The LOEL is

established at 12,000 ppm (600 mg/kg/

day) based on decreased pup litter and

pup weight.

(5) A developmental toxicity study in

rats fed doses of 500, 1,000 or 4,000 mg/

kg/day with a NOEL for developmental

toxicity of 1,000 mg/kg/day based on a

significant reduction in litter and fetal

weight, a slight increase in

malformations, and increased skeletal

variations at the 4,000 mg/kg/day dose

level.

(6) A developmental toxicity study in

rabbits fed doses of 125, 250, or 500 mg/

kg/day with no developmental toxicity

observed under the conditions of the

study.

(7) Fosetyl-Al was tested and found be

negative for mutagenic effects in a

battery of studies designed to detect

gene mutation, chromosomal

aberrations, and other genotoxic effects.

(8) A metabolism study in rats

indicates that fosetyl-Al is hydrolyzed

to ethanol, which is excreted in expired

air as carbon dioxide, and to phosphite,

which is excreted in the urine. In

addition, some of the compound is also

excreted unchanged in the urine.

The Office of Pesticide Programs’,

Health Effects Division, Carcinogenicity

Peer Review Committee (CPRC)
Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Proposed Rules 18535

determined that fosetyl-Al was not

amenable to classification using current

Agency cancer guidelines. Additionally

it was concluded that based on a

mechanistic evaluation of the only

tumor which occurred at exceptionally

high doses (40,000/30,0000 ppm) in the

bladder of male rats and possibly in the

bladder and renal pelvis of female rats,

it appears that humans are not likely to

be exposed to doses of fosetyl-Al that

produce urinary tract toxicity which

precedes and leads to the carcinogenic

response observed in rats. Based on the

available information, the CPRC

concludes that the pesticidal use of

fosetyl-al is unlikely to pose a

carcinogenic hazard to humans. EPA

has, therefore, chosen to use the

Reference Dose (RfD) to quantify dietary

risk to humans.

The Reference Dose (RfD) is

calculated at 3.0 mg/kg of body weight/

day. The RfD is based on a NOEL of 250

mg/kg/day from the 2-year dog feeding

study and an uncertainty factor of 100.

The theoretical maximum residue

contribution (TMRC) from existing

tolerances and the proposed tolerance

for blueberry utilizes 2.3 percent of the

RfD for the U.S. population, while the

TMRC for non-nursing infants utilizes

4.6 percent of the RfD. EPA generally

has no concern for exposures below 100

percent of the RfD.

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

nature of the residue in plants is

adequately understood. An adequate

analytical method, is available for

enforcement purposes. Prior to its

publication in the Pesticide Analytical

Manual, Volume II (PAM II), the

enforcement method is being made

available in the interim to anyone who

is interested in pesticide residue

enforcement from: By mail, 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: Crystal Mall #2, Rm 1128, 1921

Jefferson Davis Hwy., Arlington, VA

22202, telephone: 703–305–5805.

There are presently no actions

pending against the continued

registration of this chemical.

Based on the information and data

considered, the Agency has determined

that the tolerance established by

amending 40 CFR part 180 would

protect the public health. Therefore, it is

proposed that the tolerance be

established as set forth below.

Any person who has registered or

submitted an application for registration

of a pesticide, under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) as amended, which

contains any of the ingredients listed

herein, may request within 30 days after

publication of this notice in the Federal

Register that this rulemaking proposal

be referred to an Advisory Committee in

accordance with section 408(e) of the

FFDCA.

A record has been established for this

rulemaking under docket number [PP

5E4434/P–651] (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, excluding 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 (58 FR

51735, Oct. 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.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

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: April 11, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

Part 180 be 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 § 180.415, by adding a new

paragraph (c), to read as follows:
18536 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Proposed Rules

§ 180.415 Aluminum tris (Oethylphosphonate); tolerances for residues.

* * * * *

(c) Time-limited tolerances are

established for residues of the fungicide

aluminum tris (O-ethylphosphonate) in

or on the following raw agricultural

commodities:

Commodity Parts per

million

Expiration

date

Blueberry ............ 40 Dec. 31,

1998

[FR Doc. 96–10251 Filed 4–25–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 5E4590/P652; FRL–5363–5]

RIN 2070–AB18

Quizalofop Ethyl; Proposed Tolerance

for Residues on Pineapple

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed Rule.

SUMMARY: EPA proposes to establish a

tolerance for the residues of the

herbicide quizalofop-p ethyl ester and

its acid metabolite quizalofop-p and the

S enantiomers of both the ester and the

acid, all expressed as quizalofop-p-ethyl

ester, in or on the raw agricultural

commodity pineapple. The proposed

regulation to establish a maximum

permissible level for residues of the

herbicide was requested in a petition

submitted by the Interregional Research

Project No. 4 (IR-4).

DATES: Comments, identified by the

docket number [PP 5E4590/P652], must

be received on or before May 28, 1996.

ADDRESSES: By mail, submit written

comments 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

comments to: Rm. 1132 CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202. Comments and data may also be

submitted to OPP by sending electronic

mail (e-mail) to: oppdocket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comments and data will

also be accepted on disks in

WordPerfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number [PP 5E4590/P652].

Electronic comments on this proposed

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found in the

‘‘SUPPLEMENTARY INFORMATION’’

section of this document.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the Virginia

address given above, from 8 a.m. to 4:30

p.m., Monday through Friday, excluding

legal holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt L. Jamerson, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St. SW., Washington, DC

20460. Office location and telephone

number: Sixth Floor, Crystal Station #1,

2800 Jefferson Davis Highway,

Arlington, VA 22202, (703) 308–8783, email: jamerson.hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

5E4590 to EPA on behalf of the

Agricultural Experiment Station of

Hawaii. This petition requests that the

Administrator, pursuant to section

408(e) of the Federal Food, Drug, and

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

346a(e), amend 40 CFR 180.441 by

establishing a tolerance for combined

residues of the herbicide quizalofop-p

ethyl ester [ethyl (R)-(2-[4-((6-

chloroquinoxalin-2-yl)oxy)phenoxyl])-

propanoate], and its acid metabolite

quizalofop-p [R-(2-[4-((6-

chloroquinoxalin-2yl)oxy)phenoxy])

propanoic acid], and the S enantiomers

of both the ester and the acid, all

expressed as quizalofop-p-ethyl ester, in

or on the raw agricultural commodity

pineapple at 0.1 part per million (ppm).

IR-4 proposed that use of quizalofop

ethyl on pineapple be limited to Hawaii

based on the geographical

representation of the residue data

submitted. Additional residue data will

be required to expand the area of usage.

Persons seeking geographically broader

registration should contact the Agency’s

Registration Division at the address

provided above.

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerance include:

1. Several acute toxicology studies

placing technical-grade quizalofop ethyl

in Toxicity Category III.

2. An 18–month carcinogenicity study

with CD-1 mice fed diets containing 0,

2, 10, 80 and 320 ppm (equivalent to 0,

0.2, 1.5, 12, and 48 mg/kg/day) with no

carcinogenic effects observed under the

conditions of the study at levels up to

and including 80 ppm. There was an

elevated incidence of hepatocellular

adenomas and carcinomas combined in

CD-1 male mice at the 320 ppm dose

level, which exceeded the maximum

tolerated dose (MTD).

3. A 2–year chronic toxicity/

carcinogenicity study in rats fed diets

containing 0, 25, 100 and 400 ppm

(equivalent to 0, 0.9, 3.7, and 15.5 mg/

kg/day for males and 0, 1.1, 4.6, and

18.6 mg/kg/day for females) with no

carcinogenic effects observed under the

conditions of the study. The noobserved-effect-level (NOEL) for

systemic toxicity is established at 25

ppm (0.9 mg/kg/day) based on red blood

cell destruction in males, and slight/

minimal centrilobular enlargement of

the liver in females at the 100 ppm dose

level.

4. A 1–year feeding study in dogs fed

diets containing 0, 0.625, 2.5, and 10

mg/kg/day with a NOEL of 10 mg/kg/

day, the highest dose tested (HDT).

5. A developmental toxicity study in

rats fed dosage levels of 0, 30, 100, and

300 mg/kg/day, with no developmental

effects observed under the conditions of

the study. The NOEL for maternal

toxicity is established at 30 mg/kg/day.

6. A developmental toxicity study in

rabbits fed dosage levels of 0, 7, 20, and

60 mg/kg/day with no developmental

effects observed under the conditions of

the study. The NOEL for maternal

toxicity is established at 20 mg/kg/day

based on decreases in food consumption

and body weight gain at 60 mg/kg/day

(HDT).

7. A two-generation reproduction

study in rats fed diets containing 0, 25,

100 and 400 ppm (equivalent to 0, 1.25,

5, and 20 mg/kg/day with a NOEL for

developmental toxicity at 25 ppm based

on an increase in liver weight and

increase in the incidence of

eosinophillic changes in the liver at 100

ppm. The NOEL for parental toxicity is

established at 100 ppm based on