26746 Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations

* * * * *

Dated: April 28, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–11478 Filed 5–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F–1910]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of 2-[4,6-bis(2,4-

dimethylphenyl)-1,3,5-triazin-2-yl]-5-

(octyloxy)phenol as a stabilizer for

olefin polymers intended for use in

contact with food. This action is in

response to a petition filed by Cytec

Industries, Inc.

DATES: This rule is effective May 9,

2000. Submit written objections and

requests for a hearing by June 8, 2000.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

June 22, 1999 (64 FR 33306), FDA

announced that a food additive petition

(FAP 9B4675) had been filed by Cytec

Industries, Inc., c/o Keller and Heckman

LLP, 1001 G St. NW., suite 500 West,

Washington DC 20001. The petition

proposed to amend the food additive

regulations in § 178.2010 Antioxidants

and/or stabilizers for polymers (21 CFR

178.2010) to provide for the safe use of

2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-

triazin-2-yl]-5-(octyloxy)phenol as a

stabilizer for olefin polymers intended

for use in contact with food.

FDA has evaluated the data in the

petition and other relevant material.

Based on this information, the agency

concludes that: (1) The proposed use of

the additive is safe, (2) the additive will

achieve its intended technical effect,

and therefore, (3) that the regulations in

§ 178.2010 should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in 21 CFR

171.1(h), the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has previously considered

the environmental effects of this rule as

announced in the notice of filing for

FAP 9B4675. No new information or

comments have been received that

would affect the agency’s previous

determination that there is no

significant impact on the human

environment and that an environmental

impact statement is not required.

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by June 8, 2000. Each

objection shall be separately numbered,

and each numbered objection shall

specify with particularity the provisions

of the regulation to which objection is

made and the grounds for the objection.

Each numbered objection on which a

hearing is requested shall specifically so

state. Failure to request a hearing for

any particular objection shall constitute

a waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

are to be submitted and are to be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 178.2010 is amended in the

table in paragraph (b) by alphabetically

adding an entry under the headings

‘‘Substances’’ and ‘‘Limitations’’ to read

as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *

(b) * * *

Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations 26747

Substances Limitations

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2-[4,6-Bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol

(CAS Reg. No. 2725–22–6).

For use only:

1. At levels not to exceed 0.3 percent by weight of olefin polymers

complying with § 177.1520(c) of this chapter in contact with food

types I, II, IV–B, VI, VII–B, and VIII described in § 176.170(c) of this

chapter, table 1, under conditions of use D through G as described

in § 176.170(c), table 2, of this chapter.

2. At levels not to exceed 0.1 percent by weight of polypropylene complying with § 177.1520(c) of this chapter, items 1.1a, 1.2, and 1.3 in

contact with food under conditions of use A through H as described

in § 176.170(c), table 2, of this chapter.

3. At levels not to exceed 0.04 percent by weight of polyethylene and

olefin copolymers complying with § 177.1520(c) of this chapter, items

2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b having a minimum density of 0.94 gram per cubic centimeter, in contact with food under

conditions of use A through H as described in § 176.170, table 2, of

this chapter provided that the finished articles used in contact with

fatty food types III, IV–A, V, VII–A, and IX as described in table 1 of

§ 176.170(c) of this chapter hold a minimum of 2 gallons (7.6 liters)

of food.

4. At levels not to exceed 0.4 percent by weight of ethylene copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b,

3.1c, 3.2a, and 3.2b, having a density of less than 0.94 gram per

cubic centimeter, in contact with food under conditions of use B

through H, as described in § 176.170(c), table 2, of this chapter provided that the finished articles used in contact with fatty food types

III, IV–A, V, VII–A, and IX hold a minimum of 5 gallons (18.9 liters)

of food.

5. At levels not to exceed 0.04 percent by weight of polyethylene having a density of less than 0.94 gram per cubic centimeter, and olefin

polymers complying with § 177.1520(c) of this chapter, items 2.1,

2.2, 2.3, 3.3a, 3.3b, 3.4, 3.5, 3.6, 4, 5, and 6, in contact with food

under conditions of use D through G as described in § 176.170(c) of

this chapter, table 2, provided that the finished articles used in contact with fatty food types III, IV–A, V, VII–A, and IX hold a minimum

of 5 gallons (18.9 liters) of food.

*******

Dated: April 27, 2000

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–11479 Filed 5–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Trenbolone

and Estradiol

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental abbreviated

new animal drug application (ANADA)

filed by Ivy Laboratories, Div. of Ivy

Animal Health, Inc. The supplemental

ANADA provides for subcutaneous use

of a cattle ear implant containing

trenbolone and estradiol for pasture

cattle for increased rate of weight gain.

Technical changes are also made.

DATES: This rule is effective May 9,

2000.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0217.

SUPPLEMENTARY INFORMATION: Ivy

Laboratories, Div. of Ivy Animal Health,

Inc., 8857 Bond St., Overland Park, KS

66214, filed supplemental ANADA 200–

221 for use of Component TE–G (40

milligrams (mg) trenbolone acetate and

8 mg estradiol, in 2 pellets, each pellet

containing 20 mg of trenbolone acetate

and 4 mg of estradiol) for increased rate

of weight gain in pasture cattle

(slaughter, stocker, and feeder steers and

heifers). The supplemental ANADA is

approved as of March 6, 2000, and the

regulations in 21 CFR 522.2477 are

amended to reflect the approval. The

basis of approval is discussed in the

freedom of information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33(a)(1) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because