Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 /Rules and Regulations 29135

* * * * *

Dated: May 19, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–14105 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 96F–0489]

Indirect Food Additives: Polymers

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 5,7-bis(1,1-

dimethylethyl)-3-hydroxy-2(3H)-

benzofuranone, reaction products with

o-xylene, as an antioxidant and/or

stabilizer for olefin polymers intended

for use in contact with food. This action

responds to a petition filed by Ciba

Specialty Chemicals Corp.

DATES: The regulation is effective May

28, 1998. Submit written objections and

request for a hearing by June 29, 1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

January 2, 1997 (62 FR 100), FDA

announced that a food additive petition

(FAP 7B4529) had been filed by Ciba

Specialty Chemicals Corp., 540 White

Plains Rd., Tarrytown, NY 10591–9005.

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 5,7-bis(1,1-

dimethylethyl-3-hydroxy-2(3H)-

benzofuranone, reaction products with

o-xylene as an antioxidant and/or

stabilizer for olefin polymers intended

for use in contact with food.

FDA has evaluated 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 food additive

will achieve its intended technical

effect, and therefore, (3) 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 § 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 carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before June 29, 1998, file

with the Dockets Management Branch

(address above) written objections

thereto. 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

shall be submitted and shall 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 to read as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *

(b) * * *
29136 Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 /Rules and Regulations

Substances Limitations

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5,7-bis(1,1-dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction

products with o-xylene (CAS Reg. No. 181314–48–7).

For use only:

1. At levels not to exceed 0.1 percent by weight of olefin polymers

complying with § 177.1520(c) of this chapter. The finished polymers

may only be used in contact with food of the types identified in

§ 176.170(c) of this chapter, Table 1, under Categories I, II, IV–B,

VI–A, VI–B, VII–B, and VIII, and under conditions of use B through H

described in Table 2 of § 176.170(c) of this chapter.

2. At levels not to exceed 0.02 percent by weight of propylene polymers and copolymers complying with § 177.1520(c) of this chapter,

items 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 3.5, and ethylene polymers

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

2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of

these polymers is at least 0.94 gram per cubic centimeter), or 5. The

finished polymers may only be used in contact with food of the types

identified in § 176.170(c) of this chapter, Table 1, under Categories

III, IV–A, V, VI–C, VII–A, and IX, and under conditions of use B

through H described in Table 2 of § 176.170(c) of this chapter; provided that the finished food-contact articles have a volume of at least

18.9 liters (5 gallons).

3. At levels not to exceed 0.02 percent by weight of ethylene polymers

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

2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of

each of these polymers is less than 0.94 gram per cubic centimeter).

The finished polymers may only be used in contact with food of the

types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV–A, V, VI–C, VII–A, and IX, and under conditions of

use B through H described in Table 2 of § 176.170(c) of this chapter;

provided that the average thickness of such polymers in the form in

which they contact food shall not exceed 50 micrometers (0.002

inch).

* * * * * * *

Dated: May 11, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–14104 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[COTP San Diego; 98–011]

RIN 2115–AA97

Safety Zone; Oceanside, CA

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone in

the navigable waters of the Pacific

Ocean adjacent to Oceanside, California,

for the 2nd Annual Oceanside Grand

Prix Powerboat Race on 31 May 1998.

The race zone will encompass the water

from the Oceanside harbor entrance and

the southerly city limits of Oceanside,

approximately .5 miles from the

shoreline and running approximately

parallel thereto, in an area more

particularly described as follows:

beginning at a point located at latitude

33°09′87′′ N. longitude 117°22′81′′ W;

thence northeast to a point located at

latitude 33°10′14′′ N, longitude

117°22′33′′ W; thence northwest to a

point located at latitude 33°11′49′′ N,

longitude 117°23′36′′ W; thence north to

a point located at latitude 33°11′64′′ N.

longitude 117°23′36′′ W; thence

southeast to the point of the beginning.

This safety zone is established to

protect the lives and property of the race

participants and spectators by

establishing an exclusionary zone

around the race course. Entry into,

transit through, or anchoring within this

zone is prohibited unless authorized by

the Captain of the Port.

EFFECTIVE DATES: This regulation

becomes effective at 1:30 p.m. (DST) on

May 31, 1998, and continues until 2:45

p.m. (DST) on May 31, 1998, unless

cancelled earlier by the Captain of the

Port.

ADDRESSES: Marine Safety Office San

Diego, 2716 N. Harbor Drive, San Diego,

CA 92101–1064.

FOR FURTHER INFORMATION CONTACT: LT

Mike Arguelles, U.S. Coast Guard

Marine Safety Office San Diego at (619)

683–6484.

SUPPLEMENTARY INFORMATION: In

accordance with 5 U.S.C. 553, a notice

of proposed rulemaking was not

published for this regulation and good

cause exists for making it effective in

less than 30 days after Federal Register

publication. Publication of a notice of

proposed rulemaking and delay of its

effective date would be contrary to the

public interest since immediate action is

necessary to ensure the safety of vessels

operating in the area of the race. The

safety zone boundaries and 2nd Annual

Oceanside Grand Prix arrangements

were not finalized until a date fewer

than 30 days prior to the event date.

Following normal rulemaking

procedures in this case would be

impracticable.

Drafting Information

The drafters of this regulation are

Lieutenant Mike Arguelles, Project

Officer, U.S. Coast Guard Marine safety

Office San Diego, and LTJG Derek A.

D’Orazio, Project Attorney, Maintenance