10452 Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 96F–0242]

Indirect Food Additives: Paper and

Paperboard Components

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 additional safe use of perfluoroalkyl

substituted phosphate ester acids,

ammonium salts formed by the reaction

of 2,2-bis[(γ,ωperfluoroC4-20alkylthio)methyl]-1,3-

propanediol, polyphosphoric acid and

ammonium hydroxide, as an oil and

water repellant for paper and

paperboard intended for use in contact

with food. This action is in response to

a petition filed by Ciba-Geigy Corp.

DATES: Effective March 7, 1997; written

objections and requests for a hearing by

April 7, 1997.

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: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), 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

July 18, 1996 (61 FR 37483), FDA

announced that a food additive petition

(FAP 6B4513) had been filed by CibaGeigy Corp., P.O. Box 18300,

Greensboro, NC 27419–8300. The

petition proposed to amend the food

additive regulations in § 176.170

Components of paper and paperboard

in contact with aqueous and fatty foods

(21 CFR 176.170) to provide for the

additional safe use of perfluoroalkyl

substituted phosphate ester acids,

ammonium salts formed by the reaction

of 2,2-bis[(γ,ωperfluoroC4-20alkylthio)methyl]-1,3-

propanediol, polyphosphoric acid and

ammonium hydroxide, as an oil and

water repellant for paper and

paperboard intended for use in contact

with food.

FDA has evaluated data in the

petition and other relevant material. The

agency concludes that the proposed use

of the additive in paper and paperboard

products in contact with non-alcoholic

foods under condition of use C through

G as described in Table 2 of § 176.170(c)

is safe, that the additive will have the

intended technical effect, and, therefore,

that § 176.170 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. No

comments were received during the 30

day comment period specified in the

filing notice for comments on the

environmental assessment submitted

with the petition.

Any person who will be adversely

affected by this regulation may at any

time on or before April 7, 1997 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 176

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 176 is

amended as follows:

PART 176—INDIRECT FOOD

ADDITIVES: PAPER AND

PAPERBOARD COMPONENTS

1. The authority citation for 21 CFR

part 176 continues to read as follows:

Authority: Secs. 201, 402, 406, 409, 721 of

the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 346, 348, 379e).

2. Section 176.170 is amended in the

table in paragraph (a)(5) by revising the

entry for ‘‘Perfluoroalkyl substituted

phosphate ester acids, ammonium salts

formed by the reaction of 2,2-bis[(γ,ωperfluoroC4-20alkylthio)methyl]-1,3-

propanediol, polyphosphoric acid and

ammonium hydroxide’’ under the

heading ‘‘Limitations’’ to read as

follows:

§ 176.170 Components of paper and

paperboard in contact with aqueous and

fatty foods.

* * * * *

(a) * * *

(5) * * *
Federal Register / Vol. 62, No. 45 / Friday, March 7, 1997 / Rules and Regulations 10453

List of Substances Limitations

* * * * * * *

Perfluoroalkyl substituted phosphate ester acids, ammonium salts

formed by the reaction of 2,2-bis[(γ,ω-perfluoroC4-20alkylthio)methyl]-

1,3-propanediol, polyphosphoric acid and ammonium hydroxide.

For use only as an oil and water repellant at a level not to exceed 0.44

percent perfluoroalkyl actives by weight of the finished paper and paperboard in contact with non-alcoholic foods under condition of use

H as described in Table 2 of paragraph (c) of this section; and in

contact with food of types III, IV–A, V, VII–A, and IX described in

Table 1 of paragraph (c) of this section under conditions of use C

through G as described in Table 2 of paragraph (c) of this section.

* * * * * * *

* * * * *

Dated: February 7, 1997.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 97–5558 Filed 3–6–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD08–97–005]

RIN 2115–AE47

Drawbridge Operation Regulation;

Inner Harbor Navigation Canal, LA

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

temporarily changing the regulation for

the operation of the L&N Railroad/Old

Gentilly Road bascule span drawbridge

across the Inner Harbor Navigation

Canal, mile 3.4 in New Orleans, Orleans

Parish, Louisiana, to authorize it to

remain closed to navigation between the

hours of 8 a.m. and noon and between

the hours of 1 p.m. and 5 p.m. daily,

from March 6, 1997 through May 19,

1997. This action is necessary for the

fender system to be repaired and

portions of it replaced.

DATES: This temporary final rule is

effective beginning at 8 a.m. on March

6, 1997 and ending at 5 p.m. on May 19,

1997.

ADDRESSES: Unless otherwise indicated,

documents referred to in this preamble

are available for inspection or copying

at the office of the Eighth Coast Guard

District, Bridge Administration Branch,

Hale Boggs Federal Building, room

1313, 501 Magazine Street, New

Orleans, Louisiana 70130–3396 between

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

Friday, except Federal holidays. The

telephone number is (504) 589–2965.

Eighth Coast Guard District Bridge

Administration Branch maintains the

public docket for this temporary final

rule.

FOR FURTHER INFORMATION CONTACT:

Phil Johnson, Bridge Administration

Branch, at the address given above,

telephone (504) 589–2965.

SUPPLEMENTARY INFORMATION:

Drafting Information: The principal

persons involved in drafting this regulation

are Phil Johnson, Project Manager, Eighth

Coast Guard District Bridge Administration

Branch, and Lieutenant Commander Jim

Wilson, Project Attorney, Eighth Coast Guard

District Legal Office.

Discussion of Rule

Notice of this repair was not provided

in time to issue a notice of proposed

rulemaking. Unsafe condition of the

bridge fender system warrants the

closures so that remedial work can be

accomplished. For the same reason,

good cause exists to make this

temporary rule effective in less than 30

days after publication.

The L&N Railroad/Old Gentilly Road

bascule span drawbridge across the

Inner Harbor Navigation Canal, mile 3.4

in New Orleans, has a vertical clearance

of one foot above high tide in the closed

to navigation position. The horizontal

clearance of the bridge is only 93 feet.

A crane barge will be required to occupy

the majority of this very narrow channel

in order to reconstruct the fender

system. The Coast Guard is temporarily

changing the regulation for the

operation of the L&N Railroad/Old

Gentilly Road bascule span drawbridge

across the Inner Harbor Navigation

Canal, mile 3.4 in New Orleans, Orleans

Parish, Louisiana, to authorize it to

remain closed to navigation between the

hours of 8 a.m. and noon and between

the hours of 1 p.m. and 5 p.m. daily,

from March 6, 1997 through May 19,

1997.

This action is necessary for the fender

system to be repaired and portions of it

replaced. The barged and related

equipment will be removed from the

channel from noon until 1 p.m. and

from 5 p.m. until 8 a.m. daily at which

time the bridge may be opened to pass

marine traffic.

Navigation on the waterway consists

of tugs with tows, including crane

barges, jack-up boats, oil industry crew

vessels, fishing vessels, sailing vessels

and other recreational craft. The fender

system of the bridge has sustained

considerable damage from numerous

vessel strikes, compromising its ability

to protect the bridge. It must be

rehabilitated for the safety of rail as well

as for vehicular traffic.

The Port of New Orleans has

requested this temporary final rule so

that the fender system can be repaired

and portions of it replaced. The short

term inconvenience, attributable to a

delay of vessel traffic for a maximum of

four hours, is outweighed by the longterm benefits to be gained in the interest

of safety.

Regulatory Evaluation

This temporary final rule 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

temporary final rule 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 temporary

final rule will have a significant

economic impact on a substantial

number of small entities. ‘‘Small