Federal Register / Vol. 60, No. 69 / Tuesday, April 11, 1995 / Rules and Regulations 18349

PART 148—PERSONAL

DECLARATIONS AND EXEMPTIONS

1. The general authority citation for

Part 148 is revised to read as follows:

Authority: 19 U.S.C. 66, 1496, 1498, 1624.

The provisions of this part, except for subpart

C, are also issued under 19 U.S.C. 1202

(General Note 20, Harmonized Tariff

Schedule of the United States (HTSUS));

* * * * *

PART 151—EXAMINATION,

SAMPLING, AND TESTING OF

MERCHANDISE

1. The general authority citation for

Part 151 is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Notes 20 and 21, Harmonized Tariff Schedule

of the United States (HTSUS)), 1624. Subpart

A also issued under 19 U.S.C. 1499. * * *

* * * * *

PART 152—CLASSIFICATION AND

APPRAISEMENT OF MERCHANDISE

1. The general authority citation for

Part 152 is unchanged, but the specific

authority for subpart D and for §§ 152.13

and 152.24 are revised, to read as

follows:

Authority: 19 U.S.C. 66, 1401a, 1500, 1502,

1624;

* * * * *

Subpart D also issued under 19 U.S.C. 1202

(General Note 17, Harmonized Tariff

Schedule of the United States (HTSUS));

* * * * *

Sections 152.13 and 152.24 also issued

under 19 U.S.C. 1202 (General Note 17,

Harmonized Tariff Schedule of the United

States (HTSUS)).

§ 152.13 [Amended]

2. In § 152.13, the reference in

paragraphs (b)(1), (b)(2), (c) introductory

text, (c)(1), (c)(2), (c)(3), and (d) to

‘‘General Note 5’’ is revised to read

‘‘General Note 17’’.

PART 177—ADMINISTRATIVE

RULINGS

1. The general authority citation for

Part 177 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Note 20, Harmonized Tariff

Schedule of the United States (HTSUS)),

1624;

* * * * *

PART 181—NORTH AMERICAN FREE

TRADE AGREEMENT

1. The authority citation for Part 181

is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 20, Harmonized Tariff Schedule of the

United States (HTSUS)), 1624, and the North

American Free Trade Agreement

Implementation Act, Pub. L. 103–182, 107

Stat. 2057.

PART 191—DRAWBACK

1. The general authority citation for

Part 191 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Note 20, Harmonized Tariff

Schedule of the United States (HTSUS)),

1313, 1624;

* * * * *

Dated: April 4, 1995.

Stuart P. Seidel,

Assistant Commissioner, Office of

Regulations and Rulings.

[FR Doc. 95–8745 Filed 4–10–95; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 176 and 178

[Docket No. 93N–0420]

Indirect Food Additives: Paper and

Paperboard Components; Adjuvants,

Production Aids, and Sanitizers;

Technical Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to correct an error in

nomenclature for a food additive. The

amendment adds alkyl mono- and

disulfonic acids, sodium salts (produced

from n-alkanes in the range of C10–C18

with not less than 50 percent C14–C16)

as a component of paper and

paperboard in contact with food, as an

antistatic agent, and as an emulsifier

and/or surface active agent.

Additionally, because certain sections

contain multiple entries for the additive,

FDA is amending its food additive

regulations so that all uses of the

additive will be combined under single

entries in those sections of the

regulations.

DATES: Effective April 11, 1995; written

objections and requests for a hearing by

May 11, 1995.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Andrew Zajac, Center for Food Safety

and Applied Nutrition (HFS–216), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3095.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 21, 1994 (59

FR 3322), FDA published a proposed

rule to correct an error in nomenclature

for a food additive regulated in

§§ 176.170, 176.180, 178.3130, and

178.3400 (21 CFR 176.170, 176.180,

178.3130, and 178.3400). The agency

proposed to add alkyl mono- and

disulfonic acids, sodium salts (produced

from n-alkanes in the range of C10–C18

with not less than 50 percent C14–C16)

to those sections and to remove: (1) The

listing ‘‘n-alkylsulfonate (alkyl group is

in the range C10–C18 with not less than

50 percent C14–C16)’’ from § 176.170; (2)

the listing ‘‘petroleum sulfonates’’ from

the list of substances in § 176.180; (3)

the listings for ‘‘sodium n-alkylsulfonate

(alkyl group in the range of C10–C18 with

not less than 50 percent C14–C16)’’ and

‘‘sodium sec-alkyl mono- and

disulfonates (alkyl group in the range of

C10–C18 with not less than 50 percent

C14–C16)’’ from § 178.3130; and (4) the

listings for ‘‘n-alkylsulfonate (alkyl

group is in the range C10–C18 with not

less than 50 percent C14–C16)’’ and

‘‘sodium sec-alkyl mono- and

disulfonates (alkyl group in the range of

C10–C18 with not less than 50 percent

C14–C16)’’ from § 178.3400.

FDA received no comments on its

proposal. The agency is, therefore,

adopting the proposal as a final rule

without any changes.

The agency has previously considered

the environmental effects of this rule, as

announced in the proposed rule (59 FR

3322, January 21, 1994). No new

information or comments have been

received that would affect the agency’s

previous determination that this action

will not have a significant impact upon

the human environment and that

neither an environmental assessment

nor an environmental impact statement

is required.

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined
18350 Federal Register / Vol. 60, No. 69 / Tuesday, April 11, 1995 / Rules and Regulations

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because no current activity is

prohibited by this final rule, the

compliance costs to firms are zero.

Likewise, because no increase in the

health risks faced by consumers will

result from this final rule, total costs are

also zero. The agency certifies that the

final rule will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

Furthermore, in accordance with the

Regulatory Flexibility Act, the agency

previously considered the potential

effects that this rule would have on

small entities, including small

businesses, and has determined that no

significant economic impact on a

substantial number of small entities

would derive from this action. FDA has

not received any new information or

comments that would alter its previous

determination.

Any person who will be adversely

affected by this regulation may at any

time on or before May 11, 1995, 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

21 CFR Parts 176 and 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 parts 176

and 178 are 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 (b)(2) by removing

the entry for ‘‘n-Alkylsulfonate (alkyl

group is in the range C10–C18 with not

less than 50 percent C14–C16)’’ and by

alphabetically adding a new entry under

the headings ‘‘List of substances’’ and

‘‘Limitations’’ to read as follows:

§ 176.170 Components of paper and

paperboard in contact with aqueous and

fatty foods.

* * * * *

(b) * * *

(2) * * *

List of substances Limitations

* * * * * * *

Alkyl mono- and disulfonic acids, sodium salts (produced from nalkanes in the range of C10–C18 with not less than 50 percent C14–

C16)..

For use only:

1. As emulsifiers for vinylidene chloride copolymer coatings and limited

to use at levels not to exceed 2 percent by weight of the coating solids.

2. As emulsifiers for vinylidene chloride copolymer or homopolymer

coatings at levels not to exceed a total of 2.6 percent by weight of

coating solids. The finished polymer contacts food only of types identified in paragraph (c) of this section, Table 1, under Types I, II, III,

IV, V, VIA, VIB, VII, VIII, and IX and under conditions of use E, F,

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

* * * * * * *

* * * * *

3. Section 176.180 is amended in the

table in paragraph (b)(2) by removing

the entry for ‘‘Petroleum sulfonates’’

and by alphabetically adding a new

entry under the heading ‘‘List of

substances’’ to read as follows:

§ 176.180 Components of paper and

paperboard in contact with dry food.

* * * * *

(b) * * *

(2) * * *
Federal Register / Vol. 60, No. 69 / Tuesday, April 11, 1995 / Rules and Regulations 18351

List of substances Limitations

* * * * * * *

Alkyl mono- and disulfonic acids, sodium salts (produced from nalkanes in the range of C10–C18 with not less than 50 percent C14–

C16)..

* * * * * * *

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

4. The authority citation for 21 CFR

part 178 continues to read as follows:

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

Federal Food, Drug, and Cosmetic Act (21

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

5. Section 178.3130 is amended in the

table in paragraph (b) by removing the

entries for ‘‘Sodium n-alkylsulfonate

(alkyl group in the range of C10–C18 with

not less than 50 percent C14–C16)’’ and

‘‘Sodium sec-alkyl mono- and

disulfonates (alkyl group in the range of

C10–C18 with not less than 50 percent

C14–C16)’’ and by alphabetically adding

a new entry under the headings ‘‘List of

substances’’ and ‘‘Limitations’’ to read

as follows:

§ 178.3130 Antistatic and/or antifogging

agents in food-packaging materials.

* * * * *

(b) * * *

List of substances Limitations

Alkyl mono- and disulfonic acids, sodium salts (produced from nalkanes in the range of C10–C18 with not less than 50 percent C14–

C16)..

For use only:

1. As antistatic agents at levels not to exceed 0.1 percent by weight of

polyolefin films that comply with § 177.1520 of this chapter: Provided,

that the finished olefin polymers contact foods of Types I, II, III, IV,

V, VIA, VIB, VII, VIII, and IX described in Table 1 of § 176.170(c) of

this chapter, and under conditions of use E, F, and G described in

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

2. As antistatic agents at levels not to exceed 3.0 percent by weight of

polystyrene or rubber-modified polystyrene complying with

§ 177.1640(c) of this chapter under conditions of use B through H

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

* * * * * * *

6. Section 178.3400 is amended in the table in paragraph (c) by removing the entries for ‘‘n-Alkylsulfonate (alkyl

group is in the range C10–C18 with not less than 50 percent C14–C16)’’ and ‘‘Sodium sec-alkyl mono- and disulfonates

(alkyl group in the range of C10–C18 with not less than 50 percent C14–C16)’’ and by alphabetically adding a new

entry under the headings ‘‘List of substances’’ and ‘‘Limitations’’ to read as follows:

§ 178.3400 Emulsifiers and/or surface active agents.

* * * * *

(c) * * *
18352 Federal Register / Vol. 60, No. 69 / Tuesday, April 11, 1995 / Rules and Regulations

List of substances Limitations

Alkyl mono- and disulfonic acids, sodium salts (produced from nalkanes in the range of C10–C18 with not less than 50 percent C14–

C16)..

For use only:

1. As provided in § 176.170 of this chapter.

2. At levels not to exceed 2 percent by weight of polyvinyl chloride and/

or vinyl chloride copolymers complying with § 177.1980 of this chapter.

3. As emulsifiers in vinylidene chloride copolymer or homopolymer

coatings at levels not to exceed a total of 2.6 percent by weight of

coating solids. The finished polymer contacts food only of the Types

I, II, III, IV, V, VIA, VIB, VII, VIII, and IX as identified in Table 1 of

§ 176.170(c) of this chapter, and limited to conditions of use E, F,

and G described in Table 2 of § 176.170 of this chapter.

4. As emulsifiers and/or surface-active agents at levels not to exceed

3.0 percent by weight of polystyrene or rubber-modified polystyrene

complying with § 177.1640(c) of this chapter under conditions of use

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

* * * * * * *

* * * * *

Dated: April 3, 1995.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Intitiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 95–8772 Filed 4–10–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 178

[Docket No. 91F–0499]

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-di-tert-pentyl-6-[1-

(3,5-di-tert-pentyl-2-

hydroxyphenyl)ethyl]phenyl acrylate as

an antioxidant in the manufacture of

polystyrene and rubber-modified

polystyrene articles that contact food.

This action is in response to a petition

filed by Sumitomo Chemical America,

Inc.

DATES: Effective April 11, 1995; written

objections and requests for a hearing by

May 11, 1995.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Daniel N. Harrison, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

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

202–254–9500.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

January 30, 1992 (57 FR 3633), FDA

announced that a food additive petition

(FAP 2B4295) had been filed by

Sumitomo Chemical America, Inc., 345

Park Ave., New York, NY 10154. 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-di-tert-pentyl-6-[1-

(3,5-di-tert-pentyl-2-

hydroxyphenyl)ethyl]phenyl acrylate as

an antioxidant in the manufacture of

polystyrene and rubber-modified

polystyrene articles that contact food.

FDA has evaluated data in the

petition and other relevant material. The

agency concludes that the proposed

food additive use is safe, and that the

regulations in § 178.2010(b) 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 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 May 11, 1995, 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