2014 Federal Register / Vol. 62, No. 10 / Wednesday, January 15, 1997 / Rules and Regulations

Substances Limitations

* * * * * * *

2,2′-Ethylidenebis(4,6-di-tertbutylphenyl)fluorophosphonite (CAS Reg. No.

118337–09–0).

For use only:

1. As provided in § 175.105 of this chapter.

2. In all polymers used in contact with food of types I, II, IV–B, VI–A, VI–B, VII–B, and

VIII, under conditions of use B through H described in Tables 1 and 2 of § 176.170(c)

of this chapter at levels not to exceed 0.25 percent by weight of polymers.

3. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1, in contact with

food of types III, IV–A, V, VII–A, and IX, under:

(a) Conditions of use B through H described in Tables 1 and 2 of § 176.170(c) of this

chapter at levels not to exceed 0.25 percent by weight of the polymer; or

(b) Condition of use A, limited to levels not to exceed 0.1 percent by weight of the polymer; provided that the food-contact surface has an average thickness not exceeding

375 micrometers (0.015 inch).

4. In olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1a or 3.2a,

and containing not less than 85 percent by weight of polymer units derived from propylene, in contact with food of types III, IV–A, V, VII–A, and IX, and under:

(a) Conditions of use C through G, described in Tables 1 and 2 of § 176.170(c) of this

chapter, limited to levels no greater than 0.2 percent by weight of the copolymers; or

(b) Conditions of use A, B, and H, limited to levels no greater than 0.1 percent by weight

of the olefin copolymers; provided that the food-contact surface has an average thickness not exceeding 375 micrometers (0.015 inch).

5. In olefin polymers complying with § 177.1520(c) of this chapter, items 1.2 or 1.3 in

contact with food of types III, IV–A, V, VII–A, and IX, under conditions of use A

through H, described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to

exceed 0.1 percent by weight of the polymers; provided that the food-contact surface

has an average thickness not exceeding 375 micrometers (0.015 inch).

6. In polyethylene complying with § 177.1520(c) of this chapter, items 2.1 or 2.2, having

a density of not less than 0.94, in contact with food of types III, IV–A, V, VII–A, and IX,

and under:

(a) Conditions of use B through H, described in Tables 1 and 2 of § 176.170(c) of this

chapter limited to levels not to exceed 0.2 percent by weight of the polymers; or

(b) Condition of use A, described in Tables 1 and 2 of § 176.170(c) of this chapter, limited to levels not to exceed 0.1 percent by weight of the polymer; provided that the

food-contact surface has an average thickness not exceeding 125 micrometers (0.005

inch).

7. In olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b,

3.2a, or 3.2b, containing not less than 85 percent by weight of polymer units derived

from ethylene and having a density of not less than 0.94, in contact with food of types

III, IV–A, V, VII–A, and IX, and under:

(a) Conditions of use C through G, described in Tables 1 and 2 of § 176.170(c) of this

chapter limited to levels not to exceed 0.2 percent by weight of the copolymers; or

(b) Conditions of use A, B, and H, limited to levels not to exceed 0.1 percent by weight

of the copolymers; provided that the food-contact surface has an average thickness

not exceeding 125 micrometers (0.005 inch).

8. In olefin polymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a,

or 3.2b containing not less than 85 percent by weight of polymer units derived from

ethylene, in contact with food of types III, IV–A, V, VII–A, and IX, under conditions of

use A through H, as described in Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.1 percent by weight of the copolymer; provided that the food-contact surface has an average thickness not exceeding 75 micrometers (0.003 inch).

9. In polyethylene phthalate polymers complying with § 177.1630 of this chapter in contact with food of types III, IV–A, V, VI–C, VII–A, and IX, and under:

(a) Conditions of use B through H, described in Tables 1 and 2 of § 176.170(c) of this

chapter, limited to levels not to exceed 0.3 percent by weight of the polymers; or

(b) Condition of use A with food of types III, IV–A, V, VII–A, and IX, and limited to levels

not to exceed 0.1 percent by weight of the polymers; provided that the film thickness

does not exceed 875 micrometers (0.035 inch).

* * * * * * *

Dated: January 6, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–1021 Filed 1–14–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 178

[Docket No. 93F–0309]

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 expanded safe use of di-tertbutylphenyl phosphonite condensation

product with biphenyl as an
Federal Register / Vol. 62, No. 10 / Wednesday, January 15, 1997 / Rules and Regulations 2015

antioxidant/stabilizer for olefin

polymers and for rubber articles

intended for repeated use in contact

with food. This action is in response to

a petition filed by Sandoz AG

(currently, Clariant Huningue S.A.).

DATES: Effective January15, 1997;

written objections and requests for a

hearing by February 14, 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

October 7, 1993 (58 FR 52315), FDA

announced that a food additive petition

(FAP 3B4395) had been filed by Sandoz

AG (currently, Clariant Huningue S.A.),

c/o Registration and Consulting Co.,

Ltd., CH–4452 Itingen/Basel,

Switzerland. 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 expanded

safe use of di-tert-butylphenyl

phosphonite condensation product with

biphenyl as an antioxidant/stabilizer for

olefin polymers and for rubber articles

intended for repeated use in contact

with food.

Based on more precise analytical data

on the isomeric composition of the

antioxidant, the petitioner has obtained

a new CAS Reg. No. for the subject

additive. This final rule, therefore, uses

the new, corrected, CAS Reg. No.,

119345–01–6.

FDA has evaluated data in the

petition and other relevant material. The

agency concludes that: (1) The proposed

use of the additive is safe, (2) the food

additive will have the intended

technical effect, and (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 February 14, 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 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: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

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

2. Section 178.2010 is amended in the

table in paragraph (b) by revising the

entry for ‘‘Di-tert-butylphenyl

phosphonite condensation product with

biphenyl * * *’’ under the heading

‘‘Substances’’ and by revising entries

‘‘1.’’ and ‘‘4.’’ and adding a new entry

‘‘5.’’ under the heading ‘‘Limitations’’ to

read as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *
2016 Federal Register / Vol. 62, No. 10 / Wednesday, January 15, 1997 / Rules and Regulations

Substances Limitations

* * * * *

Di-tert-butylphenyl phosphonite condensation product with biphenyl

(CAS Reg. No. 119345–01–6) produced by the condensation of 2,4-

di-tert-butylphenol with the Friedel-Crafts addition product (phosphorus trichloride and biphenyl) so that the food additive has a minimum phosphorus content of 5.4 percent, an acid value not exceeding

10 mg KOH/gm, and a melting range of 85 °C to 110 °C (185 °F to

230 °F).

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, items 1.1, 1.2, 1.3,

3.2b, 3.3a, 3.3b, 3.4, 3.5, and 3.1a (where the density is not less

than 0.85 gram per cubic centimeter and not more than 0.91 gram

per cubic centimeter); and 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, and 3.6

(where the density is not less than 0.94 gram per cubic centimeter)

and 5.

* * * * *

4. At levels not to exceed 0.15 percent by weight of olefin polymers

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, and 3.6 (where the polyethylene component has a density less than 0.94 gram per cubic centimeter).

5. At levels not to exceed 0.1 percent by weight of repeated use rubber articles complying with § 177.2600 of this chapter.

* * * * *

Dated: December 19, 1996.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 97–946 Filed 1–14–97; 8:45 am]

BILLING CODE 4160–01–F

PENSION BENEFIT GUARANTY

CORPORATION

29 CFR Part 4044

Allocation of Assets in SingleEmployer Plans; Interest Assumptions

for Valuing Benefits

AGENCY: Pension Benefit Guaranty

Corporation.

ACTION: Final rule.

SUMMARY: The Pension Benefit Guaranty

Corporation’s regulation on Allocation

of Assets in Single-Employer Plans

prescribes interest assumptions for

valuing benefits under terminating

single-employer plans. This final rule

amends the regulation to adopt interest

assumptions for plans with valuation

dates in February 1997.

EFFECTIVE DATE: February 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Harold J. Ashner, Assistant General

Counsel, Office of the General Counsel,

Pension Benefit Guaranty Corporation,

1200 K Street, NW., Washington, DC

20005, 202–326–4024 (202–326–4179

for TTY and TDD).

SUPPLEMENTARY INFORMATION: The

PBGC’s regulation on Allocation of

Assets in Single-Employer Plans (29

CFR part 4044) prescribes actuarial

assumptions for valuing plan benefits of

terminating single-employer plans

covered by title IV of the Employee

Retirement Income Security Act of 1974.

Among the actuarial assumptions

prescribed in part 4044 are interest

assumptions. These interest

assumptions are intended to reflect

current conditions in the financial and

annuity markets.

Two sets of interest assumptions are

prescribed, one set for the valuation of

benefits to be paid as annuities and one

set for the valuation of benefits to be

paid as lump sums. This amendment

adds to appendix B to part 4044 the

annuity and lump sum interest

assumptions for valuing benefits in

plans with valuation dates during

February 1997.

For annuity benefits, the interest

assumptions will be 5.90 percent for the

first 25 years following the valuation

date and 5.00 percent thereafter. For

benefits to be paid as lump sums, the

interest assumptions to be used by the

PBGC will be 4.75 percent for the period

during which a benefit is in pay status

and 4.00 percent during any years

preceding the benefit’s placement in pay

status. The above annuity interest

assumptions represent an increase (from

those in effect for January 1997) of 0.10

percent for the first 25 years following

the valuation date and are otherwise

unchanged. The lump sum interest

assumptions represent an increase (from

those in effect for January 1997) of .25

percent for the period during which a

benefit is in pay status and are

otherwise unchanged.

The PBGC has determined that notice

and public comment on this amendment

are impracticable and contrary to the

public interest. This finding is based on

the need to determine and issue new

interest assumptions promptly so that

the assumptions can reflect, as

accurately as possible, current market

conditions.

Because of the need to provide

immediate guidance for the valuation of

benefits in plans with valuation dates

during February 1997, the PBGC finds

that good cause exists for making the

assumptions set forth in this

amendment effective less than 30 days

after publication.

The PBGC has determined that this

action is not a ‘‘significant regulatory

action’’ under the criteria set forth in

Executive Order 12866.

Because no general notice of proposed

rulemaking is required for this

amendment, the Regulatory Flexibility

Act of 1980 does not apply. See 5 U.S.C.

601(2).

List of Subjects in 29 CFR Part 4044

Pension insurance, Pensions.

In consideration of the foregoing, 29

CFR part 4044 is amended as follows:

PART 4044—[AMENDED]

1. The authority citation for part 4044

continues to read as follows:

Authority: 29 U.S.C. 1301(a), 1302(b)(3),

1341, 1344, 1362.

2. In appendix B, a new entry is

added to Table I, and Rate Set 40 is

added to Table II, as set forth below.

The introductory text of each table is

republished for the convenience of the

reader and remains unchanged.