Indirect Food Additives: Polymers

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food And Drug Administration

21 CFR Part 177

[Docket No. 96F-0213]

Indirect Food Additives: Polymers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food

additive regulations to provide for the safe use of 1,4-

benzenedicarboxylic acid, polymer with 1,4-butanediol, ()-2-

butenedioic acid, 1,2-ethanediol, ethyl 2-propenoate, hexanedioic acid

and 2-propenoic acid, graft, in Nylon 6 and Nylon 6 modified with Nylon

MXD-6 articles intended for use in contact with food. This action is in

response to a petition filed by Toyobo Co., Ltd.

DATES: Effective April 28, 1997; written objections and requests for a

hearing by May 28, 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 37484), FDA announced that a food

additive petition (FAP 6B4511) had been filed by Toyobo Co., Ltd., 2-1-

1 Hon Katata Otsu, Shiga 520-02, Japan. The petition proposed to amend

the food additive regulations in Sec. 177.1500 Nylon resins (21 CFR

177.1500) to provide for the safe use of 1,4-benzenedicarboxylic acid,

polymer with 1,4-butanediol, ()-2-butenedioic acid, 1,2-

ethanediol, ethyl 2-propenoate, hexanedioic acid, and 2-propenoic acid,

graft, in Nylon 6 and Nylon 6 modified with Nylon MXD-6 articles

intended for use in contact with food. The graft resins of this type

are generically called copolyester-graft-acrylate copolymer.

During the agency's review of the petition, the agency observed

that the nomenclature for ()-2-butenedioic acid was incorrect.

The correct nomenclature is (E)-2-butenedioic acid. This document uses

the correct designation for the subject component in the codified final

rule.

FDA has evaluated data in the petition and other relevant material.

The agency concludes that the proposed use of the additive is safe,

that the additive will have its intended technical effect, and

therefore, that the regulations in Sec. 177.1500 should be amended as

set forth below.

In accordance with Sec. 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 Sec. 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 May 28, 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 177

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 177 is amended as follows:

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

1. The authority citation for 21 CFR part 177 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 177.1500 is amended by redesignating paragraph (c) as

paragraph (d), by adding a new paragraph (c), and in the last sentence

of newly designated paragraph (d)(5)(ii) by removing the phrase

``paragraph (c)(5)(i)'' and adding in its place the phrase ``paragraph

(d)(5)(i)'' to read as follows:

Sec. 177.1500 Nylon resins.

* * * * *

(c) Nylon modifier--(1) Identity. Copolyester-graft-acrylate

copolymer is the substance 1,4-benzenedicarboxylic acid, polymer with

1,4-butanediol, (E)-2-butenedioic acid, 1,2-ethanediol, ethyl 2-

propenoate, hexanedioic acid and 2-propenoic acid, graft (CAS Reg. No.

175419-23-5), and is derived from grafting of 25 weight percent of

acrylic polymer with 75 weight percent of copolyester. The copolyester

is polymerized terephthalic acid (55 mol%), adipic acid (40 mol%), and

fumaric acid (5 mol%) with ethylene glycol (40 mol%) and 1,4-butanediol

(60 mol%). The acrylic polymer is made from acrylic acid (70 mol%) and

ethyl acrylate (30 mol%).

(2) Specifications. The finished copolyester-graft-acrylate

copolymer shall meet the following specifications:

(i) Weight average molecular weight 15,000-35,000,

(ii) pH 7.2 to 8.2, and

(iii) Glass transition temperature -15 to -25 deg.C.

[[Page 22887]]

(3) Conditions of use. (i) Copolyester-graft acrylate copolymer

described in paragraph (c)(1) of this section is intended to improve

the adhesive qualities of film. It is limited for use as a modifier of

Nylon 6 and Nylon 6 modified with Nylon MXD-6 at a level not to exceed

0.17 weight percent of the additive in the finished film.

(ii) The finished film is used for packaging, transporting, or

holding all types of foods under conditions of use B through H,

described in Table 2 of Sec. 176.170(c) of this chapter, except that in

the case of Nylon 6 films modified with Nylon MXD-6 (complying with

Sec. 177.1500, item 10.2), the use complies with the conditions of use

specified in Table 2.

(iii) Extractives. Food contact films described in paragraphs

(c)(1) of this section, when extracted with solvent or solvents

prescribed for the type of food and under conditions of time and

temperature specified for the intended use, shall yield total

extractives not to exceed 0.5 milligram per inch squared of food-

contact surface when tested by the methods described in Sec. 176.170(d)

of this chapter.

(iv) Optional adjuvant substances. The substances employed in the

production of Nylon modifiers listed in paragraph (c)(1) of this

section may include:

(A) Substances generally recognized as safe for use in food and

food packaging;

(B) Substances subject to prior sanction or approval for use in

Nylon resins and used in accordance with such sanctions or approval;

and

(C) Optional substances required in the production of the additive

identified in this paragraph and other optional substances that may be

required to accomplish the intended physical or technical effect.

Dated: April 2, 1997.

Fred R. Shank,

Director, Center for Food Safety and Applied Nutrition.

[FR Doc. 97-10909 Filed 4-25-97; 8:45 am]

BILLING CODE 4160-01-F