[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Rules and Regulations]
[Pages 22886-22887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10909]
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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
