[Federal Register Volume 61, Number 201 (Wednesday, October 16, 1996)]
[Rules and Regulations]
[Pages 53852-53854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26516]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 95F-0201]
Indirect Food Additive: 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 poly(trimethyl
hexamethylene terephthalamide) as a component of articles intended for
food-contact use. This action is in response to a petition filed by
Huls Aktiengesellschaft (Huls AG).
DATES: Effective October 16, 1996; written objections and requests for
a hearing by November 15, 1996.
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: Mark A. Hepp, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3098.
[[Page 53853]]
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 18, 1995 (60 FR 43157), FDA announced that a food
additive petition (FAP 2B4328) had been filed by Huls
Aktiengesellschaft, Marl, Germany (currently c/o Huls America, Inc.,
Turner Pl., P.O. Box 365, Piscataway, NJ 08855-0365). 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 poly(trimethyl
hexamethylene terephthalamide) as a component of articles intended for
food-contact uses. However, the petition was subsequently amended to
restrict the use of the subject additive to repeat-use articles that do
not include reusable bottles. Therefore, this final rule will amend the
regulations to authorize the use of the additive in repeat-use articles
excluding reusable bottles.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the additive in repeat-
use articles (excluding bottles) is safe and that the additive will
have the intended technical effect. The agency has also determined,
with the petitioner's concurrence, that the additive should be listed
by its classification name, Nylon resin PA 6-3-T. Therefore,
Sec. 177.1500 will 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.
Any person who will be adversely affected by this regulation may at
any time on or before November 15, 1996, 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 adding new paragraph (a)(16), in
the table in paragraph (b) by adding a new entry ``16.'', and in the
first sentence in paragraph (c)(5)(ii) by removing the word ``resin''
the first time it appears and by adding in its place the phrase ``and
Nylon PA-6-3-T resins'' to read as follows:
Sec. 177.1500 Nylon resins.
* * * * *
(a) * * *
(16) Nylon resins PA 6-3-T (CAS Registry No. 26246-77-5) are
manufactured by the condensation of 50 mol percent 1,4-
benzenedicarboxylic acid, dimethyl ester and 50 mol percent of an
equimolar mixture of 2,2,4-trimethyl-1,6-hexanediamine and 2,4,4-
trimethyl-1,6-hexanediamine.
(b) * * *
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Maximum extractable fraction in selected solvents (expressed
Melting in percent by weight of resin)
Specific point Solubility in Viscosity --------------------------------------------------------------
Nylon resins gravity (degrees boiling 4.2N HCl No. (mL/g) 95 percent
Fahrenheit) Water ethyl Ethyl Benzene
alcohol acetate
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* * * * * * *
16. Nylon resins PA 6-3-T for 1.12plus-mi NA Insoluble after 1 > 110 0.007 0.64 0.003 0
repeated-use (excluding n0.03 h.
bottles) in contact with
food of type VIA and VIB
described in Table 1 of Sec.
176.170(c) of this chapter
under conditions of use D
through H described in Table
2 of Sec. 176.170(c) of
this chapter with a hot-fill
temperature limitation of 40
C.
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[[Page 53854]]
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Dated: October 3, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-26516 Filed 10-15-96; 8:45 am]
BILLING CODE 4160-01-F
