[Federal Register Volume 61, Number 128 (Tuesday, July 2, 1996)]
[Rules and Regulations]
[Pages 34370-34371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 93F-0167]
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 Nylon 46 resins,
which are manufactured by the condensation of 1,4-butanediamine and
adipic acid, in membrane filters intended to contact beverages
containing not more than 13 percent alcohol. This action responds to a
petition filed by DSM Engineering Plastics.
DATES: Effective July 2, 1996; written objections and requests for a
hearing by August 1, 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: Julius Smith, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3091.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of June 17, 1993 (58 FR 33447), FDA announced that a petition
(FAP 3B4374) had been filed by DSM Engineering Plastics, 501 Crescent
Ave., Reading, PA 19512-5051 (currently c/o Keller and Heckman, 1001 G
St. NW., suite 500 West, Washington, DC 20001). The petitioner proposed
to amend the food additive regulations in Sec. 177.1500 Nylon resins
(21 CFR 177.1500) to provide for the safe use of Nylon 46 resins, which
are manufactured by the condensation of 1,4-butanediamine and adipic
acid, in membrane filters intended to contact alcoholic beverages.
FDA has evaluated the data in the petition and other relevant
material. The agency concludes that the proposed use of the additive is
safe and that Sec. 177.1500 should therefore 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 August 1, 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.
[[Page 34371]]
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)(15) and
in the table in paragraph (b) by adding new entry ``15'' to read as
follows:
Sec. 177.1500 Nylon resins.
* * * * *
(a) * * *
(15) Nylon 46 resins (CAS Reg. No. 50327-77-0) are manufactured by
the condensation of 1,4-butanediamine and adipic acid.
(b) * * *
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Maximum extractable fraction in selected solvents (expressed in
Melting point percent by weight of resin)
Nylon resins Specific (degrees Solubility in Viscosity No. (mL/ -----------------------------------------------------------------------
gravity Fahrenheit) boiling 4.2N HCL g) 95 percent ethyl
Water alcohol Ethyl acetate Benzene
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* * * * * * *
15. Nylon 46 resins for use only in food- 1.18 plus- 551-592 Dissolves in 1 ................... 0.3 0.2 0.2 0.3
contact membrane filters intended for minus 0.015 hour
repeated use. The finished membrane filter
is intended to contact beverages containing
no more than 13 percent alcohol, under
conditions of use E, F, and G listed in
table 2 of Sec. 176.170(c) of this chapter.
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* * * * *
Dated: June 12, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-16769 Filed 7-1-96; 8:45 am]
BILLING CODE 4160-01-F