[Federal Register Volume 59, Number 237 (Monday, December 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30495]


[[Page Unknown]]

[Federal Register: December 12, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 88F-0322]

 

Indirect Food Additives: Adhesives and Components of Coatings

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 a polyester resin 
prepared from terephthalic acid, isophthalic acid, succinic anhydride, 
ethylene glycol, diethylene glycol, and 2,2-dimethyl-1,3-propanediol as 
a component of polymeric coatings intended to contact aqueous and 
alcoholic foods. This action is in response to a petition filed by 
Nippon Gohsei (U.S.A.) Co., Ltd.

DATES: Effective December 12, 1994; written objections and requests for 
a hearing by January 11, 1995.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
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, 202-418-3080.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of November 4, 1988 (53 FR 44670), corrected on December 23, 
1988 (53 FR 51950), FDA announced that a food additive petition (FAP 
7B4017) had been filed by Nippon Gohsei (U.S.A.) Co., Ltd., 747 Third 
Ave., New York, NY 10017. The petition proposed that the food additive 
regulations in Sec. 175.300 Resinous and polymeric coatings (21 CFR 
175.300) be amended to provide for the safe use of a polyester resin 
prepared from terephthalic acid, isophthalic acid, succinic anhydride, 
ethylene glycol, diethylene glycol, and 2,2-dimethyl-1,3-propanediol as 
a component of polymeric coatings intended to contact alcoholic foods.
    Upon further review of the petition, the agency noted that the 
petitioner had also requested use of the additive in contact with 
aqueous foods in addition to its use in contact with alcoholic foods. 
In a notice published in the Federal Register of June 15, 1994 (59 FR 
30803), FDA amended the November 4, 1988, notice to state that the 
petitioner had requested that the food additive regulations be amended 
to provide for the safe use of the additive in contact with aqueous and 
alcoholic foods.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive is safe and 
that Sec. 175.300(b)(3) 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 21 CFR 
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 January 11, 1995, 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 175

    Adhesives, 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 175 is amended as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

    1. The authority citation for 21 CFR part 175 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 175.300 is amended in paragraph (b)(3) by adding new 
paragraph (xxxvii) to read as follows:


Sec. 175.300  Resinous and polymeric coatings.

* * * * *
    (b) * * *
    (3) * * *
    (xxxvii) Polymeric resin as a coating component prepared from 
terephthalic acid, isophthalic acid, succinic anhydride, ethylene 
glycol, diethylene glycol, and 2,2-dimethyl-1,3-propanediol for use in 
contact with aqueous foods and alcoholic foods containing not more than 
20 percent (by volume) of alcohol under conditions of use D, E, F, and 
G described in Table 2 of Sec. 176.170 of this chapter. The resin shall 
contain no more than 30 weight percent of 2,2-dimethyl-1,3-propanediol.
* * * * *

    Dated: November 30, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-30495 Filed 12-9-94; 8:45 am]
BILLING CODE 4160-01-F