[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
