[Federal Register Volume 61, Number 242 (Monday, December 16, 1996)]
[Rules and Regulations]
[Pages 65943-65944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31860]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 93F-0318]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers
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 2-[[2,4,8,10-
tetrakis(1,1-dimethylethyl)dibenzo[d,f][1,3,2]-dioxaphosphepin-6-
yl]oxy]-N, N-bis[2-[[2,4,8,10-tetrakis(1,1-dimethylethyl)dibenzo[d,f]
[1,3,2]dioxaphosphepin-6-yl]oxy]ethyl]ethanamine as a process
stabilizer in high density polyethylene and polypropylene polymers
intended for use in contact with food. This action is in response to a
petition filed by Ciba-Geigy Corp.
DATES: Effective December 16, 1996; written objections and requests for
a hearing by January 15, 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 October 4, 1993 (58 FR 51631), FDA announced that a food
additive petition (FAP 3B4398) had been filed by Ciba-Geigy Corp.,
Seven Skyline Dr., Hawthorne, NY 10532. The petition proposed to amend
the food additive regulations in Sec. 178.2010 Antioxidants and/or
stabilizers for polymers (21 CFR 178.2010) to provide for the safe use
of 2-[[2,4,8,10-tetrakis(1,1-dimethylethyl)dibenzo
[d,f][1,3,2]dioxaphosphepin-6-yl]oxy]-N, N-bis[2-[[2,4,8,10-
tetrakis(1,1-dimethylethyl)dibenzo [d,f][1,3,2]dioxaphosphepin-6-
yl]oxy]ethyl]ethanamine as a process stabilizer in high density
polyethylene and polypropylene polymers complying with 21 CFR 177.1520
intended for use in contact with food.
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 achieve its intended technical effect, and that
the regulations in Sec. 178.2010 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
[[Page 65944]]
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 January 15, 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 178
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 178 is amended as follows:
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
1. The authority citation for 21 CFR part 178 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 178.2010 is amended in the table in paragraph (b) by
revising the entry for ``2-[[2,4,8,10-tetrakis(1,1-
dimethylethyl)dibenzo [d,f][1,3,2]dioxaphosphepin-6-yl]oxy]-N, N-bis[2-
[[2,4,8,10-tetrakis(1,1-dimethylethyl)dibenzo
[d,f][1,3,2]dioxaphosphepin-6-yl]oxy]ethyl]ethanamine'' under the
heading ``Limitations'' to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
* * * * *
(b) * * *
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Substances Limitations
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* * * *
* * *
2-[[2,4,8,10-Tetrakis(1,1- For use only at levels not to
dimethylethyl)dibenzo[d,f][1,3,2]- exceed 0.075 percent by weight of
dioxaphosphepin-6-yl]oxy]-N,N- olefin copolymers complying with
bis[2-[[2,4,8,10-tetrakis(1,1- Sec. 177.1520(c) of this chapter,
dimethylethyl)dibenzo[d,f][1,3,2]d items 1.1, 1.2, 1.3, 2.1, 2.2, or
ioxaphosphepin-6- 2.3: Provided, That the density of
yl]oxy]ethyl]ethanamine (CAS Reg. the olefin polymers complying with
No. 80410-33-9). items 2.1, 2.2, or 2.3 is not less
than 0.94 gram per cubic
centimeter: And further provided,
That the finished polymers contact
food only of Types I, II, IV-B, VI-
A, VI-B, VII-B, and VIII described
in Table 1, of Sec. 176.170(c) of
this chapter, under conditions of
use B through H described in Table
2 of Sec. 176.170(c) of this
chapter and food only of Types
III, IV-A, V, VI-C, VII-A, and IX
described in Table 1 of Sec.
176.170(c) of this chapter, under
conditions of use C through G
described in Table 2 of Sec.
176.170(c) of this chapter.
* * * *
* * *
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Dated: November 27, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-31860 Filed 12-13-96; 8:45 am]
BILLING CODE 4160-01-F