[Federal Register Volume 60, Number 186 (Tuesday, September 26, 1995)]
[Rules and Regulations]
[Pages 49506-49507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23776]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 94F-0005]
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 oxidized
bis(hydrogenated tallow alkyl)amines as a process stabilizer for
polypropylene intended for use in contact with food. This action is in
response to a petition filed by Ciba-Geigy Corp.
DATES: Effective September 26, 1995; written objections and requests
for a hearing by October 26, 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: Daniel N. Harrison, 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 February 24, 1994 (59 FR 8995), FDA announced that a food
additive petition (FAP 4B4410) had been filed by Ciba-Geigy Corp.,
Seven Skyline Dr., Hawthorne, NY 10532. The petition proposed that the
food additive regulations in Sec. 178.2010 Antioxidants and/or
stabilizers for polymers (21 CFR 178.2010) be amended to provide for
the safe use of oxidized bis(hydrogenated tallow alkyl)amines (CAS Reg.
No. 143925-92-2) as a process stabilizer for polypropylene intended for
use in contact with food.
FDA has evaluated data in the petition and other relevant material.
The agency is not including the Chemical Abstracts Service Registry
number (CAS Reg. No. 143925-92-2) in the regulation because it
corresponds to the pure hydroxylamine component of the additive and not
to the additive itself. The agency concludes that the proposed food
additive use is safe, 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 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 October 26, 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
[[Page 49507]]
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
alphabetically adding a new entry under the headings ``Substances'' and
``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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* * * * *
Oxidized bis(hydrogenated tallow For use only at levels not to
alkyl)amines. exceed 0.05 percent by weight of
olefin polymers complying with
Sec. 177.1520(c) of this chapter,
item 1.1, 1.2, or 1.3: The
finished polymers may be used in
contact with food types I, II, IV-
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 with food types III,
IV-A, V, VI, VII-A, and IX
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.
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Dated: September 13, 1995.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and
Applied Nutrition.
[FR Doc. 95-23776 Filed 9-25-95; 8:45 am]
BILLING CODE 4160-01-F