[Federal Register Volume 60, Number 185 (Monday, September 25, 1995)]
[Rules and Regulations]
[Pages 49337-49339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23598]
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[[Page 49338]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 95F-0149]
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 phosphorous acid,
cyclic butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester as an
antioxidant and/or stabilizer in olefin polymers intended for use in
contact with food. This action is in response to a petition filed by
General Electric Co.
DATES: Effective September 25, 1995; written objections and requests
for a hearing by October 25, 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, 202-418-3081.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of June 21, 1995 (60 FR 32329), FDA announced that a food
additive petition (FAP 5B4463) had been filed by General Electric Co.,
501 Avery St., Parkersburg, WV 26102-1868. The petition proposed that
the food additive regulations be amended in Sec. 178.2010 Antioxidants
and/or stabilizers for polymers (21 CFR 178.2010) to provide for the
safe use of phosphorous acid, cyclic butylethyl propanediol, 2,4,6-tri-
tert-butylphenyl ester as an antioxidant and/or stabilizer in olefin
polymers 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, 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 25, 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 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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* * * *
* * *
Phosphorous acid, cyclic butylethyl For use only at levels not to
propanediol, 2,4,6-tri-tert- exceed 0.2 percent by weight of
butylphenyl ester (CAS Reg. No. olefin polymers complying with
161717-32-4). Sec. 177.1520(c) of this chapter,
items 1.1, 1.2, or 1.3, and items
2.1, 2.2, or 2.3 (where the
density of these polymers is not
less than 0.94 gram per cubic
centimeter), and items 3.1 or 3.2,
provide that the finished polymer
contacts food only of types I, II,
and VI-B as described in Table 1
of Sec. 176.170(c) of this
chapter only under conditions of
use B, C, D, E, F, G, and H as
described in Table 2 of Sec.
176.170(c) of this chapter.
* * * *
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[[Page 49339]]
Dated: September 15, 1995.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and
Applied Nutrition.
[FR Doc. 95-23598 Filed 9-22-95; 8:45 am]
BILLING CODE 4160-01-F