[Federal Register Volume 63, Number 35 (Monday, February 23, 1998)]
[Rules and Regulations]
[Pages 8852-8853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4530]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 97F-0375]
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 expanded safe use of
phosphorous acid, cyclic butylethyl propanediol, 2,4,6-tri-tert-
butylphenyl ester, which may contain up to 1 percent by weight of
triisopropanolamine, as an antioxidant and/or stabilizer for olefin
copolymers intended for use in contact with food. This action is in
response to a petition filed by General Electric Co.
DATES: The regulation is effective February 23, 1998; written
objections and requests for a hearing by March 25, 1998.
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-215), 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 September 16, 1997 (62 FR 48665), FDA announced that a food
additive petition (FAP 7B4553) had been filed by General Electric Co.,
One Lexan Lane, Mt. Vernon, IN 47620-9364. 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
expanded safe use of phosphorous acid, cyclic butylethyl propanediol,
2,4,6-tri-tert-butylphenyl ester, which may contain up to 1 percent by
weight of triisopropanolamine, as an antioxidant and/or stabilizer for
olefin copolymers complying with 21 CFR 177.1520(c), items 3.1 and 3.2,
intended for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that the proposed use
of the additive is safe and the additive will achieve its intended
technical effect. Therefore, the regulations in Sec. 178.2010
[[Page 8853]]
should be amended as set forth below. In amending the regulation in
Sec. 178.2010, the agency updated the reference to items 3.1 and 3.2
found in Sec. 177.1520(c) to include the current subparts listed for
these items, i.e., 3.1a, 3.1b, 3.2a, and 3.2b.
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 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 rule as announced in the notice of filing for the
petition. No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
Any person who will be adversely affected by this regulation may at
any time on or before March 25, 1998, 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: 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 ``Phosphorous acid, cyclic butylethyl
propanediol, 2,4,6-tri-tert-butylphenyl ester'' in item ``3.'' 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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* * * * * *
*
Phosphorous acid, cyclic butylethyl propanediol, 2,4,6- For use only:
tri-tert-butylphenyl ester (CAS Reg. No. 161717-32-4), * * *
which may contain not more than 1 percent by weight of 3. At levels not to exceed 0.1 percent by weight of
triisopropanolamine (CAS Reg. No. 122-20-3). olefin copolymers complying with Sec. 177.1520(c) of
this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b, having
a density less than 0.94 grams per cubic centimeter,
in contact with food only of types III, IV, V, VI-A,
VI-C, VII, VIII, and IX and under conditions of use B,
C, D, E, F, G, and H as described in Tables 1 and 2 of
Sec. 176.170(c) of this chapter; provided that the
food-contact surface does not exceed 0.003 inch (0.076
mm) in thickness.
* * * * * *
*
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Dated: February 2, 1998.
L. Robert Lake,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 98-4530 Filed 2-20-98; 8:45 am]
BILLING CODE 4160-01-F
