[Federal Register Volume 62, Number 124 (Friday, June 27, 1997)]
[Rules and Regulations]
[Pages 34629-34631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16795]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 97F-0062]
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
triisopropanolamine as a component of phosphorous acid, cyclic
butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester, a stabilizer
for olefin polymers intended for use in contact with food. This action
is in response to a petition filed by General Electric Co.
DATES: Effective June 27, 1997; written objections and requests for a
hearing by July 28, 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-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 February 28, 1997 (62 FR 9197), FDA announced that a food
additive petition (FAP 7B4535) 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 triisopropanolamine as a component of phosphorous
acid, cyclic butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester,
a stabilizer for olefin polymers intended for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that: (1) The proposed use of the additive is
safe, (2) the additive will achieve its intended technical effect, and
(3) 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
[[Page 34630]]
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 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 July 28, 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 ``Phosphorous acid, cyclic butylethyl
propanediol, 2,4,6-tri-tert-butylphenyl ester'' 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 propanediol, 2,4,6- For use only:
tri-tert-butylphenyl ester (CAS Reg. No. 161717-32-4), 1. At levels not to exceed 0.2 percent by weight of
which may contain not more than 1 percent by weight of olefin polymers complying with Sec. 177.1520(c) of
triisopropanolamine (CAS Reg. No. 122-20-3). 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, provided that the finished polymer
contacts foods 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.
2. At levels not to exceed 0.1 percent by weight of
olefin polymers complying with Sec. 177.1520(c) of
this chapter, items 1.1, 1.2, or 1.3, that contact
food of types III, IV, V, VI-A, VI-C, VII, VIII, and
IX as described in Table 1 of Sec. 176.170(c) of this
chapter, only under conditions of use C, D, E, F, and
G as described in Table 2 of Sec. 176.170(c) of this
chapter.
3. At levels not to exceed 0.1 percent by weight of
olefin copolymers complying with Sec. 177.1520(c) of
this chapter, items 3.1 or 3.2, 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 C, D, E, F, and G
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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[[Page 34631]]
Dated: June 16, 1997.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 97-16795 Filed 6-26-97; 8:45 am]
BILLING CODE 4160-01-F
