[Federal Register Volume 61, Number 251 (Monday, December 30, 1996)]
[Rules and Regulations]
[Pages 68622-68623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-33099]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 96F-0101]
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 triisopropanolamine
as a component of phosphorous acid, cyclic butylethyl propanediol,
2,4,6-tri-tert-butylphenyl ester, as 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 December 30, 1996; written objections and requests for
a hearing by January 29, 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 June 19, 1996 (61 FR 31141), FDA announced that a food
additive petition (FAP 6B4507) had been filed by General Electric Co.,
1 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 safe use
of triisopropanolamine as a component of phosphorous acid, cyclic
butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester, as a
stabilizer for olefin polymers intended for use in contact with food.
The additive, triisopropanolamine, was identified in the filing notice
(61 FR
[[Page 68623]]
31141) as being a component of the stabilizer, phosphorous acid, cyclic
butylphenyl propanediol, 2,4,6-tri-tert-butylphenyl ester. The correct
identity of the stabilizer is phosphorous acid, cyclic butylethyl
propanediol, 2,4,6-tri-tert-butylphenyl ester and is used throughout
this final rule.
FDA has evaluated the 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
therefore, 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 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 29, 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).
Sec. 178.2010 [Amended]
2. Section 178.2010 Antioxidants and/or stabilizers for polymers is
amended in the table in paragraph (b) in the entry for ``Phosphorous
acid, cyclic butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester
(CAS Reg. No. 161717-32-4'' by adding the phrase ``, which may contain
not more than 1 percent by weight of triisopropanolamine (CAS Reg. No.
122-20-3)'' before the period.
Dated: December 19, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-33099 Filed 12-27-96; 8:45 am]
BILLING CODE 4160-01-F
