[Federal Register Volume 62, Number 10 (Wednesday, January 15, 1997)]
[Rules and Regulations]
[Pages 2014-2016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-946]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 93F-0309]
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 di-tert-
butylphenyl phosphonite condensation product with biphenyl as an
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antioxidant/stabilizer for olefin polymers and for rubber articles
intended for repeated use in contact with food. This action is in
response to a petition filed by Sandoz AG (currently, Clariant Huningue
S.A.).
DATES: Effective January15, 1997; written objections and requests for a
hearing by February 14, 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 October 7, 1993 (58 FR 52315), FDA announced that a food
additive petition (FAP 3B4395) had been filed by Sandoz AG (currently,
Clariant Huningue S.A.), c/o Registration and Consulting Co., Ltd., CH-
4452 Itingen/Basel, Switzerland. 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 di-tert-butylphenyl phosphonite condensation product with
biphenyl as an antioxidant/stabilizer for olefin polymers and for
rubber articles intended for repeated use in contact with food.
Based on more precise analytical data on the isomeric composition
of the antioxidant, the petitioner has obtained a new CAS Reg. No. for
the subject additive. This final rule, therefore, uses the new,
corrected, CAS Reg. No., 119345-01-6.
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 food additive will have the 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 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 February 14, 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 ``Di-tert-butylphenyl phosphonite condensation
product with biphenyl * * *'' under the heading ``Substances'' and by
revising entries ``1.'' and ``4.'' and adding a new entry ``5.'' under
the heading ``Limitations'' to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
* * * * *
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Substances Limitations
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* * * * *
Di-tert-butylphenyl phosphonite condensation product with For use only:
biphenyl (CAS Reg. No. 119345-01-6) produced by the condensation 1. At levels not to exceed 0.1 percent by
of 2,4-di-tert-butylphenol with the Friedel-Crafts addition weight of olefin polymers complying with
product (phosphorus trichloride and biphenyl) so that the food Sec. 177.1520(c) of this chapter, items
additive has a minimum phosphorus content of 5.4 percent, an 1.1, 1.2, 1.3, 3.2b, 3.3a, 3.3b, 3.4, 3.5,
acid value not exceeding 10 mg KOH/gm, and a melting range of 85 and 3.1a (where the density is not less than
C to 110 C (185 F to 230 F). 0.85 gram per cubic centimeter and not more
than 0.91 gram per cubic centimeter); and
2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, and 3.6
(where the density is not less than 0.94
gram per cubic centimeter) and 5.
* * * * *
4. At levels not to exceed 0.15 percent by
weight of olefin polymers complying with
Sec. 177.1520(c) of this chapter, items
2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5,
and 3.6 (where the polyethylene component
has a density less than 0.94 gram per cubic
centimeter).
5. At levels not to exceed 0.1 percent by
weight of repeated use rubber articles
complying with Sec. 177.2600 of this
chapter.
* * * * *
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Dated: December 19, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-946 Filed 1-14-97; 8:45 am]
BILLING CODE 4160-01-F
