[Federal Register Volume 63, Number 205 (Friday, October 23, 1998)]
[Rules and Regulations]
[Page 56789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28409]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 96F-0164]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations for the use of sodium 2,2'-methylenebis(4,6-di-
tert-butylphenyl)phosphate as a clarifying agent in high density
polyethylene intended for use in contact with food. When the regulation
was last amended, the agency inadvertently omitted the limitation on
the use level for the additive. This document corrects that inadvertent
omission.
EFFECTIVE DATE: October 23, 1998.
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 the Federal Register of December 16, 1996
(61 FR 65942), FDA published a document amending the food additive
regulations to provide for the expanded safe use of sodium 2,2'-
methylenebis(4,6-di-tert-butylphenyl)phosphate as a clarifying agent in
high density polyethylene intended for use in contact with food. The
limitation added by this document was inadvertently omitted from the
December 16, 1996, final rule due to an administrative error. Limiting
the use level of the additive to no more than 0.30 percent by weight of
the olefin polymers is supported by the administrative record of the
final rule. Accordingly, FDA is amending the regulation to accord with
the record.
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, 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 178.3295 is amended in the table in the entry for
``Sodium 2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate'' by
revising entry ``3.'' under the heading ``Limitations'' to read as
follows:
Sec. 178.3295 Clarifying agents for polymers.
* * * * *
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Substances Limitations
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* * * * * *
*
Sodium 2,2'-methylenebis(4,6-di-tert- For use only:
butylphenyl)phosphate (CAS Reg. No. 85209-91-2) * * * * *
3. As a clarifying agent at a level not exceeding 0.30
percent by weight of olefin polymers complying with
Sec. 177.1520(c) of this chapter, item 2.2, where the
finished polymer contacts food only of types I, II, IV-
B, VI-A, VI-B, and VII-B as identified in Table 1 of
Sec. 176.170(c) of this chapter, and limited to
conditions of use B through H described in Table 2 of
Sec. 176.170(c) of this chapter, or foods of types
III, IV-A, V, VI-C, and VII-A as identified in Table 1
of Sec. 176.170(c) of this chapter and limited to
conditions of use C through G described in Table 2 of
Sec. 176.170(c) of this chapter.
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Dated: October 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-28409 Filed 10-22-98; 8:45 am]
BILLING CODE 4160-01-F
