[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