[Federal Register Volume 59, Number 93 (Monday, May 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11785]
[[Page Unknown]]
[Federal Register: May 16, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 92F-0162]
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 expand the safe use of sodium 2,2'-
methylenebis(4,6-di-tert-butylphenyl)phosphate as a clarifying agent in
polypropylene articles intended for contact with all types of food to
include frozen or refrigerated storage of ready-prepared foods intended
to be reheated in the container at the time of use. This action is in
response to a petition filed by Asahi Denka Kogyo K. K.
DATES: Effective May 16, 1994; written objections and requests for a
hearing by June 15, 1994.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Vir Anand, Center for Food Safety and
Applied Nutrition (HFS-216), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-254-9500.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of May 4, 1992 (57 FR 19133), FDA announced that a food
additive petition (FAP 2B4300) had been filed by Asahi Denka Kogyo K.
K., c/o Japan Technical Information Center, Inc., 1002 Pennsylvania
Ave. SE., Washington, DC 20003, proposing that the food additive
regulations be amended in Sec. 178.3295 Clarifying agents for polymers
(21 CFR 178.3295) to expand the safe use of sodium 2,2'-
methylenebis(4,6-di-tert-butylphenyl)phosphate (CAS Reg. No. 85209-1-2)
as a clarifying agent in polypropylene articles intended for contact
with food.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the additive is safe and
that the regulations in Sec. 178.3295 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 21 CFR
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 June 15, 1994, 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 178.3295 is amended in the table by revising the entry
for ``Sodium 2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate'' 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- For use only as a clarifying agent
tert-butylphenyl)phosphate (CAS at a level not exceeding 0.30
Reg. No. 85209-91-2). percent by weight of olefin
polymers complying with Sec.
177.1520(c) of this chapter, items
1.1, 3.1, or 3.2 (where the
copolymers complying with items
3.1 and 3.2 contain not less than
85 weight percent of polymer units
derived from polypropylene). The
finished polymers contact foods
only of types I, II, IV-B, VI-B,
VII-B, and VIII 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 all types,
limited to conditions of use C
through H described in Table 2 of
Sec. 176.170(c) of this chapter.
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Dated: May 6, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-11785 Filed 5-13-94; 8:45 am]
BILLING CODE 4160-01-F
