[Federal Register Volume 59, Number 56 (Wednesday, March 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6764]
[[Page Unknown]]
[Federal Register: March 23, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 93F-0112]
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
dimethyldibenzylidene sorbitol as a clarifying agent for polypropylene
and high-propylene olefin copolymers intended for use in contact with
food. This action is in response to a petition filed by Milliken
Chemical.
DATES: Effective March 23, 1994; written objections and requests for a
hearing by April 22, 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 D. 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 April 22, 1993 (58 FR 21583), FDA announced that a food
additive petition (FAP 2B4341) had been filed by Milliken Chemical, c/o
1001 G St. NW., suite 500 West, Washington, DC 20001, proposing that
Sec. 178.3295 Clarifying agents for polymers (21 CFR 178.3295) be
amended to provide for the safe use of dimethyldibenzylidene sorbitol
as a clarifying agent in polypropylene articles intended for use in
contact with food.
Upon further review of the petition, the agency noted that the
petitioner had requested use of the additive as a clarifying agent in
high-propylene olefin copolymers in addition to its use in
polypropylene films. In a notice published in the Federal Register of
January 4, 1994 (59 FR 307), FDA amended the filing notice of April 22,
1993, to state that the petitioner had requested that the food additive
regulations be amended to provide for the safe use of
dimethyldibenzylidene sorbitol as a clarifying agent in polypropylene
and high-propylene olefin copolymers for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the food 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 (insert date 30 days after date of publication in
the Federal Register), 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 alphabetically
adding a new entry under the headings ``Substances'' and
``Limitations'' to read as follows:
Sec. 178.3295 Clarifying agents for polymers.
* * * * *
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Substances Limitations
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Dimethyldibenzylidene sorbitol (CAS For use only as a clarifying agent
Reg. No. 135861-56-2). at a level not to exceed 0.4
percent by weight of olefin
polymers complying with Sec.
177.1520(c) of this chapter, items
1.1, 3.1, and 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; in
contact with all food types under
conditions of use B, C, D, E, F,
G, and H, described in Table 2 of
Sec. 176.170(c) of this chapter.
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Dated: March 14, 1994.
L. Robert Lake,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-6764 Filed 3-22-94; 8:45 am]
BILLING CODE 4160-01-F
