[Federal Register Volume 61, Number 127 (Monday, July 1, 1996)]
[Rules and Regulations]
[Pages 33846-33847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16662]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 96F-0052]
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 additional safe use of
dimethyldibenzylidene sorbitol as a clarifying agent for propylene
homopolymers and high-propylene copolymer articles intended for contact
with food. This action is in response to a petition filed by Milliken &
Co.
DATES: Effective July 1, 1996; written objections and requests for a
hearing by July 31, 1996.
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 February 26, 1996 (61 FR 7111), FDA announced that a food
additive petition (FAP 6B4495) had been filed by Milliken & Co., c/o
Keller and Heckman, 1001 G St. NW., suite 500 West, Washington, DC
20001. The petition proposed to amend the food additive regulations in
Sec. 178.3295 Clarifying agents for polymers (21 CFR 178.3295) to
provide for the additional safe use of dimethyldibenzylidene sorbitol
as a clarifying agent for olefin polymers complying with Sec. 177.1520
(21 CFR 177.1520), items 1.1, 3.1, and 3.2, for contact with food under
condition of use A, described in Table 2 of Sec. 176.170(c) of this
chapter.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the additive is safe,
that the additive will have the intended technical effect, 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 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 July 31, 1996, 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
[[Page 33847]]
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 ``Dimethyldibenzylidene sorbitol'' to read as follows:
Sec. 178.3295 Clarifying agents for polymers.
* * * * *
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Substances Limitations
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* * * * *
Dimethyldibenzylidene sorbitol (CAS Reg. For use only as a clarifying
No 135861-56-2). agent 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.
The finished polymers shall
be used in contact with
food under conditions of
use A through H described
in Table 2 of Sec.
176.170(c) of this chapter.
* * * * *
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Dated: June 12, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-16662 Filed 6-28-96; 8:45 am]
BILLING CODE 4160-01-F
