[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Rules and Regulations]
[Pages 26842-26844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 92F-0285]


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 expanded safe use of bis(p-
ethylbenzylidene) sorbitol as a clarifying agent for polypropylene 
articles intended for use in contact with food. This action responds to 
a petition filed by Mitsui Toatsu Chemicals, Inc. (now Mitsui 
Chemicals, Inc.).


[[Page 26843]]


DATES: Effective May 18, 1999; written objections and requests for a 
hearing by June 17, 1999

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 10, 1992 (57 FR 35595), FDA announced that a food 
additive petition (FMY 2B4330) had been filed by Mitsui Toatsu 
Chemicals, Inc., c/o 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 expanded safe use of bis(p-ethylbenzylidene) sorbitol 
as a clarifying agent for polypropylene articles intended for use in 
contact with food. Subsequent to the filing of the petition, Mitsui 
Toatsu Chemicals, Inc., merged with Mitsui Chemicals, Inc. Therefore, 
the current name of the petitioner is Mitsui Chemicals, Inc.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that the proposed use 
of the additive is safe, that the additive will achieve its intended 
technical effect, and that therefore 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.
     This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Any person who will be adversely affected by this regulation may at 
any time on or before June 17, 1999, 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: 21 U.S.C. 321, 342, 348, 379e.

    2. Section 178.3295 is amended in the table by revising the entry 
for ``Bis(p-ethylbenzylidene) sorbitol'' to read as follows:


Sec. 178.3295  Clarifying agents for polymers.

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             Substances                          Limitations
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Bis(p-ethylbenzylidene) sorbitol     For use only as a clarifying agent
 (CAS Reg. No. 79072-96-1).           at a level not to exceed 0.35
                                      percent by weight of olefin
                                      polymers complying with Sec.
                                      177.1520(c) of this chapter, items
                                      1.1a, 1.1b, 3.1a, 3.2a, or 3.2b,
                                      where the copolymers complying
                                      with items 3.1a, 3.2a, or 3.2b
                                      contain not less than 85 weight
                                      percent of polymer units derived
                                      from propylene.
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[[Page 26844]]

    Dated: May 3, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-12394 Filed 5-17-99; 8:45 am]
BILLING CODE 4160-01-F