[Federal Register Volume 64, Number 91 (Wednesday, May 12, 1999)]
[Rules and Regulations]
[Pages 25428-25430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 98F-0797]


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 5,7-bis(1,1-
dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-
xylene as an antioxidant and/or stabilizer for propylene polymers and 
copolymers intended for use in contact with food. This action is in 
response to a petition filed by Ciba Specialty Chemicals Corp.


[[Page 25429]]


DATES: The regulation is effective May 12, 1999. Submit written 
objections and requests for a hearing by June 11, 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:  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 a notice published in the Federal 
Register of September 24, 1998 (63 FR 51074), FDA announced that a food 
additive petition (FAP 8B4625) had been filed by Ciba Specialty 
Chemicals Corp., 540 White Plains Rd., Tarrytown, NY 10591-9005. The 
petition proposed to amend the food additive regulations in 
Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR 
178.2010) to provide for the expanded safe use of 5,7-bis(1,1-
dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-
xylene as an antioxidant and/or stabilizer for olefin polymers intended 
for use in contact with food. Upon further review, FDA has determined 
that the petition proposed to expand the safe use of this additive for 
use in polypropylene polymers and copolymers only.
    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed use of the additive as an antioxidant and/or stabilizer in 
olefin polymers intended for use in contact with food is safe, and (2) 
the additive will have the intended technical effect. Therefore, the 
regulations in Sec. 178.2010 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 previously considered the potential environmental 
effects of this rule as announced in the notice of filing for the 
petition. No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.
    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 11, 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 178.2010 is amended in the table in paragraph (b), in 
the entry for 5,7-bis(1,1-dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, 
reaction products with o-xylene by revising entry ``2'' under the 
headings ``Substances'' and ``Limitations'' to read as follows:


Sec. 178.2010   Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

[[Page 25430]]



 
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             Substances                          Limitations
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                  *                  *                  *
5,7-Bis(1,1-dimethylethyl)-3-        For use only:
 hydroxy-2(3H)-benzofuranone,        * * *
 reaction products with o-xylene     2. At levels not to exceed 0.02
 (CAS Reg. No. 181314-48-7).          percent by weight of:
                                     (a) Propylene polymers and
                                      copolymers complying with Sec.
                                      177.1520(c) of this chapter, items
                                      1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4,
                                      or 3.5. The finished polymer may
                                      only be used in contact with food
                                      of types identified in Sec.
                                      176.170(c) of this chapter, Table
                                      1, under Categories III, IV-A, V,
                                      VI-C, VII-A, and IX, and under
                                      conditions of use B through H
                                      described in Table 2 of Sec.
                                      176.170(c) of this chapter; or
                                     (b) Ethylene polymers and
                                      copolymers complying with Sec.
                                      177.1520(c) of this chapter, items
                                      2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a,
                                      or 3.6 (where the density of each
                                      of these polymers is at least 0.94
                                      gram per cubic centimeter), or 5.
                                      The finished polymers may only be
                                      used in contact with food of the
                                      types identified in Sec.
                                      176.170(c) of this chapter, Table
                                      1, under Categories III, IV-A, V,
                                      VI-C, VII-A, and IX, and under
                                      conditions of use B through H
                                      described in Table 2 of Sec.
                                      176.170(c) of this chapter;
                                      provided that the finished food-
                                      contact articles have a volume of
                                      at least 18.9 liters (5 gallons).
 
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                  *                  *                  *
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    Dated: May 3, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-11899 Filed 5-11-99; 8:45 am]
BILLING CODE 4160-01-F