[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Rules and Regulations]
[Pages 13506-13508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6667]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0213]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 13507]]

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the expanded safe use of 
phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-
methylphenyl)ester as an antioxidant in polypropylene homopolymer and 
copolymers not to exceed 0.25 percent by weight of polypropylene 
homopolymer and copolymers. This action is in response to a petition 
filed by Asahi Denka Kogyo K.K.

DATES: The regulation is effective March 19, 1999; submit written 
objections and requests for a hearing by April 19, 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, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-206), 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 9, 1997 (62 FR 31433), FDA announced that a petition 
(FAP 7B4542) had been filed by Asahi Denka Kogyo K.K., Shirahata 5-
Chome, Urawa City, Saitama 366, Japan. 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 phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-
butyl-4-methylphenyl) ester for use: (1) At levels not to exceed 0.25 
percent by weight of olefin copolymers complying with Sec. 177.1520 (21 
CFR 177.1520) in contact with foods of types I, II, III, IV-B, VI-B, 
and VIII, as described in Table 1, and under conditions of use B 
through H, described in Table 2 of Sec. 176.170(c) (21 CFR 176.170(c)), 
of this chapter, and with foods types IV-A, V, VI-A, VI-C, VII-A, and 
IX, under conditions of use C through G, as described in 
Sec. 176.170(c), Tables 1 and 2, respectively; and (2) at levels not to 
exceed 0.10 percent by weight of either olefin copolymers or 
polypropylene complying with Sec. 177.1520 which may be used in contact 
with foods of types IV-A, V, VI-C, VII-A, and IX, under conditions of 
use H, as described in Sec. 176.170(c) of this chapter, Tables 1 and 2 
respectively. When the petition was filed on June 9, 1997, it contained 
an environmental assessment (EA). In the notice of filing, the agency 
announced that it was placing the EA on display at the Dockets 
Management Branch for public review and comment. No comments were 
received.
     Subsequent to filing of the petition, the petitioner requested 
that the petition be amended to permit use of the subject additive as 
an antioxidant in polypropylene homopolymer and copolymers, at a use 
level not to exceed 0.25 percent by weight, for all food types 
described in Table 1 under conditions of use B through H as described 
in Table 2 of Sec. 176.170(c) of this chapter. Therefore, in a notice 
published in the Federal Register of August 28, 1998 (63 FR 46053), FDA 
announced that the filing notice of June 9, 1997, was amended to 
include the petitioned additive, phosphorous acid, cyclic 
neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl) ester for use 
as an antioxidant in polypropylene homopolymer and copolymers for all 
food types under conditions of use B through H.
     In the amended filing notice of August 28, 1998, the agency 
incorrectly stated that it was placing the EA for the petition on 
display at the Dockets Management Branch for public review and comment. 
Instead, the original EA was maintained at the Dockets Management 
Branch. On October 15, 1998, the petitioner submitted a claim of 
categorical exclusion under new Sec. 25.32(i) (21 CFR 25.32(i)), in 
accordance with the procedures in 21 CFR 25.15(a) and (d). Because the 
agency had not completed the review of an EA for the use of the subject 
additive that was described in the amended filing notice, the agency 
reviewed the claim of categorical exclusion under Sec. 25.32(i) for 
this final rule.
     FDA has evaluated data in the petition and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed use of the additive is safe, (2) the additive will achieve its 
intended technical effect, and therefore, (3) that 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 determined under Sec. 25.32(i) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
     This final rule contains no collection 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 April 19, 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 to read 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) by 
revising the entry for ``phosphorous acid, cyclic neopentanetetrayl 
bis(2,6-di-tert-butyl-4-methylphenyl) ester'' in item ``1.'' under the 
heading ``Limitations'' to read as follows:

[[Page 13508]]

Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
     (b) * * *

 
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             Substances                          Limitations
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*                    *                    *                      *
                     *                    *                    *
Phosphorous acid, cyclic             For use only:
 neopentanetetrayl bis(2,6-di-tert-  1. At levels not to exceed 0.25
 butyl-4-methylphenyl)ester (CAS      percent by weight of polypropylene
 Reg. No. 80693-00-1).                homopolymer and copolymers
                                      complying with Sec.  177.1520 of
                                      this chapter, for use with all
                                      food types described in table 1 of
                                      Sec.  176.170(c) of this chapter
                                      only under conditions of use B
                                      through H described in table 2 of
                                      Sec.  176.170(c) of this chapter.
*                    *                    *                      *
                     *                    *                    *
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    Dated: March 1, 1999.
 L. Robert Lake,
 Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-6667 Filed 3-18-99; 8:45 am]
BILLING CODE 4160-01-F