[Federal Register Volume 63, Number 167 (Friday, August 28, 1998)]
[Notices]
[Page 46053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23103]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97F-0213]


Asahi Denka Kogyo K.K.; Filing of Food Additive Petition; 
Amendment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the filing 
notice for a food additive petition filed by Asahi Denka Kogyo K.K. to 
indicate that the petitioned additive, phosphorous acid, cyclic 
neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl)ester is for use 
as an antioxidant and/or stabilizer in polypropylene homopolymer and 
copolymers not to exceed 0.25 percent by weight of polypropylene 
homopolymer and copolymers in contact with food. The previous filing 
notice indicated that the proposed additive was for use in olefin 
copolymers and polypropylene in contact with certain food categories.

DATES: Written comments on the petitioner's environmental assessment by 
September 28, 1998.

ADDRESSES:  Submit written comments 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-206), 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 June 9, 1997 (62 FR 31433), FDA announced that a food 
additive petition (FAP 7B4542) had been filed by Asahi Denka Kogyo 
K.K., Shirahata 5-Chome, Urawa City, Saitama 366, Japan, proposing that 
Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR 
178.2010) be amended 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 food 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 only 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.
    Upon further review of the petition, the agency noted that the data 
presented in the petition address use of the subject additive only in 
polypropylene homopolymer and polypropylene copolymers. The agency also 
noted that the data in the petition in combination with the data for 
those applications of the additive currently listed in Sec. 178.2010, 
apply to the use of the subject additive in polypropylene homopolymer 
and copolymers in contact with all food types under conditions of use B 
through H as described in Table 2 of Sec. 176.170(c). Based on this 
information, the petitioner agreed to amend its request. Therefore, FDA 
is amending the filing notice of June 9, 1997, to state that the 
petitioner requests that the food additive regulations be amended to 
permit use of the subject additive in polypropylene homopolymer and 
copolymers for all food types under conditions of use B through H.
    The potential environmental impact of this action is being 
reviewed. To encourage public participation consistent with regulations 
promulgated under the National Environmental Policy Act (40 CFR 
1501.4(b)), the agency is placing the environmental assessment 
submitted with the petition that is the subject of this notice on 
display at the Dockets Management Branch (address above) for public 
review and comment. Interested persons may, on or before September 28, 
1998, submit to the Dockets Management Branch (address above) written 
comments. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday. FDA will also place on public display any 
amendments to, or comments on, the petitioner's environmental 
assessment without further announcement in the Federal Register. If, 
based on its review, the agency finds that an environmental impact 
statement is not required and this petition results in a regulation, 
the notice of availability of the agency's finding of no significant 
impact and the evidence supporting that finding will be published with 
the regulation in the Federal Register in accordance with 21 CFR 
25.40(c).

    Dated: August 6, 1998.
Laura M. Tarantino,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 98-23103 Filed 8-27-98; 8:45 am]
BILLING CODE 4160-01-F