[Federal Register Volume 62, Number 110 (Monday, June 9, 1997)]
[Notices]
[Page 31433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14892]



[[Page 31433]]

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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Asahi Denka Kogyo K.K. has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of 
phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-
methylphenyl)ester as an antioxidant and/or stabilizer at a level not 
to exceed 0.25 percent by weight in olefin copolymers in contact with 
certain food categories, and at levels not to exceed 0.10 percent by 
weight in either olefin copolymers or polypropylene in contact with 
certain other food categories.

DATES: Written comments on the petitioner's environmental assessment by 
July 9, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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: Under the Federal Food, Drug, and Cosmetic 
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food 
additive petition (FAP 7B4542) has been filed by Asahi Denka Kogyo 
K.K., Shirahata 5-Chome, Urawa City, Saitama 366, Japan. The petition 
proposes 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 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.
    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 July 9, 1997, 
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: May 14, 1997.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 97-14892 Filed 6-6-97; 8:45 am]
BILLING CODE 4160-01-F