[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
