[Federal Register Volume 59, Number 20 (Monday, January 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1990]


[[Page Unknown]]

[Federal Register: January 31, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93G-0474]

 

Canadian Harvest USA L.P.; Filing of Petition for Affirmation of 
GRAS Status

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Canadian Harvest USA L.P. has filed a petition (GRASP 2G0379), 
proposing that a fiber derived from oat hulls using an alkaline 
hydrogen peroxide manufacturing process be affirmed as generally 
recognized as safe (GRAS) for use as a direct human food ingredient.

DATES: Written comments by April 1, 1994.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Aydin Orstan, Center for Food Safety 
and Applied Nutrition (HFS-217), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-254-9515.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (secs. 201(s) and 409 (21 U.S.C. 321(s) and 348)) and the 
regulations for affirmation of GRAS status in Sec. 170.35 (21 CFR 
170.35), notice is given that Canadian Harvest USA L.P., 1001 South 
Cleveland St., Cambridge, MN 55008, has filed a petition (GRASP 2G0379) 
proposing that a fiber derived from oat hulls using an alkaline 
hydrogen peroxide manufacturing process be affirmed as GRAS for use as 
a direct human food ingredient.
    The petition has been placed on display at the Dockets Management 
Branch (address above).
    Any petition that meets the requirements outlined in Secs. 170.30 
and 170.35 is filed by the agency. There is no prefiling review of the 
adequacy of data to support a GRAS conclusion. Thus, the filing of a 
petition for GRAS affirmation should not be interpreted as a 
preliminary indication of suitability for GRAS affirmation.
    The potential environmental impact of this action is being 
reviewed. If 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).
    Interested persons may, on or before April 1, 1994, review the 
petition and file comments with the Dockets Management Branch (address 
above). Two copies of any comments should be filed and should be 
identified with the docket number found in brackets in the heading of 
this document. Comments should include any available information that 
would be helpful in determining whether the substance is, or is not, 
GRAS for the proposed use. In addition, consistent with the regulations 
promulgated under the National Environmental Policy Act (40 CFR 
1501.4(b)), the agency encourages public participation by review of and 
comment on the environmental assessment submitted with the petition 
that is the subject of this notice. A copy of the petition (including 
the environmental assessment) and received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: January 21, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-1990 Filed 1-28-94; 8:45 am]
BILLING CODE 4160-01-F