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Agency Response Letter GRAS Notice No. GRN 000366

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See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory

CFSAN/Office of Food Additive Safety

April 8, 2011

Robert S. McQuate, Ph.D.
GRAS Associates, LLC
20482 Jacklight Lane
Bend, OR 97702

Re: GRAS Notice No. GRN 000366

Dear Dr. McQuate:

The Food and Drug Administration (FDA) is responding to the notice, dated December 09, 2010, that you submitted on behalf of Z Trim Holdings, Inc., in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on December 29, 2010, filed it on January 11, 2011, and designated it as GRAS Notice No. GRN 000366.

The subject of the notice is oat hull fiber. The notice informs FDA of the view of Z Trim Holdings, Inc., that oat hull fiber is GRAS, through scientific procedures, for use as an ingredient in baked goods; coatings and breadings for meat, poultry and vegetables; ground, emulsified and processed meat and poultry; and salty snacks and nutrition bars, at levels in accordance with good manufacturing principles. Z Trim Holdings states that these levels are usually in the range of 0.25 percent to 4.0 percent.

In a letter dated April 6, 2011, you asked, on behalf of Z Trim Holdings, Inc., that FDA cease to evaluate the GRAS notice for oat hull fiber. Given your request, we ceased to evaluate the GRAS notice, effective April 6, 2011, the date that we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000366, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at


Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

cc: William K. Shaw Jr., Ph.D.
Risk, Innovations, and Management Division
George Washington Carver Center (GWCC)
5601 Sunnyside Avenue, Mail STOP 5272
Beltsville, MD 20705-5272

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