[Federal Register Volume 60, Number 160 (Friday, August 18, 1995)]
[Notices]
[Page 43158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20566]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95G-0208]


Solvay Enzymes, Inc.; 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 
Solvay Enzymes, Inc., has filed a petition (GRASP 5G0415), proposing 
that pullulanase enzyme preparation derived from Bacillus licheniformis 
containing the pullulanase gene from B. deramificans be affirmed as 
generally recognized as safe (GRAS) for use as a direct human food 
ingredient.

DATES: Written comments by November 1, 1995.

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: Dennis M. Keefe, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3102.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (secs. 201(s) and 409(b)(5) (21 U.S.C. 321(s) and 348(b)(5)) and 
the regulations for affirmation of GRAS status in Sec. 170.35 (21 CFR 
170.35), notice is given that Solvay Enzymes, Inc., P.O. Box 4226, 
Elkhart, IN 46514-0226, has filed a petition (GRASP 5G0415) proposing 
that a pullulanase enzyme preparation derived from B. licheniformis 
containing the pullulanase gene from B. deramificans be affirmed as 
GRAS for use in food 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 
(21 CFR 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 November 1, 1995, review the 
petition and/or 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: August 2, 1995.
Alan M. Rulis,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 95-20566 Filed 8-17-95; 8:45 am]
BILLING CODE 4160-01-F