[Federal Register Volume 60, Number 119 (Wednesday, June 21, 1995)] [Notices] [Pages 32329-32330] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-15082] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 95G-0102] Gist-brocades International B.V.; Filing of Petition for Affirmation of GRAS Status AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that Gist-brocades International B.V., has filed a petition (GRASP 5G0413), proposing that lipase enzyme preparation derived from Rhizopus oryzae be affirmed as generally recognized as safe (GRAS) as a direct human food ingredient. DATES: Written comments by September 5, 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: Vincent E. Zenger, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3090. 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 Gist-brocades International B.V., P.O. Box 241068, Charlotte, NC 28224-1068, has filed a petition (GRASP 5G0413) proposing that a lipase enzyme preparation from Rhizopus oryzae 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 September 5, 1995, 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. [[Page 32330]] Dated: June 7, 1995. Alan M. Rulis, Acting Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition. [FR Doc. 95-15082 Filed 6-20-95; 8:45 am] BILLING CODE 4160-01-F