{"abstract":"The Food and Drug Administration (FDA) is affirming that carbohydrase enzyme preparations derived from either Bacillus subtilis or B. amyloliquefaciens and protease enzyme preparations derived from either B. subtilis or B. amyloliquefaciens are generally recognized as safe (GRAS) for use as direct food ingredients. This action is a partial response to a petition filed by the Ad Hoc Enzyme Technical Committee (now the Enzyme Technical Association).","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1999/04/23/99-10011.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"184","title":21}],"citation":"64 FR 19887","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The regulation is effective April 23, 1999. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications listed in 21 CFR 184.1148 and 184.1150, effective April 23, 1999.","disposition_notes":null,"docket_ids":["Docket No. 84G-0257"],"dockets":[{"supporting_documents":[{"title":"Response of The Enzyme Technical Association to The Letter Dated June 26, 1986, of Dr. Lawrence J. Lin Regarding GRASP 3G0016 re Comment from  Enzyme Technical Association","document_id":"FDA-1984-G-0019-0176"},{"title":"Toxicological evaluation of some enzymes, modified starches\nand certain other substances re Letter from Wallerstein Company to FDA","document_id":"FDA-1984-G-0019-0175"},{"title":"Background Material re Enzyme Preparations from Animal and Plant Sources; Affirmation of GRAS Status As Direct Food Ingredients","document_id":"FDA-1984-G-0019-0174"},{"title":"Exhibit P: Acknowledgment of receipt from FDA to Enzyme Technical Association","document_id":"FDA-1984-G-0019-0173"},{"title":"The 1978 Enzyme Survey Summarized Data from National Research Council re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0172"},{"title":"Tab 5 Determining The Safety of Enzymes Used in Food Processing,  Department of Food Microbiology and Toxicology University of Wisconsin and Food Research Institute re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0171"},{"title":"Tab 4  Enzyme Survey, Quality Assurance and Regulatory Affairs, Biotechnology Group, Miles Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0170"},{"title":"Tab 3 Methods of Enzyme Manufacture, Director of Scientific Affairs Pfizer, Inc. and NOVO Biochemical Industry, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0169"},{"title":"Tab 2 General Discussion of Enzymes Dairyland Food Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0168"},{"title":"Tab 1 Introduction Biotechnology Group, Miles Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0167"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-10-02T07:56:32.874-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1984-G-0019-0001","allow_late_comments":false,"id":"FDA-1984-G-0019-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":18,"id":"FDA-1984-G-0019","title":"Affirmation of GRAS Status of Certain Enzymes - CLOSED"}],"document_number":"99-10011","effective_on":"1999-04-23","end_page":19895,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/04/23/99-10011/carbohydrase-and-protease-enzyme-preparations-derived-from-bacillus-subtilis-or-bacillus","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-10011?publication_date=1999-04-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-04-23/99-10011/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":831,"last_updated":"2026-10-23 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-04-23/pdf/99-10011.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1999-04-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1999/04/23/99-10011.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Response of The Enzyme Technical Association to The Letter Dated June 26, 1986, of Dr. Lawrence J. Lin Regarding GRASP 3G0016 re Comment from  Enzyme Technical Association","document_id":"FDA-1984-G-0019-0176"},{"title":"Toxicological evaluation of some enzymes, modified starches\nand certain other substances re Letter from Wallerstein Company to FDA","document_id":"FDA-1984-G-0019-0175"},{"title":"Background Material re Enzyme Preparations from Animal and Plant Sources; Affirmation of GRAS Status As Direct Food Ingredients","document_id":"FDA-1984-G-0019-0174"},{"title":"Exhibit P: Acknowledgment of receipt from FDA to Enzyme Technical Association","document_id":"FDA-1984-G-0019-0173"},{"title":"The 1978 Enzyme Survey Summarized Data from National Research Council re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0172"},{"title":"Tab 5 Determining The Safety of Enzymes Used in Food Processing,  Department of Food Microbiology and Toxicology University of Wisconsin and Food Research Institute re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0171"},{"title":"Tab 4  Enzyme Survey, Quality Assurance and Regulatory Affairs, Biotechnology Group, Miles Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0170"},{"title":"Tab 3 Methods of Enzyme Manufacture, Director of Scientific Affairs Pfizer, Inc. and NOVO Biochemical Industry, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0169"},{"title":"Tab 2 General Discussion of Enzymes Dairyland Food Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0168"},{"title":"Tab 1 Introduction Biotechnology Group, Miles Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0167"}],"comments_count":12,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1984-G-0019","supporting_documents_count":18,"docket_id":"FDA-1984-G-0019","document_id":"FDA-1984-G-0019-0001","regulation_id_number":null,"title":"Affirmation of GRAS Status of Certain Enzymes - CLOSED","checked_regulationsdotgov_at":"2026-10-03T14:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19887,"subtype":null,"title":"Carbohydrase and Protease Enzyme Preparations Derived From Bacillus Subtilis or Bacillus Amyloliquefaciens; Affirmation of GRAS Status as Direct Food Ingredients","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":64}