{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled \"Guidance for Industry: Acidified Foods.\" The draft guidance, when finalized, will complement FDA's regulations regarding acidified foods, including regulations for specific current good manufacturing practice (CGMP), establishment registration, and process filing. The draft guidance is intended to assist commercial food processors in determining whether their food products are subject to these regulations. The draft guidance also is intended to assist processors of acidified foods in ensuring safe manufacturing, processing, and packing processes and in employing appropriate quality control procedures. Under the draft guidance, processors of non-acidified foods (e.g., some acid foods or fermented foods) who are not subject to the acidified food regulations may choose to voluntarily register and file scheduled processes with us using existing forms (Forms FDA 2541 and 2541a). If such processors voluntarily submit this information, we plan to make the results of any FDA evaluation of the information available to our investigators, e.g., during inspections of food facilities and during evaluations of foods offered for import.","action":"Notice.","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/2010/09/27/2010-24089.html","cfr_references":[],"citation":"75 FR 59268","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments concerning the draft guidance by December 27, 2010. Submit either electronic or written comments concerning the collection of information provisions by December 27, 2010.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0434"],"dockets":[],"document_number":"2010-24089","effective_on":null,"end_page":59272,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2010/09/27/2010-24089.xml","html_url":"https://www.federalregister.gov/documents/2010/09/27/2010-24089/draft-guidance-for-industry-acidified-foods-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2010-24089?publication_date=2010-09-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2010-09-27/2010-24089/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":848,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-09-27/pdf/2010-24089.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2010-09-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2010/09/27/2010-24089.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 - Shapiro RL, Hatheway C, and Swerdlow DL. 1998. Botulism in the United States: A Clinical and Epidemiologic Review. Annals of Internal Medicine 129 (3): 221-228 [Notice of Availability for Acidified Foods, Draft Guidance]","document_id":"FDA-2010-D-0434-0010"},{"title":"Reference 16 - U.S. Food and Drug Administration. Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods. Table of Contents. 1997 [Notice of Availability for Acidified Foods, Draft Guidance]","document_id":"FDA-2010-D-0434-0009"},{"title":"Reference 15 - U.S. Food and Drug Administration. Establishment Registration and Process Filing [Notice of Availability for Acidified Foods, Draft Guidance]","document_id":"FDA-2010-D-0434-0008"},{"title":"Reference 12 - Centers for Disease Control and Prevention. 1999. Outbreak of Salmonella serotype Muenchen infections associated with unpasteurized orange juice--United States and Canada, June 1999. MMWR. Morb. Mortal. Wkly. Rep 48 (27): 582-585 [Notice of","document_id":"FDA-2010-D-0434-0007"},{"title":"Reference 11 - Parish ME. 1997. Public health and nonpasteurized fruit juices. Crit. Rev Microbiol. 23 (2): 109-119 [Notice of Availability for Acidified Foods, Draft Guidance]","document_id":"FDA-2010-D-0434-0006"},{"title":"Reference 10 - Centers for Disease Control and Prevention. 1996. Outbreak of Escherichia coli O157:H7 infections associated with drinking unpasteurized commercial apple juice--British Columbia, California, Colorado, and Washington, October 1996. MMWR. Mor","document_id":"FDA-2010-D-0434-0005"},{"title":"Reference 5 - Institute of Food Technologists. 2001. Evaluation and Definition of Potentially Hazardous Foods. Chapter 3. IFT/FDA Contract No. 223-98-2333 [Notice of Availability for Acidified Foods, Draft Guidance]","document_id":"FDA-2010-D-0434-0004"},{"title":"List of References [Notice of Availability for Acidified Foods, Draft Guidance]","document_id":"FDA-2010-D-0434-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2010-D-0434","supporting_documents_count":8,"docket_id":"FDA-2010-D-0434","regulation_id_number":null,"title":"Acidified Foods","checked_regulationsdotgov_at":"2010-10-15T14:21:37Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59268,"subtype":null,"title":"Draft Guidance for Industry: Acidified Foods; Availability","toc_doc":"Acidified Foods","toc_subject":"Draft Guidance for Industry; Availability, etc.:","topics":[],"type":"Notice","volume":75}