{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled \"Action Level for Inorganic Arsenic in Apple Juice.\" The guidance identifies for industry an action level for inorganic arsenic in apple juice that is intended to help protect public health by reducing exposure to inorganic arsenic and is achievable with the use of current good manufacturing practices. It also describes our intended sampling and enforcement approach. Thus, the guidance finalizes the approach presented in the draft guidance issued in 2013.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2023/06/02/2023-11769.html","cfr_references":[],"citation":"88 FR 36319","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 2, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0322"],"dockets":[{"supporting_documents":[{"title":"Ref 24. Closer to Zero_ Reducing Childhood Exposure to Contaminants from Foods _ FDA RE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0052"},{"title":"Ref 23. Redan 2021 Processing aids in food and beverages manufacturing \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0051"},{"title":"Ref 22. Wang et al. 2017 Factors affecting the levels of heavy metals in juices processed with filter aids \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0050"},{"title":"Ref 21. Chen et al 2010 Ingested arsenic characteristics of well water consumption and risk \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0049"},{"title":"Ref 20. Chen et al 2010 Arsenic in drinking water and risk of urinary tract cancer \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0048"},{"title":"Ref 18. FDA Total Diet Study (TDS) _ FDA RE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0046"},{"title":"Ref 17. Speciation Results for Arsenic Analysis in Single-Strength Apple Juice -TEP (FY2013-FY2022) \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0045"},{"title":"Ref 16.  Ref 16.  Analytical Results for Total Arsenic in Single-Strength Apple Juice Sampled Under the FDA’s Toxic Elements in Food and Foodware, and Radionuclides in Food – Import and Domestic Compliance Program (FY2013-FY2022)  RE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0044"},{"title":"Ref 15. Arsenic in Apple Juice Analytical Results from the 2005-2011 Toxic Elements Food and Foodware Program _ FDA \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0043"},{"title":"Ref 14. Results of Arsenic Analysis in Single-Strength Apple Juice 2011 (ORA Sampling Assignment 2011102701) _ FDA \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0042"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2023-06-02T09:56:31.761-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2012-D-0322-0025","allow_late_comments":null,"id":"FDA-2012-D-0322-0025","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":26,"id":"FDA-2012-D-0322","title":"Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Availability"}],"document_number":"2023-11769","effective_on":null,"end_page":36320,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/06/02/2023-11769.xml","html_url":"https://www.federalregister.gov/documents/2023/06/02/2023-11769/action-level-for-inorganic-arsenic-in-apple-juice-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-11769?publication_date=2023-06-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-06-02/2023-11769/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":838,"last_updated":"2026-09-20 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-02/pdf/2023-11769.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-11769.pdf?1685623532","publication_date":"2023-06-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/06/02/2023-11769.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Ref 24. Closer to Zero_ Reducing Childhood Exposure to Contaminants from Foods _ FDA RE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0052"},{"title":"Ref 23. Redan 2021 Processing aids in food and beverages manufacturing \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0051"},{"title":"Ref 22. Wang et al. 2017 Factors affecting the levels of heavy metals in juices processed with filter aids \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0050"},{"title":"Ref 21. Chen et al 2010 Ingested arsenic characteristics of well water consumption and risk \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0049"},{"title":"Ref 20. Chen et al 2010 Arsenic in drinking water and risk of urinary tract cancer \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0048"},{"title":"Ref 18. FDA Total Diet Study (TDS) _ FDA RE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0046"},{"title":"Ref 17. Speciation Results for Arsenic Analysis in Single-Strength Apple Juice -TEP (FY2013-FY2022) \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0045"},{"title":"Ref 16.  Ref 16.  Analytical Results for Total Arsenic in Single-Strength Apple Juice Sampled Under the FDA’s Toxic Elements in Food and Foodware, and Radionuclides in Food – Import and Domestic Compliance Program (FY2013-FY2022)  RE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0044"},{"title":"Ref 15. Arsenic in Apple Juice Analytical Results from the 2005-2011 Toxic Elements Food and Foodware Program _ FDA \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0043"},{"title":"Ref 14. Results of Arsenic Analysis in Single-Strength Apple Juice 2011 (ORA Sampling Assignment 2011102701) _ FDA \nRE Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry","document_id":"FDA-2012-D-0322-0042"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-D-0322","supporting_documents_count":26,"docket_id":"FDA-2012-D-0322","document_id":"FDA-2012-D-0322-0025","regulation_id_number":null,"title":"Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Availability","checked_regulationsdotgov_at":"2023-06-03T20:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36319,"subtype":null,"title":"Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry; Availability","toc_doc":"Action Level for Inorganic Arsenic in Apple Juice","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}