The Acheson Group (TAG) is one of the most informed consulting firms around FSMA. Led by Dr. David Acheson, who was the former FDA Associate Commissioner for Foods, TAG prides itself on keeping our clients well informed and ahead of new regulatory requirements. To help keep our industry updated on FSMA, we have collaborated this quick reference – which we try to update often! If you have questions about FSMA, need assistance in assessing current programs to ensure compliance – including PCQI and FSVP training, learn how TAG can help – schedule a consultation call today. Latest News: FSMA Food Defense Rule – the Countdown is On By July 29, 2019, companies impacted by the FSMA Intentional Adulteration (IA) rule must be compliant. Prevention of intentional adulteration is imperative component of your overall food protection strategy. TAG Food Defense service offerings are helping our customers identify vulnerabilities and implement effective mitigation strategies. Strategies that will ensure FSMA readiness — and more importantly, help prevent acts intended to cause wide-scale harm to public health. Contact us if you would like to learn more about TAG’s food defense service offerings. What You Need to know About FSMA FSMA has already introduced significant new changes that impact food and beverage companies. Currently, there are a series of new rules that are having a major impact on both domestic and foreign food companies. For further guidance on these rules, TAG will continue to review and provide insight FSMA Final Rules Preventive Controls for Human Food Preventive Controls for Animal Food Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Sanitary Transportation of Human and Animal Food Mitigation Strategies to Protect Food Against Intentional Adulteration Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications Draft Guidances Issued Low-Acid Canned Foods and FSMA Juice HACCP and FSMA Seafood HACCP and FSMA Guidance for Industry: FDA’s Voluntary Qualified Importer Program Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide Guidance for Industry: Small Entity Compliance Guide – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) Draft Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals
Draft Guidance for Industry: Human Food By-Products for Use as Animal Food Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3) Draft Guidance for Industry: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards Draft Guidance for Industry: FDA’s Voluntary Qualified Importer Program Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls Compliance Dates PC Human Food PC Animal Food Subpart B PC Animal Food Subpart C Produce Safety FSVP Sanitary Transport Food Defense Third Party Certification PC HUMAN RULE COMPLIANCE DATES For the Requirements of the Supply-Chain Program PC ANIMAL RULE COMPLIANCE DATES For the Requirements of the Supply-Chain Program FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP) The following compliance dates are grouped according to the category of FSVP importer. This list does not include importers that are themselves a manufacturer or processor subject to the supply-chain program provisions in the PC rules. If importers are subject to the supply-chain program requirements in those rules, the compliance date for FSVP is the later of the applicable date in the below list or the date by which the importer is required to comply with the PC supply-chain program provisions. 1. FSVP importer whose foreign supplier is not subject to the PC or produce safety rules: May 30, 2017 2. FSVP importer whose foreign supplier is required to comply with the PC rule for human food. Compliance dates when foreign suppliers are in these categories: Small businesses as defined in 21 CFR 117.3: March 19, 2018 Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3: March 18, 2019 Suppliers subject to the Pasteurized Milk Ordinance: March 18, 2019 “All Other” Businesses Suppliers: May 30, 2017 3. FSVP importer of animal food whose foreign supplier is subject to the current good manufacturing practices (“CGMP”) requirements in subpart B of 21 CFR part 507 in the PC rule for animal food. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in 21 CFR 507.3: March 19, 2018 Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3: March 18, 2019 “All Other” Businesses: May 30, 2017 4. FSVP importer whose foreign supplier is required to comply with the animal food preventive controls requirements in subpart C of part 507 of the PC rule for animal food, but that is not required to comply with the CGMP requirements in subpart B of 21 CFR part 507. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in 21 CFR 507: March 18, 2019 Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3: March 17, 2020 “All Other” Businesses: March 19, 2018 5. FSVP importer whose foreign supplier is required to comply with the produce safety rule, except for the requirements applicable to sprouts in subpart M of 21 CFR part 112. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in 21 CFR 112.3: July 29, 2019 Very Small Businesses as defined in as defined in 21 CFR 112.3: July 27, 2020 “All Other” Businesses: July 26, 2018 6. FSVP importer whose foreign supplier is required to comply with the requirements in the produce safety rule applicable to sprouts in subpart M of 21 CFR part 112. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in 21 CFR 112.3: July 26, 2018 Very Small Businesses as defined in 21 CFR 112.3: July 29, 2019 “All Other” Businesses: July 26, 2017 7. FSVP importer whose foreign supplier is subject to the produce safety rule and eligible for a qualified exemption (other than when the foreign supplier is a farm producing sprouts). Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in21 CFR 112.3: July 29, 2019 Very Small Businesses as defined in 21 CFR 112.3: July 27, 2020 8. FSVP importer whose foreign supplier is a farm producing sprouts that is eligible for a qualified exemption under the produce safety rule. Compliance dates when foreign suppliers are in these categories: Small Businesses as defined in21 CFR 112.3: July 26, 2018 Very Small Businesses as defined in 21 CFR 112.3: July 26, 2019 GFSI FSMA TAG COMPARISONS SQF Institute SQF Level 2– Final Preventive Controls for Human Food Rule Comparison (Modules 2 & 11) – executive summary SQF Module 7 – Final FSMA Produce Safety Rule Comparison – executive summary FSSC 22000 Comparison of FSSC 22000 against the Preventive Controls for Human Food (Final Rule) – executive summary About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.achesongroup.com
