FSMA Compliance Dates
FSMA is broken down into seven foundational rules, to ensure compliance along all points of the global supply chain. Here are the deadlines for compliance with each of the seven rules.
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Preventive Controls for Human Food
21 CFR Part 117
Issue date: September 17, 2015
Category Compliance Dates Business other than small and very small Sept 19, 2016 Small Businesses (< 500 FTE) Sept 18, 2017 Very Small Businesses (<$1 M) and Businesses subject to the Pasteurized Milk Ordinance Sept 17, 2018 Requirements of Supply Chain Program (Subpart G) Receiving facility is not a small or very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Six months after the supplier is required to comply with the applicable rule Receiving facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule March 17, 2017 (18 months after publication of the final rule). Receiving facility is a small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: September 18, 2017 or six months after the supplier is required to comply with the applicable rule, whichever is later Receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule September 18, 2017 (two years after publication of the final rule) -
Preventive Controls for Animal Food
21 CFR Part 507
Issue date: September 17, 2015Category Compliance Dates Business other than small and very small Subpart B Current Good Manufacturing Practice Subpart C Hazard Analysis and Risk-Based Preventive Controls Sept. 19, 2016 Sept. 18, 2017 Small Businesses (< 500 FTE) Sept. 18, 2017 Sept. 17, 2018 Very Small Businesses (< $2.5 million/year) Sept. 17, 2018 Sept. 17, 2019 Requirements of Supply Chain Program (Subpart E) Receiving facility is not a small or very small business and its supplier will be subject to the Preventive Controls for Animal Food rule The later of: September 18, 2017 or six months after the supplier is required to comply with the applicable rule Receiving facility is a small business and its supplier will be subject to the Preventive Controls for Animal Food rule The later of: September 17, 2018 or six months after the supplier is required to comply with this rule. Receiving facility is not a small or very small business and its supplier will be subject to CGMPs but not to Preventive Controls Six months after the receiving facility’s supplier is required to comply with the CGMP requirements of this rule Receiving facility is a small business and its supplier will be subject to CGMPs but not to Preventive Controls Six months after the receiving facility’s supplier is required to comply with the CGMP requirements of this rule -
Produce Safety
21 CFR Part 112
Issue date: November 27, 2015Category Compliance Dates Business other than small and very small January 26, 2018 (two years after the effective date) Small businesses (>$250K-500K) January 26, 2019 (three years after the effective date) Very small businesses (>$25K-250K) January 26, 2020 (four years after the effective date) Compliance dates for certain aspects of the agricultural water requirements allow an additional two years beyond each of these compliance dates Compliance dates for Sprouts are 1 year earlier for all three categories of businesses; -
Prevention of Intentional Adulteration (Food Defense)
21 CFR Part 121
Issue date: July 25, 2016Category Compliance Dates Business other than small and very small July 26, 2019 Small businesses (< 500 FTE) July 27, 2020 Very small business (<$10 million) July 26, 2021 -
Foreign Supplier Verification Programs
21 CFR Part 1, Subpart L
Issue date: November 27, 2015Category Compliance Dates FSVP Importers
The later of: May 30, 2017 OR 6 Months after the supplier must comply with the Preventive Controls rules or Produce Rule If the importer is itself a manufacturer or processor subject to the Supply-Chain Program Provisions in the Preventive Controls Regulations: the date by which it has to comply with those provisions (see above). -
Accredited Third-Party Certification
21 CFR Part 1, Subpart M
Issue date: November 27, 2015Category Compliance Dates Foreign suppliers ASAP after final model accreditation standards guidance and final fee rules -
Sanitary Transportation of Human and Animal Food
21 CFR Part 1, Subpart 0
Issue date: April 5, 2016Category Compliance Dates All other businesses April 5, 2017 Businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts April 5, 2018
