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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.
  • 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, 2015

    Category 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, 2015

    Category 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, 2016

    Category 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, 2015

    Category 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, 2015

    Category 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, 2016

    Category 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