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    So…What Are the Exact Compliance Dates for FSMA Rules?

    What are the FSMA compliance dates?

    Have you ever tried reading all of the Food Safety Modernization Act (FSMA) rules, subsequent amendments, exceptions, and Federal Register notices to try to determine which rules apply to your company and what deadline matches your business’ function and company size?

    It’s quite a maze. We searched and searched to find an at-a-glance guide for FSMA compliance dates, but we came up empty-handed. So we combed through each of the final rules to compile the following list of compliance dates for various business types and company sizes.

    Take a look at the definitions for Small and Very Small Businesses as defined by the FDA

    Compliance Dates 

    Preventive Controls for Human Food

    Final Rule Published: September 17, 2015
    Effective Date: November 16, 2015

    Compliance Date for Other Businesses Not Small or Very Small: September 19, 2016 (one year after publication of the final rule), and since the one-year mark falls on a Saturday, the official compliance date is 9/19 instead of 9/17.

    Compliance Date for Small Businesses: September 18, 2017 (two years after publication of the final rule), and since the two-year mark falls on a Sunday, the official compliance date is 9/18 instead of 9/17.

    Compliance Date for Very Small Businesses: September 17, 2018 (three years after publication of the final rule), except for records to support its status as a very small business, which were required on January 1, 2016. 

    Compliance Date for Businesses Subject to the Pasteurized Milk Ordinance: September 17, 2018 (three years after publication of the final rule).

     

    Compliance Dates for Supply Chain Program:

     

    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), and since the two-year mark falls on a Sunday, the official compliance date is 9/18 instead of 9/17.

    Receiving facility is a small business and its supplier will be subject to the Human Preventive Controls Rule or the Produce Safety rule: the later of: September 18, 2017 (two years after publication of the final rule) or 6 months after the receiving facility's supplier of that raw material or other ingredient 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 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 receiving facility's supplier of that raw material or other ingredient is required to comply with the applicable rule.

    Read more about the applicable compliance dates for your business.

     

    Preventive Controls for Animal Food

    This one is interesting, as it breaks the compliance dates for certain pieces of the rule up. There are staggered dates of compliance for CGMP (Current Good Manufacturing Practice (Subpart B)) and PC (Preventive Controls (Subpart C)) requirements.

    Final Rule Published: September 17, 2015
    Effective Date: November 16, 2015

    Compliance Date for Other Businesses Not Small or Very Small:

    Subpart B and Related Requirements: September 19, 2016 (one year after publication of the final rule), and since the one-year mark falls on a Saturday, the official compliance date is 9/19 instead of 9/17.

    Subpart C and § 507.7: September 18, 2017 (two years after publication of the final rule), and since the two-year mark falls on a Sunday, the official compliance date is 9/18 instead of 9/17.

     

    Compliance Date for Small Businesses:

    Subpart B and Related Requirements: September 18, 2017 (two years after publication of the final rule), and since the two-year mark falls on a Sunday, the official compliance date is 9/18 instead of 9/17.

    Subpart C and § 507.7: September 17, 2018 (three years after publication of the final rule).

     

    Compliance Date for Very Small Businesses:

    Subpart B and Related Requirements: September 17, 2018 (three years after publication of the final rule).

    Subpart C and § 507.7: September 17, 2019 (four years after publication of the final rule), except the compliance date for a facility to retain records to support its status as a qualified facility is January 1, 2017.

     

    Compliance Dates for Requirements of the Supply-Chain Program (Subpart E)

     

    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.  

    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 is subject to the Preventive Controls for Animal Food final rule: The later of: September 17, 2018 or six months after the receiving facility's supplier of that raw material or other ingredient is required to comply with this rule.

    Receiving facility is not a small or very small business and its supplier will be subject to the Preventive Controls for Animal Food final rule: The later of: September 18, 2017 or six months after the receiving facility's supplier of that raw material or other ingredient is required to comply with the applicable rule.

    Read more about these different compliance dates

     

    Produce Safety

    Final Rule Published: November 27, 2015
    Effective Date: January 26, 2016

    Compliance Date for All Other Farms Not Small or Very Small: January 26, 2018 (two years after the effective date). 

    Compliance Date for Small Businesses: January 26, 2019 (three years after the effective date).

    Compliance Date for Very Small Business: January 26, 2020 (four years after the effective date).

    The compliance dates for certain aspects of the water quality standards, and related testing and recordkeeping provisions, allow an additional two years beyond each of these compliance dates for the rest of the final rule

    Sprouts


    Compliance Date for All Other Farms Not Small or Very Small: January 26, 2017 (one year after the effective date).

    Compliance Date for Small Businesses: January 26, 2018 (two years after the effective date).

    Compliance Date for Very Small Businesses: January 26, 2019 (three years after the effective date).

    Modified Requirements

    Compliance Date for labeling requirement (if applicable): January 1, 2020

    Compliance Date for retention of records supporting eligibility for a qualified exemption: January 26, 2016 (effective date of the final rule).

    Compliance Date for All Other Modified Requirements:

    • Very Small Businesses: January 26, 2020
    • Small Businesses: January 26, 2019

    Find out where your business fits.

     

    Foreign Supplier Verification

    Final Rule Published: November 27, 2015
    Effective Date: January 26, 2016

    Compliance Date: May 27, 2017 (18 months after publication of the final rule) 

    Compliance Date for the Importation of Food from a Supplier Subject to the Preventive Controls or Produce Safety Rules: six months after the foreign supplier is required to meet the relevant regulations. 

    Compliance Date for an Importer that 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. A range of compliance dates were established in the Preventive Controls rules for the supply-chain program provisions, which vary based on the size of the receiving facility and when the receiving facility’s supplier is required to comply with the new FSMA regulations.

    Read more about these compliance dates.

     

    Third Party Accreditation and Certification

    Final Rule Published: November 27, 2015
    Effective Date: January 26, 2016

    Compliance Date: FDA intends to implement this program as soon as possible. *

    *Provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards, which are yet to be released by FDA.

    Read the final rule.

     

    Sanitary Transportation

    Final Rule Published: April 6, 2016
    Effective Date: June 6, 2016

    Compliance Date for All Other Businesses Not Small: April 6, 2017

    Compliance Date for Small Businesses: April 6, 2018 

    Read the exact information.

     

    Food Defense

    Final Rule Published: May 27, 2016
    Effective Date: July 26, 2016

    Compliance Date for Businesses Not Small or Very Small: July 26, 2019 (three years after the effective date*).

    Compliance Date for Small Businesses: July 26, 2020 (four years after the effective date*). 

    Compliance Date for Very Small Businesses: July 26, 2021 (five years after the effective date*). 

    Make sure you know which definition you fit. 

    * While the actual published rule states compliance requirements rely on the effective date, the guidance and fact sheet issued states the compliance requirements rely on the publication date. We’re currently checking with FDA to determine the exact dates for compliance with this particular rule.

    Amendments to Registration of Food Facilities

    Final Rule Published: July 14, 2016
    Effective Date: September 12, 2016

    Owners, operators, or agents in charge must register with the FDA before the facility begins to manufacture, process, pack, or hold food for consumption in the United States.

    Additionally, during the period beginning on October 1 and ending on December 31 of each even-numbered year, the owner, operator, or agent in charge of a facility would be required to submit a registration renewal to FDA containing the information required under § 1.232.

    Download the FSVP Outline