Food

Compliance Dates

These are the compliance dates for the rules that form the foundation of the implementation of the FDA Food Safety Modernization Act (FSMA). The rules are listed in the order in which they became final. (There are no compliance dates for the rule on Accreditation of Third-Party Certification Bodies, which is a voluntary program.)


 


Preventive Controls for Human Food (Part 117)

Very small business means a business (including any subsidiaries and affiliates) that averages less than $1 million (adjusted for inflation) per year during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (e.g., for a fee).

  • Compliance Date
    September 17, 2018
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs
      Compliance Date: January 27, 2020
    • Certain facilities that would qualify as secondary activities farms except for ownership 
      Compliance Date: January 27, 2020 
    • Facilities that would qualify as farms if they did not color RACs
      Compliance Date: January 27, 2020

Small businesses are businesses (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.

  • Compliance Date
    September 18, 2017
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs
      Compliance Date: January 28, 2019 
    • Certain facilities that would qualify as secondary activities farms except for ownership
      Compliance Date: January 28, 2019
    • Facilities that would qualify as farms if they did not color RACs
      Compliance Date: January 28, 2019
    • Written assurances in the customer provisions in sections 117.136(a)(2)(ii), (3)(ii), and 4(ii)
      Compliance Date: September 18, 2019
  • Subpart G (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.
        Compliance Date: September 18, 2017
      • Receiving facility is a small business and its supplier is subject to the human preventive controls rule or the produce safety rule.
        Compliance Date: 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.

A business (including any subsidiaries and affiliates) that averages equal to or more than $1 million (adjusted for inflation) per year, during the three-year period preceding the applicable calendar year in sales AND that has more than 500 full-time equivalent employees.

  • Compliance Date
    September 19, 2016
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs
      Compliance Date: January 26, 2018 
    • Certain facilities that would qualify as secondary activities farms except for ownership
      Compliance Date: January 26, 2018
    • Facilities that would qualify as farms if they did not color RACs
      Compliance Date: January 26, 2018
    • Written assurances in the customer provisions in sections 117.136(a)(2)(ii), (3)(ii), and 4(ii)
      Compliance Date: September 19, 2018
  • Subpart G (Supply-Chain Program)
    • Receiving facility is not a small business or a very small business and its supplier will be not be subject to the human preventive controls rule or the produce safety rule.
      Compliance Date: March 17, 2017
    • Receiving facility is not a small business or a very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule.
      Compliance Date: 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the applicable rule.

Extension only applies to Grade “A” milk and milk products covered by the National Conference of Interstate Milk Shipments (NCIMS) under the PMO, and not to the manufacturing, processing, packing, or holding of other food produced in such facilities.

  • Extended Compliance Date
    September 17, 2018

Preventive Controls for Animal Food (Part 507)

A very small business is a business (including any subsidiaries and affiliates) that averages less than $2.5 million (adjusted for inflation) per year during the three-year period preceding the applicable calendar year in sales of animal food plus market value of animal food manufactured, processed, packed or held without sale (e.g., for a fee or supplied to a farm without sale).

Subpart B and Related Requirements (Current Good Manufacturing Practices - CGMPs)

  • Compliance Date
    September 17, 2018
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
      Compliance Date: January 27, 2020
    • Certain facilities that would qualify as secondary activities farms, except for ownership
      Compliance Date: January 27, 2020

Subpart C or Section 507.7, and Related Requirements (Preventive Controls)

  • Compliance Date
    September 17, 2019
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
      Compliance Date: January 26, 2021
    • Certain facilities that would qualify as secondary activities farms except for ownership
      Compliance Date: January 26, 2021
    • Facilities solely engaged in the ginning of cotton
      Compliance Date:  January 26, 2021

Small businesses are businesses (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.

Subpart B and Related Requirements (CGMPs)

  • Compliance Date
    September 18, 2017
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
      Compliance Date: January 28, 2019
    • Certain facilities that would qualify as secondary activities farms except for ownership
      Compliance Date: January 28, 2019
    • Written assurances in the customer provisions in section 507.36(a)(2)(ii), (3)(ii), and 4(ii)
      Compliance Date: September 17, 2020

Subpart C and Related Requirements (Preventive Controls)

  • Compliance Date
    September 17, 2018
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
      Compliance Date: January 27, 2020
    • Certain facilities that would qualify as secondary farms except for ownership
      Compliance Date: January 27, 2020
    • Facilities solely engaged in the ginning of cotton
      Compliance Date:  January 27, 2020

Subpart E (Supply-Chain Program)

  • Receiving facility is a small business and its supplier will be subject to the CGMPs, but not the preventive control requirements of part 507.
    Compliance Date: 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the CGMP requirements of part 507.
  • Receiving facility is a small business and its supplier is subject to part 507.
    Compliance Date: The latter of September 17, 2018 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with part 507.

A business (including any subsidiaries and affiliates) that averages equal to or more than $2.5 million adjusted for inflation per year, during the three-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale AND that has at least 500 full-time equivalent employees.

Subpart B and Related Requirements (CGMPs)

  • Compliance Date
    September 19, 2016
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
      Compliance Date: January 26, 2018
       
    • Certain facilities that would qualify as secondary activities farms except for ownership
      Compliance Date: January 26, 2018

Subpart C and Related Requirements (Preventive Controls)

  • Compliance Date
    September 18, 2017
  • Extended Compliance Dates
    • Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
      Compliance Date: January 28, 2019
    • Certain facilities that would qualify as secondary activities farms except for ownership
      Compliance Date: January 28, 2019
    • Facilities solely engaged in the ginning of cotton
      Compliance Date: January 28, 2019
    • Written assurances in the customer provisions in section 507.36(a)(2)(ii), (3)(ii), and 4(ii)
      Compliance Date: September 18, 2019

Subpart E (Supply-Chain Program)

  • Receiving facility is not a small business or a very small business and its supplier will be subject to the CGMPs, but not the preventive control requirements of part 507.
    Compliance Date: 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the CGMP requirements of part 507.
  • Receiving facility is not a small business or a very small business and its supplier is subject to part 507.
    Compliance Date: The later of September 18, 2017 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with part 507.

Produce Safety (Part 112)

For the purposes of Part 112, a covered farm is a very small business if, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 but no more than $250,000.

  • Compliance Dates
    • Covered activities involving sprouts covered under Subpart M – subject to all requirements of part 112
      January 28, 2019
    • Covered activities involving all other covered produce – subject to part 112, except subpart M
      January 27, 2020
    • Covered activities involving all other covered produce for certain specific agricultural water requirements January 26, 2022*
    • *Note: On September 12, 2017, FDA issued a proposed rule that, if finalized, would extend the compliance dates for all of the agricultural water provisions (for produce other than sprouts). FDA does not intend to take action to enforce the agricultural water requirements while this rulemaking is underway. Proposed Extended Compliance Date: January 26, 2024
       
  • Compliance Dates for Farms Eligible for Qualified Exemption (If Applicable)
    • Retention of records supporting eligibility for a qualified exemption (section 112.7(b))
      January 26, 2016
    • Modified Requirement in section 112.6(b)(1) (label statement)
      January 1, 2020
    • All other requirements in sections 112.6 & 112.7 for farms producing sprouts
      January 28, 2019
    • All other requirements in sections 112.6 & 112.7 for farms not producing sprouts
      January 27, 2020
  • Compliance Dates for Farms Relying on the Exemption for Produce That Receives Commercial Processing That Adequately Reduces Microorganisms of Public Health Concern (section 112.2(b))
    • Requirement to obtain customer written assurances in section 112.2(b)(3) for sprouts that would otherwise be subject to Subpart M
      Extended Compliance Date: January 26, 2021
    • All other requirements in section 112.2(b) for sprouts that would otherwise be subject to Subpart M
      Compliance Date: January 28, 2019
    • Requirement to obtain customer written assurances in section 112.2(b)(3) for all other produce that would otherwise be covered
      Extended Compliance Date: January 26, 2022
    • All other requirements in section 112.2(b) for all other produce that would otherwise be covered
      Compliance Date: January 27, 2020

For the purposes of Part 112, a covered farm is a small business if, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but no more than $500,000.

  • Compliance Dates
    • Covered activities involving sprouts covered under Subpart M – subject to all requirements of part 112
      January 26, 2018
    • Covered activities involving all other covered produce – subject to part 112, except subpart M
      January 28, 2019
    • Covered activities involving all other covered produce for certain specific agricultural water requirements January 26, 2021*
    • *Note: On September 12, 2017, FDA issued a proposed rule that, if finalized, would extend the compliance dates for all of the agricultural water provisions (for produce other than sprouts). FDA does not intend to take action to enforce the agricultural water requirements while this rulemaking is underway. Proposed Extended Compliance Date: January 26, 2023
       
  • Compliance Dates for Farms Eligible for Qualified Exemption (If Applicable)
    • Retention of records supporting eligibility for a qualified exemption (section 112.7(b))
      January 26, 2016
    • Modified Requirement in section 112.6(b)(1) (label statement)
      January 1, 2020
    • All other requirements in sections 112.6 & 112.7 for farms producing sprouts
      January 26, 2018
    • All other requirements in sections 112.6 & 112.7 for farms not producing sprouts
      January 28, 2019
  • Compliance Dates for Farms Relying on the Exemption for Produce That Receives Commercial Processing That Adequately Reduces Microorganisms of Public Health Concern (section 112.2(b))
    • Requirement to obtain customer written assurances in section 112.2(b)(3) for sprouts that would otherwise be subject to Subpart M
      Extended Compliance Date: January 27, 2020
    • All other requirements in section 112.2(b) for sprouts that would otherwise be subject to subpart M
      Compliance Date: January 26, 2018
    • Requirement to obtain customer written assurances in section 112.2(b)(3) for all other produce that would otherwise be covered
      Extended Compliance Date: January 26, 2021
    • All other requirements in section 112.2(b) for all other produce that would otherwise be covered
      Compliance Date: January 28, 2019

Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000.

  • Compliance Dates
      • Covered activities involving sprouts covered under Subpart M – subject to all requirements of part 112
        January 26, 2017
      • Covered activities involving all other covered produce – subject to part 112, except subpart M
        January 26, 2018
      • Covered activities involving all other covered produce for certain specific agricultural water requirements January 26, 2020*
      • *Note: On September 12, 2017, FDA issued a proposed rule that, if finalized, would extend the compliance dates for all of the agricultural water provisions (for produce other than sprouts). FDA does not intend to take action to enforce the agricultural water requirements while this rulemaking is underway. Proposed Extended Compliance Date: January 26, 2022
         
  • Compliance Dates for Farms Relying on the Exemption for Produce That Receives Commercial Processing That Adequately Reduces Microorganisms of Public Health Concern (section 112.2(b))
    • Requirement to obtain customer written assurances in section 112.2(b)(3) for sprouts that would otherwise be subject to Subpart M
      Extended Compliance Date: January 28, 2019
    • All other requirements in section 112.2(b) for sprouts that would otherwise be subject to subpart M
      Compliance Date: January 26, 2017
    • Requirement to obtain customer written assurances in section 112.2(b)(3) for all other produce that would otherwise be covered
      Extended Compliance Date: January 27, 2020
    • All other requirements in section 112.2(b) for all other produce that would otherwise be covered
      Compliance Date: January 26, 2018

Foreign Supplier Verification (Part 1, Subpart L)

The compliance dates for importers subject to the Foreign Supplier Verification Programs (FSVP) rule differ according to a number of considerations, including:

The compliance dates in this section 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. (Please refer to the relevant PC rule sections for these dates).

Compliance dates when foreign suppliers are in these categories:

  • Small businesses as defined in 21 CFR 117.3
    Compliance Date: March 19, 2018
  • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3
    Compliance Date: March 18, 2019
  • Suppliers subject to the Pasteurized Milk Ordinance (PMO)
    Compliance Date: March 18, 2019
  • "All Other" Businesses
    Compliance Date: May 30, 2017

Extended compliance dates when foreign suppliers are in these categories:

  • Facilities solely engaged in packing and/or holding activities on produce RACs
    • Small businesses as defined in 21 CFR 117.3
      Compliance Date: July 29, 2019
    • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3
      Compliance Date: July 27, 2020
    • “All Other” Businesses
      Compliance Date: July 26, 2018 
  • Certain facilities that would qualify as secondary activities farms except for ownership
    • Small businesses as defined in 21 CFR 117.3
      Compliance Date: July 29, 2019
    • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3
      Compliance Date: July 27, 2020  
    • “All Other” Businesses
      Compliance Date: July 26, 2018
  • Facilities that would qualify as farms if they did not color raw agricultural commodities (RACs) under part 117
    • Small businesses as defined in 21 CFR 117.3
      Compliance Date: July 29, 2019
    • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3
      Compliance Date: July 27, 2020
    • “All Other” Businesses
      Compliance Date: July 26, 2018
       

Compliance dates when foreign suppliers are in these categories:

  • Small businesses as defined in 21 CFR 507.3
    Compliance Date: March 19, 2018 
  • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3
    Compliance Date: March 18, 2019 
  • “All Other” Businesses
    Compliance Date: May 30, 2017

Extended compliance dates when foreign suppliers are in these categories:

  • Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
    • Small businesses as defined in 21 CFR 117.3
      Compliance Date: July 29, 2019 
    • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3
      Compliance Date: July 27, 2020 
    • “All Other” Businesses
      Compliance Date: July 26, 2018 
  • Certain facilities that would qualify as secondary activities farms except for ownership
    • Small businesses as defined in 21 CFR 117.3
      Compliance Date: July 29, 2019
    • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3
      Compliance Date: July 27, 2020
    • “All Other” Businesses
      Compliance Date: July 26, 2018 

Compliance dates when foreign suppliers are in these categories:

  • Small businesses as defined in 21 CFR 507.3
    Compliance Date: March 18, 2019
  • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3
    Compliance Date: March 17, 2020
  • “All Other” Businesses
    Compliance Date: March 19, 2018

Extended compliance dates when foreign suppliers are in these categories:

  • Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
    • Small businesses as defined in 21 CFR 507.3
      Compliance Date: July 27, 2020
    • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3
      Compliance Date: July 26, 2021
    • “All Other” Businesses
      Compliance Date: July 29, 2019
  • Certain facilities that would qualify as secondary activities farms except for ownership of the facility
    • Small businesses as defined in 21 CFR 507.3
      Compliance Date: July 27, 2020 
    • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3
      Compliance Date: July 26, 2021 
    • “All Other” Businesses
      Compliance Date: July 29, 2019
  • Facilities solely engaged in the ginning of cotton
    • Small businesses as defined in 21 CFR 507.3
      Compliance Date: July 27, 2020
    • Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3
      Compliance Date: July 26, 2021
    • “All Other” Businesses
      Compliance Date: July 29, 2019

       

Compliance dates when foreign suppliers are in these categories:

  • Small businesses as defined in 21 CFR 112.3
    Compliance Date: July 29, 2019
  • Very Small Businesses as defined in 21 CFR 112.3
    Compliance Date: July 27, 2020
  • “All Other” Businesses
    Compliance Date: July 26, 2018
     

Compliance dates when foreign suppliers are in these categories:

  • Small businesses as defined in 21 CFR 112.3
    Compliance Date: July 26, 2018
  • Very Small Businesses as defined in 21 CFR 112.3
    Compliance Date: July 29, 2019
  • “All Other” Businesses
    Compliance Date: July 26, 2017

Compliance dates when foreign suppliers are in these categories:

  • Small businesses as defined in 21 CFR 112.3
    Compliance Date: July 29, 2019
  • Very Small Businesses as defined in 21 CFR 112.3
    Compliance Date: July 27, 2020

Compliance dates when foreign suppliers are in these categories:

  • Small businesses as defined in 21 CFR 112.3
    Compliance Date: July 26, 2018
  • Very Small Businesses as defined in 21 CFR 112.3
    Compliance Date: July 29, 2019
     
  • Latest of May 28, 2019 or 30 months after the foreign supplier is required to comply with the relevant regulation triggering FSVP compliance
  • Two years beyond the otherwise-applicable FSVP compliance date (earliest compliance date would be May 28, 2019)

Sanitary Transportation (21 CFR Part 1, Subpart O)

Small businesses are those including any subsidiaries and affiliates employing fewer than 500 full-time equivalent employees (except that for carriers by motor vehicle that are not also shippers and/or receivers, this term would mean a business having less than $27.5 million in annual receipts).

  • Compliance Date
    April 6, 2018

A facility that has more than 500 full-time equivalent employees (except that for carriers by motor vehicle that are not also shippers and/or receivers, this term would mean a business having $27.5 million or more in annual receipts).

  • Compliance Date
    April 6, 2017

Intentional Adulteration (21 CFR Part 121)

Very Small Businesses are exempt, except that they must, upon request, provide for official review, documentation sufficient to show that the facility meets the exemption.

Very small businesses are businesses (including any subsidiaries and affiliates) averaging less than $10 million (adjusted for inflation) per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee)
  • Compliance Date for Having Documentation
    July 26, 2021

Small businesses are those businesses (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.

  • Compliance Date
    July 27, 2020

A business (including any subsidiaries and affiliates) that averages equal to or more than $10 million (adjusted for inflation) per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee) AND that has more than 500 full-time equivalent employees.

  • Compliance Date 
    July 26, 2019

 

Page Last Updated: 02/02/2018
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