Source: https://www.fda.gov/food/guidanceregulation/fsma/ucm540944.htm
Timestamp: 2018-07-19 20:57:58
Document Index: 737741516

Matched Legal Cases: ['art 117', 'art 507', 'art 112', 'art 1', 'art 1', 'art 121', 'art 507', 'art 507', 'art 507', 'art 507', 'art 507', 'art 507', 'art 507', 'art 112', 'art 112', 'art 112', 'art 112', 'art 117', 'art 507', 'art 507', 'art 507', 'art 112', 'art 112', 'art 1', 'art 121']

Download the Compliance Dates (PDF: 97KB)
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)
Preventive Controls for Animal Food (Part 507)
Produce Safety (Part 112)
Foreign Supplier Verification (Part 1, Subpart L)
Sanitary Transportation (Part 1, Subpart O)
Intentional Adulteration (Part 121)
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).
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
Facilities that would qualify as farms if they did not color RACs
Small businesses are businesses (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.
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.
Other Businesses (not very small or small)
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, 2018
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.
Businesses Subject to the Pasteurized Milk Ordinance (PMO)
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.
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)
Facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells for animal food
Certain facilities that would qualify as secondary activities farms, except for ownership
Subpart C or Section 507.7, and Related Requirements (Preventive Controls)
Compliance Date: January 26, 2021
Facilities solely engaged in the ginning of cotton
Subpart B and Related Requirements (CGMPs)
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)
Certain facilities that would qualify as secondary farms except for ownership
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.
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.
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.
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.
Covered activities involving sprouts covered under Subpart M – subject to all requirements of part 112
Covered activities involving all other covered produce – subject to part 112, except subpart M
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))
Modified Requirement in section 112.6(b)(1) (label statement)
All other requirements in sections 112.6 & 112.7 for farms producing sprouts
All other requirements in sections 112.6 & 112.7 for farms not producing sprouts
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
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
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.
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
Extended Compliance Date: January 27, 2020
Other Businesses (not small)
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.
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
Extended Compliance Date: January 28, 2019
Compliance Date: January 26, 2017
The compliance dates for importers subject to the Foreign Supplier Verification Programs (FSVP) rule differ according to a number of considerations, including:
the size of the foreign supplier,
the nature of the importer,
and whether the foreign supplier must meet the requirements of the final rules for
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (collectively, “PC rules”),
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (“produce safety rule”).
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).
The FSVP compliance dates can also be found at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm
FSVP Importer whose foreign supplier is not subject to the preventive controls (PC) or produce safety rules.
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
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)
"All Other" Businesses
Compliance Date: May 30, 2017
Extended compliance dates when foreign suppliers are in these categories:
Compliance Date: July 29, 2019
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
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.
Small businesses as defined in 21 CFR 507.3
FSVP importer of animal food 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 Date: March 17, 2020
Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3
Compliance Date: July 26, 2021
Certain facilities that would qualify as secondary activities farms except for ownership of the facility
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.
Small businesses as defined in 21 CFR 112.3
Very Small Businesses as defined in 21 CFR 112.3
FSVP importer of 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 Date: July 26, 2017
FSVP importer of 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).
FSVP importer of whose foreign supplier is a farm producing sprouts that is eligible for a qualified exemption under the produce safety rule.
Compliance Date for written assurance requirements in customer provisions in 21 CFR sections 1.507(a)(2)(ii), (3)(ii), (4)(ii)
Latest of May 28, 2019 or 30 months after the foreign supplier is required to comply with the relevant regulation triggering FSVP compliance
Compliance Date for the importation of food contact substances
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).
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).
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
Small businesses are those businesses (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.
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.