FSMA Produce Safety Rule Timeline
The FDA had been developing and drafting the Produce Safety Rule since FSMA was passed in 2011. There were two open comment periods during which the FDA solicited feedback from produce growers, industry members, academics, and the general public. A timeline of the process is outlined below including compliance dates.
- January 4, 2011: FSMA was passed by President Obama.
- January 16, 2013: The proposed Produce Safety Rule was published.
- First open comment period ended on November 22, 2013. The FDA received over 15,000 comments during the first open comment period!
- September 29, 2014: The FDA released a supplemental document to the proposed Produce Safety Rule to revise the standards and make them more flexible and less burdensome in key areas.
- The comment period on the proposed Produce Safety Rule Supplement closed on December 15, 2014.
- November 2, 2015: The final Produce Safety Rule is sent to the Federal Register.
- November 13, 2015: The final Produce Safety Rule is available for public viewing online.
- November 27, 2015: The official publication date of the Produce Safety Rule.
- The rules go into effect 60 days after the publication date in the Federal Register, but affect businesses and farms at different times, depending on their operation size and the specific provision.
- The largest businesses, defined as greater than $500,000 in annual (three year average) gross produce sales, have 2 years from the effective date of the rule to comply with the regulation.
- Small businesses, defined as greater than $250,000 but less than $500,000 in annual (three year average) produce sales, have 3 years from the effective date of the rule to comply with the regulation.
- Very small businesses, defined as greater than $25,000 but less than $250,000 in annual (three year average) produce sales, have 4 years from the effective date of the rule to comply with the regulation.
- September 2017
- January 4, 2018: FDA announces their enforcement discretion policy for certain FSMA regulationsJuly 3, 2018: Equivalent Testing Methodologies for Agricultural Water expanded to include presence/absence methods
- June 4, 2018: Produce Inspections for Regulators Virtual Produce Tour video released
- July 3, 2018: Equivalent Testing Methodologies for Agricultural Water expanded to include presence/absence methods
- September 17, 2018: Draft Guidance: Determination of Status as a Qualified Facility released
- October 22, 2018
- March 2019
- Final rule to extend the compliance dates for agricultural water published.
- Updated supplemental educational resources posted on the Trainer Resources page under Module 5.1
- Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds
- October 19, 2019: The Produce Safety Rule Draft Guidance was issued.
- April 22, 2019: End public comment period to the Produce Safety Rule Guidance.
Information about compliance dates for the FSMA Produce Safety Rule is available in many places, but we felt like it might be valuable to gather all the pieces of information together so you can see the specific regulatory compliance dates for the different parts of the Rule.
- Proving eligibility for the qualified exemption requires three years of sales records to support the exemption. If you plan to use the qualified exemption, you will need to have sales records beginning on your compliance date.
The provisions covering sprout production first go into effect at the beginning of 2017 for farms making over $500,000 or later depending on the farm gross receipts.
The other provisions of the rule go into effect at the beginning of 2018 or after 2018, depending on the provision and the size of your farm’s business.
1 According to the Final Rule issued on 3/18/19, Compliance dates for Subpart E, Agricultural Water, allow an additional four years.
2 A farm eligible for a qualified exemption must notify consumers as to the complete business address of the farm where the food is grown, harvested, packed, and held.
3 A farm is a small business if, on a rolling basis, the average annual monetary value of produce sold during the previous 3-year period is no more than $500,000.
4 A farm is a very small business if, on a rolling basis, the average annual monetary value of produce sold during the previous 3-year period is no more than $250,000.
Download the Compliance Dates chart in a printable format.
Before the compliance date, every covered farm that does not qualify for an exemption must have a supervisor (such as a farm owner/operator) complete a standardized food safety training program. The Produce Safety Alliance Grower Training Course is one way to satisfy this requirement.