Produce Safety Rule Compliance Dates & Timeline
FSMA Produce Safety Rule Timeline
Here is the timeline of FDA’s development of the Produce Safety Rule since FSMA was passed in 2011.
- 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 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- September 17, 2018: Draft Guidance: Determination of Status as a Qualified Facility released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
- Draft Produce Safety Rule Guidance for covered produce other than sprouts released, but does not include guidance for agricultural water.
- 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 for sprouts was issued.
- August 10, 2020: The Request for Information and Comments on Uncommon Produce Commodities was issued as one step toward a potential revision to the Rarely Consumed Raw list of excluded produce.
- December 06, 2021: A Proposed Rule to Revise Subpart E: Agricultural Water (with a focus on pre-harvest agricultural water requirements) was published in the Federal Register
- July 18, 2022: FDA Proposes Compliance Date Extension for Pre-Harvest Agricultural Water Requirements was published as a FDA Constituent Update and a Supplemental Notice of Proposed Rulemaking.
- January 06, 2023: Updates to the Efficacy Protocol for Reduction of Foodborne Bacteria in Preharvest Agricultural Water were issued.
- May 06, 2024: FDA publishes Revisions to Subpart E: Agricultural Water Requirements with a focus on pre-harvest agricultural water.
- June 25, 2024 Revised Module 5.1 posted to PSA web site under Trainer Resources, Water to replace v1.2 of the PSA Grower Training manual during delivery until Version 2.0 of the PSA Grower Training Course can be created.
Compliance Dates
Information about compliance dates for the FSMA Produce Safety Rule is available in many places, but here are 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 went into effect at the beginning of 2017 for farms selling over $500,000 in produce annually (or later depending on the farm gross receipts for produce sales).
The other provisions of the rule went into effect at the beginning of 2018 or after 2018, depending on the provision, the size of your farm’s business, and specific policies that have been put in place by FDA.
- A Final Rule issued on 3/18/19, extended compliance dates for Subpart E, Agricultural Water (other than sprouts), to allow an additional four years beyond the original compliance dates. This was followed by a period of enforcement discretion.
- A Stakeholder Update issued on 1/13/2023 described ending the period of enforcement discretion for harvest and postharvest water requirements in Subpart E, Agricultural Water (other than sprouts) with a staggered system of enforcement initiation dates that arrive one year after the previously-extended compliance dates (see above).
- A Final Rule issued on 5/06/24 finalized revisions to Subpart E, Agricultural water along with compliance dates for pre-harvest water uses for non-sprout covered produce.
Download the Compliance Dates chart in a printable format (Updated 11/5/2024)
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 satisfies this requirement.