The FDA has 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 future dates of when to expect compliance dates will become effective.
- 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.
- A redline version of the changes from the original and supplemental document is available.
- 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 will go into effect 60 days after the publication date in the Federal Register, but will 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. They will have an additional two years to comply with certain specified agricultural water requirements.
- Small businesses, defined as greater than $250,000 but less than $500,000 in annual (three year average) produce sales, will have 3 years from the effective date of the rule to comply with the regulation. They will have an additional two years to comply with certain specified agricultural water requirements.
- Very small businesses, defined as greater than $25,000 but less than $250,000 in annual (three year average) produce sales, will have 4 years from the effective date of the rule to comply with the regulation. They will have an additional two years to comply with certain specified agricultural water requirements.
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 when your compliance date arrives, you may need to begin collecting sales records beginning this year (2016) depending on your business size.
- 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 Compliance dates for certain aspects of the agricultural water requirements allow an additional two years. Provisions with extended compliance dates include:
- The specific microbiological criteria that apply to agricultural water
- Corrective measures that must be taken if agricultural water does not meet requirements
- The frequency of testing agricultural water
- Records associated with data to support a microbial die-off rate, corrective measures, test results from a public water system, or data used to support alternative die-off rates, criteria, or sampling strategies
2 Guidance published 8/24/16 indicates that a farm has the option of collecting surface water samples over two to four years. For example, a farm that is not small or very small would begin sampling in 2018 and complete the water quality profile in 2020, 2021, or 2022.
3 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.
4 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 greater than $250,000 but no more than $500,000.
5 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 greater than $25,000 but no more than $250,000.
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.