Farms covered under the Produce Safety Rule must take several steps to comply with this new regulation. Details on these steps, compliance dates and exceptions are provided throughout this website. In general, produce farms must do the following:
- Employ an individual who has completed an FDA-recognized Produce Safety Rule Grower Training Course.
- Implement required Produce Safety Rule food safety practices on your farm.
- Be able to prove that you are following and documenting all required food safety practices.
The U.S. Food and Drug Administration provides oversight, implementation and enforcement of the Produce Safety Rule. Farms found to be out of compliance may face economic, regulatory and legal consequences. The FDA also has the authority to embargo product from a farm found to be out of compliance with the Produce Safety Rule.
Produce Safety Rule compliance dates vary depending on the size and sales volume of a produce farm. Farms designated by the U.S. FDA as "large" are required to comply with the Produce Safety Rule beginning January 26, 2018. Smaller operations will be phased in over the next few years. Below is a chart summarizing the compliance dates for produce farms of all sizes.
|Farm Size||Definition||Compliance Date|
|Large Farms||Produce sales of $500,000 or more per year||January 26, 2018|
|Small farms||More than $250,000 but no more than $500,000 in average annual produce sales during the previous three-year period.||January 27, 2019|
|Very small farms||More than $25,000 but no more than $250,000 average annual produce sales during the previous three-year period||January 26, 2020|
If you are not sure if your operation is regulated under the Produce Safety Rule, please visit this flowchart prepared by the National Sustainable Agriculture Association . Specific questions may also be submitted directly to FDA's Technical Assistance Network (TAN).
A list of exemptions from the Produce Safety Rule can be found online. Exemptions generally include the following:
- Farms exclusively producing commodities that are rarely consumed raw as determined by the FDA. These are: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.
- Farms that grow produce only for personal consumption or very limited distribution.
- Farms that have annual sales under $25,000.
- Farms that grow produce that is processed in a way that would kill pathogens.
The rule also provides what is called a "qualified exemption" for certain farms with food sales less than $500,000 per year and who provide produce to qualified end-users. Qualified end-users are defined as consumers, restaurants or retail food establishments located in the same state or the same Indian reservation as the farm or if the end user is not more than 275 miles away from the farm.
A farm with the qualified exemption must still meet certain modified requirements, including disclosing the name and the complete business address of the farm where the produce was grown either on the label of the produce or at the point of purchase. These farms are also required to establish and keep specific documentation.
CDFA strongly urges farms to seek guidance from the FDA regarding specific documentation required to verify exemptions.
A full copy of the Produce Safety Rule is available online . Other helpful information and guidance is also available. FDA has announced it is currently prioritizing the finalization of guidance documents to assist farmers in developing on-farm food safety practices. If you are a member of a commodity group or other produce industry association, you may reach out to them for additional information on required food safety practices.
All farms covered under the Produce Safety Rule must employ an individual who has completed an FDA-recognized Produce Safety Rule Grower Training Course. As part of the Produce Safety Rule on-farm inspection, government inspectors will ask farms to verify a certificate is on file indicating a current employee has completed this course. Please note the certificate belongs to the individual and not to the produce farm. So, if an employee with this certificate leaves your farm for other employment, your farm will be required to ensure another employee has completed the Produce Safety Rule Grower Training Course.
Currently, courses must be approved by the Produce Safety Alliance to qualify as compliant with the Produce Safety Rule Grower Training requirements. The Produce Safety Alliance has a list of all approved classes being conducted throughout the U.S. along with information on how to register. The cost of these courses can vary widely from over $1,000 to less than $50. CDFA has received funding from the U.S. Food and Drug Administration to subsidize approved Produce Safety Rule Grower Training Courses in California at a reduced cost. A list of these subsidized courses can be found here.
The FDA had determined that official Produce Safety Rule on-farm inspections will begin in 2019. The Produce Safety Program will spend 2018 working to make sure California produce farmers understand the requirements of the Produce Safety Rule.
Produce Safety Rule inspections are being done on behalf of the U.S. Food and Drug Administration. CDFA has created the Produce Safety Program, a new unit within its Inspection Services Division that will employ FDA-credentialed inspectors to perform Produce Safety Rule inspections on California produce farms. You can learn more about the inspectors here.
The U.S. FDA has determined that Produce Safety Rule on-farm inspections will take place beginning in 2019. CDFA is working with other government agencies and associations to identify produce farms in California that are likely subject to this new rule. Farms will be selected for routine inspection by the Produce Safety Program on a random basis following verification of the farm's status.
The best way to understand what you should expect is to go through the required PSA Grower Training class.
In general, farmers should expect that inspectors will ask to review records documenting employee training, practices, procedures and water quality. It is required that farms maintain such documents for a period of two years. An inspection of the production site will be conducted, which could include growing, harvesting, packing and holding activities. Farmers should be prepared to answer specific questions regarding their operation as it relates to the Produce Safety Rule.
The Produce Safety Program is offering California produce farms the opportunity to participate in a non-regulatory On-Farm Readiness Review (OFRR). These are designed to give California produce farmers a better understanding of what they can expect from a Produce Safety Rule inspection. Information on how to schedule an OFRR will be available very soon.
All interested parties may sign up to receive news and updates about the Produce Safety Rule program. You may also wish to follow the Produce Safety Program on Facebook.
Many commodity groups and produce associations have been very active in developing a broad understanding and knowledge of the Produce Safety Rule and can be a great resource to their membership. Contact your commodity group or produce association if you have additional questions.
Questions can also be directed to CDFA by sending an email to firstname.lastname@example.org.