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Quick and Dirty: The Who, What, Where and When of FDA’s Produce Safety Rule

What does the Produce Safety Rule do?
The U.S. Food and Drug Administration’s (FDA) “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption Rule”, or the Produce Safety Rule for short, sets operational standards for “covered farms” that grow, harvest, pack, and hold “covered produce.” Covered farms must be aware of the following major provisions of the rule:

  • Employees must receive specific food safety training and there must be at least one supervisor/employee that takes certain food safety courses;
  • Farms must monitor water quality based on certain microbial water quality standards under the Rule, which involves testing water used in harvest and post-harvest activities, and water used during growing that is likely to contact covered produce
  • There are increased requirements for the handling, storage, transport, and application of animal-based soil amendments. FDA is still researching the appropriate application interval for certain applications of untreated manure.
  • Record-keeping is essential- covered farms need to keep records of employee trainings, water quality testing, and other items identified under the Rule. Additionally, if covered farms are claiming an exemption, sales records should be kept to justify a farm’s exempt status.

Who does the FDA Produce Safety Rule affect?
The Rule applies to “covered farms,”  which are defined as having more than $25,000 in gross annual produce sales, averaged across a three-year basis and adjusted for inflation, that grow, harvest, pack and hold “covered produce.” “Covered produce” is defined as fruits and vegetables, including mushrooms, peanuts, tree nuts, and herbs. A practical first step for determining if your farm may be a covered farm is to ask yourself 1) if you gross close to or more than $25,000 per year in sales and 2) if you grow, harvest, pack and hold a product that is normally consumed raw. If you think that your farm may be a covered farm, more facts may need to be gathered about the specifics of your operation before a determination can be made. There are numerous exemptions and qualified exemptions under the rule, however. For example, if your produce goes through a commercial “kill step” to kill bacteria, you may be exempt.

Where will covered farms need to make changes in their operations?
From a practical standpoint, if your hiring practices do not include some type of training for employees, you will want to implement a training program that incorporates the food safety training requirements. Additionally, you will want to evaluate your water sources and soil amendments to determine if they meet the standards in the rule. Lastly, evaluate your book-keeping practices and determine what type of record-keeping system will work best for your operation. Who will be responsible for sales record-keeping, and employee training? Who will take the required food safety courses? Who will audit the farm to determine if you are in compliance? Identifying these individuals could save a lot of headaches down the road.

When will my covered farm need to be in compliance?
Many farms are likely already in compliance or close to being in compliance with the Produce Safety Rule if they received Good Agricultural Practices (GAP) certification from the U.S. Department of Agriculture. However, if your covered farm is just getting started on implementing food safety practices, you will need to be in compliance in the next one to six years depending on the size of your operation. FDA has classified farms as very small, small, and large. Additionally, each part of the rule has a different compliance deadline. It’s highly recommended that covered farms start taking steps towards compliance now.

Contact Stock and Leader’s Agricultural Industry Group for more information on the FDA’s new rule.

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