Is your farm covered by the Food Safety Modernization Act’s Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, otherwise known as the Produce Safety Rule? This short video will help you answer that question. The codified text of the Produce Safety Rule is provided in the PSA Grower Training manual. A pdf of the Rule and the preamble of comments and responses from FDA that helped shape the Rule, is available at this URL. This is a good resource to bookmark or download because you can easily search it for specific questions you have. Another resource to help you determine if you are covered by the Produce Safety Rule, is the flowchart available on page one of the FDA/USDA Resources section of the PSA Grower Training manual. You can download the full-color version of the flowchart at this URL. Now, please turn to that page so we can walk through it step-by-step. The first question asks, “Does your farm grow, harvest, pack or hold produce?” To answer this question, we’ll refer to the definition of PRODUCE in the Produce Safety Rule and the Glossary of the PSA Grower Training manual. It says produce is “any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts…, peanuts, tree nuts, and herbs.” The definition goes on to define a fruit and a vegetable, and states that produce does not include food grains. If your answer is no, and your farm does not grow, harvest, pack or hold produce, then your farm is NOT covered by this rule. Question 2: Does your farm on average have $25,000 or less in annual produce sales? Before answering this question, you should know that this dollar amount is adjusted for inflation. $25,000 in 2011 was worth $28,106 in 2018. Visit this website for more information about adjustments for inflation. If your answer is yes, that your farm averages $25,000 or less in annual produce sales, then your farm is NOT covered by this rule. Question 3 asks, “Is your produce one of the commodities that FDA has identified as rarely consumed raw?” If you grow, harvest, pack or hold more than one produce commodity, you must ask this question separately for each one to determine whether that particular produce commodity is covered by this rule. And the key here is “commodities that FDA has identified as rarely consumed raw,” not what you, yourself, would consider rarely consumed raw. Take a moment to look at the list of rarely consumed raw produce. This list is exhaustive, meaning that these are the only produce items considered rarely consumed raw. To learn why these produce items are considered “rarely consumed raw” and how this list was developed, turn to page 20 of the FDA/USDA Resources tab in the PSA Grower Training manual. You can also find the factsheet at this URL. Okay, back to question 3. Is your produce one of the commodities that FDA has identified as rarely consumed raw? Is your produce one of the commodities that FDA has identified as rarely consumed raw? Question 4: Is your produce for personal or on-farm consumption? Produce that is produced by an individual for personal consumption or produced for consumption on the farm or another farm under the same management, to feed your employees, for example, is NOT covered by this rule. Now for exemptions. Question 5 asks, “Is your produce intended for commercial processing that adequately reduces pathogens (for example, commercial processing with a “kill step”)? To learn what this means, turn to section 112.2(b) in the Produce Safety Rule. Pause this recording to read section 112.2(b). Common examples of commercial processing that adequately reduces pathogens are canning, pasteurizing, and winemaking If your answer to question 5 is “yes,” then your produce is eligible for exemption from the rule, provided you make certain statements in documents accompanying the produce, obtain certain written assurances, and keep certain documentation, as detailed in Sections 112.2(b)(2) through (b)(6). Basically, you must disclose in documents accompanying the produce, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance,” AND receive written assurance each year from the buyer that they or another customer will commercially process the produce as described in Section 112.2(b)(1). Documentation must be kept for a minimum of two years. Question 6: Does your farm on average have less than $500,000 in annual food sales AND the majority of that food is sold directly to “qualified end-users”? There are a lot of important details in this question. First, the $500,000 value is subject to inflation the same way as the $25,000 value in Question 2. According to the FDA’s inflation table, $500,000 in 2011 equated to $562,119 in 2018. Please note, before we were only concerned with produce sales, but the qualified exemption is based on total FOOD sales, which includes covered produce and not covered produce, meat, milk, eggs, crops grown for animal feed, edible by-products like cottonseed oil, and any value-added food products that you sell. And secondly, a qualified end-user is defined in Section 112.3(c) to mean the consumer of the food OR a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm that produced the food OR within 275 miles of that farm. If your farm satisfies BOTH requirements, then your farm is eligible for a qualified exemption from the rule. If your farm is qualified exempt, then you must comply with certain modified requirements and keep certain documentation as detailed in Sections 112.6 and 112.7. The modified requirements include providing the name and complete address of the farm where the produce was grown either on a food packaging label or on a sign at the point of purchase, establishing and keeping records that demonstrate that your farm satisfies criteria for a qualified exemption, complying with the compliance and enforcement requirements of the Produce Safety Rule, and being subject to the provisions regarding the withdrawal of your status as a partially covered or “qualified exempt” operation. You can read more about each of these modified requirements by turning to the noted subparts in the Produce Safety Rule. Another important note: Proving eligibility for the qualified exemption requires three years of sales records to support the exemption. As you see on this table created in collaboration with the Southern Center, January 26, 2016 was the compliance date for retention of records supporting a qualified exemption and January 1, 2020 is the compliance date for the qualified exemption labeling requirement. Okay, we’ve made it through the FDA fact sheet on Produce Safety Rule coverage, exemptions and exclusions. Now let’s put the factsheet to use. A farm sells $19,000 in produce average over a 3-year periodat a local farmers’ market and through a CSA. Is this farm covered by the Produce Safety Rule? Question 1: Do they grow, harvest, pack or hold produce? Yes. Question 2: Does the farm average $25,000 or less in annual produce sales? So, no, they are NOT covered by the Produce Safety Rule. See how easy that is? Let’s try some harder scenarios. Practice Question 2. A farm sells $35,600 in produce, and also sells $650,000 in other food products, including sauerkraut and jam. Do they satisfy the ‘qualified exemption’ requirements? No. Since the farm has more than $25,000 in average annual produce sales and sells over $500,000 annually in food products, they are not eligible for the qualified exemption. Practice Question 3. A farm annually sells $475,000 in produce, $200,000 to a wholesaler out-of-state/more than 275 miles from the farm, $200,000 to a local restaurant, and $75,000 to a local grocery store. Do they satisfy the requirements for a qualified exemption? Yes. The farm is likely to be eligible for a qualified exemption because the sales to qualified end-users exceed the sales to other buyers, and the sales are below $500,000 annually. Practice Question 4. All of a farm’s annual $29,000 in produce sales are to a distributor located more than 275 miles away and not in the same state as where the produce was grown. The farm grows potatoes, pumpkins, sweet corn, winter squash, and has an acre of raspberries and strawberries. Is this farm covered by the Produce Safety Rule? Remember to walk through the flowchart from top to bottom to determine your answer. First, they sell produce. Second, they sell more than $25,000 worth of produce annually. Third, even though most of the commodities they grow are identified as rarely consumed raw, they count towards total food sales. And since all of this farm’s produce is sold to a distributor in another state, or more than 275 miles away from the farm, it does not meet the requirements for a qualified exemption. So the correct answer is yes, this farm is covered by the Produce Safety Rule. Practice Question 5. A grower is eligible for a qualified exemption and therefore is only subject to modified FSMA requirements. Their buyer requires a food safety audit in order to accept them as a supplier. Does this grower need to comply with the buyer’s requirements? Yes, if they want to sell their produce to that buyer. That last question was just a reminder that GAPs certification and other buyer requirements are separate from Produce Safety Rule requirements. You will need to comply with buyer requirements if you want to sell your produce to them, even if your farm or produce is not covered by the Produce Safety Rule or is qualified exempt. Regardless of Produce Safety Rule or buyer requirements, all produce growers should understand and take action to reduce food safety risks on the farm.