The Produce Safety Rule does not apply to:
- The following produce commodities that FDA has identified as rarely consumed raw: 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; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.
- Food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed).
- Produce that is not a raw agricultural commodity (a raw agricultural commodity is any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing).
- Produce that is used for personal or on-farm consumption.
- Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less.
1) The Produce Safety Rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, under certain conditions. Examples of processing include refining, distilling, manufacturing, processing produce into sugar, oil, spirits, wine, beer or similar products. For more information on the requirements for exempt produce see how produce is classified under the PS Rule.
2) The Rule also provides a qualified exemption and modified requirements.
In order to be eligible for a qualified exemption produce farms must meet these two requirements:
1). The farm must sell the majority of the food* directly to consumers, restaurants or retail food establishments within NC or not more than 275 miles from the farm or via internet sales (If the farm sells the food to a broker or any other type of business, those sales should be 49% or less of total food sales).
2). The total food* sales for the farm must be less than $500,000 annually (to calculate sales use the average over the last 3 years- starting with 2016 as year 1 and going forward).
*Food is defined as articles used for food or drink for man or animals, or articles used to make components of it. It includes seeds and beans used to grow sprouts. As farms calculate food sales take into account that cotton, tobacco and timber are not considered food.
Any farm, CSA or U-pick operation can be eligible for a qualified exemption and modified requirements as long as they meet the two conditions set above by the PS Rule.
What do “Qualified exempt” farms have to do to be in compliance with the Produce Safety Rule?
These farms have to comply with two requirements: keep financial records and follow modified labeling requirements.
Records: A farm must establish and keep adequate records necessary to demonstrate that the farm satisfies the criteria for a qualified exemption, including a written record reflecting that an annual review has been performed and verification of the farm’s continued eligibility for the qualified exemption. Farms must keep financial records to prove food sales are under $500,000 for the last three years (Year 1 for this calculation is 2016) and sales to qualified end consumers.
Any records established and kept for compliance with the Produce Safety Rule must include the following information and adhere to these guidelines:
- Include the name and location of the farm
- Provide an adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record.
- Provide the location of growing areas and packing sheds
- Records need to be created at the time an activity is performed or observed.
- Records must be accurate, legible and indelible.
- Existing records to comply with other federal, state or local regulations can be used.
- Records to substantiate the qualified exemption must be kept for 3 years.
- Records can be kept electronically; true copies are accepted or can be handwritten.
- A farm has 24 hours to obtain records kept offsite and make them accessible to FDA for inspection and copying upon oral or written request.
- The records must be signed by the person who created them and by the farm supervisor or owner.
These records do not need to be submitted to FDA, NCDA or any other agency. These records must be kept by the farm on file in case they are formally requested by an inspector.
Labeling: The labeling requirement consists of including the name and complete business address of the farm where the produce was grown either on the label of the produce or to display the same information at the point-of-purchase. The labeling requirement will be effective on 1/20/2020.
Specific guidelines about labeling produce:
- Include the name and the business address of the farm where the produce was grown on any food packaging label.
- When food packaging label is not required, display at the point of purchase, the name and complete business address of the farm where the produce was grown, on a label, poster, sign, placard or documents delivered with the produce in the normal course of business, or in the case of Internet sales, in an electronic notice.
- The complete business address must include: street address or post office box, city, state and zip code for domestic farms, and comparable full address information for foreign farms.
As long as a farm satisfies the requirements for records and labeling listed above or the FDA has not withdrawn a qualified exemption then the farm is compliant with the Produce Safety Rule. Qualified exempt farms are not considered “covered farms” by the Rule and consequently they will not be inspected or checked for the practices/standards set in the Rule as covered farms will. Nonetheless, FDA is expecting these farms to grow, harvest, pack, hold and distribute produce under sanitary conditions. Failure to comply with requirements listed is prohibited by the FDA.
If the farm is not currently implementing good agricultural practices, it is important for the farmer to attend a training session or an educational program to learn about the topic and voluntarily implement practices that reduce the risk of foodborne illness.
Important aspects of Compliance and Enforcement
- FDA can withdraw a qualified exemption if produce has been grown, harvested, packed or held in a farm under such conditions that it is unfit for food or if it has been prepared, packed or held under unsanitary conditions where it can be contaminated with filth or have been rendered injurious to health.
- An exemption can be withdrawn in the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm; or if FDA determines that is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with the farm that are material to the safety of the food.
FDA will have procedures in place to:
- Withdraw exemptions.
- For farms to request a hearing if the qualified exemption has been withdrawn.
- Submit appeals by farms that have lost the qualified exempt status.
- Reinstate qualified exemptions.
This information is not legal advice. It is based on the information published in Subparts A, O, Q and R of the PS Rule. Dated 3/7/2017.