The Food and Drug Administration (FDA) is proposing expensive requirements that would apply to almost everyone involved in the food system, including farms, cottage food operators, co-ops, and restaurants. For foods that FDA lists as “high risk,” the proposed rule imposes extensive record-keeping requirements, including electronic spreadsheets, GPS coordinates on where the foods are grown, and the location, date and time that the food is harvested, cooled, packed, shipped, or used as an ingredient in another food.

The major foodborne illness outbreaks have certainly revealed problems with traceability—but that’s in the large-scale, conventional food system. From spinach to peanut butter, the problems arise because raw ingredients are taken to a central processing facility, which often leads to widespread contamination, and then the products are packaged under dozens (if not more) of brand names and shipped all over the country. Small-scale operations with short supply and distribution chains are both inherently lower risk and easier to trace.

While this should have been resolved in the Food Safety Modernization Act (FSMA) regulations, apparently it was not. FSMA did direct FDA to impose additional traceability requirements on “high risk” foods. But FSMA called for these additional requirements to apply to “facilities,” which would exclude farms and “retail food establishments” (those whose primary purpose is to sell direct to consumer, such as grocers, restaurants, and cottage food producers).

FDA has latched onto some confusing language in FSMA and expanded the scope of this provision to cover everyone who manufactures, processes, packs, or holds food. And the agency interprets those terms to include people who grow the food, i.e. farmers.

The very narrow exemptions are:

• Personal use (the FDA actually comments that food prepared for a pot-luck dinner would be exempt. As if anyone would have guessed differently. This shows how narrow the exemption is!)
• Farms that have no more than $25,000 in annual sales of produce;
• Certain farm sales would be exempt. In other words, the farm is not exempt as a whole, but only the foods they sell in these specific ways: Foods sold direct-to-consumer (but not to local businesses), food sold in farm-to-school or farm-to-institution programs, and “identity-preserved food” where the food is packaged on the farm and the labeling remains intact all the way to the consumer—but only if the food is individually packaged in sealed plastic.
• Businesses that sell $25,000 or less of food annually.
• Egg producers with less than 3,000 hens.
• Eggs or produce that are commercially processed in a way that kills microorganisms (essentially, pasteurized or irradiated).
• Produce on the list for “rarely consumed raw” (but that list doesn’t overlap with the list of high-risk foods, so this is a meaningless exemption).
• Nonprofit food establishments, such as food banks or soup kitchens.
• Retail food establishments (grocers, restaurants, cottage food producers, and other businesses whose primary purpose is selling direct to consumer), but only for foods purchased directly from farms.

The agency is also considering, but has not committed to, exempting businesses with 10 or fewer full-time employees. One option under consideration is to exempt these tiny businesses from having an electronic spreadsheet, but not from the extensive recordkeeping and tracking requirements.

Even if your farm or food business falls within one of these narrow exemptions, you might still find yourself required to keep extensive records. That’s because the agency is requiring “first receivers”—businesses that receive the food items from the original person who grew or made them—to keep extensive records on where it was grown/made, when it was harvested/manufactured, etc. This information can only come from the small farmer or original producer. In other words, local-sourcing food businesses will only be able to buy from local farms if the farms keep all of these extensive records.

In good health,