FSMA Updates: Farm Direct & More

Authors: Lauren Gwin, Associate Director, OSU Small Farms Center, and Rebecca Landis, Corvallis-Albany Farmers’ Markets

Publish Date: Fall 2016

Implementation of the federal Food Safety Modernization Act (FSMA) is fully underway. Produce farmers and food manufacturers of all types and sizes need to know if and how the rules apply to them.

The OSU Center for Small Farms continues to track two rules – the Produce Rule and the Preventive Controls Rule – focusing specifically on how they affect small farms and local food producers. Here are some useful updates.

Oregon’s Farm Direct law is OK – mostly

We have long been concerned that FSMA – specifically the rules related to “facilities” that process and manufacture food – would undercut Oregon’s Farm Direct law. Would farms that make and sell jams, jellies, and pickles direct to consumers really have to register as facilities with FDA?

We finally have the answer: no, with one exception (hang on for that).

Here’s the (relatively) short version:

  • “Retail food establishments” are not covered by FSMA.
  • FSMA – the statute itself – directed FDA to amend the definition of retail food establishment to clarify that it includes farms that process farm products into value-added goods and sell the majority of all their products direct to consumers.
  • The final Preventive Controls rule was published last fall, but it was not until this July that

FDA published the amended RFE definition. The final Preventive Controls rule also clarified that for these farms, products, and sales, the point of sale does not have to be on the farm or even in person. Farm sales at farmers’ markets, off-site CSA drop off locations, and even online sales are still counted as sales direct to consumers.

The Preventive Controls rule allows farmers to do their processing in off-farm kitchen facilities. However, farmers using Oregon’s Farm Direct law must use facilities on their farms.

Now to the exception: Farms that make and sell value-added products under Oregon’s Farm Direct law but do not sell the majority of their products direct to consumers. (Consider, for example, a farm that sells primarily to a processor but also has a small market garden and does a small amount of value-added processing and sales.) Those farms do not qualify as retail food establishments.

If such a farm makes the products in its private residence, it will be exempt from facilities registration (per the federal 2003 BioTerrorism Rule) and therefore not subject to the Preventive Controls Rule.Otherwise, the farm will likely have to register with FDA as a food facility. It would, however, likely be partially exempt from some of the requirements (e.g., if it is a small business and processing low-risk foods, as defined in the Rule). Keep reading to learn about resources that spell out those – and other – requirements.

Flow charts and guides we can all understand

The tireless team at National Sustainable Agriculture Coalition (NSAC) continues to translate the flow of complex rules and guidance into very useful (and readable) resources.

We recommend starting with these three:

  • Flow chart to determine if and how you are covered by the Produce and Preventive Controls rules
  • Guide to the Produce Rule
  • Guide to the Preventive Controls Rule

ODA’s role in FSMA

The Oregon Department of Agriculture (ODA) will have significant FSMA-related responsibilities in the years ahead. ODA recently received a FSMA produce safety grant from FDA, specifically for “outreach, education, technical assistance, and inventory work” related to the FSMA Produce rule. The award is for approximately $3.5M over the 5-year grant period.