The First FSMA Rule is Finalized

Author: Lauren Gwin, Center for Small Farms & Community Food Systems

Publish Date: Fall 2015

On September 10, the federal Food and Drug Administration (FDA) released the final version of the “Preventive Controls for Human Food” rule, which applies to facilities that process and manufacture food for human consumption. This rule and the Produce Rule are the two FSMA rules we have been tracking closely for their potential implications for sustainable agriculture, small- and mid-sized farms, and local food systems. FDA will publish the final Produce Rule by the end of October.

The OSU Small Farms Center is working with the National Sustainable Agriculture Coalition (NSAC) and the Oregon Department of Agriculture (ODA) to digest the Preventive Controls rule. On September 11, NSAC issued a statement ( stating that FDA had clearly listened to the sustainable agriculture community on many points raised during the two comment periods. 

The rule, said NSAC Policy Specialist Sophia Kruszewski, “provides several important modifications to avoid ensnaring farms and local food markets in ill-fitting rules designed for large-scale industrial food facilities.” In particular, FDA revised the definition of a “farm” so that more regular farm activities are included and won’t trigger the “facility” definition, making the farm subject to the Preventive Controls rule. 

A top priority for us at the Small Farms Center is to learn whether the PC Rule will affect Oregon’s innovative “cottage food” laws, especially the Farm Direct exemption. This exemption allows farmers to make small amounts of low-risk value added foods and sell them direct to consumers. Because home residences are not required to register as facilities, and most farmers using the Farm Direct exemption are making products in home residences, we tentatively believe the PC Rule will not apply. However, we will work with NSAC and ODA to clarify this and report back in the next Oregon Small Farm News.