The FSMA amended section 415 of the Federal Food, Drug, and Cosmetic Act to require facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States to submit additional registration information to the Food and Drug Administration (“FDA”), including an assurance that FDA will be permitted to inspect the facility. Generally, grain elevators are exempt from most FSMA rules.
As part of the FSMA, the FDA passed many rules imposing operational and procedural requirements on food processors, distributors, manufacturers, and other entities along the human and animal food supply chains. Regulated entities must comply with Current Good Manufacturing Processes (CGMP), Hazard Analysis and Risk-Based Preventive Control (PC), and the Supply Chain Program (SC). Numerous exemptions apply, several of which are applicable to typical grain elevators. The PC and SC do not apply to facilities that are solely engaged in the storage of raw agricultural commodities (RACs) (other than fruits and vegetables) intended for further distribution or processing. Similarly, the CGMP do not apply to establishments solely engaged in holding or transporting RACs. 21 CFR 117.5; 21 CFR 507.5.
The applicable regulatory definition of "holding" means a grain elevator can fumigate, clean, dry, dehydrate, and store grains while remaining exempt. Holding also includes activities necessary for the distribution of that food, but does not include activities that transform an RAC into a processed food. 21 CFR 117.3; 21 CFR 507.3.
Sorting, culling, and grading RACs can be either a holding activity or a packing activity. Drying/dehydrating RACs is "holding" when it does not create a distinct commodity, but is manufacturing/processing when it creates a distinct commodity. Exempt facilities may "blend" RACs when the RACs are the same. For example, the FDA considers blending different lots of the same grain to meet a customer’s quality specifications to be a practical necessity for product distribution within the definition of holding. Such a facility would keep its exempt status. Mixing different types of RACs (corn and oats) likely would be considered manufacturing/processing and therefore such a facility would no longer be exempt. 80 FR 56191-56192.
Thus, in general, grain elevators engaged solely in holding grains will be exempt from most FSMA requirements. However, grain elevators may be subject to the FSMA Foreign Supplier Verification Program if they handle imported grain. This post should not be construed as legal advice; contact an attorney if you have questions about whether FSMA applies to your grain elevator.