- Farms — If you are simply growing, harvesting, and selling produce without doing any processing (other than drying whole, uncut items), then you are NOT a facility and you do not need to register or file anything with FDA.
- Retail food establishments — If the main purpose of your business is to sell directly to individual consumers, you are a retail food establishment. Your primary function is judged by whether the majority of the monetary value of your sales (of all foods) are directly to consumers. For this definition, sales to businesses do not qualify as direct sales. Retail food establishments are NOT facilities and do not need to register or file anything with FDA.
- Qualified facilities — If you don’t fit within the definition of farm or retail food establishment, then you are a “facility.” All facilities must register with FDA and comply with current Good Manufacturing Practices (which have been incorporated into most states’ requirements for a food manufacturers’ license). If you gross less than $1 million annually in all food sales, however, you are a “qualified facility” and do NOT need to comply with the new Preventive Controls’ requirements under FSMA. You DO need to submit a sworn statement to FDA that you are a qualified facility.
Important Links for More Information
For more detailed guidance on the exemptions to both rules, check out the flow charts posted at www.FarmAndRanchFreedom.org/