After nearly a decade of congressional debates, regulatory wrangling, and implementation delays, the deadline for compliance of the Food Safety Modernization Act (FSMA) is now approaching. Thanks to organizations (like FTCLDF!) working for small farmers, artisan producers, and local food consumers, most small-scale producers are exempt from the bulk of the new regulations under FSMA. But exempt from the regulatory requirements does not mean you can ignore it. Producers need to confirm that they fit within the exemptions and take some steps in terms of record-keeping, signage, and possibly registering and filing statements with the Food and Drug Administration (FDA).
Please note: FSMA and the FDA use the terms “qualified farm” or “qualified facility” to describe those farms and businesses that fall within the exemption created by the Tester-Hagan amendment. A qualified farm or qualified facility (explained below) is effectively exempt from the bulk of the expensive, difficult requirements under the FSMA regulations—but, again, producers need to comply with certain paperwork requirements.
For Produce Growers
If you grow fruits, vegetables, nuts, or mushrooms, you need to look at the exemption for the Produce Safety Rule. In brief, you are a “qualified farm” if you sell less than $500,000 in food annually and more than half of your sales are to individual consumers, local restaurants, and local retailers (where local is defined as within the same state or within 275 miles of your farm).
If you are a qualified farm, you do NOT need to register with the government or submit any documents to support the exemption. You DO need to keep your own records in case the FDA or state agency investigates. You also need to post a sign at the point of sale, or provide an invoice, that includes your farm name and address. These record-keeping and signage requirements are already in effect.
For Anyone Who Processes, Manufactures, Holds, or Stores Food for Sale
(This includes farms that do any value-added products.) You are subject to the Hazard Analysis and Risk-Based Preventive Controls (HARPC) Rule unless exempt. There are three exemptions that, among them, cover the majority of our members:
1. 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.
2. 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.
3. 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.
The FDA’s latest action relates to the qualified facility exemption, for those who are neither farms nor retail food establishments, but still grossing less than $1 million annually. If you are a qualified facility, you have until December 17 of this year to register and file your statement. Starting October 1, facilities will be able to submit these attestation forms electronically at FDA Industry Systems via the Qualified Facility Attestation Module.
Note that there is also a Preventive Controls Rule for animal foods. The same three categories of exemptions apply: farms, retail food establishments, and qualified facilities. The cutoff for qualified facilities for businesses selling animal foods is $2.5 million in gross sales annually.
Important Links for More Information
For more detailed guidance on the exemptions to both rules, check out the flow charts posted at Farm and Ranch Freedom Alliance.
The gross sales cut-offs are all adjusted for inflation and based on your average sales over the past three years. FDA has the inflation-adjusted numbers posted HERE.
Instructions for submitting Qualified Facility Attestation (sworn statement for the exemption).
YOUR FUND AT WORK
Services provided by FTCLDF go beyond legal representation for members in court cases.
Educational and policy work also provide an avenue for FTCLDF to build grassroots activism to create the most favorable regulatory climate possible. In addition to advising on bill language, FTCLDF supports favorable legislation via action alerts and social media outreach.
You can help FTCLDF by becoming a member or donating today.