**Disclaimer: The comments below are intended to try to explain the likely application of the bill and are not legal advice. The exact application of the Food Safety Modernization Act in practice will be significantly impacted by the FDA’s rulemaking process.**
Q: I sell grass-fed beef / grass-fed lamb/ pastured pork. Will I face new regulations under the Act?
A: No. The Act applies to FDA, not the USDA. Meats are regulated by USDA.
Q: I have a backyard garden where I grow food for myself and my family. Will I be regulated under this Act?
A: No. If you do not sell any food, you are not subject to the Act. [Note: FDA theoretically has power over even non-commercial activities, due to the Supreme Court’s decision in Wickard v Filburn. But this Act does not apply to that level.]
Q: I grow and sell fruits and vegetables. What new regulations will I face?
A: If you do not qualify for the Tester-Hagan amendment, you will be subject to the produce safety standards that FDA will develop. The proposed standards will have to go through the rulemaking processes, during which the public will have a chance to comment.
To determine if you qualify for the Tester-Hagan amendment, answer these questions:
1) Do you gross under $500,000 annually from the sale of food products? (the gross sales limit is averaged over three years, and will be adjusted for inflation)
2) If yes, do you sell more than half of your products to some combination of:
a. Individual consumers (regardless of where they are located);
b. Restaurants that are in the same state as your farm or within 275 miles of it; and/or
c. Retailers (such as co-ops, health food stores, and grocery stores) that are in the same state as your farm or within 275 miles of it.
i. Both the restaurants and the retailers must in turn sell directly to consumers. In other words, your farm is no more than one step removed from the consumer.
3) If you answered yes to both questions, you are exempt from the produce safety standards.
Q: I make value-added products such as jams, jellies, breads, cheeses, dried fruits, lacto-fermented vegetables. What new regulations will I face?
A: Answering this question requires a two-step process:
1) Do you sell more than half your products directly to individual consumers? The sale can occur either at the same location where you make the food or through a farmers market, farm stand, or CSA. If yes, then you are a “retail food establishment.” Retail food establishments do not have to register with the FDA nor are they subject to the new HACCP-type requirements. You still may face inspections by FDA if you engage in interstate commerce, as was the case even before the Act.
2) If you are not a retail food establishment, the next question is whether you are a “qualified facility.”
a. Do you gross under $500,000 annually from the sale of food products? (Note: the gross sales limit is averaged over three years, and will be adjusted for inflation)
b. If yes, do you sell more than half of your products to some combination of:
i. Individual consumers (regardless of where they are located);
ii. Restaurants that are in the same state as your farm or within 275 miles of it; and/or
iii. Retailers (such as co-ops, health food stores, and grocery stores) that are in the same state as your farm or within 275 miles of it.
(1) Again, both the restaurants and the retailers must in turn sell directly to consumers. In other words, your farm is no more than one step removed from the consumer.
c. If the answer to both questions is “yes,” then you are a “qualified facility.” You still must register with the FDA due to the requirements of the 2002 Bioterrorism Act. But instead of having to do a HARCP (see next), you may instead provide (1) documentation showing you meet the elements for a qualified facility; and (2) proof that you comply with applicable state and local laws. This could include such things as your commercial kitchen or food handlers’ license. If you choose, or if absolutely no local or state laws apply, then you must submit a simplified hazard analysis plan.
3) If you are neither a retail food establishment nor a qualified facility, you will have to comply with the FDA’s new regulations for Hazard Analysis and Risk Control Plans (HARCP). This requires you to develop a written analysis of known or reasonable hazards; identify and implement preventative control; establish alternative correct procedures; verify through documents, periodic monitoring and reanalysis; and keep records to document the monitoring, compliance, testing results, corrective action, efficacy. The HARCP is subject to FDA review and approval.
Q: What happens next?
A: First, Congress will have to decide how much money to appropriate for FDA to implement the Act. The estimate for full implementation is $1.4 billion, while some Congressmen are threatening to provide absolutely no funding. The final result will almost certainly be in between.
Second, FDA has to go through the rulemaking process to implement most of the provisions of the Act. The agency will provide notice of the proposed regulations in the Federal Register and the public will be able to submit comments. So keep an eye out for action alerts!