People inside and outside the Beltway had trouble keeping up with the many procedural turns taken by the FDA Food Safety Modernization Act. In the end, the bill was voted on twice by the Senate and three times by the House. President Obama signed it on January 4, 2011.
The final bill gives FDA mandatory recall power and directs the agency to inspect facilities at least every five years. Some have lauded these as important improvements, particularly in light of the complete lack of inspection of the Wright County egg facilities or the Peanut Corporation of America’s Texas plant. But the bill does not ensure that FDA will use that recall or inspection authority responsibly. It does nothing to address the revolving door between the agency and industry, epitomized by Michael Taylor’s current position as FDA’s food czar following his work for Monsanto. Nor does the bill address the underlying causes of most food-borne illness, namely the practices of the CAFOs and industrialized agriculture production and processing systems. These fundamental flaws make it far too likely that the bill will do little to actually improve food safety.
FREE REIN FOR FDA CAPRICIOUSNESS
Indeed, the bill increases FDA’s ability to act unfairly and arbitrarily by lowering the standard for “administrative detention,” whereby FDA can stop food from being moved or sold for a period of time. The previous standard required FDA to have “credible evidence” that the food posed a “threat of serious adverse health consequences.” Under the Act, FDA now merely requires “reason to believe” that the food is “adulterated or misbranded,” which could include such things as incorrect labeling. FDA already detains food on flimsy grounds, so this change may not make a major practical impact. But the Act’s new standard makes it easier for the agency to defend these detentions. In addition, the Act gives FDA the power to levy fees for such things as re-inspection of a facility, giving FDA new powers to harm facilities it doesn’t like simply by finding minor problems and requiring multiple re-inspections.
LARGE OPERATIONS FAVORED
The bill’s extensive new requirements for food producers, particularly the produce safety standards and hazard analysis plans (similar to HACCP), favor large-scale industrial producers over small-scale sustainable producers. Senator Tester of Montana fought for an amendment, co-sponsored by Senator Hagan of North Carolina, to exempt local food producers from these portions of the bill. In the final amended bill, producers who gross under half a million dollars (adjusted for inflation) and who sell more than half their products directly to individual consumers or to “qualified” retailers and restaurants are exempted from the produce safety standards and hazard analysis plans. “Qualified” retailers and restaurants are those that are either in-state or within two hundred seventy-five miles of the producer; there is no geographic limit on sales to individual consumers.
The Tester-Hagan amendment was essentially damage control. Given the overwhelming public pressure to pass a food safety bill, it was imperative to get an amendment to prevent the bill from crushing small local producers. Even with the amendment, the bill poses problems for the local foods movement. In addition to the lowered standard for administrative detention discussed above, the bill will impose extensive new regulations on medium-scale producers. But the amendment succeeded in carving out a sphere of protection for the most vulnerable, small-scale business, keeping them alive to fight the next fight.
PRECEDENT FOR SMALL, LOCAL PRODUCERS
The Tester-Hagan amendment also goes beyond damage control by setting an important precedent, namely that local food producers selling directly to consumers are different, and should be regulated differently, from the mainstream conventional food system. This should be an obvious concept, but it has never before been recognized by Congress. The importance of this precedent can be seen in Agribusiness’s reaction. Major industry organizations that had supported the food safety bill for over a year opposed the bill as soon as the Tester-Hagan amendment was included. These groups attempted to use every delay as an opening to strip the amendment back out, failing only because of the grassroots support for the amendment. The Agribusiness reaction complicates citizens’ ability to hold their Congressmen accountable. Some people have assumed that a “no” vote on the food safety bill means that their Congressperson was listening to the grassroots and opposed new FDA regulation. However, many members of Congress who voted against the final bill did so because they were listening to the Agribusiness interests. So take care and don’t assume that your Congressperson is an ally or an enemy based solely on whether he or she voted “yes” or “no” on the bill.
MORE WORK TO BE DONE
Agribusiness’s control of Congress and the agencies developed over the course of several decades, as more and more family farmers were lost to consolidation and consumers became more disconnected from the sources of their food. It will take a lot of time and work for the local foods movement to reverse this trend. In the coming year, Congress will be determining the FDA’s budget, while the FDA begins the rulemaking process to implement the food safety bill, and it is critical that the grassroots stay active and involved. We must take the principle recognized in the Tester-Hagan amendment and stated by Senator Tester—that our farmers are growing food, not commodities—and build on it to recapture control of Congress and the agencies.
FREQUENTLY ASKED QUESTIONS
Disclaimer: The comments below are my interpretation of the likely application of the bill and are NOT intended as legal advice. The application of the 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 whether you qualify for the Tester-Hagan amendment, answer these questions:
1. 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.)
2. And 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 two hundred seventy-five 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 two hundred seventy-five miles of it. Note: both the restaurants and the retailers must in turn sell directly to consumers. In other words, to be a qualifying sale, your farm must be no more than one step removed from the consumer.
3. If the answer to both questions is “yes,” you are exempt from the produce safety standards.
Q: I make value-added products such as jams, jellies, breads, cheeses, dried fruits, lactofermented vegetables. What new regulations will I face?
A: Unless you are a “retail food establishment” or a “qualified facility” (see next paragraph), 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, and efficacy.
The HARCP is subject to FDA review and approval. If you are a retail food establishment or a qualified facility, then you will be exempt from the new HARCP requirements. Here’s how those categories are determined:
1. Do you sell more than half of your products directly to individual consumers (not businesses)? 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 HARCP-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. And 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 two hundred seventy-five 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 two hundred seventy-five miles of it. Note: both the restaurants and the retailers must in turn sell directly to consumers. In other words, to be a qualified sale, your facility must be 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, 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 handler’s license. If you choose, or if absolutely no local or state laws apply, then you must submit a simplified hazard analysis plan.
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 members of Congress are threatening to provide absolutely no funding. The final result will almost certainly be something in between.
Second, FDA has to go through the rulemaking process to implement most of the provisions of the Act. Since the agency was already working on produce safety standards, those are likely to be proposed relatively quickly. The majority of the other regulations are supposed to be proposed within eighteen months. 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!
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Spring 2011.