The FDA has submitted its budget funding request for FY 2013. That request includes $220 million in food facility registration fees. FDA would use the money to “increase its capacity to establish an integrated national food safety system and further strengthen food safety inspection.”
What’s a food facility? Unfortunately, it may include a family farm or a Mom-and-Pop food stand. As it stands now, it’s anybody the FDA thinks is involved with food.
original version of the Food Safety Modernization Act (FSMA). But that, after intense criticism from us and others, was struck from the final version that was signed into law in 2011. What this new budgetary request means is that FDA is trying to circumvent the law—and the clear intent of Congress, just as they did with the NDI guidance document.
Food fees can drive small producers out of business. That might make life easier for the FDA. Like other federal agencies, they may find it easier to work with a small number of giant companies. But with or without the fees, food facility inspections can also be a big deal.
The original version of the Food Safety bill mandated that every registered facility must be inspected by the FDA. We and others were able to exempt small farms with less than $500,000 in sales from these new federal inspection requirements—so long as the majority of sales are direct to consumers, restaurants, or grocery stores and those restaurants and stores are in the same state or within 275 miles of the farm. However, many small and organic farms make just a little over $500,000 per year or do not meet all these specifications, so they are not exempt.
Under the law, as passed, high-risk facilities will be inspected initially within the first five years and then every three years thereafter; low-risk facilities, initially within seven years, and then every five. The FDA would need to hire an additional 5,000 employees to do all the inspections. Big companies love this, because the FDA would be so bogged down inspecting all the smaller operations that they wouldn’t have time to focus on the big guys—where the actual food safety problems arise. Food safety legislation should be targeted at the large industrial farms, but, no surprise, the bill as passed did just the opposite.
Inspections are also an opportunity for FDA to go on fishing expeditions when they want to target a particular company or industry—they can be as finicky as they wish, citing harmless paperwork violations as huge offenses, for example.
While FDA has not said what specifically they would do with the $220 million in new registration fees they are trying to sneak into the federal budget, it is clear that they are trying to restore what was denied them by Congress in the final version of the Food Safety bill.
The agency has also implemented interim rules for administrative detention—rules that give FDA wider authority to detain foods, including supplements. This means that if FDA even suspects that a violation has occurred, they can detain a food or supplement company’s full stock for up to twenty days (with a possible ten-day extension if FDA wishes to initiate legal action), which might be enough to destroy smaller companies.
Why does this matter? Just ask the cherry growers, who were almost driven out of business for citing peer-reviewed scientific research about the anti-inflammatory properties of cherries!
This can now happen even where FDA only thinks a violation has occurred. Let’s say FDA finds third-party praise for a supplement’s therapeutic properties on a website related or linked to from the supplement company. Even though it’s a gray area, FDA may decide to pull a company’s products and make them battle in the courts for a decision on whether a third-party testimonial is a health claim attributable to the company.
After a bill is passed into law, it usually goes through a rulemaking phase, where an agency will flesh out how all the specific provisions in the bill will be implemented. That’s where the FSMA is now—the process of writing all the rules for the Food Safety Act is still in process. FDA delivered four proposed rules to the White House’s Office of Management and Budget (OMB) toward the end of 2011, but the rules have been “stuck in review” at OMB since then.
The Consumer Federation of America (CFA), a coalition of 300 nonprofit consumer organizations, has urged FDA to make public the proposed rules dealing with preventative controls for food, animal feed, produce safety and food imports.
FDA has invited comment from the public on many of the topics covered by the FSMA, but the agency has yet to submit those four proposed rules for public comment. We will keep a close watch on the proposed rules, and as we promised to keep you updated on the process, will let you know as soon as they are released and open for comments.
One of the things mandated by the FSMA was guidance on New Dietary Ingredients. As you know, their guidance document was a disaster, and ANH-USA has asked them to withdraw the guidance altogether and start over—as have a number of senators and congressional representatives.
Regular readers will recall our serious concerns with the FSMA. And then there was the controversial way the bill was passed in the first place—the bill was dead until the Senate resurrected it as an amendment to a completely unrelated bill. You can see the full timeline of FSMA-related battles here.